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目的:评价清热解毒方联合聚乙二醇干扰素治疗肝胆湿热型慢性丙型肝炎的临床疗效及安全性。方法:采用随机、双盲和安慰剂的对照临床研究方法,将符合标准的60例患者随机分为治疗组和对照组各30例,对照组予安慰剂及聚乙二醇干扰素治疗,治疗组予清热解毒方及聚乙二醇干扰素治疗,疗程均为48周。在治疗前及治疗后第12、24、48周及随访24周检测肝功能、HCV-RNA定量及不良反应,治疗前后进行安全性指标检测。结果:治疗48周后,治疗组患者在治疗结束时病毒学应答(ETVR)、持续应答(SVR)与对照组比较,差异均有统计学意义(P<0.05)。两组患者ALT复常率在治疗后第12、24、48周比较,差异均无统计学意义(P>0.05),在随访24周时两组比较,差异均有统计学意义(P<0.05)。两组患者均出现干扰素不良反应,治疗组在发热、肌肉酸痛及中性粒细胞下降方面与对照组比较,差异均有统计学意义(P<0.05)。结论:清热解毒方联合聚乙二醇干扰素治疗肝胆湿热型慢性丙型肝炎能有效抑制病毒,减少肝组织炎症,改善干扰素不良反应。
Objective: To evaluate the clinical efficacy and safety of Qingre Jiedu Fang combined with pegylated interferon in the treatment of chronic hepatitis C with hepatobiliary and cholestatic damp-heat syndrome. Methods: A randomized, double-blind and placebo-controlled clinical study, 60 patients were randomly divided into treatment group and control group, 30 cases in each group, the control group were given placebo and pegylated interferon treatment, treatment Group Qingrejiedu side and pegylated interferon treatment, treatment for 48 weeks. The liver function, HCV-RNA quantification and adverse reactions were detected before and 12, 24, 48 and 24 weeks after treatment, and the safety indexes were detected before and after treatment. Results: After 48 weeks of treatment, the difference of ETVR and SVR between the treatment group and the control group was statistically significant at the end of treatment (P <0.05). There was no significant difference in the rate of ALT recovery between the two groups at the 12th, 24th and 48th week after treatment (P> 0.05), and there was significant difference between the two groups at the 24th week of follow-up (P <0.05 ). Adverse reactions of interferon appeared in both groups. The difference between the two groups was statistically significant (P <0.05) in fever, muscle soreness and neutrophil decline compared with the control group. Conclusion: Qingrejiedu combined with pegylated interferon in the treatment of chronic hepatitis C with hepatobiliary and damp-heat syndrome can effectively inhibit the virus, reduce the inflammation of liver tissue and improve the adverse reaction of interferon.