Article(id=1322927312492179494, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.11.038, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793340050099, onlineDateStr=2026-10-30, pubDate=1762704000000, pubDateStr=2025-11-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793340050099, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793340050099, creator=13701087609, updateTime=1793340050099, updator=13701087609, issue=Issue{id=1322926985957221241, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='11', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1762704000000', pubDateStr='2025-11-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339972247, creator='13701087609', updateTime=1793340743335, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322930220201804556, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322930220201804557, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=191, endPage=194, ext={EN=ArticleExt(id=1322927312685117479, articleId=1322927312492179494, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Clinical Efficacy and Mechanism of Peiyuan Huoxue Shoutai Decoction(培元活血寿胎方)Combined with Enoxaparine in Treatment of Recurrent Spontaneous Abortion Associated with Antiphospholipid Syndrome, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To investigate the clinical efficacy and mechanism of Peiyuan Huoxue Shoutai Decoction(培元活血寿胎方)combined with enoxaparine in the treatment of recurrent spontaneous abortion associated with antiphospholipid syndrome.

Methods

Ninety-six patients with recurrent spontaneous abortion associated with antiphospholipid syndrome admitted to the hospital between January 2021 and June 2023 who fulfilled the inclusion and exclusion criteria were enrolled,and classified into two groups using numerical parity method,each with 48 cases. The control group was given enoxaparin,and the observation group was given Peiyuan Huoxue Shoutai Decoction combined with enoxaparine. Then the clinical efficacy,TCM syndrome scores(vaginal bleeding,soreness and weakness of waist and knees,pale tongue,dizziness and tinnitus,frequent urination at night),coagulation function parameter,negative rate of antiphospholipid antibodies,pregnancy outcomes and adverse reaction rate were compared between two groups.

Results

The observation group reported a higher clinical efficacy rate compared to the control group(91.67% vs 77.08%,P<0.05). The improvement in TCM syndrome scores including vaginal bleeding,soreness and weakness of waist and knees,pale tongue,dizziness and tinnitus,frequent urination at night was more notable in the observation group than that in the control group after treatment(P<0.05). The reduction in D-dimer(D-D)and fibrinogen(FIB)and the increase in prothrombin time(PT)and activated partial thromboplastin time(APTT)were more remarkable in the observation group than those in the control group(P<0.05). The total conversion rate of antiphospholipid antibodies including anticardiolipin antibody,lupus anticoagulant and anti-β2 glycoprotein-I antibody was 91.67% in the observation group,which was higher than that(75.00%)in the control group(P<0.05). Tocolytic success rate was 83.33% in the observation group,which was higher than that(58.33%)in the control group(P<0.05). The total adverse reaction rate during treatment yielded no statistical difference between two groups[4.17%(2/48)vs 10.42%(5/48)](P>0.05).

Conclusion

The application of Peiyuan Huoxue Shoutai Decoction combined with enoxaparine for patients with recurrent spontaneous abortion associated with antiphospholipid syndrome can effectively ameliorate the clinical symptoms,improve the coagulation function,enhance the conversion rate of antiphospholipid antibody and increase the tocolytic success rate,which has a good safety profile and is worthy of recommendation.

, authors=Wenjuan WANG1, 2, Gaijuan LU2, Zeng FAN2, Shanshan LIU2, authorsList=Wenjuan WANG, Gaijuan LU, Zeng FAN, Shanshan LIU, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, 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=1322927313654001710, articleId=1322927312492179494, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产临床疗效及机制探讨, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

探讨培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产临床疗效及机制。

方法

96例抗磷脂综合征复发性流产患者均为2021年1月—2023年6月期间收治的符合纳入与排除标准的病例。根据数字奇偶法分为观察组48例与对照组48例。对照组给予依诺肝素药物治疗,观察组给予培元活血寿胎方联合依诺肝素药物治疗,比较两组治疗后临床疗效;比较两组治疗前后中医证候积分(阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多)、凝血功能;比较两组治疗后抗磷脂抗体转阴率、妊娠结局;比较两组治疗期间不良反应发生情况。

