scholarly journals Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum

2014 ◽  
Vol 9 (2) ◽  
pp. 27-32
Author(s):  
M Chhetry ◽  
A Thakur ◽  
P Basnet ◽  
R Joshi ◽  
H Sangraula ◽  
...  

Aims: The aim was to evaluate the effectiveness of intravenous ondansetron as compared to intravenous metoclopramide in hyperemesis gravidarum. Methods: Sixty-eight patients with hyperemesis gravidarum were randomized to receive either intravenous ondansetron or intravenous metoclopramide according to randomization group, till they started tolerating orally along with supportive therapy and various treatment parameters were compared. Results: No statistically significant differences were found in the number of doses of intravenous medication used (three doses of ondansetron vs four doses of metoclopramide; p value 0.77), weight changes (ondansetron - 0 kg vs. metoclopramide – 1 kg; p value 0.11) during treatment, duration of intravenous fluids (ondansetron – 24 hours vs. metoclopramide- 24 hours; p value 0.48) in the two groups. The duration of hospital stay of the patients in the two groups was comparable (ondansetron - 3 days vs. metoclopramide - 3 days; p value 0.83).Conclusions: Metoclopramide and ondansetron appear to be equally effective to treat hyperemesis gravidarum. Although this was a prospective randomized controlled study, it had a small sample size and the results should be confirmed in a larger and powered study.DOI:http://dx.doi.org/10.3126/njog.v9i2.11753

2020 ◽  
Vol 36 (2) ◽  
pp. 95-106
Author(s):  
Agnieszka M. Piróg-Balcerzak ◽  
Anna K. Bażyńska ◽  
Katarzyna Biernacka ◽  
Joanna Brągoszewska ◽  
Lidia Popek ◽  
...  

Objective. Omega–3 polyunsaturated fatty acids (PUFAs) were tested in adolescent depression and in several neurodevelopmental disorders with partial success. Anorexia nervosa (AN) is characterised by deficiencies in fatty food intake and frequent comorbidity, including depressive and cognitive symptoms. Thus supplementation with PUFAs may be beneficial in this group of patients. The aim of the study was to assess whether PUFAs as an add-on treatment is associated with better improvement of body mass index (BMI) and psychopathological symptoms than placebo in patients with AN. Method. 61 female adolescent inpatients with AN were randomly allocated to omega–3 PUFAs supplementation or placebo for 10 weeks. Patients also participated in the behavioural programme and eclectic psychotherapy (treatment as usual, TAU). At baseline and follow-up visits, patients’ BMI and psychopathology were assessed with Clinical Global Impression Scale (CGI), Patient Global Impression Scale (PGI), and Eating Attitude Test (EAT-26). Results. After 10 weeks, both groups showed improvement in all parameters. Improvement in CGI scores was observed greater in placebo vs. PUFA-s group (p = 0.015) while other differences were not statistically significant. Omega–3 PUFAs supplementation appears not to be effective as an add-on treatment in inpatient adolescent girls with anorexia nervosa. Conclusions. The results should be analysed with caution due to small sample size and heterogeneity in TAU. As the TAU turned out to be highly effective, additional therapeutic effect of PUFA might not be visible. Nevertheless, that does not explain the tendency for better improvement in the placebo group.


2021 ◽  
Vol 8 (3) ◽  
pp. 205-207
Author(s):  
Abhijit Trailokya ◽  
Amol Aiwale ◽  
Roshan Pawar ◽  
Suhas Erande

This study aimed to assess effectiveness and safety of Evogliptin 5 mg in patients with T2DM who were prescribed Evogliptin alone or with other oral hypoglycemic agents in real world scenario. Overall 20 patients who received Evogliptin as routine clinical practice in management of T2DM were analyzed retrospectively from single center. Data collected from past medical records. Primary endpoint was mean changes in HbA1c from baseline to weeks 24 and secondary endpoints were Change in HbA1c from baseline to weeks 12 Change from baseline in FPG & PPG at weeks 12 & 24.Significant reduction in HbA1c at the end of 12 and 24 weeks of Evogliptin therapy was - 0.9% and -1.45% respectively from the baseline of HbA1c 8.6% (p value <0.001). At the end of 12 and 24 weeks of addition of Evogliptin, significant reduction in FBG were seen i.e -49.5 mg/dl and -90.7mg/dl respectively from base line of 182 mg/dl and reduction in PPG was -79.4mg/dl and -116.6mg/dl respectively from base line 277 mg/dl (p value <0.001). Evogliptin was found to be effective when added to the patients who were uncontrolled on dual / triple oral anti-diabetic medications and even in treatment naïve patient. It effectively showed reduction in HbA1c, FBG and PPG and the end of 12 and 24 weeks when added to existing anti-diabetic medications & well tolerated in type 2 diabetes Indian patients.Small sample size and retrospective study


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5441-5441
Author(s):  
Meera Yogarajah ◽  
Phuong L. Nguyen ◽  
Rong He ◽  
Hassan B. Alkhateeb ◽  
Mithun Vinod Shah ◽  
...  

