Objective To imporve the service level of integrated outpatient department for cardio-oncology in healthcare facilities, and to improve and optimize pharmaceutical management within cardio-oncology integrated outpatient department. Methods Clinical issues were identified using the Delphi method. Relevant problems and existing evidence were collected and organized through systematic research. The evidence grading and recommendation intensity standards developed by the Center for Evidence-Based Medicine at Oxford University were applied to complete the evidence grading. Through questionnaire consultations with 38 experts. Results A total of 11 clinical questions were identified as consensus items. Based on these issues, expert consensus recommendations for pharmaceutical management in combined cardio-oncology outpatient departments were formulated through evidence retrieval, synthesis, and grading. Ultimately, an expert consensus on pharmaceutical management in combined cardio-oncology outpatient clinics was established. Conclusion The expert consensus serves as a reference for managing combined clinical cardio-oncology outpatient clinics, significantly contributing to offering more professional and comprehensive diagnosis and treatment services for cancer patients.
Objective To explore the optimal ratio of Baitong decoction based on efficacy, clarify its spectrum-effect relationship, and identify its potential quality markers. Methods An ulcerative colitis (UC) model in mice was established using dextran sulfate sodium. The efficacy of Baitong decoction with varying drug ratios was assessed by evaluating the apparent score, pathological score and inflammatory factor changes of UC in each group of experimental animals. The fingerprints of Baitong decoction with different ratios were established by high performance liquid chromatography (HPLC), and the relationship between the content of each substance and its efficacy was analyzed by partial least squares regression to determine the potential quality markers of Baitong decoction. Results Baitong decoction was most effective in relieving ulcerative colitis when the mass ratio of Fuzi, Ganjiang and Congbai was 1∶2∶2. The fingerprinting identified 14 common peaks across 7 ratios, with 9 peaks were found to be associated with the remission of ulcerative colitis by partial least squares regression analysis. Conclusion The optimal ratio of Fuzi, Ganjiang and Congbai for treating UC is 1∶2∶2. The spectrum-effect relationship analysis suggested that the quality markers of Baitong decoction may be the substances represented by peak 2 (benzoylaconine), 3, 5, 6, 8(mesaconine), 9 (aconitine), 10 (hypaconitine), 13 (10-gingerol) and 14.
Objective To evaluate the bioequivalence of two formulations of minocycline hydrochloride capsules administered orally after fasting administration and fed administration. Methods An open-label, randomized, two-period, self-crossover design was employed to assess the bioequivalence study. Twenty-eight healthy subjects were enrolled in both fasting and fed groups, with each period involving a single administration of either the reference formulation or the test formulation of 50 mg, separated by a washout period of 7 days. The concentration of minocycline in human plasma was determined by HPLC-MS/MS and was used for calculating pharmacokinetic parameters and evaluating the bioequivalence of the test formulation and reference formulation. Results After oral administration of test and reference formulations of minocycline under fasting condition, the Cmax Values of minocycline were (541±137) ng·mL-1 for the test formulation and (558±140) ng·mL-1 for the reference formulation. The AUC0-t values were (8 347±1 986) h·ng·mL-1 for the test and (8 205±1 790) h·ng·mL-1 for the reference. The values were (18.2±2.84) h for the test and (18.0±3.05) h for the reference. After oral administration of the test and reference formulations of minocycline under fed condition, the Cmax values of minocycline were (349±72.1) ng·mL-1 for the test and (352±73.2) ng·mL-1 for the reference. The AU were (6 428±1 077) h·ng·mL-1 for the test and (6 588±1 118) h·ng·mL-1 for the reference. The t1/2values were (18.5±3.10) h for the test and (18.4±3.21) h for the reference. Under fasting condition, the 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-t, and AUC0-∞ between the test and reference formulations were (90.84%,101.46%), (95.2%,102.8%), and (95.31%,102.71%), respectively. Under fed conditions, the 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-t, and AUC0-∞between the test formulation and the reference formulation were (94.71%,103.42%), (95.40%,99.83%), and (95.79%,100.02%), respectively. Conclusions Bioequivalence of the two minocycline formulations was demonstrated after fasting administration and fed administration in a healthy Chinese population.
