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TDF3TCEFV和AZT3TCEFV方案治疗96周对初治HIV感染者肾功能的影响

传染病信息 2019年4月30日第32卷第2期 Infect Dis Info, Vol. 32, No. 2, April 30, 2019·122·

TDF+3TC+EFV和AZT+3TC+EFV方案

治疗96周对初治HIV感染者肾功能的影响

孙建军，刘　莉，沈银忠，张仁芳，官丽倩，王江蓉，齐唐凯，王珍燕，汤　阳，宋　炜，陈　军，

卢洪洲

[摘要]　目的　探讨应用我国首选抗HIV治疗方案富马酸替诺福韦二吡呋酯（tenofovir disoproxil fumarate, TDF）+拉米夫定（lamivudine, 3TC）+依非韦伦（efavirenz, EFV）及备选方案齐多夫定（zidovudine, AZT）+3TC+EFV 对初治HIV感染者肾功能的影响。方法　回顾性分析2012年1月—2014年5月在上海市公共卫生临床中心艾滋病门诊使用上述2种方案抗病毒治疗并随访的初治HIV感染者1045例，其中应用TDF+3TC+EFV方案（TDF组） 455例，AZT+3TC+EFV方案（AZT组）590例。收集患者人口学资料及临床治疗数据，分析2组治疗过程中肾功能指标变化情况。结果　TDF组的基线、治疗48周、96周估算肾小球滤过率（estimated glomerular ? ltration rate, eGFR）分别是113.1 ml/（min·1.73 m2），114.0 ml/（min·1.73 m2）和112.2 ml/（min·1.73 m2）；AZT组的基线、治疗48周、96周eGFR分别是112.9 ml/（min·1.73 m2），116.2 ml/（min·1.73 m2）和118.1 ml/（min·1.73 m2）。与治疗前相比，TDF组治疗48周eGFR水平有稍微升高，而在治疗96周时又回落至基线水平。而AZT组，治疗48周及96周的eGFR水平与基线eGFR水平相比均有升高。TDF组中基线eGFR＜90 ml/（min·1.73 m2）者，治疗48周eGFR水平较基线有上升；AZT组中基线eGFR＜90 ml/（min·1.73 m2）者治疗48周eGFR水平较基线有所升高。结论　我国初治HIV感染者中应用TDF+3TC+EFV方案治疗者，开始治疗的2年内患者肾功能无明显减低；对于60 ml/（min·1.73 m2）＜eGFR＜90 ml/（min·1.73 m2）的初治HIV感染者，TDF组治疗后eGFR亦保持稳定。关于TDF组远期治疗后肾功能变化有待于进一步观察。

[关键词]　HIV感染；抗反转录病毒；富马酸替诺福韦二吡呋酯；齐多夫定；肾小球滤过率

[中国图书资料分类号]　R512.91 [文献标志码]A [文章编号]　1007-8134(2019)02-0122-05

DOI: 10.3969/j.issn.1007-8134.2019.02.006

Renal function of na?ve HIV patients after

96-week TDF+3TC+EFV or AZT+3TC+EFV treatment

SUN Jian-jun, LIU Li, SHEN Yin-zhong, ZHANG Ren-fang, GUAN Li-qian, WANG Jiang-rong, QI Tang-kai, WANG Zhen-yan,

TANG Yang, SONG Wei, CHEN Jun, LU Hong-zhou*

SUN Jian-jun and LIU Li are the first authors who contributed equally to the article

Department of Infection and Immunization, Shanghai Public Health Clinical Center, 201508, China

*Corresponding author, E-mail: luhongzhou@https://www.wendangku.net/doc/753088927.html,

[Abstract]　Objective　To investigate the effects of tenofovir disoproxil fumarate (TDF)+lamivudine (3TC)+efavirenz (EFV) and the optional treatment of zidovudine (AZT)+3TC+EFV on renal function of na?ve HIV-infected patients. Methods　A retrospective study was conducted among 1045 na?ve HIV-infected patients, who were treated with TDF+3TC+EFV regimen or AZT+3TC+EFV regimen and followed up from January 2012 to May 2014 in Shanghai Public Health Clinic Center. Among the involved 1045 patients, 455 cases received TDF+3TC+EFV regimen (TDF group) and 590 cases received AZT+3TC+EFV regimen (AZT group). The demographic and clinical treatment data of all patients were collected, the changes of renal function index in 2 groups were analyzed. Results　At baseline, 48-week and 96-week treatment, the eGFR of TDF group were 113.1 ml/(min·1.73 m2), 114.0 ml/(min·1.73 m2) and 112.2 ml/(min·1.73 m2), respectively. At baseline, 48-week and 96-week treatment, the eGFR of AZT group were 112.9 ml/ (min·1.73 m2), 116.2 ml/(min·1.73 m2) and 118.1 ml/(min·1.73 m2), respectively. Compared with baseline, the eGFR value of TDF group increased slightly at 48 weeks and fell back to the baseline level at 96 weeks. Compared with baseline, the eGFR value increased in AZT group at 48 and 96 weeks. For patients with baseline eGFR ＜90 ml/(min·1.73 m2) in TDF group, the eGFR increased at 48 weeks compared with baseline; For patients with baseline eGFR＜90 ml/(min·1.73 m2) in AZT group, the eGFR increased at 48 weeks compared with baseline. Conclusions　The regimen of TDF+3TC+EFV does not significantly reduce the renal function within the first two years of treatment among na?ve HIV-infected patients in China. For na?ve HIV-infected patients with 60 ml/(min·1.73 m2)＜eGFR＜90 ml/(min·1.73 m2), TDF regimen maintains stable eGFR after treatment. The changes of renal function in TDF group after long-term treatment need to be further observed.

[Key words]　HIV infection; antiretroviral therapy; tenofovir disoproxil fumarate; zidovudine; glomerular filtration rate

自1996年以来，高效抗反转录病毒治疗的广泛应用使得艾滋病的发病率和病死率明显下降[1]。[基金项目]　“十三五”国家重大新药创制专项（2017ZX09304027）[作者单位]　201508，上海市公共卫生临床中心感染与免疫科（孙建军、刘莉、沈银忠、张仁芳、官丽倩、王江蓉、齐唐凯、王珍燕、汤阳、宋炜、陈军、卢洪洲）

前两位作者对本文有同等贡献，均为第一作者

[通信作者]　卢洪洲，E-mail: luhongzhou@https://www.wendangku.net/doc/753088927.html, 而对于抗病毒治疗资源较为有限的国家和地区，可供选择的抗病毒药物仍较为有限。我国《艾滋病诊疗指南第三版（2015版）》[2]中提出富马酸替诺福韦二吡呋酯（tenofovir disoproxil fumarate, TDF）+拉米夫定（lamivudine, 3TC）+依非韦伦（efavirenz, EFV）组合仍是首选方案，而将齐多