METHODS: Patients chose to continue treatment with nonacog beta pegol in either one of two once-weekly prophylaxis arms (10IU/kg or 40IU/kg), or an on-demand arm (40IU/kg for mild/moderate bleeds; 80IU/kg for severe bleeds). The primary objective was to evaluate immunogenicity; key secondary objectives included assessing safety and haemostatic efficacy in the treatment and prevention of bleeds.
RESULTS: Seventy-one patients received prophylaxis or on-demand treatment. No patient developed an inhibitor and no safety concerns were identified. The success rate for the treatment of reported bleeds was 94.6%; most (87.9%) resolved with one injection. The median annualised bleeding rate for patients on prophylaxis was 1.36 (interquartile range [IQR] 0.00-2.23) and 1.00 (IQR 0.00-2.03) for the 10 and 40IU/kg treatment arms, respectively. The mean FIX activity trough achieved for 10 and 40IU once weekly was 9.8% and 21.3%, respectively. Fourteen patients on prophylaxis underwent 23 minor surgical procedures; haemostatic perioperative outcomes for all of those evaluated were 'excellent' or 'good'.
CONCLUSIONS: Nonacog beta pegol showed a favourable tolerability profile (with no safety issues identified) with good prophylactic protection and control of bleeding in previously treated adult and adolescent haemophilia B patients.
METHOD: This is a retrospective study of all the patients that had undergone endoscopic variceal surveillance at the Gastroenterology endoscopy unit, Serdang Hospital from 1st January 2015 to 31st March 2017. Patients' demography, aetiologies of liver cirrhosis, platelet level and international normalised ratio (INR) prior banding procedure, and the post EVL complications were recorded and further analysed with SPSS version 16.
RESULTS: In this study, 105 patients were screened for varices. Fifty-five of them had undergone EVL, with a quarter of the patients requiring repeated ligation. There was a male preponderance with 76.4%. 56.4% of patients were in age from 40-59 years. The majority of our patients were of the Malay ethnicity. The major aetiology for liver cirrhosis in our patients was viral hepatitis with Hepatitis C (31.0%), and Hepatitis B (20.0%). Most of our patients had platelet count >50,000 and INR <1.5 prior to EVL. There was no major complication in all of our subjects.
CONCLUSION: EVL is relatively safe and feasible treatment for prevention of oesophageal variceal bleeds with a low complication rate.
MATERIALS AND METHODS: Major electronic databases were searched for randomized-controlled trials comparing carbetocin with oxytocin. Only trials involving cesarean deliveries were included. Non-randomized trials, non-cesarean deliveries, studies which did not directly compare carbetocin to oxytocin and studies which did not analyze the intended outcomes were excluded. Outcomes analysed were postpartum hemorrhage, additional use of uterotonic and transfusion requirement.
RESULTS: Seven studies involving 2012 patients were included in the meta-analysis. There was a significant reduction in the rates of postpartum hemorrhage (RR 0.79; 95% CI 0.66 to 0.94; p = 0.009), use of additional uterotonics (RR 0.57; 95% CI 0.49 to 0.65; p
METHODS: A systematic review of the literature was performed to identify randomized controlled trials that compared the use of carbetocin to oxytocin in the context of cesarean deliveries. Cost effectiveness analysis was then performed using secondary data from the perspective of a maternity unit within the Malaysian Ministry of Health, over a 24 h time period.
RESULTS: Seven randomized controlled trials with over 2000 patients comparing carbetocin with oxytocin during cesarean section were identified. The use of carbetocin in our center, which has an average of 3000 cesarean deliveries annually, would have prevented 108 episodes of PPH, 104 episodes of transfusion and reduced the need for additional uterotonics in 455 patients. The incremental cost effectiveness ratio of carbetocin for averting an episode of PPH was US$278.70.
CONCLUSION: Reduction in retreatment, staffing requirements, transfusion and potential medication errors mitigates the higher index cost of carbetocin. From a pharmacoeconomic perspective, in the context of cesarean section, carbetocin was cost effective as prophylaxis against PPH. Ultimately, the relative value placed on the outcomes above and the individual unit's resources would influence the choice of uterotonic.
