摘要目的 观察不同初始方案治疗HIV感染者/艾滋病患者的换药率,并分析因药物不良反应换药的危险因素.方法 对2012年开始以替诺福韦(TDF)或齐多夫定(AZT)+拉米夫定(3TC)+依非韦伦(EFV)为初始治疗方案的14 060例HIV感染者/艾滋病患者进行回顾性队列研究,随访2年.TDF+3TC+EFV治疗5 126例(TDF组),AZT+3TC+EFV治疗8 934例(AZT组).卡方检验比较两组换药率及因不良反应而换药的情况,Cox比例风险模型分析发生换药的危险因素.结果 14 060例HIV感染者/艾滋病患者平均观察生存人年数1.85人年.共有2 795例更换初始治疗药物,总换药率为19.9%.排除因妊娠换药的200例后,AZT+3TC+EFV组换药2 070例,发生率为23.5%,因不良反应换药1 652例,占18.8%;TDF+3TC+EFV组换药525例,发生率为10.4%,因不良反应换药315例,占6.2%;两组比较差异有统计学意义(χ2值分别为366.68、416.89,均P<0.01).AZT+3TC+EFV组发生换药的风险高于TDF+3TC+EFV组[校正危险比(aHR)=2.89,95%CI:2.57~3.24],因不良反应换药的风险也高于TDF+3TC+EFV组(aHR=3.85,95%CI:3.34~4.45).结论 使用AZT+3TC+EFV为一线治疗药物的患者比使用TDF+3TC+EFV的患者更容易发生换药.女性、年龄>45岁、体质指数(BMI)<18.5 kg/cm2、基线CD4+T淋巴细胞计数<200/μL是发生换药的危险因素.

abstractsObjective To compare the rates of regimen modification between patients with different initial antiretroviral therapy, and to investigate risk factors associated with drug toxicity-related regimen modification.Methods A two-years retrospective cohort study was conducted in 14 060 patients who initiated antiretroviral treatment with Zidovudine (AZT)/Tenofovir disoproxil (TDF)+Lamivudine (3TC)+Efavirenz (EFV) since 2012.There were 5 126 patients initiated TDF+3TC+EFV therapy (TDF group) and 8 934 patients initiated AZT+3TC+EFV therapy (AZT group).Chi-square test was used to compare the rate of first-line regimen modification and the rate of toxicity-related regimen modification between two groups.Cox proportional hazard model was used to investigate the risk factors associated with regimen modification.Results A total of 14 060 acquired immunodeficiency syndrome patients were observed for a median period of 1.85 person-years.There were 2 795 patients who changed their initial antiretroviral regimen and the rate of initial regimen modification was 19.9%.Two hundred patients who changed their initial regimen due to pregnancy were excluded.There were 2 070 patients in AZT group who changed their initial regimen with a rate of 23.5%.Among them, 1 652 patients changed their regimen due to drug toxicity and the rate was 18.8%.There were 525 patients in TDF group who changed their initial regimen with a rate of 10.4% and the rate of toxicity-related regimen modification was 6.2%.The differences between two groups were statistical significance (χ2=366.68 and 416.89, respectively, both P<0.01).The risk of regimen modification in AZT group were significantly higher than that in TDF group (aHR=2.89, 95%CI: 2.57-3.24).The risk of toxicity-related regimen modification in AZT group was also significantly higher than that in TDF group (aHR=3.85, 95%CI: 3.34-4.45).Conclusions Patients initiated antiretroviral treatment with AZT+3TC+EFV are more likely to change their initial regimen than those who initiated treatment with TDF+3TC+EFV.Female, age >45 years old, BMI<18.5 kg/cm2 and baseline CD4+ T cell count<200/mL were risk factors associated with regimen modification.