Hathorn Emma, Dhasmana Divya, Duley Lelia, Ross Jonathan D C
Whittall Street Clinic, University Hospitals Birmingham, Birmingham B6 4DH, UK.
Syst Rev. 2014 Sep 19;3:104. doi: 10.1186/2046-4053-3-104.
A high level of resistance in Neisseria gonorrhoeae has developed against penicillins, sulphonamides, tetracyclines and quinolones, and recent surveillance data have shown a gradual reduction in sensitivity to current first-line agents with an upward drift in the minimum inhibitory concentration of ceftriaxone. Laboratory sensitivity testing suggests that gentamicin, an aminoglycoside, may be an effective treatment option for gonorrhoea infection when used as a single intramuscular dose.
A search of electronic reference databases and grey literature was used to identify randomised trials and well-conducted prospective studies with concurrent controls evaluating single-dose gentamicin against placebo or a comparator regimen in the treatment of uncomplicated gonorrhoea infection in men and women aged 16 years and over. The primary outcome was microbiological cure of N. gonorrhoeae.
Eight hundred and thirty-nine studies were identified, of which five (1,063 total participants) were included. All five studies administered single-dose gentamicin via intramuscular injection to men with uncomplicated gonococcal urethritis. Three studies were randomised trials, one was quasi-randomised and one was non-randomised but included a comparator arm. Comparator antibiotics included an alternative aminoglycoside or antibiotic used in the syndromic management of male urethritis. Methodology was poorly described in all five included studies. The high risk of bias within studies and clinical heterogeneity between studies meant that it was inappropriate to pool data for meta-analysis. Cure rates of 62% to 98% were reported with gentamicin treatment. The relative risk of cure was comparable between gentamicin and comparator antibiotics.
The studies identified provide insufficient data to support or refute the efficacy and safety of single-dose intramuscular gentamicin in the treatment of uncomplicated gonorrhoea infection. Additional randomised trials to evaluate gentamicin for this indication are therefore required.
PROSPERO CRD42012002490.
淋病奈瑟菌已对青霉素、磺胺类药物、四环素类药物和喹诺酮类药物产生了高度耐药性,最近的监测数据显示,对当前一线药物的敏感性逐渐降低,头孢曲松的最低抑菌浓度呈上升趋势。实验室敏感性测试表明,氨基糖苷类药物庆大霉素在单剂量肌内注射时,可能是淋病感染的一种有效治疗选择。
通过检索电子参考文献数据库和灰色文献,以确定随机试验以及进行良好的前瞻性研究,并设有同期对照,评估单剂量庆大霉素与安慰剂或对照方案相比,对16岁及以上男性和女性单纯性淋病感染的治疗效果。主要结局是淋病奈瑟菌的微生物学治愈。
共识别出839项研究,其中5项(共1063名参与者)被纳入。所有5项研究均对患有单纯性淋菌性尿道炎的男性肌内注射单剂量庆大霉素。3项研究为随机试验,1项为准随机试验,1项为非随机试验但设有对照臂。对照抗生素包括另一种氨基糖苷类药物或用于男性尿道炎综合征管理的抗生素。所有5项纳入研究对方法的描述都很差。研究中的高偏倚风险以及研究之间的临床异质性意味着合并数据进行荟萃分析是不合适的。庆大霉素治疗的治愈率报告为62%至98%。庆大霉素与对照抗生素之间的治愈相对风险相当。
已识别的研究提供的数据不足以支持或反驳单剂量肌内注射庆大霉素治疗单纯性淋病感染的疗效和安全性。因此,需要额外的随机试验来评估庆大霉素用于这一适应症的情况。
PROSPERO CRD42012002490