Objective To systematically evaluate the efficacy and safety of the ceftazidime-avibactam (CAZ-AVI) regimen versus other regimens for treatment of carbapenem-resistant Enterobacteriaceae (CRE) bloodstream infections, and to provide an evidence-based foundation for drug selection in clinical CRE bloodstream infections. Methods A computerized search was conducted in Pubmed, Embase, Cochrane Library, Web of Science, Wanfang Medical Network, CNKI and China Science and Technology Journal Database for literature on CAZ-AVI for CRE bloodstream infections from the inception of each database up to November 2023. The literature quality evaluation and data extraction were independently performed by two researchers. A meta-analysis was performed using Review Manager 5.3 software. Results A total of 15 English articles and 1 580 patients were included. The results showed that the clinical cure rate [OR=3.32, 95%CI=(2.25, 4.90), P<0.000 01] and microbial clearance rate [OR=3.00, 95%CI=(1.15, 7.81), P=0.02] were significantly higher in the CAZ-AVI group than in the control group, and the 28 d/30 d all-cause mortality rate of patients in the CAZ-AVI group was lower than that of the control group [OR=0.38, 95%CI=(0.29,0.51), P<0.000 01]. The recurrence rates of infection in the two groups were equivalent and statistically non-significant [OR=0.75, 95%CI=(0.39,1.42), P=0.37]. Subgroup analysis indicated that the CAZ-AVI group had a lower all-cause mortality rate than the tigecycline group [OR=0.20, 95%CI=(0.11,0.39), P<0.000 01]. In terms of safety, the incidence of adverse events between the two groups was comparable and statistically non-significant [RR=0.47, 95%CI=(0.20,1.07), P=0.07]. However, the nephrotoxicity was significantly lower in the CAZ-AVI group than in the control group [OR=0.36, 95%CI=(0.21,0.64), P=0.000 5]. Conclusion Based on the findings of the current study, CAZ-AVI offers potential clinical advantages in the treatment of CRE bloodstream infections by improving clinical cure rates and reducing mortality rates.
Objective For more focused prevention and management, this investigation examines the risk factors for multidrug resistant organisms (MDRO) infections in intensive care unit (ICU) patients. Methods Case-control studies and cohort studies of risk factors for MDRO infection in ICU patients were searched in the Embase, Website of Science, Cochrane Library, PubMed, CNKI, WanFang, and VIP databases from their start to October 26, 2022. The Meta-analysis was carried out with RevMan 5.3. Results A total of 32 papers were included, with 10 985 cases studied, with the quality of the literature rated as moderate to high. The results of Meta-analysis of this study showed that gender [OR=1.21, 95%CI=(1.08,1.36), P=0.002], ICU length of stay [WMD=5.36, 95%CI=(3.99,6.73), P<0.000 01], total length of stay [WMD=8.96, 95%CI=(6.51,11.41), P<0.000 01], hypertension [OR=1.33, 95%CI=(1.10,1.60), P=0.003], abnormal renal function [OR=1.69,95%CI=(1.33,2.16), P<0.000 01], hypoproteinemia [OR=1.87,95%CI=(1.51,2.32), P<0.000 01], mechanical ventilation [OR=2.26,95%CI=(1.18,4.33), P=0.01], duration of mechanical ventilation [WMD=8.83,95%CI=(2.52,15.14), P=0.006], arteriovenous placement [OR=1.46,95%CI=(1.23,1.72), P<0.000 1], placement of urinary catheter [OR=1.71,95%CI=(1.25,2.36), P<0.000 01], gastrointestinal tube placement [OR=0.10,95%CI=(0.03,0.18), P=0.008], antimicrobial drug type ≥3[OR=4.27,95%CI=(2.06,8.85), P<0.000 01], use of carbapenem antibiotics [OR=4.09, 95%CI=(300,5.58), P<0.000 01], the use of the third-generation cephalosporin[OR=1.63, 95%CI=(1.15,2.33), P=0.007], the use of quinolone antibacterials [OR=1.86,95%CI=(1.42,2.44), P<0.000 01], the use of aminoglycoside antibiotics[OR=1.99, 95%CI=(1.49,2.67),P<0.000 01], use of piperacillin-tazobactam [OR=2.94, 95%CI=(1.56,5.54), P=0.000 9], use of glycopeptide antibiotics [OR=3.78, 95%CI=(2.48,5.78), P<0.000 01], use of sedatives [OR=3.25,95%CI=(2.06,5.14), P<0.000 01], and use of acid suppressants [OR=1.51,95%CI=(1.06,2.16), P=0.02] are risk factors for MDRO infection in ICU patients. Conclusion MDRO infections in ICU patients are associated with gender, duration of ICU stay, chronic lung disease, total length of stay, hypertension, abnormal renal function, hypoproteinemia, mechanical ventilation, duration of mechanical ventilation, arteriovenous placement, placement of urinary catheters, gastrointestinal placement, type of antimicrobial drugs≥3, use of carbapenem antibiotics, use of third-generation cephalosporin, use of quinolone antibacterials, use of aminoglycoside antibiotics, use of piperacillin-tazobactam, use of glycopeptide antibiotics, use of sedatives, use of acid suppressants, and other factors. Targeted controls of different factors such as underlying diseases, comorbidities, invasive procedures performed, and the use of antimicrobial medications and other therapeutic pharmaceuticals could limit the risk of infection in MDRO in ICU patients.
