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帕米膦酸二钠在治疗恶性肿瘤所致骨痛中的作用。

The role of disodium pamidronate in the management of bone pain due to malignancy.

作者信息

Groff L, Zecca E, De Conno F, Brunelli C, Boffi R, Panzeri C, Cazzaniga M, Ripamonti C

机构信息

Rehabilitation and Palliative Care Division, National Cancer Institute of Milan, Milano, Italy.

出版信息

Palliat Med. 2001 Jul;15(4):297-307. doi: 10.1191/026921601678320287.

Abstract

A number of controlled studies have recently demonstrated the role of disodium pamidronate in the prevention of skeletal complications in patients with metastatic bone disease due to breast cancer and multiple myeloma. They have also shown that it relieves pain and is well tolerated. The aim of this open prospective study was to evaluate the acceptability of a new schedule of pamidronate infusion and to assess pain, analgesic consumption and the Karnofsky Performance Status (KPS) in patients with metastatic bone pain treated with pamidronate in association or not with chemotherapy, radiotherapy, and hormone therapy. Patients with different types of cancer and at least one painful bone metastasis were treated with two cycles of 60 mg intravenous (iv) pamidronate weekly for three consecutive doses, with a 3-week interval between the two cycles (six infusions over 7 weeks), followed by one infusion every 3 weeks for a total of 24 infusions. Two hundred patients were enrolled in the study, of whom 94 received at least the first six infusions; 25 patients received all 24 infusions. Pamidronate was well tolerated in the majority of the patients both during the first six infusions and during the whole study period. In the patients under study, pain intensity decreased compared with T0 after the first two infusions (second week of treatment). The mean equivalent daily dose of oral morphine required ranged from 21.5 to 41.5 mg/day and was low and stable during the study. For the patients who remained in the study, the KPS remained around 70 during the whole treatment period and intrasubject analysis showed a substantial stability of the KPS within each subject. A first fracture occurred within 321 days in 25% of the whole population under study. Pamidronate represents a further valid therapy to add to an already consolidated list of therapies such as radiotherapy, chemotherapy, hormone therapy and orthopaedic intervention in the pain management of patients with bone metastases. Future studies are necessary to evaluate the role of pamidronate and the appropriate schedule in patients with advanced or terminal cancer who are no longer being treated with oncological therapies.

摘要

近期多项对照研究证实了帕米膦酸二钠在预防乳腺癌和多发性骨髓瘤所致转移性骨病患者骨骼并发症方面的作用。这些研究还表明,它能缓解疼痛且耐受性良好。本开放性前瞻性研究的目的是评估一种新的帕米膦酸输注方案的可接受性,并评估接受或未接受化疗、放疗及激素治疗的转移性骨痛患者使用帕米膦酸治疗后的疼痛、镇痛药物消耗量及卡氏功能状态评分(KPS)。患有不同类型癌症且至少有一处疼痛性骨转移的患者接受两个周期治疗,每周静脉注射(iv)60mg帕米膦酸,连续给药三次,两个周期之间间隔3周(7周内进行6次输注),之后每3周输注一次,共进行24次输注。200名患者参与了该研究,其中94名患者至少接受了前6次输注;25名患者接受了全部24次输注。在多数患者中,无论是在前6次输注期间还是在整个研究期间,帕米膦酸的耐受性都良好。在本研究患者中,与治疗开始时(T0)相比在前两次输注(治疗第二周)后疼痛强度降低了。所需口服吗啡平均等效日剂量在21.5至41.5mg/天之间且在研究期间较低且稳定不变。对于留在研究中的患者,整个治疗期间KPS评分保持在70左右,个体内分析显示每个患者的KPS评分具有显著稳定性差异。在整个研究人群中,25%的患者在321天内发生了首次骨折。在骨转移患者的疼痛管理中,帕米膦酸是放疗、化疗、激素治疗及骨科干预等已成熟治疗方法之外的又一种有效治疗手段。有必要开展进一步研究,以评估帕米膦酸在不再接受肿瘤治疗的晚期或终末期癌症患者中的作用及合适的给药方案。

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