一项随机对照临床试验：用乙肝免疫球蛋白阻断乙型肝炎病毒感染的宫内传播
A randomized controlled clinical trial: interruption of intrauterine transmission of hepatitis B virus infection with HBIG.
作者信息
Xu Qin, Xiao Lin, Lu Xiao-Bo, Zhang Yue-Xin, Cai Xia
机构信息
Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.
出版信息
World J Gastroenterol. 2006 Jun 7;12(21):3434-7. doi: 10.3748/wjg.v12.i21.3434.
AIM
To evaluate the efficacy of interruption of intrauterine infection of HBV with HBIG in pregnant women with positive HBeAg and HBsAg.
METHODS
A prospective randomized controlled trial was adopted. Sixty cases with positive HBeAg and HBsAg were coincident with the criteria of inclusion, and 8 cases were excluded. Fifty-two cases were analyzed (28 cases in trial group and 24 in control group). All cases in trial group received 200 IU HBIG intravenously every 4 wk for 3 times from the 28(th) wk. The cases of control group received placebo in the same way. All pregnant women were detected for HBeAg and HBV-DNA at the beginning of the trial and end of the trial (delivery). The cord blood of all newborns were collected for detecting HBeAg and HBV-DNA simultaneously.
RESULTS
For investigation of HBeAg of newborns in trial group, 6 of 28 cases of newborns had positive HBeAg, the HBeAg positive rate being 21.4%, the total rate of 95% CI being 8%-41%. In control group, 19 of 24 cases of newborns had positive HBeAg, HBeAg positive rate was 79.2%, the rate of 95%CI being 5%-93%. By statistical analysis, chi(2) = 17.26, P < 0.01, RR = 0.27, 95% CI (6.3 multiply 10(-6), 8.6 multiply 10(-5)). For investigation of HBV-DNA of newborns in trial group, 7 of 28 cases of newborns had positive HBV-DNA, HBV-DNA positive rate being 25%, the total rate of 95% CI being 11%-45%. In control group, 20 of 24 cases of newborns had positive HBV-DNA, HBV-DNA positive rate was 83.3%, the total rate of 95% CI being 63%-95%. By statistical analysis, chi(2) = 17.62, P < 0.01, RR = 0.30, 95% CI (1.5 multiply 10(-5), 1.7 multiply 10(-4). The results indicated that there was significant difference in HBeAg positive rate and HBV-DNA positive rate of newborns between the two groups. In trial group, 7 of 28 newborns had HBV-DNA positive, but the HBV-DNA load of newborns was lower than that of their mothers. In control group, 20 of 24 newborns still had HBV-DNA positive, and the HBV-DNA load of newborns was close to those of their mothers. Statistical analysis indicated that there was no significant difference in HBV-DNA load between postnatal women without HBIG intervention and their filial generations (T = 81.5, P > 0.1).
CONCLUSION
It is effective and safe to prevent intrauterine infection of HBV with HBIG from the 28(th) wk in pregnant women with positive HBeAg and HBsAg. In clinical application, those pregnant women with negative HBeAg and positive HBV-DNA also need to be interrupted by HBIG.
目的
评估乙肝免疫球蛋白（HBIG）阻断HBeAg和HBsAg阳性孕妇宫内感染HBV的疗效。
方法
采用前瞻性随机对照试验。60例HBeAg和HBsAg阳性病例符合纳入标准，排除8例。对52例进行分析（试验组28例，对照组24例）。试验组所有病例从第28周起每4周静脉注射200IU HBIG，共3次。对照组病例以同样方式接受安慰剂。所有孕妇在试验开始时和试验结束时（分娩时）检测HBeAg和HBV-DNA。同时采集所有新生儿的脐带血检测HBeAg和HBV-DNA。
结果
试验组新生儿HBeAg检测中，28例新生儿中有6例HBeAg阳性，HBeAg阳性率为21.4%，95%可信区间总率为8% - 41%。对照组中，24例新生儿中有19例HBeAg阳性，HBeAg阳性率为79.2%，95%可信区间率为5% - 93%。经统计学分析，χ² = 17.26，P < 0.01，RR = 0.27，95%可信区间（6.3×10⁻⁶，8.6×10⁻⁵）。试验组新生儿HBV-DNA检测中，28例新生儿中有7例HBV-DNA阳性，HBV-DNA阳性率为25%，95%可信区间总率为11% - 45%。对照组中，24例新生儿中有20例HBV-DNA阳性，HBV-DNA阳性率为83.3% , 95%可信区间总率为63% - 95%。经统计学分析，χ² = 17.62，P < 0.01，RR = 0.30，95%可信区间（1.5×10⁻⁵，1.7×10⁻⁴）。结果表明两组新生儿HBeAg阳性率和HBV-DNA阳性率有显著差异。试验组28例新生儿中有7例HBV-DNA阳性，但新生儿的HBV-DNA载量低于其母亲。对照组24例新生儿中有20例仍为HBV-DNA阳性，且新生儿的HBV-DNA载量与其母亲相近。统计学分析表明，未接受HBIG干预的产后妇女与其子代的HBV-DNA载量无显著差异（T = 81.5，P > 0.1）。
结论
HBeAg和HBsAg阳性孕妇从第28周起用HBIG预防HBV宫内感染是有效且安全的。在临床应用中，HBeAg阴性而HBV-DNA阳性的孕妇也需要用HBIG进行阻断。
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