Dahlöf Björn, Degl' Innocenti Alessio, Elmfeldt Dag, Puig Juan Garcia, Gundersen Torstein, Hosie James, Januszewicz Wlodzimierz, Lindström Carl-Johan, Magometschnigg Dieter, Tanser Paul, Toutouzas Pavles, Waeber Bernhard, Wiklund Ingela
Clinical Experimental Research Laboratory, Department of Medicine, Sahlgrenska University Hospital/Ostra, Göteborg, Sweden.
Am J Hypertens. 2005 Oct;18(10):1313-9. doi: 10.1016/j.amjhyper.2005.04.017.
Most treated hypertensive patients do not achieve adequate blood pressure (BP) control. Initiating therapy with two drugs has been suggested when BP is >20/10 mm Hg above goal. To ensure patients' compliance, such treatment needs to be well tolerated and must not compromise health-related quality of life (HRQL). The primary objective of this study was to compare the effects on HRQL of initiating treatment with felodipine + metoprolol (F+M) fixed combination tablets, or enalapril (E), or placebo (P).
A total of 947 patients of both sexes with primary hypertension (diastolic BP 95 to 110 mm Hg), aged 20 to 70 years, participated in this randomized, double-blind, parallel group, 12-week, multicenter trial. Treatment was initiated with F+M 5 + 50 mg, or E 10 mg, or P. Doses were doubled after 4 or 8 weeks if diastolic BP was >90 mm Hg. The HRQL was measured at baseline and at the last visit using two validated questionnaires: the Psychological General Well-being Index (PGWB) and the Subjective Symptom Assessment Profile (SSA-P). Office BP was measured at trough, that is, 24 h after the previous dose.
The HRQL was high at baseline and generally well maintained during the study. For example, the mean (SD) PGWB total score was 104 (16) at baseline and 105 (16) at 12 weeks in all three treatment groups. The BP reductions after F+M (18/14 mm Hg) and E (12/9 mm Hg) were significantly greater than after P (7/7 mm Hg), and the reduction after F+M was significantly greater than after E.
The HRQL is maintained in the presence of substantial BP reduction during antihypertensive treatment with F+M fixed combination tablets.
大多数接受治疗的高血压患者血压控制未达理想水平。当血压高于目标值20/10 mmHg时,建议起始两种药物联合治疗。为确保患者依从性,此类治疗需耐受性良好且不得损害健康相关生活质量(HRQL)。本研究的主要目的是比较起始使用非洛地平+美托洛尔(F+M)固定复方片剂、依那普利(E)或安慰剂(P)治疗对HRQL的影响。
共有947例年龄在20至70岁之间的原发性高血压(舒张压95至110 mmHg)患者参与了这项随机、双盲、平行组、为期12周的多中心试验。治疗起始采用F+M 5 + 50 mg、E 10 mg或P。如果舒张压>90 mmHg,则在4周或8周后将剂量加倍。在基线和末次访视时使用两份经过验证的问卷测量HRQL:心理总体幸福感指数(PGWB)和主观症状评估量表(SSA-P)。在谷值时测量诊室血压,即上次服药后24小时。
HRQL在基线时较高,且在研究期间总体保持良好。例如,在所有三个治疗组中,PGWB总分的均值(标准差)在基线时为104(16),在12周时为105(16)。F+M组(18/14 mmHg)和E组(12/9 mmHg)的血压降低幅度显著大于P组(7/7 mmHg),且F+M组的降低幅度显著大于E组。
在使用F+M固定复方片剂进行降压治疗且血压大幅降低的情况下,HRQL得以维持。