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| 利巴韦林的安全性与利益-风险分析 |
| Analysis of the Safety and Benefit-risk of Ribavirin |
| 投稿时间：2006-06-13 修订日期：2006-07-17 |
| DOI： |
| 中文关键词: 利巴韦林 丙型肝炎 合胞病毒感染 药物安全性 系统综述 利益-风险分析 |
| 英文关键词:Ribavirin Hepatitis C Respiratory syncytial virus infection Drug safety Systematic review Benefit-risk analysis |
| 基金项目: |
| 吴晔 吴涛 詹思延 郭晓昕 王娟 吴婷 刘利容 |
| [1]国家食品药品监督管理局药品评价中心,北京100061 [2]北京大学公共卫生学院,北京100061 |
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| 中文摘要: |
| 目的：评价利巴韦林在丙型肝炎和呼吸道合胞病毒感染治疗中的利益-风险。方法：通过对文献的系统综述，并结合国内和世界卫生组织ADR监测数据对药品利益．风险进行半定量分析。结果：共获得581篇可用的相关文献。文献综述和病例分析的结果表明利巴韦林常见不良反应是过敏性反应和血液系统障碍，且有5例致死的不良反应病例报告。利益-风险分析表明利巴韦林对丙型肝炎的治疗效果较好，但其不良反应不容忽视，尤其是出现致畸、致死胎的严重不良反应的病例报告，提示在应用该药时应明确相关禁忌证；在治疗合胞病毒呼吸道感染方面，利巴韦林疗效远低于不良反应的得分，提示应尽量规范该类用途。结论：利巴韦林的常见不良反应为过敏性反应和血液系统障碍。利巴韦林联合干扰素对治疗丙型肝炎利益优于风险，对其他疾病的疗效尚待进一步证实。 |
| 英文摘要: |
| Objective: To evaluate the benefit and risk of ribavirin in the treatment of Hepatitis C and the infection of respiratory syncytial virus ( RSV). Method: The safety and benefit-risk of ribavirin were analyzed by means of systematic literature reviews and the use of the national and WHO surveillance databases. Result: Relative databases, websites and medical journals were searched and 581 related literatures were included. The literature review and case-analysis suggested the main adverse effects of ribavin were allergic reactions and blood system disorders while S deaths due to adverse effect were reported. The benefit-risk analysis showed ribavirin was effective in the treatment of Hepatitis C. However, the adverse effects could not be ignored. Especially the teratogenic and embryocidal cases were reported, which suggested the contraindications should be specified. When ribavirin was used in the treatment of RSV infection, the score of benefit was much less than that of risk, which means the usage purpose should be standardized. Conclusion: The main adverse effects of ribavin were allergic reactions and blood system disorders. When combined with interferon and used in treatment of Hepatitis C, ribavirin has more effect than risk but as for the effects of other diseases some further verification is still needed. |
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