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[摘要]
目的 探討中藥注射劑不良反應的發(fā)生率及其臨床表現(xiàn)類型,分析武警上海市總隊醫(yī)院中藥注射劑發(fā)生不良反應的影響因素。方法 通過回顧性分析武警上海市總隊醫(yī)院2009年8月—2012年8月發(fā)生中藥注射劑不良反應的病歷,收集中藥注射劑不良反應詳細病案,使用計量學方法對病案資料進行整理。結(jié)果 在病例中懷疑中藥注射劑不良反應117例,其中男性58例,女性59例;60歲以上患者不良反應發(fā)生率最高,為48.72%,且其治愈時間與其他各組相比顯著延長(P<0.05);不良反應發(fā)生在用藥后10~30 min較多,占41.03%;2種以上藥物聯(lián)合應用時發(fā)生不良反應占61.54%;中藥注射劑引發(fā)不良反應的主要表現(xiàn)為皮膚損害和心血管循環(huán)系統(tǒng)癥狀,其中以皮膚損害比例最高,達55.56%,循環(huán)系統(tǒng)癥狀占23.93%。較嚴重的不良反應有過敏性休克、喉頭水腫、呼吸困難等。造成中藥注射劑不良反應構(gòu)成比最高的為喜炎平注射液69例,占58.97%。結(jié)論 熟練掌握中藥注射劑的不良反應,積極應對不良反應,有利于提高中藥注射劑的合理使用水平,提高臨床療效,做到安全、合理用藥。
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[Abstract]
Objective To evaluate the characteristics and patterns of adverse drug reaction (ADR) induced by Chinese materia medica injections (CMMI) in Shanghai Armed Police Corps Hospital. Methods Statistical data from August 2009 to August 2012 were analyzed. The categories of ADR induced by CMMI were statistically analyzed by systematic evaluation and retrospective analysis. Results Cases (117) of ADR were suspected CMMI, 58 male and 59 female patients; Elderly (>60 years) patients with a higher incidence of ADR, accounting for 48.72%, and the healing time compared with the younger patients was significantly longer (P<0.05); ADR mostly occurred in 10—30 min after administration, accounting for 41.03%; Combination therapy accounted for 61.54% of ADR; Xiyanping injection had the highest ratio of ADR (69cases), accounting for 58.97% of the total number of reported ADR. The major ADR were skin damage (55.56%) and circulatory system symptoms (23.93%). The bad responses such as allergic shock, laryngeal edema, and dyspnoea were severe, which were mainly caused by allergy. Conclusion It is useful to improve the level of rational usage of CMMI by mastering ADR of CMMI, so as to improve the clinical efficacy and safety and use the drugs rationally.
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