改进中药临床试验报告的参考条目

doi:10.3736/jcim20080302

Abstract

In order to improve the quality of reporting Chinese herbal medicine (CHM) trials, an elaborated checklist was developed according to the basic characteristics of traditional Chinese medicine (TCM) and on the basis of the Reporting Randomized Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. This checklist adopted the 22 items of the Herbal CONSORT Statement with some necessary elaboration and modification in the detailed contents of 11 items, among which, the items of Participants, Intervention, Control group and Outcomes were elaborated and modified accordingly to adapt TCM characteristics. Since the design and reporting of trials on Chinese proprietary medicine and herbal decoctions are different in some aspects, the checklist provided two sets of elaborated item 4 (interventions). We hope that authors, journal editors and peer reviewers find this checklist instructive

Key words: Chinese herbal drugs, clinical trials, trial report, Consolidated Standards of Repo

CLC Number:

R-62

Yu-tong Fei, Jian-ping Liu. Improving the quality of reporting Chinese herbal medicine trials: an elaborated checklist. Journal of Chinese Integrative Medicine, 2008, 6(3): 233-237.

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项目	编号			细则
标题和摘要	1			Ⅰ 标题和摘要中至少有一处明确说明试验类型（如随机对照临床试验）
				Ⅱ 结构化摘要（如目的、方法、结果、结论）*
				Ⅲ 报告试验组和对照组的全部用药名称和剂型,包括中药（含复方）的药方名（或产品名）和剂型
				Ⅳ 摘要报告重要结果的具体数据和结论*
引言
背景	2			Ⅰ 进行此项试验的理由及研究的重要性（简短说明）
				Ⅱ 所研究疾病的流行病学特点、中医和现代医学治疗现状
				Ⅲ 中药组方或单味药的中医药理论/应用依据^△
				Ⅳ 中药组方或单味药的现代医学/药理学研究证据^△
				Ⅴ 说明选择对照组干预手段的理由及其相关临床试验和药理学证据*
				Ⅵ 若干预措施有随证加减,需说明加减的中医药理论依据^△
				Ⅶ 说明干预措施实施者的确定是否存在选择性和目的性及其存在的原因*
方法
受试者		3		Ⅰ 试验进行的场所名称、级别及试验中心数量
				Ⅱ 伦理委员会审查结果,受试者是否知情同意*
				Ⅲ 病例来源：门诊或住院
				Ⅳ 若靶疾病名称为西医病名,则必须有西医诊断标准,并提供国际疾病分类（International Classification of Diseases, ICD）ICD-10或11的疾病编码
				Ⅴ 若靶疾病名称为中医病名,则必须有中医诊断标准,要求报告出处△
				Ⅵ 纳入标准和排除标准均要求单列小标题明确表述,应反映中医辨证内容,如不需辨证,则应加以说明△
干预		4		详细描述每组的干预措施（包括药物名称、组成、质量控制、给药时间和方法、中医组方及加减药味依据）。具体如4A-4E所列。
中成药		4A：制剂基本信息		Ⅰa 中成药的商品名、生产商和药品批号
				Ⅱa 该药品在试验实施地是否经过注册
				Ⅲa 该药品是否有保留样品、保留地和样品编号
				Ⅳa 药品类型（复方制剂/单味药制剂/提取物等）、剂型和规格
				Ⅴa 如果药品为从植物、动物、矿物等物质中提取的有效成分或有效部位及其制剂,则必须报告该有效成分或有效部位的名称（同时报告中文、拉丁文和英文名）
