中华妇幼临床医学杂志（电子版）
中華婦幼臨床醫學雜誌（電子版）
중화부유림상의학잡지（전자판）
CHINESE JOURNAL OF OBSTETRICS & GYNECOLOGY AND PEDIATRICS(ELECTRONIC VERSION)
2014年
4期
499-502
,共4页
替比夫定%肝炎,乙型,慢性%病毒载量%妊娠末期%疾病传播
替比伕定%肝炎,乙型,慢性%病毒載量%妊娠末期%疾病傳播
체비부정%간염,을형,만성%병독재량%임신말기%질병전파
Telbivudine%Hepatitis B,chronic%Viral load%Pregnancy trimester,third%Disease transmission
目的：观察高载量慢性乙型肝炎病毒(HBV)感染孕妇晚孕期应用替比夫定(LdT)抗病毒治疗的疗效、安全性及其阻断母婴垂直传播的作用。方法选取2012年3月至2013年2月于江苏省常州市第三人民医院妇产科门诊进行产前检查的60例慢性 HBV感染孕妇为研究对象,并按照不同用药方式,将其分为LdT组(n=30)和对照组(n=30)(本研究遵循的程序符合江苏省常州市第三人民医院人体试验委员会所制定的伦理学标准,得到该委员会批准,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书)。两组患者年龄、体质量、孕龄等一般资料比较,差异无统计学意义(P>0.05)。LdT组孕妇自孕龄为28~32孕周开始口服LdT(600 mg/d),对照组孕妇未接受抗HBV感染治疗。检测两组孕妇孕龄为28~32孕周前及分娩时血清 HBV DNA载量,LdT组服药期间肝、肾功能水平,新生儿娩出时脐静脉血 HBV DNA载量,所生婴儿月龄为7个月时血清 HBV表面抗原(HBsAg)情况。观察 LdT组孕妇的药物不良反应。结果①两组孕妇孕龄为28~32孕周前血清 HBV DNA载量比较[(1.12±1.46)×108拷贝/mL vs.(9.01±6.65)×108拷贝/mL],差异无统计学意义(t=0.73,P=0.24)；②LdT 组孕妇分娩时(治疗后)HBV DNA载量下降均>102拷贝/mL,其抗病毒治疗有效率达100%,且两组分娩时 HBV DNA载量<5.6×103拷贝/mL孕妇数比较,差异有统计学意义(χ2=12.00,P<0.01)；③LdT 组出现丙氨转氨酶(ALT)轻度升高孕妇为7例(23.3%),无一例孕妇出现肾功能异常,治疗期均未出现药物不良反应。④LdT组脐静脉 HBV DNA载量<5.6×103拷贝/mL 新生儿为30例(100%),对照组为26例(86.6%),两组比较,差异有统计学意义(χ2=4.29,P<0.05)。⑤LdT组月龄为7个月婴儿血清 HBsAg 均呈阴性(100%),对照组呈阴性婴儿为28例(93.3%),两组比较,差异无统计学意义(χ2=0.52,P>0.05)。结论 HBV高病毒载量孕妇晚孕期应用 LdT抗病毒治疗可显著降低分娩时血清 HBV DNA载量水平,可有效阻断 HBV垂直传播。
目的：觀察高載量慢性乙型肝炎病毒(HBV)感染孕婦晚孕期應用替比伕定(LdT)抗病毒治療的療效、安全性及其阻斷母嬰垂直傳播的作用。方法選取2012年3月至2013年2月于江囌省常州市第三人民醫院婦產科門診進行產前檢查的60例慢性 HBV感染孕婦為研究對象,併按照不同用藥方式,將其分為LdT組(n=30)和對照組(n=30)(本研究遵循的程序符閤江囌省常州市第三人民醫院人體試驗委員會所製定的倫理學標準,得到該委員會批準,分組徵得受試對象本人的知情同意,併與之籤署臨床研究知情同意書)。兩組患者年齡、體質量、孕齡等一般資料比較,差異無統計學意義(P>0.05)。LdT組孕婦自孕齡為28~32孕週開始口服LdT(600 mg/d),對照組孕婦未接受抗HBV感染治療。檢測兩組孕婦孕齡為28~32孕週前及分娩時血清 HBV DNA載量,LdT組服藥期間肝、腎功能水平,新生兒娩齣時臍靜脈血 HBV DNA載量,所生嬰兒月齡為7箇月時血清 HBV錶麵抗原(HBsAg)情況。觀察 LdT組孕婦的藥物不良反應。結果①兩組孕婦孕齡為28~32孕週前血清 HBV DNA載量比較[(1.12±1.46)×108拷貝/mL vs.(9.01±6.65)×108拷貝/mL],差異無統計學意義(t=0.73,P=0.24)；②LdT 組孕婦分娩時(治療後)HBV DNA載量下降均>102拷貝/mL,其抗病毒治療有效率達100%,且兩組分娩時 HBV DNA載量<5.6×103拷貝/mL孕婦數比較,差異有統計學意義(χ2=12.00,P<0.01)；③LdT 組齣現丙氨轉氨酶(ALT)輕度升高孕婦為7例(23.3%),無一例孕婦齣現腎功能異常,治療期均未齣現藥物不良反應。④LdT組臍靜脈 HBV DNA載量<5.6×103拷貝/mL 新生兒為30例(100%),對照組為26例(86.6%),兩組比較,差異有統計學意義(χ2=4.29,P<0.05)。⑤LdT組月齡為7箇月嬰兒血清 HBsAg 均呈陰性(100%),對照組呈陰性嬰兒為28例(93.3%),兩組比較,差異無統計學意義(χ2=0.52,P>0.05)。結論 HBV高病毒載量孕婦晚孕期應用 LdT抗病毒治療可顯著降低分娩時血清 HBV DNA載量水平,可有效阻斷 HBV垂直傳播。
