Derman Richard J, Kodkany Bhalchandra S, Goudar Shivaprasad S, Geller Stacie E, Naik Vijaya A, Bellad M B, Patted Shobhana S, Patel Ashlesha, Edlavitch Stanley A, Hartwell Tyler, Chakraborty Hrishikesh, Moss Nancy
University of Missouri-Kansas City School of Medicine, MO, USA.
Lancet. 2006 Oct 7;368(9543):1248-53. doi: 10.1016/S0140-6736(06)69522-6.
Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting.
In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123.
Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control.
Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.
产后出血是发展中国家孕产妇死亡的主要原因。尽管存在预防和治疗此类出血的有效方法，如宫缩剂催产素，但在许多分娩发生在家中的资源匮乏地区，大多数方法都不可行。我们旨在研究口服米索前列醇（催产素的一种潜在替代品）能否在社区家庭分娩环境中预防产后出血。
在2002年9月至2005年12月进行的一项安慰剂对照试验中，印度农村的1620名妇女在分娩后被随机分配接受口服米索前列醇（n = 812）或安慰剂（n = 808）。25名辅助护士助产士进行分娩、给药并测量失血量。主要结局是分娩后2小时内急性产后出血（定义为出血≥500 mL）的发生率。分析采用意向性分析。该试验已在美国临床试验数据库（http://www.clinicaltrials.gov）注册，编号为NCT00097123。
口服米索前列醇与急性产后出血率显著降低相关（从12.0%降至6.4%，p<0.0001；相对风险0.53[95%CI 0.39 - 0.74]）以及急性严重产后出血率降低相关（从1.2%降至0.2%，p<0.0001；0.20[0.04 - 0.91]）。每治疗18名妇女可预防1例产后出血。米索前列醇还与产后平均失血量减少相关（从262.3 mL降至214.3 mL，p<0.0001）。两组的产后出血率均随时间下降，但安慰剂组仍显著更高。服用米索前列醇的妇女出现寒战和发热短暂症状的发生率高于对照组。
口服米索前列醇与急性产后出血率和平均失血量的显著降低相关。该药物成本低、易于给药、稳定性好且安全性良好，使其成为资源匮乏地区的一个不错选择。
