双环醇治疗慢性丙型肝炎的临床研究

Treatment of chronic hepatitis C by bicyclum, a randomized double-blind placebo controlled trial

目的 探讨双环醇治疗慢性丙型肝炎的疗效和安全性。方法 慢性病毒性丙型肝炎患者 39例 ,按随机、双盲、对照的方法 ,以 1∶1的比例分为双环醇组 (A组 )和安慰剂 (同样形状的白色淀粉片 ) 双环醇交叉组 (B组 )。 2组患者分别给予双环醇 2 5mg ,每日 3次和安慰剂。 12周后A、B 2组患者分别服用双环醇 2 5mg ,每日 3次 ,12周和 2 4周 ,停药后观察 12周。结果 A组患者服药前与服药后 2 4周血清丙氨酸转氨酶 (ALT)值分别为 12 0U L± 4 4U L和 5 7U L± 32U L ,服药前后比较差异具有显著意义 (P <0 0 1)。B组患者用安慰剂治疗 3个月 ,治疗前和治疗后ALT分别为 12 6U L± 4 8U L和 12 7U L± 97U L ,治疗前后比较差异无显著意义 (P >0 0 5 ) ;将安慰剂转为双环醇治疗后 ,ALT值从 12 7U L± 97U L降至 6 8U L± 4 5U L(P <0 0 1)。 2组患者近期降酶显效率为 6 4 1% ,有效率为2 6 % ,无效率为 33 3% ;远期显效率为 4 8 7% ,有效率为 10 3% ,无效率为 4 1 0 %。治疗结束后有 5例HCV RNA测不到 ,停药 3个月有 2例仍为阴性。结论 双环醇对慢性丙型肝炎丙氨酸转氨酶升高的患者疗效显著 。

Objective To evaluate the efficacy and safety of bicyclum, a China made new hepatcyte protecting agent, in the treatment of chronic hepatitis C (CHC) Methods Thirty nine CHC patients matched demographically and clinically were randomized into two groups: bicyclum group (group A, n =20) and placebo/bicyclum crossovergroup (group B, n =19) Bicyclum 75mg/d or placebo was administered to these two groups respectively for 3 months Then the pateients in group A received bicyclum for further 3 months and were observed for 3 months after the treatment discontinued; and the patients in group B received bicyclum 75mg/d for six months and were observed for 3 months after the treatment disontinued Investigation items included clinical manifestations,liver function, serum HCV RNA and anti HCV Results In group A, the serum ALT was 120±43 U/L before treatment and was 57±32 U/L after treatment ( P <0 01) In group B the baseline serum ALT was 126 U/L±48 U/L After the placebo administration the serum ALT was 127 U/L±97 U/L ( P >0 05) and the clinical feature showed no improvement After bicyclum treatment for 6 months, the serum ALT in group B was 68±45 U/L, significantly lower than that before bicyclum treatment ( P <0 01) and clinical symptons improved The overall ALT normalization response rate were 64 1% and 48 7% at the end of bicyclum treatment and 3 months after the treatment discontinued respectively for the total 39 patients The serum HCV RNA became negative in 5 and 2 patients at end of treatment and 3 months after the treatment discontinued Adverse drug reactions were mild and uncommon Mild dizziness occurred in 1 patient in each group Conclusion Bicyclum is effective in improving ALT and clinical manifestations of CHC patients It is safe and well tolerated and shows few adverse reactions