METHODS: An electronic search was performed via PubMed, SCOPUS, Google Scholar, and Cochrane from inception to June 2022. The included trials were evaluated according to the recommendations of the Cochrane Handbook for Systematic Reviews. The primary outcome assessed was the intraoperative bleeding score of the surgical field. The mean arterial pressure, duration of the surgery, amount of blood loss and surgeon's satisfaction score were assessed as the secondary outcomes. The risk of bias for each study was evaluated using the Cochrane risk of bias tool.
RESULTS: A total of 254 records were identified after removal of duplicates. Based on the title and abstract 246 records were excluded, leaving seven full texts for further consideration. Five records were excluded following full text assessment. Three trials with a total of 212 patients were selected. Hot saline irrigation was superior to control in the intraoperative bleeding score (MD - 0.51, 95% CI - 0.84 to - 0.18; P < 0.001; I2 = 72%; very low quality of evidence) and surgeon's satisfaction score (RR 0.18, 95% CI 0.09 to 0.33; P < 0.001; I2 = 0%; low quality of evidence). The duration of surgery was lengthier in control when compared to HSI (MD - 9.02, 95% CI - 11.76 to - 6.28; P < 0.001; I2 = 0; very low quality of evidence). The volume of blood loss was greater in control than HSI (MD - 56.4, 95% CI - 57.30 to - 55.51; P < 0.001; I2 = 0%; low quality of evidence). No significant difference between the two groups for the mean arterial pressure was noted (MD - 0.60, 95% CI - 2.17 to 0.97; P = 0.45; I2 = 0%; low quality of evidence).
CONCLUSIONS: The practice of intranasal HSI during ESS is favorable in controlling intraoperative bleeding and improving the surgical field quality. It increases the surgeon's satisfaction, reduces blood loss, shortens operative time and has no effect on intraoperative hemodynamic instability.
TRIAL REGISTRATION: PROSPERO registration number: CRD42019117083.
METHODS:: Eighty-six patients scheduled for trigger finger release between July 2016 and December 2017 were randomized into a control group (1% lignocaine and 8.4% sodium bicarbonate with arm tourniquet; given 10 min prior to procedure) and an intervention group (1% lignocaine, 1:100,000 of adrenaline and 8.4% sodium bicarbonate; given 30 min prior to procedure), with a total of 4 ml of solution injected around the A1 pulley. The onset of anesthesia and pain score upon injection of the first 1 ml were recorded. After the procedure, the surgeon rated for the hemostasis score (1-10: 1 as no bleeding and 10 being profuse bleeding). Duration of surgery and return of sensation were recorded.
RESULTS:: Hemostasis score was grouped into visibility score as 1-3: good, 4-6: moderate, and 7-10: poor. The intervention group (with adrenaline) had a 74% of good surgical field visibility compared to 44% from the controlled group (without adrenaline; p < 0.05). Duration of anesthesia was longer in the intervention group (with adrenaline), with a 2.77-h difference.
CONCLUSION:: WALANT provides excellent surgical field visibility and is safe and on par with conventional methods but without the usage of a tourniquet and its associated discomfort.
OBJECTIVE: We report end-of-trial efficacy and safety of N8-GP from pathfinder2.
METHODS: pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data for all regimens until trial end (first patient in main phase, 30 January 2012; trial end, 10 December 2018).
RESULTS: Overall, 186 patients were exposed to N8-GP for up to 6.6 years (median 5.4 years). The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm. Nearly 30% of patients experienced zero bleeds throughout the entire duration of the trial, the hemostatic response was 83.2% across all treatment arms, and patient-reported outcomes were maintained or slightly improved. No safety concerns were detected.
CONCLUSION: Data from the completed pathfinder2 trial, one of the largest and longest-running clinical trials to investigate treatment of severe hemophilia A, demonstrate the efficacy and safety of N8-GP in previously treated adolescent and adult patients.
Methods: A prospective observational study including 223 patients receiving the branded medicine Exjade® and 101 patients receiving the copy Osveral® was carried out. Data were assessed for a 1-year period and included clinical symptoms, serum ferritin (SF), serum creatinine (SC), and alanine aminotransferase (ALT). Data were analyzed with SPSS version 22 software (SPSS, Chicago, IL, USA).
Results: The median age of the sample was 8 years. There was no significant difference in gender distribution between the two groups (p = 0.625). Nausea was the most frequently reported adverse effect followed by diarrhea and abdominal pain in both groups. Patients receiving Exjade® had a higher relative reduction of SF at the end of the study compared with the Osveral® group (19.9% versus 9.93%, p = 0.028). SC was found to be significantly higher in the Osveral® group than in the Exjade® group throughout the study period. The mean platelet count was higher in the Exjade® group. ALT was significantly higher among patients receiving Osveral® over the last three months of the study.
Conclusions: Exjade® showed a better ability to reduce SF, with less liver toxicity, and better hemostasis profile. No congenital anomalies associated with short-term use of both drugs during pregnancy were observed or reported.