scholarly journals Adverse Drug Reactions Associated with Anthracyclinebased Chemotherapy in Mexican Cancer Pediatric Patients: Cohort Study

Author(s):  
Jessica Liliana Vargas Neri ◽  
Osvaldo Daniel Castelán Martínez ◽  
Gilberto Castañeda Hernández ◽  
Felipe Rodríguez Islas ◽  
Miguel Ángel Palomo Colli ◽  
...  

Introduction. Adverse drug reactions (ADR) are an important cause of illnesses and death in cancer pediatric patients. Anthracyclines are drugs used as the first-line treatment for this disease. It is necessary to apply different pharmacovigilance strategies to know the incidence, causality, and evaluation of an ADR prevention processes. The objective of this cohort study was evaluating the incidence, severity, and causality of ADRs associated with anthracycline-based chemotherapy in Mexican pediatric patients. Material and Methods. A retrospective cohort study was conducted in two pediatric institutions in Mexico. All ADRs were identified and analyzed according to pharmacovigilance guidelines. Ninety-nine patients were included in this study, 92 % had at least one ADR associated with chemotherapy. Results. A total of 718 AR were found, 354 (49.3 %) were associated, by causality analysis, as probable and definite with anthracycline-based chemotherapy. The reaction with the highest incidence was febrile neutropenia (67.7 %). The mean ADR associated with anthracycline-based chemotherapy per patient was 4 ADR / patient. Most ADRs were severe, involving hospitalization, treatment and temporary suspension of chemotherapy. Conclusions.The incidence of ADRs associated with anthracycline-based chemotherapy is high and most require monitoring and follow-up, so increasing awareness of the safety of these medications provides relevance to implement pharmacovigilance actions in pediatric hospitals.

2019 ◽  
Vol 24 (5) ◽  
pp. 549-557
Author(s):  
Malia McAvoy ◽  
Heather J. McCrea ◽  
Vamsidhar Chavakula ◽  
Hoon Choi ◽  
Wenya Linda Bi ◽  
...  

OBJECTIVEFew studies describe long-term functional outcomes of pediatric patients who have undergone lumbar microdiscectomy (LMD) because of the rarity of pediatric disc herniation and the short follow-up periods. The authors analyzed risk factors, clinical presentation, complications, and functional outcomes of a single-institution series of LMD patients over a 19-year period.METHODSA retrospective case series was conducted of pediatric LMD patients at a large pediatric academic hospital from 1998 to 2017. The authors examined premorbid risk factors, clinical presentation, physical examination findings, type and duration of conservative management, indications for surgical intervention, complications, and postoperative outcomes.RESULTSOver the 19-year study period, 199 patients underwent LMD at the authors’ institution. The mean age at presentation was 16.0 years (range 12–18 years), and 55.8% were female. Of these patients, 70.9% participated in competitive sports, and among those who did not play sports, 65.0% had a body mass index greater than 25 kg/m2. Prior to surgery, conservative management had failed in 98.0% of the patients. Only 3 patients (1.5%) presented with cauda equina syndrome requiring emergent microdiscectomy. Complications included 4 cases of postoperative CSF leak (2.0%), 1 case of a noted intraoperative CSF leak, and 3 cases of wound infection (1.5%). At the first postoperative follow-up appointment, minimal or no pain was reported by 93.3% of patients. The mean time to return to sports was 9.8 weeks. During a mean follow-up duration of 8.2 years, 72.9% of patients did not present again after routine postoperative appointments. The total risk of reoperation was a rate of 7.5% (3.5% of patients underwent reoperation for the same level; 4.5% underwent adjacent-level decompression, and one patient [0.5%] ultimately underwent a fusion).CONCLUSIONSMicrodiscectomy is a safe and effective treatment for long-term relief of pain and return to daily activities among pediatric patients with symptomatic lumbar disc disease in whom conservative management has failed.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041875
Author(s):  
Mette Nørgaard ◽  
Bianka Darvalics ◽  
Reimar Wernich Thomsen

