中国科技论文统计源期刊 中文核心期刊
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
Objective To standardize the entire process of external dispensing and usage of prescription drugs in medical institutions in China, to strengthen drug supply security, to promote the rational and scientific use of the external dispensing of prescription drugs, to uphold the standards of the pharmaceutical industry, and to effectively protect patients' legal rights. Methods Based on survey responses and extensive expert consultation, the drafting team analyzed the current state and challenges of external dispensing of prescription drugs and developed consensus recommendations. Results The consensus outlines 27 recommendations covering eight areas: the definition of external prescription dispensing, organizational management and system construction, prescription and review authority, the management of the dispensing and use of external prescriptions, monitoring and evaluation, external pharmacy management, training and communication, and patient privacy protection. These recommendations establish standardized management measures throughout the entire process of prescription medication dispensing. Conclusions This consensus provides an essential reference for the pharmaceutical management of the dispensing of external prescriptions, enhancing the professionalism and comprehensiveness of services of the external prescriptions, ensuring patient medication safety, and supporting overall improvements in healthcare quality and safety.
Objective To explore the effect of chrysin on intestinal flora in mice with alcoholic liver disease (ALD). Methods Mice were randomly assigned to normal control group, ALD model group, Silymarin group, chrysin low-dose group, chrysin high-dose group (25,50 mg·kg-1). The mice were fed with alcoholic liquid diet and a single dose of alcohol (5 g·kg-1) for eight weeks to establish the ALD model. After eight weeks of oral administration, each group's serum and plasma lipids and liver function indices were collected and detected using kits; then collected the liver and observed the pathological changes of the liver using HE staining; meanwhile, intestinal contents were collected and changes in mouse gut flora were analyzed by 16S rDNA sequencing. Results Compared with the ALD group, the level of aspartate transaminase (AST), alanine transaminase (ALT) and triacylglycerol (TG) of low-dose and high-dose chrysin groups were significantly reduced, and it can alleviate liver cell steatosis and inflammatory reactions caused by alcohol. 16S rDNA results showed that the total number and types of intestinal flora in the ethanol group were significantly reduced, as well as a change in the dominant genus to Escherichia-Shigella and Akkermansia. Compared to the ALD model group, the Shannon index of the intestinal microbiota increased significantly in mice treated with low and high doses of chrysin. In addition, at the phylum and genus level, the abundance of the high-dose chrysin group increased significantly, resulting in an overall increase in the total number and amount of microbiota. The abundance of dominant bacterial groups, such as Oscillospirales, irmicutes,andAlloprevotella, was also significantly increased. Conclusion Chrysin may exert therapeutic effects on ALD by improving intestinal flora imbalance in ALD mice.
Objective To study the pharmacokinetics of dihydralazine sulfate, triamterene, hydrochlorothiazide and reserpine in compound reserpine and triamterene in rats. Methods SD rats were randomly divided into three groups. Compound reserpine and triamterene was given at dose of3.6, 10.8 and 32.4 mg·kg-1 by single oral gavage, respectively. HPLC-MS was used to measure the blood concentrations of dihydralazine sulfate, triamterene, hydrochlorothiazide, and reserpine at various time points. DAS software was used to compute the pharmacokinetic parameters. Results After a single oral gavage of 3.6, 10.8 and 32.4 mg·kg-1 of compound reserpine tablets triamterene, the tmax of dihydralazine sulfate in rat plasma were 1.50, 1.33, and 1.42 h, and the Cmax of dihydralazine sulfate were 12.30,38.31 and 120.52 μg·L-1, respectively. The tmax of triamterene were 1.33, 1.33, and 1.42 h, and the Cmax of triamterene were 20.93, 67.36, and 168.64 μg·L-1, respectively. The tmax of hydrochlorothiazide were 2.00, 2.00, and 1.75 h, and the Cmax of hydrochlorothiazide were 19.89, 57.58, and 160.78 μg·L-1, respectively. Risperdal was found at very low levels in rat plasma, and only trace amounts were detected at 1.00 and 1.50 h of 32.4 mg·kg-1 administration. Conclusions Dihydralazine sulfate, triamterene, and hydrochlorothiazide can be eliminated quickly after compound reserpine and triamterene was given orally to rats, and their oral absorption is basically linear. The greater the dosage, the better the absorption of effective components.
