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

发布于 2023年4月29日 星期六 08:01:25 浏览:955
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草药产品被广泛使用,其成分及质量差异很大,在随机对照试验(randomized controlled trials,RCTs)中也十分常见,使用草药干预随机对照实验(Herbal medicine interventions randomized control trials, HRCT),通常对方法学的描述不够充分。HRCT的临床试验报告的统一标准(consolidated standards of reporting trials,CONSORT)扩展版可以用来指导该类试验的报告。本文概HRCT报告CONSORT声明相关内容。

关键词:随机对照试验; 草药干预随机对照实验; HRCT; 报告规范; 临床试验报告的统一标准; CONSORT扩展版

一、HRCT报告规范背景

草药(Herbal medicine interventions)一般是指民间按经验方法使用的,无经典本草记载的天然药物,使用范围较为局限,多是局部地区、特定人群或民间习用,其加工炮制方式欠规范。草药为植物药,与部分植物类中药存在交叉。中药较草药的范围更广,包括植物药、动物药、矿物药及少量的加工品等。

尽管目前已有大量草药随机临床试验的文献报道,然而,专家学者认为草药随机对照试验中存在一些问题,尤其体现在方法学描述得不够充分,如草药干预措施细节介绍缺乏或不足。未经处理的草药是多种成分组成的混合物,且各成分的种类及数量易被各种因素影响,如药材品种、生长气候和采收时间等;不同厂家生产的同类草药产品,或同一厂家不同批次之间的成分或浓度也存在差异;即使草药产品对已知活性成分或标志成分进行标准化后,各产品中其他成分的浓度依然存在差异,而这些因素均可能导致草药体外药理活性或人体生物利用度等差异。因此,对草药干预实施细节进行详细阐述十分重要。

为了规范HRCT报告,以提高HRCT报告质量,结合草药不同于常规化学合成药物的特点,相关专家基于CONSORT条目修订扩展形成了《草药随机对照临床试验的报告:CONSORT声明细则》。HRCT CONSORT扩展版包括题目与摘要、引言、方法、结果、讨论5部分共计22个条目。对其中条目1“题目与摘要”、条目2“背景”、条目3“受试者”、条目4“干预”、条目6“结局”、条目15“基线数据”、条目20“解释”、条目21“外推性”及条目22“综合证据”等9个条目进行了扩展,重点对是条目4“干预”(增补了6个报告规范子条目)进行了细化,使其更适于HRCT。

二、HRCT CONSORT扩展版条目清单

表1 HRCT CONSORT扩展版条目清单中英文对照

内容条目序号标准清单内容HRCT扩展版内容
Title and abstract
标题与摘要
1How participants were allocated to interventions(e.g., "random allocation" "randomised " or "randomly assigned")
如何把患者分配到不同的干预组(如“随机分配”“随机化”)
Either the title or abstract, or both should state the herbal medicinal product’s Latin binomial, the part of the plant used, and the type of preparation.
标题和摘要中至少有一处报告试验中所应用草药产品的拉丁名、入药部位及剂型
Introduction引言
Background
背景
2Scientific background and explanation of rationale
论述研究背景和解释相关原理
Including a brief statement of reasons for the trial with reference to the specific herbal medicinal product being tested and, if applicable, whether new or traditional indications are being investigated.
包括简要阐述进行此项试验理由及使用该特定草药产品依据,若适用,报告是否有关于该草药适应证新的或传统的研究
 
Participants
研究对象
3Eligibility criteria for participants; settings and locations where the data were collected
报告纳入标准、收集数据的环境和地点
If a traditional indication is being tested, a description of how the traditional theories and concepts were maintained. For example, participant inclusion criteria should reflect the theories and concepts underlying the traditional indication.
如果要检验的是传统适应证,则须对这种传统理论和观念进行阐述。例如,受试者纳入标准应该反映出支持这一传统适应证的理论及概念
Interventions
干预
4Precise details of the interventions intended for each group and how and when they were actually administered
准确描述每组的干预,以及实施干预的过程和时间
 
