Lipid management is very important for preventing and treating atherosclerotic cardiovascular disease (ASCVD) and improving prognosis.To better guide clinical practice,the Chinese Guidelines for Lipid Management (2023),which is based on the Chinese Guidelines for the Prevention and Treatment of Dyslipidemia in Adults (2016 Revision) with new evidence and clinical status both in China and abroad,provides guidance on lipid management throughout the life cycle from childhood to old age,including adjusting,expanding and improving lipid testing items,lipid screening frequency,ASCVD risk assessment,lipid-lowering targets for specific populations,treatment principles and drug treatment plans. This study is to review the updates of pharmacologic therapy in the guideline.
Targeted drugs play a milestone role in treating gastrointestinal stromal tumors (GIST),which not only significantly prolongs the survival rate of patients but is also expected to move GIST into the category of “chronic disease” gradually.However,targeted drugs are administered at fixed doses with large individual inter-and intra-variabilities in pharmacokinetics.Some patients may experience drug resistance or disease progression,while others may experience serious adverse reactions.Recent studies have shown that the pharmacokinetics of targeted therapy drugs are significantly correlated with clinical efficacy and/or adverse reactions,suggesting that therapeutic drug monitoring (TDM) can be a strategy to realize individualized therapy.The Hospital Pharmacy Committee of the Chinese Pharmaceutical Association and the Division of Therapeutic Drug Monitoring,Chinese Pharmacological Society have formulated and published the Chinese Expert Consensus on Therapeutic Drug Monitoring of Targeted Drugs for Gastrointestinal Stromal Tumors in 2021.The consensus made specific analysis and recommendations on five aspects,including the necessity,target population,technical methods,interpretation of results,and individualized dose adjustment of TDM for GIST-targeted drug therapy.Based on the consensus content and the latest research progress at home and abroad,this paper conducted specific demonstration and analysis of the consensus content,in order to deepen the knowledge and understanding of clinicians and pharmacists on TDM of GIST-targeted drugs to promote the individualized therapy of GIST targeted drugs.
Objective To study the acute toxicity,anti-inflammatory and analgesic effects and preliminary pharmacodynamics of compound bailian enema and gel to provide consideration for clinically safe drug use. Methods Mice were given the maximum concentration of enema twice within 24 hours,rats were given the equivalent concentration of enema for seven days,and the toxicity and death were observed,respectively;the mouse model of xylene-induced ear swelling and glacial acetic acid-induced writhing were established.Model,environmental factors plus trinitrobenzene sulfonic acid (TNBS)/ethanol method induced ulcerative colitis (UC) model was established in rats,respectively,to observe the pharmacodynamic effects of compound bailian enema and gel was observed on those models. Results The maximum dose of compound bailian preparation for enema was 161.6 g of crude drug·kg-1,equivalent to 96 times the daily dose of human beings;Compound baitian enema and gel at high,medium,and low doses can significantly reduce the ear swelling rate of mice,reduce the times of body twisting,improve the pathological damage of colon tissue in rats with damp heat UC model and reduce TNF- α、IL-6、IL-1 β activity (P<0.05). Conclusion The clinical doses of the compound bailian enema and gel are safe and no irritating effect to the rectal mucosa and have certain anti-inflammatory,analgesic,and therapeutic effects on UC rats.
Objective This study focused on the blood-entering components as the research object,the efficacy and mechanism of Danggui shaoyao powder in treating primary dysmenorrhea were investigated by network pharmacology and animal experiments. Methods Gene Cards and OMIM databases were used to screen the primary dysmenorrhea targets docking with the blood components.The R language was used to obtain key targets,and the protein-protein interaction network was constructed.The GO and KEGG pathways were enriched for the selected targets.Molecular docking was performed using AutoDock Vina 1.2.3 software to verify the effectiveness of Danggui shaoyao powder from the perspective of behavior and histopathology by the intervention of Danggui shaoyao powder in primary dysmenorrhea model rats. Results A total of 12 blood components were screened,which acted on core targets such as TNF,IL6,VEGFA,and PTGS2,and were mainly involved in signaling pathways such as IL-17,TNF,and arachidonic acid metabolism.Molecular docking showed that the three active components,Z-butenylphthalolide,ligustrolide I,and paeonifloridin had strong binding ability to the target protein.Animal experiments showed that the writhing response of primary dysmenorrhea rats was significantly increased (P<0.05),severe endometrial exfoliation and edema were observed;Danggui shaoyao powder can effectively reduce the number of twisting (P<0.05),reduce endometrial exfoliation and edema. Conclusion Danggui shaoyao powder has the effect of treating primary dysmenorrhea mainly through central analgesia,regulating hormone effect,and inhibiting uterine inflammatory reaction,and other pharmacological effects,which provides a reference for subsequent research.