Background MDS is a heterogeneous disease and the revised International Prognostic Scoring System (IPSS-R) is utilized in prognostication. The percentage (%) of blasts in the bone marrow is determined in the aspirate morphologically. Though the former is the standard of care the blast percentage is also reported by flow cytometry and biopsy which can many times be inconsistent. We previously presented the utilization of biopsy based blast percentage which showed meaningful prognostic groups compared to aspirate. In this study we compare the blasts as reported by the aspirate and flow cytometry in MDS-EB in calculating IPSS-R. Methods The MDS database was reviewed for cases of MDS-EB after due IRB approval at the Mayo clinic. We calculated IPSS-R scores based on the aspirate blast % (IPSS-RAsp) and flow blast% (IPSS-Rfl). The aspirate blast percentage was reported morphologically. Suboptimal aspirates were excluded from the study. The flow blast percentage was determined by immunophenotyping. The overall survival (OS) was determined by IPSS-RAsp and IPSS-RFl. OS estimates were calculated by Kaplan-Meier curves and log-rank testing using JMP v.13. Uno's concordance statistic was used to compare the 2 risk scoring systems. Results Of 1322 patients, 431 (33%) cases were identified with MDS-EB out of which 120 (29%) cases had blasts reported in the aspirate and flow. Based on aspirate MDS EB1: 54% (n=65), MDS EB2 46% (n=55). The hematological, cytogenetic and R-IPSS categories were compared between MDS-EB1 and MDS- EB 2. The blast percentage and hemoglobin levels was significantly different between MDS-EB1 and EB2 as seen in table 1, however the IPSS-R risk groups were not significantly different. The flow cytometry was concordant with aspirate in 66/120 (55%) cases. Out of the dis-concordant cases only 20% (11/54) was upstaged by flow cytometry with most of the patients being down staged as expected by the techniques used in processing the blood and hence not reliable when reported low (Figure 1). The OS outcomes based on the IPSS- R asp, IPSS-Rfl areshown in figure 2A,2B .The p value with aspirate based R-IPSS was more significant than flow cytometry based R-IPSS (p= 0.0007 vs 0.0174). We compared the two models for observed OS differences using the Uno model which was not statistically significant. (p= 0.6) Conclusions Both models did not show a difference which is likely due to the very small sample size. However flow cytometry did down stage more patients when disconcordant and may have less value in that setting. It would be ideal to compare all 3 models aspirate, biopsy and flow cytometry however we did not have enough number of patients to do the comparison. Disclosures Patnaik: Stem Line Pharmaceuticals.: Membership on an entity's Board of Directors or advisory committees. Al-Kali:Astex Pharmaceuticals, Inc.: Research Funding.


2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020


2013 ◽  
Vol 20 (05) ◽  
pp. 699-706
Author(s):  
HEMMATPOOR BEHZAD ◽  
MAHVAR TAYEBEH ◽  
MAKHSOSI BEHNAM REZA ◽  
Saeb Morteza

Background: shoulder pain after laparoscopic procedure is a frequent complication encountered in surgery ward. Severaltreatments have been proposed to reduce it. This study aimed to evaluate the efficacy of preoperative administration of gabapentin inpreventing and attenuating Post Laparoscpoic Shoulder Pain (PLSP) after laparoscopic cholecystectomy. Design: In a randomised,double blinded placebo controlled study. Setting: Woman's Hospital, Kermanshah University of Medical Sciences. Period: April 2011 toMarch 2012. Material and methods: 90 patients of ASA physical status I-II undergoing elective laparoscopic cholecystectomy wererandomly allocated to receive gabapentin 600 mg or placebo ,half an hour before surgery. The presence analgesia and side effects wererecorded for 12h postoperatively in same times. Results: Incidence Verbal Rating Scale (VRS) ≥ 4 at different times after arrival to PACUwere significantly lower in gabapentin group in arrival (P Value= 0.003) and then after 30 miniute (P Value= 0.02) and 2 (P Value=0.003), 4 (P Value= 0.03) and 6 (P Value= 0.04) hours after arrival to Post Anesthesia Care Unit (PACU). But this sigificancy lost at 12hours (P Value= 0.07) after arrival to PACU. Also there was a reduction in amounts of postoperative in ward analgesic consumption. Sideeffects were not different between two groups. Conclusions: 600 mg gabapentin as premedication is effective and safe for reducing postlaparoscopicshoulder pain intensity after general laparoscopy compared with placebo.


