临床试验报告的统一标准(Consolidated Standards of Reporting Trials，CONSORT)作为针对西医临床研究的规范，其内容未涉及到中医药的独特理论、方法等特征内容，因此也无法体现中医药临床研究的特色。因此，制定了中药复方临床试验报告的统一标准(CONSORT for Chinese Herbal Medicine formulas, CONSORT - CHM Formulas)，其适用范围为中医药的药物临床试验。本文主要介绍CONSORT-中药复方(CONSORT - CHM Formulas)概述。
关键词：CONSORT; 中医药临床随机对照试验报告规范; CONSORT中药复方; 随机对照试验; 报告规范
一、CONSORT-中药复方背景
传统中医药学(Traditional Chinese Medicine, TCM)是历史最悠久的具备独特和完整理论的医学体系之一，在我国医疗体系中拥有重要的地位，且越来越受到国际上关注。中药复方(Chinese Herbal Medicine formulas, CHM Formulas)是TCM临床治疗最主要的形式。目前已有数万篇与中药复方相关的临床试验报告发表，但其报告质量并不理想。这不仅降低了人们对中医药的价值的认识，影响了读者或审稿专家对其疗效和安全性的判断，也易引起各界对中医药的怀疑和批评。因此，中医药学临床专家、方法学家、流行病学家和医学期刊编辑组的共同协作完成了CONSORT–中药复方(以前称中医药临床随机对照试验报告规范，CONSORT for TCM)的制定。
2007年，CONSORT–中药复方初稿以中、英文形式同时发表并公开征求意见，包括1张含有22项条目的清单和1张流程图。2012年底，结合CONSORT 2010声明和各方反馈的意见和建议，工作组执行委员深入讨论并修订了CONSORT-中药复方的相关内容。2013年6月，执行委员将修改内容整理后分发给全部工作组成员并征求反馈意见，最后于2016年底完成了CONSORT-中药复方的修订。 CONSORT–中药复方2017是在 CONSORT 2010 声明的基础上，结合TCM中“证”的概念和中药复方特点形成的报告规范。清单新增了1项子条目“关键词”(条目1c)，且对文题和摘要(条目1a和1b)、背景和目的(条目2a和2b)、受试者(条目4a)、干预措施(条目5)、结局指标(条目6a)、可推广性(条目21)和解释(条目22)等7项条目进行了补充或修订，另依据中药复方的特点对“危害”(条目19)的解释重新进行了阐述。此扩展版也结合了“干预措施的描述和重复的框架”的具体内容(Template for Intervention Description and Replication, TIDieR)。
二、CONSORT-中药复方条目清单
表1 中药复方临床试验报告的统一标准条目清单中英文对照
| 内容 | 条目 序号 | 标准清单内容 | 中药复方扩展版内容 |
| Title, abstract, and Keywords 文題、摘要和关键词 | 1a | Identification as a randomizedtrial in the title 在题目中体现随机化试验 | Statement of whether the trial targets a TCM Pattern, a Western medicine–defined disease, or a Western medicine–defined disease with a specific TCM Pattern, if applicable 说明中药临床试验是针对某个中医证型、某个西医定义的疾病或某个具有特定中医证型的西医定义的疾病(如适用) |
| 1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 结构化摘要，包括试验设计、方法、结果和结论(详见CONSORT摘要) | Illustration of the name and form of the formula used, and the TCM Pattern applied, if applicable 说明复方的名称、剂型及所针对的中医证型(如适用) | |
| 1c | Determination of appropriate keywords, including “Chinese herbal medicine formula” and “randomized controlled trial” 确定适当的关键词，包括“中药复方”和“随机对照试验” | ||
| Introduction 引言 | |||
| Background and objectives 背景和目的 | 2a | Scientific background and explanation of rationale 研究的科学背景和试验的理由 | Statement with biomedical science approaches and/or TCM approaches 基于生物医学理论和/或传统中医学理论的解释 |
| 2b | Specific objectives or hypotheses 研究目的或假设 | Statement of whether the formula targets a Western medicine–defined disease, a TCM Pattern, or a Western medicine–defined disease with a specific TCM Pattern 说明中药临床试验是针对某个中医证型、某个西医定义的疾病或某个具有特定中医证型的西医定义的疾病(如适用) | |
| Methods 方法 | |||
| Trial design 试验设计 | 3a | Description of trial design ( such as parallel, factorial ), including allocation ratio 试验设计(如平行、析因设计)，包括分配比 | |
| 3b | Important changes to methods after trial commencement ( such as eligibility criteria ), with reasons 试验开始后方法上的重要改变(如研究对象选标准的改变)及原因 | ||
