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目的观察补肾壮骨冲剂对老年男性骨质疏松症(osteoporosis,OP)患者疼痛视觉评分、生存质量、骨代谢指标、骨密度的影响,进行临床规范综合疗效分析。方法将符合世界卫生组织(World Health Organization,WHO)诊断标准、接受药物治疗的898例OP患者,随机分为补肾壮骨冲剂组442例、阿仑膦酸钠组456例,随访时间为1年。调查疼痛程度、生存质量;分析血清中总Ⅰ型胶原氨基端前肽(procollagen I N-terminal peptide,PINP)、β-胶原降解产物(β-Crosslaps)的含量、测量骨密度。2组间及治疗前后指标进行统计学处理。结果 2组患者治疗后6个月、1年与治疗前视觉模拟评分法(visual analogue scale,VAS)的评分、生存质量、PINP及β-Crosslaps值下降、骨密度增加等差异均有统计学差异(P<0.05)。2组患者治疗后6个月、1年同期相关数据比较无统计学差异(P>0.05)。结论补肾壮骨冲剂中药与阿仑膦酸钠西药治疗骨质疏松对缓解症状、改善功能、提高生活质量方面有一定疗效,能调整骨代谢指标,提高骨密度。
Objective To observe the effects of Bushen Zhuanggu granule on pain visual score, quality of life, bone metabolism index and bone mineral density in elderly male patients with osteoporosis (OP) and evaluate the clinical effect. Methods A total of 898 OP patients who were diagnosed according to the World Health Organization (WHO) criteria and who were treated with drugs were randomly divided into two groups: 442 cases of Bushen Zhuanggu granules group and 456 cases of alendronate group with a follow-up of 1 year . The degree of pain and the quality of life were investigated. The contents of procollagen I N-terminal peptide (PINP) and β-crosslaps in serum were measured to measure the bone mineral density. Two groups and before and after treatment indicators for statistical analysis. Results The differences of visual analogue scale (VAS) scores, quality of life, PINP and β-Crosslaps values and bone mineral density between the two groups at 6 months and 1 year after treatment were significantly different (P <0.05). There was no significant difference between the two groups in the data of 6 months and 1 year after treatment (P> 0.05). Conclusion: Bushen Zhuanggu granules and alendronate western medicine can relieve symptoms, improve function and improve quality of life. It can adjust bone metabolism index and increase bone density.