Department of Social Medicine, University of Bristol, Bristol, UK.
Lancet. 2010 Aug 7;376(9739):449-57. doi: 10.1016/S0140-6736(10)60666-6. Epub 2010 Jul 15.
BACKGROUND: Prognostic models have been developed for patients infected with HIV-1 who start combination antiretroviral therapy (ART) in high-income countries, but not for patients in sub-Saharan Africa. We developed two prognostic models to estimate the probability of death in patients starting ART in sub-Saharan Africa. METHODS: We analysed data for adult patients who started ART in four scale-up programmes in Côte d'Ivoire, South Africa, and Malawi from 2004 to 2007. Patients lost to follow-up in the first year were excluded. We used Weibull survival models to construct two prognostic models: one with CD4 cell count, clinical stage, bodyweight, age, and sex (CD4 count model); and one that replaced CD4 cell count with total lymphocyte count and severity of anaemia (total lymphocyte and haemoglobin model), because CD4 cell count is not routinely measured in many African ART programmes. Death from all causes in the first year of ART was the primary outcome. FINDINGS: 912 (8.2%) of 11 153 patients died in the first year of ART. 822 patients were lost to follow-up and not included in the main analysis; 10 331 patients were analysed. Mortality was strongly associated with high baseline CD4 cell count (>/=200 cells per muL vs <25; adjusted hazard ratio 0.21, 95% CI 0.17-0.27), WHO clinical stage (stages III-IV vs I-II; 3.45, 2.43-4.90), bodyweight (>/=60 kg vs <45 kg; 0.23, 0.18-0.30), and anaemia status (none vs severe: 0.27, 0.20-0.36). Other independent risk factors for mortality were low total lymphocyte count, advanced age, and male sex. Probability of death at 1 year ranged from 0.9% (95% CI 0.6-1.4) to 52.5% (43.8-61.7) with the CD4 model, and from 0.9% (0.5-1.4) to 59.6% (48.2-71.4) with the total lymphocyte and haemoglobin model. Both models accurately predict early mortality in patients starting ART in sub-Saharan Africa compared with observed data. INTERPRETATION: Prognostic models should be used to counsel patients, plan health services, and predict outcomes for patients with HIV-1 infection in sub-Saharan Africa. FUNDING: US National Institute of Allergy And Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Cancer Institute.
背景：已经为在高收入国家开始联合抗逆转录病毒治疗（ART）的 HIV-1 感染者开发了预后模型，但尚未为撒哈拉以南非洲的患者开发。我们开发了两种预后模型来估计在撒哈拉以南非洲开始 ART 的患者的死亡概率。
方法：我们分析了 2004 年至 2007 年在科特迪瓦、南非和马拉维的四个扩大规模方案中开始接受 ART 的成年患者的数据。排除了在第一年随访中失访的患者。我们使用威布尔生存模型构建了两种预后模型：一种模型使用 CD4 细胞计数、临床分期、体重、年龄和性别（CD4 计数模型）；另一种模型用总淋巴细胞计数和严重贫血代替 CD4 细胞计数（总淋巴细胞和血红蛋白模型），因为在许多非洲的 ART 方案中，CD4 细胞计数未常规测量。ART 第一年的所有原因死亡是主要结局。
结果：在 ART 的第一年，11153 例患者中有 912 例（8.2%）死亡。822 例患者失访，未纳入主要分析；对 10331 例患者进行了分析。死亡率与高基线 CD4 细胞计数（≥200 个细胞/μL 与 <25；调整后的危险比 0.21，95%CI 0.17-0.27）、世界卫生组织临床分期（III-IV 期与 I-II 期；3.45，2.43-4.90）、体重（≥60kg 与 <45kg；0.23，0.18-0.30）和贫血状态（无与严重；0.27，0.20-0.36）密切相关。死亡率的其他独立危险因素包括低总淋巴细胞计数、高龄和男性。CD4 模型的 1 年死亡率范围为 0.9%（95%CI 0.6-1.4）至 52.5%（43.8-61.7），总淋巴细胞和血红蛋白模型的 1 年死亡率范围为 0.9%（0.5-1.4）至 59.6%（48.2-71.4）。与观察数据相比，这两种模型都能准确预测撒哈拉以南非洲开始接受 ART 的患者的早期死亡率。
解释：应使用预后模型来为患者提供咨询、规划卫生服务并预测撒哈拉以南非洲 HIV-1 感染者的结局。
资金来源：美国国家过敏和传染病研究所、美国国立儿童健康与人类发展研究所和美国国家癌症研究所。
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