利塞膦酸治疗绝经后骨质疏松症的随机双盲对照临床研究

目的:探讨利塞膦酸治疗绝经后骨质疏松症的有效性和安全性。方法:采用随机双盲安慰剂对照平行临床比较研究,共入选病例48例。利塞膦酸组给予利塞膦酸钠片5 mg,qd;安慰剂组给予安慰剂1片,qd;每组均同时给予钙维D,咀嚼片1片,qd;疗程均为12 mo。结果:完成病例共46例,每组各23例。用药后腰椎和髋骨总骨密度,利塞膦酸组增加了(0．04±s 0．04)g·cm-2和(0．03±0．05)g·cm-2,与治疗前比较差异非常显著(P<0．01);安慰剂组无明显变化,2组间比较,差异有非常显著意义(P< 0．01)。利塞膦酸组用药后血骨钙素和I型胶原交联C端多肽分别下降(4±7)μg·L-1和(0．6±0．4)nmol·L-1,与治疗前比较差异非常显著(P<0．01)。不良事件2组各发生1例,组间无显著差异(P>0．05)。结论:利塞膦酸是一种疗效和安全性均良好的治疗绝经后骨质疏松症的药物。

Risedronic acid in treating postmenopausal osteoporosis: a randomized and double-blind controlled clinical study

AIM:To evaluate the efficacy and safety of risedronic acid in the treatment of postmenopausal osteoporosis. METHODS: A randomized and double-blind controlled clinical trial was conducted for postmenopausal osteoporosis. Altogether 48 patients were enrolled, 25 patients in the risedronic acid group treated with risedronate sodium 5 mg·d-1 and 23 patients in the control group treated with placebo. All patients in the two groups were given 500 mg·d-1 of elemental calcium and 200 IU·d-1 of vitamin D3 chewable tablets. Both groups covered a course of 12-mo therapy. RESULTS: Forty-six patients had finished the trial completely, with 23 in each group. The bone mineral density of lumbar spine and hip in the risedronic acid group significantly increased after the treatment (lumbar spine: (0.04±s 0.04) g·cm-2, hip: (0.03±0.05) g·cm-2, P < 0.01), while no significant increase in the control group, showing significant difference between the two groups (P < 0.01) . The osteocalcin (BGP) and type I collagen cross-linked C-terminal telopeptide (CTX) reduced by (4±7)μg·L-1 and (0.6±0.4) nmol·L-1 respectively in the risedronic acid group demonstrating obvious difference with those before the treatment (P < 0.01). Only 1 adverse evidence occurred in either of both groups, revealing no significant difference (P > 0.05). CONCLUSION; Risedronic acid is effective and safe in the treatment of postmenopausal osteoporosis.