目的  评价2018年中国发布的临床实践指南中有关利益冲突和经济学证据的情况，并与2017年进行比较，以期了解指南制定变化情况，为完善我国临床实践指南的制定/修订提供参考。

方法  计算机检索中国知网、万方数据库及中国生物医学文献数据库，检索2018年我国发布的临床实践指南，检索时间为2018年1月1日至2028年12月31日。由2名研究者独立筛选文献、提取纳入指南的利益冲突声明与是否关注经济学证据等相关信息后，使用Microsoft Excel 2019软件进行统计分析。

结果  共纳入临床实践指南92部，其中23部指南（25.00%）声明了利益冲突，25部（27.17%）报告了资金来源，22部（23.91%）报道了经济学证据，且该报道的指南中有一半都有国家重大或重点专项支持（50.00%）。而2017年中国发布的53部临床实践指南中，有26.42%声明利益冲突，18.87%报告资金来源，11.32%提及经济学证据。

结论  相较于2017年，2018年我国加大了对临床实践指南制定资金投入的力度，在指南经济学证据方面的关注也有所提高，但是对于指南中利益冲突的声明报告和确切的经济学证据仍然很低。因此，进一步推进和完善我国临床实践指南对利益冲突的声明与经济学证据的关注，使我国临床实践指南制定更加客观、透明和独立是必要的。

美国医学科学院（Institute of Medicine，IOM）于1990年首次提出实践指南定义：系统制定的针对特定临床情况，帮助医务人员和患者做出恰当处理的指导性建议（推荐意见）[1]。随着循证医学的发展及其对指南的影响，2011年IOM更新指南定义为：指南是基于系统评价的证据和平衡了不同干预措施的利弊，在此基础上形成的能够为患者提供最佳医疗服务的推荐意见[2]。我国临床实践指南数量近年来也不断增加，医学期刊在1995-2015年期间，已发表了超过500部指南[3]。但是指南整体质量还有待进一步提高，截至到2017年10月底，美国国立指南文库（National Guideline Clearinghouse，NGC）收录高质量的循证指南数量超过1 700部，我国由中国药理学会治疗药物监测委员会组织的《中国万古霉素治疗药物监测指南》[4]被首次收录进入NGC数据库；然而，运用指南评价工具（Appraisal of Guidelines Research and Evaluation II，AGREE II）分析国内外指南质量，发现我国在指南制定的严谨性和编辑的独立性与国际水平存在较大差距[5]。利益冲突的存在可直接影响临床实践指南制定的独立性，并可以直接降低整个指南的可信度及权威性，应高度重视。随着全球医疗负担的加重，治疗成本问题得到了越来越多决策者的关注，众多的临床实践指南都需将成本问题考虑至指南推荐中[6]。但是，目前我国临床实践指南制定对于经济学证据关注不足，王强等[7]调查分析了2017年中国发布的临床实践指南，发现仅有11.32%临床实践指南涉及到卫生经济学的内容，且无经济学证据存在。本研究进一步调查2018年我国发布的临床实践指南中利益冲突与经济学证据的情况，并与2017年发布的临床实践指南进行对比，以明确我国临床实践指南制定时这两方面的情况，为进一步完善我国临床实践指南制定/修订提供依据。

1 资料与方法

1.1 纳入与排除标准

纳入2018年1月1日至2018年12月31日发布的所有中国医药卫生领域临床实践指南，仅限中文。排除标准为：①无法获取全文；②不同刊物同步发表的同一部指南，选择其中最详细的纳入；③对指南的解读或者摘译；④专家共识、计划书及草案。

1.2 文献检索策略

计算机检索中国知网（CNKI）、万方数据库（WanFang Data）和中国生物医学文献数据库（CBM），搜索2018年我国发布的有关医药卫生领域的临床实践指南，检索时间为2018年1月1日-2018年12月31日。采用“主题词+自由词”方式检索，中文检索词包括：临床实践指南、指南、诊疗常规，限定领域为“医药卫生科技”或“医药、卫生”。

