Scott-Lennox J A, Mills R J, Burt M S
Global Health Outcomes, Glaxo Wellcome, Research Triangle Park, NC.
Ann Pharmacother. 1998 May;32(5):525-30. doi: 10.1345/aph.17311.
To assess the impact of treatment with zidovudine plus lamivudine or zalcitabine on health-related quality of life (HRQOL) in patients with HIV.
HRQOL assessments were conducted as part of a double-blind, randomized, 24-week (extended to 52 wk) efficacy and safety study. The Medical Outcomes Study HIV Health Survey (MOS-HIV), which assesses 10 physical and psychological domains of HRQOL, was self-administered by patients at baseline and at weeks 16, 32, 52, or at treatment discontinuation.
Twenty-one outpatient centers in the US, Canada, and Puerto Rico.
The study enrolled 254 HIV-positive patients (CD4+ 100-300 cells/mm3); 206 patients completed the MOS-HIV at baseline and at least once during treatment. Post hoc analyses stratified patients into two subgroups: AIDS (CD4+ < 200 cells/mm3) and non-AIDS (CD4+ > or = 200 cells/mm3).
Patients received zidovudine 200 mg three times daily plus one of the following: lamivudine 150 mg twice daily, lamivudine 300 mg twice daily, or zalcitabine 0.75 mg three times daily.
Change in MOS-HIV scores from baseline to last completed questionnaire.
Following an average of 36 weeks of treatment, there were statistically significant differences across treatment groups in mean change scores on the physical functioning, role functioning, and vitality scales, with stable or increased (improved) scores in the zidovudine plus lamivudine 150 mg group and decreased scores in the zidovudine plus zalcitabine and zidovudine plus lamivudine 300 mg groups for most scales. Post hoc analyses found that in the non-AIDS subgroup, only the zidovudine plus lamivudine 150 mg group had increases in mean MOS-HIV scores (on 8 of 10 scales); in the AIDS subgroup, all but two MOS-HIV scores (in the zidovudine plus zalcitabine group) decreased in all three treatment groups.
These results suggest that, of the three combination therapies studied, zidovudine plus lamivudine 150 mg was most likely to maintain or improve HRQOL in HIV-positive patients.
评估齐多夫定联合拉米夫定或扎西他滨治疗对HIV患者健康相关生活质量（HRQOL）的影响。
HRQOL评估是一项双盲、随机、为期24周（延长至52周）的疗效和安全性研究的一部分。医学结果研究HIV健康调查（MOS-HIV）评估HRQOL的10个生理和心理领域，由患者在基线时以及第16、32、52周或治疗中断时自行填写。
美国、加拿大和波多黎各的21个门诊中心。
该研究纳入了254名HIV阳性患者（CD4+ 100 - 300个细胞/mm³）；206名患者在基线时以及治疗期间至少完成了一次MOS-HIV调查。事后分析将患者分为两个亚组：艾滋病（CD4+ < 200个细胞/mm³）和非艾滋病（CD4+ ≥ 200个细胞/mm³）。
患者接受每日三次200mg齐多夫定加以下其中一种药物治疗：每日两次150mg拉米夫定、每日两次300mg拉米夫定或每日三次0.75mg扎西他滨。
从基线到最后完成问卷时MOS-HIV评分的变化。
平均治疗36周后，各治疗组在生理功能、角色功能和活力量表的平均变化评分上存在统计学显著差异，在齐多夫定加150mg拉米夫定组中评分稳定或升高（改善），而在齐多夫定加扎西他滨组和齐多夫定加300mg拉米夫定组中，大多数量表评分下降。事后分析发现，在非艾滋病亚组中，只有齐多夫定加150mg拉米夫定组的MOS-HIV平均评分升高（在10个量表中的8个）；在艾滋病亚组中，所有三个治疗组中除了两个MOS-HIV评分（齐多夫定加扎西他滨组）外均下降。
这些结果表明，在研究的三种联合治疗方案中，齐多夫定加150mg拉米夫定最有可能维持或改善HIV阳性患者的HRQOL。
