PLACORHEN研究：一项针对伴有疼痛性骨转移的激素抵抗性前列腺癌患者，使用（186）铼-依替膦酸盐进行的双盲、安慰剂对照、随机放射性核素研究。安慰剂对照铼研究。

The PLACORHEN study: a double-blind, placebo-controlled, randomized radionuclide study with (186)Re-etidronate in hormone-resistant prostate cancer patients with painful bone metastases. Placebo Controlled Rhenium Study.

作者信息

Han Shiuw H, de Klerk John M H, Tan Suzy, van het Schip Alfred D, Derksen Bert H, van Dijk Aalt, Kruitwagen Cas L J J, Blijham Geert H, van Rijk Peter P, Zonnenberg Bernard A

机构信息

Department of Nuclear Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

J Nucl Med. 2002 Sep;43(9):1150-6.

PMID:12215552

Abstract

UNLABELLED

(186)Re-1,1-hydroxyethylidene diphosphonate (etidronate) can be used for the palliative treatment of metastatic bone pain. A randomized, placebo-controlled study using (186)Re-etidronate was conducted on end-stage prostate cancer patients with metastatic bone pain.

METHODS

Pain relief was assessed using an electronic diary containing questions reflecting the multidimensional character of chronic pain. The diary was marked twice daily for a maximum of 14 wk (2 wk before and 12 wk after the injection). Pain response was determined using a specific decision rule in which pain intensity, medication index, and daily activities were the core determinants. A positive response day was defined as a day on which pain intensity was reduced > or = 25% compared with baseline values, while medication index and daily activities were at least constant, or on which pain intensity was reduced < 25% and medication index or daily activities improved > or = 25%, without worsening of the remaining factor. The total response (%) was defined as the number of positive response days divided by the number of days of follow-up.

RESULTS

Of the 111 included patients, 79 were evaluable (43 (186)Re-etidronate, 36 placebo). Thirty-two patients were excluded from the analysis because of incomplete datasets. The total response of the patients treated with (186)Re-etidronate varied from 0% to 96% (mean, 27%, or 23/84 d). In the placebo group, the total response varied from 0% to 80% (mean, 13%, or 11/84 d; Mann-Whitney U test, P < 0.05). The number of patients who requested radiotherapy was higher in the placebo group (67%) than in the (186)Re-etidronate group (44%) (relative risk, 1.51; Fisher's exact test, P = 0.069).

CONCLUSION

This randomized controlled trial confirmed that, compared with placebo, (186)Re-etidronate resulted in a significantly longer pain response in the treatment of bone pain from metastasized prostate cancer.

摘要

未标注

（186）铼-1,1-羟基亚乙基二膦酸盐（依替膦酸）可用于转移性骨痛的姑息治疗。对患有转移性骨痛的晚期前列腺癌患者进行了一项使用（186）铼-依替膦酸的随机、安慰剂对照研究。

方法

使用包含反映慢性疼痛多维度特征问题的电子日记评估疼痛缓解情况。该日记每天标记两次，最长持续14周（注射前2周和注射后12周）。使用特定的决策规则确定疼痛反应，其中疼痛强度、用药指数和日常活动是核心决定因素。阳性反应日定义为与基线值相比疼痛强度降低≥25%，同时用药指数和日常活动至少保持不变的日子，或者疼痛强度降低<25%且用药指数或日常活动改善≥25%且其余因素未恶化的日子。总反应率（%）定义为阳性反应日数除以随访天数。

结果

在纳入的111例患者中，79例可评估（43例接受（186）铼-依替膦酸治疗，36例接受安慰剂治疗）。32例患者因数据集不完整被排除在分析之外。接受（186）铼-依替膦酸治疗的患者总反应率在0%至96%之间（平均27%，即23/84天）。在安慰剂组中，总反应率在0%至80%之间（平均13%，即11/84天；Mann-Whitney U检验，P<0.05）。安慰剂组中要求放疗的患者数量（67%）高于（186）铼-依替膦酸组（44%）（相对风险，1.51；Fisher精确检验，P = 0.069）。