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。     

To Establish A Body of Evidence on Safety for Postmarketing Chinese Medicine: A New Research Paradigm

The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for effificacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.     

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.     

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。     

中西医疗效评价方法在进展期胃癌中的比较研究

[目的]比较中医及西医两种疗效评价方法在进展期胃癌治疗应用中的差异。[方法]收集3个分中心进展期胃癌患者215例,分为2组:中药组115例采用中药注射剂联合辩证论治汤剂治疗,化疗组100例采用国际通用的胃癌OFL化疗方案治疗,疗程均为6周。以包含临床症状、瘤体、卡氏评分、体重、免疫功能评价的"中医治疗进展期胃癌患者临床受益(疗效)评定标准"和WHO实体瘤疗效评价标准同步进行疗效观察。[结果]按照"WHO实体瘤疗效评价标准"评价,化疗组疗效明显优于中药组(P<0.01);按照"中医治疗进展期胃癌患者临床受益(疗效)评定标准"评价,中药组疗效优于化疗组,两组比较差异有统计学意义(P<0.05)。[结论]"中医治疗进展期胃癌患者临床受益(疗效)评定标准"与"WHO实体瘤疗效评价标准"两种评价方法得出的结论存在差异,两者相比,前者更能反映中医药治疗肿瘤的特色与优势,具有进一步研究的价值。     

中医药期刊评价模型的建立

在对各相关期刊评价指标体系调研的基础上,初步建立了中医药期刊评价的模型,并通过对中西医结合类部分期刊的相关评价研究,为进一步系统地开展中医药期刊评价建立了相应的方式和方法。     

Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)

ObjectiveTo systematically examine the postmarketing safety of depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), identify the potential risk factors, and ensure its clinical safety.MethodsWe examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen (Radix Salviae Miltiorrhizae). Data from I-IV clinical drug trials, hospital information systems (HIS), and spontaneous reporting systems (SRS) were also analyzed.ResultsThe effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached more than 80%. The median lethal dose (LD50) calculated by the Bliss method was 1.49 g/kg, with 95% confidence intervals of 1.29–1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions (ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen (Radix Salviae Miltiorrhizae) at a dosage higher than the recommended dose.ConclusionThis study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), and discusses the factors influencing such reactions. It provides scientific reference and recommendations for clinically safe medication of the Danshen injection.     

Clinical Practice Guideline for Allergic Rhinitis Treatment with Acupuncture

With reference to international guidelines for the development of tools—Grading of Recommendations Assessment,Development and Evaluation(GRADE)system approach and reasoning,this practice guideline has been drafted reflecting the characteristics of acupuncture to improve effectiveness and safety of acupuncture treatment for allergic rhinitis.This guideline includes outlining the acupuncture diagnosis and treatment principles for allergic rhinitis,suggesting recommendations and related evidence for the acupuncture treatment of allergic rhinitis,and defining operating methods and precautions for the acupuncture treatment of allergic rhinitis.     

论中医院校教师教学评价及其应用——以中医学专业本科医学教育标准的视角

高等院校教师教学评价是教学活动重要的环节,是深化高校教育改革的关键质点。如何合理分析教学评价的内涵以及如何将评价结果应用于教学活动,对衡量教师教学水平和提高教育教学质量有其重要的现实意义。该文以中医学专业本科医学教育标准的视角,探讨中医院校教师教学评价及其应用意义,为完善学校教学质量保障体系、发挥教学评价的积极作用提供参考。     

基于德尔菲法的基层中医药服务评价体系研究

目的 构建客观、科学的基层中医药服务评价体系,为评价基层医疗机构的中医药服务能力在分级诊疗制度中所起作用提供参考依据.方法 通过文献分析法及实地调研法,初步拟定基层中医药服务评价体系咨询表,采用德尔菲法经2轮专家咨询调整各级指标,最终形成基层中医药服务评价体系.结果 构建的基层中医药服务评价指标包括一级指标5项、二级指...     

对中医药治疗原发性肝癌临床研究的方法学评价

目的 了解近50年来中医药治疗原发性肝癌临床研究的现状，并对其进行方法学评价。方法 依据临床流行病学／DME方法学原则，对1949—2002年间关于中医药治疗原发性肝癌的临床文献报道进行全面检索、筛选和方法学评价。结果 共检索到中医药治疗原发性肝癌的文献题录l182条，实际检出全文8ll篇，其中9．74％的文献采用了随机对照试验(RCT)的设计方案进行临床研究。但从总体上看，试验设计方案仍欠完善和严谨。结论 目前在中医药治疗原发性肝癌的临床研究中，随机对照设计研究方案数量较少且总体质量较低，远远不能满足临床实践的需要，中医药治疗原发性肝癌临床试验设计水平亟待提高。     

中医临床疗效评价现状与思考

基于中医临床疗效评价研究现状,对目前研究中若干观点进行阐述,包括病证结合模式下的中医临床疗效评价标准框架、证候诊断指标与疗效评价指标差异、中医疗效评价量表、中医PRO量表、中医临床疗效个体化评价方法、中医辨识证候的评价标准等观点.并就若干问题进行讨论,即病证结合研究是中医临床疗效评价研究的重要途径、中医临床疗效评价研究必须符合辨证诊疗模式、采用量表学方法以建立中医评价量表、应用多学科技术开展中医临床疗效评价研究、注意研究过程中若干重要问题的解决等.     

