摘要
目的探讨米非司酮联合缩宫素治疗人工终止妊娠术(ATP)后宫腔内残留的疗效。方法选取2016年7月1日至2017年10月31日,衡水市哈励逊国际和平医院产科收治的116例初次接受ATP,并于术后诊断为宫腔内残留患者为研究对象。采用区组随机化法,将其分为观察组(n=58,接受米非司酮联合缩宫素治疗者)和对照组(n=58,接受缩宫素治疗者)。统计学分析2组受试者治疗总有效率、治疗后阴道流血情况、血清β-人绒毛膜促性腺激素(hCG)浓度及宫腔内残留物直径变化情况,以及不良反应发生情况。2组治疗总有效率等计数资料比较,采用χ~2检验;治疗后阴道流血时间、失血量,以及血清β-hCG浓度恢复正常时间等呈正态分布、方差齐的计量资料比较,采用成组t检验;不同治疗时间段宫腔内残留物直径缩小值比较,采用Wilcoxon秩和检验。本研究征得所有受试者知情同意,并在接受ATP前,签署临床研究知情同意书。本研究遵循的程序符合2013年修订的《世界医学会赫尔辛基宣言》要求。结果 (1)2组患者年龄、孕次、体重、本次ATP时的孕龄、治疗前血清β-hCG浓度、治疗前宫腔内残留物直径、子宫肌瘤发生率、ATP方式构成比比较,差异均无统计学意义(P>0.05)。(2)观察组患者治疗总有效率为93.1%(54/58),显著高于对照组的79.3%(46/58),2组比较,差异有统计学意义(χ~2=4.702,P=0.041)。(3)观察组患者治疗后阴道流血时间、失血量分别为(6.3±1.2)d与(53.2±10.3)mL,均显著短于、低于对照组的(8.1±1.4)d与(62.7±13.1)mL,并且差异均有统计学意义(t=2.256、3.167,P=0.046、0.021)。(4)观察组患者血清β-hCG浓度恢复正常时间为(8.3±3.3)d,显著短于对照组的(9.8±4.0)d,2组比较,差异有统计学意义(t=2.376,P=0.041)。(5)观察组患者治疗第1～6天、7～12天、13～18天、19～24天,宫腔内残留物直径缩小值分别为10.2mm(3.7～14.6mm)、8.5mm(3.6～13.9mm)、8.1mm(3.1～2.5mm)、7.2mm(3.1～12.0mm),显著大于对照组的6.3mm(2.7～12.4mm)、5.8mm(2.8～10.1mm)、5.5mm(2.4～10.0mm)、4.9mm(2.3～9.8mm),并且差异均有统计学意义(Z=5.122、5.340、5.788、6.011,P<0.001)。结论采用米非司酮联合缩宫素治疗后,可促进ATP患者宫腔内残留物排出,缩短阴道流血时间,降低失血量,促进血清β-hCG浓度恢复正常。因本研究纳入样本量相对较小,该方案治疗ATP后宫腔内残留是否值得临床推广,尚待大样本、多中心、随机对照研究予以证实。
Objective To investigate the clinical effects of mifepristone combined with oxytocin in treatment of intrauterine residual after artificial termination of pregnancy （ATP）. Methods From July 1, 2016 to October 31, 2017, a total of 116 patients with intrauterine residual after the first time of ATP in the Department of Obstetrics, Harrison International Peace Hospital of Hengshui City were selected as research subjects. They were divided into observation group （ n =58, treated by mifepristone and oxytocin） and control group （ n =58, only treated by oxytocin） by bock randomization method. The total effective rate, vaginal bleeding condition, serum β-human chronic gonadotropin （hCG） concentration, diameter of residues and adverse reactions in two groups were observed after treatment. Chi-square test was performed to compare the total effective rate between two groups. Independent-samples t test was performed to compare the differences of the duration and volume of vaginal bleeding, and the recovery time of serum β-hCG concentration between two groups. Wilcoxon rank sum test was used to compare the diameter reduction of intrauterine residues between two groups in different treatment periods. Clinical informed consent was obtained from each subject before ATP. The procedures in this study were in line with the requirements of the World Medical Association Declaration of Helsinki revised in 2013. Results ①There were no significant differences between two groups in the aspects of age, gravidity, weight, gestational age at the time of ATP, serum β-hCG concentration before treatment, diameter of intrauterine residues before treatment, incidence of uterine fibroids, and constituent ratio of ATP methods （ P 〉0.05）. ②The total effective rate in observation group was 93.1% （54/58）, which was obviously higher than that in control group 79.3% （46/58）, and the difference was statistically significant （ χ 2 =4.702, P =0.041）. ③The duration and volume of vaginal bleeding in observation group both were significantly shorter and lower than those in control group, which were （6.3±1.2） d vs （8.1±1.4） d, and （53.2±10.3） mL vs （62.7±13.1） mL, respectively, and both the differences were statistically significant （ t =2.256, 3.167; P =0.046, 0.021）. ④The recovery time of serum β-hCG concentration in observation group was （8.3±3.3） d, which was significantly shorter than tfhat in control group （9.8±4.0） d, and the difference was statistically significant （ t =2.376, P =0.041）. ⑤The diameter reductions of intrauterine residues during the treatment of the 1st to the 6th day, the 7th to the 12th day, the 13th to the 18th day, and the 19th to the 24th day in observation group all were bigger than those in control group, which were 10.2 mm （3.7-14.6 mm） vs 6.3 mm （2.7-12.4 mm）, 8.5 mm （3.6-13.9 mm） vs 5.8 mm （2.8-10.1 mm）, 7.2 mm （3.1-12.0 mm） vs 5.5 mm （2.4-10.0 mm）, and 5.8 mm （2.8-10.1 mm） vs 4.9 mm （2.3-9.8 mm）, respectively, and all the differences were statistically significant （ Z =5.122, 5.340, 5.788, 6.011, P 〈0.001）. Conclusions The use of mifepristone combined with oxytocin in treatment of intrauterine residues after ATP can promote the discharge of residues, shorten the duration of vaginal bleeding, reduce the amount of vaginal bleeding, and promote the recovery of serum β-hCG concentration. Because the sample size is relatively small in this study, whether mifepristone combined with oxytocin in treatment of intrauterine residues after ATP is worthy of clinical promotion remains to be confirmed by large sample, multi-center, randomized controlled studies.
作者
李宁
孙树静
郝彤
姚水平
焦悦
Li Ning;Sun Shujing;Hao Tong;Yao Shuiping;Jiao Yue(Department of Obstetrics,Harrison International Peace Hospital of Hengshui City,Hengshui 053000,Hebei Province,China)
出处
《中华妇幼临床医学杂志（电子版）》
CAS
2018年第5期578-583,共6页
Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)
基金
河北省财政厅
卫生计生委资助临床医学优秀人才培养项目(2015054965)~~
