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目的评价利塞膦酸钠胶囊防治绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的疗效及安全性。方法240名受试者随机等分入利塞膦酸钠组(A组)和安慰剂组(B组)。A组给予利塞膦酸钠胶囊+碳酸钙D3咀嚼片,B组给予安慰剂+碳酸钙D3咀嚼片,整个试验疗程为12个月。在治疗前、用药后6月末及12月末随访,通过对腰椎2～4骨密度(bone mineral density,BMD)、髋部BMD的测量及骨代谢生化指标:血骨钙素(osteocalcin,OCN)和尿Ⅰ型胶原氨基末端肽/肌酐(urine cross-linked N-telopeptide of collagen typeⅠ/creatine,NTX/Cr)的检测,对有效性进行评估;在治疗前、3月末、6月末和12月末随访,通过对一般体征、心电图、血常规、尿常规、肝功能、肾功能的观察对安全性进行评估。结果治疗结束后,腰椎2～4BMD变化率A组增高8.28%±13.79%,B组增高4.09%±14.60%,组间有统计学差异(P<0.05);髋部BMD变化率A组增高8.49%±15.58%,B组增高6.84%±18.34%,组间无统计学差异(P>0.05)。血OCNA组下降2.94±4.73ng/ml,B组下降0.53±3.90ng/ml,组间比较有统计学差异(P<0.01);尿NTX/CrA组下降9.38±65.93nMBCE/mMCR,B组升高3.59±59.86nMBCE/mMCR,组间比较有统计学差异(P<0.05)。治疗期间,A组发生新骨折8例,发生率7.84%;B组6例,发生率5.76%,组间差别无统计学意义(P>0.05)。试验过程中未发生与药物有关的严重不良事件。结论利塞膦酸钠胶囊能够有效提高绝经后骨质疏松症妇女的骨密度,抑制骨吸收,降低骨转换,不良反应少,用于防治PMOP安全有效。
Objective To evaluate the efficacy and safety of risedronate sodium capsules in the prevention and treatment of postmenopausal osteoporosis (PMOP). Methods 240 subjects were randomized equally to risedron sodium (Group A) and placebo (Group B). Group A was given risedronate capsules + calcium carbonate D3 chewable tablets, group B was given placebo + calcium carbonate D3 chewable tablets, the entire trial period of 12 months. Before treatment, at the end of June and at the end of December, the bone mineral density (BMD) of 2 ~ 4 and BMD of lumbar spine were measured and the biochemical indexes of bone metabolism were analyzed: osteocalcin (OCN) and Urine type Ⅰ collagen amino terminal peptide / creatinine (urine cross-linked N-telopeptide of collagen type Ⅰ / creatine, NTX / Cr) of the test, to assess the effectiveness; before treatment, at the end of 3, 6 and 12 at the end of follow-up, Safety was assessed by observation of general signs, electrocardiograms, blood tests, urinalysis, liver function, and renal function. Results After the treatment, the change rate of 2 ~ 4BMD in lumbar vertebrae was 8.28% ± 13.79% in group A, 4.09% ± 14.60% in group B, and there was significant difference between groups (P <0.05). The change rate of hip BMD in group A was increased by 8.49 % ± 15.58%, B group increased 6.84% ± 18.34%, there was no significant difference between the two groups (P> 0.05). There was a significant difference between the two groups (P <0.01). The urine NTX / CrA group decreased by 9.38 ± 65.93nMBCE / mMCR, while the B group increased by 2.94 ± 4.73ng / ml in the OCNA group and 0.53 ± 3.90ng / High 3.59 ± 59.86nMBCE / mMCR, there was significant difference between the two groups (P <0.05). During the treatment period, 8 new fractures occurred in group A, with a rate of 7.84%. There were 6 cases in group B with a rate of 5.76%. There was no significant difference between the two groups (P> 0.05). No serious adverse drug-related events occurred during the trial. Conclusion risedronate sodium capsules can effectively improve the postmenopausal women with osteoporosis bone mineral density, inhibit bone resorption, reduce bone turnover, fewer adverse reactions, for the prevention and treatment of PMOP safe and effective.