摘要
目的探讨利塞膦酸钠治疗绝经后骨质疏松症的临床疗效,并评价其安全性。方法54例绝经后骨质疏松症患者采取随机双盲、安慰剂平行对照方式进行12个月的药物研究,以双能量X线骨密度测量仪比较治疗前后0月、6月、12月腰椎及髋部骨密度(BMD)改变,同时检测骨代谢标志物血Ca、ALP、BGP及尿NTX在治疗前后的变化,并监测血尿常规、肝肾功能、心电图、X线等药物安全性指标,记录不良事件。结果腰椎(L2-4)BDM用药6月时增加(3·29±1·18)%,12月时为(4·51±1·64)%,而对照组分别为(-0·62±0·24)%和(0·48±0·18)%,股骨颈、大转子和Ward s三角区BMD改变在药物组和对照组差异无显著性;反映骨形成标记物ALP和BGP在6月和12月时,药物组显著降低,骨吸收标记物NTx在治疗6月和12月较治疗前显著降低(P<0·01)。主要不良反应为消化道反应2例(7·1%)、皮肤搔痒、皮疹2例(7·1%)和血尿1例(3·6%)。结论利塞膦酸钠能有效阻止绝经后妇女的骨丢失,以腰椎骨量增加最为显著,并且显示该药物具有良好的安全性。
Objective To evaluate the effect and safety of oral administration of fisedronate sodium in treatment of osteoporosis in postmenopausal women. Methods One year randomized, double blind plaeedbo controlled study was conducted among 54 postmenopausal women with osteoporosis. The bone mineral density （BMD）, bone metabolism markers and adverse events were compared before and after given Risedronate sodium or placebo. BMD was measured by dual energy X-ray absorptionmetry（DEXA） and osteal-metabolize markers were analyzed. Results Remarkable increase in BMD of the lumbar spine [ （3.29 ± 1.18）% , （4.51 ± 1.64） % ] was found after 6 and 12 months treatment eovuparing with the placebo group [ （ - 0.62 ± 0.24） %, （0.48 ± 0.18） % ]. The resorption markers of bone turnover decreased to a stable nadir over 6 and 12 months（NTx, P 〈 0.05） and the formation marker over 12 months（ALP, P 〈 0.05;BGP, P 〈 0.05） .The safety profile of risedronate sodium was similar to that of placebo. There were no trends toward increased frequency of any adverse experience except for gastrointestinal symptoms（7.1% ）, rash（7.1% ） and hematuria（3.6% ）, which were usually mild, transient, and resolved with continued treatment. Conclusions Risedronate is an efficacious and safe drug in treatment of postmenopausal osteoporosis.
出处
《中国骨质疏松杂志》
CAS
CSCD
2006年第1期62-65,共4页
Chinese Journal of Osteoporosis
关键词
利塞膦酸钠
骨质疏松症
绝经后
骨密度
Risedronate sodium
Osteoporosis
Postmenopausal
Bone mineral density
