【Abstract】ObjectiveTo investigate the prophylactic effect of lamivudine monotherapy on the recurrence of hepatitis B after liver transplantation. MethodsThirtyone patients with hepatitis B related benign decompensated cirrhosis who underwent liver transplantation between February 1999 to June 2002 and survived more than 3 months were analyzed retrospectively. Lamivudine was administered to each patient after operation and some patients before operation for the prophylaxis of HBV recurrence. The HBV markers and HBV DNA in serum and bioptic liver tissues in all patients were evaluated before and after operation. ResultsTotal HBV recurrence rate was 19.4％（6/31） during average 38.2 months (3.2-70.2 months) follow up. HBV recurrence rate was 7.1％(2/28), 16.0％(4/25), 26.1％(6/23) and survival rate was 87.1％(27/31), 80.6％(25/31), 66.1％(20.5/31) after 1-, 3-and 5-year, respectively. One hundred milligram lamivudine administration peroral daily for 2 weeks prior to transplantation enable HBeAg 54.5％(6/11) and HBV DNA 50.0％(5/10) positive patients convert to negative respectively. ConclusionPreoperative administration of lamivudine monotherapy can effectively prevent allograft from HBV re-infection after liver transplantation. Lamivudine should be used to convert HBV DNA and HBeAg to negative.
目的 采用干扰素和阿德福韦酯治疗慢性乙型肝炎患者经拉米夫定治疗后出现YMDD变异，比较两种治疗策略的临床疗效。 方法 选择2002年2月-年12月经100 mg拉米夫定治疗后出现YMDD变异的慢性乙型肝炎患者76例。其中，男52例，女24例；年龄18~55岁，平均年龄33岁。服用100 mg拉米夫定52～156周发生YMDD变异，HBV DNA低于治疗前水平，丙氨酸转移酶(alanine aminotransferase，ALT)lt;2×ULN/L患者分为A组(26例)，继续用100 mg拉米夫定治疗48周；服用100 mg拉米夫定52～156周发生YMDD变异，HBV DNA定量检测高于或等于治疗前水平，ALTgt;2×ULN/L，根据患者自愿分为B组(27例)和C组(23例)。B组用100 mg拉米夫定联合10 mg阿德福韦酯治疗48周；C组用干扰素治疗48周。分别观察3组ALT复常率及HBV DNA转阴率、HBeAg阳性患者血清学转换率。 结果 治疗48周时，B、C组患者ALT复常率分别是74.1%和78.3%，明显高于A组的34.6%，差异有统计学意义(Plt;0.05)；B、C组患者HBV DNA转阴率分别是77.7%和73.9%，明显高于A组的11.5%，差异有统计学意义(Plt;0.05)；3组HBeAg阳性患者血清学转换率比较，差异均无统计学意义(Pgt;0.05)。 结论 慢性乙型肝炎患者经拉米夫定治疗后出现YMDD变异，继续用拉米夫定治疗疗效不理想，改用干扰素或联合阿德福韦酯治疗更安全有效。
Objective To assess the efficacy of telbivudine in the treatment of chronic hepatitis B (CHB). Methods Randomized controlled trials (RCTs) of telbivudine therapy vs. lamivudine therapy in both Chinese and English were retrieved from seven electronic databases with a cut-off date in February 2010, including PubMed, EMbase, VIP, CBM, CNKI, and The Cochrane library. The meta-analyses and evaluation on methodology quality were performed for the included studies. Results Two RCTs as Grade-A study were included. The meta-analyses showed that telbivudine was superior to lamivudine in aspects of therapeutic response (RR=1.28, 95%CI 1.10 to 1.48, P=0.001), ALT normalization (RR=1.12, 95%CI 1.01 to 1.23, P=0.02), and PCR-negative HBV DNA or below the lower limit (RR=1.44, 95%CI 1.36 to 1.53, Plt;0.000 01), primary treatment failure (OR=0.28, 95%CI 0.18, to 0.43, Plt;0.000 01), viral breakthrough (OR=0.38, 95%CI 0.32 to 0.47, Plt;0.000 01) and viral resistance (OR=0.44, 95%CI 0.36 to 0.55, Plt;0.000 01). Conclusion Based on the current clinical evidence, telbivudine demonstrates superiority in comparison with lamivudine on all direct measures of antiviral efficacy for CHB. Because of the short follow-up duration and the small sample size of the included studies, it is expected to further discuss the long-term efficacy.
