新冠肺炎疫情对医院药物临床试验的影响及对策研究

目的 探讨新冠肺炎疫情期间我院临床试验应对策略及效果,为突发公共卫生事件期间临床试验管理提供参考.方法 以方案依从率、受试者出组率、人均问题检出率为指标评价措施效果.结果 卡方检验显示疫情对疫情期间临床药物试验方案依从造成影响,采取措施后方案依从率提高,差异有统计学意义.疫情期间受试者出组率与2019年同期相比差异有统...     

基于Andersen模型探讨卒中二级预防药物依从性的影响因素

目的 分析卒中二级预防措施中药物治疗依从性的影响因素。 方法 基于Andersen卫生服务利用模型构建卒中二级预防药物依从性影响因素的理论框架,通过二分类logistic回归模型对卒中二级预防药物依从性的影响因素进行分析。 结果 617名卒中患者被纳入本次研究中,患者平均年龄（67±8.16）岁,男性占比50.1%,药物依从比为67.9%。多因素logistic回归模型结果显示,女性、参与城镇职工医疗保险、年均收入2万元以上与二级预防药物依从有关,年龄在70岁以上、有心脏病史和血脂异常病史、MRS评分25分与二级预防药物不依从有关。 结论 卒中二级预防药物依从性偏低,高龄、心脏病史、血脂异常史和较高MRS评分与药物不依从有关,应加强对具有上述影响因素的卒中患者提供预防性干预。     

风险管理在药物临床试验护理工作中的应用

目的:探究风险管理在药物临床试验护理中的作用和效果。方法:选取我院在2015年4月到2018年4月期间所参加药物临床实验的100名患者作为研究对象,按照随机分配方式分为对照组和观察组,对照组采用常规药物试验护理,观察组则采用风险管理模式下的护理实验。对比两组患者风险事件发生率及受试者失败率。结果:观察组患者风险管理模式下患者的风险事件发生人数及受访者失败发生人数显著低于对照组,且差异具有统计学意义。结论:在临床上药物临床实验过程中,通过风险管理方式能够有效的预防和减少风险事故的发生,同时提升受试者的护理满意度等。     

新冠疫情下药物临床试验受试者管理优化

目的 探讨新冠疫情下药物临床试验受试者管理优化策略.方法 回顾性选取2020年1月至2020年10月某院新冠疫情防控下的药物临床试验受试者100例,依据管理优化策略分为信息化管理组(n=50)和常规化管理组(n=50),统计分析两组受试者的访视完成率、受试者依从性和满意度.结果 信息化管理组的访视完成率显著高于常规化管理组(90.0％vs 72.0％,P＜0.05).信息化管理组受试者依从性高于常规化管理组(90.0％vs 64.0％,P＜0.01).信息化管理组受试者满意度显著高于常规化管理组(94.0％vs74.0％,P＜0.01).结论 新冠疫情下药物临床试验受试者信息化管理较常规化管理效果好.     

重复测量等级资料的时间趋势检验

新药临床试验中 ,要求连续观察受试者症状、疗效指标或实验室指标的变化 ,以动态评价药物的有效性和安全性。因对每个受试者都进行了多次随访和观察 ,形成重复测量资料。在这种临床试验中 ,除了试验药物与对照药物疗效的差别外 ,评价主要变量是否随着时间推移而上升或下降也是一个比较重要的问题 ,也就是说主要变量的时间趋势检验。反应变量为等级变量 ,如果重复测量次数较多时 ,目前没有一种比较好的趋势检验方法。现针对这一问题进行讨论 ,把Ｃｏｃｈｒａｎ Ｍａｎｔｅｌ Ｈａｎｓｅｌ检验的非零相关检验应用到重复测量等级资料的时间趋势…     

结核病患者治疗依从性及影响因素分析

中国是世界上仅次于印度的结核病（TB）高负担国家，结核病已成为我国重要的公共卫生问题之一。本调查拟通过对常住人口和流动人口结核病治疗的依从性以及影响治疗依从性的社会经济及临床影响因素的分析，探索在城镇中提高结核病的治疗依从，加强治疗管理，为制订控制结核病对策提供科学依据。     