Objective To evaluate the effect of matrine on the resistance of carbapenem-resistant Klebsiella Pneumoniae to tigecycline mediated by the efflux pump AcrAB-TolC and explore the related regulatory mechanism of its reversal of drug resistance. Methods The Checkerboard dilution method is used.Negative control,positive control,tigecycline group,matrine group,and combination group were respectively set up.After 24 hours of culture,the absorbance was measured by ELISA,and the minimum inhibitory concentration (MIC),inhibitory rate,and partial inhibitory concentration index (FIC) of each drug group were recorded.Corresponding Wells and positive control Wells of MIC in each drug group were taken,and the expressions of AcrB,MarA,RamA and AcrR,regμlatory genes of AcrAB-TolC efferent pump system,were detected by real-time fluorescence quantitative PCR. Results Compared with tigecycline or matrine alone,tigecycline combined with matrine significantly inhibited the growth of carbapenems-resistant Klebsiella Pneumoniae induced by AcrAB-TolC efferent pump system (P<0.05).The pharmacological effects of tigecycline and matrine were mainly synergic or additive. In combination,MIC values of tigecycline and matrine were significantly decreased,and MIC values of tigecycline recovered to tigecycline-sensitive MIC values.After the incubation with matrine alone or in combination,the expression of RamA and AcrB of the AcrAB-TolC efferent pump was significantly decreased (P<0.05),and the expression of AcrR gene was significantly increased (P<0.05). Conclusion Matrine can down-regulate the expression of AcrAB-TolC efferent pump regulatory proteins RamA and AcrB and up-regulate the expression of AcrR in carbapenem-resistant Klebsiella Pneumoniae,which can reverse tigecycline resistance.
Objective By analyzing the evolution of China's national pharmaceutical packaging material standards,the significance of pharmaceutical packaging material standards in ensuring drug safety,effectiveness,and accessibility is summarized,providing a reference for constructing the national pharmaceutical packaging material standard system. Methods Through reviewing the development process of national pharmaceutical packaging standards in China's pharmaceutical industry at different stages and under different regulatory models,the experience and shortcomings of establishing a national pharmaceutical packaging standard system in China were summarized. Results The national pharmaceutical packaging materials standard system in China has been closely followed by the development and regulatory needs of the pharmaceutical industry,continuously enhancing its connotation and sublimated its concept;The national pharmaceutical packaging material standard is an important guarantee for promoting the high-quality development of the pharmaceutical packaging material industry.The standard system of pharmaceutical packaging materials can effectively improve the quality of pharmaceutical packaging materials and ensure the safety,effectiveness,and accessibility of drugs only if it follows the changes of the new situation and constantly improves itself. Conclusion Drawing on the development trend of domestic and foreign pharmaceutical packaging materials and related field standard systems,establishing risk management concepts and full process management concepts based on ensuring drug safety and effectiveness,and accelerating the construction of a scientific,advanced,practical,and standardized national pharmaceutical packaging material standard system is an important task in the construction of Chinaese national pharmaceutical packaging material standard system.
Objective To analyze the current situation of studied group standards of Chinese pharmaceutical packaging (GSCPP) to further improve the Chinese pharmaceutical packaging materials standards system. Methods From the perspective of time and region,we compared Chinese group standards with those of developed countries.We also overviewed the history of Chinese group standards and GSCPP was also sorted out. Results With the development of Chinese standards,group standards have become regulated and have their own laws.The advanced group standards have also attracted more sectors to engage in programs about standardization.By March 31,2023,the number of Chinese group standards has reached 54,908.Similarly,with the development of Chinese pharmaceutical packaging materials standards,GSCPP was also improved.There is a mature procedure for group standardization,and the concept of standardization is also advanced.GSCPP is improving,covering an increasing number of packaging.By March 2023,the number of GSCPPs has reached 21. Conclusion GSCPP is well developed and has become an indispensable part of the Chinese pharmaceutical packaging materials standards system.They will play an important role in rebuilding the standards system.They will also promote the development of the pharma industry.In the future,GSCPP need to continue to maintain their own healthy development,further deep integration with national standards,strengthen international cooperation to improve international influence,and promote the high-quality development of the industry through the optimization of the group standards system for pharmaceutical packaging materials.
Objective To improve the construction of Chinese pharmaceutical packaging materials standards and standard systems to meet the industry development and regulatory requirements under the new situation. Methods The overview of the general situation of regulations and standard systems of food packaging materials at home and abroad was introduced,and the construction of food packaging and pharmaceutical packaging materials standards in China and abroad were compared. Results Learning from the advanced concepts and experiences of the food packaging standard system,composed of additive list standards,original material product standards,and testing method standards.Suggestions and strategies were proposed to improve Chinese pharmaceutical packaging material's standards and standards system. Conclusion Accelerating the construction of the standard system for Chinese pharmaceutical packaging materials is conducive to the industry's high-quality development and promoting the construction of a healthy China.
