雷公藤缓释片治疗类风湿性关节炎的临床及实验研究

Clinical and Experimental Study on Sustained Release Tablet of Tripterygium Wilfordii in Treating Rheumatoid Arthritis

采用前瞻性、多中心、随机、单盲、平行对照的方法，将符合ＡＲＡ诊断标准的２２６例类风湿关节炎患者分为２组。治疗组１１４例，采用雷公藤缓释片（ＴＷ－ＳＲ）治疗，每次２片，每天２次，连服４周；对照组１１２例采用雷公藤片（ＴＷ）治疗，每次２片，每天３次，连服４周。结果表明：，总有效率ＴＷ－ＳＲ和ＴＷ分别为９２．１１％和９０．６５％（Ｐ＞０．０５）；不良反应率ＴＷ－ＳＲ和ＴＷ分别为２０．１８％和７０．５４％（Ｐ＜０．０１）。临床前药理实验研究结果表明：ＴＷ－ＳＲ与ＴＷ一样具有显著的抗炎、镇痛和免疫抑制作用。ＴＷ－ＳＲ毒性明显小于ＴＷ。

Adopt to the prospective, multi-center, random, single-blind, equal rank-control methods, 226 patients of rheumatoid arthritis diagnosed according to the ARA criteria, were divided into 2 groups. One hundred and fourteen patients of test group were treated with sustained release tablets of Triptergium wilfordii (TW-SR) orally, 2 tablets, twice a day for 4 weeks, 112 patients of control group received tablets of Tripterygium wilfordii (TW) orally, 2 tablets 3 times per day for 4 weeks.Results showed that the total effective rate of the two groups were 92. 11 % and 90. 65%, respectively (P ＞0. 05).The adverse reaction rate of TW-SR group was 20. 18%, which was lowered than that of TW group (70 . 54%,P ＜ 0 . 01 ) . Results of pre-clinical pharmacologic experimental study showed that the TW-SR has obvious anti-inflammatory,analgesia and immunosuppress'ive action as the TW has, while its toxicity was less than the latter significantly.