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Article(id=1322211178495980304, tenantId=1146029695717560320, journalId=1319373162502258839, issueId=1322210968248107603, articleNumber=null, orderNo=null, doi=10.16016/j.2097-0927.202412141, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1735401600000, receivedDateStr=2024-12-29, revisedDate=1742918400000, revisedDateStr=2025-03-26, acceptedDate=null, acceptedDateStr=null, onlineDate=1793169310448, onlineDateStr=2026-10-28, pubDate=1747238400000, pubDateStr=2025-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793169310448, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793169310448, creator=13701087609, updateTime=1793169310448, updator=13701087609, issue=Issue{id=1322210968248107603, tenantId=1146029695717560320, journalId=1319373162502258839, year='2025', volume='47', issue='9', pageStart='893', pageEnd='1028', issueExtLink='null', onlineDate='null', pubDate='1747238400000', pubDateStr='2025-05-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793169260321, creator='13701087609', updateTime=1793325292291, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322865413818536367, tenantId=1146029695717560320, journalId=1319373162502258839, issueId=1322210968248107603, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322865413818536368, tenantId=1146029695717560320, journalId=1319373162502258839, issueId=1322210968248107603, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=989, endPage=994, ext={EN=ArticleExt(id=1322211178965742353, articleId=1322211178495980304, tenantId=1146029695717560320, journalId=1319373162502258839, language=EN, title=Clinical efficacy of curettage in treating cesarean scar pregnancy: a randomized controlled trial, columnId=1320435174995772212, journalTitle=Journal of Army Medical University, columnName=Clinical Medicine, runingTitle=null, highlight=null, articleAbstract=
Objective‍

To compare the safety and efficacy of curettage and their combination with uterine artery embolization (UAE) in the treatment of cesarean scar pregnancy (CSP) patients with a low score (≤4) in the ultrasound quantification scoring system.

Methods‍

Based on our inclusion and exclusion criteria of this randomized controlled study, the women with CSP who had an ultrasonic quantitative score ≤4 and were treated in our department from May 2020 to August 2023 were enrolled, and then randomly divided into a curettage group (n=48) and a UAE combination group (n=47) in a ratio of 1∶1. General information, intraoperative conditions, and use of rescue measures within 3 months after operation were collected in the 2 groups of patients. All the patients were followed up until October 2024 to observe the pregnancy outcomes and determine the impact on the menstrual volume after the resumption of normal menstruation.

Results‍

The patients from the both groups completed the follow-up. Except for the maximum gestational sac diameter, there were no significant differences in other baseline data between the 2 groups, and the curettage group had notably more patients having a gestational sac diameter ≤25 mm than the combination group [37 (77.1%) vs 27 (57.4%), P<0.05]. No statistical differences were observed between the 2 groups in the intraoperative bleeding volume and use of rescue measures within 3 months after surgery. The combination group had obviously more patients with reduced menstrual volume after the resumption of normal menstruation than the dilation and curettage group [30 (63.8%) vs 13 (27.1%), P<0.001]. There were no statistically differences in pregnancy outcomes and the number of days to resume menstruation between the 2 groups.

Conclusion‍

For CSP patients with a score of ≤4 in the ultrasound quantification scoring system, curettage show no significant difference in therapeutic effectiveness, and even have better efficacy and safety when compared with curettage combined with UAE.

, authors=Ying YANG, Lu ZHOU, Li LUO, Xi XIONG, Zhengqiong CHEN, authorsList=Ying YANG, Lu ZHOU, Li LUO, Xi XIONG, Zhengqiong CHEN, authorCompany=null, correspAuthors=Zhengqiong CHEN, authorNote=null, correspAuthorsNote=null, copyrightStatement=© 2025 Journal of Army Medical University, copyrightOwner=Editorial Office of Journal of Army Medical University, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322211179758465811, articleId=1322211178495980304, tenantId=1146029695717560320, journalId=1319373162502258839, language=CN, title=清宫术治疗剖宫产瘢痕妊娠的临床疗效：一项随机对照试验, columnId=1322185541475488183, journalTitle=陆军军医大学学报, columnName=临床医学, runingTitle=null, highlight=null, articleAbstract=
目的

对比清宫术与联合子宫动脉栓塞术（uterine artery embolization，UAE）治疗超声量化评分系统下低评分（≤4分）剖宫产瘢痕妊娠（cesarean scar pregnancy，CSP）患者的安全性和有效性。

