雷公藤多苷治疗原发性干燥综合征的初步观察

The clinical research of tripterygium glycosides in treatment of patients with primary Sj?gren′s syndrome

目的拟探讨雷公藤多苷治疗原发性干燥综合征(pSS)的疗效和安全性。方法 45例pSS纳入研究,接受雷公藤多苷24周的治疗,记录患者的病情评估指数(ESSDAI)、口干症状数字等级(NRS)评分、眼干症状NRS评分、关节痛NRS评分、红细胞沉降率、C反应蛋白和免疫球蛋白IgG水平。结果 40例(89%)完成24周临床观察。与基线相比,治疗12周和24周,患者ESSDAI分值有明显下降(P值均<0.01),眼干和关节痛症状也有不同程度改善(P值<0.05或<0.01),IgG、红细胞沉降率和C反应蛋白升高的比率也逐步下降(P值<0.05或<0.01),口干症状改善则不显著(P>0.05)。不良反应发生率16%,无严重不良反应。结论雷公藤多苷对pSS有一定疗效,尤其是能改善眼干和关节痛症状,有效降低IgG和急性期反应物水平,安全性较好。

Objective To evaluate the efficacy and safety of tripterygium glycosides in treatment of primary Sjogren′s syndrome （pSS） patients .Methods Forty‐five pSS patients were enrolled and treated with tripterygium glycosides for 24 weeks .EULAR SS disease activity index （ESSDAI） and other immunoserological parameters were investigated to assess the efficacy of tripterygium glycosides .Adverse drug reactions （ADRs） related to tripterygium glycosides were analyzed.Results Overall ,40 patients （89% ） completed 24 weeks of treatment . There were significant decreases in the ESSDAI scores after 12 weeks and 24 weeks treatment with tripterygium glycosides （P〈 0 .01） .Results for other efficacy endpoints showed that tripterygium glycosides can improve symptoms of dry eye and arthralgia in some pSS patients and decrease ESR ,CRP and IgG level （P〈 0.05 or 0.01） .However ,the improvement of symptom of dry mouth was not significant after 12 weeks and 24 weeks treatment （P〉0.05） .The prevalence of ADRs was 16% .No serious ADRs were found in this study .Conclusion pSS patients can benefit from tripterygium glycosides treatment .The safety of tripterygium glycosides is gener‐ally good .