| Participants 研究对象 | 4a | Eligibility criteria for participants 研究对象的纳入排除标准 | Statement of whether participants with a specific TCM Pattern were recruited, in terms of 1) diagnostic criteria and 2) inclusion and exclusion criteria. All criteria used should be universally recognized, or reference given to where detailed explanation can be found. 如招募特定中医证型的受试者，应详细说明其1) 诊断标准和2) 纳入和排除标准。须使用公认的诊断标准，或提供参考出处，使读者能查阅详细解释 |
| 4b | Settings and locations where the data were collected 数据收集的机构和地点 | ||
| Interventions 干预 | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 各组干预的详细内容，包括何时、如何实际开展，以便能够重复 | Description(s) for different types of formulas should include the following: 不同类型的中药复方，应包括以下内容： 5a. For fixed CHM formulas 1. Name, source, and dosage form (e.g., decoctions, granules, powders) 2. Name, source, processing method, and dosage of each medical substance. Names of substances should be presented in at least 2 languages: Chinese (Pinyin), Latin, or English. Names of the parts of the substances used should be specified. 3. Authentication method of each ingredient and how, when, where, and by whom it was conducted; statement of whether any voucher specimen was retained, and if so, where they were kept and whether they are accessible 4. Principles, rationale, and interpretation of forming the formula 5. Reference(s) as to the efficacy of the formula, if any 6. Pharmacologic study results of the formula, if any 7. Production method of the formula, if any 8. Quality control of each ingredient and of the product of the formula, if any. This would include any quantitative and/or qualitative testing method(s); when, where, how, and by whom these tests were conducted; whether the original data and samples were kept, and, if so, whether they are accessible. 9. Safety assessment of the formula, including tests for heavy metals and toxic elements, pesticide residues, microbial limit, and acute/chronic toxicity, if any. If yes, it should be stated when, where, how, and by whom these tests were conducted; if the original data and samples were kept; and, if so, whether they are accessible. 10. Dosage of the formula, and how the dosage was determined 11. Administration route (e.g., oral, external) 5a. 固定组成的中药复方 1. 复方的名称、出处和剂型(如汤剂、颗粒剂、散剂) 2. 复方中所有组成药物的名称、产地、炮制方法和剂量。中药名称最少以2种文字表示：中文(拼音)、拉丁文或英文，同时建议注明入药部位 3. 说明每种药物的认证方法，以及何时、何地、由何人或何机构、如何进行、说明有无保留样本。如有，说明在何处保存及可否获得 4. 组方原则、依据及方解 5. 支持复方疗效的参考资料，如有 6. 复方药理研究，如有 7. 复方制作方法，如有 8. 每种药物及复方的质量控制方法，如有。包括任何定量和/或定性测试方法，以及何时、何地、如何和由何人或何机构进行，原始数据和样品在何处保存，可否获得 9. 复方安全监测，包括重金属和有毒元素试验、农药残留试验、微生物限量试验、急性/慢性毒性试验，如适用。如有，在何时、何地、如何和由何人或何机构进行，原始数据和样本在何地保存，可否获得 10. 复方剂量、及其制定依据 11. 给药途径(如口服、外用) 5b. For individualized CHM formulas 1. See recommendations 5a 1–11 2. Additional information: how, when, and by whom the formula was modified 5b. 个体化中药复方 1. 参见5a第1-11项的报告内容 2. 