方法

根据本随机对照研究设计的纳排标准，选取2020年5月至2023年8月在陆军军医大学第二附属医院妇产科门诊经超声量化评分≤4分的CSP患者，按照1∶1比例采用随机数字表法将参与者分为2组，分别为清宫组（n=48）和UAE联合清宫组（UAE+清宫组，n=47）。收集2组患者的一般情况、术中情况、术后3个月内补救措施的使用情况、随访患者的妊娠结局及对患者恢复正常月经后经量的变化产生的影响，随访日期截止至2024年10月。

结果

清宫组与UAE+清宫组患者均完成随访，一般情况中除妊娠囊最大径线之外的基线数据对比无统计学差异，清宫组比UAE+清宫组有更多的妊娠囊最大径线≤25 mm患者［37（77.1%） vs 27（57.4%），P<0.05］。2组患者的清宫术中出血量、术后补救措施的使用情况差异无统计学意义。UAE+清宫组比清宫组有更多的恢复正常月经后经量减少患者［30（63.8%） vs 13（27.1%），P<0.001］。2组的妊娠结局及恢复月经的天数差异无统计学意义。

结论

对比清宫术联合UAE治疗超声量化评分系统≤4分的CSP患者，清宫术的治疗效果无明显差异，其有效性和安全性均较高。

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陈正琼，E-mail：
CHEN Zhengqiong，E-mail：
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Value of ultrasound-guided uterine dilatation and curettage in the treatment of cesarean scar pregnancy［J］. Prog Obstet Gynecol，2022，31（4）：260-264., articleTitle=Value of ultrasound-guided uterine dilatation and curettage in the treatment of cesarean scar pregnancy, refAbstract=null), Reference(id=1322211188105130832, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, doi=10.3389/fendo.2021.651273, pmid=null, pmcid=null, year=2021, volume=12, issue=null, pageStart=651273, pageEnd=null, url=null, language=null, rfNumber=14, rfOrder=15, authorNames=TANG Y H, ZHANG Y, TANG H Q, journalName=Front Endocrinol （Lausanne）, refType=null, unstructuredReference=TANG Y H，ZHANG Y，TANG H Q，et al. A comparison of ultrasound guided curettage with and without uterine artery embolization on controlling intraoperative blood loss for a cesarean scar pregnancy treatment：study protocol for a randomized clinical trial［J］. 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Turk J Med Sci，2024，54（6）：1244-1251., articleTitle=Evaluation of single-layer versus double-layer suturing of low transverse uterine incisions in cesarean section and follow-up of scars by ultrasound：a prospective randomized controlled study, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1322211181230666516, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, xref=1, ext=[AuthorCompanyExt(id=1322211181394244373, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, companyId=1322211181230666516, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1Department of Obstetrics and Gynecology，Second Affiliated Hospital，Army Medical University （Third Military Medical University），Chongqing，China), AuthorCompanyExt(id=1322211181427798806, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, companyId=1322211181230666516, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1陆军军医大学（第三军医大学）第二附属医院妇产科，重庆)])], figs=[ArticleFig(id=1322211185705988924, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标清宫组（n=48）UAE+清宫组（n=47）Z/χ 2P
年龄/年34.0（31.0，38.0）33.0（29.0，36.0）-0.6350.528
体质量/kg55.0（49.4，61.5）57.5（50.5，63.0）-0.6960.486
孕次4.5（3.0，5.0）5.0（4.0，6.0）-1.6290.104
产次1.0（1.0，2.0）2.0（1.0，2.0）-1.1410.274
流产次数2.0（1.0，3.0）2.0（2.0，3.0）-1.4030.162
术前血β-HCG值 /（mIU/mL）26 960.9（14 969.0，52 699.1）34 804.1（12 919.2，81 500.1）-0.5730.570
妊娠囊位置0.2910.865
宫腔型11（22.9）13（27.6）
部分型35（72.9）32（68.1）
完全型2（4.2）2（4.3）
血流信号分级-0.1240.902
Ⅰ12（25.0）9（19.2）
Ⅱ28（58.3）34（72.3）
Ⅲ8（16.7）4（8.5）
剖宫产次数-0.2950.425
127（56.3）22（46.8）
219（39.6）23（48.9）
32（4.2）2（4.3）
胎心有无0.2950.587
有10（20.8）12（25.5）
无38（79.2）35（74.5）
妊娠囊最大径线/mm4.1650.041
≤2537（77.1）27（57.4）
>2511（22.9）20（42.6）
), ArticleFig(id=1322211186016367421, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, language=CN, label=表1, caption=