2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Lalathaksha Kumbar ◽  
Jariatul Karim ◽  
Anatole Besarab

Vascular access is the lifeline of a hemodialysis patient. Currently arteriovenous fistula and graft are considered the permanent options for vascular access. Monitoring and surveillance of vascular access are an integral part of the care of hemodialysis patient. Although different techniques and methods are available for identifying access dysfunction, the scientific evidence for the optimal methodology is lacking. A small number of randomized controlled trials have been performed evaluating different surveillance techniques. We performed a study of the recent literature published in the PUBMED, to review the scientific evidence on different methodologies currently being used for surveillance and monitoring and their impact on the care of the dialysis access. The limited randomized studies especially involving fistulae and small sample size of the published studies with conflicting results highlight the need for a larger multicentered randomized study with hard clinical end points to evaluate the optimal surveillance strategy for both fistula and graft.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15032-e15032
Author(s):  
Mihai Vasile Marinca ◽  
Irina Draga Caruntu ◽  
Ludmila Liliac ◽  
Simona Eliza Giusca ◽  
Andreea Marinca ◽  
...  

e15032 Background: The 1997 IGCCCG Consensus classification provides clinicians with enough information to efficiently choose between treatment options for most GCT patients. Nevertheless, therapy is ineffective in 5-10% of cases (even more in less developed countries), and about the same numbers experience severe side effects. This exploratory study aims to assess the impact of more rigorous and detailed pathology examination on improving the assignation of these patients to prognostic groups and, consequently, making optimal therapeutic decisions. Methods: Predefined features were reviewed on histology slides from 39 GCT patients followed-up for a median of 48.28 months. We designed a uniform pathology protocol, focused on identifying potential new prognostic factors. Categorical and continuous variables were quantified using light microscopy and computer-aided morphometry and, due to the small sample size, their statistical correlation was analyzed by exact tests and Spearman’s rho, respectively. Significant (2-sided p-value <0.05, under sample size reserve) coefficient values were entered in hierarchical cluster analysis (HCA). Results: Favorable IGCCCG group, presence of seminoma, glandular tissue pattern, presence and histoarchitecture of lymphocytic infiltrate associated better survival rates and lower risk of progression. Invasion of the epididymis and spermatic cord, presence of teratoma, choriocarcinoma and yolk-sac elements, papillary pattern and cell pleomorphism predicted poorer outcomes. HCA yielded 2 significantly distinct patient groups in terms of overall survival (p=0.018) and time to progression (p=0.080), but not disease-free survival (p=0.614). Conclusions: Quantification of tumor subtypes and other histology features of GCTs (e.g. necrosis, tissue patterns, inflammation) is feasible and, if standardized, may prove useful in optimal selection of risk groups, when performed by an experienced pathologist.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 390-390 ◽  
Author(s):  
Andrew N de la Torre ◽  
Ismael Castaneda ◽  
Aram F. Hezel ◽  
Newell F. Bascomb ◽  
Gouri Shankar Bhattacharyya ◽  
...  

390 Background: Propranolol and etodolac (designated VT-122) target the adrenergic and prostaglandin stress systems activated in HCC. These stress-induced systems are proposed to induce changes in the tumor microenvironment and immune system leading to tumor promotion and immune tolerance. In a separate study, administration of VT-122 prior to sorafenib showed an increase in median overall survival (OS) of 21 months when VT-122 is administered before sorafenib compared to 10 months OS for sorafenib alone. The aim of the current study was to evaluate the effect of administering VT-122 at least 30 days after starting sorafenib. Methods: Patients with HCC receiving sorafenib for at least 30 days were eligible for this double-blind, placebo-controlled study. Patients were randomized to receive sorafenib with either VT-122 or placebo. Patients received therapy for up to 12 months or until treatment failure. VT-122 was administered twice daily. The primary endpoint was duration of therapy (DoT) and the secondary endpoint was OS. Results: Twenty patients were randomized, 11 and 9 patients to the VT122 and placebo arm, respectively. Each arm was balanced with regards to age (mean of 60.4 years), Child Pugh status (9 Child Pugh A, 11 Child Pugh B7), hepatitis virus status (6 HBV and 1 HCV positive) and C-reactive protein (CRP) (20.4 mg/L). VT122 with sorafenib was well tolerated with no unexpected serious adverse events reported. Mean OS was 13.9 months and 9.6 months in the VT-122 and placebo arms, respectively. Mean DoT (unvalidated) was 10.1 months and 7.5 months in the VT-122 and placebo arms, respectively. Conclusions: Co-administration of VT-122 with sorafenib was well tolerated and showed an increase in duration of therapy and OS versus sorafenib alone. The small sample size and number of events precludes the ability to make any significant efficacy conclusions. The increase in survival was not as great as that seen in a separate study in which VT122 was started prior to sorafenib. A further Phase 3 study of VT122 administered prior to sorafenib in patients with HCC is warranted. Clinical trial information: NCT01265576.


