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              1. 主页 > 乙肝治疗 >

              拉米夫定治疗慢性乙型肝炎病人的长期疗效

                姚光弼 王宝恩 崔振宇 姚集鲁 曾明德

                【摘要】目的 通过多中心、随机、双盲、安慰剂对照的临床试验,研究拉米夫定(lamivudine)对慢性乙型肝炎(乙肝)病人的疗效和安全性。方法 随机选择322例慢性乙肝病人用拉米夫定治疗(100mg/d),107例病人服用安慰剂作对照, 共治疗12周。在12周治疗结束后,拉米夫定组和安慰剂组病人均继续服用拉米夫定100mg治疗至52周。疗效评估包括临床症状和体征、肝功能和HBV复制指标。结果 治疗12周,拉米夫定组HBV DNA累计阴转率(低于1.6ng/L)和最终阴转率均显著高于安慰剂组(92.2%对14.1%, p<0.01;78.5%对11.1%, P<0.01)。第52周末,拉米夫定治疗组的HBV DNA最终阴转率与安慰剂/拉米夫定对照组差异无显著性(71.0%对77.7%, P>0.05)。治疗结束时,拉米夫定治疗组和安慰剂/拉米夫定对照组病人HBeAg并伴有抗-HBe阳性的血清转换率差异无显著性(7.5%对5.2%, P>0.05)。无1例发生HBsAg阴转。第12周时拉米夫定组ALT的复常率高于安慰剂组(60.3%对27.5%, P<0.05)。治疗结束时,两组病人ALT的最终复常率差异无显著性(70.9%对74.5%, P>0.05)。拉米夫定组48周时HBV YMDD的变异率显著高于安慰剂/拉米夫定组(14.6%对5.0%, P<0.05)。在12周和52周的治疗过程中,总的不良事件和反应发生的频率和轻重程度在拉米夫定组和安慰剂/拉米夫定组之间无明显差别。未发生与研究药物相关的严重不良反应。结论 拉米夫定长期治疗,可继续抑制HBV的复制,伴有ALT的明显改善。长期服用拉米夫定可以很好耐受,安全性良好。

                【关键词】 乙型肝炎 乙型肝炎病毒 拉米夫定

                Long-term effect of lamivudine treatment in chronic hepatitis B virus infection

                YAO Guangbi, WANG Bao’en, CUI Zhenyu, et al.

                The Jing’an Qu Central Hospital, Shanghai 200040

                【Abstract】 Objective To evaluate the long-term effect of lamivudine on the loss of serum HBV DNA, HBeAg/antiHBe seroconversion and ALT levels in chronic hepatitis B patients and its safety profile and tolerance with multi-center, randomized, double blind and placebo controlled trial. Method 429 patients with chronic HBV infection as defined by positive HBsAg, HBeAg and HBV DNA were enrolled and randomized into lamivudine and placebo groups. 322patients received lamivudine 100mg daily and 107 patients received placebo treatment for 12 weeks. Then, all patients were offered a further 40 weeks of open label lamivudine treatment. The efficacy and safety were evaluated with clinical, biochemical, hematological and virological parameters. Results After 12 weeks treatment, HBV DNA response (serum HBV DNA<1.6ng/L) rate in lamivudine group was higher than in placebo group (92.2% VS 14.1%, P<0.01); but at week 52, there was no difference between lamivudine and placebo/lamivudine groups (71.0% VS 77.7%, P>0.05). Rate of HBV DNA breakthrough in lamivudine group was higher than in placebo/lamivudine group (24.4% VS 8.5%, P<0.01). Proportion of HBeAg/anti-HBe seroconversion had no difference in two groups (7.5% VS 5.2%, P>0.05). By week 12, ALT normalization rate in lamivudine group was higher than in placebo group (60.3% VS 27.5%, P<0.01); but after 52 weeks treatment, there was no difference between two groups (70.9% VS 74.5%, P>0.05). At week 48, HBV YMDD mutation rate in lamivudine group was higher than in placebo/lamivudine group (14.6% VS 5.0%, P<0.05). The incidence of adverse events was similar for both lamivudine and placebo/lamivudine group up to week 12 and 52. There was few severe drug-related adverse event. Conclusion Sustained HBV replication suppression could be obtained from long-term treatment with lamivudine 100mg daily accompanied with good tolerance and safety.

                【Key words】 Hepatitis B Hepatitis B virus Lamivudine

                拉米夫定(lamivudine)是一种胞嘧啶核苷衍生物,在体外和动物模型中,有很强的抑制乙型肝炎病毒(HBV)复制的作用[1, 2]。临床试验也证明拉米夫定可迅速降低HBV DNA的浓度,改善肝组织学的病变[3,4]。我们在为期3个月的双盲、随机对照研究中证明,拉米夫定可有效地降低病人血清HBV DNA的水平,部分病人伴有血清转氨酶的恢复[5]。我们报道应用拉米夫定治疗慢性HBV感染病人长达一年的疗效、安全性和病毒变异。

                资料与方法

                1.试验设计:为多中心临床药物试验。疗程共52周。第一阶段12周,系随机、双盲、安慰剂对照试验。病人分别服用拉米夫定或安慰剂。第二阶段40周,全部服用拉米夫定。

                2.病人入选标准:年龄16~65岁,确诊为慢性HBV感染的病人。筛选前血清HBsAg和HBeAg持续阳性6个月以上,筛选时血清HBV DNA阳性(斑点杂交法),筛选前3个月内血清丙氨酸转氨酶(ALT)在正常值上限(ULN)10倍以下。签署知情同意书。排除标准:血清HCV、HDV、HIV阳性,失代偿肝病、骨髓抑制、有明显的心、脑、肾、神经、精神病和不稳定糖尿病病人,酗酒和吸毒史,试验前30天至6个月内服用过影响研究结果的药物,对核苷类过敏者,妊娠和哺乳期,有受孕可能未采取有效避孕措施者。

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