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三个海外专家讨论一篇论文

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才高八斗

发表于 2011-6-19 01:00 |显示全部帖子
本帖最后由 StephenW 于 2011-6-23 21:43 编辑

三个海外讨论一篇论文


Patrick Marcellin, MD

Norah Terrault, MD, MPH

Anna S. F. Lok, MD

文是:


Telbivudine Use in Late Pregnancy in HBeAg-Positive Mothers Safely Reduces Perinatal HBV Transmission

HBeAg阳性母在妊娠期使用替比夫定, 安全降低母婴传


Posting Date: November 04,2010

发布日期:2010114


Prospective, nonrandomized,case-controlled, open-label study

前瞻性,非随机,病例照,开放性研


Summary of Key Conclusions

结论


Telbivudine use in highlyviremic HBeAg-positive mothers during Weeks 20-32 of pregnancy reduces mother-to-child transmission of HBV

高病毒e抗原阳性的母20-32怀孕期,使用替比夫定减少母亲对儿童的乙肝病毒


Telbivudine well tolerated inlate pregnancy with no short-term safety signals in telbivudine-treated mothers or their infants

在妊娠替比夫定良好耐受性, 替比夫定治的母儿没有短期安全示意

No increase in pregnancy ordelivery complications

没有增加怀孕或分娩复杂

No congenital deformities of adverse effects on infant development through 28 postpartum weeks offollow-up

28没有无先天性畸形, 婴儿发育不良影响.


Findings support telbivudineuse in highly viremic HBeAg-positive mothers for prevention of perinatal transmission of HBV

研究结果支在高病毒血症HBeAg阳性母使用替比夫定,防乙肝病毒婴传播


Norah  Terrault, MD,MPH:
On the topic of preventing perinatal HBV transmission, Han and colleagues[27] reported the results of an important study adding to the slowly growing dataset on the use of antiviral treatment in HBV-infected women during late pregnancy to prevent perinatal transmission. This non randomized, prospective, multicenter study conducted inChina offered HBeAg-positive women with HBV DNA > 1 x 106copies/mL who were at Weeks 20-32 of gestation the choice between telbivudine600 mg/day (n = 94 women; n = 95 infants) or no antiviral therapy (n = 92 women; n = 92 infants) ([url=]CapsuleSummary[/url]).
关于防止母婴传播,(Han) 和同事[27]道一个重要的研究结果, 添加,缓慢增长,
关于HBV感染的,在妊娠后期,抗病毒治, 以防止母婴传, 的数据集。这种非随机(non-random),前瞻性,多中心研究,在中国进行. 提供e抗原阳性HBV DNA> 1× 106/毫升妇女 ,在妊娠20-32周之,替比夫定600毫克/天(N=94 妇女; N =95 婴儿)不要抗病毒治N= 92 女,N= 92 婴儿)(胶囊摘要)。

Although offering study participants the choice between treatment groups introduces the potential for bias, most baseline characteristics including age, number of previous pregnancies, HBV DNA level,and ALT levels were at least statistically similar in both groups. The median HBV DNA level was 8.19 log10 copies/mL in the telbivudine group and7.96 log10 copies/mL in the control group (P = .134). Themedian ALT levels were within the normal range in both groups at 22.35 U/L and27.60 U/L, respectively (P = .528); approximately one third ofindividuals in both groups had ALT levels greater than the upper limit ofnormal. However, women who chose to receive telbivudine had a higher prevalenceof previous antiviral therapy (10.6%) relative to women who chose not toreceive therapy (0%; P = .002).
, 参与研究者他自行选择疗组, 可以引入偏潜力(potential for bias),基线特, 包括,以前怀孕数HBV DNA 水平ALT水平, 至少统计学(statistically)相似。在替比夫定,HBV DNA中位数水平8.19 log10/毫升,对照对照(control),7.96 log10/毫升,P=0.134)。两ALT水平的中位数(medium) 均在正常范,分别为22.35 U / L 27.60 U / L(P=0.528;在两, 三分之一的, ALT水平高于正常上限然而,选择接受替比夫定抗病毒治, 已接受率较高(10.6%),对于选择不接受治疗妇女 (0%,P=0.002

This study differs from similar trials investigating third-trimester antiviral therapy[22,28,29] in that he investigators permitted treatment initiation earlier, at 20 weeks of gestation during the second trimester. Participants receiving telbivudine continued treatment for 4 weeks postpartum. Women who had indications or reason to consider longer treatment continued telbivudine therapy to postpartum Week28. All infants received HBIG and HBV vaccine within 24 hours after delivery and additional HBV vaccine at 1 and 6 months after delivery.