儿童注意缺陷多动障碍药物依从性及影响因素

注意缺陷多动障碍(ADHD)是儿童和青少年期最常见的神经发育障碍,约影响全世界5%～11%的儿童。药物治疗是6岁以上ADHD儿童首选方案,约70%患者药物治疗有效。多种药物已被应用于ADHD临床治疗,如盐酸哌甲酯和苯丙胺、盐酸托莫西汀及可乐定和胍法辛等。药物副作用、药物剂型、患儿生长速度、家庭因素、患儿用药体验、睡眠问题或障碍等多种因素均会影响药物依从性。医生、父母和患儿共享信息、商讨治疗方案、监测疗效和副作用,并积极开展医教结合、家校结合,实施行为管理和干预,有助于提高依从性、改善治疗效果,促进患儿学业成绩及社会功能、生活质量全面提升。     

瑶族高血压患者治疗依从性调查及相关因素分析

目的通过瑶族高血压患者治疗依从性调查,分析影响高血压治疗依从性的相关因素。方法选取连南瑶族自治县人民医院2014年1月—2016年1月收治的瑶族高血压患者为调查对象,采用自制调查问卷,调查患者的遵医服药行为、正确服药行为、合理日常生活管理行为、合理烟酒嗜好管理行为和治疗依从性总分及其相关因素对血压的影响。结果本次调查共收到有效调查问卷840份。遵医服药行为依从率为54.64%,正确服药行为依从率为41.55%,合理日常生活管理行为依从率为42.06%,合理烟酒嗜好管理行为依从率为56.90%,治疗依从性总分为14.09分;不同年龄组瑶族高血压患者治疗依从性总分差异有统计学意义(P0.001),35~44岁年龄段得分最高(18.05分)。血压监测依从性好的患者有271例,依从率为32.26%,比例不高;血压控制达标的瑶族高血压患者在各方面依从性均高于未达标患者。结论瑶族高血压患者总体治疗依从率比较低,血压控制水平差,应加强医务人员专业技术培训,提高他们的业务水平,积极开展健康教育,提高瑶族患者治疗依从性。     

合理用药管理对于临床常用抗菌药物使用的影响

目的:探究在进行临床常用抗菌药物合理管理时,应用合理用药管理的效果分析,对临床患者依从性造成的影响。方法:将2018年2月至2018年11月作为本次研究实验时段,在该时段内于我院内对药物应用的35例患者开展药事管理手段,同时记录2017年1月至2017年12月间进行药物应用的35例患者,将开展药事管理前的35例患者记录为对照组,而后续开展药事管理手段后的35例患者记录为实验组,对两组患者进行全面用药依从性和用药满意度进行评价,分析管理方式之间的差异。结果:经过本次研究表明:对照组的用药依从评分明显低于实验组,数据对比统计学意义存在(P0.05)。而在实验结果中,实验组患者对药物的应用满意度结果为91.43%优于对照组患者的68.57%,记录P 0.05,差异显著。结论:在医院合理用药管理当中应用药室管理方法能够有效提升患者的用药依从性,提升患者对用药的满意度,具有较高的临床应用价值,值得推广。     

临床试验中对照组的选择

国家药品监督管理局于 1999年 5月 1日颁布的新药审批办法中有关新药的临床研究 ,第四章第 12条规定新药的Ⅱ期临床试验 ,为随机盲法对照试验 ,Ⅲ期临床试验为扩大的多中心临床试验 ,应遵循随机对照原则。本文讨论临床试验中的对照组的设立。一、设立对照组的必要性比较研究是临床试验的重要方法 ,说明一个新药的疗效和安全性 ,必须设对照组。对照组是处于与试验组同样条件下的一组受试者 ,唯一的差别是试验组接受新药治疗 ,对照组则接受对照药物的治疗。设立对照组的目的是判断受试者治疗前后的变化是由试验药物引起的 ,而不是其他原因引起…     

加强医院药物临床试验质量管理的探索

新药研究是临床医学研究的重要组成部分,也是衡量一个医院科研能力的重要标志之一。近年来,本院逐步认识到加强药物临床试验的管理,完善质控的重要性。因此,为了规范药物临床试验的开展,提高质量,严格按照国家药监局颁布的GCP的相关规定,严格遵循GCP“安全性和科学性”的原则,并实施了一系列的举措,包括制定完善各项制度及标准操作规程,加强全员的GCP知识和相关技能的培训,并逐步推行“三级质控”制度,加强试验药物的管理等等。本文总结了近几年本院实施开展药物临床试验管理及质控方面的经验及不足,力求在今后的药物临床试验工作的开展中,确保各项操作规范,数据完整准确,充分保护受试者的利益,并不断强化过程管理,提高药物临床试验质量。     

Weight reduction in the prevention and treatment of hypertension: a review of representative clinical trials

Elevated blood pressure is a risk factor for cardiovascular disease, and weight reduction is currently advocated as a nonpharmacologic approach for the management of hypertension. Results of clinical trials indicate weight reduction is effective in preventing and treating hypertension. Knowledge of the results of clinical trials is extremely important for health educators since: 1) these findings provide a scientific basis for educating other health professionals about the beneficial effects of dietary approaches to the management of hypertension; 2) discussion of these results with patients may provide a means for altering patients' expectations and achieving improved treatment compliance; and 3) the processes by which clinical trials have achieved their dietary goals can provide health educators with extensive clinical experience upon which to draw in working with nonstudy patients. The content and general results of clinical trial programs are reviewed as well as features associated with health promotion in clinical trial and behavioral weight loss research.     

