来源：风湿病与关节炎,2017,6（8）:15-19.

1658例骨关节炎患者健脾化湿、补肾通络方药运用的队列研究（临床研究）

方妍妍¹，刘　健²，万　磊²，忻　凌²，董文哲¹，文建庭¹

　　【摘　要】目的：随访骨关节炎出院患者健脾化湿、补肾通络方药的运用情况，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（随访时间：2016年10月1日至2016年11月30日）安徽中医药大学第一附属医院2012年1月1日至2016年6月30日住院骨关节炎患者，记录其出院后口服中成药、中药汤剂的种类和服用时间，以及再发入院、关节外病变、手术治疗、全因死亡终点事件的发生情况，终点事件采用χ²检验、logistic回归分析中医药（刘健教授常用的健脾化湿代表药茯苓、薏苡仁、陈皮，祛风补肾代表药威灵仙、川芎、桑寄生，活血通络代表药丹参、桃仁、红花以及院内制剂新风胶囊、黄芪清热除痹胶囊、颈椎活血胶囊、五味温通除痹胶囊）治疗与终点事件发生的相关性。结果：共随访骨关节炎患者1904例，完成随访患者1658例，失访率12.92%。暴露组（出院后口服中成药和中药汤剂≥28 d）1318例，服用频次较多的中成药依次为新风胶囊、新癀片、黄芩清热除痹胶囊等，中药汤剂依次为独活寄生汤、四妙散、二陈汤、身痛逐瘀汤等。各暴露组终点事件总发生99例，其中非暴露组48 例（14.12%），低暴露组25例（12.25%），中暴露组16例（5.48%），高暴露组10例（1.22%），其发生率对比差异有统计学意义（P < 0.05）。结论：终点事件的发生与中药服用时间存在相关性，其中成药新风胶囊以及薏苡仁、红花等健脾化湿、补肾通络方药可降低骨关节炎患者终点事件的发生。

　　【关键词】　骨关节炎；健脾化湿、补肾通络药；终点事件；队列研究；新风

胶囊

Cohort Study of 1658 Cases of Osteoarthritis Treated with Formula of Fortifying the Spleen and Removing Dampness,Tonifying Kidney and Dredging Collaterals

FANG Yan-yan,LIU Jian,WAN Lei,XIN Ling,DONG Wen-zhe,WEN Jian-ting

　　【ABSTRACT】Objective:To follow up patients treated with formula of fortifying the spleen and removing dampness,tonifying kidney and dredging collaterals,and to analyze the correlation between TCM treatment and the occurrence of endpoint events.Methods:In the cohort study,a follow-up（follow-up time:from October 1,2016 to November 30,2016）was made by telephoning patients with osteoarthritis treated in the First Affiliated Hospital of Anhui University of Chinese Medicine（hospitalized from January 1,2012 to June 30,2016）,recording the time and types of Chinese patent medicine and decoction and other conditions such as readmission,extra articular lesion,surgical treatment and all-cause mortality.The end point events were tested using χ² and a logistic regression analysis was made to analyze the correlation between TCM treatment and the occurrence of endpoint events（Medicinals commonly used by Professor Liu Jian are fuling［Poria  cocos（Schw.）Wolf］,yiyiren［Coix lacryma-jobi L.var.mayuen（Roman.）Stapf］and chenpi（Citrus reticulata Blanco）for fortifying the spleen and removing dampness;weilingxian（Clematis chinensis Osbeck）,chuanxiong（Ligusticum chuanxiong Hort.）and sangjisheng［Taxillus chinensis（DC.）Danser］for dispelling wind and tonifying kidney;and danshen（Salvia miltiorrhiza Bge.）,taoren［Prunus persica（L.）Batsch］and honghua（Carthamus tinctorius L.）for activating blood circulation and dredging collaterals.Preparations made by the hospital are Xinfeng Jiaonang（新风胶囊）,Huangqi Qingre Chubi Jiaonang（黄芪清热除痹胶囊）,Jingzhui Huoxue Jiaonang（颈椎活血胶囊） and Wuwei Wentong Chubi Jiaonang（五味温通除痹胶囊）.Results:A total of 1904 patients with osteoarthritis were followed up,among which the follow-ups of 1658 patients were finished and the rate of failure was 12.92%.There were 1318 cases in the exposure group（taking Chinese patent medicine and decoction for more than28 days after leaving hospital）.According to high frequency,the Chinese patent medicines with taken by them were Xinfeng Jiaonang,Xinhuangpian（新癀片）and Huangqi Qingre Chubi Jiaonang and decoctions taken by them were Duhuo Jisheng Tang（独活寄生汤）,Simiao Sang（四妙散）,Erchen Tang（二陈汤）and Shentong Zhuyu Tang（身痛逐瘀汤）.The endpoint events happened in 99 cases of all the exposure groups,among which 48 cases were in the non-exposure group（14.12%）,25 cases were in the low exposure group（12.25%）,16 cases were in the medium exposure group（5.48%） and 10 cases were in the high exposure group（1.22%）.The difference of incidence rates was statistically significant （P < 0.05）.Conclusion:There is a correlation between the occurrence of endpoint events and the taking time of Chinese medicine.Xinfeng Jiaonang,yiyiren and honghua can reduce the occurrence of endpoint events in patients with osteoarthritis.

　　【Keywords】 osteoarthritis;formula of fortifying the spleen and removing dampness,tonifying kidney and dredging collaterals;endpoint event;cohort study;Xinfeng Jiaonang（新风胶囊）