Neilson J P, Hickey M, Vazquez J
University of Liverpool, Division of Perinatal and Reproductive Medicine, First Floor, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, UK L8 7SS.
Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002253. doi: 10.1002/14651858.CD002253.pub3.
In most pregnancies that miscarry, arrest of embryonic or fetal development occurs some time (often weeks) before the miscarriage occurs. Ultrasound examination can reveal abnormal findings during this phase by demonstrating anembryonic pregnancies or embryonic or fetal death. Treatment before 14 weeks has traditionally been surgical but medical treatments may be effective, safe, and acceptable, as may be waiting for spontaneous miscarriage.
To assess the effectiveness, safety and acceptability of any medical treatment for early pregnancy failure (anembryonic pregnancies or embryonic and fetal deaths before 24 weeks).
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2005).
Randomised trials comparing medical treatment with another treatment (e.g. surgical evacuation), or placebo, or no treatment for early pregnancy failure. Quasi-random studies were excluded.
Data were extracted unblinded.
Twenty four studies (1888 women) were included. Vaginal misoprostol hastens miscarriage (complete or incomplete) when compared with placebo: e.g. miscarriage less than 24 hours (two trials, 138 women, relative risk (RR) 4.73, 95% confidence interval (CI) 2.70 to 8.28), with less need for uterine curettage (two trials, 104 women, RR 0.40, 95% CI 0.26 to 0.60) and no significant increase in nausea or diarrhoea. Lower-dose regimens of vaginal misoprostol tend to be less effective in producing miscarriage (three trials, 247 women, RR 0.85, 95% CI 0.72 to 1.00) with similar incidence of nausea. There seems no clear advantage to administering a 'wet' preparation of vaginal misoprostol or of adding methotrexate, or of using laminaria tents after 14 weeks. Vaginal misoprostol is more effective than vaginal prostaglandin E in avoiding surgical evacuation. Oral misoprostol was less effective than vaginal misoprostol in producing complete miscarriage (two trials, 218 women, RR 0.90, 95% CI 0.82 to 0.99). Sublingual misoprostol had equivalent efficacy to vaginal misoprostol in inducing complete miscarriage but was associated with more frequent diarrhoea. The two trials of mifepristone treatment generated conflicting results. There was no statistically significant difference between vaginal misoprostol and gemeprost in the induction of miscarriage for fetal death after 13 weeks.
AUTHORS' CONCLUSIONS: Available evidence from randomised trials supports the use of vaginal misoprostol as a medical treatment to terminate non-viable pregnancies before 24 weeks. Further research is required to assess effectiveness and safety, optimal route of administration and dose. Conflicting findings about the value of mifepristone need to be resolved by additional study.
在大多数流产的妊娠中,胚胎或胎儿发育停止发生在流产前的某个时间(通常为数周)。超声检查可通过显示胚胎停育妊娠或胚胎或胎儿死亡,在此阶段发现异常情况。传统上,14周前的治疗方法是手术,但药物治疗可能有效、安全且可接受,等待自然流产也可能如此。
评估任何药物治疗早期妊娠失败(胚胎停育妊娠或24周前胚胎及胎儿死亡)的有效性、安全性和可接受性。
我们检索了Cochrane妊娠与分娩组试验注册库(2005年11月30日)。
比较药物治疗与其他治疗(如手术清宫)、安慰剂或未治疗早期妊娠失败的随机试验。排除半随机研究。
数据提取未设盲。
纳入24项研究(1888名女性)。与安慰剂相比,阴道米索前列醇可加速流产(完全或不完全流产):例如,流产时间少于24小时(两项试验,138名女性,相对危险度(RR)4.73,95%置信区间(CI)2.70至8.28),清宫需求减少(两项试验,104名女性,RR 0.40,95%CI 0.26至0.60),恶心或腹泻无显著增加。较低剂量的阴道米索前列醇方案在导致流产方面往往效果较差(三项试验,247名女性,RR 0.85,95%CI 0.72至1.00),恶心发生率相似。阴道米索前列醇的“湿”制剂给药、添加甲氨蝶呤或14周后使用海藻棒似乎没有明显优势。阴道米索前列醇在避免手术清宫方面比阴道前列腺素E更有效。口服米索前列醇在导致完全流产方面比阴道米索前列醇效果差(两项试验,218名女性,RR 0.90,95%CI 0.82至0.99)。舌下米索前列醇在诱导完全流产方面与阴道米索前列醇疗效相当,但腹泻更频繁。两项米非司酮治疗试验结果相互矛盾。13周后,阴道米索前列醇与吉美前列素在诱导胎儿死亡流产方面无统计学显著差异。
随机试验的现有证据支持使用阴道米索前列醇作为药物治疗来终止24周前的不可行妊娠。需要进一步研究来评估有效性、安全性、最佳给药途径和剂量。关于米非司酮价值的相互矛盾的研究结果需要通过更多研究来解决。