清宫组与UAE+清宫组基线数据比较［M（P25，P75），例（%）］

, figureFileSmall=null, figureFileBig=null, tableContent=
指标清宫组（n=48）UAE+清宫组（n=47）Z/χ 2P
年龄/年34.0（31.0，38.0）33.0（29.0，36.0）-0.6350.528
体质量/kg55.0（49.4，61.5）57.5（50.5，63.0）-0.6960.486
孕次4.5（3.0，5.0）5.0（4.0，6.0）-1.6290.104
产次1.0（1.0，2.0）2.0（1.0，2.0）-1.1410.274
流产次数2.0（1.0，3.0）2.0（2.0，3.0）-1.4030.162
术前血β-HCG值 /（mIU/mL）26 960.9（14 969.0，52 699.1）34 804.1（12 919.2，81 500.1）-0.5730.570
妊娠囊位置0.2910.865
宫腔型11（22.9）13（27.6）
部分型35（72.9）32（68.1）
完全型2（4.2）2（4.3）
血流信号分级-0.1240.902
Ⅰ12（25.0）9（19.2）
Ⅱ28（58.3）34（72.3）
Ⅲ8（16.7）4（8.5）
剖宫产次数-0.2950.425
127（56.3）22（46.8）
219（39.6）23（48.9）
32（4.2）2（4.3）
胎心有无0.2950.587
有10（20.8）12（25.5）
无38（79.2）35（74.5）
妊娠囊最大径线/mm4.1650.041
≤2537（77.1）27（57.4）
>2511（22.9）20（42.6）
), ArticleFig(id=1322211186117030718, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标清宫组（n=48）UAE+清宫组（n=47）Z/χ 2P
住院时间/d4.0（3.0，5.0）4.00（3.0，4.0）-0.5890.559
术后血β-HCG值恢复正常的时间/d22.0（14.0，41.0）25.00（14.0，45.0）-0.8890.377
清宫术中出血量/mL-0.8280.408
<5042（87.4）38（80.9）
50~1003（6.3）6（12.8）
>1003（6.3）3（6.4）
采用补救措施
重复清宫术2（4.2）1（2.1）-1.000
UAE1（2.1）0-1.000
妊娠病灶切除术1（2.1）0-1.000
恢复月经的天数/d30（30，40）30（30，45）-0.0740.943
术后妊娠
正常妊娠7（14.6）9（19.1）0.3530.552
重复CSP4（8.3）0-0.117
输卵管妊娠01（2.1）-0.495
恢复正常月经后经量减少的例数/例13（27.1）30（63.8）12.943<0.001
), ArticleFig(id=1322211186200916799, tenantId=1146029695717560320, journalId=1319373162502258839, articleId=1322211178495980304, language=CN, label=表2, caption=

