注射用骨瓜提取物引起过敏性休克的文献分析与评价

Evidence-based analysis and evaluation of anaphylactic shock caused by extract of Cucumis melo for injection

目的探讨病例出现的过敏性休克是否与注射用骨瓜提取物相关。方法检索CNKI原始文献数据库(1977.1—2012.12)中有关的文献,对文献证据进行分析和评价。结果检索得到54篇文献,除去综述及药品不良反应无关研究的文章,检索到29篇文献,均为个案病例,符合纳入标准,皆属于D级证据。患者严重不良反应发生在10 min和10 min以内的有31例(构成比93.9%),其中过敏性休克的有12例,占38.7%;剂量50mg/次的有15例(构成比42.9%),其中过敏性休克7例,占46.7%;无合并用药的有25例(构成比69.4%),有合并用药的11例(构成比30.6%);首次用药发生严重不良反应的有31例(构成比88.6%),其中过敏性休克12例,占38.7%。结论本病例出现的过敏性休克与文献证据较为相似,可能与静脉滴注注射用骨瓜提取物有关。

AIM To evaluate the relationship between extract of Cucumis melo for injection and anaphylactic shock. METHODS The relevant literature of CNKI （January 1977 - December 2012） were searched. The liter- ature evidences were evidence-based analyzed and evaluated. RESULTS A total of 54 articles were retrieved. Removing the reviews and independent on adverse drug reaction articles, twenty-nine articles were retrieved. These cases were included in the standard with all belonging to the class D evidence. There were 31 cases about patients with severe adverse reaction occurred within 10 minutes （ ratio of 93.9% ） , including 12 cases of anaphylactic shock, accounting for 38.7%. There were 15 doses of 50mg/times （ratio of 42.9% ）, including 7 cases of aller- gic shock, accounting for 46.7%. There were 25 cases with no drug combination （ ratio of 69.4% ）, 11 cases with drug combination （ ratio of 30. 6% ）. There were 31 cases of the first drug serious adverse reaction （ ratio of 88.6% ）, including 12 cases of allergic shock, accounting for 38.7%. CONCLUSION The cases of anaphylac- tic shock and documentary evidence is similar. The cases may be related to intravenous extract of Cucumis melo for injection.