摘要
目的评价新一代双膦酸盐类药物伊班膦酸钠间断静脉输注对北京绝经后骨质疏松症女性的疗效及安全性。方法研究纳入绝经后骨质疏松症女性60例,年龄48～74岁,绝经年限3～32年,随机分为2组,治疗组每3个月静脉输注伊班膦酸钠2mg,对照组每周口服阿仑膦酸钠70mg,疗程12个月。疗效指标为腰椎及髋部骨密度(采用双能X线骨密度仪测量)、骨吸收指标血I型胶原羧基末端肽(酶联免疫吸附法测量)及骨形成指标碱性磷酸酶(自动分析仪酶法检测)。安全性指标包括血尿生化指标、心电图及不良反应。结果59例患者完成研究。治疗12个月后,伊班膦酸钠组腰椎2-4、股骨颈及大转子骨密度增幅分别达6.3%、2.5%和0.1%(腰椎P<0.001,股骨颈P<0.01)。阿仑膦酸钠组腰椎、股骨颈及大转子骨密度改变率分别为3.7%、4.9%和-0.5%(腰椎和股骨颈P<0.001)。两组间治疗前后骨密度均无明显差别。伊班膦酸钠和阿仑膦酸钠治疗后ALP及CTX浓度均快速、显著下降,ALP降低15.8%和17.2%,CTX降低78.1%及43.2%(均P<0.001)。两组血钙磷水平、肝肾功能在正常范围内,伊班膦酸钠组常见的不良反应是首次输液后肌肉疼痛和低热,占26.7%,而反酸、上腹不适是阿仑膦酸钠组主要的不良反应,占13.3%,患者可以耐受这些轻度的不良反应。结论新一代双膦酸类药物伊班膦酸钠对于治疗绝经后骨质疏松症是安全而有效的。
Objective To assess the efficacy and tolerance of infusions of ibandronate on postmenopausal osteoporotic women from Beijing. Methods A randomized study among 60 postmenopausal women receiving either 2-hour infusions of ibandronate （2 mg） in every three months or oral 70 mg/week alendronate during one year. The bone mineral density （BMD, by DXA）, serum carboxy-telopeptide cross-links of type Ⅰ collagen （CTX, by chemiluminescence） and alkaline phosphatase （ALP,by autonomic analysor） were measured to evaluate the efficacy. The adverse effects, liver and kidney functions were checked to assess the tolerability. Results Fifty-nine patients completed the observation. After one year of treatment, at the sites of lumbar spine, femoral neck and trochanter, ibandronate increased the BMD by 6. 3% , 2.5% and 0. 1% （lumbar P 〈0. 001 ,femoral neck P 〈0. 01 ）, and alendronate changed the BMD by 3.7%, 4. 9%, -0. 5% respectively （lumbar and femoral neck, P 〈 0. 001 ）. There was no significant difference of BMD between two groups after treatment. In ibandronate and alendronate group, ALP levels were decreased by 15.8% and 17.2% ,CTX levels decline by 78. 1% and 43.2% （ P 〈0. 001 ）. The liver and kidney functions were in normal range. Mild muscle pain and fever in the first month after infusion （26.7%） was the main adverse effects of ibandronate. Mild upper GI effect（ 13.3% ） was the common effect of alendronate. Conclusion Intermittent infusions of ibandronate significantly increases BMD and inhibits bone resorption with good tolerance in postmenopausal osteoporotic women.
出处
《基础医学与临床》
CSCD
北大核心
2009年第8期867-871,共5页
Basic and Clinical Medicine
基金
国家自然科学基金科学部主任基金(30440074)
