改良输卵管保守性手术对输卵管壶腹部妊娠患者生殖状态的影响

Effects of modified tubal conservative operation on subsequent fertility outcomes of ampullary pregnancy

目的探讨改良输卵管保守性手术对输卵管壶腹部妊娠患者的安全性、治疗效果及术后生殖状态的影响。方法选择2015年1月1日至2016年3月31日,在上海市普陀区妇婴保健院确诊为输卵管壶腹部妊娠的70例患者为研究对象。这70例患者均有生育要求,需保留输卵管。按照随机数字表法,将其分为研究组(n=36,采用改良输卵管保守性手术治疗)和对照组(n=34,采用单纯腹腔镜下输卵管妊娠开窗取胚术治疗)。采用回顾性分析方法,收集2组患者一般临床资料,包括年龄、孕次、停经天数等,以及2组患者治疗情况,包括手术时间、术中出血量,术后持续性异位妊娠(PEP)发生率,术后第6、12个月宫内妊娠和复发性异位妊娠(REP)发生率,以及治愈率等。采用成组t检验,对2组患者年龄、停经天数、术前血β-人绒毛膜促性腺激素(hCG)水平、手术时间、术中出血量等进行统计学分析。采用Wilcoxon秩和检验,对2组患者孕次、术后疼痛持续时间等进行统计学分析。采用χ2检验,对宫内妊娠率,PEP、REP发生率及治愈率等进行统计学分析。采用MannWhitney U检验,对术后第3、7天不同疼痛程度所占比例进行统计学分析。本研究遵循的程序符合上海市普陀区妇婴保健院人体试验委员会所制定的伦理学标准,得到该委员会批准(批准编号:2014-18),并与所有受试者签署临床研究知情同意书。结果 (1)2组患者的年龄、孕次、停经天数、术前血β-hCG水平等一般临床资料比较,差异均无统计学意义(P>0.05)。(2)研究组患者手术时间为(58.3±11.2)min,显著长于对照组的(30.1±10.7)min,并且差异有统计学意义(t=10.759,P<0.001)。研究组术中出血量为(35.2±6.3)mL,显著高于对照组的(20.4±5.6)mL,并且差异亦有统计学意义(t=10.370,P<0.001)。(3)2组患者于术后第6个月的宫内妊娠率和REP发生率比较,差异均无统计学意义(P>0.05)。但是,术后第12个月随访结果显示,研究组宫内妊娠发生率为25.0%(9/36),显著高于对照组的5.9%(2/34),2组比较,差异有统计学意义(χ2=4.825,P=0.028);2组REP发生率比较,差异无统计学意义(P>0.05)。结论相对于单纯腹腔镜下输卵管妊娠开窗取胚术,改良输卵管保守性手术治疗输卵管壶腹部妊娠具有宫内妊娠率较高的优势,但是其手术时间较长、术中出血量较高。

Objective To evaluate the safety,efficacy and subsequent fertility outcomes of modified tubal conservative operation in treatment of ampullary pregnancy.Methods From January1,2015 to June 31,2016,a total of 70 cases of patients who were diagnosed as ampullary pregnancy in Shanghai Putuo Maternity and Infant Health Hospital were chosen as study subjects,and those 70 patients had fertility requirements to retain the fallopian tubes.According to random number table method,they were divided into study group（n=36,treated by modified tubal conservative operation）and control group（n=34,treated by laparoscopic salpingostomy）.A retrospective analysis method was used to collect general clinical data of two groups,including age,gravidity,menopause days,etc.,and to collect treatment status of two groups,including operation duration,intraoperative blood loss,incidence rates of persistent ectopic pregnancy（PEP）and intrauterine pregnancy at the 6 th and12 th months after operation,recurrent ectopic pregnancy（REP）rate,and cure rate,etc..The age,menopause days,preoperative bloodβ-human chorionic gonadotropin（hCG）levels,operation duration,and intraoperative blood loss of two groups were statistically compared by independentsamples t test.The gravidity and postoperative pain duration of two groups were statistically compared by Wilcoxon rank sum test.The incidence rates of intrauterine pregnancy,PEP,REP and cure rates of two groups were statistically compared by chi-square test.The proportions of different pain levels at the 3 rd and 7 th days after operation of two groups were statistically compared by Mann-Whitney U test.The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shanghai Putuo Maternity and Infant Health Hospital（Approval No.2014-18）.Informed consent was obtained from each participant.Results（1） There were no significant differences between two groups in the age,gravidity,menopause days,and preoperative bloodβ-hCG levels（P〉0.05）.（2） The operative duration of study group was（58.3±11.2）min,which was significantly longer than that of control group（30.1±10.7）min,and the difference was statistically significant（t=10.759,P〈0.001）.The intraoperative blood loss of study group was（35.2±6.3）mL,which was significantly higher than that of control group（20.4±5.6）mL,and the difference also was statistically significant（t=10.370,P〈0.001）.（3） There was no significant difference between two groups in the incidence rates of intrauterine pregnancy and REP at the 6 th month after operation（P〉0.05）.Follow-up results at the 12 th month after operation showed that the incidence rate of intrauterine pregnancy in study group was 25.0%（9/36）,which was significantly higher than that of control group 5.9%（2/34）,and the difference was statistically significant（χ2=4.825,P=0.028）;however,there was no significant difference between two groups in the incidence rate of REP（χ2=2.802,P=0.094）.Conclusions Modified tubal conservative operation for ampullary pregnancy has the advantage of higher intrauterine pregnancy rate than that of laparoscopic salpingostomy,but it has a longer operation duration and higher intraoperative blood loss.