中医药治疗类风湿关节炎患者随访期间终点事件发生情况的队列研究

A Cohort Study on the Occurrence of End-point Events during the Follow-up Period in Patients with Rheumatoid Arthritis Treated with Chinese Medicine

目的:随访类风湿关节炎出院患者中医药的应用情况,分析中医药治疗与终点事件发生的相关性。方法:采用队列研究设计,电话随访安徽中医药大学第一附属医院2012年1月至2015年6月首次诊断为类风湿关节炎的患者,记录出院后口服中成药及中药汤剂的种类和服用时间,以及有无再发加重入院、关节外病变、手术治疗和全因死亡等终点事件的出现,采用Logistic回归等统计学方法分析出院后患者的中医药干预与终点事件发生之间的相关性。结果:研究共纳入1812例类风湿关节炎患者,完成随访1468例,失访率18.98%。1468例患者服用频次较高的口服中成药依次为新风胶囊、黄芩清热除痹胶囊、新癀片等,中药汤剂依次为四妙散、知柏地黄汤、身痛逐瘀汤等,应用频次最高的12味中药按功效可分为健脾药、活血药、清热药、祛风湿药4类。终点事件非暴露组发生37例,低暴露组发生21例,中暴露组发生14例,高暴露组发生8例。终点事件的发生与中医药治疗及强度存在相关性。结论:类风湿关节炎患者出院后以服用中成药和中药汤剂为主,终点事件的发生与中药服用时间存在相关性,其中中药健脾药、活血药及中成药新风胶囊等可降低类风湿关节炎患者终点事件的发生。

Objective:To follow up the application of Chinese medicine in patients with rheumatoid arthritis(RA)after leaving hospital,and to analyze the correlation between the treatment of Chinese medicine and the occurrence of end-point events.Methods:According to a cohort study design,patients firstly diagnosed as rheumatoid arthritis by the First Affiliated Hospital of Anhui University of Chinese Medicine from January 2012 to June 2015 were followed up by telephone,recording the types and time of their taking Chinese Medicine after leaving the hospital and end-points such as being hospitalized again for recrudescence or aggravation,extra articular lesions,surgical treatment and all-cause death.Logistic regression method was used to analyze the correlation between Chinese medicine intervention end-point events.Results:There were a total of 1812 patients with rheumatoid arthritis in the study.One thousand four hundred and sixty eight of them were successfully followed up and 18.98%of them were not.According to frequency from high to low,oral medicines in the followed patients are Xinfeng Jiaonang(新风胶囊),Huangqin Qingre Chubi Jiaonang(黄芩清热除痹胶囊)and Xinhuang Pian(新癀片);and decoctions are Simiao San(四妙散),Zhibai Dihuang Tang(知柏地黄汤)and Shentong Zhuyu Tang(身痛逐瘀汤).According to efficacy,twelve medicinals with high frequency were divided into four categories:medicinals of tonifying spleen,medicinals of activating blood circulation,medicinals of clearing heat and medicinals of dispelling wind and dampness.As for end-point events,there were 37 cases in the non-exposure group,21 in the low exposure group,14 in the intermediate exposure group and 8 in the high exposure group.The occurrence of the end-point events was related to the treatment and intensity of Chinese medicine.Conclusion:Leaving hospital,patients mainly take Chinese patent medicine and decoction.The occurrence of end-point events is related with the taking time of Chinese medicine.Medicinals of tonifying spleen,medicinals of activating blood circulation and Xinfeng Jiaonang can lower the end-point events occurred in patients with rheumatoid arthritis.