ABSTRACT
Background: SurgiGuard® is an absorbent hemostatic agent based on oxidized regenerated cellulose. The efficacy, effects and safety of SurgiGuard® are equivalent to existing hemostatic agents in animal experiments. This study was designed to confirm that the use of SurgiGuard® alone is effective, safe and feasible compared to combination with other hemostatic methods. Methods: We retrospectively reviewed clinical data from 12 surgery departments in seven tertiary centers in South Korea nationwide. All surgeries were performed between January and December 2018. Results: A total of 807 patients were enrolled; 447 patients (55.4%) had comorbidities. The rate of major surgery (operative time ≥4 hours) was 44% (n=355 patients). Regarding the type of SurgiGuard® used in surgery, more than 70% of minor surgeries used non-woven types. In major surgery, more than five SurgiGuards® were used in 7.3% (26 patients), and the proportion of co-usage (with four other hemostatic products) was 19.7% (70 patients). The effectiveness score was higher when SurgiGuard® was used alone in both major (5.3±0.5 vs. 5.1±0.6, P=0.048) and minor surgery (5.4±0.6 vs. 5.2±0.4, P<0.001). Seven patients had immediate re-bleeding, and all of them used SurgiGuard® and other products together. Nine patients reported adverse effects, such as abscess, bleeding, or leg swelling, but we found no direct correlation with SurgiGuard®. Conclusions: SurgiGuard® exhibited greater effectiveness when used alone. No direct adverse effects associated with SurgiGuard® use were reported, and SurgiGuard® had stable feasibility. Prospective comparative studies are needed in the future.
ABSTRACT
Polycaprolactone (PCL)-based fillers are widely used for skin rejuvenation and wrinkle reduction. The objective of this study is to compare the efficacy and safety of newly developed PCL-based fillers (SYB filler®; SF-01) and widely used existing PCL-based fillers (Ellansé-M®) for correction of moderate-to-severe nasolabial folds. In a randomized, participant-and evaluator-blinded, matched-pair, prospective study, participants were randomized for injections of SF-01 or Ellansé-M® in both nasolabial folds. Efficacy was evaluated using the Wrinkle Severity Rating Scale (WSRS), Global Esthetic Improvement Scale (GAIS), and a three-dimensional (3D) scanner. All adverse events (AEs) were examined and reported. At month 12, both SF-01-and Ellansé-M®-treated groups showed statistically significant improvements in the WSRS, GAIS, and 3D scanner scores compared to baseline. The difference in changes in WSRS scores at month 12 between the two groups was 0.08 ± 0.34 compared to baseline. The upper limit of the 95.0% confidence interval was 0.0031, which was lower than the predefined margin for non-inferiority (0.35). All AEs were injection site-related (swelling, pain, and erythema) and disappeared within 30 min after the procedure. SF-01 was non-inferior to Ellansé-M® and demonstrated favorable efficacy and safety at 12 months after correcting moderate-to-severe nasolabial folds.
Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Humans , Hyaluronic Acid , Nasolabial Fold , Polyesters , Prospective Studies , Treatment OutcomeABSTRACT
Sorafenib, an oral multikinase inhibitor, exhibits a highly variable absorption profile due to enterohepatic reabsorption and poor solubility. SYO-1644 improved the solubility of sorafenib by nanoparticulation technology leading to enhanced bioavailability. To evaluate the pharmacokinetically equivalent dose of SYO-1644 to the reference Nexavar® 200 mg, a randomized, open-label, replicated two-period study was conducted in healthy volunteers. A total of 32 subjects orally received a single dose of the following assigned treatment under a fasted state in the first period and repeated once more in the second period with a two-week washout: SYO-1644 100, 150 and 200 mg and Nexavar® 200 mg. Pharmacokinetic (PK) samples were collected up to 168 h post-dose. The PK profile was evaluated by both non-compartmental analysis and population PK method. With the final model, 2 × 2 crossover trial scenarios with Nexavar® 200 mg and each dose of SYO-1644 ranging from 100 to 150 mg were repeated 500 times by Monte Carlo simulation, and the proportion of bioequivalence achievement was assessed. Transit absorption compartments, followed by a one-compartment model with first-order elimination and enterohepatic reabsorption components were selected as the final model. The simulation results demonstrated that the SYO-1644 dose between 120 and 125 mg could yielded the highest proportion of bioequivalence.