With the widespread use of carbapenem antibiotics, the clinical detection rate of carbapenem-resistant Gram-negative bacilli has shown a significant increase. Carbapenem-resistant Gram-negative bacilli isolates are often extensively or fully resistant, resulting in limited antimicrobial treatment options and high morbidity and mortality rates, posing a serious public health threat. The clinical treatment of carbapenem-resistant Gram-negative bacilli includes the use of single or combination antimicrobials such as polymyxin, tigecycline, and fosfomycin. A number of new antimicrobials and therapeutic approaches are under development. The clinical management of carbapenem-resistant Gram-negative infections is severely challenged by the limited choice of antimicrobial agents. Therefore, this article reviews the current status and progress of antimicrobial treatment for carbapenem-resistant Gram-negative bacilli to providing clinical reference.
Objective To explore the clinical characteristics and treatment strategies of patients with Carbapenem-resistant Enterobacteriaceae (CRE) bloodstream infection. Methods A retrospective analysis was conducted on demographic information, microbiological data, and clinical characteristics of patients with CRE bloodstream infections in Sichuan Provincial People's Hospital from September 2018 to December 2021. Results A total of 53 cases of CRE bloodstream infections were identified, with a treatment failure rate of 47.2%. Patients with bloodstream infections caused by carbapenem-resistant Klebsiella pneumoniae (CRKP) had a worse prognosis (P<0.05). Patients with treatment failure showed higher levels of procalcitonin, C-reactive protein, lactate dehydrogenase, and prolonged prothrombin time, along with lower levels of globulin (P<0.05). Among the 53 patients included in the outcome analysis following drugs, there was no statistically significant difference between monotherapy (n=15) and combination therapy (n=38) (P>0.05). Treatment regimens containing tigecycline were not superior to other strategies without tigecycline (P>0.05). Univariate analysis results indicated that the prognosis of CRE bloodstream infection was associated with endotracheal intubation, central venous catheterization, bacterial species which lead infection, comorbidities of the hepatobiliary system, and infection occurring after ICU admission (P<0.05). Health issues involving the hepatobiliary system and ICU-onset admission were independent risk factors for the prognosis of CRE bloodstream infection (P<0.05). Conclusion Patients with CRE bloodstream infections have a high mortality rate, and those with elevated procalcitonin and C-reactive protein levels indicate a poor prognosis. The use of tigecycline in combination or alone may not be the optimal treatment choice for CRE-related BSI.
Prostate cancer (PCa) is one of the most common malignant tumors in men, marked by the high expression of prostate-specific membrane antigen (PSMA). Radionuclide drug conjugates (RDCs) targeting the PSMA antigen have become a hot topic in PCa research. The development of PSMA-targeted RDCs has progressed rapidly in recent years, significantly contributing to the diagnosis and treatment of PCa. Numerous novel PSMA-related RDCs are now part of clinical research. Due to the special properties of radiopharmaceuticals, it is essential to consider the impact of ionizing radiation in comprehensive clinical evaluation. This article, review the clinical studies from the past decade, and discusses the scope and methodologies of comprehensive clinical evaluation for PSMA-related RDCs.
