基于文献的康莱特注射液不良反应报告分析

目的探讨康莱特注射液导致不良反应的发生规律、特点、影响因素、临床转归,为临床合理用药提供参考。方法以检索词“康莱特”和“致”或“引起”或“过敏”或“不良反应”组合搭配,检索1979年1月1日-2018年9月30日中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中文科技期刊数据库(维普网)康莱特注射液导致的不良反应病例,分析患者性别、年龄、基础疾病、合并用药、日剂量及滴速、发生不良反应时的用药时间、累及器官/系统及主要临床表现和转归。结果共纳入17篇文献,涉及患者20例。70岁以上患者7例,为发生不良反应的高危人群;男性(14例)高于女性(6例);合并心脑血管疾病等基础疾病可能是不良反应的高危因素;康莱特注射液与合并用药间的相互作用可能是不良反应的诱因;首次输注康莱特注射液2 d内为发生危险期,发生不良反应14例;不良反应累及器官包括皮肤损害、全身损害、神经系统损害、心血管系统损害、肝胆系统损害等,主要表现为皮疹、过敏性反应、静脉炎,少见胸闷、胸痛、心悸、头晕。结论使用康莱特注射液应严格把握适应证,注重老年患者使用情况,合并心脑血管疾病者应慎用,并应加强用药教育,用药2 d内密切监护患者,避免发生严重不良反应。

Analysis on Adverse Drug Reactions Induced by Kanglaite Injection Based on Literature

Objective To investigate the general patterns,characteristics,related factors and clinical outcomes of adverse drug reactions(ADR)caused by Kanglaite Injection;To provide a basis of clinical rational medication.Methods The combination of“Kanglaite”and“induce”,“cause”,“allergy”,or“ADR”were set as retrieval words,CNKI,Wanfang Data and VIP databases of Jan 1st.1979 to Sep302018.were retrieved to count ADR caused by Kanglaite Injection,and the gender,age,basic disease,combined medication,daily dosage and drip rate of patients,the time of medication when ADR occurred,the involvement of organs/systems,and the main clinical manifestations and outcomes.Results Totally 17 articles,involving 20 cases were collected.Patients over 70 years of age were 7 cases,and were at high risk for ADR.Men(14 cases)were higher than women(6 cases);Combining basic diseases such as cardiovascular and cerebrovascular diseases may be a high risk factor for ADR;The interaction between Kanglaite Injection and concomitant medication may be the cause of ADR;The dangerous period of Kanglaite Injection was first infusion within 2 d,and the patients of ADR were 14 cases;ADR involving organs included skin damage,systemic damage,nervous system damage,cardiovascular system damage,hepatobiliary system damage,etc.The main clinical symptoms were rash,allergic reactions,phlebitis,rare chest tightness,chest pain,palpitations,and dizziness.Conclusion The use of Kanglaite Injection should strictly grasp the indications,and pay attention to the use of elderly patients.Kanglaite Injection for combined cardiovascular and cerebrovascular diseases should be used with caution,medication education should be strengthened,and patients should be closely monitored within 2 days of medication to avoid serious ADR.