EFFECT OF ORAL CLODRONATE ON METASTATIC BONE PAIN - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
EFFECT OF ORAL CLODRONATE ON METASTATIC BONE PAIN - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
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DOI：
10.1200/jco.1995.13.9.2427
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发表时间：
1995-09-01
影响因子：
45.3
通讯作者：
RALSTON, SH
中科院分区：
文献类型：
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作者：
ROBERTSON, AG;REED, NS;RALSTON, SH
目的：研究口服氯屈磷酸钠对晚期转移性骨疾病患者骨痛的影响。患者和方法：55例进展性骨转移患者随机分为口服氯屈磷酸钠1600 mg/d(n=27)和配伍安慰剂(n=28)。主要观察指标为骨痛(视觉模拟评分)、止痛药使用和治疗依从性。结果：氯屈磷酸酯组视觉模拟疼痛评分(中位数[四分位数范围])较治疗前降低(-0.9[-2.6至-0.4])，而安慰剂组(+0.4[-1.0至+4.0])(组间P=0.03)。两组中随着疾病进展止痛剂使用量增加的程度相似(氯屈膦酸酯组增加59%，安慰剂组增加%；差异不显着)。氯屈膦酸酯组有10名患者(37%)和安慰剂组患者(12名)(46%)过早退出研究，最常见的原因是吞咽胶囊困难。结论：氯屈磷酸钠在一定程度上改善了晚期转移性癌症患者的骨痛控制，但并未显著减少止痛药的需求。也许由于这些因素，事实证明很难维持患者的治疗。需要进一步的研究，以确定双膦酸盐，如氯屈膦在这种情况下的作用，并与现有的治疗方法，如放射治疗和止痛药进行比较。(C)1995年，由美国临床肿瘤学会主办。
Purpose: To study the effects of oral clodronate on bone pain in patients with advanced metastatic bone disease.Patients and Methods: Fifty-five patients with progressing bone metastases were randomized to receive oral clodronate 1,600 mg/d (n = 27) or matching placebo (n = 28). The main outcome measures were bone pain (visual analog score), analgesic use, and compliance with therapy.Results: Visual analog pain score (median [interquartile range]) decreased from the pretreatment value in the clodronate group (-0.9 [-2.6 to -0.4]), but increased in the placebo group (+0.4 [-1.0 to +4.0]) (P = .03 between groups). Analgesic use increased with disease progression to a similar extent in both groups (59% increased use in the clodronate group v 64% of placebo group; difference not significant). Ten patients (37%) in the clodronate group and 12 (46%) in the placebo group withdrew from the study prematurely, most often because of difficulty with swallowing the capsules.Conclusion: Clodronate improved control of bone pain to a modest degree in patients with advanced metastatic cancer, but did not reduce analgesic requirement significantly. Perhaps as a result of these factors, it proved difficult to maintain patients on therapy. Further studies will be needed to define the role of bisphosphonates such as clodronate in this situation, in comparison with established treatments such as radiotherapy and analgesics. (C) 1995 by American Society of Clinical Oncology.