慢性胃炎中医学临床实践指南制作方法暨治疗性文献的质量评价研究

【作者】 卞立群；

【导师】 唐旭东； 刘绍能；

【作者基本信息】 中国中医科学院 ， 中医内科学， 2008， 硕士

【摘要】 目的1探讨中医学临床实践指南的制作方法,并以之指导慢性胃炎中医学临床实践指南的制作。2探讨慢性胃炎治疗性文献中各相关因素对临床疗效的影响,为临床试验设计提供参考。方法1慢性胃炎中医学临床实践指南制作方法研究在系统分析国外指南制作方法和指南评价方法的基础上,将其与中医学的特点相结合,并联系慢性胃炎的中医临床研究实际,制定慢性胃炎中医学临床实践指南制作流程;对各个流程的具体操作方法加以分解,用以指导慢性胃炎临床实践指南的制作。通过实践操作,对原方案加以修正,形成相对完善的中医学临床指南开发方法。2慢性胃炎治疗性文献的质量评价影响因素研究收集1998.3-2008.3十年间有关慢性胃炎的治疗性文献,制定纳入标准和排除标准,对筛选合格的文献,通过分析慢性胃炎各临床类型研究文献的临床试验方法、样本量、诊断标准、疗效标准等因素对疾病痊愈率、有效率的影响,归纳总结影响中医药临床试验质量的因素。结果1慢性胃炎中医学临床实践指南制作方法研究1.1制定了慢性胃炎中医学临床实践指南慢性胃炎中医学临床实践指南的开发流程包括:建立指南开发小组、文献预调查、临床问题的分解与定义、文献检索、文献评价与证据形成、证据评价与推荐建议形成、书写指南草案、指南草案的专家评审、指南的初稿定稿九个步骤。其中对中医学文献评价方法作了探讨,并在指南制作的过程中加以应用。1.2慢性胃炎中医学临床实践指南评价(1)慢性胃炎中医学临床实践指南的AGREE评价:①AGREE评分结果:在范围与目的领域标准化得分为71.4%;参与人员领域的得分为50.0%;制定的严谨性领域的得分为80.6%;清晰性和可读性领域的得分为66.7%,编辑独立领域的得分为83.3%;由于指南开发小组不负责指南的发行与推广,在应用性领域(条目19(指南中已经讨论了应用推荐建议时可能会遇到的来自一些组织的障碍)、条目20(指南考虑了应用推荐建议时潜在的费用问题)、条目21(指南提供了为今后便于监控/或审计的标准))得分较低。②对指南的全面评估:建议指南在局部地区进行预试验后,结合各地的实际情况进行推广。(2)指南的专家评审意见:指南引进国际上先进的指南制作方法,并与中医学的特点相结合,制定出慢性胃炎中医学临床实践指南,符合中医治疗慢性胃炎的临床实际,体现了中医学的特色,具有科学性和实用性,建议在临床验证后加以推广。2慢性胃炎治疗性文献的质量评价影响因素研究2.1临床类型临床类型对慢性胃炎的临床疗效有影响。慢性胃炎、慢性浅表性胃炎的临床疗效较高,胆汁反流性胃炎次之,慢性萎缩性胃炎的临床疗效较差。2.2样本量样本量对慢性浅表性胃炎的痊愈率有影响,对慢性胃炎、慢性浅表性胃炎、慢性萎缩性胃炎的有效率均有影响。样本量对临床疗效的作用方向具有一致性,大样本量的临床试验痊愈率与有效率高于小样本量者。2.3诊断标准诊断标准对慢性胃炎、慢性萎缩性胃炎、胆汁反流性胃炎的痊愈率有影响,对慢性浅表性胃炎、慢性萎缩性胃炎的有效率有影响。在各组中,诊断标准对临床疗效的作用方向具有一致性,诊断标准不明确的临床试验痊愈率与有效率高于诊断标准明确者。2.4疗效标准疗效标准对慢性胃炎、胆汁反流性胃炎的痊愈率有影响,对慢性浅表性胃炎的有效率有影响。在各组中,疗效标准对临床疗效的作用方向具有一致性,疗效标准不明确的临床试验痊愈率与有效率高于疗效标准明确者。2.5临床试验方法临床试验方法对慢性胃炎、慢性浅表性胃炎的疗效影响未显示出统计学差异,对慢性萎缩性胃炎与胆汁反流性胃炎痊愈率与有效率的影响均显示出统计学差异。总体而言,病例系列研究的痊愈率与有效率高于随机对照临床试验;有对照组的前后对比试验总体疗效低于病例系列,但与随机对照临床试验相比,结果呈现不确定性。2.6痊愈率与有效率对各组的痊愈率(症状痊愈率、镜下痊愈率、病理痊愈率、总痊愈率)的分析表明:除胆汁反流性胃炎三种痊愈率无差异外,其余均有差异。总体而言,症状痊愈率、总痊愈率较高,镜下痊愈率次之,病理痊愈率最低。对各组有效率(症状有效率、镜下有效率、病理有效率、总有效率)的分析表明:各组中不同的有效率比较均有统计学差异。总体而言,症状有效率、总有效率较高,镜下有效率次之,病理有效率最低。结论1中医学临床实践指南制作方法符合中医学的特点,与中医学临床文献特点基本相适应,能够指导慢性胃炎临床实践指南的制作。2慢性胃炎中医学临床实践指南符合中医学治疗慢性胃炎的临床实际,体现了中医学特色,具有科学性与实用性。3中医临床试验设计因素中的临床类型、样本量、诊断标准、疗效标准、临床试验方法对临床疗效均有一定的影响,尤其是诊断标准与疗效标准不明确,缺乏对照等均可夸大临床疗效。有必要提高慢性胃炎中医学临床研究质量,建立中医学临床研究论文的发表规范。4慢性胃炎中医药临床研究中应对各临床类型单独研究;对中医药进行临床疗效评价时应明确疗效指标,在痊愈率方面,将症状痊愈率、镜下痊愈率、病理痊愈率单独评价;在有效率方面,将症状有效率、镜下有效率、病理有效率单独评价。更多还原

