护士与医生管理接受抗逆转录病毒治疗的 HIV 感染患者（CIPRA-SA）：一项随机非劣效性试验。
Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial.
机构信息
Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
出版信息
Lancet. 2010 Jul 3;376(9734):33-40. doi: 10.1016/S0140-6736(10)60894-X.
BACKGROUND
Expanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor management of ART care for HIV-infected patients.
METHODS
This randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV-positive individuals with a CD4 cell count of less than 350 cells per microL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored ART care. Patients were randomly assigned by stratified permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primary objective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurse versus doctor group for cumulative treatment failure was prespecified as an upper 95% CI for the hazard ratio that was less than 1.40. This study is registered with ClinicalTrials.gov, number NCT00255840.
FINDINGS
408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group. The hazard ratio for composite failure was 1.09 (95% CI 0.89-1.33), which was within the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60-144), deaths (ten vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctor groups, respectively.
INTERPRETATION
Nurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART.
FUNDING
National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.
背景
在资源匮乏的环境中，扩大联合抗逆转录病毒疗法（ART）的可及性依赖于将任务从医生转移到其他卫生保健提供者。我们比较了护士与医生管理抗逆转录病毒治疗（ART）对艾滋病毒感染者的护理结果。
方法
这项随机非劣效性试验在南非的两家初级保健诊所进行。CD4 细胞计数低于每微升 350 个细胞或符合世界卫生组织（WHO）第 3 或 4 期疾病的 HIV 阳性个体被随机分配到护士监测或医生监测的 ART 护理组。患者按分层排列区组随机分配，患者和分析数据的人员均不了解分组情况。主要终点是包含死亡率、病毒失败、治疗限制毒性作用和按访视计划服药在内的治疗限制事件的综合终点。分析采用意向治疗。护士组与医生组累积治疗失败的非劣效性预先设定为危险比的上限 95%CI 小于 1.40。本研究在 ClinicalTrials.gov 注册，编号为 NCT00255840。
结果
408 名患者被分配到医生监测的 ART 护理组，404 名患者被分配到护士监测的 ART 护理组，所有参与者均进行了分析。371 名（46%）患者达到了治疗失败的终点：护士组 192 名（48%），医生组 179 名（44%）。复合失败的危险比为 1.09（95%CI 0.89-1.33），在非劣效性范围内。中位随访 120 周（IQR 60-144）后，护士组和医生组的死亡人数（10 例比 11 例）、病毒学失败（44 例比 39 例）、毒性失败（68 例比 66 例）和项目流失（70 例比 63 例）相似。
结论
护士监测的 ART 与医生监测的治疗无差异。这项研究的结果为将任务转移到经过适当培训的护士以监测 ART 提供了支持。
资助
美国国立卫生研究院；美国国际开发署；美国国立过敏和传染病研究所。
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