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[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] To observe the equivalence of Liuwei Wuling tablet with western medicine and diammonium glycyrrhizinate in combination with Western medicine in treating drug-induced liver injury. [Methods] A total of 158 inpatients and outpatients were randomly divided into two groups according to the randomized parallel control method. 500 mL of 5% dextrose and 20 mL of compound Salvia Miltiorrhiza injection were injected intravenously once a day for 5 minutes; 500 mL of 5% dextrose and Vitamin C 3.0g + Vitamin B6 0.3g, 1 time / d, intravenous infusion. The control group 80 cases of diammonium glycyrrhizinate, 150mg / times, 3 times / d. Treatment group, 78 cases of Liuwei Wuling tablets, 1.5g / times, 3 times / d. Continuous treatment 28d for a course of treatment. Observed clinical symptoms, liver function, adverse reactions. Treatment of a course of treatment to determine the efficacy. [Result] In the treatment group, 49 cases were markedly effective, 28 cases were effective, 3 cases were ineffective, and the total effective rate was 96.25%. The control group 38 cases markedly effective in 35 cases, 5 cases, the total effective rate 93.59%. The total effective rate was no significant difference between the two groups (P> 0.05). Clinical symptoms and signs improved no significant difference between the two groups (P> 0.05). Liver function indicators improved in both groups (P <0.05), the treatment group improved better than the control group (P <0.05). [Conclusion] Liuwei Wuling tablets combined with western medicine and diammonium glycyrrhizinate combined with Western medicine have the same effect on drug-induced liver injury. Liuwei Willing tablets combined with Western medicine’s liver function indexes are better than diammonium glycyrrhizinate combined with Western medicine, which is worth promoting.