School of Public Health and Family Medicine, University of Cape Town, Anzio Road, Cape Town, South Africa.
AIDS. 2010 Feb 20;24(4):563-72. doi: 10.1097/QAD.0b013e328333bfb7.
OBJECTIVES: We report on outcomes after 7 years of a community-based antiretroviral therapy (ART) programme in Khayelitsha, South Africa, with death registry linkages to correct for mortality under-ascertainment. DESIGN: This is an observational cohort study. METHODS: Since inception, patient-level clinical data have been prospectively captured on-site into an electronic patient information system. Patients with available civil identification numbers who were lost to follow-up were matched with the national death registry to ascertain their vital status. Corrected mortality estimates weighted these patients to represent all patients lost to follow-up. CD4 cell count outcomes were reported conditioned on continuous virological suppression. RESULTS: Seven thousand, three hundred and twenty-three treatment-naive adults (68% women) started ART between 2001 and 2007, with annual enrolment increasing from 80 in 2001 to 2087 in 2006. Of 9.8% of patients lost to follow-up for at least 6 months, 32.8% had died. Corrected mortality was 20.9% at 5 years (95% confidence interval 17.9-24.3). Mortality fell over time as patients accessed care earlier (median CD4 cell count at enrolment increased from 43 cells/microl in 2001 to 131 cells/microl in 2006). Patients who remained virologically suppressed continued to gain CD4 cells at 5 years (median 22 cells/microl per 6 months). By 5 years, 14.0% of patients had failed virologically and 12.2% had been switched to second-line therapy. CONCLUSION: At a time of considerable debate about future global funding of ART programmes in resource-poor settings, this study has demonstrated substantial and durable clinical benefits for those able to access ART throughout this period, in spite of increasing loss to follow-up.
目的:我们报告了南非开普敦一个基于社区的抗逆转录病毒治疗(ART)项目实施 7 年后的结果,该项目通过死亡登记系统来纠正死亡率的低估。
设计:这是一项观察性队列研究。
方法:自项目启动以来,患者的临床数据一直通过现场电子患者信息系统进行前瞻性采集。对于那些随访失访但有可用的公民身份号码的患者,与国家死亡登记系统进行匹配以确定其生存状况。通过将这些患者加权来代表所有随访失访的患者,对校正后的死亡率进行估计。CD4 细胞计数结果是根据持续病毒学抑制来报告的。
结果:2001 年至 2007 年间,7323 名未经治疗的成年患者(68%为女性)开始接受 ART,每年的入组人数从 2001 年的 80 人增加到 2006 年的 2087 人。9.8%的随访失访至少 6 个月的患者中,32.8%已经死亡。校正后的死亡率为 5 年时为 20.9%(95%置信区间为 17.9-24.3)。随着患者更早地获得治疗,死亡率随时间下降(2001 年入组时的中位 CD4 细胞计数从 43 个/微升增加到 2006 年的 131 个/微升)。持续病毒学抑制的患者在 5 年内继续获得 CD4 细胞(中位每 6 个月增加 22 个/微升)。5 年后,14.0%的患者发生病毒学失败,12.2%的患者转为二线治疗。
结论:在资源匮乏地区关于未来全球 ART 项目资金的激烈争论之际,本研究证明了在整个研究期间能够获得 ART 的患者获得了大量且持久的临床益处,尽管随访失访率不断增加。
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