Kenji Momo1,2,3,4, Hiroka Nagaoka5, Yoshiyuki Kizawa5,6, Hiroki Bukawa7, Shigeru Chiba8, Yukinao Kohda9,10, Masato Homma9,10. 1. Department of Pharmacy, University of Tsukuba Hospital, Amakubo 2-1-1, Tsukuba, Ibaraki, 305-8576, Japan. k.momo@thu.ac.jp. 2. Department of Pharmaceutical Sciences, Faculty of Medicine, University of Tsukuba, Ten-nodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan. k.momo@thu.ac.jp. 3. Palliative Care Unit, University of Tsukuba Hospital, Amakubo 2-1-1, Tsukuba, Ibaraki, 305-8576, Japan. k.momo@thu.ac.jp. 4. Faculty of Pharmaceutical Sciences, Teikyo Heisei University, 4-21-2, Nakano, Nakano-ku, Tokyo, 164-8530, Japan. k.momo@thu.ac.jp. 5. Palliative Care Unit, University of Tsukuba Hospital, Amakubo 2-1-1, Tsukuba, Ibaraki, 305-8576, Japan. 6. Department of Palliative Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan. 7. Department of Oral and Maxillofacial Surgery, Faculty of Medicine, University of Tsukuba, Ten-nodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan. 8. Department of Hematology, Faculty of Medicine, University of Tsukuba, Ten-nodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan. 9. Department of Pharmacy, University of Tsukuba Hospital, Amakubo 2-1-1, Tsukuba, Ibaraki, 305-8576, Japan. 10. Department of Pharmaceutical Sciences, Faculty of Medicine, University of Tsukuba, Ten-nodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Abstract
PURPOSE: The efficacy and safety of indomethacin (IM) oral spray (OS) as a pain control therapy for oropharyngeal mucositis due to anticancer chemo- and radiotherapy were assessed in patients with head and neck carcinomas and haematological tumours. METHOD: We observed 35 patients (male/female, 20/15; 53 ± 17 years) with oropharyngeal mucositis who were treated with IM-OS preparation for pain relief at University of Tsukuba Hospital, Japan. Analgesic effects were assessed using the six-grade face scale for pain in 28 patients at the start of IM oral spray treatment. Systemic exposure was assessed by determining urinary excretions of IM in seven patients. RESULTS: Pain relief was achieved in 26 (93%) patients at 25 (5-60) min after applying the IM-OS preparation (15.6 ± 3.4 μg/kg) and analgesic effects were maintained for 120 (10-360) min. The pain was significantly decreased after using the spray (3.6 ± 0.7 vs. 2.4 ± 0.9, p < 0.01). Moreover, urinary IM excretion rates after applying the IM spray preparation were 1.8 ± 0.8% of the IM oral spray dose (130.5 ± 77.7 μg/kg/day), which was markedly lower than that following oral administration of IM (60%). No adverse events were observed following application of the spray. CONCLUSIONS: The present IM spray is an effective and safe preparation for pain relief and can be used as an alternative therapeutic option for oropharyngeal mucositis in cancer patients.
PURPOSE: The efficacy and safety of indomethacin (IM) oral spray (OS) as a pain control therapy for oropharyngeal mucositis due to anticancer chemo- and radiotherapy were assessed in patients with head and neck carcinomas and haematological tumours. METHOD: We observed 35 patients (male/female, 20/15; 53 ± 17 years) with oropharyngeal mucositis who were treated with IM-OS preparation for pain relief at University of Tsukuba Hospital, Japan. Analgesic effects were assessed using the six-grade face scale for pain in 28 patients at the start of IM oral spray treatment. Systemic exposure was assessed by determining urinary excretions of IM in seven patients. RESULTS:Pain relief was achieved in 26 (93%) patients at 25 (5-60) min after applying the IM-OS preparation (15.6 ± 3.4 μg/kg) and analgesic effects were maintained for 120 (10-360) min. The pain was significantly decreased after using the spray (3.6 ± 0.7 vs. 2.4 ± 0.9, p < 0.01). Moreover, urinary IM excretion rates after applying the IM spray preparation were 1.8 ± 0.8% of the IM oral spray dose (130.5 ± 77.7 μg/kg/day), which was markedly lower than that following oral administration of IM (60%). No adverse events were observed following application of the spray. CONCLUSIONS: The present IM spray is an effective and safe preparation for pain relief and can be used as an alternative therapeutic option for oropharyngeal mucositis in cancerpatients.
Entities:
Keywords:
Cancer patients; Indomethacin; Indomethacin oral spray preparation; Oral mucositis; Oropharyngeal mucositis; Pain control
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