药源性急性全身过敏反应发生风险系统评价

Risk of Drug-Induced Acute Systemic Anaphylaxis:A Systematic Review

目的系统评价药源性急性全身过敏反应的发生率及危险因素。方法利用计算机检索PubMed,Embase,The Cochrane Library,以及中国知网、万方数据库、维普数据库、中国生物医学文献数据库,收集药源性急性全身过敏反应相关研究,检索时间为自建库至2020年5月。采用美国医疗保健研究与质量局关于观察性研究的质量评价标准评价偏倚风险;描述性分析药源性急性全身过敏反应的发生率及危险因素。结果共纳入14篇文献(216315例患者),其中队列研究2篇,病例对照1篇,横断面研究11篇。描述性分析结果显示,由于研究人群、药物或结局指标的不同,药源性急性全身过敏反应发生率差异较大;抗肿瘤药物的发生率超过10%;全身麻醉药和造影剂的发生率分别为0.16%和0.12%;院内药源性急性全身过敏反应的发生率为0.03%;有速发型药物过敏史人群的发生率超过50%。发生急性全身性过敏反应的患者中重症占比超过35%;重症患者死亡率为3%~4%。危险因素或加重因素为患者或其家族有哮喘史或过敏史,患有高血压或其他心血管疾病史,以及使用β受体阻滞剂、血管紧张素转化酶抑制剂或血管紧张素受体拮抗剂;性别、年龄和基础胰酶水平是否为危险因素仍有争议。结论院内药源性急性全身过敏反的应总发生率较低,但重症比例和死亡率较高,某些疾病史和某些药物可增加发生风险。受纳入研究的数量和质量限制,尚需开展更多高质量的研究。

Objective To systematically evaluate the incidence and risk factors of drug-induced acute systemic anaphylaxis.Methods PubMed,Embase,The Cochrane Library,CNKI,WanFang,VIP and CBM databases were electronically searched to collect relevant clinical trials on drug-induced acute systemic anaphylaxis from the establishment of the database to May 2020.The quality assessment criteria for observational studies of Agency for Healthcare Research and Quality was used to evaluate the risk of bias,and descriptive analysis of the incidence and risk factors of drug-induced acute systemic anaphylaxis was conducted.Results A total of fourteen articles(involving216315 patients)were included,including two cohort studies,one case-control study and eleven cross-sectional studies.The results of descriptive analysis showed that the incidence of drug-induced acute systemic anaphylaxis was significantly different due to different study population,drugs or outcome indicators(P<0.05).The incidence of acute systemic anaphylaxis induced by anti-tumor drugs was more than 10%,and that induced by general anesthesia and contrast media was 0.16%and 0.12%,respectively.The incidence of drug-induced acute systemic anaphylaxis in the hospital was 0.03%.More than 50%of the population had a history of anaphylaxis.Severe cases accounted for more than 35%of the patients with acute systemic anaphylaxis.The mortality of severe patients was 3%-4%.The risk factors or aggravating factors were as follows:the patient or his family had a history of asthma or allergy,the patient had a history of hypertension or other cardiovascular diseases,and the patient usedβreceptor blockers,angiotensin-converting enzyme inhibitors(ACEI)or angiotensin receptor blocker(ARB).However,some risk factors remained controversial,which included gender,age and basal trypsin levels.Conclusion The total incidence of drug-induced acute systemic anaphylaxis in the hospital is low,but the proportion of severe cases and mortality is high.Some disease history and some drugs can increase the risk of drug-induced acute systemic anaphylaxis.Due to the limited quantity and quality of included researches,more high-quality studies are required to verify the above conclusion.