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目的研究双环醇片治疗他汀类降脂药所致肝损害的临床疗效。方法将91例他汀类降脂药所致肝损害的患者随机分为两组,试验组46例,每日口服双环醇片75mg治疗,对照组45例,每日口服水飞蓟素胶囊280mg,疗程3周。观察治疗前后的疗效。结果治疗3周后,两组肝功能均有不同程度改善,但试验组更为明显(P<0.05)。在综合疗效方面,试验组显效率及总有效率均明显优于对照组,有非常显著性差异(P<0.01)。经研究者判断,未发现与研究药物有关的不良事件。结论双环醇片75mg/d能有效治疗他汀类降脂药所致药物性肝损害。
Objective To study the clinical efficacy of bicyclol tablets in treatment of liver damage caused by statins lipid-lowering drugs. Methods Ninety-one patients with hepatic impairment caused by lipid-lowering statins were randomly divided into two groups. The experimental group received 46 mg daily oral bicyclol tablets and the control group received 45 mg daily oral administration of 280 mg silymarin capsules for 3 weeks . Observed before and after treatment. Results After 3 weeks of treatment, the liver function of both groups improved to some extent, but the experimental group was more obvious (P <0.05). In terms of comprehensive curative effect, the markedly effective rate and total effective rate of the experimental group were significantly better than that of the control group, with significant difference (P <0.01). Judged by the investigators, no adverse drug-related events were found. Conclusion Bicyclomethanol tablets 75mg / d can effectively treat drug-induced liver damage caused by statins lipid-lowering drugs.