复方雷公藤涂膜剂治疗活动期类风湿关节炎的临床再观察

A Further Study on Compound Tripterygium Wilfordii Hook Film in Treating Rheumatoid Arthritis at Active Stage

为检验自行研制的以雷公藤为主的中药复方外用涂膜剂的临床疗效与安全性，于１９９７年上半年对６０例类风湿关节炎患者进行了随机双盲对照的临床疗效观察，以对类风湿关节炎的西医常规治疗加复方雷公藤涂膜剂为治疗组、以西医常规治疗加安慰药涂膜剂为对照组，各３０例，疗程６周。结果表明，治疗后治疗组关节肿胀、压痛、疼痛及双手握力、晨僵时间、关节功能分级的改善均优于对照组，差异有显著性（Ｐ＜０．０５），治疗组血沉（ＥＳＲ）、类风湿因子（ＲＦ）、Ｃ－反应蛋白（ＣＲＰ）在治疗后有改善（与治疗前比较，均Ｐ＜０．０５）；与对照组比较，各症状指标改善均优于对照组（Ｐ＜０．０５）。治疗组仅有１例在治疗期间出现局部皮肤红点、瘙痒。治疗期间两组的血尿常规、心、肝、肾功能未见异常。表明复方雷公藤涂膜剂对类风湿关节炎有疗效。

To observe the clinical effects and safety of a self-developed Chinese herbal film (Tripterygium Wilfordii Hook as a main component),a randomized double-blinded controlled study was carried out.Sixty patients (30 in the treatment group and 30 in the control group) with rheumatoid arthritis were treated with a treatment course of 6 weeks in the first half year of 1997.The results showed that joints swelling, tenderness and pain were relieved,and two hands grip strength, morning stiffness and joint function classification were improved significantly in the treatment group compared with the control group(P< 0.05 );ESR,RF,CRP in the treatment group decreased after treatment (P< 0.05 ) while the above symptoms and indexes kept steady in the control group(P> 0.05 ).During the treatment,blood and urine routine, functions of heart, liver and kidney stayed normal in the two groups.Only one case in the treatment group experienced eruption and itching.It is suggested that Tripterygium Wilfordii Hook film Co. develops the advantages of traditional Chinese film and avoids the toxic and side effects induced by the long_term oral administration of Tripterygium Wilfordii Hook,and has a broad prospect of application and popularization.