摘要
目的进一步评价茵兰益肝颗粒(茵陈、郁金、当归、连翘、丹参、板蓝根、拳参、淡竹叶)治疗慢性病毒性肝炎(肝胆湿热、气滞血瘀证)的疗效及安全性。方法采用多中心、随机、双盲、茵兰益肝颗粒360例与阳性药利肝隆颗粒120例平行对照的研究方法,治疗期共12周,服药后2周、4周、8周、12周各进行1次访视,观察丙氨酸转氨酶、天冬氨酸转氨酶复常率和未反跳率,中医证候总积分变化值,以及安全性指标。结果主要疗效指标丙氨酸转氨酶复常率试验组59.8%,对照组32.2%,两组差异有显著统计学意义(P<0.01);次要疗效指标天冬氨酸转氨酶复常率试验组61.5%,对照组45.8%;丙氨酸转氨酶未反跳率试验组87.9%,对照组58.8%;天冬氨酸转氨酶未反跳率试验组90.5%,对照组63.2%,以上指标以及中医证候总积分变化值两组差异均有显著统计学意义(P<0.01)。安全性方面不良事件发生率试验组为0.8%,对照组为5.2%。结论茵兰益肝颗粒治疗慢性病毒性肝炎(肝胆湿热、气滞血瘀证)具有改善肝功能,恢复丙氨酸转氨酶、天冬氨酸转氨酶,抑制丙氨酸转氨酶、天冬氨酸转氨酶反跳以及改善患者症状的作用,同利肝隆颗粒比较具有优势。
AIM To further evaluate the efficacy and safety of Yinlan Yigan Granules （Artemtstae scopartae Herba, Curcumae Radix, Angelicae sinensis Radix, Forsythiae Fructus, Salviae miltiorrhizae Radix et Rhizoma, Isa- tidis Radix, Bistortae Rhizoma, Lophatheri Herba） in treating the chronic viral hepatitis （Syndrome of damp-heat of liver and gallbladder ＆ qi stagnation and blood stasis）. METHODS In multicenter, randomized, double- blind, and parallel comparison of Yinlan Yigan Granules （360 cases） and the positive medicine Liganlong Gran- ules （120 cases）, the total treatment period was twelve weeks. Follow-ups in the 2 nd, 4th, 8th and 12th weeks, normalization rates, not-rebound rates of alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, the changes in value of the total scores of TCM syndromes and assessing relevant safety index were carried out. RE- SULTS In the treatment group, normalization rates of ALT and AST were 59. 8% and 61.5%. In the controlgroup, these of ALT and AST were 32. 2% and 45.8% , the former not-rebound rates of ALT and AST were 87.9% and 90. 5% , the latters were 58.8% and 63.2% , the difference of the above indexes and the changes in value of the total scores of TCM syndromes between the two groups was significant （P 〈 0. 01 ）. The incidence of adverse events was 0. 8% in the treatment group and 5.2% in the control group. CONCLUSION Yinlan Yigan Granules have the efficacy and safety of treating chronic viral hepatitis, and are superior to Liganlong Granules in recovering the levels of ALT and AST, controlling their rebounce and improving the patients＇ syndromes.
出处
《中成药》
CAS
CSCD
北大核心
2013年第12期2610-2613,共4页
Chinese Traditional Patent Medicine
基金
国家"十二五"重大新药创制科技专项课题(2012ZX09303-001-002)
关键词
茵兰益肝颗粒
慢性病毒性肝炎
肝胆湿热
气滞血瘀
临床试验
Yinlan Yigan Granules
chronic viral hepatitis
damp-heat of liver and gallbladder
qi stagnation and blood stasis
clinical test
