中华皮肤科杂志 ›› 2015, Vol. 48 ›› Issue (4): 245-247.

• 论著 • 上一篇    下一篇

双环醇和甘草酸二铵治疗严重银屑病患者药物性肝损伤的随机对照研究

周小勇1,杨雪源2,孙云芸2,李新宇2   

  1. 1. 武汉市第一医院
    2. 南京 中国医学科学院北京协和医学院皮肤病研究所
  • 收稿日期:2014-07-02 修回日期:2014-08-13 出版日期:2015-04-15 发布日期:2015-03-27
  • 通讯作者: 杨雪源 E-mail:yangxueyuan@medmail.com.cn

Bicyclol versus diammonium glycyrrhizinate for the treatment of drug-induced hepatic injury in patients with severe psoriasis: a randomized controlled trial

  • Received:2014-07-02 Revised:2014-08-13 Online:2015-04-15 Published:2015-03-27

摘要:

目的 研究双环醇片对严重银屑病药物性肝损伤的保护作用。 方法 将106例符合纳入标准的肝损伤银屑病患者随机分为双环醇组与甘草酸二铵组,分别给予口服双环醇片(25 mg,每日3次)和甘草酸二铵胶囊(150 mg,每日3次)治疗,疗程均为8周。比较2组治疗前后肝功能血清生化指标及综合疗效的组内和组间差异,观察记录用药后的不良反应。 结果 双环醇组(52例)与甘草酸二铵组(51例)肝功能指标均得到了明显改善(P < 0.01),且双环醇组疗效优于甘草酸二铵组(P < 0.01),双环醇组与甘草酸二铵组的显效率分别为71.15%和47.06%(P < 0.05),有效率分别为84.62%和66.67%(P < 0.05)。2组均未发生与研究药物有关的不良反应。 结论 双环醇能有效缓解银屑病药物所致的肝损伤,且安全性好。

Abstract:

Zhou Xiaoyong*, Yang Xueyuan, Sun Yunyun, Li Xinyu. *Wuhan No. 1 Hospital, Wuhan 430022, China Corresponding author: Yang Xueyuan, Email: yangxueyuan@medmail.com.cn 【Abstract】 Objective To investigate the protective effect of bicyclol tablets on drug-induced hepatic injury in patients with severe psoriasis. Methods One hundred and six patients with severe psoriasis and drug-induced hepatic injury were enrolled in this study, and randomly divided into 2 groups: bicyclol group (53 cases) treated with oral bicyclol tablets (25 mg thrice a day) for 8 weeks, diammonium glycyrrhizinate group (53 cases) treated with diammonium glycyrrhizinate capsules (150 mg thrice a day) for 8 weeks. Serum biochemical indices of hepatic function were measured before and after treatment, therapeutic efficacy was evaluated, and adverse reactions were observed and recorded after treatment. Intergroup and intragroup differences in these parameters were assessed. Results During the treatment, 3 patients were lost to follow up. After treatment, serum biochemical indices of hepatic function markedly improved in both the bicyclol group (52 cases) and diammonium glycyrrhizinate group (51 cases) (both P < 0.01), and the bicyclol group showed a better treatment response than the diammonium glycyrrhizinate group (P < 0.01). The marked response rate was 71.15% and 47.06% (P < 0.05), and the response rate was 84.62% and 66.67% (P < 0.05), respectively, in the bicyclol group and diammonium glycyrrhizinate group. No adverse reactions related to tested drugs were observed in either of the two groups. Conclusion Bicyclol can attenuate antipsoriatic drug-induced hepatic injury with good safety.