中华肝脏病杂志
中華肝髒病雜誌
중화간장병잡지
CHINESE JOURNAL OF HEPATOLOGY
2014年
4期
299-304
,共6页
周凡%高冰心%王晓东%李静
週凡%高冰心%王曉東%李靜
주범%고빙심%왕효동%리정
妊娠并发症%治疗学%熊去氧胆酸%S-腺苷蛋氨酸%综合分析%妊娠肝内胆汁淤积症
妊娠併髮癥%治療學%熊去氧膽痠%S-腺苷蛋氨痠%綜閤分析%妊娠肝內膽汁淤積癥
임신병발증%치료학%웅거양담산%S-선감단안산%종합분석%임신간내담즙어적증
Pregnancy complications%Therapy%Urdeosoxycholic acid%S-adenosylmethionine%Meta-analysis%Intrahepatic cholestasis of pregnancy
目的 评价熊去氧胆酸(UDCA)与S-腺苷蛋氨酸(SAMe)联合及单独使用改善妊娠肝内胆汁淤积症(ICP)妊娠结局的疗效和安全性. 方法 计算机检索MEDLINE、EMBASE、Cochrane library、CBM、CNKI和万方数据库,检索日期为建库始至2011年12月,根据Cochrane手册评价纳入研究的偏倚风险. 结果 共纳入10项随机对照试验的727例研究对象,偏倚风险低.Meta分析显示:UDCA与SAMe联合使用,较单用UDCA能降低剖宫产率(OR=0.45,95％ CI:0.24 ～ 0.86)、早产率(OR=0.36,95％ CI:0.20 ～ 0.63)和新生儿窒息率(OR=0.27,95％ CI:0.13 ～ 0.56),差异均有统计学意义(P＜0.05),但不能改善羊水粪染率(OR=0.38,95％ CI:0.14 ～ 1.01)和新生儿出生体质量(MD=397.36,95％CI:-96.17 ～ 890.89);联合使用较单用SAMe能降低早产率(OR =0.39,95％CI:0.21 ～ 0.73)、新生儿窒息率(OR=0.23,95％CI:0.07 ～ 0.75)和羊水粪染率(OR =0.41,95％ CI:0.20 ～ 0.85),差异均有统计学意义(P＜0.05),但不能改善剖宫产率(OR=0.62,95％CI:0.27 ～ 1.44)和新生儿出生体质量(MD=445.95,95％CI:-143.51 ～ 1035.42);单用UDCA与单用SAMe在改善剖宫产率(OR=0.91,95％CI:0.47 ～ 1.78)、早产率(OR=0.82,95％CI:0.49 ～ 1.38)、新生儿窒息率(OR =0.90,95％CI:0.38 ～ 2.12)、羊水粪染率(OR=1.14,95％ CI:0.61 ～ 2.13)和新生儿出生体质量(MD=-62.86,95％ CI:-157.81 ～ 32.09)方面,差异无统计学意义.6项研究报道无不良反应产生.本系统评价纳入研究未使用随机分配方案的隐藏和盲法.结论 UDCA与SAMe联合使用较单用UDCA或SAMe能更好改善ICP妊娠结局,且较为安全,但仍需高质量、大样本、严格设计和实施的多中心随机对照研究提供证据.
目的 評價熊去氧膽痠(UDCA)與S-腺苷蛋氨痠(SAMe)聯閤及單獨使用改善妊娠肝內膽汁淤積癥(ICP)妊娠結跼的療效和安全性. 方法 計算機檢索MEDLINE、EMBASE、Cochrane library、CBM、CNKI和萬方數據庫,檢索日期為建庫始至2011年12月,根據Cochrane手冊評價納入研究的偏倚風險. 結果 共納入10項隨機對照試驗的727例研究對象,偏倚風險低.Meta分析顯示:UDCA與SAMe聯閤使用,較單用UDCA能降低剖宮產率(OR=0.45,95％ CI:0.24 ～ 0.86)、早產率(OR=0.36,95％ CI:0.20 ～ 0.63)和新生兒窒息率(OR=0.27,95％ CI:0.13 ～ 0.56),差異均有統計學意義(P＜0.05),但不能改善羊水糞染率(OR=0.38,95％ CI:0.14 ～ 1.01)和新生兒齣生體質量(MD=397.36,95％CI:-96.17 ～ 890.89);聯閤使用較單用SAMe能降低早產率(OR =0.39,95％CI:0.21 ～ 0.73)、新生兒窒息率(OR=0.23,95％CI:0.07 ～ 0.75)和羊水糞染率(OR =0.41,95％ CI:0.20 ～ 0.85),差異均有統計學意義(P＜0.05),但不能改善剖宮產率(OR=0.62,95％CI:0.27 ～ 1.44)和新生兒齣生體質量(MD=445.95,95％CI:-143.51 ～ 1035.42);單用UDCA與單用SAMe在改善剖宮產率(OR=0.91,95％CI:0.47 ～ 1.78)、早產率(OR=0.82,95％CI:0.49 ～ 1.38)、新生兒窒息率(OR =0.90,95％CI:0.38 ～ 2.12)、羊水糞染率(OR=1.14,95％ CI:0.61 ～ 2.13)和新生兒齣生體質量(MD=-62.86,95％ CI:-157.81 ～ 32.09)方麵,差異無統計學意義.6項研究報道無不良反應產生.本繫統評價納入研究未使用隨機分配方案的隱藏和盲法.結論 UDCA與SAMe聯閤使用較單用UDCA或SAMe能更好改善ICP妊娠結跼,且較為安全,但仍需高質量、大樣本、嚴格設計和實施的多中心隨機對照研究提供證據.