摘要:目的: 观察拉米夫定联合阿德福韦酯治疗E抗原阴性的慢性乙型肝炎患者的疗效和安全性。 方法 :2006～2007年来我院就诊的慢性乙型肝炎患者,给予拉米夫定100 mg/d,阿德福韦酯 100 mg/d,观察治疗前及治疗后12、24 及48周谷丙转氨酶水平、HBV DNA水平、乙型肝炎病毒血清标志物的应答效果及肾功能变化。 结果 :治疗12周、24周和48周时,HBV DNA转阴率分别为17%、43%和87%,且各组间差异具有统计学意义(P lt;005);ALT复常率分别为13%,67%和100%,且各组间差异具有统计学意义(P lt;005);治疗48周时,所有患者均未发生表面抗原的消失;整个治疗过程中,患者的耐受性良好,未发生一例严重不良事件。 结论 :拉米夫定联合阿德福韦酯治疗E抗原阴性的慢性乙肝患者,可获得较好的临床疗效,该治疗策略为临床抗病毒治疗提供了新的选择。Abstract: Objective: To observe the curative efficacy and safety of lamivudine combined with adefovir dipivoxil on HBeAgnegative initial treated chronic hepatitis B (CHB) patients. Methods : Outatients from our hospital between June, 2006 and August, 2007, who received lamivudine 100 mg and adefovir dipivoxil 10 mg per day were screened. And the level of ALT, HBV DNA, and urea nitrogen, as well as the statue of HBsAg and antiHBs were detected at week 12, 24, and 48 Results : The undetectable rates of HBV DNA were 17%, 43%, and 87% at week 12, 24, and 48 respectively, and the difference in response rate were statistic significantly (Plt;005). The ALT normalization rate were 13%, 67%, and 100% at week 12, 24, and 48 respectively, and the difference in response rate were statistic significantly (Plt;005); During the course of antiviral therapy, the loss of HBsAg was not observed and all patients were well tolerated. Conclusion : The combination of lamivudine and adefovir dipivoxil were effective for HBeAgnegative CHB patients, and this treatment strategy provided us a new option in clinical antiviral practice.
Objective To systematically review the effectiveness and safety interferon-α (IFN-α) combined with lamivudine vs. IFN-α alone in treating children with Hepatitis B. Methods Such databases as The Cochrane Library, PubMed, EMbase, Web of Science, CBM, CNKI, VIP and WanFang Data were electronically searched for randomized controlled trials (RCTs) on IFN-α combined with lamivudine in treating children with hepatitis B. Two reviewers screened literature, extracted data, and assessed the methodological quality of the included studies. Then, meta-analysis was performed using RevMan 5.0 software. Results 8 RCTs were included, with comparable baseline. The results of meta-analysis showed that, compared to the IFN-α alone group, the combined therapy group had higher negative rates of serum HBV-DNA and HBeAg. There was no significant difference in the positive rate of anti-Hbe and the incidence of adverse reaction between the two groups. Conclusion Current evidence shows that IFN-α combined with lamivudine was more effective than IFN-α alone in treating children’s hepatitis B.
