Autologous bone marrow mononuclear cell infusion and hyperbaric oxygen therapy in type 2 diabetes mellitus: an open-label, randomized controlled clinical trial.

BACKGROUND AIMS: The use of bone marrow mononuclear cells (BM-MNCs) has achieved great outcomes in clinical practice. We aim to evaluate the efficacy and safety of autologous BM-MNC infusion and hyperbaric oxygen therapy (HOT) in type 2 diabetes mellitus. METHODS: This single-center, randomized, open-label, controlled clinical trial with a factorial design included two phases. The patients received standard medical therapy in the run-in phase; in the treatment phase, patients with glycated hemoglobin of 7.5-9.5% were randomly assigned into four groups and underwent BM-MNC infusion along with HOT (BM-MNC+HOT group), BM-MNC infusion (BM-MNC group), HOT (HOT group) and standard medical therapy (control group), respectively. The area under the curve of C-peptide was recorded as a primary end point. Our research is registered at ClinicalTrials.gov (NCT00767260). RESULTS: A total of 80 patients completed the follow-up. At 12 months after treatment, the area under the curve of C-peptide (ng/mL per 180 min) of the BM-MNC+HOT group and the BM-MNC group were significantly improved (34.0% and 43.8% from the baseline, respectively). The changes were both significant compared with that in the control group, but no remarkable change was observed in the HOT group. Treatment-related adverse events were mild, including transient abdominal pain (n = 5) and punctual hemorrhage (n = 3). CONCLUSIONS: BM-MNC infusion for type 2 diabetes mellitus improves islet function and metabolic control, with mild adverse effects. HOT does not synergize with BM-MNC infusion.

Electrosurgical enucleation versus bipolar transurethral resection for prostates larger than 70 ml: a prospective, randomized trial with 5-year followup.

PURPOSE: We compared the perioperative and postoperative characteristics of prostate PlasmaKinetic™ enucleation and bipolar transurethral resection for large volume benign prostatic hyperplasia. MATERIALS AND METHODS: In this prospective, randomized, controlled trial 80 patients with benign prostatic hyperplasia and a prostate of larger than 70 ml were randomly assigned to prostate bipolar transurethral resection or PlasmaKinetic enucleation. Operative time, resected adenoma weight, changes in hemoglobin, catheterization time and postoperative hospital stay were recorded and compared. Patients were followed 1, 6, 12, 24, 36, 48 and 60 months after surgery. RESULTS: Greater resected prostate weight (mean ± SD 64.2 ± 19.0 vs 50.6 ± 20.0 gm, p = 0.03), less blood loss (mean 0.87 ± 0.42 vs 1.74 ± 0.63 gm, p <0.01), and shorter catheterization time (mean 35.5 ± 5.8 vs 60.1 ± 5.8 hours, p <0.01) and postoperative hospital stay (mean 3 vs 4 days, [corrected] p <0.01) were recorded in the enucleation group than in the resection group. The postoperative improvement in International Prostate Symptom Score, quality of life, maximal flow rate and post-void residual urine volume was similar in the 2 groups at 1, 6, 12 and 24 months but significantly better in the enucleation group at 36, 48 and 60 months. During the 5-year followup no patient in the enucleation group but 2 in the resection group experienced recurrence. CONCLUSIONS: For large volume benign prostatic hyperplasia PlasmaKinetic enucleation of the prostate is associated with less blood loss, shorter hospital stay and catheterization time than bipolar transurethral resection of the prostate. Moreover, PlasmaKinetic enucleation seems to be superior at long-term followup with fewer reoperations necessary.

High- vs low-power holmium laser lithotripsy: a prospective, randomized study in patients undergoing multitract minipercutaneous nephrolithotomy.

OBJECTIVE: To determine the efficacy and safety of high-power holmium: yttrium aluminum-garnet (Ho:YAG) laser lithotripsy for multitract modified minimally invasive percutaneous nephrolithotomy (MPCNL) in the treatment of patients with large staghorn renal calculi. METHODS: A randomized, prospective study was conducted. Two-hundred seventy-three consecutive patients (291 renal units) with large staghorn renal calculi were randomized to undergo multitract MPCNL with 30-W low-power or 70-W high-power Ho:YAG laser lithotripsy. Both groups were compared in terms of perioperative findings and postoperative outcomes, including procedure time, stone-free rate, length of hospital stay, transfusion rates, renal function recovery, and other complications. RESULTS: The average patient age was 49.2 years (range 22-73) and mean stone size was 5.54±0.7 cm. The 2 groups had some comparable perioperative findings and outcome, including tracts required per operated renal unit (n), blood loss, postoperative fever, postoperative hospital stay, stone-free rate, and improvement of operated renal function. The operation time in the high-power group was significantly shorter than that in the low-power group (129.20±17.2 vs 105.18±14.2, P<.01). CONCLUSION: A combination of multitract MPCNL and high-power Ho:YAG laser lithotripsy can greatly decrease the operative time without increasing the intraoperative complications or delaying postoperative renal function recovery when compared with low-power Ho:YAG laser lithotripsy.