목적 평개웅거양담산(UDCA)여S-선감단안산(SAMe)연합급단독사용개선임신간내담즙어적증(ICP)임신결국적료효화안전성. 방법 계산궤검색MEDLINE、EMBASE、Cochrane library、CBM、CNKI화만방수거고,검색일기위건고시지2011년12월,근거Cochrane수책평개납입연구적편의풍험. 결과 공납입10항수궤대조시험적727례연구대상,편의풍험저.Meta분석현시:UDCA여SAMe연합사용,교단용UDCA능강저부궁산솔(OR=0.45,95％ CI:0.24 ～ 0.86)、조산솔(OR=0.36,95％ CI:0.20 ～ 0.63)화신생인질식솔(OR=0.27,95％ CI:0.13 ～ 0.56),차이균유통계학의의(P＜0.05),단불능개선양수분염솔(OR=0.38,95％ CI:0.14 ～ 1.01)화신생인출생체질량(MD=397.36,95％CI:-96.17 ～ 890.89);연합사용교단용SAMe능강저조산솔(OR =0.39,95％CI:0.21 ～ 0.73)、신생인질식솔(OR=0.23,95％CI:0.07 ～ 0.75)화양수분염솔(OR =0.41,95％ CI:0.20 ～ 0.85),차이균유통계학의의(P＜0.05),단불능개선부궁산솔(OR=0.62,95％CI:0.27 ～ 1.44)화신생인출생체질량(MD=445.95,95％CI:-143.51 ～ 1035.42);단용UDCA여단용SAMe재개선부궁산솔(OR=0.91,95％CI:0.47 ～ 1.78)、조산솔(OR=0.82,95％CI:0.49 ～ 1.38)、신생인질식솔(OR =0.90,95％CI:0.38 ～ 2.12)、양수분염솔(OR=1.14,95％ CI:0.61 ～ 2.13)화신생인출생체질량(MD=-62.86,95％ CI:-157.81 ～ 32.09)방면,차이무통계학의의.6항연구보도무불량반응산생.본계통평개납입연구미사용수궤분배방안적은장화맹법.결론 UDCA여SAMe연합사용교단용UDCA혹SAMe능경호개선ICP임신결국,차교위안전,단잉수고질량、대양본、엄격설계화실시적다중심수궤대조연구제공증거.
Objective To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) that have assessed the effect and safety of ursodeoxycholic acid (UDCA),S-adenosylmethionine (SAMe) and UDCA-SAMe combination therapies for intrahepatic cholestasis of pregnancy (ICP).Methods Using searching protocols and assessment methods recommended by the Cochrane Collaboration to reduce bias in systematic reviews,the databases of Medline,EMBASE,Cochrane Central Register of Controlled Trials (CCRT),China National Knowledge Infrastructure (CNKI),Chinese BioMedical Literature (CBM) and Wanfang China Online Journals were searched to identify relevant RCTs published from database inception to December 2011.Results Ten RCTs (of 727 pregnant women) were included in the study and represented a low risk for bias.Compared to the patients who received UDCA monotherapy,those who received UDCA-SAMe combination therapy had significantly lower rates of Cesarean section (odds ratio (OR) =0.45,95％ confidence interval (CI):0.24-0.86),preterm birth (OR =0.36,95％ CI:0.20-0.63),and fetal asphyxia (OR =0.27,95％ CI:0.13-0.56) (all,P ＜ 0.05); however,the UDCA-SAMe therapy did not provide better rates of amniotic fluid pollution (OR =0.38,95％ CI:0.14-1.01) or better new bom weight (mean difference (MD) =397.36,95％ CI:-96.17-890.89).Compared to the patients who received SAMe monotherapy,those who received UDCA-SAMe combination therapy had significantly lower rates of preterm birth (OR =0.39,95％ CI:0.21-0.73),fetal asphyxia (OR =0.23,95％ CI:0.07-0.75),and amniotic fluid pollution (OR =0.41,95％ CI:0.20-0.85) (all,P ＜ 0.05); however,the UDCA-SAMe therapy did not provide better rates of Cesarean section (OR =0.62,95％ CI:0.27-1.44) or better new bom weight (MD =445.95,95％ CI:-143.51-1035.42).Comparison of the two monotherapies (UCDA vs.SAMe) showed no statistical differences in rates of Cesarean section (OR =0.91,95％ CI:0.47-1.78),preterm birth (OR =0.79,95％ CI:0.49-1.38),fetal asphyxia (OR =0.90,95％ CI:0.38-2.12),and amniotic fluid pollution (OR =1.14,95％ CI:0.61-2.13),as well as of new born weight (MD =-62.86,95％ CI:-157.81-32.09).Six studies reported no side effects.None of the included studies reported use of allocation concealment or blinding.Conclusion UDCA-SAMe combination therapy is better than either UDCA or SAMe monotherapy for improving the outcome of ICP without adverse effects.Large-scale trials with adequate sample sizes and higher quality study design are needed to further confirm the efficiency and safety of UDCA and SAMe for treating ICP.
