Mrus Joseph M, Williams Paige L, Tsevat Joel, Cohn Susan E, Wu Albert W
Health Services Research and Development, Department of Veterans Affairs Medical Center, USA
Qual Life Res. 2005 Mar;14(2):479-91. doi: 10.1007/s11136-004-4693-z.
In studies evaluating the general US population, patients in primary care, and patients with chronic conditions, women consistently report poorer health-related quality of life (HRQoL) than men; however, studies evaluating HRQoL in patients with HIV/AIDS have not completely corroborated those findings. The objective of this study was to evaluate gender differences in HRQoL for participants in a large randomized trial comparing antiretroviral regimens.
AIDS Clinical Trials Group (ACTG) 320 was a randomized, blinded, placebo-controlled trial comparing the 3-drug regimen of indinavir + zidovudine (or stavudine) + lamivudine with the 2-drug combination of zidovudine (or stavudine) + lamivudine in subjects with CD4 cell counts less than 200 cells/microl and no prior treatment with protease inhibitors. Nine quality of life domains scored on 0-100 scales were assessed using the ACTG QOL 601-602 Health Survey at 3 points in the trial: baseline, 24 weeks and 40 weeks. Differences between men and women in HRQoL scores were assessed using the Wilcoxon rank-sum test and generalized estimating equation (GEE) models.
Overall, 202 females and 976 males were randomized to one of two treatment arms. Female participants were more likely to be black or Hispanic and tended to be younger. At baseline, females reported lower HRQoL scores than males in all of the domains except social functioning, and at week 40, women scored lower in all of the domains except overall health. In repeated measures models, women were found to score lower in all HRQoL domains except overall health, with significant differences of 3.5-6.7 points in 3 of the 9 quality of life domains: physical functioning, pain, and energy/fatigue. HRQoL scores improved for participants in the study over time and in response to potent treatment, and the improvements were similar for men and women.
Women with HIV/AIDS report substantially poorer HRQoL than men with HIV/AIDS in several HRQoL domains. However, changes in domain scores over time and in response to treatment do not differ significantly by gender, implying that changes in domain scores may be better HRQoL outcomes to compare between HIV-infected men and women in clinical trials than mean domain scores.
在评估美国普通人群、初级保健患者以及慢性病患者的研究中，女性始终报告称其健康相关生活质量（HRQoL）低于男性；然而，评估艾滋病毒/艾滋病患者HRQoL的研究并未完全证实这些发现。本研究的目的是评估在一项比较抗逆转录病毒治疗方案的大型随机试验中参与者的HRQoL性别差异。
艾滋病临床试验组（ACTG）320是一项随机、双盲、安慰剂对照试验，在CD4细胞计数低于200个/微升且未接受过蛋白酶抑制剂治疗的受试者中，比较茚地那韦+齐多夫定（或司他夫定）+拉米夫定的三联疗法与齐多夫定（或司他夫定）+拉米夫定的二联疗法。在试验的三个时间点：基线、24周和40周，使用ACTG QOL 601 - 602健康调查评估九个生活质量领域，评分范围为0 - 100分。使用Wilcoxon秩和检验和广义估计方程（GEE）模型评估HRQoL评分在男性和女性之间的差异。
总体而言，202名女性和976名男性被随机分配到两个治疗组之一。女性参与者更可能是黑人或西班牙裔，且年龄往往更小。在基线时，除社会功能外，女性在所有领域的HRQoL评分均低于男性，在第40周时，除总体健康外，女性在所有领域的评分均较低。在重复测量模型中，发现女性在除总体健康外的所有HRQoL领域评分较低，在九个生活质量领域中的三个领域：身体功能、疼痛和精力/疲劳，存在3.5 - 6.7分的显著差异。随着时间推移以及对有效治疗的反应，研究参与者的HRQoL评分有所改善，男性和女性的改善情况相似。
艾滋病毒/艾滋病女性在几个HRQoL领域报告的HRQoL明显低于艾滋病毒/艾滋病男性。然而，随着时间推移以及对治疗的反应，各领域评分的变化在性别上没有显著差异，这意味着在临床试验中，各领域评分的变化可能比平均领域评分更适合作为比较艾滋病毒感染男性和女性HRQoL结果的指标。
