Li Yehui, Zhu Wen, He Hailang, Garov Yordan Angelov, Bai Le, Zhang Li, Wang Jing, Wang Jinghai, Zhou Xianmei
Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Jiangsu Provincial Hospital of Chinese Medicine, Nanjing, China.
Front Pharmacol. 2021 Jun 10;12:691031. doi: 10.3389/fphar.2021.691031. eCollection 2021.
Tripterygium wilfordii Hook. F (TwHF), a Chinese herbal medicine used to treat CTD-ILD patients in China, has been previously found to have immunoinhibitory, antifibrotic and anti inflammatory effects. It has also shown good results in treating autoimmune and inflammatory diseases. This systematic review and meta-analysis aims to evaluate the efficacy and safety of TwHF for CTD-ILD. A systematic search was performed on PubMed, Embase, Cochrane Library, Web of Science, PsycINFO, Scopus, CNKI, Wanfang, VIP, and CBM databases up to May 2021. Randomized controlled trials (RCTs) comparing TwHF plus conventional therapy versus conventional therapy alone were included. We followed the PRISMA checklist, and applied Cochrane handbook 5.1.0 and RevMan 5.3 for data analysis and quality evaluation of the included studies. Based on Cochrane handbook 5.1.0, nine RCTs consisting 650 patients met the inclusion/exclusion criteria and were selected for further analysis. The obtained data showed significant improvement in lung function with TwHF plus conventional treatment compared with conventional treatment (post-treatment FVC% (MD= 8.68, 95%Cl (5.10, 12.26), < 0.00001), FEV1% (MD = 11.24, 95%Cl (6.87, 15.61), < 0.00001), TLC% (MD = 5.28, 95%Cl (0.69, 9.87), = 0.02)], but no significant difference in the post-treatment DLCO% [(MD = 4.40, 95%Cl (-2.29, 11.09), = 0.20)]. Moreover, the data showed that TwHF combined with conventional treatment significantly reduced the HRCT integral of patients [MD = -0.65, 95% (-1.01, -0.30), 0.0003], the level of erythrocyte sedimentation rate (MD = -9.52, 95%Cl (-11.55, -7.49), < 0.00001), c-reactive protein (CRP) (MD = -8.42, 95%Cl (-12.47, -4.38), < 0.0001), and rheumatoid factor (MD = -25.48, 95%Cl (-29.36, -21.60), < 0.00001). Compared to conventional therapy, TwHF combined with conventional therapy significantly improved clinical effects (RR = 1.33, 95%Cl (1.17, 1.51), < 0.0001), in five trials with 354 patients. In terms of improvement of symptoms and signs, the TwHF group showed a more significant improvement than the conventional treatment group (Cough (MD = -0.96, 95%Cl (-1.43, -0.50), < 0.0001), velcro rales (MD = -0.32, 95%Cl (-0.44, -0.20), < 0.00001), shortness of breath (MD = -1.11, 95%Cl (-1.67, -0.56), < 0.0001)], but no statistical difference in dyspnea (MD = -0.66, 95%Cl (-1.35, 0.03), = 0.06). There was no statistical significance in the incidence of adverse reactions. The performed meta-analysis indicated that TwHF combined with conventional treatment was more beneficial to patients for improving symptoms, lung function and laboratory indicators. As it included studies with relatively small sample size, the findings require confirmation by further rigorously well-designed RCTs.
雷公藤（TwHF）是一种在中国用于治疗CTD-ILD患者的草药，此前已发现它具有免疫抑制、抗纤维化和抗炎作用。它在治疗自身免疫性和炎性疾病方面也显示出良好效果。本系统评价和荟萃分析旨在评估雷公藤治疗CTD-ILD的疗效和安全性。截至2021年5月，我们在PubMed、Embase、Cochrane图书馆、Web of Science、PsycINFO、Scopus、中国知网、万方、维普和中国生物医学文献数据库中进行了系统检索。纳入了比较雷公藤联合传统疗法与单纯传统疗法的随机对照试验（RCT）。我们遵循PRISMA清单，并应用Cochrane手册5.1.0和RevMan 5.3对纳入研究进行数据分析和质量评估。根据Cochrane手册5.1.0，9项包含650例患者的RCT符合纳入/排除标准，并被选作进一步分析。获得的数据显示，与传统治疗相比，雷公藤联合传统治疗可使肺功能显著改善（治疗后FVC%（MD = 8.68，95%CI（5.10，12.26），<0.00001），FEV1%（MD = 11.24，95%CI（6.87，15.61），<0.00001），TLC%（MD = 5.28，95%CI（0.69，9.87），=0.02）]，但治疗后DLCO%无显著差异[（MD = 4.40，95%CI（-2.29，11.09），=0.20）]。此外，数据显示雷公藤联合传统治疗可显著降低患者的HRCT积分[MD = -0.65，95%（-1.01，-0.30），0.0003]、红细胞沉降率水平（MD = -9.52，95%CI（-11.55，-7.49），<0.00001）、C反应蛋白（CRP）（MD = -8.42，95%CI（-12.47，-4.38），<0.0001）和类风湿因子（MD = -25.48，95%CI（-29.36，-21.60），<0.00001）。在5项包含354例患者的试验中，与传统疗法相比雷公藤联合传统疗法显著改善了临床疗效（RR = 1.33，95%CI（1.17，1.51），<0.0001）。在症状和体征改善方面，雷公藤组比传统治疗组改善更显著（咳嗽（MD = -0.96，95%CI（-1.43，-0.50），<0.0001），捻发音（MD = -0.32，95%CI（-0.44，-0.20），<0.00001），气短（MD = -1.11，95%CI（-1.67，-0.56），<0.0001）]，但呼吸困难无统计学差异（MD = -0.66，95%CI（-1.35，0.03），=0.06）。不良反应发生率无统计学意义。所进行的荟萃分析表明，雷公藤联合传统治疗在改善症状、肺功能和实验室指标方面对患者更有益。由于纳入研究的样本量相对较小，研究结果需要通过进一步严格设计良好的RCT加以证实。
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