结果

治疗后观察组临床疗效91.67%(44/48),与对照组77.08%(37/48)对比显著提升(P<0.05);治疗后观察组阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多中医证候积分改善幅度均优于对照组(P<0.05);治疗后观察组D-二聚体(D-dimer,D-D)、纤维蛋白原(Fibrinogen,FIB)水平下降幅度优于对照组,凝血酶原时间(Prothrombin time,PT)、部分活化凝血活酶时间(Activated partial thromboplastin time,APTT)水平升高幅度优于对照组(P<0.05);治疗后观察组抗磷脂抗体(抗心磷脂抗体、狼疮抗凝物质、抗β2-糖蛋白I抗体)总转阴率91.67%(44/48),与对照组75.00%(36/48)对比显著提升(P<0.05);治疗后观察组保胎成功率83.33%(40/48),与对照组58.33%(28/48)对比显著提升(P<0.05);治疗期间观察组与对照组不良反应总发生率[4.17%(2/48)vs10.42%(5/48)]对比差异无统计学意义(P>0.05)。

结论

抗磷脂综合征复发性流产患者采取培元活血寿胎方联合依诺肝素治疗整体疗效显著,能有效改善临床症状及凝血功能,提升抗磷脂抗体转阴率及保胎成功率,且安全性较高,值得临床推广应用。

, authors=王文娟1, 2, 鲁改娟2, 范曾2, 刘杉杉2, authorsList=王文娟, 鲁改娟, 范曾, 刘杉杉, authorCompany=null, correspAuthors=null, authorNote=

王文娟(1973-),女,河南洛阳人,主任中医师,学士,研究方向:中医妇科疾病及不孕不育。

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articleId=1322927312492179494, companyId=1322927313985351730, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.北京中医药大学东直门医院洛阳医院,洛阳市中医院,河南 洛阳 471000)])], figs=[ArticleFig(id=1322927315868594260, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数临床控制显效有效无效总有效
观察组4826(54.17)11(22.92)7(14.58)4(8.33)44(91.67)
对照组4814(29.17)13(27.08)10(20.83)11(22.92)37(77.08)
χ2值3.872
P值0.049
), ArticleFig(id=1322927315977646165, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=CN, label=表1, caption=

两组抗磷脂综合征复发性流产患者临床疗效对比

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组别例数临床控制显效有效无效总有效
观察组4826(54.17)11(22.92)7(14.58)4(8.33)44(91.67)
对照组4814(29.17)13(27.08)10(20.83)11(22.92)37(77.08)
χ2值3.872
P值0.049
), ArticleFig(id=1322927316069920854, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间阴道流血量腰膝酸软舌质淡黯头晕耳鸣夜尿频多
观察组48治疗前2.24±0.212.29±0.242.11±0.222.01±0.221.96±0.19
治疗后0.65±0.16*#0.69±0.18*#0.62±0.15*#0.64±0.17*#0.59±0.14*#
对照组48治疗前2.27±0.202.31±0.252.13±0.211.99±0.231.95±0.20
治疗后0.96±0.18*1.02±0.20*0.95±0.19*0.94±0.16*0.88±0.15*
), ArticleFig(id=1322927316178972759, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=CN, label=表2, caption=

两组抗磷脂综合征复发性流产患者治疗前后中医证候积分对比(±s)

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组别例数时间阴道流血量腰膝酸软舌质淡黯头晕耳鸣夜尿频多
观察组48治疗前2.24±0.212.29±0.242.11±0.222.01±0.221.96±0.19
治疗后0.65±0.16*#0.69±0.18*#0.62±0.15*#0.64±0.17*#0.59±0.14*#
对照组48治疗前2.27±0.202.31±0.252.13±0.211.99±0.231.95±0.20
治疗后0.96±0.18*1.02±0.20*0.95±0.19*0.94±0.16*0.88±0.15*
), ArticleFig(id=1322927316258664536, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间D-D/(μg/mL)FIB/(g/L)PT/(s)APTT/(s)
观察组48治疗前0.59±0.214.93±0.529.74±1.1622.69±3.47
治疗后0.17±0.11*#2.32±0.41*#13.82±2.23*#33.71±3.59*#
对照组48治疗前0.61±0.244.89±0.559.81±1.1922.84±3.51
治疗后0.28±0.17*2.98±0.46*11.38±2.46*29.87±3.65*
), ArticleFig(id=1322927316355133529, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=CN, label=表3, caption=

两组抗磷脂综合征复发性流产患者治疗前后凝血功能对比(±s)