清宫组与UAE+清宫组临床观察指标比较［M（P25，P75），例（%）］

, figureFileSmall=null, figureFileBig=null, tableContent=
指标清宫组（n=48）UAE+清宫组（n=47）Z/χ 2P
住院时间/d4.0（3.0，5.0）4.00（3.0，4.0）-0.5890.559
术后血β-HCG值恢复正常的时间/d22.0（14.0，41.0）25.00（14.0，45.0）-0.8890.377
清宫术中出血量/mL-0.8280.408
<5042（87.4）38（80.9）
50~1003（6.3）6（12.8）
>1003（6.3）3（6.4）
采用补救措施
重复清宫术2（4.2）1（2.1）-1.000
UAE1（2.1）0-1.000
妊娠病灶切除术1（2.1）0-1.000
恢复月经的天数/d30（30，40）30（30，45）-0.0740.943
术后妊娠
正常妊娠7（14.6）9（19.1）0.3530.552
重复CSP4（8.3）0-0.117
输卵管妊娠01（2.1）-0.495
恢复正常月经后经量减少的例数/例13（27.1）30（63.8）12.943<0.001
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清宫术治疗剖宫产瘢痕妊娠的临床疗效：一项随机对照试验
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杨颖 , 周潞 , 罗莉 , 熊希 , 陈正琼
陆军军医大学学报 | 临床医学 2025,47(9): 989-994
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陆军军医大学学报 |临床医学 2025 , 47 (9) : 989 -994
清宫术治疗剖宫产瘢痕妊娠的临床疗效：一项随机对照试验
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杨颖, 周潞, 罗莉, 熊希, 陈正琼
作者信息
  • 1陆军军医大学（第三军医大学）第二附属医院妇产科，重庆
通讯作者:
陈正琼，E-mail：
CHEN Zhengqiong，E-mail：
Clinical efficacy of curettage in treating cesarean scar pregnancy: a randomized controlled trial
Ying YANG, Lu ZHOU, Li LUO, Xi XIONG, Zhengqiong CHEN
Affiliations
  • 1Department of Obstetrics and Gynecology，Second Affiliated Hospital，Army Medical University （Third Military Medical University），Chongqing，China
出版时间: 2025-05-15 doi: 10.16016/j.2097-0927.202412141
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摘要
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目的

对比清宫术与联合子宫动脉栓塞术（uterine artery embolization，UAE）治疗超声量化评分系统下低评分（≤4分）剖宫产瘢痕妊娠（cesarean scar pregnancy，CSP）患者的安全性和有效性。

方法

根据本随机对照研究设计的纳排标准，选取2020年5月至2023年8月在陆军军医大学第二附属医院妇产科门诊经超声量化评分≤4分的CSP患者，按照1∶1比例采用随机数字表法将参与者分为2组，分别为清宫组（n=48）和UAE联合清宫组（UAE+清宫组，n=47）。收集2组患者的一般情况、术中情况、术后3个月内补救措施的使用情况、随访患者的妊娠结局及对患者恢复正常月经后经量的变化产生的影响，随访日期截止至2024年10月。

结果

清宫组与UAE+清宫组患者均完成随访，一般情况中除妊娠囊最大径线之外的基线数据对比无统计学差异，清宫组比UAE+清宫组有更多的妊娠囊最大径线≤25 mm患者［37（77.1%） vs 27（57.4%），P<0.05］。2组患者的清宫术中出血量、术后补救措施的使用情况差异无统计学意义。UAE+清宫组比清宫组有更多的恢复正常月经后经量减少患者［30（63.8%） vs 13（27.1%），P<0.001］。2组的妊娠结局及恢复月经的天数差异无统计学意义。

结论

对比清宫术联合UAE治疗超声量化评分系统≤4分的CSP患者，清宫术的治疗效果无明显差异，其有效性和安全性均较高。

剖宫产瘢痕妊娠  /  清宫术  /  联合子宫动脉栓塞术  /  超声量化评分系统
Objective‍

To compare the safety and efficacy of curettage and their combination with uterine artery embolization (UAE) in the treatment of cesarean scar pregnancy (CSP) patients with a low score (≤4) in the ultrasound quantification scoring system.

Methods‍

Based on our inclusion and exclusion criteria of this randomized controlled study, the women with CSP who had an ultrasonic quantitative score ≤4 and were treated in our department from May 2020 to August 2023 were enrolled, and then randomly divided into a curettage group (n=48) and a UAE combination group (n=47) in a ratio of 1∶1. General information, intraoperative conditions, and use of rescue measures within 3 months after operation were collected in the 2 groups of patients. All the patients were followed up until October 2024 to observe the pregnancy outcomes and determine the impact on the menstrual volume after the resumption of normal menstruation.

Results‍

The patients from the both groups completed the follow-up. Except for the maximum gestational sac diameter, there were no significant differences in other baseline data between the 2 groups, and the curettage group had notably more patients having a gestational sac diameter ≤25 mm than the combination group [37 (77.1%) vs 27 (57.4%), P<0.05]. No statistical differences were observed between the 2 groups in the intraoperative bleeding volume and use of rescue measures within 3 months after surgery. The combination group had obviously more patients with reduced menstrual volume after the resumption of normal menstruation than the dilation and curettage group [30 (63.8%) vs 13 (27.1%), P<0.001]. There were no statistically differences in pregnancy outcomes and the number of days to resume menstruation between the 2 groups.