Objective To analyze the situation of standards by the American Society for Testing and Materials(ASTM) to provide a reference and guidance for establishment and improvement of the system of group standards for pharmaceutical packaging in China. Methods This paper uses literature research and case studies to analyze and outline the ASTM standards system through literature and case studies.Focusing on its working principles and characteristics,standards classification,and the citation of ASTM standards by other U.S standards,trying to sort out the situation and characteristics of standards related to pharmaceutical packaging. Results ASTM standards have a large of numbers and wide range of specialties. It is a typical market driven standard which has strong technical authority. ASTM standards not only have been adopted by global industries, but also many standards have been adopted in law and regulation as mandatory standards. Conclusion ASTM standards are the model of group standards.Although there are only a few standards related to pharmaceutical packaging,the development process and standardization characteristics have important reference significance for the development of group standards for pharmaceutical packaging products in China.
Propranolol,as a non-selective,lipophilic beta-adrenergic receptor blocker,is mainly used for treating hypertension,arrhythmia,and anxiety,and has become the first-line drug for infantile hemangioma in clinical practice.A large amount of clinical data has shown that propranolol for the treatment of infancy hemangioma shows some individual differences in efficacy and adverse effects.The differences may be related to receptor variation,drug metabolism,and other reasons.In addition,a growing number of preclinical and clinical studies suggest that propranolol can also be used to treat other different types of tumors.In this review,we focus on summarizing studies on the precision pharmacy of propranolol for antitumor therapy and discuss the bottlenecks in its current use for cancer treatment,which help to shed light on the repurposing of propranolol.
Objective To investigate the perceptions of pharmacists and nursing staff on anti-tumor biological agents and explore the pharmaceutical needs and influencing factors of cognition of nursing staff,to provide a reference for the rational use of anti-tumor biological agents and pharmaceutical services. Methods A questionnaire was conducted to investigate the cognitive status of six biological agents,including cetuximab,bevacizumab,trastuzumab,rituximab,sintilimab,and camrelizumab,and the pharmaceutical needs of nursing staff,including basic information,drug knowledge,drug configuration and clinical infusion cognition,and the pharmaceutical needs of nursing staff. Results ①495 staff (112 pharmacists and 383 nurses) from 35 hospitals in 14 provinces and cities were investigated;②The drug admixture locations are mainly in both the ward and pharmacy intravenous admixture services (51.43%),or only in the ward (42.86%),62.86% of which are admixtured in the biosafety cabinets,and 80% of which are protected according to the standard for admixturing cytotoxic drugs,and 24 hospitals have launched mobile nursing systems;③Except for bevacizumab,the cognition of nursing staff on the indications of six drugs was higher than that of pharmacists.Among them,the cognitive differences of cetuximab,trastuzumab,sintilimab and camrelizumab were statistically significant (P<0.05),while the cognitive differences of rituximab were not statistically significant (P>0.05);nurses' cognition of the usage and dosage of the six drugs was significantly higher than that of pharmacists (P<0.05);④Drug admixture and infusion: the cognition of nursing staff on the visual examination of the liquid/powder before admixture was higher than that of pharmacists,among which the cognition of cetuximab was statistically different (P<0.05);with the exception of bevacizumab,the cognition of nursing staff to gently flip mixing was higher than that of pharmacists,but there was no statistical difference (P>0.05);nursing staff have higher cognition of the final concentration requirements of cetuximab and rituximab than pharmacists,and the cognition of the final concentration requirements of bevacizumab and sintilimab is lower than that of pharmacists;nurses' cognition of storage requirements of prepared solution is higher than that of pharmacists,with no statistical difference;more than 83.95% of nursing staff knew the requirements of drug infusion;⑤The hospital level and whether there is mobile nursing system,the conditions and locations of drug allocation,the gender of nursing staff,knowledge of drugs and training times all affect the cognition of nursing staff;⑥More than 76.50% of nursing staff have different pharmaceutical needs. Conclusion The general cognition level of pharmacists and nursing staff on anti-tumor biological agents is general,and the cognition level of nursing staff on drugs is generally higher than that of pharmacists;There are many factors influencing the cognition of nursing staff;Nursing staff have a higher pharmaceutical need.