Objective To investigate the effects of Xiaoyukang capsule on neuroinflammation and neuronal apoptosis after Intracerebral hemorrhage (ICH) in rats by regulating JNK/c-JUN signaling pathway. Methods Adult male SD rats were intrastriatally injected with bacterial collagenase VII to induce an ICH model and they were randomly divided into blank control group, model control group, Xiaoyukang capsule small dose group, medium dose group, and large dose group. Neurobehavioral tests, body mass measurements, hematoma volume statistics, hematoxylin-eosin (HE) staining, immunofluorescence, deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) staining, enzyme-linked immunosorbent assay (ELISA) and Western Blotting were performed after 3 and 5 days, respectively. Results Compared with the blank control group, the rats in the model control group had severe neurobehavioral defects and weight loss (P<0.05). The arrangement of neurons in brain tissue was disordered,and there was microglia/macrophages activation, neutrophil infiltration, neuronal apoptosis (P<0.05).The levels of pro-inflammatory factors TNF-α, IL-1β and the expression of p-JNK, p-c-JUN, Bax, Caspase-3 and Cleaved Caspase-3 protein around hematoma were significantly increased (P<0.05), while the anti-inflammatory factor IL-10 and anti-apoptotic protein Bcl-2 were decreased (P<0.05). Compared with the model control group, Xiaoyukang capsule large dose group significantly improved the neurobehavioral function of rats, promoted weight recovery and hematoma absorption (P<0.05). Reduce the pathological injury of brain tissue, inhibition of microglia/macrophages activation, neutrophil infiltration and neuronal apoptosis(P < 0.05). In addition, the levels of pro-inflammatory factors TNF-α, IL-1β and the expression of p-JNK, p-c-JUN, Bax, Caspase-3, Cleaved Caspase-3 protein around hematoma were significantly decreased (P<0.05), and the anti-inflammatory factor IL-10 and anti-apoptotic protein Bcl-2 were increased (P<0.05). Conclusion Xiaoyukang capsule can improve neurobehavioral defects in ICH rats, promote body mass recovery and hematoma absorption, reduce pathological damage of brain tissue, inhibit microglia/macrophage activation and neutrophil infiltration, its mechanism may be achieved by inhibiting JNK/c-JUN-mediated neuroinflammation and neuronal apoptosis.
Objective To analyze the historical and current inclusion of heavy metals and specific elemental impurity tests in the monographs of pharmaceutical excipients in the Pharmacopeias of the US (USP), Europe (EP) and Japan (JP) pharmacopeias. By examining the characteristics and trends in these pharmacopeias, the study seeks to provide insights that can inform the strategy for incorporating elemental impurity tests in the Chinese Pharmacopoeia and offer guidance for the industry to enhance control over elemental impurities in drugs and excipients. Methods The study reviews the inclusion and revision processes of heavy metals and specific elemental impurity tests in the pharmacopeias of the US, Europe and Japan, focusing on aspects such as the number of excipient monographs, the proportion of heavy metal tests, professional categories, and treatment methods. A comparative analysis with the Chinese Pharmacopoeia was conducted to explore the reasons behind the observed differences and to identify potential future developments. Results The USP contains the largest number of excipient monographs, the EP has the fastest progress in the evaluation of elemental impurities in excipients, the JP relies most heavily on wet chemical methods for testing. Conclusion The strategies of the US, European, and Japanese pharmacopeias can serve as valuable references for the development of elemental impurity testing strategies in the Chinese Pharmacopoeia. It is recommended to classify pharmaceutical excipients by risk level, removing heavy metal tests for low-risk categories and conducting elemental impurity risk assessments for higher-risk mineral-based excipients. The inclusion of specific elemental impurity tests should be determined based on these risk assessments, with specific limits or methods established as needed according to excipient category or individual monographs.
Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients. Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed, and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents (ICH Q3C) and the coordination of foreign pharmacopoeias were compared and were analyzed. Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism. Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system, enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry, and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.
