目的:评价《类风湿关节炎中医诊疗指南》的临床应用情况,为指南修订提供参考。方法:采用前瞻性、多中心临床病例观察法,由5家国家中医药管理局中医药标准研究推广基地根据《中医临床诊疗指南应用评价病例调查表》完成病例信息采集,主要评价指南的应用符合度、应用效果等内容。统计学采用描述性分析方法。结果:指南应用符合度分析,证候分类符合率最高(90.7%),西医疾病诊断、分证治则治法的符合率较高(89.0%、84.7%),分证方药、调摄预防的符合率较低(47.3%、40.1%);应用效果评价分析,安全性〉经济性〉疗效,临床应用效果评价较好的比例分别为99.0%、94.3%、35.0%;指南综合评分,技术水平6.69,满意度6.59,适用性6.42;未采用指南的临床应用方案主要来源于重点专科方案、专家经验和医院的诊疗常规。结论:本指南整体技术水平、满意度和适用性较好,对临床实践具有一定的指导作用;指南在中医疾病诊断、分证用药、调摄预防等方面临床符合度低,需要依据循证医学证据修订完善,提高共识度;指南安全性、经济性较好,需要定期根据最新研究成果及时更新,进一步提高指南的临床疗效。
Objective: Evaluating application effect in TCM Clinical Practice Guideline of Rheumatoid Arthritis. Methods: Using prospective multi-center clinical case observation method, rheumatoid arthritis cases were observed by five standardization research and promotion bases of State Administration of TCM, according to The Case Evaluation Questionnaire of TCM Clinical Practice Guidelines. The authors compared the clinical treatment scheme with TCM clinical practice guidelineof rheumatoid arthritis, meanwhile, filled out the application and evaluation questionnaire of TCM clinical practice guideline of rheumatoid arthritis, using statistics method of descriptive analysis. Results: According to clinical practice guideline application, coincidence rates of the syndrome classification was highest(90.7%). Most of the coincidence rates of the guideline TCM clinical diagnosis and treatment were relatively high(89.0%, 84.7%). Coincidence rates of medicine and prevention were low(47.3% and 40.1% respectively). According to analysis of clinical practice guideline application, safety was higher than economy. Economy was higher than efficacy, The rate of clinical application was 99.0%94.0%35.0%, respectively. According to the comprehensive score of guideline, technological level was 6.69, degree of satisfaction was 6.59, and applicability was 6.42. The sections of not using guideline were key specialty plan, expert advice, and clinical convention in hospital. Conclusion: The whole technological level, safety and applicability of the clinical practice guideline of rheumatoid arthritis were high. TCM clinical diagnosis, treatment and prevention were low. The clinical practice guideline of rheumatoid arthritis should be revised in order to improve clinical application effect. The safety and economy were high and need to be renewed timely.