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组别例数时间D-D/(μg/mL)FIB/(g/L)PT/(s)APTT/(s)
观察组48治疗前0.59±0.214.93±0.529.74±1.1622.69±3.47
治疗后0.17±0.11*#2.32±0.41*#13.82±2.23*#33.71±3.59*#
对照组48治疗前0.61±0.244.89±0.559.81±1.1922.84±3.51
治疗后0.28±0.17*2.98±0.46*11.38±2.46*29.87±3.65*
), ArticleFig(id=1322927316459991130, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数抗心磷脂抗体狼疮抗凝物质抗β2-糖蛋白I抗体总转阴
观察组4820(41.67)10(20.83)14(29.17)44(91.67)
对照组4815(31.25)11(22.92)10(20.83)36(75.00)
χ2值4.800
P值0.029
), ArticleFig(id=1322927316543877211, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=CN, label=表4, caption=

两组抗磷脂综合征复发性流产患者治疗后抗磷脂抗体转阴率对比

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组别例数抗心磷脂抗体狼疮抗凝物质抗β2-糖蛋白I抗体总转阴
观察组4820(41.67)10(20.83)14(29.17)44(91.67)
对照组4815(31.25)11(22.92)10(20.83)36(75.00)
χ2值4.800
P值0.029
), ArticleFig(id=1322927316619374684, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数流产早产胎儿存活早产胎儿死亡足月产保胎成功
观察组485(10.42)11(22.92)3(6.25)29(60.42)40(83.33)
对照组4815(31.25)12(25.00)5(10.42)16(33.33)28(58.33)
χ2值7.261
P值0.007
), ArticleFig(id=1322927316690677853, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=CN, label=表5, caption=

两组抗磷脂综合征复发性流产患者治疗后妊娠结局对比

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组别例数流产早产胎儿存活早产胎儿死亡足月产保胎成功
观察组485(10.42)11(22.92)3(6.25)29(60.42)40(83.33)
对照组4815(31.25)12(25.00)5(10.42)16(33.33)28(58.33)
χ2值7.261
P值0.007
), ArticleFig(id=1322927316908781662, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927312492179494, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数阴道流血增多过敏肝肾功能异常骨质疏松总发生
观察组481(2.08)0(0.00)1(2.08)0(0.00)2(4.17)
对照组482(4.17)1(2.08)2(4.17)0(0.00)5(10.42)
χ2值1.387
P值0.239
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两组抗磷脂综合征复发性流产患者治疗期间不良反应对比

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组别例数阴道流血增多过敏肝肾功能异常骨质疏松总发生
观察组481(2.08)0(0.00)1(2.08)0(0.00)2(4.17)
对照组482(4.17)1(2.08)2(4.17)0(0.00)5(10.42)
χ2值1.387
P值0.239
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培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产临床疗效及机制探讨
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王文娟 1, 2 , 鲁改娟 2 , 范曾 2 , 刘杉杉 2
中华中医药学刊 | 省级项目平台 2025,43(11): 191-194
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中华中医药学刊 |省级项目平台 2025 , 43 (11) : 191 -194
培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产临床疗效及机制探讨
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王文娟1, 2, 鲁改娟2, 范曾2, 刘杉杉2
作者信息
  • 1.河南中医药大学,河南 郑州 450000
  • 2.北京中医药大学东直门医院洛阳医院,洛阳市中医院,河南 洛阳 471000
作者简介:

王文娟(1973-),女,河南洛阳人,主任中医师,学士,研究方向:中医妇科疾病及不孕不育。

Clinical Efficacy and Mechanism of Peiyuan Huoxue Shoutai Decoction(培元活血寿胎方)Combined with Enoxaparine in Treatment of Recurrent Spontaneous Abortion Associated with Antiphospholipid Syndrome
Wenjuan WANG1, 2, Gaijuan LU2, Zeng FAN2, Shanshan LIU2
Affiliations
  • 1.Henan University of Chinese Medicine,Zhengzhou 450000,Henan,China
  • 2.Luoyang Branch of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Luoyang Hospital of Traditional Chinese Medicine,Luoyang 471000,Henan,China
出版时间: 2025-11-10 doi: 10.13193/j.issn.1673-7717.2025.11.038
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目的

探讨培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产临床疗效及机制。

方法

96例抗磷脂综合征复发性流产患者均为2021年1月—2023年6月期间收治的符合纳入与排除标准的病例。根据数字奇偶法分为观察组48例与对照组48例。对照组给予依诺肝素药物治疗,观察组给予培元活血寿胎方联合依诺肝素药物治疗,比较两组治疗后临床疗效;比较两组治疗前后中医证候积分(阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多)、凝血功能;比较两组治疗后抗磷脂抗体转阴率、妊娠结局;比较两组治疗期间不良反应发生情况。

