赤丹退黄颗粒与加诺片对照治疗急慢性病毒性淤胆型肝炎

目的 :评价赤丹退黄颗粒治疗淤热发黄所致的急、慢性病毒性淤胆型肝炎退黄及改善中医症状的有效性和安全性。方法 :采用多中心、随机、双盲、双模拟、阳性药物平行对照试验。 2 48例患者分为赤丹退黄颗粒 (试验 )组 ( 10 g ,tid) 12 4例及加诺片 (对照 )组 ( 1片 ,tid) 12 4例 ;疗程 8周。 结果 :试验组在降低血清总胆红素、退黄显效及总有效率、降低转氨酶、改善中医症状记分 (总分 )及中医综合疗效等方面均优于对照组 ,差异有显著性。试验组血、尿、粪常规、肾功、心电图等安全耐受性指标无明显变化。试验组不良事件发生率与对照组比较无明显差异(P >0 .0 5 ) ,无因不良事件退出试验者。结论 :赤丹退黄颗粒是治疗淤热发黄所致的急、慢性病毒性淤胆型肝炎有效、安全的药物。

Comparison of Chidan Tuihuang Keli and Galle-Donau in the treatment of acute and chronic viral cholestatic hepatitis

Objective:To evaluate the efficacy and safety of Chidan Tuihuang Keli for treatment of acute and chronic viral cholestatic hepatitis caused by stagnant heat with extinction of jaundice and improvement of symptom of TCM,compared with Galle-Donau. Methods :The double blind clinical trial was adopted.248 cases of acute and chronic viral cholestatic hepatitis patients were randomly divided into the test group(n=124)and the control group(n=124)to receive chidan Tuihuang Keli 10g,tid and Galle-Donau 1 tablet,tid,respectivly,for both eight weeks. Results :The test group were superior significantly to the control group in the field of reduction of serum total bilirubin,the total effective rates and the follow-up survey,improvement of symptom of TCM and the effective rates of TCM.The incidence rate of adverse event in the test group was similar to that in the control group ( P > 0.05). Conclusion :Chidan Tuihuang Keli is an effective and safe drug for treatment of acute and chronic viral cholestatic hepatitis caused by stagnant heat.