1.3 文献筛选与资料提取

由2名研究者独立筛选文献、提取资料并交叉核对，如遇分歧，则讨论解决或交由第三名研究者解决，缺乏相关资料尽量与原作者联系并予以补充。首先通过阅读标题进行文献筛选，在排除明确不相关的文献后，进一步阅读全文和摘要，最终确定是否纳入。预先设计好资料提取表，提取资料内容主要包括：指南的标题、制定组织、涉及专业领域、版本、关注领域、利益冲突声明、资金来源及是否关注经济学证据。

1.4 统计分析

使用Microsoft Excel 2019软件进行资料整理和数据分析。以描述性分析为主，对2017年与2018年指南的三个方面比较采用柱状图形式展示；对2018年指南的学科分布领域按照内科学、外科学、儿科学、口腔科学、妇产科学、麻醉学和护理学进行领域分类，并以柱状图展示结果。

2 结果

2.1 文献筛选流程及结果

初步检索共获取8 678部相关的指南文献，严格按照纳入与排除标准筛选后，最终纳入92部[8-99]临床实践指南。文献筛选的流程及结果详见图1。

图1 2018年中国发布临床实践指南筛选的流程及结果

2.2 纳入研究的基本信息

2018年中国发布的临床实践指南有关利益冲突和经济学证据的基本信息详见表1。

表1 2018年中国临床实践指南发布的有关利益冲突声明和经济学证据的基本信息

2.3 纳入2018年临床实践指南中关于利益冲突与经济学证据分析结果

纳入临床实践指南中，声明利益冲突的有23部[34,75,79-99]（25.00%），其中有7部[79-85]（7.61%）指南仅粗略报道无利益冲突，并未声明相关利益冲突的具体内容；报告资金来源有25部[8-10,12,24,38,42,47,53,65,69,73,75,84-85,87,89-95,97-98] （27.17%）,多数资金来源于国家自然科学基金及国家重点研发计划专项基金；报道经济学证据有22部指南[14-15,30,33-35,42, 46-47,65,75,80,83,86-87,89,90-95]（23.91%），其中11部[42,47, 65,75,87,89-94] （50.00%）指南均有国家重点或重大专项基金支持。在不同的学科领域，中国临床实践指南的利益冲突声明、资金来源与经济学证据分布有差异，在内科学中利益冲突声明有9部[34,79-85,98]（22.00%）,报告资金来源8部[8-9,42,53,65,84-85,98]（20.00%）与提及经济学证据7部[15,33-34,42,65,80,83]（17.00%）；在外科学中三者分布分别为24.00%，30.00%与21.00%；而在儿科学中三者分布均为75.00%，妇产科中差异很大，具体详见图2。临床实践指南学科进一步细分，涵盖了26个专业，主要分布在骨科12部[10,17,25,36,48,51-52, 58-62,86-87,95]（13.04%）和妇产科10部[13,16,20,30,38, 45-46,60-61,78]（10.87%），其次是中医科和心血管科各8部[39,53,72,79-81,84,85]（8.70%）；指南类型涵盖6大领域，主要针对的是疾病的诊疗62部[7-13,16,17,19-20,22-29,41-42,44-68,72,79-80,82-87,89-93, 98-99]（67.39%）；基于循证医学方法制定指南有28部（30.43%），其他内容详见表1。相较于2018年中国发布的临床实践指南，2017年中国发布的指南中，利益冲突声明26.40%略高于2018年，而资金来源及指南对经济学证据关注低于2018年指南，详见图3。

