PEG-IFNα-2a和利巴韦林联合自拟中药复方治疗慢性丙型肝炎的临床疗效

Clinical efficacy of pegylated interferonα-2a and ribavirin combined with self-extracting traditional Chinese medicine in the treatment of chronic hepatitis C

目的研究聚乙二醇干扰素α-2a(PEG-IFNα-2a)和利巴韦林联合自拟中药复方治疗肝肾阴虚夹湿热型慢性丙型肝炎(CHC)患者的临床疗效。方法将该院确诊的59例肝肾阴虚夹湿热型CHC患者按随机数字表法分为对照组(29例)和联合组(30例),对照组患者给予PEG-IFNα-2a注射液和利巴韦林治疗,联合组患者在此基础上加用自拟中药复方进行治疗,比较两组患者治疗前后中医症状分级量化积分差异、肝功能改善情况、丙型肝炎病毒(HCV)RNA阴转率、炎症因子、临床疗效的总有效率及不良反应的发生情况。结果联合组患者治疗后胁肋疼痛、腰膝酸软、腕腹胀闷、舌红苔黄、头昏身重、失眠多梦的中医症状分级量化积分均低于对照组(P<0.05),其他中医症状分级量化积分差异无统计学意义(P>0.05)。联合组患者治疗48周后丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总胆红素(TBIL)改善情况优于对照组(P<0.05),但两组清蛋白(ALB)、谷氨酰转肽酶(GGT)差异无统计学意义(P>0.05)。联合组患者在治疗36、48周时的HCV RNA阴转率要高于对照组(P<0.05),但在治疗12、24周及随访24周时差异无统计学意义(P>0.05)。联合组患者治疗48周后炎症因子IL-21、IL-6、TNF-α指标水平低于对照组(P<0.05)。联合组的临床疗效的总有效率要优于对照组(93.33%vs.72.41%,P<0.05)。两组治疗中发生的不良反应差异无统计学意义(P>0.05)。结论采用PEG-IFNα-2a(PEG-IFNα-2α)、利巴韦林联合自拟中药复方治疗CHC,能明显改善患者的临床症状和肝功能指标,提高HCV RNA阴转率。

Objective To study the clinical efficacy of pegylated interferonα-2 a（PEG-IFNα-2 a）and ribavirin combined with self-extracting traditional Chinese medicine（TCM）in the treatment of chronic hepatitis C（CHC）of gan-shen yin-deficiency and damp-heat syndrome.Methods A total of 59 cases of CHC of gan-shen yin-deficiency and damp-heat syndrome confirmed in our hospital was randomly divided into control group（n=29）and combined group（n=30）.The patients in both groups were treated with PEG-IFNα-2 ainjection and ribavirin,and then the self-extracting TCM was added on the patients in combined group.The differences of quantitative score,improvement of liver function,RNA negative rate of HCV,the levels of IL-21,IL-6 and TNF-α,clinical treatment of total efficiency and adverse reactions were compared between the two groups before and after treatment.Results After treatment,the quantitative scores of TCM symptoms（rib-side pain,soreness and weakness of waist and knees,abdominal distension,red tongue with yellowish fur,dizziness with heavy body,insomnia and dreaminess）in combined group were significantly lower than those in control group（P〈0.05）,but the difference of quantitative scores of other TCM symptoms between the two groups was not statistically significant（P〉0.05）;The levels of alanine aminotransferase（ALT）,aspartate aminotransferase（AST）and total bilirubin（TBIL）in combined group were better than those in control group（P〈0.05）after 48 weeks of treatment,but the difference of the levels of albumin（ALB）and glutamyl transpeptidase（GGT）were not statistically significant in both groups（P〉0.05）;The RNA negative rate of HCV in combined group was significantly higher than that in control group after 36-week or 48-week treatment（P〈0.05）,but there was no statistically significant difference between the two groups after 12-week or 24-week treatment and 24-week follow-up;The levels of TNF-α,IL-17,IL-23 in combined group were significantly lower than those in control group（P〈0.05）after 48 weeks of treatment;The total efficiency of combined group is better than that of control group（93.33% vs.72.41%,P〈0.05）.There was no significant difference in adverse reactions between the two groups（P〉0.05）.Conclusion The application of PEG-IFNα-2 aand ribavirin combined with the self-extracting TCM in the treatment of CHC can obviously ameliorate the clinical symptoms and liver function indexes,improve the RNA negative rate of HCV,reduce the levels of inflammatory factors,and improve the clinical efficacy.