黄磊 于莉 沈健 邱召娟

摘要：目的 探讨应用戴明环在减少中药注射剂不良反应（ADR）中的作用。方法 选取本院2013年上报的ADR发生例次较多的中药注射剂品种，分析其使用情况及ADR的特点，根据戴明环制定ADR防治策略并在2014年付诸循环实施。结果 2014年中药注射剂引起的ADR发生例数均有不同程度的减少，总例数比2013年减少41.3%，其中丹参酮ⅡA磺酸钠注射液、心脉隆注射液、斑蝥酸钠注射液、参芪扶正注射液和生脉注射液减少最多，减少率均在50%以上；与2013年相比，2014年皮疹瘙痒、寒战发热、静脉炎、胸闷心悸等ADR临床表现均减少，尤其是静脉炎和皮疹瘙痒等减少最多，分别减少14.9%和13.4%。结论 通过将戴明环应用于中药注射剂临床合理用药实践，有效地减少了中药注射剂ADR的发生，更好地保证了中药注射剂临床使用的安全性。

关键词：戴明环；中药注射剂；不良反应

DOI：10.3969/j.issn.1005-5304.2016.06.032

中图分类号：R288 文献标识码：A 文章编号：1005-5304（2016）06-0116-03

Abstract： Objective To discuss the effects of Deming cycle on reducing adverse drug reactions （ADR） induced by injections of traditional Chinese medicine （TCM）. Methods The TCM injections which induced much more ADRs in 2013 were selected. The usage of these TCM injections and characteristics of the ADRs were analyzed. Strategies for controlling ADRs were developed according to Deming cycle and put into the recycle implementation in 2014. Results The ADRs induced by TCM injections were all reduced； the number of total cases was reduced by 41.3% compared to 2013， among which Tanshinone IIA Sulfonate injection， Xinmailong injection， Mylabris injection， Shenqi Fuzheng injection and Shengmai injection were reduced significantly， and their reduction rates were all more than 50%. The clinical manifestations of ADRs， including rash， itching， chills， fever， phlebitis， chest distress and palpitation， were all reduced in 2014 compared to 2013， among which especially the allergic reactions， including phlebitis， rash and itching， were reduced by 14.9% and 13.4%. Conclusion Application of Deming cycle in the practice of TCM injections for clinical rational medication can effectively reduce the occurrence of ADRs and better ensure the safety of clinical use of TCM injections.

Key words： Deming cycle； TCM injections； adverse drug reaction

随着中药注射剂在临床的广泛应用，有关安全性问题的报道也逐渐增多。据2010年国家药品不良反应（ADR）监测中心监测数据提示，中药注射剂ADR占中成药ADR/不良事件（ADE）病例报告的50.9%，中药注射剂严重ADE报告约占中药严重病例报告的87.2%[1]。2013年国家ADR监测年度报告显示，2013年全国ADR监测网络共收到中药注射剂ADR报告12.1万例次，与2012年相比，中药注射剂ADR报告数量增长17.0%，高于总体报告增长率[2]。这表明中药注射剂引起的ADR仍有不断上升趋势，防治中药注射剂ADR的形势十分严峻。在临床应用中如何通过科学管理以减少中药注射剂ADR的发生是值得研究的课题。……