Conclusion‍

For CSP patients with a score of ≤4 in the ultrasound quantification scoring system, curettage show no significant difference in therapeutic effectiveness, and even have better efficacy and safety when compared with curettage combined with UAE.

caesarean scar pregnancy  /  curettage  /  uterine artery embolization  /  ultrasound quantitative scoring system
杨颖, 周潞, 罗莉, 熊希, 陈正琼. 清宫术治疗剖宫产瘢痕妊娠的临床疗效：一项随机对照试验. 陆军军医大学学报, 2025 , 47 (9) : 989 -994 . DOI: 10.16016/j.2097-0927.202412141
Ying YANG, Lu ZHOU, Li LUO, Xi XIONG, Zhengqiong CHEN. Clinical efficacy of curettage in treating cesarean scar pregnancy: a randomized controlled trial[J]. Journal of Army Medical University, 2025 , 47 (9) : 989 -994 . DOI: 10.16016/j.2097-0927.202412141
正文
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剖宫产瘢痕妊娠（cesarean scar pregnancy，CSP）是受精卵着床于前次剖宫产子宫切口瘢痕处的一种特殊类型的异位妊娠［1］。近年来，由于国内剖宫产率的居高不下、恰逢生育政策的开放，CSP的发病率在持续升高［2-3］。由于孕囊植入剖宫产瘢痕部位的裂隙，继续妊娠多发生胎盘植入性疾病和前置胎盘，妊娠期可能随时出现阴道出血、甚至子宫破裂等严重并发症，术中手术难度大，子宫切除率高，严重产后出血甚至危及孕产妇生命安全［4］。
目前CSP的治疗方式繁多［5-6］，但如何根据患者的病情轻重，选择尽可能无创、经济的方法，尚值得进一步探索。本中心在前期研究中建立了超声量化评分系统［7］，用于评估CSP病情的严重程度及根据不同严重程度选择不同的治疗方式。该系统前期根据回顾性及前瞻性研究初步验证了分层治疗的可行性［8-9］，但尚需随机对照研究（randomized controlled trial，RCT）对该系统进一步验证以便于临床应用及推广。本研究通过RCT比较清宫术与联合子宫动脉栓塞术（uterine artery embolization，UAE）治疗低评分（≤4分）CSP患者的有效性和安全性，以期实现分层治疗。
1　资料与方法
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1.1　研究对象
本研究为单中心的随机对照临床研究，2020年5月至2023年8月在陆军军医大学第二附属医院妇产科门诊诊断为CSP且超声量化评分系统评分≤4分的患者为研究对象。按照1∶1比例采用随机数字表法将参与者分为2组。2组均先采用米非司酮口服预处理治疗2 d，随后1组仅接受清宫术治疗（即清宫组，n=48）；另1组先接受UAE，继以清宫术治疗（即UAE+清宫组，n=47）。所有患者充分知情同意。该试验获得了陆军军医大学第二附属医院伦理委员会审批同意（2020-研第008-01）。同时，本研究已在中国临床试验注册中心注册（ChiCTR2000028739）。
1.1.1　纳入标准
①既往有1次及以上剖宫产史；②所有患者通过超声检查诊断为CSP；③使用本研究中心超声量化评估表评估分数≤4分；④患者及家属同意终止妊娠且知情同意治疗方案。
1.1.2　排除标准
①难免流产或不全流产；②严重的心、肝、肾、肺等脏器疾病不能耐受口服药物或手术者；③对栓塞剂或造影剂过敏；④已在院外进行过其他方案的治疗，再转诊来我院者。