The study and control of elemental impurities are crucial for ensuring the quality and safety of drugs. The ICH has published the Q3D guideline as a globally harmonised approach for the research and control of elemental impurities in drugs. In accordance with the requirements of the ICH Q3D guideline for risk assessment and control of elemental impurities, how to carry out the development and validation of detecting methods for elemental impurities is important to analysts. In this research, the key points of ICP-AES and ICP-MS method development are summarized, including the determination of the types and limits of the elements to be measured, the selection of pretreatment methods, interferences and corrections; the validation requirements for the two methods in ICH Q2(R2) and different pharmacopoeial general rules are analyzed, and the evaluation methods of each validation experiments are compared in detail. This paper can provide a reference for the development and validation of detecting methods for elemental impurities, and research ideas for related research workers.
Objective To analyze and evaluate the differences between the standards for elemental impurities in pharmaceutical excipients in the "Chinese Pharmacopoeia" and ICH Q3D, and to explore strategies for harmonization between them. Methods This study summarizes and reviews the main differences between the general chapters and specific monographs of pharmaceutical excipients in the 2020 edition of the "Chinese Pharmacopoeia" and its first supplement, compared with ICH Q3D. Results By integrating the harmonization strategies for elemental impurities in foreign pharmacopoeias and the risk assessment results for pharmaceutical excipients, this study proposes harmonization strategies and pathways for the standards of pharmaceutical excipients in the "Chinese Pharmacopoeia." Conclusions A systematic risk assessment of elemental impurities in pharmaceutical excipients in the "Chinese Pharmacopoeia" should be conducted based on their risk levels. The revision methods should be determined and continuously updated according to the assessment results.
Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents (ICH Q3C), aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C. Methods Through literature research and review, compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C, analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries, and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias. Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C. Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C, based on the national conditions of China.
Objective Taking the medicinal excipient pectin as an example, based on the ICH Q3C risk assessment and management concept, this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia. Methods Pectin products from different processes and manufacturers were analyzed, the types of solvent residues in pectin were identified, and the solvent residues of products from different manufacturers were analyzed by gas chromatography. Results According to the product process, there was a risk of residual methanol(class 2), ethanol and isopropanol(class 3) in pectin products. In 18 batches of samples, the residual amount of methanol was measured in the range of 0.05%-0.17%, the residual amount of ethanol was in the range of 0.01%-0.38%, isopropanol was not detected, and the total amount of residual solvents was in the range of0.07%-0.55%. Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia. It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.
Objective To evaluate the suitability and accessibility of the national Class 1.1 new drug imrecoxib,and provided reference for rational use of drugs in clinical practice. Methods Constructing a suitability and accessibility evaluation system for the national Class 1.1 new drug imrecoxib based on the Delphi method and evaluated through a survey questionnaire. Results After two rounds of expert inquiries, the authority coefficient of the experts was 0.795, the coefficient of variation of the third level indicator of expert opinions was 0.15, and the coordination coefficient was 0.244.Finally, the evaluation index system for the suitability and accessibility of nonsteroidal anti-inflammatory drugs was determined. The evaluation index system including 2 primary indicators, 8 secondary indicators, and 39 tertiary indicators. 173 survey questionnaires were distributed in total. The results indicate that in terms of suitability, imrecoxib has good suitability in both drug use and drug technology characteristics; In terms of accessibility, the price level of imrecoxib is relatively low, and its affordability,accessibility, and patient acceptability are good. Conclusions This study comprehensively evaluated the suitability and accessibility of the national Class 1.1 new drug imrecoxib, provided a reference basis for clinical rational use and regulatory decision-making.
Objective The multi-dimensional evaluation of hemocoagulase drugs was carried out to provide reference data for clinical drug use and drug selection in medical institutions. Methods According to the evaluation system established by the A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition), part of the scoring rules was adjusted, and relevant literatures from CNKI, Wanfang, VIP, PubMed, Embase, Cochrane Library and other databases were referred to. Four hemocoagulase drugs listed in China were quantitatively scored from five dimensions: pharmaceutical properties, effectiveness, safety, economy and other attributes (medical insurance, essential drugs, manufacturers, etc.). The recommendation levels were divided according to the scoring results. Results The quantified scoring results, in descending order,were ashaemocoagulaseagkistrodon(HCA)(68.50 points), hemocoagulaseagkistrodonhalys(HAH)(59.89 points), hemocoagulase injection(HI)(52.84 points) and hemocoagulasebothropsatrox(HBA)(49.31 points). Conclusions The overall score of hemocoagulase drugs is low, and other hemostatic drugs can be preferred when alternative drugs are available. Among them, the HCA is weakly recommended in medical institutions. This study can provide reference for the selection of hemocoagulase drugs in medical institutions, and also provide basis for clinical rational drug use.