结果

治疗后观察组临床疗效91.67%(44/48),与对照组77.08%(37/48)对比显著提升(P<0.05);治疗后观察组阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多中医证候积分改善幅度均优于对照组(P<0.05);治疗后观察组D-二聚体(D-dimer,D-D)、纤维蛋白原(Fibrinogen,FIB)水平下降幅度优于对照组,凝血酶原时间(Prothrombin time,PT)、部分活化凝血活酶时间(Activated partial thromboplastin time,APTT)水平升高幅度优于对照组(P<0.05);治疗后观察组抗磷脂抗体(抗心磷脂抗体、狼疮抗凝物质、抗β2-糖蛋白I抗体)总转阴率91.67%(44/48),与对照组75.00%(36/48)对比显著提升(P<0.05);治疗后观察组保胎成功率83.33%(40/48),与对照组58.33%(28/48)对比显著提升(P<0.05);治疗期间观察组与对照组不良反应总发生率[4.17%(2/48)vs10.42%(5/48)]对比差异无统计学意义(P>0.05)。

结论

抗磷脂综合征复发性流产患者采取培元活血寿胎方联合依诺肝素治疗整体疗效显著,能有效改善临床症状及凝血功能,提升抗磷脂抗体转阴率及保胎成功率,且安全性较高,值得临床推广应用。

抗磷脂综合征复发性流产  /  培元活血寿胎方  /  依诺肝素  /  临床疗效  /  机制探讨
Objective

To investigate the clinical efficacy and mechanism of Peiyuan Huoxue Shoutai Decoction(培元活血寿胎方)combined with enoxaparine in the treatment of recurrent spontaneous abortion associated with antiphospholipid syndrome.

Methods

Ninety-six patients with recurrent spontaneous abortion associated with antiphospholipid syndrome admitted to the hospital between January 2021 and June 2023 who fulfilled the inclusion and exclusion criteria were enrolled,and classified into two groups using numerical parity method,each with 48 cases. The control group was given enoxaparin,and the observation group was given Peiyuan Huoxue Shoutai Decoction combined with enoxaparine. Then the clinical efficacy,TCM syndrome scores(vaginal bleeding,soreness and weakness of waist and knees,pale tongue,dizziness and tinnitus,frequent urination at night),coagulation function parameter,negative rate of antiphospholipid antibodies,pregnancy outcomes and adverse reaction rate were compared between two groups.

Results

The observation group reported a higher clinical efficacy rate compared to the control group(91.67% vs 77.08%,P<0.05). The improvement in TCM syndrome scores including vaginal bleeding,soreness and weakness of waist and knees,pale tongue,dizziness and tinnitus,frequent urination at night was more notable in the observation group than that in the control group after treatment(P<0.05). The reduction in D-dimer(D-D)and fibrinogen(FIB)and the increase in prothrombin time(PT)and activated partial thromboplastin time(APTT)were more remarkable in the observation group than those in the control group(P<0.05). The total conversion rate of antiphospholipid antibodies including anticardiolipin antibody,lupus anticoagulant and anti-β2 glycoprotein-I antibody was 91.67% in the observation group,which was higher than that(75.00%)in the control group(P<0.05). Tocolytic success rate was 83.33% in the observation group,which was higher than that(58.33%)in the control group(P<0.05). The total adverse reaction rate during treatment yielded no statistical difference between two groups[4.17%(2/48)vs 10.42%(5/48)](P>0.05).

Conclusion

The application of Peiyuan Huoxue Shoutai Decoction combined with enoxaparine for patients with recurrent spontaneous abortion associated with antiphospholipid syndrome can effectively ameliorate the clinical symptoms,improve the coagulation function,enhance the conversion rate of antiphospholipid antibody and increase the tocolytic success rate,which has a good safety profile and is worthy of recommendation.