Objective To construct the Internet+ intelligent pharmaceutical care pathway management model in the Pharmacist-managed cough and wheeze clinic of pulmonary and critical care medicine (PCCM) and evaluate its work result. Methods A total of 300 patients with asthma and COPD diagnosed in the outpatient clinic of PCCM in the First Affiliated Hospital of Soochow University from September 2020 to March 2021 were selected, and randomly divided into a control group and intervention group with 150 cases in each group.The control group received routine pharmacy services;The intervention group was included in the Internet+ intelligent pharmaceutical care pathway management in the pharmacist-managed cough and wheeze clinic of PCCM,including patient information filing and consultation,pharmacy evaluation,pharmacy intervention(human intervention and intelligent intervention),medication education,patient follow-up,Internet+ pharmaceutical care.The study period was six months.The scores of inhalation device usage,medication compliance (MMAS-8),and clinical effective control rate were compared between the two groups in the third and sixth months after enrollment.After six months of enrollment,the number of acute attacks/exacerbations,incidence of adverse drug reactions,satisfaction with pharmacy services,and willingness to pay for the pharmaceutical care in the pharmacy clinic were compared between the two groups. Results At the third and sixth months after enrollment,the inhalation device usage score,and MMAS-8 score of the intervention group were significantly higher than those at the time of enrollment and the control group during the same period (P<0.05);The clinically effective control rate was significantly higher than the control group during the same period (P<0.05).After six months of enrollment,the number of acute attacks/exacerbations in the intervention group was significantly less than those at the time of enrollment,and in the control group during the same period (P<0.05),the incidence of adverse reactions was reduced by 9.87%,the satisfaction of the work quality and the patient experience were 91.83%,96.64%,and the proportion of patients willing to pay was 67.12%. Conclusion The Internet+ intelligent pharmaceutical care pathway management in the pharmacist-managed cough and wheeze clinic of PCCM could provide effective,safe,and professional pharmaceutical care for the patients,which is a beneficial exploration to develop high-quality pharmaceutical care in a standardized and homogeneous manner.
Objective To understand the status quo of patients' cognition of pharmacy outpatient clinics in medical institutions,to explore patients' needs for pharmacy outpatient clinics,and to provide a reference for medical institutions to standardize and optimize the pharmaceutical care in pharmacy outpatient clinics. Methods The patients who voluntarily answered the self-designed questionnaires were selected as the research objects at 14 medical institutions in Suzhou city.The survey contents included: basic patient demographic information,awareness of pharmacy outpatient clinics,evaluation of pharmaceutical care,and demand.Analysis was carried out of influencing factors on the cognitive status of the pharmacy outpatient clinics.The patient's evaluation and willingness to pay for the pharmacy outpatient clinics were subjected to a single-sample T-test.Multi-response analysis was performed on demand for pharmaceutical care. Results ①In this survey,1853 questionnaires were distributed,and 1769 valid questionnaires were recovered.A total of 557 outpatients were aware of pharmacy outpatient clinics,and the awareness rate was 31.48%;②The main factors affecting the awareness rate of pharmacy outpatient clinics were age,occupation,education level,family members or friends with or without a medical background,and the level of the hospital(P<0.05);③The patients who knew the pharmacy outpatient clinics had a positive evaluation on the pharmaceutical care,57.60% of patients were willing to register and pay;④Patients had the highest demand for the pharmacist in terms of "guiding patients to take medication (71.45%),have comprehensive pharmacy knowledge (78.04%),chronic disease drugs,such as diabetes drugs (61.11%)".Most of the patients expected that the pharmacy outpatient clinics should be carried out by pharmacists with intermediate professional titles or above (52.49%),and should be carried out in the form of a "physician-pharmacist joint clinic (39.78%)". Conclusion Medical institutions at all levels should actively carry out pharmacy outpatient clinics,further strengthen publicity and guidance,improve the quality of pharmaceutical care in combination with clinical needs,and promote the sustainable and high-quality development of pharmacy outpatient clinics.
Objective To investigate the efficacy of adequate prednisone combined with cyclophosphamide in the treatment of IgAN,and analyze its influencing factors. Methods Review 33 patients who were diagnosed with IgAN by renal biopsy and were treated with sufficient prednisone combined with cyclophosphamide intravenous pulse therapy in the nephrology department of our hospital from January 2018 to January 2020 were collected,and the efficacy and factors affecting the efficacy were analyzed. Results After treatment,33 patients had complete remission in 10 cases (30.30%),partial remission in 11 cases (33.33%),no remission in 12 cases (32.36%),and total remission in 21 cases (63.64%).The age,24-hour urine protein quantification,and Lee's grade in the remission group were lower than in the non-remission group (P<0.05).After grouping according to Oxford classification,compare the remission rate of each group were compared: glomerular capillary endothelial cell hyperplasia (E) 1 group>E0 group (P<0.05);renal tubular atrophy and/or renal interstitial fibrosis (T) 2 groups<T0 group and T1 group (P<0.05),T1 group<T0 group (P<0.05);crescent(C) 2 groups<C0 group and C1 group (P<0.05);there was no significant difference in remission rate between C1 group and C0 groups. Conclusion Adequate prednisone dose combined with cyclophosphamide therapy has a significant effect on IgAN;the older the age,the higher the 24-hour urine protein level,the more severe the renal tubular atrophy and/or the renal interstitial fibrosis,the more crescents,and the lower the remission rate;E1 and C1 have a good response to adequate doses of prednisone combined with cyclophosphamide intravenous pulse therapy.
