Analysis of the Current Situation of Drug Clinical Trial Institutions in Shaanxi Province

To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.

Appropriateness of Amikacin Dose Prescription, Monitoring and Safety during Hospitalization as an Impact of Clinical Pharmacologist Intervention, in the Israeli Regional Hospital

Background: Use of inappropriate amikacin dose is one of the most important factors in inducing toxicity, prolonged hospitalization as well as in increasing patient’s mortality. Objective: The aims of this study are the analysis of amikacin dose, serum level and the examination of the effectiveness of the clinical pharmacologist (CP) therapeutic drug monitoring (TDM) intervention to guarantee the safety of amikacin use. Methods: This is a one-year retrospective observational chart review study, which evaluates amikacin dose, serum drug level, development of adverse effects in patients on amikacin with or without CP TDM consultation. Results: Amikacin was prescribed for 393 complex patients, with median age 83. Amikacin group (AG) included 140 (32%) courses with CP consultation (AG1) and 292 (68%) courses without CP consultation (AG2). The distribution of most study characteristics in both groups was similar including amikacin dose (9-10 mg/kg/day), renal failure (14%) and mortality (12%). Acceptance for CP consultation was in 46% of amikacin courses and dose changes were done in 63% after CP intervention. Prolonged antibiotic course (4.6 ± 1.5 vs 3.8 ± 1.6 days, p < 0.0001) and the patient’s hemodynamic instability (15% vs 7%, p = 0.01) were more frequent in the AG1 compared to the AG2. There was a strong association between CP consultation and prolonged hospitalization (p = 0.005), while no association between it and amikacin adverse effects, renal failure or mortality. Conclusions: There was no trend to reducing amikacin toxicity, days of hospitaliza tion or mortality in patients with CP consultation. CP TDM intervention was more in the management of complicated clinical situations. However, it is necessary to optimize it.

Quality Management Model for Phase I Clinical Drug Trials:A Structural Equation Model

This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials.Exploratory and confirmatory factor analyses were used to develop the survey tool.Structural equation modeling was used to construct a quality management model for phase I clinical drug trials.The results showed that the final survey tool had good reliability and validity(Cronbach’sα=0.938,root mean square error of approximation=0.074,comparative fit index=0.962,and Tucker—Lewis index=0.955).The model included five dimensions:government regulation,industry management,medical institution management,research team management,and contract research organization(CRO)management.In total,22 measurement items were obtained.The structural equation model indicated government regulation,industry management,medical institution management,and CRO management significantly affected the quality of phase I clinical drug trials(β=0.195,β=0.331,β=0.279,andβ=−0.267,respectively;P<0.05).Research team management had no effect on the quality of trials(β=0.041,P=0.610).In conclusion,the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.

The Assessment of the Clinical Effect of the Drug Compatibility and Course of Treatment to the Brucellar Spondylitis

Objective: To evaluate five drug treatment regimens in the treatment of Brucella spondylitis. Methods: Patients with clinical symptoms compatible and diagnostic test consistent with Brucella spondylitis were randomly assigned to five drug treatment regimens. Results: Combination therapy with doxycycline, rifampin and sulfamethoxazole for 56 consecutive days showed the highest cure rate of 20% after a single course and of 85% after a double course with affectivity rates of 55% and 95%. Cure rate and affectivity rate was significant better (P 0.05) than for patients receiving doxycycline, rifampin and streptomycin for the same period and regimens containing doxycycline were significant better than regimens without this drug. Conclusion: Combination therapy of doxycycline, rifampin and sulfamethoxazole for 8 weeks using one or two full courses should be recommended for Brucella spondylitis.

The Role of Study Nurses in Clinical Trials of IBD Drugs

Objective: To explore the establishment and roles of study nurses in IBD drug clinical trials. Methods: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. Results: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. Conclusions: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.

The Expanding Roles of Hospital Pharmacists in Clinical Drug Trials in China

Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and responsibilities of Chinese hospital pharmacists were listed and categorized.Results and Conclusion There has been an upsurge in clinical drug trials in China.Hospital pharmacists play increasingly important roles in all aspects of clinical trials,such as stakeholder liaisons,protocol developers,ethics committee members,research team members,study drug managers,and subject intervention agents.Hospital pharmacists are an integral part of a clinical drug trial multidisciplinary team.Their value is reflected in several pharmacist-led or pharmacist-participating clinical trials as well as the trial project management position within hospitals.Pharmacists should be the designers,researchers,managers and supervisors of clinical drug trials.We expect that all clinical trial projects will include hospital pharmacists in their research teams soon.

PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF NEW DRUGS FROM CLINICAL PHARMACOLOGY STUDIES

The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-

Assessment of drug-induced hepatotoxicity in clinical practice: A challenge for gastroenterologists

Currently, pharmaceutical preparations are serious contributors to liver disease; hepatotoxicity ranking as the most frequent cause for acute liver failure and post-commercialization regulatory decisions. The diagnosis of hepatotoxicity remains a difficult task because of the lack of reliable markers for use in general clinical practice. To incriminate any given drug in an episode of liver dysfunction is a step-by-step process that requires a high degree of suspicion, compatible chronology, awareness of the drug’s hepatotoxic potential, the exclusion of alternative causes of liver damage and the ability to detect the presence of subtle data that favors a toxic etiology. This process is time-consuming and the final result is frequently inaccurate. Diagnostic algorithms may add consistency to the diagnostic process by translating the suspicion into a quantitative score. Such scales are useful since they provide a framework that emphasizes the features that merit attention in cases of suspected hepatic adverse reaction as well. Current efforts in collecting bona fide cases of drug-induced hepatotoxicity will make refinements of existing scales feasible. It is now relatively easy to accommodate relevant data within the scoring system and to delete low-impact items. Efforts should also be directed toward the development of an abridged instrument for use in evaluating suspected drug-induced hepatotoxicity at the very beginning of the diagnosis and treatment process when clinical decisions need to be made. The instrument chosen would enable a confident diagnosis to be made on admission of the patient and treatment to be fine-tuned as further information is collected.

Demographic, Clinical and Biochemical Characteristics of Drug Naive Type 2 Diabetes Patients of Bangladesh

Background: Although the frequencies of getting drug naive type 2 diabetes patients among all the diabetic patients are very low, nowadays it claims more attention in the treatment procedures of drug naive diabetic patients. But in Bangladesh, we have very few research-oriented data regarding the demographic, clinical and biochemical characteristics of drug naive type 2 diabetes patients. The aim of this study was to determine the demographic clinical and biochemical characteristics of drug naive type 2 diabetes patients of Bangladesh. Methods: This was an open label observational real-life study which was conducted in the chambers of the investigators in several places of Bangladesh as outdoor setting during the period from August 2020 to December 2020. In total, 250 patients with drug naive type 2 diabetes mellitus were enrolled as the study population. Proper written consents were taken from all the participants before starting data collection. A pre-designed questionnaire was used in patient data collection. All data were processed, analyzed and disseminated by MS Office and SPSS version as per need. Result: Two hundred and fifty (250) participants were selected as study population. The male-female ratio of the participants was 1.4:1. The highest number of participants was from 51 - 60 years’ age group (31.20%). The highest number of participants (41%) was with overweight (BMI: 25 - 30 kg/m2). Majority (65%) of the patients of this study suffered from diabetes for ≤5 years. The mean (±SD) SBP of the participants was 137.25 ± 17.50 mmHg and the mean (±SD) DBP of the participants was 85.16 ± 13.39 mmHg. We found the mean (±SD) fasting blood sugar (mg/dl), post prandial blood sugar (mg/dl), total cholesterol (mg/dl), triglycerides (mg/dl), HDL-Cholesterol (mg/dl), LDL-cholesterol (mg/dl), VLDL-cholesterol (mg/dl), uric acid (mg/dl), creatinine (mg/dl), urea (mg/dl), total bilirubin (mg/dl), direct bilirubin (mg/dl), SGOT (IU/L) and SGPT (IU/L) were 251.51 ± 112.08, 349.72 ± 128.68, 219.59 ± 68.25, 196.44 ± 94.34, 35.14 ± 11.85, 145.72 ± 64.33, 40.88 ± 18.12, 3.45 ± 1.51, 0.86 ± 0.37, 29.16 ± 9.81, 0.87 ± 0.4, 0.48 ± 0.4, 37.15 ± 10.9 and 35.83 ± 23.04 respectively. Conclusion: Obesity and hypertension demand more attention of diabetologists in diagnosis and treatment of patients or suspected patients of diabetes. Patients aged ≥ 50 years are most vulnerable and suspicious for diabetes. Besides age consequence habits of tobacco smoking, family history, smoking and HTN, alcohol intake and presence of nitrites in the urine may be considered as the most potential comorbidities for diabetic patients. Diagnosis of demographic, clinical and biochemical characteristics of drug naive type 2 diabetes patients may play a vital role in proper treatment.

