两种静脉使用的双膦酸盐治疗绝经后骨质疏松症的安全性研究

Safety of two intravenous bisphosphonates in the treatment of postmenopausal osteoporosis

目的评估绝经后骨质疏松症妇女静脉注射唑来膦酸和3个月伊班膦酸钠的安全性。方法分析使用唑来膦酸(n=122)或静脉注射伊班膦酸钠(n=140)治疗的262例绝经后妇女的安全性数据。通过使用标准化问卷在电话访谈中收集安全性数据(包括急性期反应的发生和下颌骨坏死)。结果与伊班膦酸盐治疗的患者相比,唑来膦酸患者的不良事件患者数明显增多,且给药后出现症状类别也较多(P<0.05)。除了发烧(在唑来膦酸输注后更常见),其他流感样症状(肌痛、关节痛、头痛)在静脉注射治疗后(24~36 h)出现在相似比例的患者中。大约50%的患者症状持续3 d。输注后症状发生率下降。唑来膦酸治疗后流感样症状发生率高于静脉注射伊班膦酸盐给药后,但之前口服双膦酸盐患者发生率相似。没有发现颌骨坏死、心律失常或骨折愈合延迟。结论尽管静脉注射双膦酸盐通常是安全的,但在临床实践中,静脉注射双膦酸盐后出现的短暂流感样症状似乎比临床试验中报道的更为多见。

Objective We assessed the safety of intravenous administration of zoledronic acid and 3-monthly of ibandronate in women with postmenopausal osteoporosis.Methods In this retrospective study we analyzed safety data from 262 postmenopausal women treated with zoledronic acid(n=122)or intravenous(IV)ibandronate(n=140).Safety data(including occurrence of acute-phase reactions and osteonecrosis of the jaw)were gathered during telephone interviews by using a standardized questionnaire.Results The number of patients with adverse events was significantly higher in zoledronic acid-treated as compared to ibandronate-treated patients,primarily because of a larger number of post-dose symptoms after bisphosphonate administrations(P<0.05).Except for the occurrence of fever(more common after zoledronic acid infusion),other influenza-like symptoms(myalgia,arthralgia and headache)appeared in a similar proportion of patients after IV treatment(within 24-36 h).Symptoms lasted for 3 days in approximately 50%of patients.The incidence of symptoms decreased in subsequent infusions.The rate of influenza-like symptoms was more frequent after zoledronic acid than after IV ibandronate administration in bisphosphonate-na ve patients but comparable in patients pretreated with oral bisphosphonates before.There were no spontaneous reports of osteonecrosis of the jaw,arrhythmia or delayed fracture healing.Conclusion Although IV bisphosphonates are generally safe,the occurrence of transient influenza-like symptoms after IV bisphosphonates seems to be more frequent in clinical practice than has been reported in clinical trials.