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三种氯膦酸盐静脉给药方案治疗骨Paget病的比较。

Comparison of three intravenous regimens of clodronate in Paget disease of bone.

作者信息

Khan S A, McCloskey E V, Eyres K S, Nakatsuka K, Sirtori P, Orgee J, Coombes G, Kanis J A

机构信息

Department of Human Metabolism and Clinical Biochemistry, University of Sheffield Medical School, United Kingdom.

出版信息

J Bone Miner Res. 1996 Feb;11(2):178-82. doi: 10.1002/jbmr.5650110206.

Abstract

We compared the effects of three different regimens of intravenous clodronate in a retrospective study of 60 patients with Paget disease. A total dose of 1500 mg of clodronate was given as 300 mg for 5 consecutive days (n = 20), 1500 mg as a single infusion (n = 20), or 300 mg as a single infusion for 5 consecutive months (n = 20). The response to treatment and the duration of the effect were assessed from sequential changes in the activity of serum alkaline phosphatase. Treatment with clodronate induced a significant response in 85% of patients. The response rate was comparable in patients treated with 5 daily infusions (90%), with a single infusion (75%), and with 5 monthly infusions (90%). The median duration of response from the start of treatment was 11 months for those treated with five daily infusions and 12 months for the other two regimens. At one year, 22, 40, and 44% of patients had maintained their response in the daily, single, and monthly infusion regimen, respectively (NS). Six patients (32%) treated with 5 daily infusions achieved a remission (complete response) compared with 3 patients treated with a single infusion and 5 monthly infusions, respectively (16 and 15% respectively, NS). Patients attaining a complete response had a significantly longer duration of response compared with partial responders (median time 15.0 versus 11.5 months, respectively, p < 0.05). We conclude that intravenous clodronate (total dose 1500 mg) suppresses disease activity in the majority of patients with Paget disease of bone. The degree and duration of response were similar for the three regimens. Thus, in the treatment of Paget disease, the choice of regimen is a matter of convenience.

摘要

在一项针对60例佩吉特病患者的回顾性研究中,我们比较了三种不同静脉注射氯膦酸盐方案的效果。总共1500毫克氯膦酸盐的给药方式分别为:连续5天每天300毫克(n = 20);单次输注1500毫克(n = 20);或连续5个月每月单次输注300毫克(n = 20)。根据血清碱性磷酸酶活性的连续变化评估治疗反应和效果持续时间。氯膦酸盐治疗使85%的患者产生了显著反应。每日输注5次(90%)、单次输注(75%)和每月输注5次(90%)的患者反应率相当。从治疗开始起,每日输注5次的患者反应的中位持续时间为11个月,其他两种方案为12个月。一年时,每日、单次和每月输注方案中分别有22%、40%和44%的患者维持了反应(无显著性差异)。每日输注5次治疗的6例患者(32%)达到缓解(完全反应),相比之下,单次输注和每月输注5次治疗的患者分别为3例(分别为16%和15%,无显著性差异)。达到完全反应的患者与部分反应者相比,反应持续时间显著更长(中位时间分别为15.0个月和11.5个月,p < 0.05)。我们得出结论,静脉注射氯膦酸盐(总剂量1500毫克)可抑制大多数骨佩吉特病患者的疾病活动。三种方案的反应程度和持续时间相似。因此,在佩吉特病的治疗中,方案的选择只是方便与否的问题。

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