Clinical Observation and Safety Evaluation of Zhuang Medicine Xiaoyan Zhiyang Formula for Dermatosis

[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 females,115 cases of contact dermatitis and 110 cases of acute eczema.Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated.[Results]After one week of treatment,among 225 patients with contact dermatitis and acute eczema,76 cases were cured(33.78%),133 cases showed marked response(59.11%),16 cases(7.11%)were improved,0 case was ineffective,and the overall response rate was 92.89%.After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment,the symptoms of itching,pain and swelling were significantly improved in all patients,and the rash was partially crusted without new symptom,and there were no complications and adverse reactions.[Conclusions]Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.

Clinical decision support for drug related events: Moving towards better prevention

Clinical decision support(CDS) systems with automated alerts integrated into electronic medical records demonstrate efficacy for detecting medication errors(ME) and adverse drug events(ADEs). Critically ill patients are at increased risk for ME, ADEs and serious negative outcomes related to these events. Capitalizing on CDS to detect ME and prevent adverse drug related events has the potential to improve patient outcomes. The key to an effective medication safety surveillance system incorporating CDS is advancing the signals for alerts by using trajectory analyses to predict clinical events, instead of waiting for these events to occur. Additionally, incorporating cutting-edge biomarkers into alert knowledge in an effort to identify the need to adjust medication therapy portending harm will advance the current state of CDS. CDS can be taken a step further to identify drug related physiological events, which are less commonly included in surveillance systems. Predictive models for adverse events that combine patient factors with laboratory values and biomarkers are being established and these models can be the foundation for individualized CDS alerts to prevent impending ADEs.

基于Clinicaltrials.gov平台的口腔鳞状细胞癌临床研究注册特点分析

目的:基于Clinicaltrials.gov平台分析全球口腔鳞状细胞癌(oral squamous cell carcinoma,OSCC)的临床研究注册特点,了解研究现状和发展趋势,为OSCC临床研究和诊疗提供新思路。方法:通过挖掘Clinicaltrials.gov平台建库至2023年3月24日已注册的OSCC临床试验数据,从年度趋势、地域分布、临床分期、研究类型、受试者人数、经费来源、机构数量等多方面进行统计分析,归纳其临床研究特征。结果:共纳入OSCC临床注册研究332项,注册数量最多的3个国家是美国(188项,56.63%),中国(37项,11.14%)和法国(18项,5.42%)。332项研究中干预性研究和观察性研究分别占83.43%和16.57%,277项干预性试验中药物干预204项(73.65%),其中单克隆抗体药物研究79项(28.52%),顺铂60项(21.66%)。119项平行试验中105项(88.24%)采用随机方法,44项(36.97%)为盲法。332项研究中约1/3(111项,33.43%)归属于Ⅱ期临床试验,受试者人数在50以下的占比超过一半(177项,53.31%)。结论:OSCC的临床研究存在地区不均衡性,多中心大样本随机三盲对照的高质量临床研究不足,应加强临床试验注册的培训和审查,以促进OSCC临床试验高质量的开展,推动其治疗方案的优化。

基于OBE理念的药物临床试验课程教学改革研究

首都医科大学将成果导向型教学(OBE)理念引入药物临床试验课程教学改革中。教师针对课程教学内容更新速度快、教学方式传统陈旧、考评模式较为单一等普遍存在的问题,以学生为中心组织和引导教学过程,优化教学大纲、改善教学方法、提升自身教学能力、完善学生评价体系,有效提升了教学产出和学生的创新性学习能力,可为相关课程教学改革提供借鉴。

广东省药物临床试验机构备案情况及监管现状分析

目的:了解广东省药物临床试验机构备案形势、临床试验开展情况和临床试验机构监管现状,为监管相关工作提供参考。方法:从药物临床试验机构备案管理信息系统提取药物临床试验机构备案信息,通过电子调查问卷收集药物临床试验项目数量,梳理汇总药物临床试验机构监督检查情况,并从多个维度统计分析相关数据。结果:截至2023年12月31日,广东省共备案140家药物临床试验机构,主要为三级甲等公立医院,累计备案118个专业。备案药物临床试验机构分布于19个地级市,其中位于广州市的药物临床试验机构(占比32%)承接了广东省78%的药物临床试验。监督检查中发现一些机构在组织管理、责任意识和伦理审查方面尚存在问题,新备案机构尤为突出。结论:药物临床试验机构备案制的施行促进了广东省药物临床试验资源的释放,但凸显了技术层次不齐、专业布局不合理和区域发展不均衡等制约资源有效利用的问题。建议监管部门从加强指导服务力度方面完善监管机制,助力提升药物临床试验资源的利用效率,进而推动广东省药物临床试验机构健康发展。