2020 ◽  
Author(s):  
Jérôme E Dauvergne ◽  
Anne-Laure GEFFRAY ◽  
Karim ASEHNOUNE ◽  
Bertrand ROZEC ◽  
Karim LAKHAL

Abstract Background Endotracheal tube cuff underinflation contributes to microaspiration of contaminated oropharyngeal content, source of pneumonia. Overinflation exposes to airway damage. Intermittent manual adjustment of the cuff pressure (P cuff ) may delay the detection of under- or overinflation. Devices for automated continuous adjustment of P cuff are promising but some are inconvenient, expensive or even harmful. This prospective randomized controlled study tested whether the Tracoe Smart Cuff Manager TM reduced the rate of patients undergoing ≥1 episode of underinflation (P cuff <20 cmH 2 O), as compared with routine manual P cuff adjustment. Secondary endpoints included comparisons of the rate of patients with ≥1 overinflation episode (P cuff >30 cmH 2 O), of the incidence of under- and overinflation episodes and of their magnitude. Methods Patients likely to receive invasive mechanical ventilation for >48 hours because of acute brain injury were randomly allocated to receive, during 48 hours, automated P cuff adjustment (combined with manual adjustment) or manual adjustment alone. In each group, P cuff was measured with a dedicated manual manometer, at least every 8 hours. Results Sixty patients were analyzed (28 patients with automated and 32 with manual P cuff adjustment) for 506 measurements of P cuff (237 and 269, respectively). As compared with manual adjustment, automated adjustment of P cuff was associated with 1) a lower rate of patients with ≥1 episode of underinflation (63% and 18%, respectively, p<0.001), 2) a lower incidence of underinflation episodes (15% vs. 2%;p<0.001), 3) a lower rate of manual adjustments (77% vs. 56%;p<0.001) and 4) manual adjustments of lower magnitude (5.9±4.5 vs. 3.6±4.7 cmH 2 O;p<0.001). For overinflation, there was no significant between-groups differences (p>0.99). Conclusions The adjunction of a continuous P cuff control with the Tracoe Smart Cuff Manager TM to routine manual intermittent adjustment reduced both the incidence of P cuff underinflation episodes and their magnitude without provoking overinflation.


2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Cinzia Mancuso ◽  
Antonio Curcio ◽  
Angelo Lamberti ◽  
Giuseppe Santarpia ◽  
Angela Quirino ◽  
...  

Abstract Aims Device implantation is growing exponentially, as well as associated infections, ranging from isolated pocket erosion to endocarditis and bacteraemia, all worsening the prognosis of patients with frailty and comorbidity. Transvenous lead extraction (TLE) can resolve the complications, although a 1-year mortality risk of up to 25% is reported; despite higher health costs, prolonged hospitalization, and poor quality of life, strategies for predicting increased infection risk and reduced infection incidence are yet missing. Currently applied clinical scores do not consider etiologic microbial agents. We aimed to assess whether PADIT and UPCM scores could be implemented when bacteria or fungi are known to be causative of infection, and how these agents affected the outcome. Methods and results A retrospective analysis of patients undergone cardiac implantable electronic device (CIED) pocket revision, and/or TLE between 2016 and 2021 was performed. For each procedure, microbiological samples of both generator pocket tissue and intracardiac portions of the leads were analysed. In addition, blood cultures were performed in three sets. Transesophageal echocardiography was performed in all cases for ruling out suspected endocarditis. Spearman ad Pearson coefficients were tested for correlation among microorganism, prior infection and/or procedure, PADIT and UPCM scores; a P-value less than 0.05 was considered significant. We analysed 14 patients (10 males, 4 females, mean age ± SD: 72 ± 13): one case (4%) affected by pocket erosion, seven cases (50%) affected by both pocket site and lead infection (with associated bacteraemia in one subject), and one case (4%) due to lead-related infective endocarditis. Of these, five (36%) underwent device replacement, while nine (64%) to extraction or pocket/lead revision. Nine (64%) patients had positive culture examinations (Figure 1). The correlation method gave a statistically significant association between Gram- infection and prior sepsis (r 0.63; P-value 0.02). We considered the number of procedures on the same pocket and/or CIED previous infections as markers of frailty and increased infectious risk. As expected, the PADIT score, but not UPCM, significantly correlated with the number of previous procedures (r 0.70; P-value 0.006). Indeed, both scores had a similar infectious risk prediction. Conclusions In our analysis, predictive PADIT score of infectious risk performed better than UPCM, while both proved their reliability in identifying high-risk patients. The absence of correlation between UPCM score and infective agents is not conclusive, but probably due to the small sample size. Interestingly, growing rate of device reinfection correlates with the risk of Gram- bacterial infection. Thus, the integration of the microbiological data in the current prediction models could significantly increase their performance.


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