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利塞膦酸钠胶囊治疗绝经后骨质疏松症疗效再评价
【摘要】 目的 运用LSC校正法评定利塞膦酸钠胶囊治疗绝经后骨质疏松症(PMOP)的疗效。方法 采用随机、双盲、安慰剂平行对照方法，入选的42例PMOP患者随机分为试验组(n=21)和对照组(n=21)。试验组晨起口服利塞膦酸钠胶囊，对照组口服安慰剂，2组均在晚间口服碳酸钙D咀嚼片，疗程为12个月。治疗前、治疗6个月、12个月时，测量腰椎和髋部骨密度(BMD)，用LSC校正法计算BMD的疗效，并与正态分析法比较。结果 LSC校正法分析表明，试验组腰椎BMD在6个月、治疗12个月时的变化与对照组比较差异均有显著性(P<0.05)，但2组髋部BMD的变化之间的差异无显著性(P>0.05)。上述结果与正态分析法对BMD的疗效评价结果一致。结论 LSC校正法评价疗效的结果与正态分析法具有高度一致性，两种方法在评价疗效时各有优缺点，临床评价BMD的疗效时可视具体情况选用或同时应用。
【关键词】 绝经后骨质疏松症;骨密度;最小有意义变化;双能X线吸收法
Reassessment of the efficacy of risedronate sodium capsules
in the treatment of postmenopausal osteoporosis
GUO Junhao, YAO Rubing, ZHAO Zhiming, CAI Hui
(Department of Integrated Traditional Chinese and Western Medicine, Nanjing General Hospital of
Nanjing Military Command, PLA, Nanjing, Jiangsu 210002, China医.学全.在.线网站www.med126.com)
Abstract:Objective To evaluate efficacy of risedronate sodium capsules in the treatment of postmenopausal osteoporosis (PMOP) by the least significant change (LSC)-adjusted method (LAM).Methods This is a randomized double-blind, placebo-controlled clinical trial. 42 patients with PMOP were randomly divided into 2 groups: trial group (n=21) and control group (n=21). During 12 months, patients in the trail group received risedronate sodium capsules orally every morning, while patients of control group took placebo orally every morning, and meanwhile all patients took calcichew D orally every night. The double-energy bone density measurement was used to determine lumbar and hip bone mineral density (BMD) at 3 time points (before treatment, 6 months and 12 months after treatment). Meanwhile, the effect on BMD was evaluated by LAM to compare with the result evaluated by normal distribution analytical method (NAM).Results The sample change data for lumbar BMD by (LAM) showed that there was statistical significance in the changes 6 and 12 months after continuous treatment between the trial group and control group respectively (P<0.05), while no statistical significance in the change data for hip BMD was observed between the two groups (P>0.05). The results of efficacy about BMD by LAM were consistent with those by NAM.Conclusion The results by LAM and NAM have high concordance. There are both advantages and disadvantages respectively in the evaluation of the efficacy about BMD by LAM and NAM. The two methods should be used alone or meanwhile when necessary.
