Geng Qi, Liu Bin, Ma Yanfang, Li Huizhen, Shi Nannan, Ouyang Guilin, Nie Zhixing, Yi Jianfeng, Chen Yaolong, Wang Yanping, Lu Cheng
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Chemical and Biological Engineering, Yichun University, Yichun 336000, China.
Evid Based Complement Alternat Med. 2022 Mar 24;2022:1251478. doi: 10.1155/2022/1251478. eCollection 2022.
This study aimed to systematically review the efficacy and clinical safety of different courses and doses of tripterygium glycoside (TG) adjuvant methotrexate (MTX) therapy in the treatment of rheumatoid arthritis (RA).
Randomized controlled trials (RCTs) of TG adjuvant MTX therapy in patients with RA were retrieved from SinoMed, China Network Knowledge Infrastructure, WanFang Data, PubMed, Cochrane Library, and Embase from inception to September 30, 2021. The effects and clinical safety evaluations were conducted using RevMan 5.3 software.
A total of 9 RCTs and 892 patients with RA were included in this study. In the meta-analysis, a total of 463 and 429 patients were enrolled into the TG adjuvant MTX therapy group and MTX monotherapy group, respectively. In comparison with MTX monotherapy, the results of the analyzed effects showed that the TG adjuvant MTX therapy can achieve 20%, 50%, and 70% improvements in American College of Rheumatology (ACR) criteria ACR20, ACR50, and ACR70 at = 0.005, = 0.0001, and = 0.004, respectively. Simultaneously, the efficacy of the TG adjuvant MTX therapy was improved at either 30 or 60 mg/day over a six-month course compared to MTX monotherapy ( < 0.0001). There was no statistical difference in the effects between the doses of 30 and 60 mg/day after three months ( = 0.82). TG adjuvant MTX also reduced the expression rate of the swollen joint count, tender joint count, erythrocyte sedimentation rate, rheumatoid factor, and C-reactive protein in subgroup analyses with different courses and doses. In terms of hepatic adverse effects ( = 0.28), leukopenia ( = 0.78), gastrointestinal adverse effects ( 0.17), cutaneous adverse effects ( = 0.94), and irregular menstruation adverse effects ( = 0.29), there was no statistically significant difference with TG adjuvant MTX therapy and MTX monotherapy with different courses and doses.
TG adjuvant MTX therapy is more effective than MTX monotherapy and is a safe strategy for RA treatment in doses of 30 or 60 mg/day over a treatment course of six months. However, high-quality multicenter RCT studies with large sample sizes are still needed to confirm the effects and clinical safety of different courses and doses of TG adjuvant MTX therapy.
本研究旨在系统评价不同疗程及剂量的雷公藤多苷（TG）联合甲氨蝶呤（MTX）治疗类风湿关节炎（RA）的疗效及临床安全性。
从中国生物医学文献数据库、中国知网、万方数据、PubMed、Cochrane图书馆和Embase中检索自建库至2021年9月30日期间关于TG联合MTX治疗RA患者的随机对照试验（RCT）。使用RevMan 5.3软件进行疗效和临床安全性评价。
本研究共纳入9项RCT及892例RA患者。在荟萃分析中，分别有463例和429例患者纳入TG联合MTX治疗组和MTX单药治疗组。与MTX单药治疗相比，分析结果显示，TG联合MTX治疗在第0、0.005、0.0001和0.004时，美国风湿病学会（ACR）标准的ACR20、ACR50和ACR70改善率分别可达20%、50%和70%。同时，与MTX单药治疗相比，TG联合MTX治疗在6个月疗程中，每日30或60mg剂量时疗效更佳（<0.0001）。3个月后，30mg/天和60mg/天剂量组之间的疗效无统计学差异（=0.82）。在不同疗程和剂量的亚组分析中，TG联合MTX还降低了肿胀关节计数、压痛关节计数、红细胞沉降率、类风湿因子和C反应蛋白的表达率。在肝不良反应（=0.28）、白细胞减少（=0.78）、胃肠道不良反应（=0.17）、皮肤不良反应（=0.94）和月经不调不良反应（=0.29）方面，TG联合MTX治疗与不同疗程和剂量的MTX单药治疗之间无统计学显著差异。
TG联合MTX治疗比MTX单药治疗更有效，且在6个月治疗疗程中，每日30或60mg剂量是治疗RA的安全策略。然而，仍需要高质量、大样本量的多中心RCT研究来证实不同疗程和剂量的TG联合MTX治疗的疗效及临床安全性。
