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拉米夫定临床安全性研究
Studies on clinical safety of lamivudine
【摘要】 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。
【Abstract】 Objective: To observe prospectively the adverse reactions of a new drug, lamivudine, for hepatitis B. Methods: The adverse reactions were observed and both hematology and biochemical analyses were made in two groups, with lamivudine 100 mg a day and the other with starch tablet by random double blind placebo control clinical method for twelve weeks, and then the treatment followed for forty to one hundred and fifty-six weeks with lamivudine 100 mg a day. Results: During the double blind treatment period, no significant differences were shown in their incidence of the adverse reactions and hematology and biochemical indices. Some light adverse reactions were produced in patients, but with good tolerance in the open treatment period. The most patients’ liver function was improved. However, more studies must be done on whether it is associated with a hyperlipidaemia or cardiovascular complications. Conclusion: Lamivudine is safe for hepatitis B. It has few adverse reactions and can be used for a long time with care of the blood lipid profile.
- 【文献出处】 药物不良反应杂志 ,Adverse Drug Reactions Journal , 编辑部邮箱 ,1999年03期
- 【分类号】R96
- 【被引频次】3
- 【下载频次】117