Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group.
Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group.
复制标题
帕米膦酸钠减少晚期多发性骨髓瘤患者骨骼事件的功效。
DOI：
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发表时间：
1996
影响因子：
158.5
通讯作者：
R. Knight
中科院分区：
文献类型：
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作者：
J. Berenson;A. Lichtenstein;L. Porter;M. Dimopoulos;Roldolfo Bordoni;S. George;A. Lipton;A. Keller;O. Ballester;M. Kovacs;H. Blacklock;R. Bell;Joseph F. Simeone;D. Reitsma;M. Heffernan;J. Seaman;R. Knight
背景
骨骼并发症是多发性骨髓瘤的主要临床表现。这些并发症是由刺激破骨细胞吸收骨的可溶性因子引起的。双膦酸盐如帕米膦酸盐抑制骨代谢活性并减少骨吸收。
方法
患有III期多发性骨髓瘤和至少一个溶瘤性病变的患者除了抗骨髓瘤治疗外，还接受安慰剂或帕米膦酸二钠（90 mg）静脉输注4小时，每4周给药一次，共9个周期。根据患者入组研究时是否接受一线（第1层）或二线（第2层）抗骨髓瘤化疗对患者进行分层。每月评估骨骼事件（病理性骨折、骨放射或手术、脊髓压迫）、高钙血症（症状或血清钙浓度≥ 12 mg/dl [3.0 mmol/L]）、骨痛、镇痛药使用、体力状态和生活质量。
结果
在392例接受治疗的患者中，196例接受帕米膦酸盐治疗，181例接受安慰剂治疗。帕米膦酸二钠组发生任何骨骼事件的患者比例（24%）显著低于安慰剂组（41%，P < 0.001），并且在第1层（P = 0.04）和第2层（P = 0.004）中均明显降低。接受帕米膦酸盐治疗的患者骨痛明显减轻，体力状态和生活质量没有恶化。帕米膦酸二钠耐受性良好。
结论
每月输注帕米膦酸盐可显著预防骨骼并发症，并改善III期多发性骨髓瘤患者的生活质量。
BACKGROUND
Skeletal complications are a major clinical manifestation of multiple myeloma. These complications are caused by soluble factors that stimulate osteoclasts to resorb bone. Bisphosphonates such as pamidronate inhibit osteoclastic activity and reduce bone resorption.
METHODS
Patients with stage III multiple myeloma and at least one lytic lesion received either placebo or pamidronate (90 mg) as a four-hour intravenous infusion given every four weeks for nine cycles in addition to antimyeloma therapy. The patients were stratified according to whether they were receiving first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy at entry into the study. Skeletal events (pathologic fracture, irradiation of or surgery on bone, and spinal cord compression), hypercalcemia (symptoms or a serum calcium concentration > or = 12 mg per deciliter [3.0 mmol per liter]), bone pain, analgesic-drug use, performance status, and quality of life were assessed monthly.
RESULTS
Among 392 treated patients, the efficacy of treatment could be evaluated in 196 who received pamidronate and 181 who received placebo. The proportion of patients who had any skeletal events was significantly lower in the pamidronate group (24 percent) than in the placebo group (41 percent, P < 0.001), and the reduction was evident in both stratum 1 (P = 0.04) and stratum 2 (P = 0.004). The patients who received pamidronate had significant decreases in bone pain and no deterioration in performance status and quality of life. Pamidronate was tolerated well.
CONCLUSIONS
Monthly infusions of pamidronate provide significant protection against skeletal complications and improve the quality of life of patients with stage III multiple myeloma.
影响因子：
4
作者：
G. Mundy;D. Bertolini
通讯作者：
G. Mundy;D. Bertolini