Bensadoun Rene-Jean, Daoud Jamel, El Gueddari Brahim, Bastit Laurent, Gourmet Rene, Rosikon Andrzej, Allavena Christophe, Céruse Philippe, Calais Gilles, Attali Pierre
Department of Radiation Oncology, Antoine Lacassagne Center, Nice, France.
Cancer. 2008 Jan 1;112(1):204-11. doi: 10.1002/cncr.23152.
Topical antifungal treatments are recommended but rarely used as first-line therapy for oropharyngeal candidiasis (OPC) in patients with cancer. Miconazole Lauriad 50-mg mucoadhesive buccal tablet (MBT) Loramyc reportedly delivered rapid and prolonged, effective concentrations of miconazole in the mouth. The objective of the current study was to compare MBT with miconazole 500-mg oral gel (MOG) in patients with head and neck cancer.
Two hundred eighty-two patients with head and neck cancer received a 14-day treatment of either single-dose MBT or MOG administered in 4 divided doses. The primary endpoint was clinical success at Day 14, and secondary endpoints included clinical success at Day 7, clinical cure, improvement in clinical symptoms, mycologic cure, recurrence rate, and safety.
The success rate was statistically not inferior (P < .0001) in the MBT population to the rate observed in the MOG group (56% vs 49%, respectively; P < .0001). After adjustment for the extent of lesions and salivary secretions, a trend toward superiority was observed in favor of MBT (P = .13), particularly among patients with multiple lesions (P = .013). Results for secondary endpoints were comparable to those observed for the primary endpoint. Compliance with MBT was excellent, and >80% of patients completed treatment. Both treatments were safe.
The success rate of MBT Loramyc was significantly not inferior to that of MOG in the treatment of cancer patients with OPC; and, after adjusting for prognostic variables, it was more effective than MOG. MBT was well tolerated and, thus, may be recommended as first-line treatment in cancer patients who have OPC as an alternative to systemic antifungal agents. Society.
对于癌症患者的口腔念珠菌病（OPC），推荐使用局部抗真菌治疗，但很少用作一线治疗。据报道，咪康唑劳里亚德50毫克粘膜粘附口腔片（MBT）洛拉米可在口腔中迅速且持久地释放有效浓度的咪康唑。本研究的目的是比较MBT与500毫克咪康唑口服凝胶（MOG）在头颈部癌症患者中的疗效。
282名头颈部癌症患者接受了为期14天的治疗，分别为单剂量MBT或分4次给药的MOG。主要终点是第14天的临床成功，次要终点包括第7天的临床成功、临床治愈、临床症状改善、真菌学治愈、复发率和安全性。
MBT组的成功率在统计学上不低于MOG组（分别为56%和49%；P <.0001）。在调整病变范围和唾液分泌后，观察到MBT有优势趋势（P =.13），特别是在有多处病变的患者中（P =.013）。次要终点的结果与主要终点相当。MBT的依从性极佳，超过80%的患者完成了治疗。两种治疗均安全。
在治疗患有OPC的癌症患者时，MBT洛拉米可的成功率显著不低于MOG；并且，在调整预后变量后，它比MOG更有效。MBT耐受性良好，因此可推荐作为患有OPC的癌症患者的一线治疗，以替代全身抗真菌药物。学会。