Objective In order to provide a better reference and basis for the selection of reasonable hypoglycemic drugs for clinical treatment, the study conducted a comprehensive clinical evaluation of the innovator sodium-glucose transporters 2 (SGLT-2) inhibitors, based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition). Methods The real-world studies, randomized controlled trials, Meta-analysis/systematic review, drug clinical use guidelines, expert consensus and drug description evaluation evidence were collected, and the included drugs were assigned and evaluated from five dimensions: pharmaceutical characteristics, efficacy, safety, economy and other attributes. Results All SGLT-2 inhibitors had evaluation scores above 75, with dagaglifloztin tablets having the highest score of 84.6, and canaglifloztin having the lowest score of 75.1. Conclusions All five original SGLT-2 inhibitors showed good clinical utility, the difference is that the participating original drugs have different advantageous intervals in clinical use. The results show that dagliflozin has the most ideal clinical utility, and its clinical use should be safer and more effective. Due to the short time on the market and insufficient evidence-based reasons, the advantages of clinical use of proline hemegliflozin are not obvious compared with other evaluated drugs.
Objective To systematically evaluate the safety and efficacy of replacing tyrosine kinase inhibitors (TKIs) with similar drugs after they cause liver injury, based on case reports and case series studies. Methods PubMed, Embase, Cochrane, Web of Science, CNKI, Wanfang, and VIP databases were searched up to October 2023. Two reviewers independently screened the literature, extracted data, and assessed the quality of the studies. Descriptive and statistical analyses were performed. Results Twenty-six studies (22 case reports and 4 case series) were included, involving 75 patients who switched to similar drugs for TKI-induced liver injury, primarily targeting the epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and multiple targets. The results indicate that majority of patients have favorable safety profiles after switching drugs, with normal liver function or no severe liver injury. Only one patient reported a serious liver adverse reaction, characterized by (grade 3 total bilirubin elevation). In terms of clinical efficacy, most patients responded well to the new TKIs, maintaining stable disease, or showing no progression during follow-up. Disease progression occurred in only two patients who switched from gefitinib to erlotinib after dose reduction due to non-hepatic adverse effects. Additionally, one patient who switched from erlotinib to afatinib experienced worsening tumor symptoms. Conclusion Evidence from published case reports and case series suggests that continuing treatment with similar drugs after TKI-induced liver injury, targeting EGFR, ALK, and multiple targets, demonstrates a certain degree of safety, efficacy, and clinical practicability. This can be a strategy after TKI discontinuation due to liver injury. However, there are no clear guidelines on drug selection, timing, and dosage, and further research is urgently needed.
Baricitinib is a new type and small molecule targeted disease-modifying antirheumatic drug. By targeting tyrosine protein kinase (JAK) 1 and JAK2, it selectively inhibits the transcription, expression and response function of inflammatory cytokines, chemokines and cell growth factors that are involved in immune abnormalities regulated by the JAK-STAT pathway. A variety of pharmacological effects, such as anti-inflammatory, protecting musculoskeletal, reducing proteinuria and preventing inflammatory cytokine storm effects, and protecting skin and hair from immune damage, have shown good efficacy in a variety of rheumatic and autoimmune skin diseases. Based on the current basic and clinical research of baricitinib, this article gives an overview of the pharmacological effects and clinical application of baricitinib, and provides certain reference for the standardized and rational use of baricitinib in clinical practice.
