Shwekerela B, Kalumuna R, Kipingili R, Mashaka N, Westheimer E, Clark W, Winikoff B
Kagera Regional Hospital, Bukoba, Tanzania.
BJOG. 2007 Nov;114(11):1363-7. doi: 10.1111/j.1471-0528.2007.01469.x. Epub 2007 Sep 5.
To investigate the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion.
A prospective open-label randomised trial.
Kagera Regional Hospital, Bukoba, Tanzania.
Three hundred women with a clinical diagnosis of incomplete abortion and a uterine size <12 weeks.
A total of 150 women were randomised to either a single dose of 600 micrograms of oral misoprostol or MVA. If abortion was clinically complete at 7-day follow up, the woman was released from the study. If it was still incomplete, the woman was offered the choice of an additional 1-week follow up or immediate MVA. Cases still incomplete after a further week were offered MVA.
Incidence of successful abortion (success defined as no secondary surgical intervention provided), incidence of adverse effects, patient satisfaction.
Success was very high in both arms (misoprostol: 99%; MVA: 100%; difference not significant). Most adverse effects were higher in the misoprostol arm, although the mean pain score was higher in the MVA arm (3.0 versus 3.5; P < 0.001). More women were very satisfied with misoprostol (75%) than with MVA (55%, P = 0.001), and a higher proportion of women in the misoprostol arm said that they would recommend the treatment to a friend (95% versus 75%, P < 0.001).
Misoprostol is as effective as MVA at treating incomplete abortion at uterine size of <12 weeks. The acceptability of misoprostol appears higher. Given the many practical advantages of misoprostol over MVA in low-resource settings, misoprostol should be more widely available for treatment of incomplete abortion in the developing world.
探讨米索前列醇与人工负压吸引术(MVA)治疗不全流产的安全性、有效性及可接受性。
前瞻性开放标签随机试验。
坦桑尼亚布科巴的卡盖拉地区医院。
300名临床诊断为不全流产且子宫大小<12周的女性。
总共150名女性被随机分为口服600微克单剂量米索前列醇组或MVA组。如果在7天随访时流产临床完成,该女性退出研究。如果仍未完成,该女性可选择再随访1周或立即进行MVA。再过一周仍未完成的病例接受MVA。
成功流产的发生率(成功定义为无需二次手术干预)、不良反应发生率、患者满意度。
两组的成功率都很高(米索前列醇组:99%;MVA组:100%;差异无统计学意义)。米索前列醇组的大多数不良反应发生率更高,尽管MVA组的平均疼痛评分更高(3.0对3.5;P<0.001)。对米索前列醇非常满意的女性(75%)多于MVA组(55%,P = 0.001),米索前列醇组中表示会向朋友推荐该治疗方法的女性比例更高(95%对75%,P<0.001)。
米索前列醇在治疗子宫大小<12周的不全流产方面与MVA同样有效。米索前列醇的可接受性似乎更高。鉴于在资源匮乏地区米索前列醇相对于MVA有许多实际优势,米索前列醇应在发展中国家更广泛地用于治疗不全流产。