六味五灵片+复方丹参注射液+维生素C治疗药物性肝损伤与甘草酸二铵+复方丹参注射液+维生素C等效性随机平行对照研究

Liuweiwuling Piece + Compound Salvia Injection + VitaminC Therapy Drug-induced Liver Injury and Licorice Diammonium+Danshen Injection + Vitamin C Equivalence Randomized Parallel Group Study

[目的]观察六味五灵片联合西药与甘草酸二铵联合西药治疗药物性肝损伤等效性。[方法]使用随机平行对照方法,将158例住院及门诊患者按抽签法简单随机分为两组,5%葡萄糖500mL+复方丹参注射液20mL,1次/d,静滴;5%葡萄糖500mL+维生素C 3.0g+维生素B6 0.3g,1次/d,静滴。对照组80例甘草酸二铵,150mg/次,3次/d。治疗组78例六味五灵片,1.5g/次,3次/d。连续治疗28d为1疗程。观测临床症状、肝功能、不良反应。治疗1疗程,判定疗效。[结果]治疗组显效49例,有效28例,无效3例,总有效率96.25%。对照组显效38例,有效35例,无效5例,总有效率93.59%。总有效率两组间无明显差异(P>0.05)。临床症状及体征改善两组间无明显差异(P>0.05)。肝功能指标两组均有改善(P<0.05),治疗组改善优于对照组(P<0.05)。[结论]六味五灵片联合西药与甘草酸二铵联合西药治疗药物性肝损伤具有等效性,六味五灵片联合西药肝功能指标改善优于甘草酸二铵联合西药,值得推广。

[ Objective ] Liuweiwuling efficacy in treatment of drug-induced liver injury . [ Methods ] Random parallel control method, 158 cases of inpatient and outpatient divided into two groups by drawing lots . The control group 80 cases of glyeyrrhizin diammonium capsules, 150mg / time, 3 times / d, orally. Treatment group 78 cases Liuweiwuling tablets, 1.5g / time, 3 times / d, orally. 28d is a continuous course of treatment . Observation of clinical symptoms, improvement of clinical symptoms and signs, liver function, adverse reactions. A course of treatment to determine efficacy. [ Results ] 49 cases markedly effective in 28 cases, 3 cases, the total efficiency of 96.25% . The control group 38 cases markedly effective in 35 cases, 5 cases ineffective, the total effective rate 93.59%. Treatment group than the control group （ P 〈0.05 ） . Improvement of clinical symptoms and signs two equivalent （ P〉 0.05 ） . Liver function were improved in both groups （ P 〈0.05 ）, improvement in the treatment group than the control group （ P 〈0.05 ） . [ Conclusion ] Liuweiwuling tablets in the treatment of drug-induced liver injury effect is significant, it is worth promoting.