recurrent abortion with antiphospholipid syndrome  /  Peiyuan Huoxue Shoutai Decoction(培元活血寿胎方)  /  enoxaparine  /  clinical efficacy  /  mechanism
王文娟, 鲁改娟, 范曾, 刘杉杉. 培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产临床疗效及机制探讨. 中华中医药学刊, 2025 , 43 (11) : 191 -194 . DOI: 10.13193/j.issn.1673-7717.2025.11.038
Wenjuan WANG, Gaijuan LU, Zeng FAN, Shanshan LIU. Clinical Efficacy and Mechanism of Peiyuan Huoxue Shoutai Decoction(培元活血寿胎方)Combined with Enoxaparine in Treatment of Recurrent Spontaneous Abortion Associated with Antiphospholipid Syndrome[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (11) : 191 -194 . DOI: 10.13193/j.issn.1673-7717.2025.11.038
抗磷脂综合征是一种以病理妊娠、血小板减少、动静脉血栓形成为主要临床表现,以持续存在抗磷脂抗体(抗心磷脂抗体、狼疮抗凝物质、抗β2-糖蛋白I抗体)为特征的非炎症性自身免疫性疾病,是导致复发性流产的重要原因之一[1-2]。抗磷脂综合征复发性流产治疗通常以抗凝为主,临床以低分子肝素钠为首选[3]。低分子肝素钠虽能抑制凝血因子活性,控制病情,发挥防止妊娠丢失作用,但易出现肝肾功能受损、阴道流血等不良反应,潜在风险日益增加[4-5]。近年来,中医学在抗磷脂综合征复发性流产治疗中取得了较为理想的效果。中医认为该病属于“数堕胎”“滑胎”“屡孕屡堕”范畴,多为肾虚血瘀、冲任失调所致,故应以补肾化瘀、培元安胎为治疗原则[6]。培元活血寿胎方是我院妇产科在张锡纯《医学衷中参西录》寿胎丸基础上结合多年临床实践而得出的经验方,可培元补肾、益气活血、固冲安胎,适用于“肾气不足,瘀血阻络,胎元不固”滑胎患者的临床治疗[7]。本研究观察了培元活血寿胎方联合依诺肝素对抗磷脂综合征复发性流产的临床疗效,以期为今后此类患者临床治疗提供参考,现报道如下。
本研究96例抗磷脂综合征复发性流产患者均为2021年1月—2023年6月期间我院收治的符合纳入与排除标准的病例。根据数字奇偶法分为48例观察组与48例对照组。观察组年龄24~38岁,平均(32.56±4.53)岁;体质量指数20~27 kg/m2,平均(23.88±0.87)kg/m2;孕次3~8次,平均(5.87±1.15)次;自然流产次数3~7次,平均(5.34±1.01)次;病程3~6年,平均(4.53±1.21)年。对照组年龄24~37岁,平均(32.14±4.49)岁;体质量指数20~27 kg/m2,平均(23.78±0.91)kg/m2;孕次3~8次,平均(5.82±1.11);自然流产次数3~7次,平均(5.41±1.03)次;病程3~7年,平均(4.66±1.27)年。两组一般资料对比差异无统计学意义(P>0.05),具有可比性。本研究通过医院伦理委员会批准。
参照《产科抗磷脂综合征诊断与处理专家共识》[8]《复发性流产诊治的专家共识》[9],抗磷脂抗体指标(抗心磷脂抗体、狼疮抗凝物质、抗β2-糖蛋白I抗体)至少1项指标2次检测为阳性(间隔6周及以上),同时与同一配偶连续发生3次及以上的妊娠丢失(妊娠28周之前)。
参照《中药新药临床研究指导原则》[10]《中医妇科学》[11]中“滑胎”辨证分型为肾虚血瘀型,主症:孕后阴道少量流血、屡孕屡堕、小腹隐痛坠胀、腰膝酸软;次症:精神倦怠、头晕耳鸣、眩晕健忘、夜尿频多、失眠梦多;舌脉:舌质淡黯、舌苔薄白,脉弦滑或沉滑。具备2项主症、2项次症,结合舌脉即可诊断。
(1)符合上述西医、中医相关诊断标准;(2)辨证分型为肾虚血瘀型;(3)年龄18~40岁;(4)在排卵后3周,阴道超声提示宫内妊娠;(5)生命体征平稳,依从性良好;(6)自愿签署知情同意书。
