国内外冠心病临床指南研究现状调查及对中医临床指南的思考

目的 了解国内外中西医诊疗指南的研究状况和差距,为建立中医临床指南提供思路.方法 仅以冠心病为例,通过PubMed,CNKI,CMB等网络检索系统查找近年资料,从指南的开发程序、方法、内容等方面进行分析和比较,进而对中医临床指南的研究方向进行思考.结果 中医临床指南的制定工作不可能完全套用国际上现有的循证指南模式,但要为世界所认可,又必须在方法上与国际接轨.结论 中医学应借鉴循证医学的方法,建立符合自身理论特点和临床实际的中医证据评价体系,并据此制定出为国际同行所认可同时又符合中医学理论的中医临床指南.     

特发性膜性肾病中医临床实践指南（2021）

特发性膜性肾病占我国肾小球疾病的24.9%，已跃居第二位且比例有逐年增高趋势。中医药治疗已广泛应用于特发性膜性肾病的临床实践中，然而目前尚无中医治疗膜性肾病的循证实践指南。本指南按照国际指南制订方法与步骤，证据质量及推荐意见强度使用GRADE方法，通过访谈国医大师以及广东省名中医，确定指南范围、形成临床问题提纲；基于访谈结果和现有中西医肾病指南、权威教材以及临床研究文献的系统梳理和回顾的结果拟定临床问题、膜性肾病临床疗效评价指标以及中医证型的调查清单，在全国范围内进行专家调查；然后针对临床问题检索到的证据进行质量评价，并举行专家共识会议，最终形成关于中医治疗特发性膜性肾病的10条推荐意见。本指南聚焦于中医治疗特发性膜性肾病的临床实践，适用于各级中医/中西医结合医疗机构以及开展中医药服务的医疗机构及医务工作者。     

糖尿病患者甲病管理的最佳证据总结

背景 及时识别和正确处理甲病，对糖尿病患者足溃疡的预防意义重大，但目前临床医务人员对糖尿病患者甲病的认识普遍不足，而我国尚缺乏有关糖尿病患者甲病管理的循证依据。 目的 全面检索和分析糖尿病患者甲病管理相关证据，并对最佳证据进行总结。 方法 检索2021-12-06前在BMJ Best Practice、UpToDate、世界卫生组织网站、国际指南协作网、英国国家卫生与临床优化研究所网站、美国国立指南库、加拿大安大略护士学会、苏格兰学院间指南网、新西兰指南协作网、医脉通、JBI循证卫生保健中心、PubMed、Embase、CINAHL、中国知网、万方数据知识服务平台中与糖尿病患者甲病管理相关的临床决策、指南、系统评价、专家共识，对其进行质量评价，依据JBI循证卫生保健中心证据预分级系统（2016版）进行证据分级，对最佳证据进行汇总。 结果 共纳入文献8篇，包括临床决策1篇、指南4篇、专家共识3篇。1篇临床决策来自UpToDate直接纳入；4篇指南中2篇质量评价为B级，2篇为A级，均纳入；3篇专家共识的质量评价结果均为准予纳入。最终围绕评估内容、处理方式、健康教育3个方面共汇总9条最佳证据，其中5条证据为A级推荐，4条为B级推荐。 结论 本研究检索了糖尿病患者甲病管理相关的临床决策、指南及专家共识，通过分析总结了糖尿病患者甲病管理的最佳证据，涉及评估内容、处理方式、健康教育3个方面，证据等级为A级推荐和B级推荐，可为医务人员针对糖尿病患者进行甲病的早期评估与处理提供循证证据。     