Objective To explore the similarity between young fruits of Citrus aurantium ‘Changshan-huyou’ and Pharmacopoeia origin Aurantii Fructus Immaturus. Methods The fingerprints of young fruits of Citrus aurantium ‘Changshan-huyou’ and the Pharmacopoeia origin Aurantii Fructus Immaturus were established by high performance liquid chromatography (HPLC). The similarity analysis was carried out by using the software of Traditional Chinese medicine chromatographic fingerprint similarity evaluation system. The whole components of young fruit of Citrus aurantium ‘Changshan-huyou’ and the Pharmacopoeia origin Aurantii Fructus Immaturus were compared by using chemometrics, and the 14 compounds were analyzed quantitatively. Results ①The results of similarity and cluster analysis were affected by the origin and producing area, for example, the similarity between citrus sinensis (L.) Osbeck and other origin was only 0.2, the similarity of citrus aurantium L. from different producing areas ranged from 0.802 to 0.986, with relative large dispersion; ②young fruit of Citrus aurantium ‘Changshan-huyou’, some citrus aurantium L.,citrus aurantium L. cv. Daidai, stink orange and citrus aurantium L.cv. Zhulan all belong to the same category, and the similarity was above 0.9;③VIP method screened out 21 common peaks that had important effects on quality, mainly including neohesperidin, naringin, umbellitin, tangeretin, hesperidin hydrate and hesperidin.The quantitative analysis results showed that Naringin and neohesperidin were abundant in young fruits of Citrus aurantium ‘Changshan-huyou’and Aurantii Fructus Immaturus,followed by hesperidin and naringin,there were significant differences in the content of principal components among Aurantii Fructus Immaturus from different origins, especially in citrus sinensis (L.) Osbeck,the young fruits of Citrus aurantium ‘Changshan-huyou’was relatively stable. Conclusion The young fruits of Citrus aurantium ‘Changshan-huyou’ had good similarity with most origin of Aurantii Fructus Immaturus,so it is feasible to be used as Aurantii Fructus Immaturus.
Objective To analyze the influencing factors of substandard steady state blood trough concentration of meropenem in the first monitoring. Methods Patients who were treated with meropenem and monitored steady-state blood trough concentration from July 2021 to June 2023 in the First Affiliated Hospital of Xi 'an Jiaotong University were selected as the study subjects, and the patient's age, gender, and other medical history data were recorded. The steady-state blood trough concentration of meropenem was determined and the target was identified. According to the monitoring results, the patients were categorized into the standard group (2.0-16.0 mg·L-1) and non-standard group(<2.0 mg·L-1 in the low concentration group and >16.0 mg·L-1 in the high concentration group). Univariate and multivariate logistic regression analyses of relevant variables were performed for the low and high concentration groups, respectively, compared with the standard group to screen for risk factors for substandard steady-state trough concentration of meropenem. Results A total of 324 patients were included, there were 189 cases (58.33%) were reached the standard concentration, while 135 cases (41.67%) were failed to meet the standard (86 cases in low concentration group and 49 cases in high concentration group). The results of multivariate logistic regression analysis showed that glomerular filtration rate (P<0.05), abumin (P<0.05) and craniocerebral diseases (P<0.05) were risk factors in the low concentration group compared with the standard group, the glomerular filtration rate of patients with brain injury was significantly higher than patients without brain injury; cystatin-C(P<0.05) was a protective factor for the concentration of meropenem in both groups. The daily dose of meropenem (P<0.05) and procalcitonin (P<0.05) were risk factors for high meropenem blood concentrations in the high-concentration group compared with the standard group, whereas glomerular filtration rate (P<0.05) was ta protective factor for the concentration of meropenem in the two groups. Conclusion Glomerular filtration rate, albumin and brain injury were risk factors for low steady-state blood trough concentrations of meropenem, whereas daily dose of meropenem and procalcitonin of meropenem were risk factors of high steady-state blood trough concentrations of meropenem.