4aHerbal medicinal product name
草药产品名称
1. The Latin binomial name together with botanical authority and family name for each herbal ingredient; common name(s) should also be included.
2. The proprietary product name (i.e., brand name) or the extractname (e.g., EGb-761) and the name of the manufacturer of the product.
3. Whether the product used is authorized (licensed, registered) in the country in which the study was conducted.
1.每种草药成分的拉丁双语名、植物学权威名和科名还包括常用名
2.正确的商品名(例如商标名称)或提取物名称(例如EGb-761),生产厂家名称
3.该药品在研究所在国是否经过认证(注册,登记)
4bCharacteristics of the herbal product
草药产品特征
1. The part(s) of plant used to produce the product or extract.
2. The type of product used [e.g., raw (fresh or dry), extract].
3. The type and concentration of extraction solvent used (e.g., 80% ethanol, 100% H2O, 90% glycerine) and the herbal drug to extract ratio (drug:extract; e.g., 2:1)
4. The method of authentication of raw material (i.e., how done and by whom) and the lot number of the raw material. State if a voucher specimen (i.e., retention sample) was retained and, if so, where it is kept or deposited, and the reference number.
1.生产该草药产品或提取物所采用的植物部位
2.草药产品类型[如生药(鲜或干)、提取物]
3.提取所用溶剂的类型和浓度(例如80%乙醇、100%水、90%甘油等);草药提取比例(例如药物与提取物之比为2:1)
4.生药材的鉴定方法(即如何鉴定,谁鉴定)和批号;阐述是否保存了凭证标本(即保留样品)及其贮存地和编号
4cDosage regimen and quantitative description
给药方案和数量描述
1. The dosage of the product, the duration of administration, and how these were determined.
2. The content (e.g., as weight, concentration; may be given asrange where appropriate) of all quantified herbal product constituents, both native and added, per dosage unit form. Added materials, such as binders, fillers, and other excipients; (e.g., 17% maltodextrin, 3% silicon dioxide per capsule), should also be listed.
3. For standardized products, the quantity of active/marker constituents per dosage unit form.
1.草药产品用药剂量、疗程及其依据
2.所有定量的草药产品(含生药和添加剂)每单位剂量药物的质量、浓度等指标(若适用,可用范围来表示)。添加剂材料,例如黏合剂、辅料和其他赋形剂(如每片17%麦芽糊精,3%二氧化硅),也需要在文中报告
3.标准化草药产品,必须报告每单位剂量活性/标志性成分的数量
4dQualitative testing
质量检测
1. Product’s chemical fingerprint and methods used (equipment and chemical reference standards) and who performed it (e.g., the name of the laboratory used). Whether or not a sample of the product (i.e., retention sample) was retained and if so, where it is kept or deposited.
2. Description of any special testing/purity testing (e.g., heavymetal or other contaminant testing) undertaken. Which unwanted components were removed and how (i.e., methods).
3. Standardization: what to (e.g., which chemical component(s) ofthe product) and how (e.g., chemical processes or biological/functional measures of activity).
1.草药产品的化学指纹及其检测方法(设备和化学参比标准品)和检测者(例如实验室名称),是否保存了产品样品(如保留样品)及贮存地点
2.描述进行过的全部特殊检验/纯度测定如重金属或其他污染物测定),报告去除了哪些杂质及去除方法
3.标准化:被标准化的对象(如草药产品中哪种化学成分)和方法(如化学过程或生物/功能活性测定)
4ePlacebo/control group
安慰剂/对照组
The rationale for the type of control/placebo used.
所使用的对照/安慰剂的依据
4fPractitioner
研究人员
A description of the practitioners (e.g., training and practice experience) that are a part of the intervention.
描述实施干预的研究人员情况(如培训和实践经验)
Objectives
目的
5Specific objectives and hypotheses
明确说明目标和假设
 
Outcomes
结局
6Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors)
清楚定义主要结局和次要结局,如果可以的话,还应报告提高结局测量质量的方法(如多次测量,测量者培训)
Outcome measures should reflect the intervention and indications tested considering, where applicable, underlying theories and concepts.
若适用,结局指标应反映干预措施与适应证的理论及概念
Sample size
样本量
7How sample size was determined; explanation of any interim analyses and stopping rules when applicable
报告如何确定样本量,相关的话还应该报告中期分析和终止试验的规则
 
Randomisation-sequence generation
随机分配序列的产生
8Method used to generate the random allocation sequence, including details of any restriction (eg, blocking, stratification)
报告产生随机分配序列的方法,包括任何限制性随机化的细节(如区组、分层)
 
Randomisation-allocation concealment
分组隐匿
9Method used to implement the random allocation sequence (eg, numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned
报告实施随机的方法(如编码容器或中心电话),明确在实施干预之前分配是否隐藏
 