老年痴呆患者使用口服营养补充剂的最佳证据总结

目的 对老年痴呆患者使用口服营养补充剂(ONS)的最佳证据进行评价及总结。方法 以循证“6S”证据模型为基础，通过计算机检索UpToDate数据库、BMJ Best Practice数据库、国际实践指南注册平台网站、英国卫生与临床优化研究所网站、国际指南网、加拿大安大略注册护士协会网、苏格兰学院间指南网、欧洲肠内肠外营养协会网、美国肠内肠外营养协会网、澳大利亚乔安娜布里格斯研究所循证卫生保健中心数据库、Cochrane Library数据库、PubMed数据库、中国生物医学文献数据库中有关老年痴呆患者使用ONS的相关证据，包括临床指南、临床决策、证据总结、系统评价、专家共识和意见、随机对照试验。进行文献质量评价后，提取相关证据，并确定证据分级和推荐级别。结果 共纳入12篇文献，包括证据总结1篇、临床指南2篇、系统评价7篇、随机对照试验2篇，总结涉及老年痴呆患者营养风险筛查与评估、ONS的使用原则、ONS的使用方法、ONS制剂的选择、使用ONS的依从性、ONS的应用效果评估方法、ONS的疗效与评价7个方面共19条最佳证据，其中A级推荐证据11条(57.9%)。结论 总结老年痴呆患者使用O...     

预防老年抑郁症复发的最佳证据总结

背景老年抑郁症复发率高,但目前国内外较缺乏预防老年抑郁症复发干预方案的研究。课题组前期探究了老年抑郁症复发的危险因素,其中可控性危险因素为服药依从性差、活动少、进食少。目的 根据以上3个危险因素检索、评价和总结预防老年抑郁症复发的相关证据。方法 2022年10月,计算机检索Web of Science、PubMed、Cochrane Library、美国指南网、英国指南库、加拿大安大略护理学会网站（RNAO）、复旦大学循证护理中心、中国知网等数据库,收集关于预防老年抑郁症和老年疾病伴发抑郁症复发方面的相关证据,包括指南、系统评价、专家共识、证据总结等,检索时限为从建库至2022年10月。由接受过循证医学系统培训的研究者分别采用临床指南研究与评估系统Ⅱ（AGREEⅡ）、AMSTAR、澳大利亚乔安娜布里格斯研究所（JBI）循证中心评价标准（2016版）对纳入的指南、系统评价、专家共识和原始研究进行质量评价。最后采用2014年澳大利亚版本JBI循证卫生保健中心证据分级及证据推荐级别系统进行证据汇总、评价和等级划分。结果 共纳入15篇文献,包括指南3篇、系统评价11篇、随机对照试验1篇。纳入的...     

49部中国急诊相关临床指南现状的初步分析

目的评价我国急诊相关临床指南的现状。方法检索维普数据库、万方数据库、中国知网和中国生物文献数据库,明确纳入和排除标准,收集整理1978年~2013年9月发布的急诊相关指南,从指南制定的目的、制定过程的严谨性、内容清晰度等角度进行分析。结果纳入分析的49部指南及专家共识指南制定目的及目标人群均相对明确,并做了清晰描述;对指南制定过程描述较少;未声明指南的独立性不受资助方的利益竞争的影响;在发布之前是否经过外部专家评审并征询使用者意见未详细描述。结论我国急诊相关临床指南目的明确,内容清晰,严谨性方面需与国际规范接轨以提升质量。中医及中西医结合临床指南因自身特点难以适应循证证据要求,需要在临床科研方法学及指南评价模式有关探索和创新。     

中医和中西医结合临床治疗指南存在的问题与对策

目前参与中医、中西医结合指南制订的成员构成并没有严格要求，制订指南最大的问题是证据不足，没有根据证据的可信度注明推荐意见。建立指南应根据临床治疗指南开发的原则，首先要筛选好人员，成立指南开发小组，对证据进行合理的分类处理，对临床治疗指南进行分级说明推荐理由，以利于临床实际应用。严格遵循指南制订的原则和流程，才能制订出符合我国国情的中医药及中西医结合治疗疾病的临床医疗指南。     

中医临床实践指南评价的思路和方法

指南制定的目的在于应用,没有应用,任何指南都是废纸一张。质量评价和适用性评价是保证指南作用发挥的前提。中医共识临床实践指南和中医循证临床实践指南是中医临床实践指南的主体。中医循证临床实践指南宜在指南发布前,采用AGREEⅡ进行质量评价,为指南使用者提供参考。中医共识临床实践指南应在指南推广应用中,采用《中医临床诊疗指南适用性调查问卷》评价,为指南进一步制修订提供依据。     