【Abstract】 Objective1 To explore the methods of developing clinical practice guidelines of TCM,and take it as the guidance in the making of clinical practice guidelines of CG in TCM.2 To evaluate the factors related to therapeutic literature of CG in the contribution of clinical therapeutic effect in order to provide references for clinical trials in TCM.Method1 Research on the making of clinical practice guidelines of CG in TCMOn the basis of analyzing the methods of the making and evaluation of clinical practice guidelines abroad systematically,we developed the procedure of clinical practice guidelines of CG in TCM,combining with the character of TCM and TCM literature.Following by the practical operation,the former procedure was amended.2 Research on influential factors in quality assessment of therapeutic literature of CGLiterature of CG clinical trials in 1998.3 to 2008.3 was collected and clinical design factors such as clinical trial methods,sample size,diagnostic criteria,and curative effect criteria were recorded.By statistic analysis,we appraised the factors which affected quality of clinical trials of TCM.Result1 Research on the making of clinical practice guidelines of CG in TCM1.1 The completeness of CG clinical practice guideline of TCMIn the making of CG clinical practice guidelines of TCM,the following work had been done:establishing the guideline development group;pre-examining the literature; decomposing and defining clinical questions;literature searching;appraising literature and forming evidence;evaluating evidence and composing the recommendations;the writing of guideline draft;experts review;rectifying and completing the final draft. The quality assessment methods of literature was especially discussed and used in the guideline development.1.2 The appraisal of CG clinical practice guideline of TCM (1)The appraisal of CG guideline by AGREE instrument:①The score by AGREE instrument appraisal:the standardized domain score of scope and purpose is 71.4%;score of stakeholder involvement is 50.0%;score of rigor of development is 80.6%;score of clarity and presentation is 66.7%;score of editorial independence is 83.3%;for the independence of the implementation and dissemination of the guideline, the standardized score of applicability(item 19,20,21) is low.②The comments of the guideline:the guideline should be tested in local area first;proper adjustment should be taken in the implementation according to clinical practice locally.(2)The comments of experts:This guideline was established by introducing the world modern advanced guideline development methods,which was modified with the clinical practice of CG in the treatment of TCM.The content of the guideline embodies the characteristic of CG treatment of TCM,and is wholly scientific and applicable.Dissemination can be performed after local implementation.2 Research on influential factors in quality assessment of therapeutic literature of CG2.1 Clinical typeClinical type of CG has impacts on the therapeutic effect.CG,CSG has a better curative effect,BRG is second to CG and CSG,and CAG is relatively lower than above.2.2 Sample sizeSample size influences on the recovery power of CSG,and to CG,CSG,CAG,it mainly impacts on the effective power.Clinical trials of big samples have a better curative effect than the ones of small sample size.2.3 Diagnostic criteriaDiagnostic criteria impacts on recovery power of CG,CAG.BRG,and to CSG, CAG,it mainly influences on effective power.Clinical trials of improper diagnostic criteria have a higher effective power than the ones of proper diagnostic criteria.2.4 Therapeutic effect criteriaTherapeutic effect criteria impacts on recovery power of CG,BRG,and has influences on the effective power of CSG.Clinical trials of improper therapeutic effect criteria have a better therapeutic effect than the ones of proper therapeutic effect criteria.2.5 Clinical trial methodClinical trial method has no impact on CG and CSG,while to CAG and BRG,it affects on both recovery power and effective power.Clinical trials of CSS have a higher recovery and effective power than the ones of RCT.To trials of CBAS,the therapeutic rate is lower than the ones of CSS,but compared to the ones of RCT,the result is not a fixed one.2.6 Recovery power and effective powerThere are differences in the recovery power of symptoms,gastroscope and pathological changes in all types of CG but BRG.The recovery power of symptoms and the total recovery power are higher,the recovery power of gastroscope is second to the former ones,and the recovery power of pathological changes is relatively lower. There are differences in the effective power in all types of CG.The effective power of symptoms and the total effective rate are higher,the effective power of gastroscope is second to the former ones,and the effective power of pathological changes is relatively lower.Conclusion1 This clinical practice guideline development procedure of TCM is consistent with the characteristic of TCM treatment,and corresponds with the feature of clinical literature of TCM,which can be use as the guidance of the making of CG guideline development of TCM.2 The draft of CG clinical practice guideline of TCM is the embodiment of clinical practice of CG in TCM,and is scientific and applicable.3 Factors in clinical trial designs such as clinical type,sample size,diagnostic criteria, therapeutic effect criteria,clinical trial method have certain effects in the curative effect.Improper diagnostic criteria and therapeutic effect criteria,lack of controlled group can exaggerate the curative effect.It is necessary to raise the quality of clinical research and establish standards of articles of TCM clinical trials.4 Each pattern of CG should be researched independently.The therapeutic effect index should be specifically chosen in clinical trials.In the evaluation of recovery power,recovery power of symptoms,gastroscope,and pathological changes should be calculated separately,things are the same to the effective power.更多还原