ObjectiveTo assess whether metformin use affects risk of benign prostatic hyperplasia (BPH) by comparing the risk of BPH in men with type 2 diabetes who initiated first-line treatment with either metformin or sulfonylurea monotherapy between 2000 or 2006 in Northern Denmark. In this period, sulfonylurea and metformin were both frequently used as first-line glucose-lowering drug (GLD) treatment.DesignA population-based cohort study.SettingNorthern Denmark.ParticipantsAll men who filled at least two prescriptions for metformin or for sulfonylurea, respectively, during their first 6 months of GLD treatment. Follow-up started 6 months after treatment start.Primary outcome measuresRates of subsequent BPH, identified based on community prescriptions for BPH-related treatment or hospital BPH diagnoses, and rates of transurethral resection of the prostate (TURP). Rates in metformin and sulfonylurea users were compared overall and stratified by 6-month haemoglobin A1c (HbA1c) using Cox regression and an intention-to-treat (ITT) approach and an as-treated analysis.ResultsDuring follow-up, less than five persons were lost to follow-up due to emigration. In 3953 metformin initiators with a median follow-up of 10 years, the 10-year cumulative BPH incidence was 25.7% (95% CI 24.2 to 27.1). Compared with 5958 sulfonylurea users (median follow-up 8 years, 10-year cumulative incidence 27.4% (95% CI 26.2 to 28.6)), the crude HR for BPH was 0.83 (95% CI 0.77 to 0.89) and adjusted HR in the ITT analyses was 0.97 (95% CI 0.88 to 1.06). For TURP, the adjusted HR was 0.96 (95% CI 0.63 to 1.46). In the as-treated analysis, adjusted HR for BPH was 0.91 (95% CI 0.81 to 1.02).ConclusionsCompared with sulfonylurea, metformin did not substantially reduce the incidence of BPH in men with diabetes.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040819
Author(s):  
Pontus Rygh ◽  
Ina Asklund ◽  
Eva Samuelsson

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.


Author(s):  
Tran Anh Quynh ◽  
Pham Duy Hien ◽  
Le Quang Du ◽  
Le Hoang Long ◽  
Nguyen Thi Ngoc Tran ◽  
...  

AbstractRobotic surgery offers three-dimensional visualization and precision of movement that could be of great value to gastrointestinal surgeons. There were many previous reports on robotic technology in performing Soave colonic resection and pull-through for Hirschsprung’s disease in children. This study described the follow-up of the Robotic-assisted Soave procedure for Hirschsprung’s disease in children. Robotic-assisted endorectal pull-through was performed using three robotic arms and an additional 5-mm trocar. The ganglionic and aganglionic segments were initially identified by seromuscular biopsies. The rest of the procedure was carried out according to the Soave procedure. We left a short rectal seromuscular sleeve of 1.5–2 cm above the dentate line. From December 2014 to December 2017, 55 pediatric patients were operated on. Age ranged from 6 months to 10 years old (median = 24.5 months). The aganglionic segment was located in the rectum (n = 38), the sigmoid colon (n = 13), and the left colon (n = 4). The mean total operative time was 93.2 ± 35 min (ranging from 80 to 180 min). Minimal blood was lost during the surgery. During the follow-up period, 41 patients (74.6%) had 1–2 defecations per day, 12 patients (21.8%) had 3–4 defecations per day, and 2 patients (3.6%) had more than 4 defecations per day. Fecal incontinence, enterocolitis, and mild soiling occurred in three (5.4%), four (7.3%), and two pediatric patients, respectively. Robotic-assisted Soave procedure for Hirschsprung’s disease in children is a safe and effective technique. However, a skilled robotic surgical team and procedural modifications are needed.


Neurosurgery ◽  
2010 ◽  
Vol 67 (2) ◽  
pp. 404-407 ◽  
Author(s):  
R. Shane Tubbs ◽  
Christoph J. Griessenauer ◽  
Todd Hankinson ◽  
Curtis Rozzelle ◽  
John C. Wellons ◽  
...  

