Osteoradionecrosis of the mandible: treatment outcomes and factors influencing the progress of osteoradionecrosis.

PURPOSE: The present study was undertaken to evaluate our recent experience with mandibular osteoradionecrosis (ORN) and to identify factors that contribute to its progress. PATIENTS AND METHODS: The medical records of 114 patients who had been treated for ORN during a 16-year period (1989 to 2004) were reviewed. The patients were then divided into 2 groups according to their response to conservative treatment. Group 1 consisted of patients whose ORN resolved with conservative treatment (n = 47). Group 2 consisted of patients whose ORN was unresolved with conservative treatment or who had required radical resection of the involved tissue (n = 67). The information was obtained from the medical records of the patients and analyzed. RESULTS: The patients whose ORN was associated with an early-stage tumor or preirradiation extraction had a favorable response to conservative treatment. However, those who had an advanced primary tumor, had continued smoking and drinking after radiotherapy, had received palliative radiotherapy or a radiation dose of more than 6,000 rads, and who had an orocutaneous fistula, a pathologic fracture, swelling, or trismus had a poor response to conservative treatment. In these latter cases, radical resection of the involved tissue proved useful. CONCLUSIONS: The results of the present study have indicated that several factors (ie, the stage of the primary tumor, signs of ORN) can influence the progress of ORN. Our results suggest that radical resection is a useful method for treating mandibular ORN that does not respond to conservative treatment.

Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method.

OBJECTIVE: To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. METHODS: A randomized, double-blind, active comparator controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent (or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. RESULTS: While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT: aOR=1.37, 95% CI= (0.8200, 2.26), PP: aOR=1.47, 95% CI= (0.73, 2.95) ). The goodness-off it statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. CONCLUSIONS: Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.