van Staa T P, Leufkens H, Abenhaim L, Cooper C
Procter & Gamble Pharmaceuticals, Staines, United Kingdom.
Pharmacotherapy. 1998 Sep-Oct;18(5):1121-8.
To evaluate the safety of cyclic etidronate in routine clinical practice, we obtained information from 550 general practices in the United Kingdom that provide the medical records to the General Practice Research Database. A group of 7977 patients taking cyclic etidronate and two age-, gender-, and practice-matched control groups, one with osteoporosis and one without, were analyzed. For the group taking cyclic etidronate, the average age was 71.6 years and follow-up was 10,328 person-years. Conditions that do not induce osteoporosis generally occurred in these patients at a rate comparable to that in the control groups. The incidence of osteomalacia was low and comparable between patients taking cyclic etidronate and controls with osteoporosis. No medically significant increases in frequency were observed among patients taking cyclic etidronate for a broad group of diseases that may potentially be induced by exposure to the drug. These data support the favorable risk:benefit ratio of cyclic etidronate.
为评估环丙膦酸在常规临床实践中的安全性，我们从英国550家向全科医疗研究数据库提供病历的全科诊所获取了信息。分析了一组7977名服用环丙膦酸的患者以及两个年龄、性别和诊所匹配的对照组，其中一个对照组患有骨质疏松症，另一个没有。对于服用环丙膦酸的组，平均年龄为71.6岁，随访时间为10328人年。一般不会诱发骨质疏松症的病症在这些患者中的发生率与对照组相当。骨软化症的发生率较低，服用环丙膦酸的患者与患有骨质疏松症的对照组之间相当。在服用环丙膦酸的患者中，对于一大类可能由接触该药物诱发的疾病，未观察到频率有医学上显著的增加。这些数据支持环丙膦酸良好的风险效益比。
