Whittall Street Clinic, University Hospitals Birmingham NHS Trust, Birmingham, UK.
Faculty of Health, Education and Life Sciences, Birmingham City University, Birmingham, UK.
Br J Clin Pharmacol. 2018 Feb;84(2):223-238. doi: 10.1111/bcp.13439. Epub 2017 Nov 3.
To systematically review the frequency and type of adverse events associated with a single dose of intravenous or intramuscular gentamicin in adults, for any indication, in studies where a comparator was available.
A review protocol was developed and registered (PROSPERO: CRD42013003229). Studies were eligible for review if they: recruited participants aged ≥16 years; used gentamicin intramuscularly or intravenously as a single one-off dose; compared gentamicin to another medication or placebo; and monitored adverse events. MEDLINE, EMBASE, Cochrane Library, trial registries, conference proceedings and other relevant databases were searched up to November 2016. Risk of bias was assessed on all included studies.
In total, 15 522 records were identified. After removal of duplicates, screening of title/abstracts for relevance and independent selection of full texts by two reviewers, 36 studies were included. Across all the included studies, 24 107 participants received a single one-off dose of gentamicin (doses ranged from 1 mg kg to 480 mg per dose). Acute kidney injury was described in 2520 participants receiving gentamicin. The large majority of cases were reversible. There were no cases of ototoxicity reported in patients receiving gentamicin. A meta-analysis was not performed due to study heterogeneity.
A significant number of patients saw a transient rise in creatinine after a single dose of gentamicin at doses up to 480 mg. Persistent renal impairment and other adverse events were relatively rare.
系统回顾任何适应证下单次静脉或肌内给予庆大霉素时与不良事件相关的频率和类型,研究中存在对照药物。
制定并注册了综述方案(PROSPERO:CRD42013003229)。如果研究符合以下标准,则可纳入综述:纳入年龄≥16 岁的参与者;使用肌内或静脉单次给予庆大霉素;将庆大霉素与其他药物或安慰剂进行比较;监测不良事件。截至 2016 年 11 月,检索了 MEDLINE、EMBASE、Cochrane 图书馆、试验注册库、会议记录和其他相关数据库。对所有纳入的研究进行了偏倚风险评估。
共确定了 15522 条记录。去除重复项后,通过标题/摘要筛选相关性,并由两名评审员独立选择全文,最终纳入 36 项研究。在所有纳入的研究中,24107 名参与者接受了单次庆大霉素单剂量治疗(剂量范围为 1mg/kg 至 480mg/剂量)。在接受庆大霉素治疗的 2520 名参与者中描述了急性肾损伤。绝大多数病例是可逆的。接受庆大霉素治疗的患者未报告耳毒性病例。由于研究异质性,未进行荟萃分析。
在高达 480mg 的剂量下,单次给予庆大霉素后,相当数量的患者肌酐短暂升高。持续性肾损伤和其他不良事件相对较少。