儿童侵袭性肺炎链球菌病伴坏死性肺炎临床特点、耐药性和预后不良相关因素分析

目的探讨儿童侵袭性肺炎链球菌病(IPD)伴坏死性肺炎(NP)临床特点、耐药性和预后不良相关因素。方法选取2018年6月—2022年6月西安交通大学第一附属医院IPD伴NP患儿158例(观察组),以同期92例肺炎支原体感染NP患儿作为对照组。比较2个组患儿临床特征和实验室相关指标检测结果。对肺炎链球菌进行体外药物敏感性试验。根据预后情况将IPD伴NP患儿分为预后不良组(26例)和预后良好组(132例)。采用多因素Logistic回归分析筛选IPD伴NP患儿预后不良的影响因素,并构建预测IPD伴NP患儿预后不良的列线图模型。采用受试者工作特征(ROC)曲线评价列线图模型的预测效能。结果观察组发热时间、气促发生率和C反应蛋白(CRP)、白细胞(WBC)计数、中性粒细胞绝对数(NEUT#)、肿瘤坏死因子α(TNF-α)、降钙素原(PCT)水平,以及胸腔积液乳酸脱氢酶(LDH)、WBC计数、葡萄糖水平均显著高于对照组(P<0.05)。肺炎链球菌对万古霉素、左氧氟沙星和利奈唑胺较敏感,对红霉素、克林霉素的敏感率较低。CRP>161.75 mg·L^(-1)、WBC计数>20.24×10^(9)/L、NEUT#>0.86×10^(9)/L、PCT>2.98μg·L^(-1)、血钠<2.24 mmol·L^(-1)、血钙<136.35 mmol·L^(-1)与IPD伴NP患儿预后不良有关(P<0.05)。结论IPD伴NP患儿发热时间长,易发生气促,感染菌株对万古霉素、左氧氟沙星和利奈唑胺较敏感。高水平CRP、WBC、NEUT#、PCT和低水平血钠、血钙与IPD伴NP患儿预后不良有关。

药物临床试验培训导入临床药学教学的分析与思考

基于国家大健康产业、医药产业创新发展对临床药学和临床试验人才数量和质量的新需求,初步探讨在临床药学人才教学中导入药物临床试验相关理论、实践的必要性和方式。依据院校临床药学培养教学内容和特点,将临床试验相关理论和实践整合到临床药学培养的不同阶段开展教学,在临床药学基础理论教学中导入药物临床试验理论和案例教学,在临床药学毕业实践中进行临床试验实践教学提升能力,在临床药学研究生培养阶段进行临床试验创新培养。一方面提高临床药学专业学生实践能力,扩大临床试验人才培养路径;另一方面提升临床药学学生的创新思维和能力,满足社会大健康产业多元需求。

医药联合门诊在老年患者合理用药管理中的工作模式探讨及成效分析

目的介绍南京医科大学第二附属医院老年患者医药联合门诊的工作模式与成效,分析优点与不足,以期为其他药学门诊的建立提供参考。方法选取2019年7月至2022年7月年于该门诊就诊并建立完整随访档案的680例患者,统计分析其一般情况、疾病及用药情况、药物治疗相关问题、药学服务内容等。结果680例患者中53.82%患有高血压,51.91%患者同时患有3种及以上慢性疾病,43.82%患者同时使用4~6种药物。680例患者中有441例存在854个药物治疗问题,平均1.94个/人。其中类型最多的是用药依从性问题,占38.17%。药师干预后患者依从性评分显著提高(P<0.05)。结论药师通过建立医药联合门诊,参与老年患者慢性病药物治疗管理,显著改善患者依从性,提高药物治疗有效性和安全性,进一步促进合理用药。

临床药师参与会诊在特殊使用级抗菌药物规范管理中的作用

目的 规范特殊使用级抗菌药物的合理使用。方法 比较特殊使用级抗菌药物会诊系统上线前后特殊使用级抗菌药物的用药频度(DDDs)、抗菌药物使用强度(AUD)、使用量占比、销售额、多重耐药菌检出率。结果 会诊系统上线后,临床药师参与特殊使用级抗菌药物会诊率达80.28%,临床医师采纳率为90.99%。与2021年相比,2022年特殊使用级抗菌药物的DDDs、AUD、使用量占比及销售额均显著下降(P <0.05);多重耐药菌检出率下降,以耐甲氧西林金黄色葡萄球菌最显著(P <0.05)。结论 临床药师参与特殊使用级抗菌药物的会诊,可促进特殊使用级抗菌药物的合理使用,延缓细菌耐药。