关键词: bacterial vaginosis clindamycin individual participant data meta-analysis metronidazole preterm delivery systematic review

Mesh : Female Humans Infant, Newborn Pregnancy Anti-Bacterial Agents / therapeutic use Clindamycin / therapeutic use Metronidazole / therapeutic use Premature Birth / epidemiology prevention & control Vaginosis, Bacterial / drug therapy prevention & control

来  源:   DOI:10.1111/ppe.12947   PDF(Pubmed)

Abstract:
Bacterial vaginosis (BV) increases preterm delivery (PTD) risk, but treatment trials showed mixed results in preventing PTD.
Determine, using individual participant data (IPD), whether BV treatment during pregnancy reduced PTD or prolonged time-to-delivery.
Cochrane Systematic Review (2013), MEDLINE, EMBASE, journal searches, and searches (January 2013-September 2022) (\"bacterial vaginosis AND pregnancy\") of (i) clinicaltrials.gov; (ii) Cochrane Central Register of Controlled Trials; (iii) World Health Organization International Clinical Trials Registry Platform Portal; and (iv) Web of Science (\"bacterial vaginosis\").
Studies randomising asymptomatic pregnant individuals with BV to antibiotics or control, measuring delivery gestation. Extraction was from original data files. Bias risk was assessed using the Cochrane tool. Analysis used \"one-step\" logistic and Cox random effect models, adjusting gestation at randomisation and PTD history; heterogeneity by I2 . Subgroup analysis tested interactions with treatment. In sensitivity analyses, studies not providing IPD were incorporated by \"multiple random-donor hot-deck\" imputation, using IPD studies as donors.
There were 121 references (96 studies) with 23 eligible trials (11,979 participants); 13 studies (6915 participants) provided IPD; 12 (6115) were incorporated. Results from 9 (4887 participants) not providing IPD were imputed. Odds ratios for PTD for metronidazole and clindamycin versus placebo were 1.00 (95% CI 0.84, 1.17), I2  = 62%, and 0.59 (95% CI 0.42, 0.82), I2  = 0 before; and 0.95 (95% CI 0.81, 1.11), I2  = 59%, and 0.90 (95% CI: 0.72, 1.12), I2  = 0, after imputation. Time-to-delivery did not differ from null with either treatment. Including imputed IPD, there was no evidence that either drug was more effective when administered earlier, or among those with a PTD history.
Clindamycin, but not metronidazole, was beneficial in studies providing IPD, but after imputing data from missing IPD studies, treatment of BV during pregnancy did not reduce PTD, nor prolong pregnancy, in any subgroup or when started earlier in gestation.
摘要:
背景:细菌性阴道病(BV)增加早产(PTD)风险,但治疗试验显示,在预防PTD方面效果参差不齐.
目标:确定,使用个人参与者数据(IPD),妊娠期间BV治疗是否减少PTD或延长分娩时间。
方法:Cochrane系统评价(2013),MEDLINE,EMBASE,日记搜索,并搜索(2013年1月至2022年9月)(“细菌性阴道病和妊娠”)(i)clinicaltrials.gov;(ii)Cochrane对照试验中央登记册;(iii)世界卫生组织国际临床试验注册平台门户;和(iv)科学网(“细菌性阴道病”)。
方法:将无症状妊娠合并BV的个体随机接受抗生素或对照治疗的研究,测量分娩妊娠。提取来自原始数据文件。使用Cochrane工具评估偏差风险。分析使用“一步”逻辑和考克斯随机效应模型,随机化时调整妊娠和PTD病史;I2异质性。亚组分析测试了与治疗的相互作用。在敏感性分析中,不提供IPD的研究是通过“多个随机供体热甲板”归因纳入的,使用IPD研究作为捐赠者。
结果:共有121篇参考文献(96项研究),23项符合条件的试验(11,979名参与者);13项研究(6915名参与者)提供IPD;12项(6115)纳入。对9名(4887名参与者)未提供IPD的结果进行估算。与安慰剂相比,甲硝唑和克林霉素的PTD的赔率为1.00(95%CI0.84,1.17),I2=62%,和0.59(95%CI0.42,0.82),I2=0之前;和0.95(95%CI0.81,1.11),I2=59%,和0.90(95%CI:0.72,1.12),I2=0,归因后。两种治疗的分娩时间与无效时间均无差异。包括估算的IPD,没有证据表明这两种药物在早期给药时更有效,或者有PTD病史的人。
结论:克林霉素,但不是甲硝唑,在提供IPD的研究中有益,但是在从缺失的IPD研究中输入数据后,在怀孕期间治疗BV并没有减少PTD,也不能延长怀孕时间,在任何亚组或在妊娠早期开始时。
公众号