卡前列甲酯用于宫腔镜检查子宫颈预处理的多中心临床研究

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

目的 探讨卡前列甲酯（卡孕栓）用于宫腔镜检查子宫颈软化的临床效果.方法 选取2014年7月—2015年7月全国12家临床医学机构在门诊行宫腔镜检查的1614例患者进行随机、双盲、安慰剂对照研究.按照随机编码表将患者随机分入卡孕栓组（1233例）和安慰剂组（411例）.于宫腔镜检查前1.0～1.5 h,将卡孕栓或安慰剂1枚放入患者阴道上1/3处,观察两组子宫颈软化程度、扩宫及宫腔镜检查时间、疼痛程度、药物不良反应、并发症以及术者和患者的满意度情况.结果 （1）卡孕栓组与安慰剂组患者子宫颈无阻力通过Hegar扩宫棒的号数分别为6.11±1.11、5.95±1.11,两组比较,差异有统计学意义（P=0.034）;需要补充扩宫患者的比例,卡孕栓组低于安慰剂组分别是28.3％（342/1209）、34.6％（140/405）,两组比较,差异有统计学意义（P=0.020）.（2）在无阴道分娩史的患者中,子宫颈无阻力通过Hegar扩宫棒的号数在卡孕栓组与安慰剂组分别为6.07±1.11、5.85±1.16,两组比较,差异有统计学意义（P=0.034）;卡孕栓组与安慰剂组的补充扩宫率分别为29.6％（223/755）、37.6％（87/231）,两组比较,差异有统计学意义（P=0.026）.（3）在原发性不孕症患者中,子宫颈无阻力通过Hegar扩宫棒的号数在卡孕栓组与安慰剂组分别为5.88±1.05、5.36±1.31,两组比较,差异有统计学意义（P=0.013）;卡孕栓组与安慰剂组的补充扩宫率分别为37.6％（62/165）、58.1％（25/43）,两组比较,差异有统计学意义（P=0.015）.（4）两组中子宫颈无阻力通过≤4号Hegar扩宫棒的患者,卡孕栓组的扩宫时间短于安慰剂组[分别为（34±25）、（52±49）s],两组比较,差异有统计学意义（P=0.028）.（5）卡孕栓组与安慰剂组患者扩宫及置入宫腔镜时的疼痛视觉模拟评分（VAS）均无差异（P〉0.05）;对于补充扩宫的患者,宫腔镜置镜时的VAS评分与扩宫时的VAS评分具有较强相关性（r=0.802,P〈0.05）.（6）卡孕栓组与安慰剂组患者宫腔镜检查后24、48及72 h药物不良反应的整体发生率无差异（P〉0.05）.（7）卡孕栓组与安慰剂组术者和患者的满意度、并发症发生率均无差异（P〉0.05）.结论 卡孕栓能够有效软化扩张子宫颈,降低子宫颈坚韧患者宫腔镜检查时的补充扩宫率及宫腔镜置镜难度,尤其是对无阴道分娩史和原发性不孕症患者子宫颈软化效果更为突出,是门诊宫腔镜检查时值得推荐的子宫颈预处理方法.

Objective To evaluate the effectiveness of carboprost methylate suppository for cervical ripening before diagnostic hysteroscopy in premenopausal women. Methods From July 2014 to July 2015, 1614 women who were undergone diagnostic hysteroscopy in 12 hospitals were randomly assigned into study group（n=1209）and control group（n=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. Results （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（P=0.034）;the percentage of women requiring cervical dilatation in study group was lower than the percentage in control group significantly [28.3％（342/1209）versus 34.6％（140/405）, P=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, P=0.028] for the patients whose mean cervical widths≤4.（3）There was no significant difference in pain scores between the two groups（P〉0.05）.（4）The incidence of side reactions 24, 48, 72 hours after operation were no significant difference between the two groups （P〉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 P〉0.05）. Conclusion Application of carboprost methylate suppository by vagina before hysteroscopy is an effective and safe method of cervical ripening.