Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma
Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma
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DOI：
10.1056/nejm199602223340802
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发表时间：
1996-02-22
影响因子：
158.5
通讯作者：
Knight, RD
中科院分区：
文献类型：
--
作者：
Berenson, JR;Lichtenstein, A;Knight, RD
背景资料。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向骨吸收的可溶性因素引起的，帕米磷酸钠等双膦酸盐抑制破骨细胞活性，减少骨吸收。除了抗骨髓瘤治疗外，III期多发性骨髓瘤和至少一个溶解病变的患者接受安慰剂或帕米磷酸钠(90毫克)的静脉输注，每4周一次，共9个周期。根据患者在进入研究时是否接受一线(第1层)或第二线(第2层)抗骨髓瘤化疗进行分层。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(症状或血清钙浓度大于或等于12毫克/分升[3.0 mmol/升])、骨痛、止痛药使用、功能状态和生活质量。在392名接受治疗的患者中，196名接受帕米磷酸钠治疗的患者和181名接受安慰剂治疗的患者可以评估治疗效果。帕米磷酸酯组患者发生任何骨骼事件的比例(24%)显著低于安慰剂组(41%，P
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 greater than or equal to 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