The killing effect of radiation therapy on healthy cells has led to the creation of targeted radionuclide therapy, which effectively reduces the damage to surrounding normal cells. At present, alpha (α) and beta (β) radionuclides are the research hotspots of targeted therapy. Numerous preclinical and clinical studies have shown that radiation therapy not only has local anti-tumor effects, but also exerts systemic anti-tumor effects by triggering the body's immune response. This paper describes in detail the characteristics and clinical applications of commonly used radionuclides, and discusses the mechanism of radiation-triggered body immune response as well as the related research on the combined use of radiation therapy, targeted radionuclide therapy and immunotherapy.
Targeted radiation therapy using radionuclides is a favored approach for treating tumors. This procedure involves the delivery of drugs to the lesion site via carriers or interventional methods, followed by the emission of radiation energy that selectively irradiates the lesion tissue. This approach minimizes damage to normal tissue and achieves the desired therapeutic effect. Factors such as the type of therapeutic radionuclide, radiation energy, physical half-life, method of preparation, and toxicity determine their clinical application. In this paper, the characteristics and clinical application of therapeutic radionuclides were reviewed to providing reference for the clinical application of targeted therapeutic radionuclides.
Nuclear medicine plays an indispensable role in the diagnosis, treatment, and prognosis of a wide range of diseases. Nuclear medicine using radionuclides for diagnosis has the advantages of accuracy, speed, high sensitivity and high resolution. Currently, several radionuclides play pivotal roles in disease diagnosis. This article primarily examines the clinical application and research of diagnostic radionuclides, including 18F, 89Zr, 68Ga, 99mTc, 131I, 123I, and 11C. The objective is to offer valuable insights for disease diagnosis and staging of diseases.
Radiopharmaceuticals play an important role in the medical field, but they also carry certion risks and potential safety concerns. Medical institutions implement pharmacovigilance to ensure the safety of patients’ drug use, including the safety of Radiopharmaceuticals. The operation and management of the pharmacovigilance system in the United States and the European Union are relatively mature. China can learn from their advanced concepts and establish our own radiopharmaciligence system.
Objective To adapt to the requirements of medical technology innovation under the new situation. To explore the establishment of a scientific, standardized, and reasonable management institution and system. It aims to actively promote the development of Investigator Initiate Trials (IITs) in medical and health institutions. Methods By conducting a literature review, policy interpretation, and examing work practices, this study identified the pain points and difficulties in IIT management. It sorted out the core requirements and elements needed for effective IIT management and proposed measures. Results The study proposed the development of five support systems for IIT management. A functional responsibility system for implementing classified and tiered management of IITs with clear delineation of responsibilities and authority; A quality supervision system that introduces a third-party co-management mechanism to fill the gaps of IIT quality management in the three-level quality control system; A fund support system that reduces or waives the hospital management fees for IITs, and incorporate the IIT undertaking into the annual evaluation metrics for optimized SMO; A collaborative innovation system that connect with external enterprises and coordinates internal departments to jointly promote the efficient operation of IITs; A risk early warning system that establishes IIT risk assessment criteria and conducts real-time dynamic supervision, strengthening IIT data management, and ensuring IIT data security. Conclusions Currently, IIT management generally lacks sufficient attention in China, and there is no complete framework or practice. By constructing the five IIT system construction scheme. It is conducive to optimizing the process, improving efficiency, ensuring quality and reducing risk, which has certain reference significance for the improvement and development of IIT management.
Objective To establish an audit team at the Clinical Trial Institution and explore the feasibility of a new model involving clinical pharmacists in auditing clinical trial projects in hospitals. Methods The audit team consists of 6 clinical pharmacists trained as clinical trial auditors by the National Medical Products Administration Institute of Executive Development and specialized coaching by experts from other hospitals. Results The audit team completed a total of 16 audit reports and identified 189 problems, including 128 general problems, 58 important problems and 3 serious problems. The institution, sponsors, investigators and subjects were all involved. Conclusion Based on the actual situation of our hospital, the mode of clinical pharmacists establishing audit teams in medical institutions can effectively improve the quality management level of drug clinical trial projects.