				Ⅵa 若为中药复方或单味药制剂,在不影响知识产权的前提下,说明复方中全部药材名称（同时报告中文名及其拼音、拉丁名、英文名）及含量（或比例）
		4B：给药方案		Ⅰa 给药方法、时间、剂量、疗程及注意事项^△
汤药^▲		4A：制剂基本信息		在不影响知识产权的前提下,要求报告下列内容。
				Ⅰb 每种药材的正规中文名称及其拼音、拉丁名、英文名、组方（药物及用量）
				Ⅱb 药材或饮片的来源（产地、采摘季节、药用部位）及炮制方法^△
				Ⅲb 药材是否有保留样品,储存地和编号
				Ⅳb 汤药的制备者和煎煮的具体方法^△
				Ⅴb 若是在固定方基础上随证加减,则须报告加减的药物和用量^△
		4B：给药方案		Ⅰb 给药方法、时间、剂量、疗程及注意事项^△
		4B：给药方案		Ⅱb 如果存在辨证论治,请说明给药方案是否发生改变^△
共有^□		4C：定性或定量检验		Ⅰ 条件许可应报告药材和（或）中药产品的化学指纹及其检测方法、检测者和质量标准
		4C：定性或定量检验		Ⅱ 描述进行过的全部特殊检验和纯度测定（如重金属或其他污染物测定）
		4D：安慰剂或对照干预*		Ⅰ 若用安慰剂对照,必须说明安慰剂的制备原料、方法、厂家及能表明安慰剂可靠性的检测结果*
				Ⅱ 若对照为西药,则需报告其商品名、化学名、生产商及药品批号*
				Ⅲ 若对照为中成药,则也要达到以上4A~4C的要求*
				Ⅳ 若用其他非药物疗法（如针灸、气功、生活方式干预等）作为对照,则须报告方案、操作方法和疗程*
				Ⅴ 若用天然药物或保健品作为对照,可参照以上中药的条目来报告*
		4E：联合治疗及变异度*		Ⅰ 详细说明所有联合使用的干预措施的细节*
		4E：联合治疗及变异度*		Ⅱ 如果试验允许或设计为非标准化或不严格标准化的干预措施和（或）对照措施,必须清楚报告试验实施中允许的变异度*
		4F：研究人员		描述实施治疗的中医师的标准（包括教育背景、职称、资格及专科领域临床经验等）和试验前培训情况
目标		5		明确的目标和假说（多在文章开头或背景中说明）
结局		6		Ⅰ 清楚定义主要和次要结局指标。建议除测量替代指标和可行的终点指标外,还应测量症状指标、生活质量、卫生经济学和安全性指标*
				Ⅱ 说明各种指标的具体检测方法和测量时间点
				Ⅲ 说明是否采用多次检测和结局评价者培训等方法以提高测量质量
样本量		7		详细清楚地说明样本量计算的方法及结果
随机				说明是否采用了随机的方法分配受试者入组,如果是,请说明如下要点。
序列产生		8		产生随机序列的方法,如计算机随机生成和随机排列法等
分配隐藏		9		说明是否有分配隐藏,如果有,其具体方法和起止时间如何
实施		10		介绍生成分配序列的研究人员和分配受试者的研究人员
盲法		11		Ⅰ 说明是否使用了盲法,若未用,则需说明理由*
				Ⅱ 如果用了盲法,则应说明盲法的对象,包括受试者、干预措施实施者、结局评价者和统计人员
				Ⅲ 如果用了盲法,报告评价盲法是否成功的方法
				Ⅳ 如果用了盲法,说明试验中止、终止和破盲标准及方法*
统计方法		12		Ⅰ 说明统计方法的名称和结果统计量值
				Ⅱ 保持统计报告方法与文章“方法”部分一致*
				Ⅲ 至少有一项关键结局指标结果有组间统计比较
结果
流程图			13	推荐报告流程图,特别是报告参加随机分组、接受治疗、完成研究方案和参加主要结果分析的受试者数目
募集受试者			14	Ⅰ 明确定义募集受试者的时间
募集受试者			14	Ⅱ 明确定义随访的时间
基线资料			15	基线人口统计学、临床特征和联用其他医疗措施的情况,报告组间可比性
数据分析			16	Ⅰ 如果存在退出或失访,必须报告退出和失访的例数及退出的理由
				Ⅱ 结局指标中至少有一项主要结局指标的测量结果来自超过85%的最初纳入试验的全部受试者*
				Ⅲ 报告纳入每一结局分析的受试者数,若不存在退出和失访,则须报告所有受试者的所有结局指标检测结果;若存在退出和（或）失访,则至少应该对一项重要结局指标结果进行意向性分析
结局或估计值			17	Ⅰ 保持结果报告指标与观察指标（文章“方法”部分）一致*
结局或估计值			17	Ⅱ 全部指标均报告具体数据[包括效应值和（或）精确度]和文字说明
辅助分析			18	报告进行的其他分析,包括亚组分析和校正分析等,说明进行该分析的原因
不良事件			19	各组所有重要不良事件或副作用
讨论
解释			20	Ⅰ 根据产品或给药方案解释结果
				Ⅱ 对中医辨证、治则和组方的必要解释和说明^△
				Ⅲ 对结果可能存在的方法学偏倚的解释
				Ⅳ 对结果效应及其精确性的解释
可推广性			21	针对中药产品和给药方案,讨论试验结果和结论的可推广性^△
综合证据			22	Ⅰ 根据当前证据（本试验之外的证据）对结果进行概括性解释
综合证据			22	Ⅱ 报告可能存在的利益冲突,如研究实施者、统计分析者和报告撰写者与资助方之间的关系*

References 8

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