对氧化镁反应不充分的癌症和阿片类药物引起的便秘患者加用纳尔代丁治疗的效果:两项随机对照试验的分组汇总分析。

IF 1.9 4区 医学 Q3 ONCOLOGY Japanese journal of clinical oncology Pub Date : 2024-10-01 DOI:10.1093/jjco/hyae135
Takaomi Kessoku, Toshikazu Akamatsu, Yasuhide Morioka, Takaaki Yokota, Masayuki Kobayashi, Kohei Uchida, Yuichi Koretaka, Atsushi Nakajima
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引用次数: 0

摘要

目的评估对氧化镁治疗反应不佳的癌症患者服用甲磺酸纳尔代丁(naldemedine tosylate)对阿片类药物引起的便秘的叠加效应:我们合并了纳尔代明的两项随机、双盲、安慰剂对照的IIb期和III期试验,并进行了事后亚组分析。我们评估了116名在接受氧化镁治疗的同时接受纳尔代丁治疗的患者(纳尔代丁组)和117名在接受氧化镁治疗的同时接受安慰剂治疗的患者(安慰剂组)的纳尔代丁治疗效果和安全性。两组患者都包括对氧化镁治疗阿片类药物引起的便秘反应不足的患者。疗效通过自发性排便应答率、完全自发性排便应答率、自发性排便变化和完全自发性排便来评估。此外,还对安全性进行了评估:结果:在为期两周的治疗期间,纳尔德美定组的自发性排便应答率和完全自发性排便应答率分别为 73.3%和 43.1%,显著高于其他组(P 结论:纳尔德美定组的自发性排便应答率和完全自发性排便应答率显著高于其他组(P该研究表明,对氧化镁治疗反应不佳的癌症患者而言,添加纳尔代丁是治疗阿片类药物所致便秘的一种有效方法。
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Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials.

Objective: To evaluate the additive effect of naldemedine tosylate (naldemedine) on opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

Methods: We combined two randomized, double-blind, placebo-controlled, phase IIb and III trials of naldemedine and conducted a post hoc subgroup analysis. We evaluated the effect and safety of naldemedine in 116 patients who received naldemedine in addition to magnesium oxide (naldemedine group) and 117 patients who received placebo in addition to magnesium oxide (placebo group). Both groups included patients insufficiently responding to magnesium oxide for opioid-induced constipation. Effect was assessed using spontaneous bowel movement responder rate, complete spontaneous bowel movement responder rate, changes in spontaneous bowel movements and complete spontaneous bowel movements. Safety was also assessed.

Results: During the 2-week treatment period, the responder rates for spontaneous bowel movement and complete spontaneous bowel movement were 73.3 and 43.1% in naldemedine group, respectively, which were significantly higher (P < 0.0001) than 41.9 and 14.5% in placebo group, respectively. Median time to first spontaneous bowel movement and first complete spontaneous bowel movement was significantly shorter (P < 0.0001) in the naldemedine group (4.0 and 21.3 h, respectively) than in the placebo group (27.7 and 211.7 h, respectively). The incidence of adverse events and diarrhoea was significantly higher (P < 0.05) in the naldemedine group than in the placebo group, while the incidence of serious adverse events and severe diarrhoea was not significantly different between the naldemedine and placebo groups.

Conclusion: The study suggested the addition of naldemedine as an effective treatment option for opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

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来源期刊
CiteScore
3.70
自引率
8.30%
发文量
177
审稿时长
3-8 weeks
期刊介绍: Japanese Journal of Clinical Oncology is a multidisciplinary journal for clinical oncologists which strives to publish high quality manuscripts addressing medical oncology, clinical trials, radiology, surgery, basic research, and palliative care. The journal aims to contribute to the world"s scientific community with special attention to the area of clinical oncology and the Asian region. JJCO publishes various articles types including: ・Original Articles ・Case Reports ・Clinical Trial Notes ・Cancer Genetics Reports ・Epidemiology Notes ・Technical Notes ・Short Communications ・Letters to the Editors ・Solicited Reviews
期刊最新文献
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