Overgaard K, Lindsay R, Christiansen C
Center for Clinical & Basic Research, Ballerup, Denmark.
Clin Ther. 1995 Jul-Aug;17(4):680-5. doi: 10.1016/0149-2918(95)80044-1.
A subanalysis of results from a randomized, double-blind, placebo-controlled, parallel-group, 2-year study was conducted to evaluate the response of individual patients to therapy with 200 IU/d calcitonin salmon nasal spray compared with placebo in postmenopausal women who had low bone mass. All patients received 500 mg/d of oral supplemental calcium. A response to therapy was defined as an increase from baseline in lumbar vertebral bone mineral density, measured by use of dual-energy x-ray absorptiometry, at the end of 2 years of treatment. Of 41 valid completers (ie, patients who met the entry criteria, were compliant with the protocol, and completed the study) treated with calcitonin salmon nasal spray, 31 (76%) responded positively to treatment. Of 40 valid completers who received placebo, 25 (63%) lost bone mass (P = 0.001 between groups). The relative risk of bone loss for patients receiving calcitonin salmon nasal spray was 0.19 (95% confidence interval, 0.07 to 0.50), representing an 81% risk reduction. This subanalysis demonstrates that the benefits of calcitonin salmon nasal spray therapy were seen in the majority of women studied. Calcitonin salmon nasal spray represents an effective therapeutic alternative for osteoporotic women more than 5 years postmenopause who reject or cannot tolerate estrogens or for whom estrogens are contraindicated.
对一项随机、双盲、安慰剂对照、平行组、为期2年的研究结果进行了亚组分析，以评估骨量低的绝经后女性个体患者接受每日200 IU鲑鱼降钙素鼻喷雾剂治疗与安慰剂治疗相比的反应。所有患者均接受每日500 mg的口服补充钙。治疗反应的定义为在治疗2年后，通过双能X线吸收法测量的腰椎骨矿物质密度相对于基线有所增加。在接受鲑鱼降钙素鼻喷雾剂治疗的41名有效完成者（即符合入选标准、遵守方案并完成研究的患者）中，31名（76%）对治疗有积极反应。在接受安慰剂治疗的40名有效完成者中，25名（63%）骨质流失（两组之间P = 0.001）。接受鲑鱼降钙素鼻喷雾剂治疗的患者骨质流失的相对风险为0.19（95%置信区间，0.07至0.50），意味着风险降低了81%。该亚组分析表明，在大多数研究女性中都观察到了鲑鱼降钙素鼻喷雾剂治疗的益处。鲑鱼降钙素鼻喷雾剂是绝经后5年以上拒绝或不能耐受雌激素或雌激素禁忌的骨质疏松女性的一种有效治疗选择。
