1 289例注射用头孢曲松钠与地塞米松同瓶配伍不良反应分析
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篇名: 1 289例注射用头孢曲松钠与地塞米松同瓶配伍不良反应分析
TITLE:
摘要: 目的:分析注射用头孢曲松钠与地塞米松同瓶配伍药品不良反应(ADR)发生情况,探究发生的规律和特点,为临床安全合理用药提供依据。方法:对2007年1月1日-2016年12月31日上报至国家药品不良反应监测系统的头孢曲松钠与地塞米松同瓶配伍ADR进行统计分析,包括报告类型、给药途径、报告单位类别、患者性别与年龄、ADR发生时间和月份、累及系统-器官、转归等,并分析可能的原因。结果:共计检索2 111例,最终纳入1 289例(2 177例次),其中严重报告166例(占12.88%);给药途径以静脉滴注为主(1 275例,占98.91%);报告主要来自基层医疗卫生机构(838例,占65.01%);患者中男性(679例,占52.68%)略多于女性(610例,占47.32%),患者年龄为18 d~111岁,其中4岁及以下儿童发生ADR较多(“例数/年龄跨度”值为141/5=28.20,高于其他年龄段);ADR发生在给药后1 min内~14 d,多数在给药后30 min以内发生(853例,占66.18%);夏季(6~8月)发生ADR较多(424例,占32.89%);ADR主要累及皮肤及其附件(1 059例次,占总例次的48.64%)、胃肠系统(343例次,占总例次的15.76%)和全身(291例次,占总例次的13.37%);1 289例ADR患者中,好转和痊愈共1 255例(占97.36%)、死亡28例(占2.17%)、未好转4例(占0.31%)、出现后遗症2例(占0.16%)。头孢曲松钠与地塞米松同瓶配伍,存在理化性质改变的风险,进而降低药效和引起更多ADR。同瓶加入地塞米松不足以完全预防头孢曲松钠的过敏反应。结论:临床应避免将头孢曲松钠与地塞米松同瓶配伍给药,临床药师和医师应提高基层医疗机构临床药学服务能力,加强对患者的监护和宣传,防止药品ADR的发生。
ABSTRACT: OBJECTIVE: To analyze the occurrence of the adverse reactions (ADRs) caused by the compatibility of Ceftriaxone sodium for injection and dexamethasone in the same bottle, and to explore the regularity and characteristics of ADRs, so as to provide reference for clinical rational use of drugs. METHODS: The ADRs caused by the compatibility of ceftriaxone sodium and dexamethasone in the same bottle, reported to the National Adverse Drug Reaction Monitoring System from January 1, 2007 to December 31, 2016 were analyzed statistically, including the type of report, route of administration, type of reporting unit, gender and age of patients, occurrence time and month of occurrence of ADR, involved systems/organs and outcome, etc. the potential reasons were analyzed. RESULTS: A total of 2 111 cases were searched, and 1 289 cases (2 177 case times) were collected, of which 166 cases (12.88%) were severe ADR; route of administration was mainly intravenous drip (1 275 cases, 98.91%); ADR reports mainly came from primary medical institutions (838 cases, 65.01%); the male (679 cases, 52.68%) were slightly more than the female (610 cases, 47.32%); the age of patients ranged 18 days-111 years old. The children under 4 years of age had more ADR (“number/age span” value was 141/5=28.20 and higher than other age groups); ADR occurred within 1 min to 14 d after medication, most of which occurred within 30 min (853 cases, 66.18%); in summer (6-8 months), ADR occurred more frequently (424 cases, 32.89%); systems/organs involved in ADR were mainly skin and its appendants (1 059 case times, 48.64% of total case times), followed by gastrointestinal system (343 case times, 15.76% of total case times), systemic injury (291 case times, 13.37% of total case times). Among 1 289 ADR patients, 1 255 cases (97.36%) were cured or recovered, 28 cases (2.17%) were died, 4 cases (0.31%) did not improve, and 2 cases (0.16%) had sequelae. The compatibility of ceftriaxone sodium and dexamethasone in bottles had the risk of physical and chemical changes, which can reduce the efficacy and cause more ADR. Dexamethasone in the same bottle was not enough to completely prevent the allergic reaction of ceftriaxone sodium. CONCLUSIONS: In clinic, ceftriaxone sodium and dexamethasone should be avoided to be administered in the same bottle; clinical pharmacists and physicians can improve the ability of clinical pharmaceutical care in primary medical institutions, strengthen monitoring and publicity for patients, and prevent the occurrence of adverse drug reactions.
期刊: 2019年第30卷第17期
作者: 李永辉,王芳,郭瑞锋,张轶华
AUTHORS: LI Yonghui,WANG Fang,GUO Ruifeng,ZHANG Yihua
关键字: 注射用头孢曲松钠;地塞米松;配伍;药品不良反应;安全性
KEYWORDS: Cefatriaxone sodium for injection; Dexamethasone; Compatibility; Adverse drug reactions; Safety
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