Hajenius P J, Mol F, Mol B W J, Bossuyt P M M, Ankum W M, van der Veen F
Academic Medical Center, University of Amsterdam, Obstetrics and Gynecology (H4-205), Meibergdreef 9, Amsterdam, Netherlands, 1105 AZ.
Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD000324. doi: 10.1002/14651858.CD000324.pub2.
Treatment options for tubal ectopic pregnancy are; (1) surgery, e.g. salpingectomy or salpingo(s)tomy, either performed laparoscopically or by open surgery; (2) medical treatment, with a variety of drugs, that can be administered systemically and/or locally by various routes and (3) expectant management.
To evaluate the effectiveness and safety of surgery, medical treatment and expectant management of tubal ectopic pregnancy in view of primary treatment success, tubal preservation and future fertility.
The Cochrane Menstrual Disorders and Subfertility Group's Specialised Register, Cochrane Controlled Trials Register (up to February 2006), Current Controlled Trials Register (up to October 2006), and MEDLINE (up to October 2006) were searched.
Randomised controlled trials (RCTs) comparing treatments in women with tubal ectopic pregnancy.
Data extraction and quality assessment was done independently by two reviewers. Differences were resolved by discussion with all reviewers.
Thirty five studies have been analysed on the treatment of tubal ectopic pregnancy, describing 25 different comparisons.
Laparoscopic salpingostomy is significantly less successful than the open surgical approach in the elimination of tubal ectopic pregnancy (2 RCTs, n=165, OR 0.28, 95% CI 0.09, 0.86) due to a significant higher persistent trophoblast rate in laparoscopic surgery (OR 3.5, 95% CI 1.1, 11). However, the laparoscopic approach is significantly less costly than open surgery (p=0.03). Long term follow-up (n=127) shows no evidence of a difference in intra uterine pregnancy rate (OR 1.2, 95% CI 0.59, 2.5) but there is a non significant tendency to a lower repeat ectopic pregnancy rate (OR 0.47, 95% 0.15, 1.5). Salpingostomy alone is significantly less successful than when combined with a prophylactic single shot methotrexate (2 RCTs, n=163, OR 0.25, 95% CI 0.08-0.76) to prevent persistent trophoblast.
Systemic methotrexate in a fixed multiple dose intramuscular regimen has a non significant tendency to a higher treatment success than laparoscopic salpingostomy (1 RCT, n=100, OR 1.8, 95% CI 0.73, 4.6). No significant differences are found in long term follow-up (n=74): intra uterine pregnancy (OR 0.82, 95% CI 0.32, 2.1) and repeat ectopic pregnancy (OR 0.87, 95% CI 0.19, 4.1). One single dose intramuscular methotrexate is significantly less successful than laparoscopic salpingostomy (4 RCTs, n=265, OR 0.38, 95% CI 0.20, 0.71). With a variable dose regimen treatment success rises, but shows no evidence of a difference compared to laparoscopic salpingostomy (OR 1.1, 95% CI 0.52, 2.3). Long term follow-up (n=98) do not differ significantly (intra uterine pregnancy OR 1.0, 95% CI 0.43, 2.4, ectopic pregnancy OR 0.54, 95% CI 0.12, 2.4). The efficacy of systemic single dose methotrexate alone is significantly less successful than when combined with mifepristone (2 RCTs, n=262, OR 0.59, 95% CI 0.35, 1.0). The same goes for the addition of traditional Chinese medicine (1 RCT, n=78, OR 0.08, 95% CI 0.02, 0.39). Local medical treatment administered transvaginally under ultrasound guidance is significantly better than a 'blind' intra-tubal injection under laparoscopic guidance in the elimination of tubal ectopic pregnancy (1 RCT, n=36, methotrexate OR 5.8, 95% CI 1.3, 26; 1 RCT, n=80, hyperosmolar glucose OR 0.38, 95% CI 0.15, 0.93). However, compared to laparoscopic salpingostomy, local injection of methotrexate administered transvaginally under ultrasound guidance is significantly less successful (1 RCT, n=78, OR 0.17, 95% CI 0.04, 0.76) but with positive long term follow up (n=51): a significantly higher intra uterine pregnancy rate (OR 4.1, 95% CI 1.3, 14) and a non significant tendency to a lower repeat ectopic pregnancy rate (OR 0.30, 95% CI 0.05, 1.7). EXPECTANT MANAGEMENT: Expectant management is significantly less successful than prostaglandin therapy (1 RCT, n=23, OR 0.08, 95% CI 0.02-0.39).
