羊膜移植在宫腔镜下宫腔黏连分离术后预防宫腔黏连复发中的有效性和安全性

Effectiveness and safety of amniotic membrane transplantation in preventing recurrence of uterine adhesion after transcervical resection of adhesions

目的探讨羊膜移植对预防中、重度宫腔黏连(IUA)患者行宫腔镜下宫腔黏连分离术(TCRA)后黏连复发的有效性与安全性。方法选择2016年12月至2017年8月,在武汉大学人民医院生殖中心因中、重度IUA行TCRA的121例患者为研究对象。根据手术日为单、双日,将其分为2组,A组(n=76)行羊膜移植,B组(n=45)为常规治疗组[放置宫内节育器(IUD)和可吸收生物医用膜],比较2组患者一般临床资料及疗效(宫腔恢复情况、月经量改变、术后子宫内膜厚度)和术后不良反应率等。采用成组t检验,对2组患者年龄、孕次、子宫内膜厚度进行统计学比较。采用Wilcoxon秩和检验,对2组患者人体质量指数(BMI)、病程等进行统计学分析。采用χ2检验、连续性校正χ^2检验或者Fisher确切概率法,对TCRA前月经异常情况构成比、IUA程度构成比、宫腔恢复率、月经量改善率、不良反应率等进行分析。本研究遵循的程序符合武汉大学人民医院医学伦理委员会所制定的伦理学标准,得到该委员会批准(批准文号:WDRY2016-Q007),所有受试者均签署临床研究知情同意书。结果①2组患者的年龄、孕次、BMI、病程、TCRA前月经异常情况构成比及IUA程度构成比比较,差异均无统计学意义(P>0.05)。②2组TCRA疗效评价如下。A组患者的宫腔恢复率(84.2%,64/76)显著高于B组(64.4%,29/45),月经量改善率(75.0%,57/76)明显高于B组(37.8%,17/45),术后子宫内膜厚度为[(4.2±1.6)mm],亦明显高于B组的(3.6±1.5)mm,并且上述指标比较,差异均有统计学意义(χ^2=4.367、16.485、2.168,P=0.037、<0.001、=0.033)。③2组患者中,无一例患者发生水中毒、子宫穿孔等严重并发症。此外,2组患者术后不良反应,如月经间期反复阴道不规则出血发生率、阴道分泌物异常发生率、腹痛发生率、外阴瘙痒发生率比较,差异均无统计学意义(P>0.05)。结论羊膜移植为IUA患者TCRA后预防黏连复发的有效方法之一。但是,该方法的远期安全性仍然需要大样本、随机对照试验进一步证实。

Objective To investigate the effectiveness and safety of amniotic membrane transplantation in preventing recurrence of intrauterine adhesions(IUA)after transcervical resection of adhesions(TCRA).Methods From December 2016 to August 2017,a total of 121 patients who underwent TCRA due to moderate or severe IUA in the Center for Reproductive Medicine of Renmin Hospital of Wuhan University were enrolled into this study.According to the odd-numbered and even-numbered operation days,they were divided into two groups:group A(n=76)for amniotic membrane transplantation,group B(n=45)for conventional treatment,induding intrauterine device(IUD)and absorbable biomedical membrane.The general clinical data,curative effects(uterine cavity recovery,menstrual volume changes,postoperative endometrial thickness)and incidence of postoperative adverse reactions were compared between two groups.Independent-samples t test was used to statistically compare the age,gestational age and endometrial thickness between two groups.Wilcoxon rank sum test was used to statistically analyze body mass index(BMI)and disease course.The composition ratio of IUA degree,menstruation improvement rate and adverse reaction rate were analyzed by chi-square test,continuity correction of chi-square test or Fisher′s exact test.The procedures followed in this study was in accordance with the ethical standards established by the Human Beings Test Committee of Renmin Hospital of Wuhan University,and was approved by the committee(Approval No.WDRY2016-Q007).Informed consent was obtained from each participate.Results①There were no significant differences in the aspects of age,gestational age,BMI,disease course,composition ratio of abnormal menstruation types before TCRA and composition ratio of IUA degree between two groups(P>0.05).②The therapeutic effects of TCRA in two groups were evaluated as follows.The recovery rate of uterine cavity in group A was 84.2%(64/76),which was significantly higher than that of 64.4%(29/45)in group B,the improvement rate of menstrual volume of group A was 75.0%(57/76),which was significantly higher than that of 37.8%(17/45)in group B,and the thickness of postoperative endometrium of group A was(4.2±1.6)mm,which was significantly higher than that of(3.6±1.5)mm in group B.All the above indexes between two groups were statistically significant(χ^2=4.367,16.485,2.168;P=0.037,<0.001,=0.033).③In two groups of patients,none of them had serious complications such as water poisoning and uterine perforation.In addition,there were no significant differences in postoperative adverse reactions between two groups,such as the incidences of recurrent irregular vaginal bleeding during menstruation,more vaginal secretions,abdominal pain and pruritus vulvae(P>0.05).Conclusions Amniotic membrane transplantation is one of the effective methods to prevent the recurrence of adhesion after TCRA of IUA patients.While,its long-term safety needs to be confirmed by large-sample randomized,controlled trials.