Objective To analyze the effect of diltiazem on blood concentration of tacrolimus(TAC) retrospectively, and to provide reference for individual administration of tacrolimus in patients with nephrotic syndrome(NS). Methods The patients with NS who were treated in the outpatient/inpatient department of our hospital from January 2018 to December 2022 were collected, and the general information, combined drug use, blood drug concentration and other information of the patients were recorded. The patients were divided into two groups according to whether diltiazem was used or not: TAC group alone and TAC group combined with diltiazem. The effect of diltiazem on tacrolimus concentration was analyzed. Results A total of 45 patients with NS were included in this study, and 21 patients in the TAC group were treated with TAC alone. The mean blood concentration of TAC after medication was (5.77±2.87) ng·mL-1, which reached the effective therapeutic concentration range. The average blood concentration of TAC+ Diltiazem group in the 24 patients was (2.90±1.29) ng·mL-1 before combined treatment, and increased to (5.74±2.46) ng·mL-1 after combined with diltiazem, with a growth rate of (127.34±119.57)%. The increase range was from 10% to 288%, and there was significant difference (P<0.05). According to the observation within 6 months after the combination of the two drugs, the average blood concentration of TAC continued to increase, especially in the 5th month after the administration of TAC, and the concentration tended to be stable after 5 months. By compare with the effect of diltiazem dosage on the blood concentration of TAC, 90 mg·d-1 and 180 mg·d-1 had little difference in improving the blood concentration of TAC. At the same time, the combination of the two drugs did not cause adverse reactions. Conclusion A daily dose of 90 mg of Diltiazem can significantly increase the TAC blood concentration in patients with NS who cannot reach the effective therapeutic concentration with conventional doses. It can reach the effective clinical therapeutic concentration without increasing the dose of tacrolimus. The combination of the two drugs were generally safe and effective.
Teicoplanin, currently one of the preferred drugs for treating infections caused by multidrug-resistant Staphylococcus aureus and Enterococcus in clinical practice, has a high plasma protein binding rate. Most of the drug binds to protein after entering the body, only a portion of the drug exists in a free form. Since the free drug can pass through biological membranes and enter the target tissue to exert its therapeutic effect, monitoring the free teicoplanin blood concentration is clinically important and plays a role in guiding individualized drug therapy. This article summarizes and compares the current methods for determining the concentration of free teicoplanin in the blood, and analyzes their advantages and disadvantages. Based on this, it analyzes the possible factors affecting the concentration of free teicoplanin in the blood, providing a reference for the development of new methods for detecting free teicoplanin concentration and providing more accurate individualized medication plans based on free concentration.
Objective To investigate the occurrence and characteristics of Antineutrophil cytoplasmic antibody(ANCA) associated vasculitis induced by methimazole, and to provide references for clinical safe drug use. Methods Case reports of ANCA associated vasculitis induced by methimazole published in Wanfang, CNKI, PubMed, and Web of Science were searched from the inception to October 31st, 2023. Demographic characteristics, drug use, complications, treatment and outcome were analyzed using descriptive statistical method. Results A total of 14 patients from 14literature were included. There were 3 males and 11 females with ages ranging from 8 to 79 years, with a mean age of (47.79±23.47) years. Four patients developed symptoms within 1 year, nine patients developed symptoms from 2 to12 years,and 1 patient developed symptoms 24 years after medication. ANCA associated vasculitis affected kidney in 5 patients, lung and skin in 5patients, vision in 2 patients and heart in 2 patients. All patients discontinued methimazole, 2 patients improved spontaneously without treatment, 1 patient improved after anti-infection, and all others received hormonal or immunosuppressive therapy. 1 patient developed death, and all others improved or were cured after treatment. Conclusions ANCA-associated vasculitis is a rare adverse reactionof methimazole. Most patients have a long latency period before the onset of disease, mainly involving multiple organs such asskin, kidney, lung, and eyesight. Clinicians should pay attention to differentiate it from primary vasculitis and discontinue the drug as soon as possible. When serious organ damage occurs, glucocorticoids and immunosuppressants should be adminstered promptly to avoid aggravation of the disease and endangerment of life.
The patient was admitted to the hospital with a diagnosis of diffuse large B-cell lymphoma for one month, accompanied by limb numbness for one week. Upon admission, the patient was initially prescribed vitamin B1 and mecobalamin for symptomatic relief, which led to an improvement in the symptoms of limb numbness. Subsequently, the patient was administered chemotherapy consisting of rituximab, lenalidomide, and prednisone. However, following the initiation of chemotherapy, the symptoms of limb numbness became more severe. After review of the patient's medication history and analysis of relevant data, the clinical pharmacist suggested that the patient's limb numbness was caused by lenalidomide-induced peripheral neuropathy.
