EFFECTIVENESS AND SAFETY OF MEDIUM-TERM AND LONG-TERM ELCATONIN USE IN THE PREVENTION AND TREATMENT OF BONE MASS-LOSS
EFFECTIVENESS AND SAFETY OF MEDIUM-TERM AND LONG-TERM ELCATONIN USE IN THE PREVENTION AND TREATMENT OF BONE MASS-LOSS
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DOI：
10.1016/0011-393x(95)85007-4
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发表时间：
1995-04-01
影响因子：
1.9
通讯作者：
CANALES, AG
中科院分区：
文献类型：
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作者：
JIMENEZ, FE;ALBIZURI, JMA;CANALES, AG
在诊断为绝经后/老年性骨质疏松症的患者的前瞻性研究中评估了依降钙素的有效性。在第一阶段，招募了521名有骨质疏松临床证据的患者（490名女性[平均绝经时间，14.4岁]和31名男性;平均年龄，61.4岁）。对486名患者进行了骨密度（BMD）测量，并对疼痛和功能能力进行了评估。在第二阶段，对腰椎BMD结果比正常参考人群峰值骨量低1个标准差的患者，连续10天每天用40 U肠外依卡宁治疗，然后在剩余的20天中隔日治疗。第一个月，并在随后的几个月，只有前10天的一个月，口服钙补充1克/天的建议。在研究开始时进行临床检查，然后每隔3个月进行一次，在开始时和6个月、12个月和24个月后进行密度测定。数据由48名专家收集，他们每人选择一组在前一年未接受骨质疏松症治疗的患者。共有130例患者完成了一年的治疗与依降钙素，其中67%的反应，如所示的增加3.53%的腰椎BMD的方差分析（P = 0.001）。根据Wilcoxon检验，在治疗6个月和12个月后，视觉模拟量表（VAS）上的疼痛严重程度分别从63 mm逐渐下降至31 mm和22 mm（P < 0.0001）。无功能损害从研究开始时的18%上升至12个月时的69%（P < 0.0001）。68例患者完成治疗2年，有72.1%的患者骨量有积极反应，腰椎BMD增加9.86%（P < 0.001）。在24个月时，VAS疼痛严重程度从研究开始时的58 mm下降至23 mm（P < 0.0001）。术后24个月时85%的患者无功能损害（P < 0.001）。总之，我们的研究证实，依卡宁治疗是一个长期治疗骨质疏松症患者的有效选择。
The effectiveness of elcatonin was assessed in a prospective study of patients with a diagnosis of postmenopausal/senile osteoporosis. In the first stage, 521 patients (490 women [mean time since menopause, 14.4 years] and 31 men; mean age, 61.4 years) with clinical evidence of osteoporosis were recruited. Bone mineral density (BMD) was measured in 486 of the patients, and pain and ability to function were assessed, In the second stage, the patients whose results for lumbar BMD were lower by 1 standard deviation than the peak bone mass of the normal reference population were treated with 40 U of parenteral elcatonin daily for 10 consecutive days and then on alternate days for the remaining 20 days of the first month, and in subsequent months for only the first 10 days of the month, A supplement of 1 g/d of oral calcium was recommended. Clinical examination was done at the beginning of the study and then at 3-month intervals, Densitometry was performed at the start and after 6, 12, and 24 months, The data were collected by 48 specialists, each of whom chose a group of patients who had not been treated for osteoporosis in the previous year. A total of 130 patients completed a year of treatment with elcatonin; 67% of these were responders, as shown by an increase of 3.53% in lumbar BMD using analysis of variance (P = 0.001). According to Wilcoxon's test, there was a progressive fall in pain severity on the visual analog scale (VAS) from 63 mm to 31 mm and 22 mm after treatment for 6 and 12 months, respectively (P < 0.0001), Absence of impairment of function rose from 18% of the patients at the beginning of the study to 69% at 12 months (P < 0.0001). Sixty-eight patients completed treatment for 2 years; there was a positive response in bone mass in 72.1%, with a rise in lumbar BMD of 9.86% (P < 0.001). At 24 months, pain severity had fallen from 58 mm at the start of the study to 23 mm (P < 0.0001) on the VAS. There was no impairment of function in 85% of the patients at 24 months (P < 0.001). In conclusion, our study confirmed that elcatonin therapy is an effective choice for long-term treatment of patients with osteoporosis.