1.2　方法
1.2.1　CSP诊断及评估标准
CSP超声诊断采用的超声诊断仪器为GE VOLUSON E8和Philips IU22 ，腔内超声探头频率为4.0~9.0 MHz，腹部超声探头频率为3.5 MHz；操作由固定的3名工龄>10年的高年资超声医生完成。采用经阴道超声联合腹部超声进行诊断CSP［4］。超声诊断标准如下：①宫腔或宫颈管内无妊娠囊；②膀胱壁和妊娠囊之间正常子宫肌层缺失；③妊娠囊位于子宫峡部前壁，超声下可见原始心管搏动或仅见混合包块。CSP的严重程度评估标准采用本研究中心前期建立并公开发表的超声量化评分系统［7］。
1.2.2　样本量估算
该研究为非劣效性研究两独立样本频率比较，以主要终点低评分CSP患者的治疗有效率作为计算样本量的依据，本中心的前瞻性研究中使用超声量化评估系统预测UAE+清宫组成功治疗的有效率约83.6%，清宫组成功治疗的有效率约95.1%［7］。双尾检验显著性水平为0.05，统计功效为0.90，假设随机对照试验可接受的2种处置方式有效率差为10%，加上10%的脱落率，使用G-Power3.1.9.7进行样本量估算，每组样本量为47例，至少需要94例。
1.2.3　随机化设计
本试验随机方案隐蔽，专家和试验负责人未参与筛选和纳入受试者，治疗前由经治医生揭盲。
1.2.4　试验设计
2组患者术前口服米非司酮75 mg/d，连续2 d（期间如果出现出血量大于月经量，及时予原方案中下一步治疗）。清宫组患者在第3天阴道放置卡前列甲酯栓1 mg，1~2 h内由具有丰富临床经验的手术医生行超声引导下清宫术，若术毕仍有活动性阴道出血，则行宫腔水囊压迫止血；若持续出血超过500 mL妊娠物清除困难，则急诊行UAE。UAE+清宫组患者在第3天由具有丰富介入经验的医生行UAE，予明胶海绵栓塞双侧子宫动脉，于栓塞后24 h内行超声引导下清宫术。2组患者均在清宫术后3 d内复查血β-人绒毛膜促性腺激素（beta human chorionic gonadotropin，β-HCG）、阴道超声、血常规；如无发热等特殊情况，术后3~5 d出院；术后1~2周随访1次直至患者超声检查提示子宫恢复正常、血β-HCG值恢复正常。随访过程中，若残留包块持续增大或出现大量出血，根据情况行再次子宫动脉栓塞术、腹腔镜下病灶切除术或者子宫切除术。
1.2.5　观察指标
采集患者的一般情况并进行详细记录，包括年龄、体质量、剖宫产次数、孕次、产次、流产次数、术前血β-HCG值等；记录超声影像学资料包括妊娠囊最大径线、妊娠囊位置、血流信号分级、胎心有无等，主要用于术前CSP患者严重程度评估（评分）及术后测量残留包块大小。记录患者住院期间的住院时间、清宫术中出血量及采取补救措施情况。所有患者术后3个月内1~2周随访1次，关注阴道出血、发热、腹痛等情况；检查血β-HCG值和阴道超声；记录患者术后血β-HCG值恢复正常的时间、恢复月经的天数及恢复正常月经后经量减少的例数等。之后每6~12个月电话随访1次，记录患者术后妊娠情况，随访日期截止至2024年10月。
疗效主要包括治愈：清宫术治疗时，不需要使用其他紧急止血方案进行补救，术后病灶局部未形成包块或包块完全消退时间<1个月；显效：清宫术治疗时，未使用其余止血措施补救，术后病灶局部形成混合性包块，包块于1~3个月内消退；失败：清宫术中因出血量多，需要使用UAE、妊娠病灶切除术或子宫切除术进行补救者，术后包块1~3个月无法消退，需要行妊娠病灶切除术切除或者子宫切除术等补救治疗。治疗有效率=（治愈例数+显效例数）/总例数×100%。本次研究的主要终点为低评分CSP患者的治疗有效率，次要终点为住院时间、清宫术中出血量、恢复正常月经的时间、术后血β-HCG值恢复正常的时间及恢复正常月经后经量减少的例数。
1.2.6　安全性指标
随访过程中包块未自行消退可采用重复清宫术作为补救治疗措施；当出现清宫术中出血超过500 mL或妊娠物清除困难，可根据实际情况采用UAE、妊娠病灶切除术或子宫切除术等补救。监测术中情况，出现严重过敏反应、低血压、心率降低予药物治疗无法纠正，则立即终止原手术方案。清宫术中出血>500 mL发生的频数；需急诊行补救止血措施的频数；如果以上不良事件发生率超过30%，则需提前终止本试验。
1.3　统计学分析
