Kusek J W, Lee J Y, Smith D E, Milligan S, Faulkner M, Cornell C E, Kopple J D, Greene P G
NIDDK, NIH, Bethesda, MD 20892-6600, USA.
Control Clin Trials. 1996 Aug;17(4 Suppl):40S-46S. doi: 10.1016/s0197-2456(97)82681-5.
The African American Study of Kidney Disease and Hypertension (AASK) Pilot Study evaluated the feasibility of carrying out a randomized, multicenter, 7-year clinical trial to determine the effects of two goal levels of blood pressure control and three antihypertensive drug regimens on decline in glomerular filtration rate in African Americans with clinically diagnosed hypertensive nephrosclerosis. Participants were randomized to either a usual mean arterial blood pressure (MAP) goal group (102-107 mm Hg) or a low-MAP goal group (< or = 92 mm Hg) and to a drug regimen (initial therapy with either atenolol, amlodipine, or enalapril). Quality of life was assessed by the Medical Outcomes Short-Form 36 (MOS SF-36) at baseline and the last follow-up visit for 84 of the 94 participants of the AASK Pilot Study. Symptoms were assessed at baseline and throughout the course of therapy by participant self-report. Mean SF-36 scores increased significantly on physical functioning (9.2), role limitations (physical) (19.0), social functioning (9.0), and vitality dimensions (5.6) from baseline to the last follow-up visit in the usual MAP goal group. Scores for the eight health dimensions assessed by the MOS SF-36 did not change significantly during the same time period either in the low-MAP goal group or in any of the drug regimens. The mean score for general health perception was significantly lower at the last follow-up visit in the enalapril drug regimen (49.9) compared to drug regimens with atenolol (65.4) or amlodipine (63.9). Physical functioning, role limitations (emotional), social functioning, mental health, vitality, and general health perception scores were negatively correlated with self-reported symptoms during treatment. We conclude that selected dimensions of quality of life improved during the AASK Pilot Study only in participants randomized to the usual MAP goal group. Significant differences between MAP goal groups and drug regimens at the end of follow-up were observed for only a few health dimensions.
非裔美国人肾脏疾病与高血压研究（AASK）初步研究评估了开展一项为期7年的随机、多中心临床试验的可行性，该试验旨在确定两个血压控制目标水平以及三种抗高血压药物治疗方案对临床诊断为高血压性肾硬化的非裔美国人肾小球滤过率下降的影响。参与者被随机分为常规平均动脉压（MAP）目标组（102 - 107毫米汞柱）或低MAP目标组（≤92毫米汞柱），并随机分配至一种药物治疗方案（初始治疗使用阿替洛尔、氨氯地平或依那普利）。在AASK初步研究的94名参与者中，有84名在基线和最后一次随访时通过医学结局简表36（MOS SF - 36）评估生活质量。在基线和整个治疗过程中，通过参与者自我报告评估症状。在常规MAP目标组中，从基线到最后一次随访，SF - 36平均得分在身体功能（9.2）、角色限制（身体方面）（19.0）、社会功能（9.0）和活力维度（5.6）上显著增加。在低MAP目标组或任何药物治疗方案中，在同一时期通过MOS SF - 36评估的八个健康维度的得分均未显著变化。与使用阿替洛尔（65.4）或氨氯地平（63.9）的药物治疗方案相比，依那普利药物治疗方案在最后一次随访时的总体健康感知平均得分显著更低（49.9）。在治疗期间，身体功能、角色限制（情感方面）、社会功能、心理健康、活力和总体健康感知得分与自我报告的症状呈负相关。我们得出结论，在AASK初步研究期间，仅在随机分配至常规MAP目标组的参与者中，生活质量的选定维度有所改善。随访结束时，MAP目标组和药物治疗方案之间仅在少数健康维度上观察到显著差异。
