【摘要】 目的:分析痰热清注射液不良事件(ADE)的发生规律和特点,为ADE机制研究奠定基础。方法:以"痰热清注射液""不良反应"为关键词检索2014年1月1日-2018年10月30日收录于中国期刊全文数据库、中文科技期刊数据库、中国生物医学文献数据库和万方数据中痰热清注射液ADE的文献,对患者的性别、年龄、药物过敏史、原发疾病,药物剂量及所用溶剂、累及器官及系统,不良事件主要临床表现、发生时间、联合用药进行统计分析。结果:共纳入126篇文献,合计1 577例患者。男性906例(57.45%)、女性671例(42.55%),年龄6个月～98岁、其中以0～10岁最多(625例,39.63%);1 577例患者中537例记录了原患疾病,主要是支气管炎及肺炎(323例,60.15%);687例记录了使用剂量,其中612例为正常剂量(89.08%)、75例为超说明书剂量(10.92%);779例记录了溶剂,主要是5%葡萄糖注射液或0.9%氯化钠注射液(715例,91.78%);共记录ADE 1 960例次,其中以皮肤及其附件为主(930例次,47.45%),其次为全身性反应(231例次,11.79%)、消化系统(221例次,11.28%)和心血管系统(220例次,11.22%);1 172例记录了ADE发生时间,以用药后10～30 min为主(434例);1 356例患者记录了详细用药情况,其中521例存在联合用药,以抗菌药物为主,其次为一些具有清热解毒作用的中药注射剂及抗病毒药等。结论:临床应该重视痰热清注射液的不良反应,一方面加强ADE监测,对其进行总结、分析、评价;另一方面当患者存在上述情况时应予以重视,促进临床采取合理有效措施,保证患者用药安全。更多还原

【Abstract】 OBJECTIVE:To analyze the regularity and characteristics of ADE induced by Tanreqing injection,and to lay the foundation for ADE mechanism study. METHODS:Using"Tanreqing injection"and"ADE"as keywords,the literatures about ADE induced by Tanreqing injection were retrieved from CJFD,VIP,CBM and Wanfang database during Jan. 1 st,2014 to Oct.30 th,2018. Patient’s gender,age,drug allergy history,primary diseases,drug dosage,solvent,organs or systems involved,main clinical manifestation of ADE,occurrence time,drug combination were all analyzed statistically. RESULTS:A total of 126 literatures were included,involving 1 577 patients. There were 906 male(57.45%)and 671 female(42.55%);the age ranged from 6 months to 98 years old,of which 625 cases(39.63%) were aged from 0 to 10 years. Among 1 577 patients,primary diseases of 537 patients were recorded and mainly were bronchitis and pneumonia(323 cases,60.15%). Drug dosages of 687 patients were recorded,among which there were 612 cases of normal dose(89.08%),75 cases of off-label dose(10.92%). 779 cases of solvent(mainly containing 5% Glucose injection or 0.9% Sodium chloride injection,715 cases,91.78%). 1 960 case times of ADE were recorded,mainly including lesion of skin and its appendents(930 case times,47.45%),followed by systemic response(231 case times,11.79%),digestive system(221 case times,11.28%) and cardiovascular system(220 case times,11.22%). Occurrence time of ADE was recorded in 1 172 cases,mainly 10-30 min after medication(434 cases). Detailed drug use was recorded in 1 356 patients,among which there were 521 cases of drug combination,mainly containing antibiotics,followed by TCM injection for clearing away heat and toxic material and antiviral drugs,etc. CONCLUSIONS:Attention should be paid to ADE induced by Tanreqing injection. On the one hand,ADE monitoring should be strengthened to summarize,analyze and evaluate ADE;on the other hand,attention should be paied when patients have above situations,so as to promote rational and effective clinical measures and to ensure drug safety of patients.更多还原