双环醇片治疗2200例慢性病毒性肝炎的安全性和疗效分析

目的:通过Ⅳ期临床试验评估双环醇片治疗慢性乙型肝炎和慢性丙型肝炎的安全性和疗效。方法:随机选择12～65a的2200例慢性乙型肝炎和慢性丙型肝炎病人接受治疗,每日口服双环醇片75mg,观察连续用药24wk(近期)及停药12wk后(远期)的安全性和疗效,以血清丙氨酸转氨酶(ALT)作为主要疗效评估指标。结果:试验过程中未发生严重不良事件,不良事件发生率为10.87%。意向性分析(ITT)统计显示,慢性乙型肝炎和慢性丙型肝炎病人治疗24wk末的ALT复常率分别为60.37%和54.0%,停药12wk后的ALT持续复常率分别为71.88%和65%。结论:双环醇片75mg·d-1治疗慢性乙型肝炎和慢性丙型肝炎安全,对改善肝功能有效。

Efficacy and safety of bicyclol in treatment of 2 200 chronic viral hepatitis

AIM: To evaluate the efficacy and safety of bicyclol, a new national patent medicine in the treatment of chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC). METHODS: Two thousand and two hundred patients with C HB or CHC orally received bicyclol 75 mg daily for 24 wk; and then stopped the t reatment and followed up to 12 wk. The normalization of alanine aminotransferace (ALT) wa s taken as the main efficacy assessments. RESULTS: There was no serious adverse events occuring during the study. The adverse events rate in the duration was (10.87 %). According to th e in tention to treat analysis statistics, the normalization rates of ALT for CHB pat ients and CHC patients were respectively (60.37 %) and (54.0 %) after 24 wk treatment, and the sustaine d no rmal iz ation rates of ALT were respectively (71.88 %) and 65 % at 12 wk after stop of tre at ment. CONCLUSION: Bicyclol 75 mg daily is effective and safe for the treatment of CHB and CHC.