附加资料：复方如何、何时和由何人进行加减 5c. For patent proprietary CHM formulas 1. Reference to publicly available materials, such as pharmacopeia, for the details about the composition, dosage, efficacy, safety, and quality control of the formula 2. Illustration of the details of the formula, namely 1) the proprietary product name (i.e., brand name), 2) name of manufacturer, 3) lot number, 4) production date and expiry date, 5) name and percentage of added materials, and 6) whether any additional quality control measures were conducted 3. Statement of whether the patent proprietary formula used in the trial is for a condition that is identical to the publicly available reference 5c. 中成药 1. 组成、剂量、疗效、安全性及质量控制方法等具体内容可参照已公开的文献资料(如药典) 2. 说明复方的详细资料包括：1) 产品名称(即商品名)、2) 生产厂家、3) 生产批号、4) 生产日期及有效期、5) 辅料在成品中的比例、 及6) 是否有附加的质量控制方法 3. 说明中成药在本试验中所针对适应症是否与已公开的资料相同 5d. Control groups Placebo control 1. Name and amount of each ingredient 2. Description of the similarity of placebo with the intervention (e.g., color, smell, taste, appearance, packaging) 3. Quality control and safety assessment, if any 4. Administration route, regimen, and dosage 5. Production information: where, when, how, and by whom the placebo was produced Active control 1. If a CHM formula was used, see recommendations 5a–5c 2. If a chemical drug was used, see item 5 of the CONSORT Statement (24) 5d. 对照组 -安慰剂对照 1. 每种成份的名称和剂量 2. 描述安慰剂和试验中药从颜色、气味、味道、外观和包装等的相似程度 3. 质量控制和安全监测的标准和方法，如有 4. 给药途径、疗程和剂量 5. 生产资料，包括：何地、何时、由何人或何机构制作 -阳性对照 1. 中药复方可参见5a至5c的内容 2. 化学药品可参考CONSORT声明(24)中条目5的内容 |
| Outcomes 结局 | 6a | Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed 完整明确地定义预先规定的主要和次要结局指标，包括何时、如何评价 | Illustration of outcome measures with Pattern in detail 详细报告与中医证候相关的结局指标 |
| 6b | Any changes to trial outcomes after the trial commenced, with reasons 试验开始后结局的改变及原因 | ||
| Sample size 样本量 | 7a | How sample size was determined 样本量如何确定 | |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines 对期中分析和中止试验的条件进行解释(如适用) | ||
| Randomization 随机化 | |||
| Sequence generation 序列产生 | 8a | Method used to generate the random allocation sequence 产生随机分配序列的方法 | |
| 8b | Type of randomization; details of any restriction (such as blocking and block size) 随机化类型；任何限定情况(如区组和区组大小) | ||
| Allocation concealment mechanism 分配隐藏机制 | 9 | Mechanism used to implement the random allocation sequence(such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 实施随机序列的方法(如连续编码的容器)，阐明隐藏分配序列的措施 | |
| Implementation 实施 | 10 | Who generated the random allocation sequence, who enrolled participants , and who assigned participants to interventions 产生分配序列、纳入研究对象、分配研究对象的人员 | |
| Blinding 盲法 | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 如果实施了盲法，应说明对谁设盲(如研究对象、干预提供者、结局评价者)，如何实施的 | |
| 11b | If relevant, description of the similarity of interventions 组间干预的相似性 | ||
| Statistical methods 统计方法 | 12a | Statistical methods used to compare groups for primary and secondary outcomes 组间比较，主要结局与次要结局的统计方法 | |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses 其他分析方法，如亚组分析和校正分析 | ||
| Results 结果 | |||
| Participant flow (a diagram is strongly recommended) 研究对象纳入流程(推荐流程图) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome 各组接受随机分配、接受干预和进入主要结局分析的研究对象数量 | |
