TREATMENT WITH LAMIVUDINE, ZIDOVUDINE, OR BOTH IN HIV-POSITIVE PATIENTS WITH 200 TO 500 CD4+ CELLS PER CUBIC MILLIMETER

TREATMENT WITH LAMIVUDINE, ZIDOVUDINE, OR BOTH IN HIV-POSITIVE PATIENTS WITH 200 TO 500 CD4+ CELLS PER CUBIC MILLIMETER
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DOI:
10.1056/nejm199512213332502
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发表时间:
1995-12-21
影响因子:
158.5
通讯作者:
RUBIN, M
RUBIN, M
中科院分区:
医学1区
文献类型:
--
作者:
ERON, JJ;BENOIT, SL;RUBIN, M

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背景逆转录酶抑制剂拉米夫定与齐多夫定在体外对人类免疫缺陷病毒(HIV)具有协同作用。我们研究了拉米夫定联合齐多夫定与单用任何一种药物治疗HIV感染患者的活性和安全性,其中大多数患者以前没有接受过齐多夫定。366例CD 4+细胞数在200 ~ 500/mm 3之间的患者,接受齐多夫定治疗4周或更短时间,随机分为4种治疗方案:拉米夫定300 mg/12小时;齐多夫定200 mg/8小时;拉米夫定150 mg/12小时+齐多夫定;或每12小时300毫克拉米夫定加齐多夫定。该研究是双盲的,持续24周,扩展期为28周。在24周期间,低剂量和高剂量拉米夫定和齐多夫定联合治疗方案与CD 4+细胞计数(分别为P=0.002和P=0.015)和CD 4+细胞百分比(P
Background. The reverse-transcriptase inhibitor lamivudine has in vitro synergy with zidovudine against the human immunodeficiency virus (HIV). We studied the activity and safety of lamivudine plus zidovudine as compared with either drug alone as treatment for patients with HIV infection, most of whom had not previously received zidovudine.Methods. Three hundred sixty-six patients with 200 to 500 CD4+ cells per cubic millimeter who had received zidovudine for four weeks or less were randomly assigned to treatment with one of four regimens: 300 mg of lamivudine every 12 hours; 200 mg of zidovudine every 8 hours; 150 mg of lamivudine every 12 hours plus zidovudine; or 300 mg of lamivudine every 12 hours plus zidovudine. The study was double-blind and lasted 24 weeks, with an extension phase for another 28 weeks.Results. Over the 24-week period, the low-dose and high-dose regimens combining lamivudine and zidovudine were associated with greater increases in the CD4+ cell count (P=0.002 and P=0.015, respectively) and the percentage of CD4+ cells (P