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Efficacy and safety of tolvaptan in patients with malignant ascites: a phase 2, multicenter, open-label, dose-escalation study.

托伐普坦治疗恶性腹水患者的疗效和安全性: 一项2期、多中心、开放标签、剂量递增研究。

  • 影响因子:2.04
  • DOI:10.1093/jjco/hyaa196
  • 作者列表:"Kudo T","Murai Y","Kojima Y","Uehara K","Satoh T
  • 发表时间:2021-03-03
Abstract

OBJECTIVE:This phase 2 study examined the efficacy and safety of tolvaptan, an aquaretic drug, in the treatment of ascites associated with cancer. METHODS:In the dose-escalation phase, oral tolvaptan was initiated at a dose of 3.75 mg/day, and the dose was increased daily to 7.5, 15 and 30 mg/day. Dose escalation was terminated once the increase from baseline in the daily urine volume reached 500 ml, at which point the patient proceeded to the maintenance phase of 5-7 days. Improvement of ascites was determined primarily by reduction in body weight and ascitic fluid volume. RESULTS:The mean change from baseline in body weight was maintained below 0 kg throughout the study. The mean change (±standard deviation) from baseline in ascitic fluid volume at the end of treatment (EOT) was 237.45 ± 868.14 ml in 33 evaluable patients. Although an increase from baseline in ascitic fluid volume at the EOT was observed in 23 of 33 patients (maximum: 1589.3 ml, minimum: 3.83 ml), a reduction in ascitic fluid volume was observed in the remaining 10 patients (maximum: -2304.3 ml, minimum: -27.5 ml). The common treatment-emergent adverse events included vomiting (5 of 43 patients, 11.6%), abdominal distension, constipation, thirst, blood osmolarity increased and renal impairment (3 of 43 patients, 7.0% each). CONCLUSIONS:Tolvaptan seemed to have no definitive effect on reducing ascites; however, it might be effective in at least some cancer patients. No new safety concerns were identified at doses of 3.75-30 mg/day.

摘要

目的: 本2期研究考察了水提药物托伐普坦治疗与癌症相关的腹水的疗效和安全性。 方法: 在剂量递增阶段,口服托伐普坦以3.75 mg/天的剂量开始,每天增加剂量至7.5、15和30 mg/天。一旦每日尿量从基线的增加达到500毫升,则终止剂量递增,此时患者进入5-7天的维持期。腹水的改善主要通过体重和腹水液量的减少来确定。 结果: 在整个研究中,体重从基线的平均变化保持在0千克以下。在33例可评估患者中,治疗结束时 (EOT) 的腹水液量相对于基线的平均变化 (± 标准差) 为237.45 ± 868.14毫升。虽然在33例患者中,有23例在EOT时观察到腹水容量较基线增加 (最大值: 1589.3毫升,最小值: 3.83毫升),但在其余10例患者中观察到腹水容量减少 (最大值:-2304.3毫升,最小值:-27.5毫升)。常见的治疗中出现的不良事件包括呕吐 (43例患者中的5例,11.6%) 、腹胀、便秘、口渴、血渗透压升高和肾功能损害 (43例患者中的3例,各7.0%)。 结论: 托伐普坦似乎对减少腹水没有确切的作用; 然而,它可能对至少一些癌症患者有效。在3.75-30 mg/天的剂量下没有发现新的安全性问题。

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