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阿仑膦酸盐和降钙素对绝经后骨质疏松症女性骨密度的影响。一项观察性研究。

Effects of alendronate and calcitonin on bone mineral density in postmenopausal osteoporotic women. An observational study.

作者信息

Hejdova Miroslava, Palicka Vladimir, Kucera Zdenek, Vlcek Jiri

机构信息

Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, Heyrovskeho 1203, 500 05, Hradec Kralove, Czech Republic.

出版信息

Pharm World Sci. 2005 Jun;27(3):149-53. doi: 10.1007/s11096-005-0014-z.

Abstract

OBJECTIVE

Alendronate and calcitonin are antiresorptive drugs that were used for the treatment of postmenopausal osteoporosis and were shown to increase bone mineral density (BMD). However, the effect of both drugs in daily clinical practice may differ from that observed in clinical trials.

METHOD

About 50 postmenopausal osteoporotic women were observed during their first year of treatment. Among them, 32 patients used alendronate and 18 used calcitonin. Lumbar spine and femoral neck BMD were measured by dual energy X-ray absorptiometry (DXA) at baseline and after 1 year of therapy. Biochemical markers (B-ALP--bone-specific alkaline phosphatase, OTC--osteocalcin and DPD/UCr--deoxypyridinoline/creatinine ratio) of bone metabolism were measured at baseline and 6 months later. Patient compliance was assumed by tablet counting and verified at interview. Each patient was further questioned about her attitude towards the treatment, as well as her dairy product intake, physical activity, use of other medications, smoking and social status.

MAIN OUTCOME MEASURE

(1) Annual percent change in BMD in lumbar spine and femoral neck after the one-year treatment with either alendronate or calcitonin. (2) The change in biochemical markers of bone turnover.

RESULTS

The lumbar spine BMD significantly increased by 7.0% (P < 0.001), the femoral neck BMD by 4.3% (P < 0.01). OTC, B-ALP and DPD/UCr decreased significantly during the therapy with alendronate. Compliance with therapy was 79% (95% CI 68-90%). In the calcitonin-treated group, the lumbar spine BMD significantly increased by 3.1 % (P < 0.05), while the femoral neck BMD remained unchanged. OTC, B-ALP and DPD/UCr did not change significantly during the treatment with calcitonin. Compliance with calcitonin therapy was 87% (95% CI 63-110%). The annual change of BMD in both treatment groups was independent on all questioned factors.

CONCLUSION

In daily practice, alendronate enhanced significantly BMD both in lumbar spine and femoral neck. Calcitonin showed increase only in the lumbar spine BMD.

摘要

目的

阿仑膦酸盐和降钙素是用于治疗绝经后骨质疏松症的抗吸收药物,已证实可增加骨矿物质密度(BMD)。然而,这两种药物在日常临床实践中的效果可能与临床试验中观察到的有所不同。

方法

约50名绝经后骨质疏松症女性在治疗的第一年接受观察。其中,32例患者使用阿仑膦酸盐,18例使用降钙素。在基线和治疗1年后,采用双能X线吸收法(DXA)测量腰椎和股骨颈的骨密度。在基线和6个月后测量骨代谢的生化标志物(B-ALP——骨特异性碱性磷酸酶、OTC——骨钙素和DPD/UCr——脱氧吡啶啉/肌酐比值)。通过药片计数评估患者依从性,并在访谈时进行核实。进一步询问每位患者对治疗的态度,以及她的乳制品摄入量、身体活动情况、其他药物使用情况、吸烟情况和社会地位。

主要观察指标

(1)使用阿仑膦酸盐或降钙素治疗一年后腰椎和股骨颈骨密度的年度百分比变化。(2)骨转换生化标志物的变化。

结果

腰椎骨密度显著增加7.0%(P<0.001),股骨颈骨密度增加4.3%(P<0.01)。在使用阿仑膦酸盐治疗期间,OTC、B-ALP和DPD/UCr显著下降。治疗依从性为79%(95%CI 68-90%)。在降钙素治疗组中,腰椎骨密度显著增加3.1%(P<0.05),而股骨颈骨密度保持不变。在使用降钙素治疗期间,OTC、B-ALP和DPD/UCr没有显著变化。降钙素治疗的依从性为87%(95%CI 63-110%)。两个治疗组骨密度的年度变化与所有询问的因素无关。

结论

在日常实践中,阿仑膦酸盐显著提高了腰椎和股骨颈的骨密度。降钙素仅使腰椎骨密度增加。

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