Abstract BACKGROUND Retroclival epidural hematomas (REDHs) are infrequently reported. To our knowledge, only 19 case reports exist in the literature. OBJECTIVE This study was performed to better elucidate this pathology. METHODS We prospectively collected data for all pediatric patients diagnosed with REDH from July 2006 through June 2009. Data included mechanism of injury, Glasgow Coma Scale score, neurological examination, treatment modality, and outcome. Magnetic resonance imaging was used to measure REDH dimensions. RESULTS Eight children were diagnosed with REDH, and the hematomas were secondary to motor vehicle–related trauma in all cases. The mean age of patients was 12 years (range 4–17 years). The mean REDH height (craniocaudal) was 4.0 cm, and the mean thickness (dorsoventral) was 1.0 cm. At presentation, the mean Glasgow Coma Scale score was 8 (range 3–14), and there was no correlation between hematoma size and presenting symptoms. Two patients died soon after injury, and 2 additional patients had atlanto-occipital dislocation that required surgical intervention. No patient underwent surgical evacuation of the REDH. The mean follow-up was 14 months. At most recent follow-up, 4 patients are neurologically intact, 1 patient has a complete spinal cord injury, and 1 patient has mild bilateral abducens nerve palsy. CONCLUSION To our knowledge, this study of 8 pediatric patients is the largest series of patients with REDH thus far reported. Based on our study, we found that REDH is likely to be underdiagnosed, atlanto-occipital dislocation should be considered in all cases of REDH, and many patients with REDH will have minimal long-term neurological injury.


Drug Safety ◽  
2018 ◽  
Vol 41 (8) ◽  
pp. 753-765 ◽  
Author(s):  
Helen Byomire Ndagije ◽  
Victoria Nambasa ◽  
Leonard Manirakiza ◽  
Donna Kusemererwa ◽  
Dan Kajungu ◽  
...  

2021 ◽  
pp. 112067212110206
Author(s):  
Iliya Simantov ◽  
Lior Or ◽  
Inbal Gazit ◽  
Biana Dubinsky-Pertzov ◽  
David Zadok ◽  
...  

Background: Retrospective cohort study evaluating long term keratoconus progression amongst cross-linking (CXL) treated pediatric patients in the treated and the fellow untreated eyes. Methods: Data on 60 eyes of 30 patients, 18 years old or younger, who underwent CXL in at least one eye was collected and analyzed. Follow-up measurements taken from the treated and untreated eye up to 7 years after CXL treatment, were compared to baseline measurements. Parameters included uncorrected distance visual acuity (UCDVA), best-corrected spectacle visual acuity (BCSVA), manifest refraction, pachymetry, corneal tomography, and topography. Results: Mean age of patients was 16 ± 2.1 years. For the treated eyes, during follow-up period mean UCDVA had improved (from 0.78 ± 0.22 at baseline to 0.58 ± 0.26 logMAR at 7 years; p = 0.13), as well as mean BCSVA (from 0.23 ± 0.107 at baseline to 0.172 ± 0.05 logMAR at 7 years; p = 0.37). The mean average keratometry showed a significant flattening (from 49.95 ± 4.04 to 47.94 ± 3.3 diopters (D); p < 0.001), However there was no change in the mean maximal keratometry. The mean minimal corneal thickness (MCT) showed a significant mild reduction of 26 µm ( p = 0.006). Although statistically insignificant, the mean manifest cylinder was also reduced to 2D ( p = 0.15). During the follow-up period, eight untreated eyes (26.6%) deteriorated and underwent CXL, while only one treated eye (3.33%) required an additional CXL. Conclusion: CXL is a safe and efficient procedure in halting keratoconus progression in the pediatric population, the fellow eye needs to be carefully monitored but only a 25% of the patients will require CXL in that eye during a period of 7 years.


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