这项研究的目的是评估宫腔镜手术后使用的任何抗粘连屏障凝胶治疗与子宫腔异常相关的不孕症的效果。在不孕妇女的宫腔镜手术后,妇科医生可能会使用任何屏障凝胶来减少从头粘连的形成;使用任何屏障凝胶与较不严重的从头粘连和较低的平均粘连评分有关。然而,不孕妇女应被告知,目前没有证据表明活产或怀孕率较高。缺乏流产结果的数据。临床前研究表明,使用可生物降解的手术屏障可以减少术后粘连的形成。人类的观察性研究报告了相互矛盾的结果。我们检索了Cochrane月经失调和低生育专业登记册(2013年4月10日),Cochrane中央受控试验登记册(Cochrane图书馆2013,第1期),MEDLINE(1950年至2013年4月4日),EMBASE(1974年至2013年4月4日),和其他电子审判数据库,包括审判登记册,未发表文献的来源,和参考列表。我们手工检索了《微创妇科杂志》(1992年1月1日至2013年4月13日);我们还联系了该领域的专家。我们纳入了任何抗粘连屏障凝胶与另一种屏障凝胶之间的随机比较,安慰剂,或宫腔镜手术后没有辅助治疗。主要结果是活产率和二次宫腔镜检查的从头粘连形成。次要结果是妊娠率和流产率,平均粘连评分,再次宫腔镜检查时粘连的严重程度。两位作者独立评估了纳入和偏倚风险的合格研究,并提取数据。我们联系了主要研究作者以获取更多信息或其他澄清。5项试验符合纳入标准。没有证据表明在宫腔镜手术后使用任何屏障凝胶对活产或临床妊娠的关键结局有有利的作用(风险比(RR)3.0,95%置信区间(CI)0.35至26,P=0.32,一项研究,30个女人,质量非常低的证据);没有关于结果流产的数据。在宫腔镜手术后使用任何凝胶可降低1至3个月宫腔镜检查的二次粘连发生率(RR0.65,95%CI0.45至0.93,P=0.02,5项研究,372名女性质量很低的证据)。需要治疗才能受益的人数为9(95%CI5至33)。自交联透明质酸凝胶在子宫肌瘤手术中的应用,子宫内膜息肉,或子宫间隔与3个月时第二次宫腔镜检查时的平均粘连评分较低相关(一项研究,平均差异(MD)-1.44,95%CI-1.83至-1.05,P<0.00001,24名妇女;在接受宫腔镜手术治疗宫腔粘连的妇女中,这种益处甚至更大(MD-3.30,95%CI-3.43至-3.17,P<0.00001,一项研究,19名妇女)。在宫腔镜手术后使用任何凝胶后,有更多的美国生育协会1988年第一阶段(轻度)粘连(RR2.81,95%CI1.13至7.01,P=0.03,四项研究,79名妇女)。需要治疗才能受益的人数为2(95%CI1至4)。同样,在第二次宫腔镜检查中,“中度或重度粘连”较少(RR0.25,95%CI0.10至0.67,P=0.006,四项研究,79名妇女)。需要治疗才能受益的人数为2(95%CI1至4)(所有非常低的质量证据)。对于非方法论质量存在一些担忧。只有两项试验包括不育妇女;在其余三项研究中,目前尚不清楚是否以及有多少参与者患有不孕症。因此,应质疑纳入研究的结果对目标人群的适用性。此外,只有一项小型试验研究了抗粘连屏障凝胶对妊娠关键结局的影响;随访时间为,然而,未指定。需要进行更精心设计和足够有力的随机研究,以评估任何抗粘连凝胶的使用是否会影响目标不育女性人群的关键生殖结局。
The aim of this study was to assess the effects of any anti-adhesion barrier gel used after operative hysteroscopy for treating infertility associated with uterine cavity abnormalities. Gynecologists might use any barrier gel following operative hysteroscopy in infertile women for decreasing de novo adhesion formation; the use of any barrier gel is associated with less severe de novo adhesions and lower mean adhesion scores. Nevertheless, infertile women should be counseled that there is at the present no evidence for higher live birth or pregnancy rates. There is a lack of data for the outcome miscarriage. Preclinical studies suggest that the use of biodegradable surgical barriers may decrease postsurgical adhesion formation. Observational studies in the human report conflicting results. We searched the Cochrane Menstrual Disorders and Subfertility Specialized Register (10 April 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2013, Issue 1), MEDLINE (1950 to 4 April 2013), EMBASE (1974 to 4 April 2013), and other electronic databases of trials including trial registers, sources of unpublished literature, and reference lists. We handsearched the Journal of Minimally Invasive Gynecology (from 1 January 1992 to 13 April 2013); we also contacted experts in the field. We included the randomized comparisons between any anti-adhesion barrier gel versus another barrier gel, placebo, or no adjunctive therapy following operative hysteroscopy. Primary outcomes were live birth rates and de novo adhesion formation at second-look hysteroscopy. Secondary outcomes were pregnancy and miscarriage rates, mean adhesion scores, and severity of adhesions at second-look hysteroscopy. Two authors independently assessed eligible studies for inclusion and risk of bias, and extracted data. We contacted primary study authors for additional information or other clarification. Five trials met the inclusion criteria. There is no evidence for an effect favoring the use of any barrier gel following operative hysteroscopy for the key outcomes of live birth or clinical pregnancy (risk ratio (RR) 3.0, 95 % confidence interval (CI) 0.35 to 26, P = 0.32, one study, 30 women, very low quality evidence); there were no data on the outcome miscarriage. The use of any gel following operative hysteroscopy decreases the incidence of de novo adhesions at second-look hysteroscopy at 1 to 3 months (RR 0.65, 95 % CI 0.45 to 0.93, P = 0.02, five studies, 372 women, very low quality evidence). The number needed to treat to benefit is 9 (95 % CI 5 to 33). The use of auto-cross-linked hyaluronic acid gel in women undergoing operative hysteroscopy for fibroids, endometrial polyps, or uterine septa is associated with a lower mean adhesion score at second-look hysteroscopy at 3 months (mean difference (MD) -1.44, 95 % CI -1.83 to -1.05, P < 0.00001, one study, 24 women; this benefit is even larger in women undergoing operative hysteroscopy for intrauterine adhesions(MD -3.30, 95 % CI -3.43 to -3.17, P < 0.00001, one study, 19 women). After using any gel following operative hysteroscopy, there are more American Fertility Society 1988 stage I (mild) adhesions (RR 2.81, 95 % CI 1.13 to 7.01, P = 0.03, four studies, 79 women). The number needed to treat to benefit is 2 (95 % CI 1 to 4). Similarly there are less\' moderate or severe adhesions\' at second-look hysteroscopy (RR 0.25, 95 % CI 0.10 to 0.67, P = 0.006, four studies, 79 women). The number needed to treat to benefit is 2 (95 % CI 1 to 4) (all very low quality evidence). There are some concerns for the non-methodological quality. Only two trials included infertile women; in the remaining three studies, it is not clear whether and how many participants suffered from infertility. Therefore, the applicability of the findings of the included studies to the target population under study should be questioned. Moreover, only one small trial studied the effects of anti-adhesion barrier gels for the key outcome of pregnancy; the length of follow-up was, however, not specified. More well-designed and adequately powered randomized studies are needed to assess whether the use of any anti-adhesion gel affects the key reproductive outcomes in a target population of infertile women.