图2 2018年中国分布的临床实践指南中利益冲突及经济学证据在不同学科领域分布情况

图3 2017-2018年中国发布临床实践指南有关利益冲突声明及经济学证据的对比结果

3 讨论

随着循证医学、转化医学和人工智能的兴起，作为医务人员临床诊疗工作最重要的决策依据，临床实践指南的发展已经从专家共识进入一个全新的时代。2011年IOM更新指南的定义，再次强调了循证医学在指南制定中的重要地位。本次研究纳入的92部指南中，有28部（30.43%）是基于循证方法制定的，其中占比最多的是儿科指南5部（5.43%），刘雅莉等人[100]调查2010-2017年针对儿内科临床实践指南发现39部（28.89%）指南提及应用循证方法制定指南，且2010-2013年占12部（31.00%），2014-2017年占27部（69.00%），间接证实我国基于循证方法制定指南在逐年增高，但是每个专业领域是有差异的。除此以外，我们还发现不同学科领域中临床实践指南对利益冲突声明、资金来源的报道及经济学证据的关注分布也是有差异的，内科学临床实践指南中三者的分布由高到低分别为利益冲突声明22.00%，资金来源报道20.00%及提及经济学证据17.00%；外科学指南中最高为资金来源的报道30.00%，而儿科学指南中三者分布一致，均为75.00%，妇产科学指南中有关利益冲突声明为0.00%，且学科领域的临床实践指南分布亦不均，此次调查分析中并未发现与口腔学科相关的临床实践指南的发布。故我们在倡导大家基于系统评价证据制定临床实践指南时，不能一概而论，应根据不同学科领域具体情况，针对性提倡和推广基于循证方法制定指南，全面提高我国临床实践指南制定的规范性。

利益冲突可直接影响临床实践指南制定的独立性，是临床实践指南制定的重要因素。利益冲突主要包括经济和非经济两类[101]。本研究纳入的指南中有23部（25.00%）声明利益冲突，其中7部指南仅以“无”来表述利益冲突，未描述是否填写利益冲突声明表及是否会影响最终推荐建议的形成等详尽的信息。2017年我国发布的临床实践指南有关利益冲突声明[7]是26.40%，相比之下，我国临床实践指南在利益冲突声明方面依然需要大力的提倡和改进。值得提及的是，相对于2017年我国对于临床实践指南制定资金的投入力度有所加强，由原来18.90%提高至27.17%，说明国家对临床实践指南制定的支持。

近年来科学证据逐渐增多，高新技术层出不穷，患者及家属知识水平和法律意识的增强，使得临床决策不仅仅考虑诊治问题，还要平衡治疗成本，效益及风险等。故临床实践指南作为指导文件，在其制定过程中涉及到证据向推荐意见转化时需要平衡利弊关系，这里面的弊主要包括成本，这里的成本主要是指与治疗有关的经济负担及随访管理中可能的成本消耗[102]。本次纳入的指南中有22部（23.91%）指南提及经济学证据，其中11部[42,47,65,75,87,89-94]（50.00%）指南均有国家重点专项基金支持。相对于2017年中国发布的临床实践指南报道的经济学证据11.30%，2018年指南制定在经济学证据方面有所改善。这跟国家投入资金大力支持有关；但是，我们发现临床实践指南中有关经济学证据方面的报道，大部分只是在推荐意见中宽泛的提及，在治疗时除考虑患儿及其家属的观点及意愿，还需兼顾有效性，安全性和经济性，没有确切的经济学证据支持。为更好的制定/更新临床实践指南与科学化的临床决策，建议如下：其一，完善指南制定团队，在原来人员组成的基础上，增加卫生经济学专家，研究表明卫生经济学专家能帮助指南制定团队得出干预或服务可能的成本效果[103]，以提供确切的经济学证据；其二，国家继续投入资金，支持临床实践指南的制定/更新；其三，提高我国有关卫生经济学的原始研究，积极培养具有临床实践指南制定和卫生经济学思维的交叉学科人才。

总之，本研究的结果显示，虽然国家提高了对于临床实践指南制定资金的投入，指南制定过程中对经济学证据方面关注也有所提高，但是我国临床实践指南制定在利益冲突声明和确切的经济学证据方面依然薄弱，而这些又影响到我国临床实践指南制定整体的客观性、独立性及透明性。因此，加强对利益冲突的声明及管理，加大对经济学证据关注及生产的落实，对未来我们制定更规范，更实用的临床实践指南是很有必要的。

利益冲突声明：所有作者均声明不存在利益冲突。

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