목적：관찰고재량만성을형간염병독(HBV)감염잉부만잉기응용체비부정(LdT)항병독치료적료효、안전성급기조단모영수직전파적작용。방법선취2012년3월지2013년2월우강소성상주시제삼인민의원부산과문진진행산전검사적60례만성 HBV감염잉부위연구대상,병안조불동용약방식,장기분위LdT조(n=30)화대조조(n=30)(본연구준순적정서부합강소성상주시제삼인민의원인체시험위원회소제정적윤리학표준,득도해위원회비준,분조정득수시대상본인적지정동의,병여지첨서림상연구지정동의서)。량조환자년령、체질량、잉령등일반자료비교,차이무통계학의의(P>0.05)。LdT조잉부자잉령위28~32잉주개시구복LdT(600 mg/d),대조조잉부미접수항HBV감염치료。검측량조잉부잉령위28~32잉주전급분면시혈청 HBV DNA재량,LdT조복약기간간、신공능수평,신생인면출시제정맥혈 HBV DNA재량,소생영인월령위7개월시혈청 HBV표면항원(HBsAg)정황。관찰 LdT조잉부적약물불량반응。결과①량조잉부잉령위28~32잉주전혈청 HBV DNA재량비교[(1.12±1.46)×108고패/mL vs.(9.01±6.65)×108고패/mL],차이무통계학의의(t=0.73,P=0.24)；②LdT 조잉부분면시(치료후)HBV DNA재량하강균>102고패/mL,기항병독치료유효솔체100%,차량조분면시 HBV DNA재량<5.6×103고패/mL잉부수비교,차이유통계학의의(χ2=12.00,P<0.01)；③LdT 조출현병안전안매(ALT)경도승고잉부위7례(23.3%),무일례잉부출현신공능이상,치료기균미출현약물불량반응。④LdT조제정맥 HBV DNA재량<5.6×103고패/mL 신생인위30례(100%),대조조위26례(86.6%),량조비교,차이유통계학의의(χ2=4.29,P<0.05)。⑤LdT조월령위7개월영인혈청 HBsAg 균정음성(100%),대조조정음성영인위28례(93.3%),량조비교,차이무통계학의의(χ2=0.52,P>0.05)。결론 HBV고병독재량잉부만잉기응용 LdT항병독치료가현저강저분면시혈청 HBV DNA재량수평,가유효조단 HBV수직전파。
Objective To observe the efficacy and safety of telbivudine(LdT)on pregnancy women with high viral load of hepatitis B virus (HBV)infection during the third trimester.Methods From March 2012 to February 2013,a total of 60 pregnant women with chronic HBV infection were enrolled in this study.They were divided into LdT group (n=30)and control group (n=30)according to whether taking LdT or not.LdT group were administered 600 mg/d LdT from 28-32 gestational weeks and control group were treated without antiviral drugs.Adverse reactions were observed in LdT group after treatment.The serum HBV DNA levels were tested in both groups.The HBV DNA levels of umbilical vein after delivery and serum HBsAg of the baby after seven months were also detected.The study protocol was approved by the Ethical Review Board of Investigation in Human Being of The Third People′s Hospital of Changzhou. Informed consent was obtained from each participants.Results ①There was no significant difference of HBV DNA levels between two groups at 28-32 gestational weeks [(1.12 ± 1.46)× 108 copies/mL vs. (9.01±6.65)× 108 copies/mL](t=0.73,P=0.24).②HBV DNA level of LdT group declined over 100 copies/mL when delivering,the anti-viral treatment effective rate in LdT group was 100%.There had significant difference in rates of HBV DNA <5.6×103 copies/mL between both groups at childbirth (χ2=12.00,P<0.01).③No seriously adverse reaction and birth defect was found in LdT group.④The rates of HBV DNA<5.6×103copies/mL of umbilical vein in LdT group was higher than that of control group(χ2=4.29,P=0.05).⑤After 7 months,babies with HBsAg-positive were found in control group, none in LdT group.Conclusions The usage of LdT on pregnant women with high viral load of HBV during the third trimester can significantly inhibit maternal serum HBV DNA levels,and effectively block HBV vertical transmission with good security.
