Differences Between Women and Men in Adverse Events and CD4+ Responses to Nucleoside Analogue Therapy for HIV Infection
Differences Between Women and Men in Adverse Events and CD4+ Responses to Nucleoside Analogue Therapy for HIV Infection
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女性和男性在艾滋病毒感染核苷类似物治疗的不良事件和 CD4 反应方面的差异
DOI：
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发表时间：
2000
期刊：
影响因子：
--
通讯作者：
D. Cotton
中科院分区：
文献类型：
--
作者：
J. Currier;C. Spino;J. Grimes;C. Wofsy;D. Katzenstein;M. Hughes;S. Hammer;D. Cotton
目的：在核苷类似物治疗的临床试验中，前瞻性地研究HIV感染女性和男性之间基线特征和研究结果的差异。方法：ACTG 175将CD4+计数在200 - 500细胞/mm3之间的HIV感染患者随机分配到四种核苷类似物方案中的一种：齐多夫定（ZDV），二腺苷（ddl）， ZDV + ddI或ZDV + zalcitabine （ddC）。在首次剂量调整的时间、自愿停药、毒性和症状的发展以及艾滋病进展方面的差异按性别进行比较。结果：该研究包括438名女性和2029名男性。在接受检测的一组患者中，女性的HIV RNA血浆浓度基线值（0.3 log10）显著低于男性，并且在调整CD4+计数后这种差异仍然存在。与男性相比，女性报告减少剂量和停止使用含ddI的方案的频率更高；体重调整并不能完全解释这种差异。女性进展到研究终点的风险低于男性（女性为19%，男性为24%；p < 0.0001）。在那些接受ZDV的抗逆转录病毒初始研究受试者中，男性进展到研究终点的可能性是女性的四倍。结论：在这项临床试验中，男女受试者在预处理特征和研究经验上存在差异。未经抗逆转录病毒治疗的研究对象对ZDV单药治疗的反应存在性别差异，女性HIV RNA基线值较男性低，这为病毒复制、CD4+下降和核苷类似物治疗反应之间的关系存在性别差异提供了证据。
Objective: To prospectively examine differences in baseline characteristics and study outcomes between HIV‐infected women and men during a clinical trial of nucleoside analogue therapy. Methods: ACTG 175 randomized HIV‐infected patients with CD4+ counts between 200 and 500 cells/mm3 to one of four nucleoside analogue regimens: zidovudine (ZDV), didanosine (ddl), ZDV + ddI, or ZDV + zalcitabine (ddC). Differences in time to first dose modification, voluntary withdrawal, development of toxicity and symptomatology, and AIDS progression were compared by gender. Results: The study included 438 women and 2029 men. Baseline values of HIV RNA plasma concentrations were significantly lower for women (0.3 log10) than men in a subset of patients in whom assays were taken and this difference persisted after adjustment for CD4+ count. Women reported reducing dosage and discontinue ddI‐containing regimens more frequently than men did; adjustment for weight did not completely explain this difference. Women were at lower risk than men for progression to a study endpoint (19% of women versus 24% of men; p < .0001). Among those antiretroviral‐naive study subjects receiving ZDV, men were four times more likely to progress to a study endpoint than women. Conclusions: Differences in pretreatment characteristics and on study experiences were demonstrated between women and men enrolled in this clinical trial. The suggestion of a gender difference in response to ZDV monotherapy by antiretroviral‐naive study subjects and the lower baseline values for HIV RNA in women compared with those in men provides evidence for gender differences in the relationship between virus replication, CD4+ decline, and responses to nucleoside analogue therapy.
对 CD4 细胞计数为每立方毫米 500 或更多的无症状 HIV 感染成人进行立即治疗和延迟齐多夫定治疗的比较。
DOI：
10.1056/nejm199508173330701
发表时间：
1995
期刊：
The New England journal of medicine
影响因子：
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作者：
Volberding,PA;Lagakos,SW;Grimes,JM;Stein,DS;Rooney,J;Meng,TC;Fischl,MA;Collier,AC;Phair,JP;Hirsch,MS
通讯作者：
Hirsch,MS