伊班膦酸钠注射液治疗超高龄老年性骨质疏松症疗效研究

Efficacy and Safety of Ibandronate Injection in Treatment of Senile Osteoporosis

目的观察伊班膦酸钠注射液治疗超高龄老年性骨质疏松症(OP)的疗效。方法选择2008年1月—2009年6月中国人民解放军第452医院和四川省成都军区总医院门诊及住院超高龄老年性OP患者共110例,年龄75～92岁,先将患者分为男性组和女性组,再随机分为对照组和试验组,每组55例。对照组给予钙尔奇D片口服,1片/d;试验组在对照组基础上每3个月给予伊班膦酸钠注射液2 mg加入0.9%氯化钠溶液250 ml静脉滴注,至少2 h。两组疗程均为12个月,治疗结束后随访12个月。测量患者治疗后6个月和12个月股骨颈骨密度(BMD)及腰椎BMD;记录患者治疗过程中及随访时间内新发骨折发生率;观察患者治疗后6个月和12个月腰背部疼痛疗效;记录患者治疗过程中出现的不良反应,血尿常规、肝肾功能及心电图改变。结果治疗过程中对照组有1例患者因脑出血死亡,试验组有1例患者因移居其他城市而退出试验,其余患者均完成治疗和随访。治疗后6个月,两组股骨颈BMD〔(0.64±0.12)g/cm2 vs.(0.62±0.11)g/cm2〕和腰椎BMD〔(0.78±0.09)g/cm2 vs.(0.76±0.10)g/cm2〕比较,差异均有统计学意义(P<0.05);治疗后12个月,两组股骨颈BMD〔(0.64±0.10)g/cm2vs.(0.61±0.09)g/cm2〕和腰椎BMD〔(0.82±0.08)g/cm2vs.(0.75±0.11)g/cm2〕比较,差异亦均有统计学意义(P<0.01)。对照组新发骨折发生率为27.78%(15/54),试验组为16.67%(9/54),差异有统计学意义(χ2=4.289,P<0.05)。治疗后6个月和12个月两组腰背部疼痛疗效比较,差异均有统计学意义(P<0.01)。试验组有8例患者首次输液后出现肌肉酸痛等类流感样症状,其中1例出现低热,均经对症处理1～2 d后症状缓解。两组患者血尿常规、肝肾功能及心电图未见明显异常变化。结论在使用钙尔奇D片的基础上加伊班膦酸钠注射液治疗超高龄老年性OP,可明显增加患者股骨颈和腰椎BMD,降低新发骨折发生率,有效缓解患者腰背部疼痛,且不良反应较轻,对患者血常规、肝肾功能及心功能无明显影响;采用静脉输注,治疗频率低,患者治疗依从性较好。

Objective To explore the clinical efficacy and safety of ibandronate injection in treatment of senile osteoporosis.Methods Totally 110 elderly patients（75~95 years old） with senile osteoporosis were enrolled in this study.These patients were randomly divided into two groups：the control group was orally administered with caltrate D daily,whereas the ibandronate group received ibandronate（2 mg）infusions every three months in addition to the treatment in the control group.Both groups were treated for 12 months and then followed up for 1 year after the completion of the treatment.The changes of bone mineral density（BMD）of the lumbar spine and femoral neck,the resolve of low back pains,and the new-onset fractures within 2 years after the initiation of treatment were measured.The adverse effects,electrocardiogram,liver and kidney functions,and routine blood and urine test results were recorded.Results Totally 108 patients completed the observation.After 6 months of treatment,the BMD of lumbar spine and femoral neck in the ibandronate group were（0.64±0.12）g/cm2 and（0.78±0.09）g/cm2,which were respectively significantly different from those in the control group（（0.62±0.11）g/cm2 and（0.76±0.10）g/cm2）（P0.05）.After 12 months of treatment,the BMD of lumbar spine and femoral neck in the ibandronate group were（0.64±0.10）g/cm2 and（0.82±0.08） g/cm2 respectively,which were significantly higher than those in the control group（（0.61±0.09）g/cm2 and（0.75±0.11）g/cm2）（P0.01）.The incidence of new-onset fractures was 16.67%（9/54）in the ibandronate group and 27.78%（15/54）in the control group.After 6 months or 12 months of treatment,the resolve of low back pain was significantly different between these two groups（P0.01）.No obvious adverse reaction was observed throughout the treatment.Conclusion Ibandronate injection is effective and safe for the treatment of senile osteoporosis in elderly patients.