Robertson A G, Reed N S, Ralston S H
Beatson Oncology Centre, Western Infirmary, Glasgow, United Kingdom.
J Clin Oncol. 1995 Sep;13(9):2427-30. doi: 10.1200/JCO.1995.13.9.2427.
To study the effects of oral clodronate on bone pain in patients with advanced metastatic bone disease.
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.
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.
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.
研究口服氯膦酸盐对晚期转移性骨病患者骨痛的影响。
55例骨转移进展期患者被随机分为两组，分别接受每日1600毫克口服氯膦酸盐治疗（n = 27）或匹配的安慰剂治疗（n = 28）。主要观察指标为骨痛（视觉模拟评分）、镇痛药使用情况及治疗依从性。
氯膦酸盐组视觉模拟疼痛评分（中位数[四分位间距]）较治疗前下降（-0.9[-2.6至-0.4]），而安慰剂组上升（+0.4[-1.0至+4.0]）（组间P = 0.03）。两组中镇痛药使用量均随疾病进展而增加，且增加程度相似（氯膦酸盐组增加59%，安慰剂组增加64%；差异无统计学意义）。氯膦酸盐组10例患者（37%）和安慰剂组12例患者（46%）提前退出研究，最常见原因是吞咽胶囊困难。
氯膦酸盐在晚期转移性癌症患者中对骨痛控制有一定程度改善，但未显著降低镇痛药需求量。或许由于这些因素，维持患者治疗存在困难。与放疗和镇痛药等既定治疗方法相比，需要进一步研究以明确氯膦酸盐等双膦酸盐在此情况下的作用。
