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目的观察阿德福韦酯(ADV)单药和联合拉米夫定(LAM)治疗YMDD变异的慢性乙型肝炎(CHB)患者抗HBV疗效和肝功能恢复正常率,停药后HBV DNA定量反跳率以及肝功能再次异常率。方法61例发生YMDD变异的CHB患者随机分成两组:Ⅰ组(ADV单药治疗组)共32例,予口服ADV10mg,每日一次,治疗12个月;Ⅱ组(ADV+LAM联合治疗组)共29例,ADV(10mg)+LAM1(00mg),每日一次,共12个月,分别在治疗后1个月,3个月,6个月,12个月及停药后3个月,6个月,12个月检测HBV DNA定量、肝功能、YMDD耐药变异株,分析对比。结果ADV对LAM治疗后发生YMDD变异的CHB患者有效好疗效;但随着治疗时间延长,单用ADV的疗效不及ADV+LAM联合用药;停药后12个月内两组治疗后HBV DNA定量转阴患者中仍保持HBV DNA定量阴性的比例随着时间的延长,ADV组较ADV+LAM组显著降低;两组肝功能恢复正常率均较高,Ⅱ组比Ⅰ组更高,但无显著差异,停药12个月内正常率逐渐下降,两组下降率也无显著差异;两组在治疗12个月内YMDD变异率逐渐下降,但Ⅱ组比Ⅰ组下降更快,但无明显差异;HBeAg(-)者的HBV DNA定量转阴率和肝功能正常率均较HBeAg(+)者高,但无显著差异;治疗过程中HBV DNA定量早期转阴者,停药后HBV DNA定量反跳率较低。结论ADV对LAM治疗后发生YMDD变异的CHB患者有较好的疗效,远期疗效单用ADV不及ADV+LAM联合治疗,联合治疗可降低停药后的反跳率(序贯治疗时单用ADV相对容易诱导ADV耐药变异,使疗效降低,ADV+LAM治疗可减少ADV耐药发生,可增加疗效。)单用ADV和ADV+LAM治疗均能有效恢复肝功能;HBeAg(-)患者HBV DAN定量转阴率、肝功能正常率均较HBeAg(+)患者高,但也无明显差异;病毒的早期应答可减少停药后的复发。
Objective To observe the anti-HBV efficacy and the normal rate of liver function recovery in patients with chronic hepatitis B (CHB) treated with adefovir dipivoxil (ADV) monotherapy and combined with lamivudine (LAM) for YMDD mutation. Rate of jump and abnormal liver function again rate. Methods Sixty-one CHB patients with YMDD mutation were randomly divided into two groups: group Ⅰ (ADV monotherapy group), with 32 cases treated with ADV 10 mg once daily for 12 months; group Ⅱ (ADV + LAM combined treatment group) A total of 29 cases, ADV (10mg) + LAM1 (00mg), once daily for 12 months were treated at 1 month, 3 months, 6 months, 12 months and 3 months after drug withdrawal, 6 months, 12 months detection of HBV DNA quantitative, liver function, YMDD resistant variants, analysis and comparison. RESULTS: ADV was effective in treating CHB patients with YMDD mutation after LAM treatment. However, with the prolongation of treatment time, the effect of ADV alone was not as good as that of ADV + LAM treatment. After 12 months of treatment, Over time, the proportion of negative HBV DNA in patients with negative results was significantly lower than that in ADV + LAM group. The recovery rates of liver function were higher in both groups, while those in group Ⅱ were higher than those in group Ⅰ, but there was no significant difference , The normal rate gradually decreased within 12 months of withdrawal, and there was no significant difference between the two groups. The mutation rate of YMDD decreased gradually in both groups within 12 months after treatment, but it decreased more rapidly in group Ⅱ than in group Ⅰ, but there was no significant difference. HBeAg (-) in patients with HBV DNA quantitative negative rate and normal liver function were higher than those of HBeAg (+), but no significant difference; HBV DNA quantification in the course of treatment, Lower rate. Conclusions ADV has good effect on CHB patients with YMDD mutation after LAM treatment. Long-term treatment combined ADV with ADV + LAM can reduce the rate of rebound after stopping treatment (ADV Relatively easy to induce ADV resistance mutation, so that the curative effect is reduced, ADV + LAM treatment can reduce ADV resistance, can increase the curative effect.) The treatment of ADV and ADV + LAM can effectively restore liver function; HBeAg (-) patients with HBV DNA Quantitative negative conversion rate, normal liver function were higher than HBeAg (+) patients, but no significant difference; early response to the virus can reduce the recurrence after stopping.