To evaluate the effectiveness of intravenous clodronate in ameliorating refractory bone pain in patients with metastatic bone disease, 60 patients with established osseous metastases and persistent bone pain were randomized to receive either clodronate (600 mg or 1500 mg in 500 mL of normal saline) or 500 mL of saline as placebo. After 2 weeks, the patients were crossed over to receive the alternate treatment. After another 2 weeks, each patient and investigator made a blinded choice. Daily visual analogue scales (VAS) and analgesic diaries were recorded throughout the study period. Forty-six patients were evaluable (77%). A treatment x period interaction was identified in the VAS and daily morphine equivalent dose (DMED) scores. First period analysis of the VAS scores for general pain, pain at rest, and pain upon movement demonstrated an average reduction of 13, 14, and 24 mm, respectively, from baseline, but were not significantly different from changes following placebo. The average change in DMED was -6.4 (SE = 2.9) following clodronate and was +24.6 (SE = 14.9) following placebo (p = 0.03). In the blinded choice of which agent resulted in improvement in pain, 26 (57%) patients chose clodronate, 12 (26%) chose placebo, and eight (17%) had no preference (p = 0.0021). For the investigators who also made a blinded selection, clodronate was chosen in 30 (65%) patients, placebo in ten (22%) patients, and no difference was apparent in six (13%) (p < 0.0001). Intravenous clodronate appeared to have analgesic effect in patients with refractory bone pain due to metastatic bone disease. The optimal dose and duration of effect require further evaluation, particularly in patients with stable disease and persistent bone pain.

译文

:为评估静脉使用氯膦酸盐缓解转移性骨病患者难治性骨痛的有效性,随机将60例骨转移明确且持续性骨痛的患者随机接受氯膦酸盐(600毫克或1500毫克于500毫升生理盐水中)或500 mL生理盐水作为安慰剂。 2周后,将患者交叉接受替代治疗。再过2周后,每个患者和研究者都做出了盲目的选择。在整个研究期间记录每日视觉模拟量表(VAS)和止痛日记。 46名患者可评估(77%)。在VAS和每日吗啡当量剂量(DMED)评分中确定了治疗x周期相互作用。对一般性疼痛,静止性疼痛和运动性疼痛的VAS评分的第一阶段分析显示,与基线相比平均减少了13 mm,14 mm和24 mm,但与安慰剂治疗后的变化无显着差异。氯膦酸盐治疗后DMED的平均变化为-6.4(SE = 2.9),安慰剂治疗后为24.6(SE = 14.9)(p = 0.03)。在对导致疼痛改善的药剂的盲目选择中,有26名(57%)患者选择了氯膦酸盐,12名(26%)患者选择了安慰剂,而八名(17%)患者没有偏爱(p = 0.0021)。对于同样盲目选择的研究者,在30名(65%)患者中选择了氯膦酸,在十名(22%)患者中选择了安慰剂,在六名(13%)中没有发现明显的差异(p <0.0001)。在由于转移性骨病导致的难治性骨痛患者中,静脉注射氯膦酸盐似乎具有镇痛作用。最佳剂量和效果持续时间需要进一步评估,尤其是在疾病稳定且持续存在骨痛的患者中。

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