中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 500-504.
DOI: 10.19803/j.1672-8629.20230108

• 中草药及抗肿瘤治疗相关肝损伤专栏（二） • 上一篇    下一篇

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

罗琼1, 李盟1, 李光耀2, 何彦春2, 周祖山2, 孙鑫1,3#, 刘成海1,3,4,*   

  1. 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
  • 收稿日期:2023-02-27 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *刘成海,男,博士,研究员,教授,中西医结合防治慢性肝病。E-mail: chenghailiu@hotmail.com;#为共同通信作者。
  • 作者简介:罗琼,女,硕士,住院医师,中西医结合防治慢性肝病。
  • 基金资助:
    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(shslczdzk01201); 湖北省卫生健康委中医药青年人才项目（ZY2021Q040）

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

LUO Qiong1, LI Meng1, LI Guangyao2, HE Yanchun2, ZHOU Zushan2, SUN Xin1,3#, LIU Chenghai1,3,4,*   

  1. 1Institute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;
    2Honghu Hospital of Traditional Chinese Medicine, Honghu Hubei 433200, China;
    3Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai 201203, China;
    4Key Laboratory of Liver and Kidney Diseases, Ministry of Education, Shanghai 201203, China
  • Received:2023-02-27 Online:2023-05-15 Published:2023-05-16

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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。

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

Abstract: 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-dampness obstruction syndrome (P=0.029); The serum uric acid level in the damp-heat obstruction syndrome group was significantly higher than that in the qi and blood deficiency syndrome group (P=0.013). The degree of liver injury is mainly mild to moderate, and most patients have a good prognosis. Conclusion Tripterygium wilfordii single preparation (Huangteng extract tablet) combined with other TCM based on syndrome differentiation was the common clinical TCM treatment of rheumatoid arthritis. Reasonable combination of Qingre Tongbi tablet under the damp-heat obstruction syndrome could reduce the occurrence of liver injury to a certain extent. However, the combination of other TCM decoction, TCM liquor, meloxicam, leflunomide or non-steroidal anti-inflammatory drugs increased the incidence of liver injury.

Key words: rheumatoid arthritis, Tripterygium wilfordii, drug induced liver injury, TCM syndrome differentiation, combined medication

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