摘要
目的:探讨依库珠单抗引起的非感染性不良反应(non-infectious adverse reactions,niADRs)及其特点,为临床用药提供参考。方法:检索PubMed、Embase、Cochrane、中国知网(CNKI)、万方数据库中依库珠单抗致niADRs的文献(截至2021年5月31日),按纳入排除标准筛选并提取信息,采用SPSS 20.0统计软件进行描述性统计分析。结果:纳入的16篇文献41例病例报道了44次niADRs,男女比约1∶1.4。年龄18岁以下19例,占比47%。12岁以下总占比30%,其中0~2岁占比15%,2~12岁占比15%。依库珠单抗用于治疗6种原发疾病,其中用于治疗溶血尿毒综合征报道33例,占比81%。所有niADRs累及中枢神经、胃肠道、肝胆、血液、心血管、骨关节及皮肤等多个系统。发生时间范围为5 min至73个月,中位时间和四分位间距为10(27)d。输液反应、胃肠道症状及头痛等多见于7 d以内,占比66%,1个月以内发生niADRs占比91%。24例病例痊愈恢复,占比59%,其中7例经治疗后痊愈,17例未经治疗自行恢复。明确报道转归的病例中结局良好的占比63%。不良预后占比7%,2例最终肝移植,1例死亡。发生不良反应后药物复用率为41%。结论:依库珠单抗作为新型生物制剂,niADRs累及多个系统,涉及成人与儿童,小年龄儿童更易发生。不良反应表现为速发和迟发,迟发型发生时间最长可达1年以上,临床应用中应密切监护,延长监护周期,避免不良结局。
OBJECTIVE To investigate the non-infectious adverse reactions(niADRs)caused by eculizumab and their characteristics to provide reference for clinical medication.METHODS The literature of niADRs induced by eculizumab before May 31,2021 from PubMed,Embase,Cochrane,CNKI and WanFang database were retrieved.The information was extracted according to the inclusion and exclusion criteria,and statistical analysis was conducted by using SPSS 20.0statistical software.RESULTS A total of 41 cases were included in16 papers,and a total of 44 niADRs were reported,and the male-to-female ratio was about 1∶1.4.Nineteen cases were younger than 18 years old,and accounted for 47%.Among them,0-2 years old accounted for 15%,2-12 years old accounted for 15%,and under 12 years old accounted for 30%.All niADRs involved multiple systems including central nervous system,gastrointestinal system,liver and gallbladder system,blood system,cardiovascular system,bone and joint system,and skin system.The onset time ranged from5 min to 73 months,and the median time to interquad interval was 10(27)d.Infusion reaction,gastrointestinal symptoms and headache were more common within 7 days,and accounted for 66%,and niADRs within one month accounted for 91%.Twenty-four cases recovered,and accounted for 59%,of which 7 cases recovered after treatment and17 cases recovered without treatment.Totally63%of the cases with clear reported outcomes had good outcomes.Poor prognosis accounted for 7%.Two patients received final liver transplantation with one death.The drug reuse rate after adverse reactions was 41%.CONCLUSION Eculizumab as a new biological agent,its niADRs involve multiple systems of both adults and children,and are more likely to occur in younger children.The symptoms are rapid and late onset,and the time of late onset can be more than one year.In clinical application,close monitoring should be extended to avoid adverse outcomes.
作者
海莉丽
吕萌
李涛
陶兴茹
段彦彦
张淼
HAI Li-li;LV Meng;LI Tao;TAO Xing-ru;DUAN Yan-yan;ZHANG Miao(Department of Pharmacy,Children’s Hospital of Zhengzhou University,Henan Zhengzhou 450000,China)
出处
《中国医院药学杂志》
CAS
北大核心
2022年第3期293-298,共6页
Chinese Journal of Hospital Pharmacy
基金
河南省医学科技攻关计划联合共建项目[编号:〔2021〕1号(LHGJ20200622)]。