As a neurodegenerative disease,Parkinson's disease (PD) is hard to be cured.There are even no good methods to prevent its progression.Therapeutic durgs for PD are limited and only used for symptomatic control.Dopaminergic system is the major target for anti-PD drugs (such as dopamine precursor drug levodopa,dopamine receptor agonists,and dopamine metabolizing enzyme inhibitors),but side effects or complications may accompany the treatment.Due to the large population of PD patients,many pharmaceutical companies and researchers have invested a lot of efforts in developing new drugs for PD in order to develop more therapeutic and effective drugs,and certain results have been achieved.In order to help related professionals fully understand the current status and future of PD treatment and the development direction of anti-PD new drugs,this paper summarizes the characteristics,efficacy and safety of various PD therapeutic drugs,and reviews new anti-PD drugs in clinical trials in recent years.
In recent years,with the widespread clinical use of tigecycline (TGC),TGC-associated liver injury (TALI) has gradually attracted the attention of scholars.Studies have shown that TALI mostly occurred 4-12 days after treatment,and cholestatic liver injury was the dominant type.High-dose TGC,long-term treatment,liver injury at onset,and severity of the primary disease may increase the risk of TALI.The mechanism of liver injury may be related to the fact that TGC was mainly excreted through the biliary tract,hepatocyte oxidative stress or apoptosis induced by TGC,and alteration of intestinal flora.Clinicians should fully consider relevant risk factors of TALI and closely monitor the liver function during TGC treatment for timely detection and management of TALI.
Objective To develop a national CRM for the chemical purity of caffeic acid with accurate quantity and uncertainty. Methods According to the technical specifications and relevant technical requirements for the development of first-class reference materials in China,the chemical purity reference materials of caffeic acid were prepared,and the homogeneity,short-term and long-term stability were tested by high-performance liquid chromatography (HPLC);two methods with different principles,mass balance method and coulometric titration,were used for the value determination and uncertainty evaluation of caffeic acid chemical purity reference materials. Results The developed chemical purity reference material of caffeic acid met the requirements of the technical specifications for certified reference standards in China.The standard value and uncertainty evaluation were 99.5%±0.7% (k=2,P=0.95). Conclusion The caffeic acid chemical purity reference material developed in this paper has the characteristics of accurate quantity and traceability.It has been approved as a national first-class certified reference material,providing effective reference materials and material standards for the quality control of Chinese herbal medicine,proprietary Chinese medicine and other related drugs in China.
Objective To study the chemical composition of Rubus ellipticus Smith.var obcordatus (Franch.) Focke and to determine its content. Methods The separation and purification of Rubus ellipticus Smith.var obcordatus (Franch.) Focke was performed by column chromatography,and its structure was identified based on the spectral data,and the content of each component was determined by high performance liquid chromatography (HPLC). Results Six triterpenoid monomers were isolated and identified as euscaphic acid (1),kaji-ichigoside F1 (2),niga-ichigoside F1 (3),rotundic acid-28-O-β-D-glucopyranosyl ester (4),rosamultin (5),2α,3β,23-trihydroxyurs-12,18-dien-28-oic acid 28-O-β-D-glucopyranoside (6).The established HPLC chromatographic conditions were gradient elution with acetonitrile-0.1% phosphoric acid solution as the mobile phase,detection wavelength of 203 nm,and column temperature 25 ℃. Conclusion Compound 4 was first isolated from Rubus ellipticus Smith.var obcordatus (Franch.) Focke;the established method for the simultaneous determination of five components was stable and reliable,and euscaphic acid,kaji-ichigoside F1 and niga-ichigoside F1 were high as the key contents,which can be considered as quality control indicators for Rubus ellipticus Smith.var obcordatus (Franch.) Focke.The study provides a basis for its resource utilization.