Randomisation-implementation
随机化实施
10Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups
说明由谁生成随机分配序列,谁招募研究对象,谁将研究对象进行分组
 
Blinding
盲法
11Whether participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment
报告研究对象、干预实施者、结局评估者是否不知道分组情况
 
Statistical methods
统计学方法
12Statistical methods used to compare groups for primary outcomes; methods for additional analyses, such as subgroup analyses and adjusted analyses
说明比较主要结局指标的统计方法;其他分析方法,如亚组分析和调整分析
 
Results
结果
Participant flow
研究对象纳入流程
13Flow of participants through each stage (a diagramis strongly recommended)—specifically, for eachgroup, report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analysed for the primary outcome; describe deviations from planned study protocol, together with reasons
报告每一阶段参与试验的研究对象人数(建议使用流程图)—即每个组的随机分配的人数、接受治疗的人数、完成治疗方案的人数、用于主要结局分析的人数等。对于违背研究计划之处,还要对其原因加以解释
 
Recruitment
招募
14Dates defining the periods of recruitment and follow-up
说明招募和随访的日期
 
Baseline data
基线数据
15Baseline demographic and clinical characteristics of each group
描述每组的人口统计学基线资料和临床特征
Including concomitant medication, herbal, and complementary medicine use.
包括联合使用的医疗措施、草药和补充治疗
Number analyzed
分析例数
16Number of participants (denominator) in each group included in each analysis and whether analysis was by "intention-to-treat"; state the results in absolute numbers when feasible (eg, 10/20, not 50%)
每项分析中都需要报告每组分析的研究对象人数(分母),注明是否采用了意向性分析;如果可能,应该采用绝对数报告结果(例如10/20,而非50%)
 
Outcomes and estimation
结局和效应值
17For each primary and secondary outcome, a asummary of results for each group and the estimated effect size and its precision (eg, 95% CI)
对于每一项主要结局和次要结局,需报告每组的结果、效应值及其精确度(如95%置信区间)
 
Ancillary analyses
其他分析
18Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which are prespecified and which are exploratory
若处理多因素,应报告其他分析,包括亚组分析和调整分析,并指出哪些是事先设定的,哪些是探索性的
 
Adverse events
不良事件
19All important adverse events or side effects in each intervention group
报告每个组发生的所有重要的不良事件或副作用
 
Discussion
讨论
Interpretation
解释
20Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes
解释结果时要考虑研究假设、潜在的偏倚或不精确性,以及多重比较和多种结局的问题
Interpretation of the results in light of the product and dosage regimen used.
依据草药产品/给药方案解释结果
Generalizability
外推性
21Generalisability (external validity) of the trial findings
解释试验结果的外推性(外部真实性)
Where possible, discuss how the herbal product and dosage regimen used relate to what is used in self-care and/or practice.
若可能,讨论试验所用的草药产品及给药方案与自我保健和/或临床实践中应用的关系
Overall evidence
整体证据
22General interpretation of the results in the context of current evidence
基于当前证据对结果进行概括性解释
Discussion of the trial results in relation to trials of other available products.
对比其他可获得药物产品的研究,讨论试验结果

三、HRCT CONSORT扩展版使用注意事项

HRCT CONSORT扩展版主要针对条目4“干预”相关的条目进行修订扩展,其中标明“若适用”(条目2、6、4c、7)或“若可能”(条目21)的条目建议能提供相关信息的尽可能提供;此外,部分条目可能不适用于某些类型的草药干预试验。

草药干预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HRCT CONSORT扩展版;投稿时,根据需要或要求可将HRCT CONSORT扩展版清单(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HRCT CONSORT扩展版标准和作者提供的清单来审稿。HRCT CONSORT流程图较CONSORT标准版未作修改。

注:本文内容是参考相关文献后对HRCT CONSORT扩展版原文的概述,仅代表本网站观点。关于HRCT CONSORT扩展版的更多内容详见官方网站(http://www.consort-statement.org)或Joel J Gagnier等发表的论文“Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration (https://pubmed.ncbi.nlm.nih.gov/17027423/)”、田然等发表的论文“报告草药干预措施随机对照试验的建议:解释和说明(http://www.cjebm.com/article/10.7507/1672-2531.202008179)”、Joel J Gagnier等发表的论文“Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement (https://pubmed.ncbi.nlm.nih.gov/16520478/)”和田然等发表的论文“草药干预措施随机对照试验报告:CONSORT 扩展声明(http://www.cjebm.com/article/10.7507/1672-2531.202008178)”。

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