统计分析均采用SPSS 26.0进行。对于符合正态分布的计量资料，采用x¯±s表示，两组间比较采用独立样本t检验；对于不符合正态分布的计量资料，采用M（P25，P75）表示，两组间比较采用使用Mann-Whitney U检验。计数资料以例（%）表示，两组间比较采用χ2检验或Fisher精确检验。有序多分类变量采用Mann-Whitney U检验。P<0.05为差异具有统计学意义。
2　结果
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2.1　一般指标
研究共纳入95名患者，所有患者顺利完成手术并积极配合随访。清宫组与UAE+清宫组的年龄、孕次、产次、流产次数、剖宫产次数、术前血β-HCG值等基线数据的差异无统计学意义，但清宫组与UAE+清宫组妊娠囊最大径线的差异有统计学意义（P<0.05，表1）。
2.2　临床结局指标
总共纳入的95例患者均先接受了2 d共150 mg的米非司酮口服预处理后，其中48例患者仅接受清宫治疗，治疗有效率为95.8%（46/48）；47例患者接受UAE+清宫术治疗，治疗有效率为100%（47/47），2组患者治疗结果差异无统计学意义。清宫组与UAE+清宫组在住院时间、清宫术中出血量、恢复正常月经的天数，术后血β-HCG值恢复正常的时间之间的差异无统计学意义。清宫组术中出血量<50 mL的患者占87.4%（42/48），术中出血量50~100 mL的患者占6.3%（3/48），术中出血量>100 mL的患者占6.3%（3/48）。UAE+清宫组清宫术中出血量<50 mL的患者占80.9%（38/47），清宫术中出血量50~100 mL的患者占12.8%（6/47），清宫术中出血量>100 mL的患者占6.4%（3/47）。清宫组48名患者中有4名患者需要行补救措施，2名患者行重复清宫术，1名患者行UAE，1名患者行腹腔镜切除妊娠病灶。UAE+清宫组47名患者中1名患者行重复清宫术作为补救措施。
2组患者的随后妊娠情况，清宫组患者中正常妊娠的患者占14.6%（7/48），重复CSP的患者占8.3%（4/48），输卵管妊娠的患者占0。UAE+清宫组患者中正常妊娠患者占19.1%（9/47），重复CSP患者占0，输卵管妊娠患者占2.1%（1/47）。清宫组中恢复正常月经后经量减少的患者占27.1%（13/48），UAE+清宫组患者中恢复正常月经后经量减少的患者占63.8%（30/47），2组数据的比较提示差异有统计学意义（P<0.001，表2）。本研究中未出现清宫术中大出血（出血量>500 mL）、子宫穿孔等并发症。
3　讨论
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3.1　CSP治疗方式选择的多样性
CSP是一种低发病率但高危害的异位妊娠。临床强调早诊断、早终止、早清除原则［10］。现有治疗手段繁多，主要分为手术、药物及辅助治疗［4］，但需权衡疗效、创伤及成本。手术治疗主要包含直接清宫术、妊娠病灶切除术及子宫切除术。直接清宫术操作简便，但大出血、子宫穿孔的风险高；妊娠病灶切除术成功率高、并发症少，但创伤大、费用高；子宫切除术仅适用于病情危重或无生育要求的患者。药物治疗周期长且病灶残留率增加，可能继发感染或大出血。UAE作为一种辅助治疗手段，通常联合清宫术、甲氨蝶呤或宫腔镜等治疗CSP。UAE联合治疗可显著提高成功率降低出血量，但费用增加且存在栓塞相关的并发症。CSP的严重程度与瘢痕缺陷程度、孕囊植入位置的深浅密切相关，当前缺乏统一分层标准，临床治疗多依赖医生经验及医疗资源可及性，若能根据患者的严重程度选择不同的治疗手段才应是最理想的方法。
3.2　清宫术用于治疗CSP的争议
对CSP进行量化评分，筛选出那些病情较轻的患者，仅以清宫术治疗，将极大减少创伤，节约医疗资源。清宫术治疗CSP具有操作简单、恢复快、损伤小、经济成本低、对未来生育影响小等优点。然而，因清宫术中刮匙无法完全去除子宫内膜腔外（剖宫产瘢痕处）的滋养组织；且子宫下段瘢痕部位肌层薄弱或缺失，收缩力差；直接清宫还可能会切断深度侵入的血管，可能出现大出血和子宫穿孔等严重并发症，使患者面临持续出血的风险，因此不可盲目使用清宫术治疗CSP患者［4，11］。有文献指出，清宫术治疗CSP患者的并发症发生率高，不建议仅使用清宫术治疗CSP患者［11］。也有文献指出，清宫术比药物或期待治疗具有更高的有效率和更低的并发症发生率［12］。因缺乏统一的术前量化评估标准，不同文献报告清宫术治疗CSP结局差异较大。有研究指出子宫瘢痕厚度、血β-HCG值、孕囊大小等因素可作为清宫术治疗CSP患者的危险因素重点评估［13］。也有研究中心通过回顾性研究建立预估清宫术中出血量的评分系统，对清宫术的安全性进行评估［14］，但未做前瞻性对照研究进一步验证该系统。