制定中西医结合临床指南应注意的问题

一部好的中西医结合临床指南的制定，应由多学科专家，包括中西医结合临床专家、中医临床专家、西医临床专家、不同层次医疗保健机构的医务人员、有关临床科研人员、基础医学研究者、统计学家、临床流行病学家、临床经济学家和医学决策与管理专家共同参与；遵循以下程序：中西医结合学会和（或）各专科分会确定指南题目，组成专题指南制定小组（或以研究项目的形式确定），系统文献评价，草拟初稿，同行咨询及评议，向学术界公开内容，收集反馈意见与建议并进行分析，对指南进行修改，发表与发行，各地应用，反馈审计与评价．再修订完善；在循证医学基础上强调科学证据与证据更新，不断补充和完善原定的指南版本；坚持病证结合，以病统证，规范证型标准，合理设置证型数量，在典型证型基础上，设置加减治疗的标准与方法；注意原则性与灵活性相结合，强调指南只能作为临床医生的诊疗参考，实际应用应灵活处理，不能机械照搬；注重指南的实用性，使使用者看后很容易使用与操作，同时指南制定组织有义务对医务人员进行培训，以推进临床指南的实施。只有这样，才能确保所制定的中西医结合临床指南具有一定的科学性、权威性、规范性与适用性，达到制定指南的目的。     

证据分级体系的演进及其对中医临床实践指南的启示

中医治疗手段及疗效存在巨大差异,基于证据的循证临床实践指南可以规范医疗行为,缩小诊疗过程中的差异,推广中医诊疗技术,促进中医药走向世界.纳入国际上较有影响力的13个证据分级体系,梳理现行证据体系的演进过程,并分析中医证据分级体系现状及特点,比较中医和现代医学证据的差异,认为西医和中医属于两种不同医疗实践模式,中医学兼具...     

混合方法研究制定中医药临床实践指南及实例解读

中医药临床实践指南的制定是实现中医药标准化的重要工作内容。中医药指南对临床的指导意义极大,但目前仍存在临床实际使用情况不佳的现状,这可能与指南的内容有关。由于高质量的中医药临床研究数量较少,以循证医学证据,即定量研究结果为主导的指南,在指南推荐干预措施的确定上存在一定的局限性。而混合方法研究重视实用主义,其将定量研究与定性研究的结果相结合,在中医药指南的制定中存在一定优势。本文初步探讨混合方法研究在指南制定过程中的思路及作用,并以《中医药治疗流感临床实践指南》为例,探讨以定量研究为主导制定指南时遇到的问题及混合方法研究在指南制定中的具体应用。结果发现,混合方法研究可以弥补单纯依赖定量研究或定性研究结果的不足,有可能成为未来指南制定的主要方法之一,但仍存在一定的局限性,需进一步研究。     

Integrative medicine: A characteristic china model for cancer treatment

Integrative medicine(IM) has attracted increasing attention of the experts and patients around the world.Chinese medicine(CM),as the important part of IM,has played an important role in the treatment of cancer.CM is practiced side by side with Western medicine in many of China’s hospitals and clinics.On the basis of the review of the clinical practices and basic researches these years,we introduce the current situation and progress in integrative oncology in China,and show the main feature of CM approach in the cancer treatment.Furthermore,we also discuss the main problems limiting the progress of CM,and point out international collaboration will provide new opportunity to promote the development of IM in China.     

Study on the Methodology of Developing Evidence-Based Clinical Practice Guidelines of Chinese Medicine

At present,evidence-based clinical practice guideline(EBCPG) is the main mode of developing clinical practice guidelines(CPGs) in the world,but in China,most of CPGs of Chinese medicine(CM) are still guidelines based on expert consensus.The objective of this study is to construct initially the methodology of developing EBCPGs of CM and to promote the development of standardization of CM.Based on the development of "Guideline for Diagnosis and Treatment of Common Pediatric Diseases in CM",the methodology of developing EBCPG of CM was explored by analyzing the pertinent literature and considering the characteristics of CM.In this study,the key problem was to put forward the suggestion and strategies.However,due to the methodology study of developing EBCPG of CM is still in the initial stage,there are still some problems which need further study.     