Estimating treatment effect in the presence of non-compliance measured with error: precision and robustness of data analysis methods

Non-compliance with the nominal prescribed dosage causes unintended variability in actual drug exposure during clinical trials. In the ideal case that compliance is not a confounder, and it is known--hence actual dosage is known--true dose-response can be validly estimated. Measuring compliance presents a challenge, however. A simulation study of the case that dosage history questionnaires (C(Q)--usually over-optimistic estimates of actual compliance) are available in all subjects enrolled in a clinical trial, but accurate compliance measurements (C--e.g. from electronic medication event monitors), are only available in a (random) fraction of subjects is reported. It reveals that a 'Maximum Penalized Marginal Likelihood' (MPML) method which uses all compliance data, effectively calibrating C(Q) to C, is superior to other methods which use only one compliance measure, or both, or neither (neither = ITT, intention to treat, which assumes actual dosage equals nominal dosage), but do not calibrate. MPML yields the most precise estimates of dose-response over widely varying clinical trial designs, extremes in quality and quantity of compliance information, and a range of drug effect sizes. It is most beneficial when compliance data are sparse and maintains good performance even when its key assumptions are somewhat violated.     

中西医结合治疗艾滋病依从性的影响因素及对策分析

高效抗逆转录病毒治疗（HAART）是目前治疗艾滋病的有效方法，但它的局限性越来越多地引起学者的关注。中医是我国传统医学，中西医结合治疗艾滋病是近年来学者一直探讨的热点问题。服药的依从性直接影响到治疗效果，然而影响依从性的因素是多方面的，了解这些影响因素开展对策分析和干预是提高依从性的有效措施。     

乙肝患者口服核苷类药物依从性调查及干预策略

目的：了解慢性乙肝患者口服抗病毒药物依从性,对其进行有效干预,提高治疗效果。方法：对160例应用核苷类药物的慢性乙肝患者依从性现状进行调查,将服药依从性好者93例作为观察组,依从性差者67例作为对照组,比较两组患者年龄、自我评估病情、药物费用、肝病认知程度、担心不良反应、医疗费用支付方式、文化程度等方面的差异。结果：服药依从性良好者年龄、自感病情稳定、费用高、肝病认知程度较好、担心不良反应和初中以上文化程度分别是（46.8±5.4）岁、34.41%、47.31%、95.70%、22.58%、86.02%,服药依从性差者则是（51.4±4.7）岁、91.04%、79.10%、22.39%、70.15%、26.87%。结论：慢性乙肝患者口服核苷类药物依从性受多种因素影响,临床医生应依据患者情况设定个体化诊疗方案。     

基于潜在狄利克雷分布模型的我国临床试验管理研究热点及其演化分析

目的 分析国内临床试验管理研究领域的研究主题和热点主题的演化过程,揭示其研究现状。方法 本文采用潜在狄利克雷分布模型(Latent Dirichlet Allocation,LDA)对本领域的研究文献进行主题分析,根据主题生命周期坐标图识别热点主题,基于不同发展阶段热点主题所属文献的关键词分析主题内容的演化脉络。结果 国内临床试验管理领域的主要研究主题有13个。按研究内容可分为两类:临床试验的质量管理类和临床试验受试者权益保护类; 按主题的发展类型可分为:5个具有进一步发展潜力的潜在主题、4个具有分化趋势的衰退主题和4个热点主题。热点研究主题的演化脉络既有自身特点,也呈现出一些共性特征。结论 近年来,我国临床试验管理的研究快速发展。热点主题中,临床试验机构管理研究的落脚点从宏观向微观转变、信息管理系统的设计从独立系统转向多系统的融合开发、受试者的权益保护研究的侧重点在发生变化、受试者依从性研究从关注生理向关注心理转变。     