Objective To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for imultaneous determining of 25 inorganic elements in Quisqualis Fructus from 24 origins,and the quality of Quisqualis Fructus was evaluated by fingerprints、chemometrics,and risk assessment models. Methods Microwave digestion was used to digest the Herbs,and the elements were determined by internal standard method in “He” mode.The fingerprints of the contents of 25 inorganic elements in Quisqualis Fructus from different origins were established and analyzed by chemometrics,and the contents of heavy metals,and harmful elements were evaluated according to the health risk assessment model. Results The linear correlation coefficients of the 25 inorganic elements were r≥0.999 4,and the detection limits were 0.000 3~3.377 0 μg·L-1,the precision,stability,and reproducibility were good,the average recoveries were in the range of 85.49%~116.84%,with the RSDs were less than 10%.All batches of Quisqualis Fructus contain similar inorganic element profiles,and the cluster analysis could be roughly divided into two categories,the Quisqualis Fructus of Chongqing and the Quisqualis Fructus from Sichuan,Yunnan,Guangxi,Fujian,and Jiangxi.The principal component analysis showed that Na,Mg,Al,K,Ca,V,Fe,Co,Ga,Se,Ag,Hg and TI were the characteristic inorganic elements of Quisqualis Fructus from various origins,and the health risk assessment results indicated that there was no apparent health risk. Conclusion The inductively coupled plasma mass spectrometry method is fast,accurate,and sensitive.it can comprehensively evaluate the inorganic elements in Quisqualis Fructus combined with fingerprints、chemometrics,and health risk assessment model.
Objective To explore the independent risk factors for the application of infliximab (IFX) for secondary loss of response treated with infliximab in patients with Crohn's disease in southern Anhui. Methods Patients with Crohn's disease in southern Anhui who were admitted and treated with IFX in the Department of Gastroenterology of Yijishan Hospital of the first affiliated Hospital of Southern Anhui Medical College from January 2018 to April 2021 were analyzed.According to the clinical response of IFX,the patients were divided into a continuous response group and a secondary loss of response group.The differences in clinical data,such as TNF-α-308 gene polymorphism,were analyzed,the independent risk factors of secondary failure treated with IFX were screened,and its diagnostic efficacy was evaluated. Results The incidence of secondary loss of response in 70 patients with Crohn's disease was 28.6%.The proportion of patients with previous perianal lesions and the history of perianal surgery and the level of CRP before the fourth infliximab treatment in the secondary loss of response group were higher than those in the continuous response group(P<0.05).There was no significant correlation between the TNF-α-308 gene polymorphism groups(P>0.05).Previous perianal lesions [(P=0.009,OR=15.633,95%CI=(1.959,123.740)] and CRP levels prior to 4th IFX treatment [(P=0.010,OR=1.055,95%CI=(1.013,1.099)] as independent risk factors for secondary loss of response to infliximab treatment,the diagnostic efficacy of the combination of two variables in predicting a secondary loss of response of infliximab in the treatment of infliximab is better than that of a single variable. Conclusion More Clinical attention should be paid to the patients with Crohn's disease with CRP more than 3.89 mg·L-1 before the fourth IFX treatment and previous perianal lesions and their clinical response should be closely monitorede.TNF-α-308 gene polymorphism can not be used to predict therapeutic response to infliximab in patients with Crohn's disease in southern Anhui.
Objective To investigate whether the conventional dosage regimen of meropenem (1 g,q8h,ivgtt for 0.5 h) can achieve the acceptable probability of target attainment (PTA) in patients with hematological malignancies and to screen the covariates affecting pharmacokinetics (PK) parameters of meropenem to establish a population pharmacokinetic (PPK) model then provide theoretic supports for the rational administration of meropenem in patients with hematological malignancies. Methods Twenty-nine patients who were diagnosed with hematological malignancies and received the conventional dosage regimen of meropenem for empirical antibacterial therapy from December 2020 to June 2021 were enrolled.Blood concentrations of meropenem were collected at three-time points after administration in patients.Based on these sparse sampling data,the PK basic model is constructed by a non-linear mixed effect method with Phoenix 64 software.The PTA in different PK/PD targets was calculated according to the concentration-time curve simulated by the PK basic model.Stepwise regression was used to screen the covariates affecting the PK parameters of meropenem,and the final PPK model was constructed by and validated. Results Only when the minimum inhibitory concentration (MIC) of meropenem to pathogens is ≤ 1 μg·mL-1 and the preset PK/PD target is 40%fT >MIC,the PTA could reach >90%.Covariates screening showed that serum albumin level affects the PK parameters of meropenem,and the final PPK model is adequate after the inclusion of the covariate. Conclusion Experiential treatment with a conventional dosage regimen of meropenem cannot obtain satisfactory effects in patients with hematological malignancies,and it is necessary to consider increasing the dose or extending the infusion time of meropenem.The final PPK model of meropenem constructed in this study has a high correlativity,fine stability,and precise predictability,which can be used to assist physicians in developing individualized regimens for patients.