3.3　超声量化评分系统的建立和识别仅需清宫术治疗的CSP
本课题组的前期研究［7］发现孕囊最大直径、胎心有无、瘢痕处剩余肌层厚度、孕囊植入类型及血流分级等5个因素与CSP治疗预后独立相关。在回顾性研究中建立了较为科学的CSP量化评分系统［7］，探索了分层治疗的可行性［15］。随后进行了前瞻性验证［9］，研究显示，评分≤4分者，仅需清宫治疗即可得以治愈。本随机对照临床研究中，清宫组与UAE+清宫组治疗成功率的差异无统计学意义。这一阴性结果进一步证实了，评分≤4分的低风险患者仅行清宫术治疗可达到治疗目的。这与CHEN等［16］的研究发现清宫术可有效治疗低风险内源性CSP患者结论一致。这从疾病的角度是可以理解的：当瘢痕缺陷不深、胚胎着床浅、孕龄小、血供不丰富、剩余肌层厚者，虽然达到了CSP的诊断，但临床过程更类似于普通早孕，可以通过清宫术彻底清除。
3.4　UAE辅助清宫术治疗CSP的优劣势
UAE可阻断子宫血供、减少术中出血、降低滋养细胞活性，常与其他手段联合治疗CSP［17］。UAE+清宫术治疗CSP患者可降低术中大出血的风险，可显著增加成功率并降低并发症发生率［18］。但其费用偏高，且可能出现下肢麻木、子宫内膜损害、月经量减少、卵巢功能损害、生育能力下降等并发症。近期有研究提出UAE联合清宫术治疗CSP不会影响40岁以下患者的生育能力，对患者卵巢功能破坏的影响较小，但部分患者的月经量可能会减少［6，19］。本研究中UAE+清宫组比清宫组有更多的恢复正常月经后经量减少患者。月经量减少的可能原因：①UAE手术中可能栓及子宫动脉卵巢支，或栓塞剂通过交通支进入卵巢动脉，造成卵巢缺血，影响卵巢功能；②UAE影响子宫血供，可能损害子宫浅肌层和内膜基底层，严重时可继发宫腔粘连，造成月经量减少甚至闭经［20］。尽管如此，本研究纳入的95名CSP患者的后续生殖结局（包括正常妊娠、复发CSP、输卵管妊娠），差异无统计学意义。UAE对生殖结局的远期影响到底如何，尚需进一步更长时间、更大样本量的观察。
本研究仍有一些设计不足的地方：①本研究是单中心临床研究，样本量不够大；②本研究只比较了清宫术和UAE+清宫术治疗CSP患者，对其余的治疗方式的成功率及效果未给予评价；③随访时间不足，对远期生育结局的影响尚不能得出结论；④本次研究的纳入标准中未明确规定孕周，考虑随着妊娠的进展，妊娠囊的大小将发生显著变化，清宫组与UAE+清宫组妊娠囊最大径线的差异有统计学意义（P<0.05），影响了本次随机对照临床研究的质量，后续的临床研究中可参照2016年专家共识对入组CSP患者的孕周进行明确的规定［10］。未来尚需设计多中心、大样本、长期随访的RCT才能得出更明确的结论，进一步验证结果。
本研究进一步验证了剖宫产瘢痕妊娠超声量化评分系统评分≤4分的CSP患者可采用清宫术治疗，有效率和安全性均较高。

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2025年第47卷第9期
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doi: 10.16016/j.2097-0927.202412141
  • 接收时间：2024-12-29
  • 首发时间：2026-10-28
  • 出版时间：2025-05-15
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  • 收稿日期：2024-12-29
  • 修回日期：2025-03-26
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    1陆军军医大学（第三军医大学）第二附属医院妇产科，重庆

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