(1)夫妇双方任一方存在家族性遗传病;(2)先天性血栓前状态、子宫结构异常;(4)既往存在宫颈癌、子宫腺肌病、生殖道感染等妇科疾病史;(5)因感染因素、遗传因素等其他原因导致复发性流产;(6)合并血液系统、内分泌系统、免疫系统等疾病;(7)合并精神疾病、意识或视听功能障碍;(8)对本研究使用药物存在禁忌证;(9)入组前3个月内接受过对本研究结果可产生影响的相关治疗;(10)正参加其他研究或中途自愿退出。
对照组:确认妊娠后,给予依诺肝素钠注射液(苏州二叶制药有限公司),皮下注射,每次6000 IU,1次/d。观察组:给予培元活血寿胎方联合依诺肝素钠注射液治疗,依诺肝素治疗方法、计量等与对照组相同;培元活血寿胎方药物组成:续断15 g,菟丝子15 g,桑寄生15 g,阿胶6 g、太子参15 g,黄芪10 g,丹参10 g,白芍12 g,白术10 g,黄芩10 g,炙甘草6 g。由我院中药房配制,1剂/d,水煎为400 mL中药汤剂,分早晚两次等量(200 mL)温服。
两组均治疗至妊娠12周,期间每月复查安全性指标。
参照《中药新药临床研究指导原则》[10]:临床控制:治疗后中医证候积分与治疗前对比降低≥95%,症状及体征完全消失,相关实验室检测数据恢复正常;显效:治疗后中医证候积分降低≥70%,<95%,症状、体征及相关实验室检测数据可见明显改善;有效:治疗后中医证候积分降低≥30%,<70%,症状、体征有所好转或缓解,相关实验室检测数据有所改善;无效,未达到以上标准,甚至病情出现加重趋势。总有效率=(临床控制+显效+有效)例数/总例数×100%。
参照《中药新药临床研究指导原则》[10],根据病情程度评价阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多症状的中医证候积分,重度症状记3分、中度症状记2分、轻度症状记1分、无症状记0分。
记录治疗前后凝血功能指标:D-二聚体(D-dimer,D-D)、纤维蛋白原(Fibrinogen,FIB)、凝血酶原时间(Prothrombin time,PT)、部分活化凝血活酶时间(Activated partial thromboplastin time,APTT)。
治疗前后检测抗心磷脂抗体、狼疮抗凝物质、抗β2-糖蛋白I抗体情况,记录抗体转阴率。
治疗后两组均随访至分娩比较保胎成功率[(早产胎儿存活例数+足月产例数)/总例数×100%]。
比较两组治疗期间不良反应(阴道流血增多、过敏、肝肾功能异常、骨质疏松)发生情况。
双人录入数据,采用SPSS 24.0统计学软件完成数据分析,符合正态分布的计量资料以()描述,行独立样本t检验,计数资料以例(%)描述,行χ2或校正χ2检验,检验水准α=0.05。
治疗后观察组临床疗效91.67%,与对照组77.08%对比显著提升(P<0.05)。见表1。
两组治疗前阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多中医证候积分对比差异无统计学意义(P>0.05);治疗后两组上述中医证候积分均改善,且观察组所有中医证候积分改善幅度均优于对照组(P<0.05)。见表2。
两组治疗前D-D、FIB、PT、APTT水平对比差异无统计学意义(P>0.05);治疗后两组D-D、FIB水平均下降,PT、APTT水平均升高,且观察组D-D、FIB水平下降幅度优于对照组,PT、APTT水平升高幅度优于对照组(P<0.05)。见表3。
治疗后观察组抗磷脂抗体总转阴率91.67%,与对照组75.00%对比显著提升(P<0.05)。见表4。
治疗后观察组保胎成功率83.33%,与对照组58.33%对比显著提升(P<0.05)。见表5。
治疗期间观察组不良反应(阴道出血增多、过敏、肝肾功能异常、骨质疏松)总发生率4.17%,与对照组10.42%对比差异无统计学意义(P>0.05)。见表6。
复发性流产是育龄期女性常见病之一,发生率高达5%,近年来受工作压力、生活环境改变等诸多因素影响,发病率逐年增加,严重影响患者身心健康[12]。目前,复发性流产病因尚未完全阐明,普遍认为与免疫、遗传、感染等因素有关[13]。抗磷脂综合征是一种非炎症性自身免疫性疾病,发病后相关抗磷脂抗体可与滋养层细胞、内皮细胞等靶细胞上的自身抗原结合后促进炎症因子产生,进而引发机体免疫活动及损伤,破坏滋养层细胞、诱发血栓形成,最终导致相关产科不良事件发生,已被证实是诱发复发性流产的主要原因之一[14]。
