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The self-crosslinked hyaluronic acid (scHA) and steroids are considered as efficient factors for postoperative management after chronic rhinosinusitis (CRS) nasal surgery. This randomized clinical trial is designed to investigate the efficacy and potential of scHA gel as a topical drug sustained release carrier for steroid of budesonide.
The study is performed with 30 patients of chronic rhinosinusitis with nasal polyps (CRSwNP) who underwent functional endoscopic sinus surgery (FESS). The single application of scHA was assessed in the control patient group for postoperative recovery. In the treatment patient group, the combination of scHA/budesonide was applied for postoperative management. The patients are followed up in 2weeks, 4weeks and 12weeks after surgery.
The combination of scHA/budesonide results in better endoscopic scoring and mucus evaluation than the single scHA application.
The results indicate that the combination of scHA/budesonide is a valuable treatment for the FESS postoperative management and implies the potential of scHA gel as a topical drug sustained release scaffold.
The results indicate that the combination of scHA/budesonide is a valuable treatment for the FESS postoperative management and implies the potential of scHA gel as a topical drug sustained release scaffold.The correct layout of Table 1 is presented in this paper.
Remimazolam is a novel and ultra-short-acting sedative currently developed for intravenous use in procedural sedation, general anesthesia, and ICU sedation. However, intravenous administration is not always appropriate, depending on the patient or setting. This study evaluated intranasal administration as a potential alternative route.
The study used a randomized, double-blind, 9 period cross-over design to compare the pharmacokinetics, pharmacodynamics, and safety of single intranasal doses of 10, 20, and 40mg remimazolam (as powder or solution) with intranasal placebo and 4mg intravenous remimazolam.
Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T
was 10min; AUC and C
were dose-proportional. The higher doses of intranasal solution, however, resulted in decreasing bioavailability and loss of dose-proportionality in AUC and C
despite complete drug absorption due to partial swallowing of dose and the resulting first-pass effect. Pharmacodynamics were generally consistent with PK. Peak effects (drowsiness, relaxation, any, memory, response time) were in similar ranges after intranasal (10 to 40mg) as intravenous (4mg) dosing and were partially, but not consistently, dose-related. Safety results were generally consistent with other benzodiazepines; however, intranasal remimazolam (but not placebo) caused nasal discomfort/pain, in some cases even severe.
Intranasal administration of remimazolam was safe and caused sedative effects. However, the severe pain and discomfort caused by intranasal remimazolam prohibit its use by this route of administration, at least with the currently available intravenous formulation.
Intranasal administration of remimazolam was safe and caused sedative effects. However, the severe pain and discomfort caused by intranasal remimazolam prohibit its use by this route of administration, at least with the currently available intravenous formulation.
Feature films are increasingly being used in teaching health sciences. However, few publications address the effectiveness of this approach. We hypothesized that using feature films could help students learn. We aimed to assess the effectiveness of using a feature film to teach students about adverse drug reactions and pharmacovigilance.
The study population comprised third-, fifth-, and sixth-year undergraduate students of medicine, third-year undergraduate students of human biology, and graduate students in a master's degree program about the pharmaceutical and biotechnology industry. Students watched clips from the film 150 Miligrams (La fille de Brest) and discussed them afterward. To measure learning, we administered a 10-question multiple-choice test about pharmacovigilance concepts. We assessed students' satisfaction with the activity through a questionnaire. selleckchem An exploratory comparative analysis was performed.
A total of 237 students participated. Postintervention assessment scores were significantly higher than preintervention scores for the entire population and for all subgroups. The mean number of correct answers was 4.41 on the preintervention assessment and 5.78 on the postintervention assessment (mean gain 1.37; 95% CI 1.10-1.65). Similar results were found when analyzing groups of students from each group. Student satisfaction with this teaching activity was high in all groups.
Cinemeducation is a useful tool for teaching about adverse drug reactions and pharmacovigilance processes. Most students were highly satisfied.
Cinemeducation is a useful tool for teaching about adverse drug reactions and pharmacovigilance processes. Most students were highly satisfied.
The incidence rate and risk factors of antiresorptive agent-related osteonecrosis of the jaw (ARONJ) in prostate cancer patients with bone metastasis are not clear.
We retrospectively reviewed patients' records of prostate cancer patients with bone metastasis who were treated with zoledronic acid or denosumab between 1/Dec/2008 and 31/Mar/2019. ARONJ-free survival rate was analyzed with Kaplan-Meier analysis, and risk factors for ARONJ were analyzed with Cox proportional hazard model.
We identified 124 and 67 patients treated with zoledronic acid and denosumab, respectively. Seventy-six patients were hormone sensitive, and 115 patients were castration resistant when they started bone-modifying agents (BMA). Twenty-eight patients developed ARONJ during the observation period (median 23months, range 1-130months). Their number of doses of BMA ranged 3-69 (median 21.5). The 2-year ARONJ-free survival rate was 91.1%, and the 5-year ARONJ-free survival rate was 72.5%. There was no significant difference in the incidence rate of ARONJ between zoledronic acid and denosumab. However, multivariate analysis revealed that use of denosumab (hazard ratio [HR] 3.67, 95% confidence interval [CI] 1.01-13.31; p = 0.0484), serum calcium < 9.2mg/dL (HR 3.16, 95% CI 1.10-9.13; p = 0.033)), and concomitant or prior use of chemotherapeutic agents (HR 4.71, 95% CI 1.51-14.71; p = 0.0076) were independent risk factors for the development of ARONJ.
Almost one-quarter of patients had a risk of developing ARONJ within 5years after starting BMA. Low serum calcium, use of chemotherapeutic agents, and use of denosumab might contribute to the development of ARONJ.
Almost one-quarter of patients had a risk of developing ARONJ within 5 years after starting BMA. Low serum calcium, use of chemotherapeutic agents, and use of denosumab might contribute to the development of ARONJ.