Objective To explore how to achieve isolation of clinical trial fees and general medical expenses of hospitalized subjects through information technology. Methods This article analyzed various methods for separating clinical trials fees from medical insurance and suggested that all methods need to protect subjects' medical insurance reimbursement rights and ensure that they do not occupy medical insurance funds. Based on this principle, A clinical trial cost segregation information module was developed based on inpatient’s workstation. Results Through this information module, subjects could choose their medical status according to the actual medical situation. Doctors could issue medical orders in hospital information system (HIS) according to normal medical or trail needs, change the nature of the orders by adding or deleting clinical trial tags. The system automatically intercepts the clinical trial orders for reimbursement of medical insurance, while other expenses are reimbursed according to rules of medical insurance. Conclusion The application of this information module has improved the subjects' enthusiasm and compliance to participate in clinical trials, reduced their economic burden, and ensured their rights to enjoy reimbursement of medical insurance, which can be used as a reference example for newly registered clinical trial institution.
Objective To examine the process of the initial ethical review of drug clinical trials in medical institutions in Shaanxi province, analyze the current situation of initial reviews, and make suggestions to expedite the speed of initial ethical review of drug clinical trial projects. Methods Based on the drug clinical trial institutions in Shaanxi recorded in the "drug and medical device clinical trial institutions for the record management information system". This study involved retrieving information through hospital website, WeChat public accounts, and conducting telephone consultations to usnderstand the process. The analysis focused on the initial review requirements, documents submission, and approval documents. Results A total of 44 drug clinical trial institutions were assessed. 63.6% of these institutions had clearly issued ethical review / application guidelines, with some lacking detailed provisions on the initial review submission list, simplified data and seal requirements. 31.8% of the institutions had established ethics review management systems. The average time of obtaining ethics approval was from5.13to6 d. Conclusion It is recommended to further improve ethical review guidelines, standardize the initial review process, refine the initial ethical review documents and institutional project approval documents, build an information management platform, reduce the time for initial review of drug clinical trial projects, and improve the speed of clinical trial initiation.
Objective To understand the trends and characteristics of clinical trials on cancer pain medications in recent years,and to provide a reference basis for the development and clinical research of cancer pain medications. Methods Relevant information on clinical trials of cancer pain medications from 1987 to 2022 was retrieved from the ClinicalTrials.gov database,and a descriptive analysis was conducted from the perspectives of trial types,registration dates,reporting regions,cancer pain type,and cancer pain medications. Results A total of 376 clinical trials were selected,Among them,the number of investigator-initiated trials (IIT) was greater than that of industry-sponsored trials (IST).North America had the highest total number of projects,IIT and IST projects.The total number of trials and IST projects increased first and then decreased,while the number of IIT trials steadily increased.There was relatively higher amount nof research focused on chronic cancer pain,breakthrough cancer pain,and severe cancer pain.The highest proportion of subjects studied were opioids,with fentanyl being particularly prominent among them. ConclusionClinical trials of cancer pain medications have played an important role in advancing cancer pain medication,but there is a need to further strengthen IST research on novel cancer pain medications and conduct more IIT studies to better optimize cancer pain treatment outcomes.
Objective To standardize the management of clinical trials in our hospital, reduce the incidence of protocol deviations, and provide a reference for improving the quality of clinical trials. Methods The healthcare failure mode and effect analysis (HFMEA) method was used to determine the potential failure modes of the current protocol deviation. The frequency, severity and detectability of failure modes were quantified and evaluated. The risk priority number (RPN) was calculated and the corresponding improvement measures were proposed. The RPN values before and after the implementation of HFMEA were statistically analyzed to evaluate the improvement effect. Results After the implementation of HFMEA activities, the RPN values of 14 potential failure modes decreased significantly (P<0.05); The risk level of 12 potential failure modes decreased. The HFMEA team members’ ability in finding and solving problems, communication and cooperation were significantly improved. Conclusions The implementation of HFMEA activities contributes to the management of protocol deviation in clinical trials, can effectively reduce the occurrence of protocol deviation, and provides experience for improving the quality of drug clinical trials.