根据抗磷脂综合征复发性流产临床表现,中医学将其称为“滑胎”“数落胎”[15]。早在《产经》“数落胎”一词就有关于本病的记载;随后《医宗金鉴·妇科心法要诀》中也提及,如“无故而胎自堕……则谓之滑胎”。中医学认为,“母体冲任受损,胎元不固”是滑胎的基本病机,与肾虚、血瘀、血热、气虚等关系密切[16]。《素问·奇病论篇》云:“胞络者,系于肾”,肾藏精,是生殖之根基,是孕育胚胎重要前提。《傅青主女科》曰“脾肾亏损,则带脉无力,胞胎即无以胜任矣”,提示母体脾肾两脏盛衰与胎儿生长发育之间存在重要关联。《灵枢·邪气脏腑病形》言:“有所堕坠,恶血留内”。清代王清任在《医林改错》中述:“常有连伤数胎者……不知子宫内,先有瘀血占其地,……其内无容身之地,……血既不入胞胎,胎无血养,故小产”,阐述瘀血导致滑胎的病机。因此本病发生多为肾虚封藏失司,冲任虚损,瘀滞胞宫胞络,而致胎元不固屡堕,因此治疗应以补肾培元,活血安胎为法[17-18]。
本研究结果显示,治疗后观察组阴道流血量、腰膝酸软、舌质淡黯、头晕耳鸣、夜尿频多中医症状积分明显降低,与对照组对比差异有统计学意义(P<0.05),与既往研究结果相似[19-20]。分析认为,培元活血寿胎方由续断、菟丝子、桑寄生、阿胶、太子参、黄芪、丹参、白芍、白术、黄芩、炙甘草11味中药组成,方中以寿胎丸为核心,续断、菟丝子、桑寄生补肾固冲,太子参、黄芪、白术健脾益气,丹参、白芍、阿胶养血祛瘀,黄芩清热止血,炙甘草调和诸药。全方有效强壮胎元,调节气血,改善患者症状,提高保胎成功率。本研究结果表明,观察组治疗后D-D、FIB水平比对照组低,PT、APTT水平比对照组高,抗磷脂抗体转阴率高于对照组。现代药理研究发现,续断、丹参具有抗凝和调节免疫的作用,桑寄生、白芍、黄芩具有抑制血小板聚集、缓解子宫及血管平滑肌收缩[21-22]的作用,从而能够增强子宫内膜血流及孕囊血供,促进胚胎正常发育[23],故能有效改善子宫高凝状态,提高抗磷脂抗体转阴率,降低不良妊娠发生率。本研究结果还显示,观察组治疗后保胎成功率高于对照组。分析其原因,方中桑寄生中黄酮类化合物与雌激素作用类似,可调节患者机体雌激素活性,促进胚胎顺利生长[24];菟丝子黄酮类化合物能调节复发性流产相关通路,影响人绒毛外滋养细胞、蜕膜基质细胞、早期滋养细胞增殖、分化、迁移等,进而影响胚胎着床,促进胎盘及血管形成[25];表明补肾健脾类中药有类激素样作用,能够补充激素前体物质和遗传物质[26],以维持正常妊娠需求,降低早孕流产风险。另外,本研究发现治疗期间两组不良反应发生率无明显差异,可知此方安全性较高。但本研究仍存在不足,如研究纳入96例患者,样本量较少;本研究选取中医辨证分型为肾虚血瘀型患者,治疗证型单一,培元活血寿胎方治疗其他证型患者临床疗效尚不明确。今后若条件允许,可纳入更多疾病证型,扩大样本量,进一步开展多中心临床对照研究,为本病临床治疗提供更准确、更全面的指导。
综上所述,抗磷脂综合征复发性流产患者采取培元活血寿胎方联合依诺肝素治疗整体疗效显著,能有效改善患者症状及凝血功能,提升抗磷脂抗体转阴率及保胎成功率,且安全性较高,值得临床推广应用。
  • 河南省医学科技攻关计划项目(LHGJ20220967)
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2025年第43卷第11期
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doi: 10.13193/j.issn.1673-7717.2025.11.038
  • 首发时间:2026-10-30
  • 出版时间:2025-11-10
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河南省医学科技攻关计划项目(LHGJ20220967)
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    1.河南中医药大学,河南 郑州 450000
    2.北京中医药大学东直门医院洛阳医院,洛阳市中医院,河南 洛阳 471000
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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