痰热清注射液不良事件文献分析
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篇名: 痰热清注射液不良事件文献分析
TITLE:
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。
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. 1st, 2014 to Oct. 30th, 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.
期刊: 2019年第30卷第5期
作者: 王亮,张凤,陈万生
AUTHORS: WANG Liang,ZHANG Feng,CHEN Wansheng
关键字: 痰热清注射液;药物不良事件;文献分析;安全性
KEYWORDS: Tanreqing injection; ADE; Literature analysis; Safety
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