TDF+3TC+EFV初始抗病毒治疗48周不良反应观察分析

Observation and Analysis of Adverse Reactions in 48 Weeks After Initial Antiviral Therapy of TDF+3TC+EFV

目的探讨TDF+3TC+EFV作为HIV/AIDS成年患者初始抗逆转录病毒治疗(HAART)方案治疗48周的主要不良反应。方法建立前瞻性研究队列,纳入300例HIV/AIDS成年患者,给予TDF+3TC+EFV初始HAART 48周,监测治疗期间的主要不良反应。结果 TDF+3TC+EFV初始HAART 48周期间不良反应总发生率99. 30%(283/285),不同类型的发生率依次为神经系统症状84. 21%(240/285)、胃肠道反应18. 95%(54/285)、肝功异常16. 14%(46/285)、皮疹12. 28%(35/285)、肌酐清除率下降1. 75%(5/285); HAART 2、4、8、12、24、48周不良反应发生率分别为91. 23%(260/285)、21. 05%(60/285)、13. 69%(39/285)、9. 47%(27/285)、11. 23%(32/285)、9. 22%(26/282),在接受HAART开始的4周内不良反应发生率最高,差异有统计学意义(P<0. 05),随着HAART治疗时间的延长,不良反应发生率下降;大部分不良反应较轻微,可自行缓解,因不良反应更换HAART方案的仅有1. 05%(3/285)。结论 TDF+3TC+EFV作为HIV/AIDS成年患者初始抗病毒一线治疗方案,短期内具有良好的安全性。

Objective To investigate the major adverse reactions of TDF ＋ 3 TC ＋ EFV as an initial antiretroviral therapy（ HAART） regimen for 48 weeks in adult patients with HIV/AIDS.Methods A prospective cohort of 300 adult patients with HIV/AIDS was established and given TDF ＋ 3 TC ＋ EFV initial HAART for 48 weeks. The main adverse reactions were monitored during the treatment. Results The total incidence of adverse reaction was 99. 30%（ 283/285） during the initial 48 weeks of HAART.The incidence of different types were as follows： neurological symptoms 84. 21%（ 240/285）,gastrointestinal reaction18. 95%（ 54/285）,liver dysfunction 16. 14%（ 46/285）,rash 12. 28%（ 35/285）,creatinine clearance rate decreased by 1. 75%（ 5/285）; The incidence of adverse reactions in HAART 2,4,8,12,24,48 weeks were 91. 23%（ 260/285）,21. 05%（ 60/285）,13. 69%（ 39/285）,9. 47%（ 27/285）,11. 23%（ 32/285）,9. 22%（ 26/285）.The incidence of adverse reactions was the highest in4 weeks after the beginning of HAART,and the difference was statistically significant（ P〈0. 05）. With the prolongation of HAART treatment time,the incidence of adverse reactions decreased; Most of the adverse reactions were mild,and they could relieve themselves. Only 1. 05%（ 3/285） of the HAART scheme was replaced because of adverse reactions.Conclusion TDF＋3 TC＋EFV as an initial antiviral first-line treatment for HIV/AIDS adult patients is safe in the short term.