During the pain treatment process, to reduce the use of opioids, alternative pain relievers have been used. Increasing data indicated that N-methyl-D-aspartic acid (NMDA) receptor antagonists may enhance the analgesic effect of opioids. Furthermore, numerous studies have shown that the auxiliary analgesic effect of magnesium sulfate has a good application prospect in pain treatment and perioperative anesthesia. The primary pharmacological mechanism of magnesium sulfate in pain treatment is that it acts as a physiological voltage-dependent blocker of NMDA coupling channels, and its anti-nociceptive effect is related to magnesium blocking calcium inflow, thereby inhibiting central sensitization and reducing preexisting hyperalgesia. This paper reviewed the current application of magnesium sulfate in perioperative period, focusing on its auxiliary analgesic effect through intravenous, intrathecal, and local administration, and the reduction of opioid consumption. As well as its potential role and application prospects in opioid-free anesthesia program.
Objective To establish the method of infrared fingerprint, TLC identification and content determination of phenolic acid components of Yao medicine Calonyction muricatum (Linn)G. Methods The infrared fingerprint of 10 batches of Calonyction muricatum (Linn)G were established by infrared spectroscopy. The spectral datas were analyzed by similarity analysis,infrared spectroscopy (HCA), principal component analysis (PCA) and Partial-least-squares discriminant analysis (PLS-DA). Chlorogenic acid, heterochlorogenic acid A and caffeic acid of Calonyction muricatum (Linn)G were identified by TLC. The contents of neochlorogenic acid, chlorogenic acid, caffeic acid, cryptochlorogenic acid, isochlorogenic acid A and C were determined simultaneously by HPLC method. Results It could be suggested that organic acids, flavonoids and other compounds of Calonyction muricatum (Linn)G by infrared spectroscopy and nine common peaks were calibrated by infrared fingerprint;the similarity evaluation was above 0.999; the results of cluster analysis (CA) and principal component analysis (PCA) showed that it could be clustered into 2 categories, including S1, S2 and S3 were clustered into one categoriy and the rest were one. 5 differential components (VIP> 1) were selected by Partial-least-squares discriminant analysis; the test and control samples of TLC showed consistent locations the spots were clear, with good separation degree;the six components of Calonyction muricatum (Linn)G showed good linear relationship (r≥0.999 2), average sample recovery rate 97.77%-102.59%, and RSD less than 2.90%. Conclusion The TLC and infrared fingerprint were simple and stable, and the results of the six components were reliable, which can lay a scientific foundation for the quality control of the materials.
Objective To analyze the onset time and short-term clinical effect of rituximab (RTX) in the treatment of glomerular diseases. Methods All case data of rituximab used in the treatment of glomerular diseases in a tertiary hospital from January 2021 to December 2022 were extracted for retrospective study. The changes in blood routine, liver function, kidney function, immunity and other related indexes were analyzed after the treatment of RTX and the clinical effect in the short term was observed. Results A total of 52 patients were collected, of which 30 received RTX standardized therapy. During the follow-up period, plasma albumin showed an upward trend, and the 24-hour urine protein and B cell count showed a downward trend. The values of these indexes after 3 months and 6 months after treatment were significantly different from those before treatment, which was statistically significant (P<0.05). The clinical response rates after the first injection, the second injection, the third injection, the fourth injection, 3 months later, and 6 months after RTX treatment were 26.92%, 36.00%, 51.85%, 57.69%, 76.92% and 81.82%, respectively. No serious adverse effects occurred during the follow-up period. Conclusions RTX can improve 24-hour urine protein, plasma albumin level and B cell count in glomerular-related diseases, stabilize renal functionand have good safety.
