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研究拉米夫定治疗慢性乙型肝炎病人 2年的临床疗效。方法 88例病人按 3∶1比例随机分成治疗组和安慰剂组 ,每日服拉米夫定 10 0mg和安慰剂各一片 ,12周以后全部服拉米夫定每日 10 0mg ,持续到 10 4周。定期检测ALT、HBVDNA、HBeAg和抗 HBe。用PCR后直接测序方法检测YMDD变异。结果 75例病人完成 2年试验。 12周时 ,治疗组和安慰剂组HBVDNA阴转分别为 47例 (80 % )和 4例 (2 1% )。 10 4周时 48例 (6 4% )HBVDNA保持阴转。血清转换 19例 (2 5 .33% ) ,8例 (10 .6 6 % )HBeAg已转阴 ,抗 HBe还未转阳。在治疗前ALT值为 <1ULN、>1～ 2ULN、>2～ 5ULN、>5ULN的病人中 ,血清转换率和e抗原转阴率分别为 5例 (13 .15 % )、6例 (33 .33% )、5例 (38.46 % )、3例(5 0 % )和 6例 (15 .78% )、6例 (33 .33% )、11例 (84.6 0 % )、4例 (6 6 .6 6 % )。治疗前和 10 4周时的ALT中位值分别为(71.82 7± 71.6 2 7)U/L和 (34.2 6 7± 31.415 )U/L(P <0 .0 1)。 36例发生YMDD变异 ,总变异率为 48%。变异和非变异者的ALT中位值分别为 (4 5 .0 5 6± 40 .90 3)U/L和 (2 3.6 2 7± 12 .6 9)U/L(P <0 .0 1)。HBVDNA中位值分别为 (2 86 .6 2 5± 482 .877)和 (10 2 .44 8± 380 .2 5 )mEq/ml。血清HBeAg转阴分别为 10和 17例
To study the clinical efficacy of lamivudine in treating patients with chronic hepatitis B for 2 years. Methods 88 patients were randomly divided into treatment group and placebo group according to the ratio of 3: 1, lamivudine daily dose of 100 mg and placebo, after 12 weeks all the service lamivudine daily 10 0mg, until 10 4 weeks. ALT, HBVDNA, HBeAg and anti-HBe are tested regularly. The YMDD mutation was detected by direct sequencing after PCR. Results 75 patients completed the 2-year trial. At 12 weeks, HBVDNA was negative in 47 and 80%, respectively, in the placebo and placebo groups. Eighty-four (64%) HBVDNA remained negative at 10 weeks. 19 cases (25.33%) were seroconverted, and 8 cases (10.66%) had negative HBeAg and anti-HBe had not been transferred. Among the patients with ALT values <1ULN,> 1-2ULN,> 2-5ULN, and> 5ULN before treatment, the seroconversion rates and e antigen negative rates were 5 (13.15%) and 6 (33.3%), respectively. (33%), 5 cases (38.46%), 3 cases (50%) and 6 cases (15.78%), 6 cases (33.33%), 11 cases (84.6%) and 4 cases .6 6%). The median ALT before and at 104 weeks was (71.82 7 ± 71.6 27) U / L and (34.2 6 ± 31.415) U / L, respectively (P <0.01). 36 cases of YMDD mutation, the total mutation rate was 48%. The median ALT of the mutants and non-mutants were (45.56 ± 40.90 3) U / L and (2.36 2 7 ± 12.69) U / L, respectively (P <0.01 ). The median HBVDNA values were (286.5 ± 482.8877) and (10.2448 ± 380.255) mEq / ml, respectively. Serum HBeAg negative were 10 and 17 cases