The article reported a case of 59-year-old male patient with novel coronavirus infection who developed acute kidney injury after treatment with azvudine, which is considered as an adverse reaction caused by azfudine. After 13 days of discontinuation of azvudine, the renal function gradually returned to normal. It is suggested that the adverse reaction of kidney injury should be vigilant in the clinical application of azvudine, and clinical attention should be paid to improve drug safety.
The patient was hospitalized for treatment due to ovarian cancer 22 months post-surgery and recurrence for 3 months. During chemotherapy, carboplatin was administered intravenously following pretreatment with dexamethasone and diphenhydramine to mitigate potential adverse reactions. Thirteen minutes after the administration of carboplatin, the patient developed an acute allergic reaction manifesting as chest tightness and skin itching, followed by a significant increase in heart rate and blood pressure, a decrease in blood oxygen saturation, laryngeal edema, and respiratory distress. In response to this emergency, the administration of carboplatin was immediately halted, fluid was extracted from the PICC line, and epinephrine, dexamethasone, and diphenhydramine were given for treatment. Additional supportive measures included oxygen therapy and fluid resuscitation. Following these interventions, the patient's condition stabilized, with blood oxygen saturation, heart rate and blood pressure returning to normal levels.
Objective To evaluate the predictive efficacy of individualized dosage support software-Smart Dose, PharmVan and JPKD-on vancomycin plasma concentration in patients undergoing infective endocarditis (IE) surgery, and to analyze the influencing factors. Methods A retrospective analysis was conducted in IE patients who received intravenous vancomycin in our hospital from January 2019 to December 2022. The above softwares were used to predict the steady-state trough concentration of vancomycin, and the relative prediction error and absolute weight deviation (AWE) between the predicted and measured values were compared. According to the AWE value, the results were divided into accurate prediction group (AWE<30%) and the inaccurate prediction group (AWE≥30%). Univariate analysis and Logistic regression analysis were used to explore the influencing factors, and to evaluate the predictive value through the receiver operating characteristic curve (ROC). Results A total of 27 patients were enrolled, with 27 concentrations of initial regimen and 35 of adjustment regimen. When PharmVan predicted the adjusted concentration, the AWE was 24.84(11.54,39.78)%, with higher accuracy than other predicted results. The Univariate analysis of factors influencing the performance of PharmVan in predicting the adjusted concentration showed that patients in the accurate prediction group was significantly younger than that in the inaccurate prediction group (P<0.05). Multivariate analysis showed that advanced age was an independent risk factor for the inaccurate prediction of PharmVan for adjustment concentration [OR=0.856, 95% CI was (0.757,0.969), P=0.014]. ROC curve analysis indicated that when patients were older than 48.5 years old, the risk of inaccurate prediction was increased with a sensitivity of 78.9% and a specificity of 93.7%. Conclusions Only the PharmVan software has a higher accuracy in predicting the adjusted concentration among the three softwares, but it is still need to be cautious in combination with the analysis results of ROC curve. Therefore, when using vancomycin in IE patients, attention should be paid to renal function and plasma concentration should be actively monitored.
Objective To explore and study the new nationwide centralized volume-based procurement model of Chinese patent medicines (CPM), aiming further to promote the normalization and institutionalization of such procurement practices. Methods This study conducts a retrospective analysis of the entire 2023 national CPM procurement process, comparing it with the 19-province alliance procurement, the national chemical drugs procurement, and the national insulin special procurement and highlighting its similarities and differences. Results In contrast to the 19-province alliance procurement, the national CPM alliance procurement introduced a daily average cost rule to reduce the price selection deviation. It also improved and optimized the criteria for qualification, bidding unit formation principles, selection rules, resurrection mechanisms, and principles for allocating procurement volumes under agreements. A comprehensive analysis of the results from two rounds of CPM procurement indicates statistically significant differences in resurrection rates, brand substitution rates, and reduction in selected prices, with the national procurement outperforming the 19-province alliance procurement. Compared with the national chemical drugs and special insulin procurements, this procurement distinctly showcases its unique characteristics. Conclusion The new mode of the national CPM alliance procurement is innovative and has contributed valuable experiences towards the sustained advancement of CPM procurement and establishing a medical insurance payment standard system.