Objective To investigate the cost-effectiveness of paricalcitol and calcitriol in treating secondary hyperparathyroidism (SHPT) in hemodialysis CKD-MBD patients. Methods By cost-effectiveness analysis,patients were divided into the paricalcitol treatment group and the calcitriol control group,both groups could be treated with cinacalcet,and the effect index was the compliance rate of patients in the two groups.Included in direct medical costs are the cost of medication and periodic examinations.Using Incremental Cost-Effective Ratio (ICER) as a decision-making index,a single-factor sensitivity analysis was performed on efficacy and drug prices,and a probabilistic sensitivity analysis was performed on parameter random sampling by Monte Carlo simulation. Results The effective rates of the two groups were 88.7% (paricalcitol group) and 56.5% (calcitriol group).The cost-effectiveness analysis showed that compared with calcitriol,the ICER value of paricalcitol in treating SHPT was 41 554.702 yuan (less than one times China's per capita GDP).Univariate sensitivity analysis showed that the effective rate of paricalcitol was the most influential factor on ICER value.The results of probabilistic sensitivity analysis showed that when the willingness to pay (WTP) was greater than 32,500 yuan,paricalcitol had more cost-effectiveness advantages. Conclusion Compared with calcitriol,paricalcitol's clinical efficacy in treating SHPT is obvious.According to the WHO standard of doubling China's per capita GDP,paricalcitol has a cost-effectiveness advantage.
Objective To investigate the relationship between PAI-1 4G/5G gene polymorphisms and venous thromboembolism (VTE) in tumor patients and to provide reference for early identification of high-risk groups of VTE and prevention of VTE. Methods ① Comparison of genetic differences: malignant tumors patients were enrolled by His system of our hospital and divided into a venous thromboembolism group (30 cases) and a non-venous thromboembolism control group (118 cases) according to whether VTE occurred or not. PAI-1 4G/5G gene screening was performed on both groups of patients, and the differences in gene distribution frequency and Hardy-Weinberg genetic balance test were compared between the two groups. ② Gene intervention study:malignant tumor patients without VTE were randomly divided into the gene guidance group (n=30) and the non-gene guidance group (n=30) by a single-blind randomized number table method. The gene guidance group took VTE preventive measures according to the results of gene testing, while the non-gene guidance group did not take VTE preventive measures without gene screening. The number and incidence of venous thromboembolism events were compared between the two groups. Results The gene distribution frequency of the VTE group and the non-venous thromboembolism control group was statistically different (P<0.05) and all were in consistent with Hardy-Weinberg genetic balance;The number of venous thromboembolism events in the gene guidance group was 0, and that in the non-gene guidance group was 4 (13.33%), the difference was statistically significant (P<0.05). Conclusion The 4G/5G polymorphism of PAI-1 gene can be used as a risk-discriminating factor for VTE in tumor patients, and at the same time, it can provide certain guidance for early identification of high-risk groups of VTE and intervention measures.
Objective To detect thromboembolic adverse drug reaction (ADR) signals of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors,using the U.S.FDA Adverse Event Reporting System (FAERS) database,and to provide a reference for the safe and rational medication. Methods The reporting odds ratio (ROR) and the Combined Criteria Method (medicines and healthcare products regulatory agency method,MHRA) were used to mine ADR signals of CDK4/6 inhibitors from the first quarter of 2019 to the third quarter of 2021 in FAERS database. Results Six hundred and twenty-seven reports of thrombotic events related to CDK4/6 inhibitors were mined,and seven types of thrombotic adverse events formed signals,involving two systems: "vascular diseases" and "Respiratory,thoracic and mediastinal diseases",thrombosis and pulmonary embolism were the most reported cases of the seven adverse events,and they also caused the highest proportion of death and life-threatening outcomes. Conclusion The current study supports the concern about the risk of thromboembolic adverse events in breast cancer patients using CDK4/6 inhibitors.Clinicians must fully assess the risk factors for thrombosis (including age,obesity,and past history of thrombosis and other factors),before using CDK4/6 inhibitors,and alert patients to pay attention to clinical symptoms related to thrombosis and seek prompt medical attention if identified.
Objective To promote the safe and rational use of drugs by the elderly and better carry out community pharmacy services for the elderly,the current situation of the elderly in Guiyang receiving community pharmacy services and thetheir needs for community pharmacy services,provides a scientific basis for the development of community pharmacy services for the elderly in Guizhou Province. Methods The questionnaire survey method was used to understand the awareness,medication,satisfaction and demand of the elderly in Guiyang on community pharmacy services,820 formal questionnaires were distributed,and 755 valid questionnaires were recovered,with an effective recovery rate of 92.07%. Results The awareness rate of the elderly group in Guiyang for pharmacists was 72.85%,while the awareness rate of community pharmacy services was 74.30%.The average score of drug perception awareness was 3.21 points (out of 6 points),the average overall satisfaction with community pharmacy services was 2.84 points (out of 5 points),and 71.79% of the respondents expected community health service centers to provide drug consultation. Conclusion The demand for community pharmacy services among the elderly in Guiyang is high and the level of community pharmacy services needs to be further optimized.Community pharmacy services should be further improved by strengthening the quality and ability training of pharmacists,constructing community pharmacist talent teams,improving patient satisfaction and trust,and vigorously carrying out health education activities to publicize rational drug use knowledge and correct drug use concepts to meet the needs of pharmaceutical services for the elderly in Guiyang.
