不同给药方案阿仑膦酸钠治疗绝经后妇女骨质疏松症18个月效果研究

Efficacy analysis of different proposals using alendronate for the treatment of postmenopausal osteoporosis in 18 months

目的阿仑膦酸钠是临床治疗绝经后妇女骨质疏松症的首选药物。本实验观察阿仑膦酸钠不同给药方案对绝经后妇女骨质疏松症的治疗效果以及不良反应的发生情况。方法本实验为开放、随机、平行对照临床研究。纳入西安两社区绝经后妇女共80名,年龄49～79岁,绝经年限3～31年。实验分为低剂量组和常规剂量组。低剂量组为每两周口服阿仑膦酸钠一次,每次70mg,疗程18个月。常规剂量组为每周口服阿仑膦酸钠一次,每次70mg,疗程18个月。两组同时每日服用钙尔奇D3600mg。实验主要观察指标为:第二腰椎到第四腰椎(L2-L4)、股骨颈、大转子、股骨干骨密度值变化,血液指标(血钙、血磷、碱性磷酸酶),肝肾功能指标(丙氨酸氨基转移酶、血肌酐),不良反应及新发骨折情况。结果 80例患者全部进入结果分析:①骨密度测定:每组患者治疗18个月后L2-L4、股骨颈、股骨大转子、股骨干的骨密度与治疗前相比均明显升高,差异有显著性意义(P﹤0.05)。低剂量组与常规剂量组相比L2-L4骨密度、股骨颈骨密度、股骨干骨密度值差异无统计学意义(P﹥0.05),表明两种给药方案相比增加骨密度效果相似。②两组患者血液指标及肝肾功能指标治疗前后均在正常范围内,显示两种用药方法均安全可靠。③不良反应主要为上腹部不适,两组不良反应差异有统计学意义(P﹤0.05),低剂量组显著低于常规剂量组。④两组患者均无新发骨折病例。结论阿仑膦酸钠治疗绝经后妇女骨质疏松症安全有效,低剂量用药方案与常规剂量用药方案相比增加骨密度效果和药物安全性相似,用药更加简单方便,不良反应更小,经济效益更高,是临床值得推荐的用药方案。

Objective Alendronate is a clinical preferred drug for treating postmenopausal osteoporosis.This research wants to observe effects of different proposals using alendronate on efficacy and side effects in women with postmenopausal osteoporosis.Methods The study was a open,randomized,controlled clinical trial.Eighty postmenopausal women from 2 different communities in Xi＇an,aged 49～79 years old with menopause time 3～31 years,were enrolled.Patients were randomly divided to low does group and routine dose group.Patients in low dose group received 70 mg alendronate every 2 weeks for 18 months.Patients in normal does group received 70 mg alendronate every week for 18 months.They both were given Caltrate D3 600mg every day.BMD of the lumbar vertebrae 2～4（L2-L4）,the femoral neck,the greater trochanter,and the femoral shaft was measured.Adverse reactions,new fractures,and changes in blood（calcium,phosphorus,alkaline phosphatase）,liver and kidney functions（ALT,Cr） were detected.Results All 80 patients were included in the analysis.1） BMD in L2-L4,the femoral neck,the greater trochanter,and the femoral shaft increased in both groups（P0.05） after the treatment.No difference was found between the lower does group and the normal dose group in the BMD of the L2-L4,the femoral neck and the femoral shaft.2） The blood index and liver and kidney functions were in the normal ranges before and after the treatment in both groups,indicating both dose proposals were safe.3） The mainly adverse reaction was abdominal discomfort.The occurrence was lower in low dose group than in normal dose group（P0.05）.4） No new fractures were found in both groups.Conclusion It is safe and effective to use alendronate to treate postmenopausal osteoporosis.The low dose proposal has the same effects as the normal dose in BMD increase and drug safety.It is also an easily and economic proposal for the treatment,and is worth of recommendation in the clinic.