Objective To communicate the paternal medication behaviors and patterns during the peri-pregnant period in China and to explore the types of pharmaceutical care services that clinical pharmacists can provide. Methods Focusing on patients exposed to paternal medication during the perinatal period, the clinical practice model of our hospital's clinical pharmacists consultation for paternal drug exposure was introduced. Furtherly, a retrospective survey on the information of consultants was conducted and the characteristics of drug exposure were analysed in this population, and a comparation made with data from foreign teratogenic information service centers. Results From October 2017 to September 2022, leveraging our hospital's Pregnancy Registration Platform for Medication, clinical pharmacists provided pharmaceutical consultation services for 404 outpatient cases of paternal exposure, and established a standardized consultation flow. Paternal exposure counseling accounted for 3.6% of cases, with medication use during an unplanned pregnancy being the most common situation (79.2%). The average number of exposed drugs was (2.6±1.7). The top five types of drugs consulted were antimicrobials, Chinese traditional patent medicine, cardiovascular system drugs, digestive system drugs and endocrine system drugs. The five most frequently used drugs were cephalosporins, sartans, entecavir, levofloxacin and metformin. Effective follow-up was conducted on 261 cases, with a follow-up rate of 81.6%, and no congenital abnormal signals were indicated after exposure to the father's medication. Conclusion Pateral drug exposure in China has received little attention, with very limited research evidence available. Clinical pharmacists providing evidence-based drug risk assessment and medication advice to the public and healthcare professionals, along with conducting observational studies based on cases, are of significant importance in promoting the the safe use of paternal medications.
Objective To explore the application effect of medication therapy management (MTM) services on the treatment of childhood asthma. Methods A total of 107 children aged 5-11 with asthma who visited the Cough and Asthma Pharmacy Clinic of Hebei General Hospital from July to December 2022 were selected, and randomly divided into the control group (50 cases) and the intervention group (52 cases).The control group of children only received single inhalation medication education services at the first visit. The intervention group received standardized MTM services throughout the entire process. The economic, clinical and human outcomes (ECHO) model was used to analyze the differences between the two groups of children in economic (medication costs, cost-effectiveness ratio), clinical (ACT score, correct rate of inhaled preparation, number of asthma attacks) and humanistic (EQ-5D-5L utility value, Morisky medication compliance, patient satisfaction) results before the intervention, 3 months after the intervention, and 6 months after the intervention, evaluate the application effect of MTM services in children with asthma. Results Compared with the control group, there was no significant difference between the two groups before the intervention. After the intervention, the children in the intervention group showed statistically significant differences in economic, clinical, and humanistic outcomes (P<0.05). Conclusions The MTM service led by pharmacists can benefit children with asthma from multiple dimensions such as economy, clinical practice, and humanities. This not only enables long-term effective control of asthma in children, but also enhances pharmacist pharmacy specialist service capabilities.
Objective To understand the cases of allergic shock induced by iohexol injection, analyze the characteristics of adverse drug reactions (ADRs), and identify potential influencing factors, ensureing the safety of clinical medication. Methods A literature review and bibliometric analysis were conducted on 23 cases of allergic reactions induced by iohexol injections reported in China from 2010 to 2023. Results Among the cases of allergic reactions induced by iohexol injections, 17 cases (73.91%) occurred in males, while 6 cases (26.09%) occurred in females. Individuals aged from 41 to 80 years accounted for a significant proportion (82.61%). Systemic damage was observed in 8 cases (34.78%), neurological damage in 7 cases (30.43%), respiratory and circulatory system damage in 5 cases (21.74%), and skin and appendage involvement in 3 cases (13.04%). The majority of allergic reactions had a rapid onset (72.91%). Patients with pre-existing chronic illnesses and other medical conditions had a higher occurrence rate (82.61%). Conclusions Iohexol injection can lead to allergic reactions influenced by multiple factors. Healthcare professionals should closely monitor adverse reactions, especially severe ones like allergic shock.
Objective To introduce a traceability closed-loop management system for the entire process of drug dispensing in the inpatient department. Methods In line with the requirements for intelligent healthcare construction and six-level electronic medical records development, a paperless drug dispensing process for the inpatient department was designed. A traceability closed-loop management system was established by improving both hardware equipment and software function. The system’s practical effectiveness was evaluated from multiple perspectives. Results With process transformation, the workflow efficiency of doctors, nurses, pharmacists and clinical support staff has been significantly improved. Costs in terms of human resources and materials have been reduced, and the safe and rational use of medication has been promoted. Conclusions The improved process, which is based on the construction of intelligent devices and information technology, achieves a closed-loop and traceable management system for the entire drug dispensing process in the inpatient department. This system offers the benefits of safety, standardization, efficiency, and closed-loop traceability. It reduces the risk of dispensing mistakes, improves the safety of medication and has strong scalability.
