Kurkinen-Räty M, Vuopala S, Koskela M, Kekki M, Kurki T, Paavonen J, Jouppila P
Department of Obstetrics and Gynaecology, Oulu University, Finland.
BJOG. 2000 Nov;107(11):1427-32. doi: 10.1111/j.1471-0528.2000.tb11660.x.
To determine whether treatment of bacterial vaginosis (BV) with vaginal clindamycin affects pregnancy outcome.
Mothers with singleton pregnancies and without previous preterm delivery in 17 health centres in Oulu from March 1996 Until March 1998, in whom BV was diagnosed by Gram stain of a vaginal swab at the first antenatal visit (at the 12th gestational week) were randomised at Oulu University Hospital to have a one-week course of vaginal clindamycin, or placebo. A follow up sample of Gram stain was taken two weeks after randomisation and at the 30th gestational weeks. Pregnancy outcome data was obtained from hospital records. Primary outcome was preterm birth, and puerperal infectious morbidity the other outcome measure.
During the study period 1956 women were screened, of whom 143 (7.3%) were BV- positive. One hundred and one were randomised. The total preterm birth rate of BV+ women randomised was 9.9% (10/101). Preterm birth occurred in 20.7% (6/29) vs 0% (0/26) according to whether BV persisted or not (P < 0.01). The preterm birth rate was 13.7% (7/51) in the clindamycin group vs 6.0% (3/50) in the placebo group (OR 2.5, 95% CI 0.6-10). BV was cured just after treatment in 17 out of 51 (33%) of the clindamycin- treated patients vs 17 out of 50 (34%) of the placebo- treated patients (OR 1.0, 95% CI 0.4-2.2). There was a difference in puerperal infectious morbidity in patients where BV persisted (31%, 9/29) compared with those in which BV did not persist (7.7%, 1/26) (OR 5.4, 95% CI 1.04-28). Infections were seen in 4/51 (8%) of the clindamycin treated vs 10/50 (20%) of the placebo treated cases, (OR 0.3, 95% CI 0.1-1.2).
The prevalence of BV was lower than expected in this low risk population, but nevertheless it increased the risk of preterm birth and puerperal infectious morbidity, the risk being highest in cases where BV persisted during pregnancy. Vaginal clindamycin treatment for BV in the first trimester of pregnancy did not appear to reduce the risk of preterm birth or puerperal infections.
确定阴道用克林霉素治疗细菌性阴道病（BV）是否会影响妊娠结局。
1996年3月至1998年3月期间，在奥卢的17个健康中心，单胎妊娠且既往无早产史的母亲，在首次产前检查（妊娠第12周）时通过阴道拭子革兰氏染色诊断为BV，在奥卢大学医院被随机分为接受为期一周的阴道用克林霉素治疗组或安慰剂组。随机分组后两周及妊娠第30周时采集革兰氏染色的随访样本。妊娠结局数据从医院记录中获取。主要结局是早产，另一个结局指标是产褥期感染发病率。
在研究期间，对1956名女性进行了筛查，其中143名（7.3%）为BV阳性。101名被随机分组。随机分组的BV阳性女性的总早产率为9.9%（10/101）。根据BV是否持续存在，早产发生率为20.7%（6/29）对比0%（0/26）（P<0.01）。克林霉素组的早产率为13.7%（7/51），安慰剂组为6.0%（3/50）（比值比2.5，95%可信区间0.6 - 10）。51名接受克林霉素治疗的患者中有17名（33%）在治疗后BV治愈，50名接受安慰剂治疗的患者中有17名（34%）治愈（比值比1.0，95%可信区间0.4 - 2.2）。BV持续存在的患者产褥期感染发病率（31%，9/29）与BV未持续存在的患者（7.7%，1/26）相比存在差异（比值比5.4，95%可信区间1.04 - 28）。克林霉素治疗组4/51（8%）出现感染，安慰剂治疗组10/50（20%）出现感染（比值比0.3，95%可信区间0.1 - 1.2）。
在这个低风险人群中，BV的患病率低于预期，但它仍增加了早产和产褥期感染发病率的风险，在孕期BV持续存在的情况下风险最高。妊娠早期阴道用克林霉素治疗BV似乎并未降低早产或产褥期感染的风险。
