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| 克林霉素磷酸酯注射液药品说明书所致用药风险定性评估 |
| Assessment of Risk Caused by the Label of Clindamycin Phosphate Injection |
| 投稿时间：2011-09-09 修订日期：2012-01-20 |
| DOI： |
| 中文关键词: 克林霉素；说明书；风险评估 Borda序值；层次分析法 |
| 英文关键词:Clindamycin Drug Labeling Risk Assessment Borda Count Analytical Hierarchy Process |
| 基金项目: |
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| 中文摘要: |
| 摘 要 目的：评估国产克林霉素磷酸酯注射液说明书与国外原研药说明书差异所致用药风险，探索仿制药风险管理研究模式，促进合理用药。方法：引入基于矩阵法和层次分析法的安全风险评估模型，通过Borda序值法计算风险总值，定性评估克林霉素磷酸酯注射液国内外说明书差异可能导致的用药风险。结果：国产克林霉素磷酸酯注射液说明书与国外原研药说明书差异较大，可能导致不合理用药、药物致伪膜性结肠炎（CDAD）误诊、患者用药依从度不高、患者不能自我发现CDAD等5方面的风险，综合风险总值为3.7，风险较高。结论：我国克林霉素磷酸酯注射液说明书与国外原研药说明书存在较大差异，差异造成用药安全高风险。 |
| 英文摘要: |
| ABSTRACT Objective: To assess the risk caused by difference of the Chinese and American label of clindamycin phosphate injection to explore a model of risk management for the generic drugs in China. Method:The Chinese and American labels of clindamycin phosphate injection were compared, and the risk caused by their difference was assessed. The risk assessment model that based on risk matrix was processed by expert 2-dimension matrix, Borda sequence and gray analytical method.Result:Through the assessment, the Chinese label had its different information which might cause the risk of irrational drug use, resistant strains, increasing incidence of adverse events and delaying treatment. The value of total risk was 3.7.Conclusion:The Chinese label of clindamycin phosphate injection was different from the American label, and the former might cause its high safety risk in China. |
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