Objective To establish and evaluate a talent training system for hospital information pharmacists based on a competency model, thereby enhancing refined management of pharmaceutical affairs in hospitals and promoting high-quality development of pharmacy services. Methods The current development status of hospital information pharmacists at home and abroad was examined. A competency model for hospital information pharmacist positions was established using methods such as behavioral event interviews. In conjunction with this model, training course outlines addressing knowledge and capability requirements were developed. National skill training classes for hospital information pharmacists were conducted using innovative teaching methods like scenario simulation and case discussion. Training effectiveness was evaluated by tracking participants' work performance and scientific research achievements in the field of pharmaceutical information through questionnaire surveys before and after the training. Results The hospital information pharmacist positions competency model was constructed in four parts: knowledge, experience, skills, and personal traits. Based on this model, a training system for hospital information pharmacists was established, which included setting job responsibilities and performance indicators, establishing a pharmacy information department system, designing a series of training courses and publishing textbooks, founding national training classes, creating a specialized question bank, and developing a digital pharmacy network platform. The project team tracked the work performance and scientific research achievements of participants before and after training, using the national hospital information pharmacist training class hosted by the Guangdong Pharmaceutical Association as an example. From 2018 to 2024, a total of 465 information pharmacists from 298 hospitals across 28 provinces and cities were trained over seven sessions. Questionnaires were sent to participants who had completed at least one year since graduation, and 236 valid responses were received. Of these, 169 (71.6%) participants reported playing a major role in pharmacy informatization projects after the training, and 65 (27.5%) participants published papers, applied for projects, or filed for patents after the training, with the majority related to pharmacy automation and informatization. Conclusion A competency model for hospital information pharmacist positions was constructed and applied nationwide, achieving favorable results.
Objective To explore the establishment of a new model of informational drug treatment pathway management. Methods The orthopedic drug treatment pathways was developed through multidisciplinary diagnosis and treatment (MDT), and the pathway management was implemented with the help of an information systems to implement refined control rules. Cases before the implementation of the management pathway (January to May 2022) were selected as the control group, and cases after the implementation of the management pathway (June to December 2022) were selected as the improvement group to evaluate the management effectiveness. Results After establishing drug treatment pathways for 8 major types of surgeries, maintaining 990 medical prescriptions for recommended drugs in the HIS system, and 176 control rules in the MINDS system. There was a significant improvement in the orthopaedic department’s indexes of antimicrobial drug use rate, antibacterial drug use intensity, average inpatient medication cost, and percentage of the amount of basic medication after applying a new model of drug treatment pathway management. According to the case analysis before and after the implementation of the pathway, the rational rate of using orthopedic antibiotics, analgesics, fluid replacement and volume expansion drugs, acid inhibiting and stomach protecting drugs, blood activating and swelling-reducing proprietary Chinese medicines were increased by 21.6%, 12.7%, 23.3%, 32.1% and 27.1%, respectively. The average drug costs was reduced by 111.51 yuan, 15.33 yuan, 49.84 yuan, 42.29 yuan and 14.23 yuan, respectively. Conclusion The management mode of drug treatment pathway based on MDT established by our hospital is practical and effective, and the relevant experience may provide valuable insights for pharmaceutical peers.
Objective To understand and assess the quality status of national drug sampling inspection in 2022 and the possible risks of drug quality. Methods With the aim of identifying issues and preventing risks, a sampling model of "dispersed sampling, centralized inspection, exploratory research, and comprehensive evaluation" was used to review the historical inspection data of national drug sampling. The overall quality and potential risks of national drug sampling in 2022 were analyzed, with a focus on identifying and examining the main quality problems and risks. Results The average pass rate of the sampling inspection in 2022 was 99.4%. The overall safety situation of China's post-marketing drug quality is stable and manageable, indicating that the drug quality is at a high level. Conclusions By carrying out exploratory studies related to drug safety, authenticity, and efficacy, national sampling plays an important role in comprehensively evaluating the quality status of drugs. It aids in improving the quality control level of drug varieties and industry standards, strengthening quality and safety supervision, combating illegal practices such as adulteration and falsification, and providing public warnings about drug safety.