Clinical Pharmacy Services in the Home

Articles on clinical pharmacy services in the home began appearing 3 decades ago but numbers have greatly increased in the last decade. This overview of the English language literature identified 66 reports describing 57 home-based clinical pharmacy programs. Most programs were provided in the context of a time-limited research project. Medication reviews (defined as comprehensive assessment of the appropriateness of the medication regimen) and medication management (defined as assessment and support of medication compliance) were the most common services provided. Primary care, post-hospital discharge, and home healthcare were the typical service contexts, and elderly patients at high risk of medication problems were the primary target population. The early literature predominantly focused on medication management and patient counseling services based in the US; however, since 1991, reports of medication review programs in the UK and Australia have dominated.Barriers to home-based clinical services have been identified at the healthcare system, pharmacy, pharmacist, physician, and patient levels. The most common barriers are lack of (or inadequate) remuneration and the related barriers of community pharmacy or pharmacist time constraints, and the cost and time to attain and maintain pharmacist qualifications. Other important barriers are difficulty in accessing the physician to discuss drug therapy recommendations, and inadequate patient referrals. Additional barriers pertaining to the delivery of the clinical service include inadequate clinical training of community pharmacists, service provision by a pharmacist unknown to the patient, and limited access to patient information for the pharmacist. Patient barriers are lack of awareness, reluctance to accept an intervention from the pharmacist, inaccessibility, and forgetting appointments or refusing the service after initial agreement.The most commonly cited facilitators pertain to the pharmacist-physician relationship; foremost among these is having an established working relationship between the pharmacist and family physician. Others are face-to-face meetings between pharmacist and prescribing physician, and facilitator positions in Divisions of General Practice. A few facilitators of the referral system, pharmacist motivation, and service delivery have also been identified.Evaluative data were provided for 48 programs; 21 programs were evaluated within a randomized controlled trial. Thirteen of these trials found at least one statistically significant difference between groups; however, although important outcomes such as hospitalization and quality of life were often examined, the only parameter that was affected on a consistent basis was medication compliance (four of six trials).The literature on clinical pharmacy services in the home is growing and maturing. While medication review is the most common type of service reported, several other types of clinical services have been explored in this setting. Although evaluation of impact has become more rigorous over time, the overall evidence is limited and many questions remain about optimal practice models and target patient populations. Given the time intensity of home-based services, it is important that more research be conducted to provide firm evidence of value.     

强化中药应用安全性管理

当前患者在使用中药的问题上存在不少误区，形成了用药的安全隐患。影响中药安全有效的因素可概括为药物因素、医学因素和社会因素。主要表现在：盲信中药无毒副作用或过分顾虑中药的毒性作用等。政府及相关部门应加强有效的管理，以保证中药临床应用的安全性。加强中药应用安全的管理具有十分重要和紧迫的意义。     

Analysis of clinical trials by treatment actually received: Is it really an option?

The primary analysis of a randomized clinical trial should compare patients in their randomly assigned treatment groups (intention to treat analysis). When a substantial number of subjects fail to take a prescribed medication or are switched to a different study medication, it is tempting to consider treatment comparisons using only those subjects with treatment as actually received rather than as prescribed. There are several arguments against this approach: the prognostic balance brought about by randomization is likely to be disturbed; sample size will be reduced; and the validity of the statistical test procedures will be undermined. Further, results of analysis by treatment actually received may suffer from a bias introduced by using compliance, a factor often related to outcome independently of the treatment received, to determine the groups for comparison. The extent and nature of this bias will be related to the definition of compliance in an as treated analysis, a definition which could be unintentionally self-serving. We have investigated the problem of the definition of actual treatment in the context of a recent clinical trial. We used several definitions to classify patients as having received or not received treatment as prescribed. These definitions, when used in as treated analyses, provided results that were at times inconsistent or counter-intuitive, and which neither helped to confirm nor further explain the intention to treat analysis.     

Estimation of treatment effect for the sequential parallel design

The sequential parallel clinical trial is a novel clinical trial design being used in psychiatric diseases that are known to have potentially high placebo response rates. The design consists of an initial parallel trial of placebo versus drug augmented by a second parallel trial of placebo versus drug in the placebo non-responders from the initial trial. Statistical research on the design has focused on hypothesis tests. However, an equally important output from any clinical trial is the estimate of treatment effect and variability around that estimate. In the sequential parallel trial, the most important treatment effect is the effect in the overall population. This effect can be estimated by considering only the first phase of the trial, but this ignores useful information from the second phase of the trial. We develop estimates of treatment effect that incorporate data from both phases of the trial. Our simulations and a real data example suggest that there can be substantial gains in precision by incorporating data from both phases. The potential gains appear to be greatest in moderate-sized trials, which would typically be the case in phase II trials.