Caro J J, Speckman J L, Salas M, Raggio G, Jackson J D
Caro Research, Concord, Mass., USA.
CMAJ. 1999 Jan 12;160(1):41-6.
Rational medical decisions should be based on the best possible evidence. Clinical trial results, however, may not reflect conditions in actual practice. In hypertension, for example, trials indicate equivalent antihypertensive efficacy and safety for many medications, yet blood pressure frequently remains uncontrolled, perhaps owing to poor compliance. This paper examines the effect of initial choice of treatment on persistence with therapy in actual practice.
The authors examined all outpatient prescriptions for antihypertensive medications filled in Saskatchewan between 1989 and 1994 by over 22,000 patients with newly diagnosed hypertension whose initial treatment was with a diuretic, beta-blocker, calcium-channel blocker or angiotensin-converting-enzyme (ACE) inhibitor. Rates of persistence over the first year of treatment were compared.
After 6 months, persistence with therapy was poor and differed according to the class of initial therapeutic agent: 80% for diuretics, 85% for beta-blockers, 86% for calcium-channel blockers and 89% for ACE inhibitors (p < 0.001). These differences remained significant when age, sex and health status in the previous year were controlled for. Changes in the therapeutic regimen were also associated with lack of persistence.
A relation not seen in clinical trials--between persistence with treatment and initial antihypertensive medication prescribed--was found in actual practice. This relation also indicates the importance of real-world studies for evidence-based medicine.
合理的医疗决策应基于尽可能充分的证据。然而,临床试验结果可能无法反映实际临床中的情况。例如,在高血压治疗中,试验表明许多药物具有相当的降压疗效和安全性,但血压常常仍未得到有效控制,这可能是由于依从性差所致。本文探讨了在实际临床中初始治疗选择对治疗持续性的影响。
作者研究了1989年至1994年间在萨斯喀彻温省超过22000例新诊断为高血压且初始治疗使用利尿剂、β受体阻滞剂、钙通道阻滞剂或血管紧张素转换酶(ACE)抑制剂的患者所开具的所有门诊降压药物处方。比较了治疗第一年的持续性比率。
6个月后,治疗持续性较差,且因初始治疗药物类别而异:利尿剂为80%,β受体阻滞剂为85%,钙通道阻滞剂为86%,ACE抑制剂为89%(p<0.001)。在对年龄、性别和上一年健康状况进行控制后,这些差异仍然显著。治疗方案的改变也与持续性不足相关。
在实际临床中发现了一种在临床试验中未观察到且与初始开具的降压药物有关的治疗持续性关系。这种关系也表明了真实世界研究对循证医学的重要性。