Safe and effective deodorization of malodorous fungating tumors using topical metronidazole 0.75 % gel (GK567): a multicenter, open-label, phase III study (RDT.07.SRE.27013).
Safe and effective deodorization of malodorous fungating tumors using topical metronidazole 0.75 % gel (GK567): a multicenter, open-label, phase III study (RDT.07.SRE.27013).
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DOI：
10.1007/s00520-015-3067-0
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发表时间：
2016-06
期刊：
影响因子：
--
通讯作者：
Nakamura S
中科院分区：
文献类型：
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作者：
Watanabe K;Shimo A;Tsugawa K;Tokuda Y;Yamauchi H;Miyai E;Takemura K;Ikoma A;Nakamura S
恶性真菌性肿瘤是与皮肤溃疡相关的肿瘤，其易受微生物定植的影响。细菌感染和增殖可能导致恶臭，给患者带来痛苦。甲硝唑是一种有效的抗厌氧菌药物，可能有助于减少和改善生活质量（QOL）。本研究探讨了外用0.75%甲硝唑凝胶缓解厌氧菌感染的真菌性肿瘤患者恶臭的有效性和安全性。这是一项多中心、开放标签、非对照、III期研究，包括年龄在20岁或以上的患有释放恶臭的皮肤真菌性肿瘤的受试者（基于研究者的评估，在0（无气味）至4（极度难闻气味）的量表上，最低评分为2（轻度难闻气味））。受试者根据研究者的判断每天应用0.75%甲硝唑凝胶一次或两次，持续14天。成功定义为第14天气味评分为0或1，由研究者评估。使用满意度调查问卷评估患者满意度。还报告了应用0.75%甲硝唑凝胶后发生的不良事件（AE）。共入组了21例受试者，中位年龄为65.0岁。第14天的成功率为95.2%（20/21例受试者）。患者满意度评估显示71.4%（15/21）的受试者明显或中度改善。治疗耐受性良好，仅2例皮肤肿瘤出血AE病例（1例轻度和1例中度）。甲硝唑0.75%凝胶是一种安全有效的治疗真菌性肿瘤的方法.
Malignant fungating tumors are neoplastic tumors associated with skin ulcers, which are susceptible to microbial colonization. Bacterial infection and proliferation may lead to malodor causing distress to patients. Metronidazole—an effective agent against anaerobes—may contribute to deodorization and improvement in quality of life (QOL). This study investigated the efficacy and safety of topical metronidazole 0.75 % gel for alleviation of malodor in anaerobically infected fungating neoplastic tumors. This was a multicenter, open-label, non-controlled, phase III study including subjects aged 20 years or older with cutaneous fungating tumors releasing malodor (minimum score of 2 (mildly offensive smell) on a scale from 0 (no smell) to 4 (extremely offensive smell) based on investigator’s assessment). Subjects applied metronidazole 0.75 % gel once or twice daily at the investigator’s discretion for 14 days. Success was defined as an odor score of 0 or 1 at day 14, as assessed by the investigator. Patient satisfaction was assessed using a satisfaction questionnaire. Adverse events (AEs) that occurred after application of metronidazole 0.75 % gel were also reported. A total of 21 subjects at a median age of 65.0 years were enrolled. The success rate of deodorization at day 14 was 95.2 % (20/21 subjects). The patient satisfaction assessment showed that 71.4 % (15/21) of subjects were markedly or moderately improved. The treatment was well tolerated with only two AE cases of skin neoplasm bleeding (one mild and one moderate). Metronidazole 0.75 % gel is an effective and safe treatment for deodorization of malodorous fungating tumors.