| 13b | For each group, losses and exclusions after randomization，together with reasons 各组随机化之后发生的脱落或失访、排除，以及原因 | ||
| Recruitment 研究对象的招募 | 14a | Dates defining the periods of recruitment and follow-up 招募研究对象和随访的日期范围 | |
| 14b | Why the trial ended or was stopped 研究结束或停止的原因 | ||
| Baseline data 基线数据 | 15 | A table showing baseline demographic and clinical characteristics for each group 反映各组基线人口学特征和临床特征的表格 | |
| Number analyzed 分析数量 | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 各组纳入分析的研究对象数量(分母)，是否按照最初分组进行分析 | |
| Outcomes and estimation 结局和效应估计 | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 对每个主要和次要结局，报告各组结果、效应估计和精度(如95%置信区间) | |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended 对二分类结局，报告绝对效应和相对效应 | ||
| Ancillary analyses 其他分析 | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses，distinguishing prespecified from exploratory 报告其他分析(包括亚组分析和校正分析)结果，区分预先设定的分析和探索性分析 | |
| Harms 危害 | 19 | All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms) 所有重要损害或未预期到的效应(详见CONSORT扩展版：不良事件报告) | (There is no extension for this item) (此条目无扩展) |
| Discussion 讨论 | |||
| Limitations 局限性 | 20 | Trial limitations; addressing sources of potential bias; imprecision; and, if relevant, multiplicity of analyses 试验局限性；关注偏倚的来源；不精确程度；多重比较问题 | |
| Generalizability 外推性 | 21 | Generalizability (external validity, applicability) of the trial findings 试验结果的外推性(外部有效性、适用性) | Discussion of how the formula works on different TCM Patterns or diseases 讨论中药复方在不同中医证候和疾病的作用 |
| Interpretation 结果解释 | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 权衡收益和损害，并考虑其他相关证据，对结果进行解释 | Interpretation with TCM theory 以传统中医学理论作解释 |
| Other information 其他信息 | |||
| Registration 注册 | 23 | Registration number and name of trial registry 注册机构与注册号 | |
| Protocol 研究方案 | 24 | Where the full trial protocol can be accessed, if available 可以获得完整研究方案的地方 (如适用) | |
| Funding 资助 | 25 | Sources of funding and other support(such as supply of drugs), role of funders 资助来源和其他支持，资助者的作用 | |
三、CONSORT-中药复方使用注意事项
中药复方随机对照试验在设计时，为了更好地了解此类试验设计、实施和分析中的注意事项，建议参考CONSORT-中药复方；投稿时，根据需要或要求可将CONSORT-中药复方清单(checklist)作为投稿材料之一递交，并引用已发表的相关报告规范文献。审稿人也可根据编辑部要求参照CONSORT-中药复方标准和作者提供的清单来审稿。一般CONSORT声明的注意事项和局限性同样适用于本扩展版声明。CONSORT-中药复方流程图仍然沿用CONSORT 2010标准版，未作任何修改。
CONSORT-中药复方并不适用于草药和针刺试验的临床试验报告，因为后者未涉及TCM中理、法、方、药的内容。草药临床试验报告可参考草药干预随机对照实验(herbal medicine interventions randomized control trials, HRCT)报告的统一标准(consolidated standards of reporting trials，CONSORT)扩展版——概述。
注：本文内容是参考相关文献后对中药复方临床试验报告的统一标准(CONSORT for Chinese Herbal Medicine formulas, CONSORT - CHM Formulas)的概述。关于CONSORT-中药复方的更多内容详见官方网站(http://www.consort-statement.org)或论文CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (https://pubmed.ncbi.nlm.nih.gov/28654957/)、CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Simplified Chinese Version) (https://pubmed.ncbi.nlm.nih.gov/28654957)
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