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Kirby R等回顾了7项国际临床试验,以评论多沙唑嗪治疗老年良性前列腺增生症(BPH)患者的安全性。他们对来自这7项双盲、安慰剂对照、?期临床试验的数据进行了核对和分析,其中试验对象包括正常血压和高血压的BPH患者。有341名年龄≥65岁患者的数据可用于分析多沙唑嗪。尽管老年患者易发生药物不良反应,但没有明显的证据提示老年BPH患者对多沙唑嗪的耐受性差。较年轻组(年龄…65岁)的正常血压BPH患者中,至少山现一项不良事件的比例多沙唑嗪组为47%,安慰剂组为44%,而老年组(年龄≥65岁)的正常血压BPH患者中,相应的比例分别为42%和38%。较年轻组的高血压BPH患者中,不良事件的发生率多沙唑嗪组为55%,安慰剂组为42%,而老年组的高血压BPH患者中,相应的比例分别为43%和30%。所有试验中最常见的不良事件有头昏,头痛,疲乏,很少有严重不良反应。所以得出结论,多沙唑嗪在较年轻和老年BPH患者中无论是正常血压或伴高血压均具有良好的耐受性。
Kirby R et al. Reviewed seven international clinical trials to review the safety of doxazosin in the treatment of elderly patients with benign prostatic hyperplasia (BPH). They checked and analyzed data from these seven double-blind, placebo-controlled, and phase-clinical trials in BPH patients with normotensive and high blood pressure. Data from 341 patients ≥65 years of age were available for the analysis of doxazosin. Although elder patients are predisposed to adverse drug reactions, there is no clear evidence that doxazosin is poorly tolerated in older BPH patients. In the younger group (age ... 65 years) of normotensive BPH patients, the proportion of at least one adverse event in the mountains was 47% in the doxazosin group and 44% in the placebo group, whereas in the elderly group (≥65 years) Of the normotensive BPH patients, the corresponding proportions were 42% and 38%, respectively. Among younger BPH patients, the incidence of adverse events was 55% in the doxazosin group and 42% in the placebo group, and 43% and 30% in the elderly hypertensive BPH group %. The most common adverse events in all trials were dizziness, headache, fatigue, and seldom serious adverse reactions. Therefore, it has been concluded that doxazosin is well tolerated both in normal and hypertensive patients in younger and older BPH patients.