635例类风湿性关节炎患者应用雷公藤制剂所致肝损伤的中医证候及联合用药特点  

Chinese medical evidence and characteristics of combined medication in 635 cases of rheumatoid arthritis patients with liver injury caused by the application of Tripterygium wilfordii preparations

作　　者：罗琼 李盟 李光耀 何彦春 周祖山 孙鑫 刘成海 LUO Qiong;LI Meng;LI Guangyao;HE Yanchun;ZHOU Zushan;SUN Xin;LIU Chenghai(Institute of Liver Diseases,Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Honghu Hospital of Traditional Chinese Medicine,Honghu Hubei 433200,China;Shanghai Key Laboratory of Traditional Chinese Clinical Medicine,Shanghai 201203,China;Key Laboratory of Liver and Kidney Diseases,Ministry of Education,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院肝病研究所,上海201203 [2]湖北省洪湖市中医院,湖北洪湖433200 [3]上海市中医临床重点实验室,上海201203 [4]肝肾疾病病证教育部重点实验室,上海201203

出　　处：《中国药物警戒》2023年第5期500-504,510,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(81730109,82274305);上海市中医药事业发展三年行动计划[ZY(2018-2020)-CCCX-5001];上海市科学技术委员会科技计划项目(20Z21900100);上海市临床重点专科建设项目(shslczdzk 01201);湖北省卫生健康委中医药青年人才项目(ZY2021Q040)。

摘　　要：目的分析类风湿性关节炎患者应用雷公藤制剂所致肝损伤的中医证候及联合用药特点。方法回顾性收集2014年12月22日至2020年12月10日于洪湖市中医院使用雷公藤制剂治疗类风湿性关节炎患者的临床资料,根据有无肝损伤分为观察组和对照组,组间两两比较采用SNK-Q检验或Nemenyi检验,以探讨其中医证候及联合用药特点。结果共收集到使用雷公藤制剂类风湿关节炎患者635例;年龄40~59岁人数居多(56.69%);成年女性多于男性,男女比例1∶3.12;其中发生肝损伤患者349例(观察组),匹配同时期使用相同治疗未发生肝损伤患者286例(对照组)。其中合并高血压(P=0.003)发生肝损伤的患者比例显著高于对照组;类风湿性关节炎治疗上均使用黄藤浸膏片配合中医辨证用药,其中以加用清热通痹片(湿热痹阻证)占比最多,且发生肝损伤患者比例降低(P=0.043)。多数患者还与其他药物联用,其中联用中药汤剂(P<0.001)、中药酒剂(P=0.026)、美洛昔康(P=0.03)、来氟米特(P<0.001)和/或非甾体类抗炎药(P=0.012)的患者发生肝损伤比例显著高于对照组。在肝损伤观察组中,湿热痹阻证(P=0.008)患者血清碱性磷酸酶的水平显著高于寒湿痹阻证(P=0.029);湿热痹阻证组血清尿酸水平显著高于气血两虚证组(P=0.013)。肝损伤程度多以轻中度为主,大部分患者预后良好。结论雷公藤单品制剂(黄藤浸膏片)配合中医辨证治疗是类风湿性关节炎的临床常用方案,同时联用其他中药汤剂、酒剂、美洛昔康、来氟米特、非甾体抗炎药等药物致使肝损伤发生率增加。Objective To analyze the traditional Chinese medicine(TCM)syndromes and combined medication of liver injury caused by Tripterygium wilfordii preparation in patients with rheumatoid arthritis.Methods The clinical data of patients with rheumatoid arthritis treated with Tripterygium wilfordii preparation in Honghu Hospital of Traditional Chinese Medicine from December 22,2014 to December 10,2020 were retrospectively collected,and divided into observation group and control group according to the presence or absence of liver injury.The SNK-Q test or Nemenyi test was used for comparison between the two groups to explore the characteristics of TCM syndromes and combined medication.Results A total of 635 patients with rheumatoid arthritis who used Tripterygium wilfordii preparation were collected in the past six years;The majority of people aged 40 to 59 years old(56.69%);Adult females are more than males,the ratio of males to females is 1∶3.12;Among them,349 patients with liver injury(observation group)and 286 patients without liver injury(control group)were matched with the same treatment at the same time.The proportion of patients with liver injury complicated by hypertension(P=0.003)was significantly higher than that of the control group.In the treatment of rheumatoid arthritis,Huangteng extract tablets were used in combination with other TCM based on syndrome differentiation,among which Qingre Tongbi tablets(damp-heat obstruction syndrome)accounted for the most proportion,and the proportion of patients with liver injury decreased(P=0.047).Most of the patients were also combined with other drugs,among which the proportion of liver injury was significantly higher in the patients combined with TCM decoction(P<0.001),TCM liquor(P=0.026),meloxicam(P=0.03),leflunomide(P<0.001)and/or non-steroidal anti-inflammatory drugs(P=0.012).In the observation group of liver injury,the level of serum alkaline phosphatase in patients with damp-heat obstruction syndrome(P=0.008)was significantly higher than that in patients with cold-

关 键 词：类风湿性关节炎 雷公藤 药物性肝损伤 中医辨证 联合用药 

分 类 号：R961[医药卫生—药理学] R994.11[医药卫生—药学]