DATA SOURCES: EMBASE, MEDLINE, CENTRAL, and ISI Web of Science were systematically searched from their inception until May 31, 2019.
REVIEW METHODS: Parallel-arm randomized controlled trials were included.
RESULTS: Seventy-one trials (7539 participants: orthopedics 5450 vs nonorthopedics 1909) were included for quantitative meta-analysis. In comparison to placebo, topical TXA significantly reduced intraoperative blood loss [mean difference (MD) -36.83 mL, 95% confidence interval (CI) -54.77 to -18.88, P < 0.001], total blood loss (MD -319.55 mL, 95% CI -387.42 to -251.69, P < 0.001), and incidence of blood transfusion [odds ratio (OR) 0.30, 95% CI 0.26-0.34, P < 0.001]. Patients who received topical TXA were associated with a shorter length of hospital stay (MD -0.28 days, 95% CI -0.47 to -0.08, P = 0.006). No adverse events associated with the use of topical TXA were observed, namely mortality (OR 0.78, 95% CI 0.45-1.36, P = 0.39), pulmonary embolism (OR 0.73, 95% CI 0.27-1.93, P = 0.52), deep vein thrombosis (OR 1.07, 95% CI 0.65-1.77, P = 0.79), myocardial infarction (OR 0.79, 95% CI 0.21-2.99, P = 0.73), and stroke (OR 0.85, 95% CI 0.28-2.57, P = 0.77). Of all included studies, the risk of bias assessment was "low" for 20 studies, "unclear" for 26 studies and "high" for 25 studies.
CONCLUSIONS: In the meta-analysis of 71 trials (7539 patients), topical TXA reduced the incidence of blood transfusion without any notable adverse events associated with TXA in adults undergoing surgery.
PROSPERO: CRD 42018111762.
OBJECTIVES: To review and assess the efficacy of currently available treatment options for preventing and managing advanced liver disease in children and adults with cystic fibrosis.
SEARCH METHODS: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 November 2019. We also searched the reference lists of relevant articles and reviews and online trials registries. Date of last search: 01 January 2020.
SELECTION CRITERIA: Any published and unpublished randomised controlled trials and quasi-randomised controlled trials of advanced liver disease in cystic fibrosis with cirrhosis or liver failure, portal hypertension or variceal bleeding (or both).
DATA COLLECTION AND ANALYSIS: Authors independently examined titles and abstracts to identify potentially relevant trials, but none were eligible for inclusion in this review.
MAIN RESULTS: A comprehensive search of the literature did not identify any published eligible randomised controlled trials.
AUTHORS' CONCLUSIONS: In order to develop the best source of evidence, there is a need to undertake randomised controlled trials of interventions for preventing and managing advanced liver disease in adults and children with cystic fibrosis.
METHODS: The selected patients were divided into three groups, Group I (PDT + SRP), Group II (SP + SRP) and group III (SRP alone). Clinical inflammatory periodontal parameters including plaque index (PI), bleeding on probing (BOP), probing depth (PD) and clinical attachment level (CAL) gain were assessed. Assessment of crevicular fluid interleukin (IL)-6 and tumor necrosis factor alpha (TNF-α) was performed using enzyme-linked immunosorbent assay technique. All measurements were recorded at baseline, 3 months and 6 months follow-up periods, respectively.
RESULTS: A total of 73 patients completed the study. A significant improvement in the BOP was seen in Group II at both follow up visits when compared with other groups (p < 0.05). Only in Group-I that showed statistically significant reduction in moderate periodontal pockets at 3 months (p = 0.021), and significant reductions in deep pockets at 3-months (p = 0.003) and 6-months (p = 0.002), respectively. CAL gain also was reported to be seen in group-I at both visits (p < 0.05). Group- I and II significantly reduced the levels of IL-6 at 3-month period compared to Group-III. This reduction was further maintained by group-II and group-III at 6 months, respectively. TNF-α showed statistically significant decrease in Group II as compared to Group I and Group-III and this reduction was maintained by the end of 6-month visit (p = 0.045).
CONCLUSION: Both the treatment modalities PDT and SP helped in reducing periodontal inflammation. PDT reported significant gain in clinical attachment level, whereas the SP significantly reduced the bleeding levels.