这项研究不同于[22,28,29]类似调查从第三孕期 (third-trimester) 进行抗病毒治试验 . 这项研究允在妊娠20, 孕中期(second trimester), 开始治疗. 接受替比夫定治疗者会继续4周。妇女,认为有指示或理由,继续替比夫定治28周。所有儿在24收到HBIG和乙肝疫苗, 16 个月后的外乙肝疫苗。


The investigators compared HBsAg positivity at 28 weeks of age among infants in the treated and untreated groups by both intent-to-treat and per protocol analyses.

研究人员比较婴28,乙肝表面抗原阳性, 处理和未经处 ,意向處理分析(intent-to-treat)协议(per ptotocol))分析。

[在流行病學方面, 意向處理分析 (intention-to-treatanalysis; ITT analysis)是分析根據最初的治療意向,不是在治療最終被執行。它根據假定,和在真正的生活中,患者全部有時不接受優選的治療,即使那是最初的意





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发表于 2011-6-19 01:02 |显示全部帖子
本帖最后由 StephenW 于 2011-6-19 01:17 编辑

Anna S. F. Lok, MD: According to the intent-to-treat analysis,2.1% of infants in the telbivudine group vs 13.0% of infants in the untreatedgroup were HBsAg positive 28 weeks after birth (P = .004). In thesensitivity (per protocol) analysis, the rates of HBsAg positivity were 0% vs8.7%, respectively (P = .003).

安娜S.F. MD
根据, 意向處理分析,在替比夫定2.1在治疗组13.0, HBsAg阳性的,在出生后28周(P =0.004)。
在灵敏度(sensitivity)per protocol)的分析,乙肝表面抗原阳性率分别为 0
8.7%,(P=0.003)。

The proportion of infants who tested positivefor HBsAg at the time of delivery was much higher in both groups: 6.3% withtelbivudine vs 30.4% without treatment. Many other studies examining perinatalHBV transmission have similarly reported that the rate of HBsAg detection ismuch higher in cord blood at the time of birth relative to venous blood a fewmonths after birth. My interpretation is that cord blood may be contaminatedwith maternal blood; the presenter’s interpretation was that the higher ratesat birth reflected infants who acquired intrauterine HBV infection that wassubsequently eradicated by HBIG and vaccine administration.
儿在分娩时测试, HBsAg的阳性比例是高得多.:替比夫定6.3%,相没有接受治30.4%。多研究母婴传播等研究,样报告说,乙肝表面抗原检出,在出生时脐带(cord)的血,要高得多于出生几个月后静脉的血液。我的理解是,脐带血可能与母体血液污染; 研究者的解释是出生儿的高率反映乙肝病毒内感染,后来被HBIG
疫苗管理得根除。

Norah Terrault, MD, MPH:This study also reported reassuring safety outcomesshowing similar pregnancy duration and similar risk of abnormal pregnancy,cesarean section, and postpartum hemorrhage with telbivudine vs no treatment.In addition, there were no early discontinuations as a result of adverse eventsin mothers receiving telbivudine, and no congenital deformities occurred ininfants from either group.

这项研究还报令人欣慰的安全性, 显示类似怀孕期,类似异常妊娠的风险,剖宫产(caesarean) 后出血的风险 , 在替比夫定治疗组没有任何治疗组。此外,,在接受替比夫定治, 没有不良事件早期停,并没有儿先天畸形。


Another very useful finding from this studywas that women receiving telbivudine experienced a lower rate of postpartum ALTflare relative to women who did not receive antiviral therapy (7.45% vs 18.48%,respectively; P = .025). Among the subset of women who discontinuedtelbivudine at postpartum Week 4 (n = 55), 12.73% experienced a subsequentpostpartum ALT flare. This result does not suggest that discontinuingtelbivudine put women at an increased risk for ALT flares.

