替诺福韦联合聚乙二醇干扰素α2a注射液治疗耐药慢性乙型病毒性肝炎患者的临床研究

Clinical trial of tenofovir combined with polyethylene glycol interferon α 2a injection in the treatment of drug resistance patients with chronic hepatitis

目的观察替诺福韦联合聚乙二醇干扰素α2a注射液治疗耐药慢性乙型病毒性肝炎(乙肝)患者的临床疗效和安全性。方法将76例耐药性慢性乙肝患者分为对照组和试验组,每组38例。对照组给予替诺福韦300 mg,每天1次,口服。试验组在对照组的基础上给予聚乙二醇干扰素α2a注射液180μg,每周1次,皮下注射。2组均持续治疗48周。比较2组患者的临床疗效,观察2组患者的血清乙肝病毒脱氧核糖核酸(HBV-DNA)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、乙肝病毒的脱氧核糖核酸(HBV-DNA)转阴率及药物不良反应发生情况。结果治疗后,试验组和对照组总有效率分别为86.84%(33例/38例)和65.79%(25例/38例),HBV-DNA转阴率分别为73.68%(28例/38例),50.00%(19例/38例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组血清HBV-DNA分别为(2.98±0.35),(4.13±0.43)log10copies·m L^(-1),ALT分别为(38.97±8.44),(58.51±8.15)U·L^(-1),AST分别为(39.13±4.21),(50.62±6.45)U·L^(-1),差异均有统计学意义(均P<0.05)。治疗过程中,对照组出现头晕3例,胃肠道反应5例,药物不良反应发生率为21.05%(8例/38例);试验组出现血液系统异常4例,胃肠道反应3例,皮肤异常3例,药物不良反应发生率为26.32%(10例/38例),差异无统计学意义(P>0.05)。结论替诺福韦联合聚乙二醇干扰素α2a注射液治疗耐药慢性乙肝患者的临床疗效高于单用替诺福韦,能够降低血清HBV-DNA,ALT和AST。

Objective To evaluate the clinical effect of tenofovir com- bined with polyethylene glycol interferon a2a injection in the treatment of drug resistance patients with chronic hepatitis. Methods Seventy - six patients with drug - resistant chronic hepatitis were divided into control group and treatment group, 38 cases in each group. Control group was treated with tenofovir 300 rag, qd, orally. Treatment group was treated with pegylated interferon a2a injection 180 p,g on the basis of control group, 1 time per week, subcutaneous injection. All patients were trea- ted for 48 weeks. Clinical effect, serum hepatitis B virus deoxyri bonu- eleic acid （ HBV - DNA）, alanine aminotransferase （ ALT）, aspartate aminotransferase（AST）, HBV -DNA negative rate and adverse drug reactions in two group were evaluated. Results After treatment, thetotal effective rates in treatment group and control group were 86. 84% （33 cases/38 cases） and 65.79% （25 cases/ 38 cases）, the HBV -DNA overcast rates were 73.68% （28 cases/38 cases） and 50. 00% （19 cases/38 cases）, with significant difference （ P 〈 0. 05 ）. The serum HBV DNA in treatment group and control group were （2. 98 ± 0. 35 ） and （4. 13 ± 0. 43 ） log10 copies · mL-1, ALT were （ 38.97 ± 8.44 ） and （58.51± 8.15 ） U ·L-1, AST were （39. 13 ± 4. 21 ） and （50. 62 ± 6. 45 ） U · L- l, with significant difference （ P 〈 0. 05 ）. There were 3 cases of dizzi- ness, 5 cases of gastrointestinal reaction in control group, and were 4 cases of abnormal blood system, 3 cases of gastro- intestinal tract reaction, 3 cases of skin abnormalities in treatment group. The incidence of adverse drug reactions in control group and treatment group were 21.05% （8 cases/38 cases） and 26. 32% （ 10 cases/38 cases）, with no signifi- cant difference （P 〉 0. 05 ）. Conclusion The clinial effect of tenofovir combined with polyethylene glycol interferon a2a injection in the treatment of drug resistance patients with chronic hepatitis is better than tenofovir alone, and can reduce the serum HBV- DNA, ALT, AST.