乙肝康片剂的研制与180例临床应用效果观察

CLINICAL EFFECT OF YI GAN KANG TABLETS

目的 :开发研制治疗病毒性乙型肝炎有效的新型中药制剂。方法 :选取临床中药验方制成乙肝康片剂 ,并经临床疗效对比观察 (乙肝康片与α -干扰素及病毒唑比较 ,乙肝康片剂与汤剂比较 )及采用薄层扫描法 ,高效液相色谱法对其成分和含量进行测定。结果 :乙肝康片临床治愈率达 6 2 % ,有效率达 98 3% ,较α -干扰素及病毒唑有显著性差异 (P <0 0 1) ;治疗后治疗组与对照组肝功能变化有显著性差异 (P <0 0 1) ,治疗组治疗前后肝功能变化有显著性差异 (P <0 0 1) ,对照组治疗前后肝功能变化无显著性差异 (P >0 0 5 ) ;治疗组与对照组HBV -DNA阴转情况 (阴转率、阴转时间 )有显著性差异 (P <0 0 1) ;乙肝康片剂与汤剂临床疗效无显著性差异 (P >0 0 5 )。结论

OBJECTIVE:To investigate clinical effect of Yi Gan Kang Tablets treating hepatitis B. METHOD:Therapeutic effect of Yi Gan Kang Tablets was compared with interferon and virazole as well as Yi Gan Kang decoction treating hepatitis B. The contents of Yi Gan Kang Tablets were detected by thin-layer scanning, liqued chromatography technique.RESULTS:Cure rate of Yi Gan Kang Tablets was 62% with an effective rate 98.3%, significantly higher than interferon and virazole (P<0 01). Liver function was remarkably improved after the therapy in experimental group (P<0 01), but not much different in control group (P>0 05) and so was HBV-DNA negative transformation in the two groups. There was no therapentic difference between Yi Gan Kang Tablets and Yi Gan Kang decoction (P>0 05). CONCLUSION:Yi Gan Kang Tablets can receive satisfied results in treating hepatitis B .