这项研究的另一个发现是非常有用的.女性接受替比夫定经历较低ALT突然上升(flare) 对于性不接受抗病毒治(分别为7.4518.48%,P=0.025)。其中后第4, 停止替比夫定的N=55),12.73%,其后经历ALT突然上升(flare)这个结果并不意味着停止替比夫定妇女ALT突然上升(flare)风险


Anna S. F. Lok, MD:
However, study follow-up continued only topostpartum Week 28, therefore the incidence of ALT flare in women who stoppedtelbivudine treatment at postpartum Week 28 is not known.

然而,研究后第28周,因此后第28,停止使用替比夫定治妇女,不知道有没有ALT突然上升(flare)发生


Patrick Marcellin, MD: Although the study is not perfect, itincludes a relatively large number of pregnant women with high HBV DNA levelsand provides results that are consistent with other studies suggesting thatantiviral treatment during late pregnancy should be considered in pregnantHBeAg-positive women with high HBV DNA levels.[22,28,29]
尽管这项研究是不完美的,它包括了比HBV DNA水平高的孕提供了与其他研究如一(consistent)果,表明在妊娠, HBV DNA水平的e抗原阳性怀孕,接受抗病毒治[22,28,29]

Norah Terrault, MD, MPH: I agree with that assessment. In my opinion,this study makes an important contribution to the literature on this topic.
我同意这一评估。在我看来,这项研, 这一主题的文学,作出了重要的贡献

It would be very helpful to the treatingcommunity if the study investigators were to perform an additional analysis totry to define an appropriate maternal HBV DNA cutoff level above whichantiviral therapy offers the greatest benefit in reducing perinataltransmission. The inclusion criteria required an HBV DNA level > 1 x 106copies/mL, which is somewhat lower than previous studies.[22,28]Other studies have generally focused on women with HBV DNA levels ofapproximately 107-109 copies/mL, and most physicians usea cutoff level of 108 copies/mL or approximately 2 x 107IU/mL to define which pregnant women should be offered antiviral therapy in thethird trimester. A recent study from Australia found that among 138 infantsborn to HBsAg-positive women, the only cases of transmission were fromHBeAg-positive mothers who had HBV DNA levels > 108 copies/mL.[21]It would be useful to examine similardata on maternal HBV DNA levels in cases of transmission from the current studyto help refine recommendations. It is possible that treatment could berestricted to HBeAg-positive pregnant women who have high HBV DNA levels, buthaving a specific HBV DNA cutoff level would lead to more consistency amongpractitioners.

这将是非常有帮助治医生群体,如果调查人员执行额外的分析,试图确定一个合适的孕产妇HBV DNA截止(cut-off)水平, 高于水平, 抗病毒治提供了减少母婴传播的最大好。入选这项临床试验, HBV DNA水平> 1× 106/毫升,是比以往的研究有所降低[22,28]. 其他研究一般集中在乙肝病毒DNA1x107-109 /毫升程度的女,和大多数医生使用的1x108/毫升2 ×107 IU/mL 截止(cut-off) ,义哪些孕妇应提供在孕抗病毒治来自澳大利最近的一项研发现
在乙肝表面抗原阳性的女出生的138儿,播的唯一案件,来自一个e抗原阳性的母HBV DNA水平> 108/ ml[21] . 将是有益的,从目前的研究,讨传产妇
HBV DNA的水平的类似的数据,以帮助改这可能可以限制在HBeAg阳性具有较高HBV DNA水平的孕如果有一个具体的HBV DNA截止(cut-off)水平 , 导致更业人员之间的一致性。

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才高八斗

发表于 2011-6-19 19:53 |显示全部帖子
本帖最后由 StephenW 于 2011-6-19 19:54 编辑

从这个讨论中,我学到三件事情:

1。从婴儿的脐带血测试HBsAg的结果是不可靠的;
2。医生很谨慎,采用一个医疗治疗方法前, 他们要看到许多临床观察与许多类似的
结果;
3。海外医生认真关注从中国到医学研究.

From this discussion, I learn 3 things:

1. Test result for HbSag from a baby's cord blood is not reliable;
2. Doctors are very cautious, they like to see results from many clinical observations before adopting a medical treatment;
3. Overseas doctors are paying serious attentions to medical studies from China.

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发表于 2011-6-22 20:49 |显示全部帖子
谢楼主提供的资料。
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