Objective This article focuses on the investment promotion policies at the municipal and district levels (park management committee level) of biomedical industrial parks in China at different development stages. It aims to reveal the characteristics and patterns of these policies, providing a reference for the formulation of development policies for biomedical industrial parks in China. Methods A total of 166 policies issued by three biomedical industrial parks (LifeBay, Nanjing Biotech and Pharmaceutical Valley and BioBay) from January 2013 to June 2023 were coded and quantitatively analyzed using a three-dimensional analytical framework of policy tool-development stage-issuing body. Results At the municipal level, the use of policy tools by administrative development is supply-oriented and environmental-oriented. At the district level, the types of policy tools used are closely related to the stage of the park. Start-up parks have a high proportion of supply-based policy tools, growth parks have a high proportion of demand-based policy tools, and mature parks have a high proportion of environmental policy tools. Conclusion Policy insights such as the strategic use of policy tools according to the development stage of the park, the optimization of the internal structure of the tools and the enhancement of the complementarity and coordination among the tools, and the use of policy tools to promote industrial agglomeration in line with local realities are put forward.
Objective To introduce the formulation and effect evaluation of performance appraisal scheme for pharmacists in comprehensive pharmacy. Methods A comprehensive evaluation method formulated by critical event method and grade scoring method was adopted to evaluate the workload, work ability, learning ability, and work discipline. Results From September 2022 to August 2023, the average score of monthly pharmacist assessment increased from 73.9 to 87.9, the satisfaction rate increased from (7.5±1.52) to (11.5±2.66)(P<0.05), and the number of patients with drug consultation increased from 5 cases to 61 cases. Conclusion The performance appraisal scheme can significantly improve the work ability and enthusiasm of pharmacists.
Objective This study aims to discuss and summarize the management system for drugs used in clinical trials, with the objective of elevating the management standards. Methods Considering the situation of diverse departmental needs and the multi-campus structure, the study analyzed and explored the management of drugs for clinical trials to build a corresponding management system,including pharmacy construction, equipment, personnel qualifications, data management, drug reception, storage, distribution, and recycling protocols. The effecttivness of the system was evaluated through comparative analysis of data from 2022 to 2023 at our hospital. Result Improvements in the management of drugs for clinical trials were observed in 2023 across varous aspects. Conclusion Refining the management system of drugs for clinical trials can enhance Good Clinical Practice (GCP) supervision and service, providing an important reference for the management system.
Objective To investigate the knowledge, attitude, and practice(KAP)related to medication use among pregnant and lactating women in Hubei province, to comprehend the specific requirements of pregnant and lactating women for pharmaceutical assistance, to assess the critical stages in the process of medication,and to furnish factual backing for devising a secure medication education framework tailored to pregnant and lactating women. Methods Through a multi-center study design, with pregnant and lactating women as the research subjects,a questionnaire survey was carried out to gather fundamental information and assess their knowledge, attitude, and practices towards medication use. Data analysis involved utilizing one-way analysis of variance, non-parametric tests, and multiple linear regression. Results A total of 548 valid questionnaires were collected. The average scores for knowledge, practice and attitude among pregnant and lactating women were (58.26±30.68), (52.18±22.32), and (46.60±14.66) points, respectively.Overall, the scores for medication knowledge and behavior were good, while the attitude scores were passable. These results suggest that pregnant and lactating women have a certain level of understanding about safe medication practices and hold a positive attitude towards receiving medication education. However, there are still potential safety hazards in their daily medication behavior. The results of multiple linear regression indicate that age, educational level, and occupation are the main factors influencing the knowledge, attitude, and practice of medication use among pregnant and lactating women. Conclusions Pregnant and lactating women require urgent education on the safe use of medication.It is recommended that targeted drug education should be carried out based on the knowledgegaps and medication misconceptions of different objects.Additionally, it is crucial to effectively utilize new media platforms, such as WeChat official accounts and channels, and to engage in offline scientific outreach activities, such as offering free consultations and giving lectures on rational drug use.This will provide pregnant and lactating women with convenient and practical educational content on safe medication.
