Oral Platelet Gel Supernatant Plus Supportive Medical Treatment Versus Supportive Medical Treatment in the Management of Radiation-induced Oral Mucositis: A Matched Explorative Active Control Trial by Propensity Analysis.

OBJECTIVES: In this active control trial, the rate of radio-induced WHO grade 3/4 oral mucositis and the change in quality of life, assessed by OMWQ-HN, were measured in subjects with head and neck cancer treated by platelet gel supernatant (PGS) and supportive medical treatment versus subjects treated by supportive medical treatment alone. MATERIALS AND METHODS: Eighty patients with nonmetastatic head and neck cancer underwent curative or adjuvant radiotherapy. All patients underwent supportive medical treatment and/or PGS at the beginning and during radiotherapy. Sixteen patients received PGS in association with supportive medical treatment. To obtain 2 groups virtually randomized for important clinical characteristics subjects were matched, by propensity analysis, with a group of subjects (64 patients) treated with supportive medical treatment alone. RESULTS: Subjects treated with standard supportive treatment experienced significant higher WHO grade 3/4 toxicity (55%; 35/64) than subjects treated by PGS (13%; 3/16). The reduced toxicity found in PGS group paralleled with the evidence that they developed later symptoms with respect to controls. The Cox proportional hazard model indicated that patients treated with standard supportive medical treatment experienced 2.7-fold increase (hazard ratio=2.7; 95% confidence interval, 1.3-5.7) in the occurrence of WHO grade 3/4 toxicity. PGS group significantly experienced higher quality of life than control groups as measured by OMWQ-HN. A significant decrease in the opioid analgesics usage was found in the PGS group. CONCLUSIONS: These preliminary data should be interpreted with caution and could serve as a framework around which to design future trials.

Treatment of Solitary Painful Osseous Metastases with Radiotherapy, Cryoablation or Combined Therapy: Propensity Matching Analysis in 175 Patients.

PURPOSE: aim of this study was to identify outcomes in pain relief and quality of life in patients with a solitary painful osseous metastasis treated by radiotherapy, cryoablation or the combination using a propensity score matching study design. MATERIALS AND METHODS: 175 patients with painful bone metastases were included in the study. Twenty-five of them underwent a radiation course (20 Gy in five daily fractions) 15 days after the cryoablation. These subjects were retrospectively matched by propensity analysis with a group of subjects treated by radiotherapy (125 subjects) and with a group treated byCryoablation (25 subjects). The pain relief in terms of complete response, rate of subjects requiring analgesics after treatments and the changes in self-rated quality of life were measured. Informed consent was obtained from the subject and the study was approved by the local Ethical Committee. RESULTS: An higher proportion of subjects treated by cryoablation (32%) or cryoablation followed by RT (72%;) experienced a complete response compared with patients treated by radiotherapy alone (11.2%). After Bonferroni correction strategy, the addition of radiotherapy to cryoablation significantly improved the rate of complete response compared with cryoablation alone (p = 0.011) and this paralleled with an improved self-rated quality of life. Seventeen subjects (13.6%) of patients in the radiotherapy group, 9 (36%) in the cryoablation group, and 19 (76)% in the cryoablation- radiotherapy group did not require narcotic medications. CONCLUSIONS: The addition of radiotherapy to cryoablation favorably impacts on perceived pain, with a favorable toxicity profile. However, our data should be interpreted with caution and could serve as a framework around which to design future trials.

Long-term outcome after microendoscopic diskectomy for lumbar disk herniation: a prospective clinical study with a 5-year follow-up.

BACKGROUND: Several authors have reported results obtained with the microendoscopic diskectomy (MED) technique, but the long-term outcome has not been described. This report summarizes our clinical experience with the lumbar MED technique with a long-term follow-up period. OBJECTIVE: To evaluate the efficacy of the MED for lumbar disk herniation and to report long-term outcome and complications (5-year follow-up). METHODS: One hundred twenty consecutive patients with lumbar disk herniation were treated with the METRx system.We included all types of lumbar herniated disks: contained, not contained, foraminal, and migrated disk herniations. The results were evaluated with the Visual Analog Scale (VAS) pain score, Oswestry Disability Index score, patient satisfaction questionnaire, and modified Macnab criteria. RESULTS: The average age of patients was 41 years; 65 were men and 55 were women. The most commonly affected level was L5-S1 (54.2%). The follow-up time after surgery was 5 years in all cases. We obtained good or excellent results in 75% of patients and regular results in 18%. Good subjective satisfaction was observed with surgery in 92% of patients. The mean decrease in the Oswestry Disability Index score was 52.8 ± 21.6; the mean decrease in leg VAS score was 6.1 ± 2.3; and the mean decrease in lumbar VAS score was 1.9 ± 3.3. Adjusted mean differences were statistically significant in all cases (P < .05). CONCLUSION: MED not only reduces the incision, tissue damage, and postoperative period of incapacity but also offers long-term results comparable to those of conventional techniques.

Midterm outcome after microendoscopic decompressive laminotomy for lumbar spinal stenosis: 4-year prospective study.

OBJECTIVE: To evaluate the efficacy of radicular decompression in lumbar spinal stenosis using a microendoscopic technique. METHODS: This was a longitudinal prospective study of 50 patients with a diagnosis of lumbar spinal stenosis who were treated by microendoscopic decompression using an 18-mm METRx tubular retractor according to the METRx technique (Medtronic Sofamor Danek, Memphis, TN). Twenty of the patients had an additional disc prolapse, and a microendoscopic discectomy was associated with decompressive laminectomy. The results were evaluated using the visual analog scale pain score, Oswestry Disability Index score, patient satisfaction questionnaire, and modified Macnab classification. RESULTS: The average age of the patients was 56 years; 29 (58%) were men and 21 (42%) were women. The most commonly affected level was L4-L5 (64%). The mean surgical intervention time was 94.3 (+/- 14.3) minutes. Mean postoperative hospital stay was 3.16 (+/- 2.3) days. The follow-up time after surgery was 4 years (48 +/- 6.6 months; range, 24-72 months). We obtained good or excellent results in 72% of patients, achieving good subjective satisfaction in 68% of the patients. The mean decrease in the Oswestry Disability Index score was 30.23 (+/- 24.29), the mean decrease in the leg pain visual analog scale score was 6.02 (+/- 2.57), and the mean decrease in the lumbar pain visual analog scale score was 0.84 (+/- 2.06). Adjusted mean differences were in all cases statistically significant (P < 0.05). CONCLUSION: Data indicate that, in our experience, on midterm follow-up, microendoscopic laminectomy decompression is an effective technique for the treatment of lumbar spinal stenosis.