Complete Restoration of Refractory Mandibular Osteoradionecrosis by Prolonged Treatment with a Pentoxifylline-Tocopherol-Clodronate Combination (PENTOCLO): A Phase II Trial

摘要: Purpose Osteoradionecrosis (ORN) is a nonhealing wound of the bone that difficult to manage. Combined treatment with pentoxifylline and vitamin E reduces radiation-induced fibrosis ORN good prognosis. We previously showed combination clodronate (PENTOCLO) useful in healing sternocostal some mandibular ORN. Is PENTOCLO effective poor prognosis? Methods 54 eligible patients irradiated for head neck cancer (among 72 treated) mean 5 years received exteriorized refractory 1.4 ± 1.8 years, mainly after local surgery hyperbaric oxygen had been ineffective. The length exposed (D) was 17 8 mm as primary endpoint, Subjective, Objective, Management, Analytic evaluation injury (SOMA) score 16 4. Between August 2000 2008, all were given daily oral PENTOCLO: 800 mg pentoxifylline, 1,000 IU E, 1,600 days per week alternating 20 prednisone ciprofloxacin 2 week. duration related consolidated healing. Results Prolonged (16 9 months) safe well tolerated. All improved, an exponential progressive--(f[t] = a.exp(-b.t)--and significant (p Conclusion Long-term effective, safe, curative induces mucosal symptom improvement. These findings will need be confirmed randomized trial.