pian ( 4 pieces, three times a day ) for one month.Results:The proportion of the patients who had hepatic insufficiency of the prevent treatment group was 1.9%, the prevent contrast treatment group was 4.8%, and the contrast group was 7.1%. The show effect proportion of the treatment group with hepatic insufficiency was 76.5%, the contrast group with hepatic insufficiency was 40%. There was notable difference between the two groups (P<0.01). Conclusion:The Granule of Huganyifei can reduce the proportion of the patients who has hepatic insufficiency because of using INH, PZA ,RFP and so on , and can do better for the patients who has hepatic insufficiency. None of the patients has any side effect because of using the Granule after three monthes.
Key words:The Granule of Huganyifei;Antipulmonary tuberculosis;Hepatic damage
护肝益肺颗粒为我院自行研制开发的一种中药制剂。该制剂由五味子、胡黄连、白头翁等12味中药组成,具有护肝解毒、敛肺止咳的功效,主要用以防治抗结核药所致的肝损害。现将我科2000~2003年对使用护肝益肺颗粒患者的临床观察资料总结如下。
1资料和方法
1.1病例选择随机选取我科2000~2003年住院肺结核患者646例,男418例,女228例;年龄19~65岁,平均39岁。预防治疗组205例,预防对照组208例,空白对照组126例。肝损害治疗组52例,肝损害对照组55例。各组在性别、年龄、病史、肝损害等方面具有可比性。
1.2治疗方法预防治疗组在进行抗痨治疗(异烟肼+利福平+吡嗪酰胺)基础上口服护肝益肺颗粒2个月(3次/d,4 g/次); 空白对照组仅给抗痨治疗(药物同预防治疗组)2个月;预防对照组在进行抗痨治疗(药物同预防治疗组)基础上口服肝泰乐2个月(3次/d,0.2 g/次)。肝损害治疗组用护肝益肺颗粒(3次/d,8 g/次)保肝治疗1个月;肝损害对照组用齐墩果酸片(3次/d,20 mg/次),护肝片(3次/d,4片/次)保肝治疗1个月。
1.3药物性肝损害诊断及疗效判定标准
1.3.1药物性肝损害诊断标准肝功能指标中ALT>100 U/L,AST>100 U/L,胆红素高于20 μmol/L,伴有乏力、纳差、腹胀等消化道反应,药物性肝损害预防效果以药物性肝损害发生率评判。
1.3.2药物性肝损害疗效评判标准参照卫生部药政局所定《中药对病毒性肝炎的临床治疗指导原则》中的新药疗效综合评定标准。完成疗程时,症状消失或基本消失,ALT及AST正常,胆红素正常,为显效;完成疗程时,症状明显改善,ALT及AST下降50%以上,胆红素下降50%以上,为有效;达不到有效标准或恶化,为无效。
2结果
2.1药物性肝损害发生情况见表1。
表1各
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