中医临床疗效评价终点指标选择的思路与方法

分析中医临床疗效评价终点指标选择现状,指出目前存在终点指标的研究较少,终点指标的概念和特点认识不清,终点指标的选择缺乏依据和方法指导等问题。基于终点指标的特点及适用范围,结合中医药复杂干预整体调节的特色,借鉴西医选择终点指标的经验,推荐使用联合指标全面评价临床疗效。针对终点指标具有客观性的特点,主观性选择方法不适合终点指标的选择,且单一选择方法难免存在偏倚,宜结合多种选择方法,如首先采用文献调查法初步筛选,然后借助大规模临床流行病学调查收集数据,最后运用数学模型构建中医药临床疗效评价的终点指标集合。本文通过对终点指标选择思路与方法的探讨,为终点指标的选择提供方法学参考。     

医学学科带头人评价指标体系研究及其对中医药人才管理的启示

医学学科带头人的评价工作十分重要,而建立科学、合理的评价指标体系是关键。通过分析医学学科带头人评价指标体系的研究方法与现状,提出应加强中医药学人才管理,重视中医药学学科带头人的评价工作;应细化评估指标,逐步形成系统的中医药学学科带头人评价指标体系;要体现专业差异与中医人文思想,突出中医药特色。     

HPLC指纹图谱在中药及民族药品质评价中的应用

叙述了高效液相指纹图谱的特点,认为其在中药及民族药品质评价方面具有优势.以民族药广枣、翼首草、沙棘及川产道地药材川芎为例,采用化学计量学等方法,用具体试验说明HPLC指纹图谱在药材品种鉴定、药用部位鉴定、产地加工及道地特征分析4个方面的应用.     

关于中医药治疗艾滋病疗效评价的认识与思考

根据中医药治疗艾滋病具有多靶点药理作用和整体综合疗效的特点,采用疗效评价以免疫功能为主,病毒载量、临床症状、体征为辅的综合评价体系较为符合临床实际.     

中医妇科学案例教学模式的评估

在不同班种开展中医妇科学案例教学,设计问卷从对学生学习的主动性、积极性、启发性等方面调查,结果表明学生对案例教学法是积极肯定的,普遍认为该种方法能提高学习兴趣,有助于加强对知识的理解,增强学习的主观能动性,有助于培养临床思辨能力。     

中医治疗多发性硬化临床试验疗效评价

目的：了解中医治疗多发性硬化的疗效及疗效评价方法运用现状,为构建中医治疗多发性硬化的疗效评价体系提供借鉴。方法：检索1985—2010年国内中文期刊发表的中医治疗多发性硬化的临床随机对照或对照试验文献,将疗效评价相关的信息录入数据库,并对资料进行汇总分析。结果：共检索到符合标准的中医治疗多发性硬化文献9篇,文献采用的诊断标准、疗效评价标准、疗效评价指标较为混乱,不同文献的观察疗程相差悬殊;疗效评价结果提示,中医治疗多发性硬化的总体有效率、对神经症状体征的改善以及对减少复发次数上均优于对照组。结论：现有文献报道的中医治疗多发性硬化的疗效表现形式复杂多样,疗效评价方法混乱,应根据中医的疗效特点构建疗效评价体系,以使中医治疗多发性硬化的疗效得到医药界同行的认同。     

中医药治疗阳痿随机对照研究文献的质量评价

目的对中医药治疗阳痿随机对照试验文献进行分析,以期系统地衡量中医药治疗阳痿的临床研究质量,从而客观地评价中医药治疗阳痿的临床疗效。方法按照临床流行病学/DME和循证医学的原则,采用统一编制的《中医药治疗性文献系统质量评价及信息采集表》,对1989～2008年发表的阳痿中医药治疗性文献进行质量评价。结果检索到符合标准的随机对照试验文献共72篇,虽均有提及随机、random、随机分组等字样,但只有7篇说明了具体的随机分配方法;8篇采用盲法。72篇文献均未说明样本含量的估算及失访、退出病例;有不良反应观察的共11篇;有随访的1篇。在组间均衡性分析及疗效评价、结论推导等方面还存在很大的不足。结论中医药治疗阳痿的临床研究在科研设计和实施方面仍存在着很多问题,其研究的方法学设计有待加强。