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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 ,而且安全性好
Objective To investigate the efficacy and safety of bicyclol in the treatment of chronic hepatitis C Methods Thirty-nine patients with chronic viral hepatitis C were divided into two groups according to a randomized, double-blind, controlled trial: bicyclol group (group A) and placebo (white tablets of the same shape) (Group B). Two groups were given bicyclol 25mg, 3 times a day and placebo. Twelve weeks later, patients in groups A and B were given cyclosporine 25mg, three times a day, 12 weeks and 24 weeks, respectively. Results Serum alanine aminotransferase (ALT) values were 12 0U L ± 4 4U L and 57U L ± 32U L respectively before and after taking medicine in group A, and there was significant difference before and after taking medicine (P <0 0 1). Patients in group B were treated with placebo for 3 months. Before and after treatment, ALT was 12 6U L ± 48U L and 12 7U L ± 97U L, respectively. There was no significant difference between before and after treatment in group B (P> 0.05) ALT values decreased from 12 7U L ± 97U L to 6 8U L ± 4 5U L (P <0.01) after placebo was converted to bicyclol. In the two groups, the effective rate of reducing enzyme was 6 4 1%, the effective rate was 26%, the inefficiency was 33 3%, the long-term effective rate was 48.7%, the effective rate was 103% and the inefficiency was 4 1 0%. After the treatment of 5 cases of HCV RNA can not be measured, 3 months withdrawal 3 cases were still negative. Conclusion Bicyclol has a significant effect on patients with chronic hepatitis C with elevated alanine aminotransferase and is safe