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine

Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.     

从循证医学角度探讨中医对慢性乙型病毒性肝炎的研究

从现中医研究慢性乙肝所存在的问题出发,提出中医对慢性乙肝的研究应由经验医学向循证医学转变,并探讨运用循证医学对慢性乙肝中医临床研究方法、四诊合参、辨证论治进行改进和规范,同时提出与其相关的可行性操作。     

Diagnosis and treatment of malignant tumors using integrated traditional and western medicine: Progress, challenges and reflections

Malignant tumors are one of the leading causes of death in the world.Considerable progresses have been made on the treatment of tumors in recent decades,especially in the prevention,early diagnosis and the model changing of therapeutics.But we are still facing tough challenges,including the increasing treatment burden and limited improvement of efficacy.In China, Chinese medicine(CM) provides a powerful arsenal to fight against tumors.CM can be well applied to the onset and progression of tumors in China,bearing the characteristics of multi-target,multi-phase and multi-effect.But there are also many problems demanding urgent attention in the use of CM.Some most debated problems in this field were summarized.We should upgrade our concepts in using CM,find its position scientifically,and establish evidence of its effect by high quality clinical research.     

Guidelines for the Diagnosis and Management of Herb-Induced Liver Injury

Herb-induced liver injury(HILI) is a type of adverse drug reactions related to using Chinese medicine(CM) or herbal medicine(HM), and is now a growing segment of drug-induced liver injury(DILI) worldwide. Owing to the complicated compositions and miscellaneous risk factors associated with the clinical usage of CM or HM, it is more challenging to diagnose and manage HILI than DILI. In the present guideline issued by the China Association of Chinese Medicine(CACM), the authors present an evidence chain-based workflow with 9 structured judgment criteria for diagnosing HILI. The 3 diagnostic ending points—suspected diagnosis, clinical diagnosis, and confirmed diagnosis—could be reached according to the length of the evidence chain acquired in the structured diagnostic workflow. Either identifying the species of CM or HM or excluding adulterations and toxin contaminants was strongly recommended to improve the level of evidence for a clinical diagnosis of HILI. In addition, the authors report that the improper use of CM, which violates the general law of CM theory, is one of the most important factors that contributes to HILI and should be avoided. By contrast, based on syndrome differentiation, some CM can also be used to treat HILI if used in accordance with the general law of CM theory. Therefore, 9 recommendations are put forward in this guideline.     

Clinical Practice Guideline of Integrative Chinese and Western Medicine for Acute Myocardial Infarction

With increasing morbidity and mortality, acute myocardial infarction (AMI) has become one of the major causes of human death, leading to heavy burdens to individuals, families and society. Previous researches have found that though large amount of resources and great effort were devoted, no significant improvements were achieved in reducing the in-hospital mortality of AMI patients. Meanwhile, extensive studies about Chinese medicine (CM) have found that CM has special advantages in treating AMI patients. However, there is no standardized and unified clinical practice guideline (CPG) of CM for AMI. Therefore, a CPG with strict standard and generally acknowledgement is urgent to be established. This guideline was developed following the methodological process established by the World Health Organization Handbook for Guideline Development. Extensive search on clinical evidences including systematic review (SR), randomized controlled trial (RCT), observational study and case reports was launched, covering evidence of CM for AMI on several aspects, such as diagnosis, CM patterns, CM interventions on AMI and complications, cardiac rehabilitation and clinical pathway management. Besides, the application of Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach enabled the evaluation of evidence and formulation of grade of recommendation (GOR) and level of evidence (LOE). With the help of GOR and LOE, this CPG recommends the integrative CM and WM treatment method in AMI patients and provides useful information on medical decision for clinical physicians.