唑来膦酸对老年男性骨质疏松患者骨密度及骨代谢指标的影响

Effects of zoledronic acid on bone mineral density and indexes of bone metabolism in elderly male patients with osteoporosis

目的研究唑来膦酸对老年男性骨质疏松患者骨密度及骨代谢指标的影响。方法 80例原发性老年男性骨质疏松症患者随机分为两组,每组40例。对照组每日予碳酸钙D3片和骨化三醇口服,治疗组在上述治疗外,加用唑来膦酸5 mg静脉滴注1次。于治疗前和治疗6、12个月末检测患者骨密度及骨代谢指标骨特异性碱性磷酸酶(BALP)、抗酒石酸酸性磷酸酶5b(TRACP-5b)、I型胶原羧基末端肽(CTx)、骨钙素水平,并观察药物不良反应。结果治疗6、12个月末,对照组骨密度及骨代谢指标均无明显变化(P>0.05);治疗组腰椎正位L2-L4、股骨颈、Ward三角和大转子区骨密度与治疗前相比均升高(P<0.05),且高于对照组,差异显著(P<0.05);血BALP、TRACP-5b、CTx和骨钙素水平均下降(P<0.05),且低于对照组,差异显著(P<0.05)。治疗组8例患者出现发热、关节痛、头痛等症状,但均能耐受,未发生肾损害、下颌骨坏死等严重不良反应。结论唑来膦酸5 mg每年1次用药能显著增加老年男性骨质疏松患者的骨密度,降低骨代谢指标,疗效优于单纯服用钙剂和维生素D,且安全性好。

AIM To study the effects of zoledronic acid on bone mineral density （BMD） and indexes of bone metabolism in elderly male patients with osteoporosis. METHODS Eighty elderly male patients with osteoporosis were randomly divided into control group and treatment group, 40 patients in each group. All patients received calcium carbonate and vitamin D3 tablets and calcitriol. The patients in the treatment group were received infusion zoledronic acid 5 mg once. Bone mineral density （BMD）, the biochemical markers of bone metabolism such as bone-specific alkaline phosphatase （BALP） , tartrate- resistant acid phosphatase 5b （TRACP-5b）, osteocalcin （OC） and collagen type I C-end peptides （CTx） in serum were measured at the baseline and 6 and 12 months after treatment. The adverse drug reactions were observed. RESULTS The BMD at lumbar spine L2 - L4, neck of femur, Ward＇ s triangle and greater trochanter were significantly increased andthe serum BALP, TRACP-Sb, OC and CTx levels were significantly decreased after 6 and 12 months in the treatment group （P 〈 0.05）. But there was no significant difference of BMD and bone metabolism indexes before and after treatment in the control group （P 〉 0.05）. There were significant difference in above indexes between two groups （P 〈 0.05）. Symptoms such as fever, joint pain and headaches occurred in eight patients in the treatment group, but no serious adverse reactions such as kidney damage and mandible necrosis occurred. CONCLUSION Zoledronic acid can improve BMD and reduce bone metabolism indexes in treating elderly male patients with osteoporosis, and is well tolerated, superior to calcium and vitamin D alone.