Widmer Mariana, Lopez Ivana, Gülmezoglu A Metin, Mignini Luciano, Roganti Ariel
Department of Reproductive Health and Research, World Health Organization, Office X031, Geneva, Switzerland, 1211.
Cochrane Database Syst Rev. 2015 Nov 11;2015(11):CD000491. doi: 10.1002/14651858.CD000491.pub3.
A previous Cochrane systematic review has shown that antibiotic drug treatment of asymptomatic bacteriuria in pregnant women substantially decreases the risk of pyelonephritis and reduces the risk of preterm delivery. However, it is not clear whether single-dose therapy is as effective as longer conventional antibiotic treatment.
To assess the effects of different durations of treatment for asymptomatic bacteriuria in pregnancy.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2015) and reference lists of identified articles.
Randomized and quasi-randomized trials comparing antimicrobial therapeutic regimens that differed in duration (particularly comparing single dose with longer duration regimens) in pregnant women diagnosed with asymptomatic bacteriuria.
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.
We included 13 studies, involving 1622 women. All were comparisons of single-dose treatment with short-course (four- to seven-day) treatments. The risk of bias of trials included in this review was largely unclear, and most trials were at high risk of performance bias. The quality of the evidence was assessed using the GRADE approach. When the any antibiotic agent was used, the 'no cure' rate for asymptomatic bacteriuria in pregnant women was slightly lower for the short-course treatment over the single-dose treatment, although there was evidence of statistical heterogeneity (average risk ratio (RR) 1.28, 95% confidence interval (CI) 0.87 to 1.88; women = 1502, studies = 13; I² = 56%; very low quality evidence). Data from only good quality trials also showed better cure rates with short (four- to seven-day) regimens of the same microbial agent (average RR 1.72, 95% CI 1.27 to 2.33; women = 803, studies = two; I² = 0%; high quality evidence). There was no clear difference in the recurrence of asymptomatic bacteriuria rate between treatment and control groups, whether the same or different microbial agents were used (RR 1.13, 95% CI 0.77 to 1.66; 445 women studies = eight; I² = 0%; very low quality evidence). Differences were detected for low birthweight babies, favoring a short course (four- to seven-day treatment) of the same microbial agent, although the data come from a single trial (RR 1.65, 95% CI 1.06 to 2.57; 714 women; high quality evidence), but no differences were observed for preterm delivery (RR 1.17, 95% CI 0.77 to 1.78; women = 804; studies = three; I² = 23%; moderate quality) or pyelonephritis (RR 3.09, 95% CI 0.54 to 17.55; women = 102; studies = two; I² = 0%; very low quality evidence). Finally, single-dose treatment of any microbial agent was associated with a decrease in reports of 'any side effects' (RR 0.70, 95% CI 0.56 to 0.88; 1460 women, studies = 12; I² = 9%; low quality evidence). Evidence was downgraded for risk of bias concerns in trials contributing data and for imprecise effect estimates (wide confidence intervals crossing the line of no effect, and in some cases, small studies with few events).
AUTHORS' CONCLUSIONS: A single-dose regimen of antibiotics may be less effective than a short-course (four- to seven-day) regimen, but more evidence is needed from large trials measuring important outcomes, such as cure rate. Women with asymptomatic bacteriuria in pregnancy should be treated by the standard regimen of antibiotics until more data become available testing seven-day treatment compared with shorter courses of three- or five-day regimens.
Cochrane系统评价先前显示,对孕妇无症状菌尿进行抗生素药物治疗可大幅降低肾盂肾炎风险并减少早产风险。然而,尚不清楚单剂量疗法是否与较长疗程的传统抗生素治疗效果相同。
评估孕期无症状菌尿不同治疗时长的效果。
我们检索了Cochrane妊娠与分娩组试验注册库(2015年8月31日)以及已识别文章的参考文献列表。
比较诊断为无症状菌尿的孕妇中不同疗程(特别是比较单剂量与较长疗程方案)的抗菌治疗方案的随机和半随机试验。
两位综述作者独立评估试验是否纳入及偏倚风险,提取数据并检查其准确性。我们使用GRADE方法评估证据质量。
我们纳入了13项研究,涉及1622名女性。所有研究均为单剂量治疗与短疗程(4至7天)治疗的比较。本综述纳入试验的偏倚风险大多不明确,且大多数试验存在较高的实施偏倚风险。使用GRADE方法评估证据质量。当使用任何抗生素时,短疗程治疗的孕妇无症状菌尿“未治愈”率略低于单剂量治疗,尽管有统计学异质性的证据(平均风险比(RR)1.28,95%置信区间(CI)0.87至1.88;女性=1502,研究=13;I²=56%;极低质量证据)。仅来自高质量试验的数据也显示,相同微生物制剂的短疗程(4至7天)方案治愈率更高(平均RR 1.72,95%CI 1.27至2.33;女性=803,研究=2;I²=0%;高质量证据)。无论使用相同还是不同的微生物制剂,治疗组和对照组之间无症状菌尿复发率无明显差异(RR 1.13,95%CI 0.77至1.66;445名女性,研究=8;I²=0%;极低质量证据)。低出生体重儿方面存在差异,支持相同微生物制剂的短疗程(4至7天治疗),尽管数据来自单个试验(RR 1.65,95%CI 1.06至2.57;714名女性;高质量证据),但早产(RR 1.17,95%CI 0.77至1.78;女性=804;研究=3;I²=23%;中等质量)或肾盂肾炎(RR 3.09,95%CI 0.54至17.55;女性=102;研究=2;I²=0%;极低质量证据)方面未观察到差异。最后,任何微生物制剂的单剂量治疗与“任何副作用”报告减少相关(RR 0.70,95%CI 0.56至0.88;1460名女性,研究=12;I²=9%;低质量证据)。由于提供数据的试验存在偏倚风险以及效应估计不精确(宽置信区间跨越无效应线,且在某些情况下,事件数少的小型研究),证据被降级。
抗生素单剂量方案可能不如短疗程(4至7天)方案有效,但需要更多大型试验提供证据,以衡量诸如治愈率等重要结局。孕期无症状菌尿的女性应采用标准抗生素方案治疗,直到有更多数据可用于比较7天治疗与3天或5天较短疗程治疗。