摘要
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
出处
《中华医学杂志》
CAS
CSCD
北大核心
2002年第14期958-960,共3页
National Medical Journal of China
基金
国家"九五"科技攻关课题资助项目 (9690 10 14 5 )
