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卡前列甲酯栓用于诊断性宫腔镜检查术前宫颈成熟的临床多中心研究

[Clinical multicenter study of carboprost methylate suppository for cervical ripening prior to diagnostic hysteroscopy].

作者信息

Duan H, Hao M, Wang S M, Meng Y J, Wang Y, Yuan R, Xue X, Yang Q, Lin J, He Y L, Shi Y L, Liu J H, Wang X, Wang S

机构信息

Gynecologic Minimally Invasive Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China.

出版信息

Zhonghua Fu Chan Ke Za Zhi. 2018 Sep 25;53(9):602-607. doi: 10.3760/cma.j.issn.0529-567x.2018.09.004.

Abstract

To evaluate the effectiveness of carboprost methylate suppository for cervical ripening before diagnostic hysteroscopy in premenopausal women. From July 2014 to July 2015, 1 614 women who were undergone diagnostic hysteroscopy in 12 hospitals were randomly assigned into study group (1 209) and control group (405) . The cases in study group were given 1 mg carboprost methylate suppository in vagina before hysteroscopy, the cases in control group were given 1 mg placebo. The extent of cervical ripening, the time of dilated cervix, pain scoring, incidence of drug side reactions after 24, 48, 72 hours, satisfaction degree of operators and patients, the time of hysteroscopy, incidence of complications between the two groups were observed and compared. (1) Mean cervical widths in the study and control groups were 6.11±1.11 and 5.95±1.11, and showed a significant difference (0.034) ; the percentage of women requiring cervical dilatation in study group was lower than the percentage in control group significantly [28.3% (342/1 209) versus 34.6% (140/405) , 0.020]. (2) The time of dilated cervix in study group was shorter than the time in control group significantly [ (34±25) versus (52±49) s, 0.028] for the patients whose mean cervical widths≤4. (3) There was no significant difference in pain scores between the two groups (0.05) . (4) The incidence of side reactions 24, 48, 72 hours after operation were no significant difference between the two groups (0.05) . (5) The satisfaction degree of operators and patients, the time of hysteroscopy, incidence of complications between the two groups were no singnifcant difference between the two groups (all 0.05) . Application of carboprost methylate suppository by vagina before hysteroscopy is an effective and safe method of cervical ripening.

摘要

评估甲氨前列素栓用于绝经前妇女诊断性宫腔镜检查术前宫颈成熟的有效性。2014年7月至2015年7月,12家医院的1614例行诊断性宫腔镜检查的妇女被随机分为研究组(1209例)和对照组(405例)。研究组患者在宫腔镜检查前阴道给予1mg甲氨前列素栓,对照组患者给予1mg安慰剂。观察并比较两组患者宫颈成熟程度、宫颈扩张时间、疼痛评分、术后24、48、72小时药物不良反应发生率、术者及患者满意度、宫腔镜检查时间、并发症发生率。(1)研究组和对照组的平均宫颈宽度分别为6.11±1.11和5.95±1.11,差异有统计学意义(0.034);研究组需要宫颈扩张的女性比例显著低于对照组[28.3%(342/1209)对34.6%(140/405),0.020]。(2)对于平均宫颈宽度≤4的患者,研究组的宫颈扩张时间显著短于对照组[(34±25)对(52±49)秒,0.028]。(3)两组疼痛评分差异无统计学意义(0.05)。(4)术后24、48、72小时两组不良反应发生率差异无统计学意义(0.05)。(5)两组术者及患者满意度、宫腔镜检查时间、并发症发生率差异均无统计学意义(均为0.05)。宫腔镜检查前经阴道应用甲氨前列素栓是一种有效且安全的宫颈成熟方法。

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