Materials and Methods: Biodegradable polymeric microneedle arrays were fabricated out of poly lactic-co-glycolic acid (PLGA) using the micromolding technique under aseptic conditions, and the morphology of the microneedles was characterized using light microscopy. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis was used to rule out drug-polymer interactions. Standard procedures were used to analyze the prepared microneedle arrays for in vitro drug release and to perform a microneedle insertion test. Enzyme-linked immunosorbent assay was used to quantify rHuKGF.
Results: The PLGA polymer was safe for use in the fabrication of rHuKGF microneedles as there was no interaction between the drug and the polymer. The fabricated rHuKGF microneedle arrays had fully formed microneedles with a height of 600 µm and a base of 300 µm. The drug from the microneedle patch was released in vitro within 30 minutes. The strength of the microneedles in the patch was good, as they were able to reach a depth of 381±3.56 µm into parafilm without any structural change or fracture.
Conclusion: Microneedle transdermal patches were successfully prepared for rHuKGF, and their evaluation suggested excellent quality and uniformity of patch characteristics. This can have potential applications in the therapeutic arena, offering advantages in terms of reduced dosing frequency, improved patient compliance, and bioavailability.
METHODS: This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications.
RESULTS: 244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %; P = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2; P
METHODS: A literature search was performed in 3 electronic databases for articles published before August 2018. Randomized clinical trials published in English that compared PP between machine-assisted agitation and syringe irrigation with needles as part of nonsurgical root canal treatment were included. Two authors were independently involved in the article selection process, data extraction, and assessment of the quality of included studies using the revised Cochrane risk of bias tool. The pooled effect estimates of the standardized mean difference (SMD) between machine-assisted agitation and syringe irrigation with needle was calculated by a random effects-modeled meta-analysis. A subgroup meta-analysis was performed. The quality of evidence was evaluated by the Grading of Recommendations, Assessment, Development and Evaluations approach.
RESULTS: Six studies were included for systematic review. Meta-analysis was performed using 3 studies and showed that machine-assisted agitation resulted in less PP compared with syringe irrigation with needle at 24 hours (SMD = -0.73; 95% confidence interval, -1.04 to -0.42; I2 = 30.6%) and 48 hours (SMD = -0.60; 95% CI, -0.85 to -0.35; I2 = 0%). The quality of evidence by Grading of Recommendations, Assessment, Development and Evaluations for the PP outcomes (24 hours and 48 hours) was graded as "moderate" quality.
CONCLUSIONS: Machine-assisted agitation reduced PP compared with syringe irrigation with needles in nonsurgical root canal treatment. Future clinical trials are needed to support the result of this review.