芪术冲剂加减治疗难治性病毒性丙型肝炎的临床研究

Clinical study of refractory hepatitis C treated with modified Qizhu granules

目的:客观评价芪术冲剂加减治疗难治性丙型病毒性肝炎的临床疗效及安全性。方法:采用多中心、随机、双盲、平行对照的临床研究方法,将入组的204例难治性丙型肝炎患者按1∶1比例随机分为治疗组和对照组,治疗组予芪术冲剂(治疗过程中的兼夹证进行固定药物和固定剂量的随证加味)治疗,对照组予安慰剂,治疗疗程均为48周。在第0周(治疗前)、第4周、第12周、第24周、第48周(治疗后)检测HCV RNA定量及肝功能水平,治疗前后进行安全性指标检测。结果:治疗48周结束,治疗组患者HCV RNA阴转率为16.40%,随访24周,持续病毒应答率为16.67%,均优于对照组(分别为6.10%和4.41%),差异有统计学意义(P<0.05)。治疗48周,治疗组患者ALT复常率为54.17%,优于对照组的39.53%(P<0.05)。结论:以芪术冲剂为基本方,结合治疗过程中的兼夹证进行固定药物和固定剂量的随证加味,为治疗难治性丙型肝炎的有效方法。

Objective： To evaluate the clinical efficacy and safety of modified Qizhu granules for the treatment of refractory hepatitis C. Methods： Implementing a combination of multi-centric,randomized,placebo-controlled and blinding design trial techniques,204 patients with refractory hepatitis C were randomly divided into the treatment group（ the modified Qizhu granules treatment group） and the control group（ the placebo-controlled group） according to 1 ∶ 1. Two groups were treated for 48 weeks. The patients＇ liver function and HCV RNA were monitored before treatment as well as during the 4th,12 th,24th and 48 th week. Security indexes were detected before and after treatment. Results： After treatment for 48 weeks,the negative conversion rate of HCV RNA of the treatment group was 16. 40%,the SVR rate was 16. 67% followed up for 24 weeks,better than the control group which was 6. 1%,4. 41% respectively. The ALT recovery rate of the treatment group was 54. 17% better than the control group which was 39. 53%,after treatment. The difference of two groups were significant. Conclusion： Modified Qizhu granules is an effective method for the treatment of refractory hepatitis C.