四种双膦酸盐药物在骨质疏松症中的临床综合评价

Clinical comprehensive evaluation of four bisphosphonate drugs in osteoporosis

目的从多个维度评估我国临床常用的4种双膦酸盐制剂作用与价值,以期为医疗单位药物选择与疾病治疗奠定理论基础,提供数据支持。方法参照《中国医疗机构药品评价与遴选快速指南(第二版)》的规范化内容,在药学特性、有效性、安全性、经济性等不同层面上,分别论述评估了4种不同双膦酸盐制剂作用与价值。结果4种双膦酸盐制剂的卫生技术评分分别为阿仑膦酸钠79.00分、利塞膦酸钠71.07分、伊班膦酸钠75.77分、唑来膦酸66.42分,均可安全有效地用于骨质疏松症的治疗。但这几种药品各有优劣,其中,阿仑膦酸钠在药学特性、有效性、经济性均有优势;唑来膦酸安全性最差,其他属性最好;伊班膦酸钠的安全性最高。结论阿仑膦酸钠综合评价分值最高,四种双膦酸盐药物在绝经后女性、成年男性、糖皮质激素性骨质疏松症的治疗中均有较好的疗效,伊班膦酸钠安全性表现最为令人满意,肝肾功能异常患者也可以应用且不良反应发生率相对较低;研究结果为医院药品目录遴选提供了科学依据。

Objective To evaluate the effects and value of four commonly used bisphosphonate preparations in clinical practice in China from multiple dimensions,in order to lay a theoretical foundation for drug selection and disease treatment in medical institutions and provide data support.Methods Referring to the standardized content of the"Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions(Second Edition)",the effects and value of four different bisphosphonate preparations were discussed and evaluated at different levels such as pharmaceutical characteristics,effectiveness,safety and economical efficiency.Results The health technical scores of 4 kinds of bisphosphonate preparations were 79 points of alendronate sodium,71.07 points of risedronate sodium,75.77 points of ibandronate sodium and 66.42 points of zoledronic acid,all of which could be safely and effectively used in the treatment of osteoporosis.However,each of these drugs has its advantages and disadvantages,among which alendronate sodium has advantages in pharmaceutical properties,effectiveness and economy.Zoledronic acid has the worst safety and the best other properties.Ibandronate sodium has the highest safety.Conclusion Alendronate sodium has the highest comprehensive evaluation score,and the four bisphosphonate drugs have good efficacy in the treatment of postmenopausal women,adult men and glucocorticoid-induced osteoporosis.Ibandronate sodium has the most satisfactory safety performance.It can also be used in patients with abnormal liver and kidney function and the incidence of adverse reactions is relatively low.The result provides scientific basis for the selection of hospital drug list.