Testa M A
Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115.
J Cardiovasc Pharmacol. 1993;21 Suppl 2:S18-25. doi: 10.1097/00005344-199321002-00004.
A multicenter clinical trial comparing nifedipine gastrointestinal therapeutic system (GITS) to atenolol was conducted to evaluate the effects of reporter (physician, patient, and spouse) and assessment of environment (clinic vs. take-home), and structure (long vs. short forms). After a 4-week single-blind, placebo washout, 394 male patients with mild-to-moderate hypertension were randomized to receive 20 weeks of either atenolol or nifedipine GITS, titrated to achieve goal blood pressure of < 90 mm hg for 8 weeks and maintained at the final dose for 12 weeks. Quality-of-life assessments included "long-form" clinical assessments by the patient, parallel "short-form," take-home, mail-back assessments by patient and spouse and a side effects and symptom distress evaluation by the physician. Patients completing 20 weeks of therapy indicated a more favorable quality-of-life profile (p < 0.05) for nifedipine GITS compared with atenolol for psychosocial, positive well-being, emotional ties, behavior/emotional control, vitality, and leisure scales using the long-form clinical assessment. The short-form, take-home, mail-back assessments were highly correlated with the clinic assessments, but their responsiveness to treatment differences was less owing to item structure and lower return rates. Spouse reports were more sensitive to treatment differences in sexual functioning with a more favorable response for patients taking nifedipine GITS (p < 0.02). Physicians were less sensitive to the overall impact of side effects, reporting only 14.9% of symptoms reported by the patient. Physician evaluation of symptoms and side effects does not provide the sensitivity required for detecting quality-of-life treatment differences.(ABSTRACT TRUNCATED AT 250 WORDS)
开展了一项多中心临床试验,比较硝苯地平胃肠道治疗系统(GITS)与阿替洛尔,以评估报告者(医生、患者及其配偶)以及环境评估(门诊与带回家评估)和结构(长表与短表)的影响。经过4周的单盲安慰剂洗脱期后,394例轻至中度高血压男性患者被随机分为两组,分别接受20周的阿替洛尔或硝苯地平GITS治疗,滴定剂量以在8周内达到目标血压<90 mmHg,并在最终剂量下维持12周。生活质量评估包括患者进行的“长表”临床评估、患者及其配偶进行的平行“短表”、带回家后邮寄回的评估,以及医生进行的副作用和症状困扰评估。完成20周治疗的患者表明,使用长表临床评估,硝苯地平GITS在心理社会、积极幸福感、情感关系、行为/情绪控制、活力和休闲量表方面的生活质量状况比阿替洛尔更有利(p<0.05)。短表、带回家后邮寄回的评估与门诊评估高度相关,但由于项目结构和较低的回收率,它们对治疗差异的反应性较小。配偶报告对性功能治疗差异更敏感,服用硝苯地平GITS的患者反应更有利(p<0.02)。医生对副作用的总体影响不太敏感,仅报告了患者报告症状的14.9%。医生对症状和副作用的评估不能提供检测生活质量治疗差异所需的敏感性。(摘要截断于250字)