Objective To assess the efficacy of lamivudine in patients with HBeAg positive chronic hepatitis B.Methods MEDLINE, SCI, Current Content Connect, The Cochrane Library, and Chinese Biomedical Database were searched from the beginning to September 2005, and the references of eligible studies were manually screened. R.andomized controlled trials comparing lamivudine with non-antiviral interventions （ placebo, no treatment and standard care ） in patients with chronic hepatitis B were eligible for inclusion. Two investigators independently assessed the quality and extracted the data. Heterogeneity was examined by Chi-square test. Fixed and random effect meta-analysis were used to pool the data. Subgroup analyses were used in treatment course. Results Eleven R.CTs were included （ n = 1 237 ）. All reported the effect of lamivudine （100 mg/d） , and one of them included lamivudine （25 mg/d）. The treatment duration of 52 weeks and less than 26 weeks were reported in eight and three RCTs, respectively. Six RCTs adequately applied randomization, while other five RCTs were not reported in detail. Four RCTs adequately enforced allocation concealment, five RCTs enforced blinding bitterly. The others were not reported in detail. It was found by meta-analysis that, compared with the control, lamivudine （100 mg/d, 52 W） could significantly clear HBeAg [42.6% vs. 13% , RR 3.20, 95% CI （2.33, 4. 38）] and clearHBVDNA [71.78% vs. 20, 36%, RR3.42, 95%CI （2.80,4.19）], normalize ALT [65% vs. 34.9%, RR1.91, 95%CI （1.64,2.21）], achieve HBeAgseroconversion [16.1% vs. 7.29% , RR2.12, 95%CI （1.24,3.80） ] and histology response [57. 9% vs. 26.2%, RR 2. 17, 95% CI （ 1.67,2.81 ） ] ; Lanfivudine （100 mg/ d, 12 W） could effectively clear HBV DNA [ 50.7% vs 3.92% , RR 8.68, 95% CI （1.72,43.74 ） ] , but was not effective in loss of HBeAg, HBeAg seroconversion and normalization of ALT, Lamivudine （25 mg/d） could effectively clear HBV DNA [97.7% vs. 22.2% , RR 4.41, 95% CI （2.86,6.79） ] and improve histology response [59.3% vs. 30% , RR1.98, 95% CI （1.31,2.99 ） ], but was not effective in HBeAg seroconversion. Conclusions Lamivudine （100 mg/ d） is effective in clearing HBV DNA and HBeAg, normalizing ALT and achieving HBeAg seroconversion.
Objective To assess the effectiveness and safety of combination therapy of zidovudine and lamivudine (ZDV+3TC) for preventing mother-to-child transmission (MTCT) of HIV. Methods A systematic review of randomized controlled trials (RCTs) was conducted using the methodology of The Cochrane Collaboration. PUBMED, EMBASE, CINAHL, AIDSearch, AIDSLINE, AIDSTRIALS, The Cochrane Library (Issue 2, 2007), AIDSDRUGS, AIDSinfo, CRD (Center of Review and Dissemination) databases and three Chinese Databases (CBM, CNKI, VIP) were searched from their establishment to 31 May 2007. We also searched documents of governmental and non-governmental organizations (NGOs), and the proceedings of relevant conferences, including the International AIDS Conferences, and the annual Conference on Retroviruses and Opportunistic Infections. RCTs assessing the effects of ZDV+3TC for preventing MTCT were included. Trial selection, quality assessment and data extraction were done by two reviewers independently. Different opinions were resolved by discussion with a third party. Meta-analyses were conducted using The Cochrane Collaboration’s RevMan 4.2.9 software. Results Three studies in breastfeeding populations were included. One trial (PETRA, 1797 participants) found that ZDV+3TC decreased the risk of transmission by 35%-65% within 15 months compared with placebo. However, there was no evidence that ultra-short course ZDV+3TC (during labor) decreased the risk of transmission, compared with placebo. The safety of different courses of ZDV+3TC and placebo were similar (Pgt;0.05). Another trial (SAINT, 1317 participants) found that short course ZDV+3TC (from 36weeks gestation to labor) did not significantly reduce HIV infection among children at 8 weeks after delivery, when compared with single dose nevirapine given to the mother and the infant (Pgt;0.05). No significant difference was found in the maternal and infants mortality and side effects of two groups. One small trial (Moodley1998, 20 participants) found no infant infection in both ZDV+3TC and 3TC alone within 2 weeks after birth. Conclusions Long course (from 36 weeks gestation to 1 week after delivery) and short course (from 36 weeks gestation to labor) ZDV+3TC were more effective than placebo in preventing MTCT of HIV in breastfeeding women with a similar safety profile. Short course ZDV + 3TC had similar effects to single dose nevirapine, and long course ZDV + 3TC had similar effects to lamivudine alone.