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作 者:史静琤[1] 孙振球[1] 莫显昆[1] 蔡太生[2]
机构地区:[1]中南大学公共卫生学院流行病与卫生统计学系,长沙410078 [2]中南大学湘雅二医院医学心理研究中心
出 处:《中华老年医学杂志》2013年第4期368-371,共4页Chinese Journal of Geriatrics
基 金:”十五”国家科技攻关项目(2001BA702805);湖南省科技计划项目(湘科技字22072109)
摘 要:目的比较a。受体阻滞剂、5α还原酶抑制剂和联合治疗良性前列腺增生(BPH)的疗效,并探讨多水平统计模型在BPH药物治疗医疗结局评价中的应用。方法采用实际临床试验设计(PCT)对接受α,受体阻滞剂、5α还原酶抑制剂和联合治疗(即α1受体阻滞剂与5α还原酶抑制剂合用)的BPH患者随访4年,采用多水平模型比较患者国际前列腺症状评分(IPSS)和BPH患者生活质量评分(BPH-QLS)。结果IPSS评分和BPH-QLS评分的组内相关系数分别为0.6136和0.6946,研究数据存在明显的层次结构。在随访期内,随着治疗时间延长,各药物治疗组IPSS评分和BPH-QLS评分均有改善,呈曲线变化趋势(P〈O.05)。α1受体阻滞剂组、5α还原酶抑制剂组与联合治疗组比较,变化趋势差异无统计学意义(均P〉0.05)。结论对于生活质量受到一定影响的中度症状BPH患者,α1受体阻滞剂、5α还原酶抑制剂和联合治疗方案均能明显改善症状、提高生活质量,且在4年随访期内效果相当。在BPH治疗的医疗后果评价研究中,多水平统计模型比传统的统计分析方法更为合适和精确。Objective To compare the efficacy of a1-adrenergic receptor blocker, 5α-reductase inhibitor or combination therapy in benign prostatic hyperplasia (BPH), and to explore the application of multi-level statistical model in assessment of BPH treatments. Methods Pragmatic clinical trials (PCT) design was used. BPH patients received drug therapy including α-adrenergic receptor blocker, 5α-reductase inhibitor, and combination therapy were followed up for 4 years. Multilevel statistical model was used to compare the scores of international prostate symtom score(IPSS) and BPH-qality of life scate(QLS) among the 3 therapeutic regimens. Results The intra-class correlation coefficients of I-PSS and BPH-QLS were 0. 6136 and 0. 6946 respectively, which indicated that both data were hierarchical structured. During the follow-up period, scores of IPSS and BPH-QLS were improved along with the drug therapy in 3 regimens. There was curve relationship between treatment time and IPSS and BPH-QLS scores in 3 regimens (all P〈0.05), and there was no significant differences in the trend of curves between the 3 regimens (P)0.05). Conclusions For BPH patients with moderate symptoms bothering the quality of life, α-adrenergic receptor blocker, 5α-reductase inhibitor, or combination therapy are significantly effective in reducing symptoms and improving quality of life. There are no efficacy differences among the 3 drug therapy during the 4-years follow-up. Compared with traditional analysis, multilevel statistical model is a more suitable and precise method for assessment of BPH treatments.
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