AUTHORS' CONCLUSIONS: In the surgical treatment of tubal ectopic pregnancy laparoscopic surgery is a cost effective treatment. An alternative nonsurgical treatment option in selected patients is medical treatment with systemic methotrexate. Expectant management can not be adequately evaluated yet.
输卵管异位妊娠的治疗方法有:(1)手术,如输卵管切除术或输卵管造口术,可通过腹腔镜或开腹手术进行;(2)药物治疗,使用多种药物,可通过多种途径全身和/或局部给药;(3)期待治疗。
从初次治疗成功率、输卵管保留情况和未来生育能力方面评估输卵管异位妊娠手术、药物治疗和期待治疗的有效性和安全性。
检索了Cochrane月经紊乱与不育症小组专业注册库、Cochrane对照试验注册库(截至2006年2月)、当前对照试验注册库(截至2006年10月)以及MEDLINE(截至2006年10月)。
比较输卵管异位妊娠女性不同治疗方法的随机对照试验(RCT)。
由两名评价员独立进行数据提取和质量评估。通过与所有评价员讨论解决分歧。
对35项关于输卵管异位妊娠治疗的研究进行了分析,描述了25种不同的比较。
在消除输卵管异位妊娠方面,腹腔镜输卵管造口术的成功率显著低于开腹手术方法(2项RCT, n = 165,OR 0.28,95% CI 0.09,0.86),因为腹腔镜手术中持续性滋养细胞率显著更高(OR 3.5,95% CI 1.1,11)。然而,腹腔镜手术方法的成本显著低于开腹手术(p = 0.03)。长期随访(n = 127)显示,宫内妊娠率无差异(OR 1.2,95% CI 0.59,2.5),但重复异位妊娠率有降低的非显著趋势(OR 0.47,95% 0.15,1.5)。单独输卵管造口术的成功率显著低于联合单次预防性甲氨蝶呤时(2项RCT,n = 163,OR 0.25,95% CI 0.08 - 0.76),以预防持续性滋养细胞。
固定多剂量肌肉注射甲氨蝶呤全身用药的治疗成功率比腹腔镜输卵管造口术有升高的非显著趋势(1项RCT,n = 100,OR 1.8,95% CI 0.73,4.6)。长期随访(n = 74)未发现显著差异:宫内妊娠(OR 0.82,95% CI 0.32,2.1)和重复异位妊娠(OR 0.87,95% CI 0.19,4.1)。单次肌肉注射甲氨蝶呤的成功率显著低于腹腔镜输卵管造口术(4项RCT,n = 265,OR 0.38,95% CI 0.20,0.71)。采用可变剂量方案时治疗成功率升高,但与腹腔镜输卵管造口术相比无差异证据(OR 1.1,95% CI 0.52,2.3)。长期随访(n = 98)无显著差异(宫内妊娠OR 1.0,95% CI 0.43,2.4,异位妊娠OR 0.54,95% CI 0.12,2.4)。单独全身单次剂量甲氨蝶呤的疗效显著低于联合米非司酮时(2项RCT,n = 262,OR 0.59,95% CI 0.35,1.0)。联合中药时情况相同(1项RCT,n = 78,OR 0.08,95% CI 0.02,0.39)。在超声引导下经阴道局部给药治疗在消除输卵管异位妊娠方面显著优于腹腔镜引导下“盲目”输卵管内注射(1项RCT,n = 36,甲氨蝶呤OR 5.8, 95% CI 1.3, 26;1项RCT,n = 80,高渗葡萄糖OR 0.38,95% CI 0.15,0.93)。然而,与腹腔镜输卵管造口术相比,超声引导下经阴道局部注射甲氨蝶呤的成功率显著较低(1项RCT,n = 78,OR 0.17,95% CI 0.04,0.76),但长期随访结果良好(n = 51):宫内妊娠率显著更高(OR 4.1,95% CI 1.3,14),重复异位妊娠率有降低的非显著趋势(OR 0.30,95% CI 0.05,1.7)。
期待治疗的成功率显著低于前列腺素治疗(1项RCT,n = 23,OR 0.08,95% CI 0.02 - 0.39)。
在输卵管异位妊娠的手术治疗中,腹腔镜手术是一种具有成本效益的治疗方法。对于部分患者,另一种非手术治疗选择是全身应用甲氨蝶呤进行药物治疗。期待治疗目前尚无法得到充分评估。