A double-blind, crossover study of controlled-release metoclopramide and placebo for the chronic nausea and dyspepsia of advanced cancer
A double-blind, crossover study of controlled-release metoclopramide and placebo for the chronic nausea and dyspepsia of advanced cancer
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DOI：
10.1016/s0885-3924(00)00138-x
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发表时间：
2000-06-01
影响因子：
4.7
通讯作者：
Darke, A
中科院分区：
文献类型：
--
作者：
Bruera, E;Belzile, M;Darke, A
为了比较一种新的甲氧氯普胺控释制剂与安慰剂对癌症相关消化不良综合征患者的治疗效果，研究人员将26名患有癌症相关消化不良综合征≥1个月的成年患者随机分为两组，一组每12小时控释40 mg甲氧氯普胺，另一组接受4天的安慰剂治疗。在第5天，患者转入另一种治疗，持续4天。两个阶段均允许剂量调整和抢救止吐药。恶心、厌食、腹胀、呕吐/干呕和嗜睡在每日日记的100毫米VAS量表上进行评估。在每个阶段治疗的最后一天，与安慰剂相比，控释胃复安组的恶心程度显著降低（17 +/- 12 mm vs 12 +/- 10 mm）。在安慰剂期，恶心评分呈增加趋势，在控释胃复安期，恶心评分呈下降趋势。控释胃复安除食欲外，所有症状的强度均有改善的趋势，但这一趋势仅达到恶心的统计学意义。虽然安慰剂组的嗜睡、头晕和睡眠质量较差，但不同治疗组引起的不良事件的频率和严重程度没有显著差异。在任何情况下都没有必要因为毒性而停止控释甲氧氯普胺。这些结果表明控释甲氧氯普胺可减轻这类晚期癌症患者的胃肠道症状。(C)美国癌症疼痛缓解委员会，2000。
To compare a novel controlled-release formulation of metoclopramide with placebo in patients with cancer-associated dyspepsia syndrome, 26 adult patients with a greater than or equal to 1 month history of cancer-associated dyspepsia syndrome were randomized to receive either controlled-release metoclopramide 40 mg every 12 hours or matching placebo for a period of 4 days. On day 5, patients crossed over to the alternate treatment for a further period of 4 days. Dose adjustments and rescue antiemetics were permitted during both phases. Nausea, anorexia, bloating, vomiting/retching, and drowsiness were assessed on a 100-mm VAS scale in a daily diary. On the last day of treatment of each phase nausea was significantly lower in the controlled-release metoclopramide group compared to placebo (17 +/- 12 mm versus 12 +/- 10 mm). Nausea scores tended to increase across days during the placebo phase and to decrease during the controlled release metoclopramide phase. There was a trend for improvement in the intensity of all symptoms on controlled-release metoclopramide with the exception of appetite, but this trend only reached statistical significance nausea. The frequency and severity of elicited adverse events did not differ significantly between treatments, although drowsiness, dizziness, and poor sleep were somewhat higher in the placebo group. In no case was it necessary to discontinue controlled-release metoclopramide because of toxicity. These results indicate that controlled-release metoclopramide reduces gastrointestinal symptoms in this population of advanced cancer patients. (C) U.S. Cancer Pain Relief Committee, 2000.