Objective To investigate the current status of clinical use and cognition of fentanyl transdermal patches among medical staff in China and the related influencing factors,and provide a basis for promoting the standardized treatment of cancer pain. Methods A total of 500 medical staff that deal with cancer pain in work were selected using whole group sampling method.A questionnaire survey was conducted on the basic information of medical staff,clinical use of fentanyl transdermal patch,and relevant cognition level about medication use,and chi-square test and binary logistic regression were used for statistical analysis. Results A total of 500 valid questionnaires were obtained,among which doctors accounted for the majority (80.8%),59.4% of the medical staff were from Grade-A tertiary hospitals.The dosage of fentanyl transdermal patches is much lower than that of oxycodone sustained-release tablets and morphine sustained-release tablets,and its common specification is 4.125 mg per patch. About 88.2% of the respondents had received training in the standardized treatment of cancer pain,but only 56% had a high level of cognition about the fentanyl transdermal patch.There were statistically significant differences in the knowledge of fentanyl transdermal patches among medical staff regarding working years,local area,and whether they often used cancer pain assessment tools (P<0.001 or P<0.05).Further regression analysis found that the region where medical staff worked and whether they often used cancer pain assessment tools influenced their cognition of fentanyl transdermal patch use. Conclusion The level of rational application of fentanyl transdermal patch in China still needs to be improved.Education and training in standardized treatment for cancer pain should be paid more attention,especially in Western China.The standardized diagnosis and treatment of cancer pain are worth further promotion,and medical staff need to develop awareness of pain assessment tools so that patients can get safer and more rational medication instruction.
Objective Bibliometric and visualization analysis of literature related to antibiotic-resistant bacterial infection after abdominal solid organ transplant (SOT) was conducted to provide references for identifying clinical research hotspots and related research in the future. Methods The “Web of Science” (WOS) database was searched with keywords such as“carbapenem-resistant Enterobacteriaceae”,“carbapenem-resistant Klebsiella pneumonia”,“multidrug-resistant” and “solid organ transplant”.CiteSpace software was used to detect citation prominences,and VOS viewer was used to cluster keywords to analyze research status and development trends visually.The bibliometrics method was applied to analyze the number of articles related to abdominal solid organ transplant published per year,countries,authors,and institutions. Results A total of 710 articles on antibiotic-resistant bacterial infection after solid organ transplant was finally included in the bibliometric analysis.Fifty-one keywords occurred more than six times,and five related theme clusters were identified,mainly focusing on molecular epidemiology,carbapenem-resistant Enterobacteriaceae,risk factors for infection and antibiotic treatment,immunosuppressant pharmacogenetics,and surgical site infection.The United States has made the greatest contribution,followed by China.Molecular epidemiology of antibiotic-resistant bacterial infection and donor-derived infection were emerging hot topics that would probably attract future research interest. Conclusion Hot topics such as molecular epidemiology of multi-drug resistant Enterobacteriaceae infection and donor-derived infection would not only direct future research but also help us better understand SOT antibiotic-resistant bacterial infection thus implementing the effective antibiotic stewardship program.
Objective It provides data support and reference for Wuhan or other regions to carry out for the prepayment work of the first procurement batch with a target quantity in the second half of the year and provides a reference for the later procurement with a target quantity in Wuhan. Methods Data analysis was conducted on the implementation of supporting policies related to the centralized volume-based procurement of the first batch in Wuhan and the use of centralized procurement of drugs and medical devices within the 1-year period of the medical institutions in the alliance. Results From May 2020 to April 2021,the first batch of non-evaluated drugs centralized procurement in Wuhan were purchased and used by medical institutions in the alliance in a total of 51.35 million selected drugs (tablets),and the overall completion rate was 129.11% according to the quantitative calculation.Among the 150 specifications of 39 varieties selected,there were 113 specifications of 38 varieties of chemical drugs.The number of varieties that had completed the quantity was 32,and the number of varieties that had yet to be completed was 6.The overall completion percentage of varieties was 84.21%.There were 37 regulations for biological insulin drugs,of which ten had completed the prescribed quantity,and 27 had not completed the prescribed quantity.The overall completion rate was 85.72%,according to the prescribed quantity calculation. Conclusion The first batch of procurement with a target quantity in Wuhan has been generally completed well,and further supervision on the quality of the collected drugs and the use by medical institutions in the alliance need to be strengthened.