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目的:对治疗乙型肝炎的新药拉米夫定进行前瞻性不良反应的观察。方法:拉米夫定100mg和淀粉片的随机、双盲、安慰剂对照的临床研究治疗12周,继续应用拉米夫定100mg开放治疗40～156周,观察其不良反应的发生及血液学和生化学的检查。结果:两组患者在双盲治疗期间不良反应的发生率和血液学及生化学指标无显著差异。在开放治疗期间的不良反应轻微,患者耐受性好,多数患者在治疗后肝功能改善。但其是否对血脂及心血管有影响尚待进一步研究。结论:拉米夫定治疗乙型肝炎安全性较大,不良反应较少,可长期应用,但应注意血脂的检查。
Objective: To observe the prospective adverse reaction of lamivudine, a new drug for treating hepatitis B Methods: Randomized, double-blind, and placebo-controlled clinical trial of lamivudine 100 mg and starch tablets for 12 weeks followed by 100 mg of lamivudine for 40 to 156 weeks. The incidence of adverse reactions, Biochemical examination. Results: There was no significant difference in adverse reactions and hematological and biochemical parameters between the two groups during double-blind treatment. Adverse reactions were mild during open treatment, patients were well tolerated, and most patients had improved liver function after treatment. However, whether it has effects on blood lipids and cardiovascular diseases remains to be further studied. Conclusion: Lamivudine treatment of hepatitis B more safe, less adverse reactions, long-term use, but should pay attention to blood lipids.