随机、双盲、二期试验的硝酸镓与磷酸盐对急性癌症相关的血钙过多的控制权。

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Cvitkovic F,阿尔芒JP, Tubiana-Hulin M,罗西摩根富林明,Warrell RP Jr .

随机、双盲、二期试验的硝酸镓与磷酸盐对急性癌症相关的血钙过多的控制权。

癌症j . 2006; 1 - 2月12 (1):47-53。

PubMed ID
16613662 (在PubMed
]
文摘

背景:硝酸镓和磷酸盐都是高度有效的急性癌症相关的血钙过多的控制权。然而,患者的比例实际上实现normocalcemia在报道不同。因此,我们进行了一次探索性、随机、双盲试验相比,硝酸镓的疗效和安全性,磷酸盐与癌症相关的住院病人血钙过多。患者和方法:符合条件的患者血钙过多,定义为albumin-adjusted血清钙> = 12.0 mg / dL或静脉水化后,进行分层的基础上肿瘤组织学(即。、表皮样或nonepidermoid)和学习网站。病人被随机分配接受静脉注射硝酸镓连续5天每天200 mg / m2或静脉注射磷酸盐60毫克(在研究增加到90毫克初始患者血清钙> = 13.5 mg / dL)其次是安慰剂输液4天。这项研究的主要终点是比较患者的比例normocalcemia实现。结果:六十四名患者被随机分配,所有患者可评价的有效性和安全性。Normocalcemia 22也取得了32名患者(69%)的硝酸镓与18 32位病人(56%)接受磷酸盐。患者随机分配到磷酸盐初始血清钙> = 13.5 mg / dL或没有回应更好90毫克(3 6;50%)比60毫克(7 13; 54%), or compared with the response to gallium nitrate in this subset (15 of 21; 71%). Response to pamidronate was also lower in patients with epidermoid cancers (33%, vs 68% for gallium nitrate). Duration of normocalcemia was examined using both an intent-to-treat analysis irrespective of response and an analysis that examined only responding patients. By intent-to-treat analysis, the median duration of normocalcemia was 1 day for the pamidronate group and 7 days for the gallium nitrate group. Estimated normocalcemic duration in responders was 10 days for the pamidronate group and 14 days for the gallium nitrate group. Both drugs were well tolerated, and clinically significant nephrotoxicity was not observed in either treatment group. DISCUSSION: Gallium nitrate appears to be at least as effective as pamidronate for acute control of cancer-related hypercalcemia. Results from this trial suggest that gallium nitrate may be particularly useful in patients with epidermoid cancers or severe hypercalcemia at baseline, and in patients who have previously exhibited a poor response to bisphosphonates.

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