Attitudes of Croatian pulmonologists concerning obstacles to earlier, more appropriate use of biologics in severe asthma: Survey results

Aims Biologics have been proven efficacious for patients with severe asthma (SA). It is essential to diagnose such individuals correctly. This study was designed to survey pulmonologists to identify barriers to early diagnosis and subsequent appropriate use of biologics for SA in Croatia. Methods A pulmonologist group with expertise in SA developed the initial list of questions, with the final questionnaire created according to a 2-round Delphi method. The resulting survey consisted of 23 items consequently divided into 4 domains: 1) Pulmonologists’ demographics and professional experiences; 2) Concerns about asthma management; 3) Attitudes toward SA diagnosis; and 4) Beliefs and attitudes regarding the use of biologics in managing SA. The given answers represented the respondents’ estimates. Results Eighty-four surveys were analyzed, with pulmonologists observing that general practitioners often inaccurately diagnose asthma and treat acute exacerbations. Although specialist centers are capably and correctly equipped, the time to diagnose patients with SA is approximately 3.5 months, with initial use of biologics delayed an additional 2 months. The primary indications for prescribing biologics are conventional therapy with oral glucocorticoids (91.7%) and frequent acute exacerbations (82.1%). In addition to improper diagnosis (64.3%), many patients with SA do not receive the indicated biologics owing to strict administrative directives for reimbursement (70.2%) or limited hospital resources (57.1%). Limitations The limitations of this survey include the subjective nature of the collected data, the relatively small sample size, and the lack of the biologic efficacy evaluation. Conclusions Croatian pulmonologists observed that a significant number of patients with SA who are eligible for biologics are not prescribed them, largely because of an inaccurate and/or delayed diagnosis, a delayed referral to a specialist center, highly restrictive criteria for reimbursement, and/or institutional budgetary limitations.

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Abstract W P224: Higher Pre-Hospital Blood Pressure Prolongs Door to Needle Thrombolysis Times

Stroke ◽

10.1161/str.46.suppl_1.wp224 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Digvijaya Navalkele ◽

Chunyan Cai ◽

Mohammad Rahbar ◽

Renganayaki Pandurengan ◽

Tzu-Ching Wu ◽

...

Keyword(s):

Blood Pressure ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Small Sample Size ◽

Heart Association ◽

Small Sample ◽

Categorical Variables ◽

Continuous Variables ◽

Intravenous Tissue Plasminogen Activator ◽

Number Of Patients

Background: Per American Heart Association guidelines, blood pressure (BP) should be < 185/110 to be eligible for intravenous tissue plasminogen activator (tPA). It is shown that door to needle (DTN) time is prolonged in patients who require anti-hypertensive medications prior to thrombolysis in the emergency department (ED). To our knowledge, no studies have focused on pre-hospital BP and its impact on DTN times. We hypothesize that DTN times are longer for patients with higher pre-hospital BP. Methods: We conducted a retrospective review of acute ischemic stroke patients who presented between 1/2010 and 12/2010 to our ED through Emergency Medical Services (EMS) within 3-hrs of symptom onset. Patients were identified from our registry and categorized into two groups: Pre-hospital BP ≥ 185/110 (Pre-hsp HBP) and < 185/110 (Pre-hsp LBP). BP records were abstracted from EMS sheets. Two groups were compared using two-sample t-test or Wilcoxon rank sum test for continuous variables and Chi-square test or Fisher’s exact test for categorical variables. Results: A total of 107 consecutive patients were identified. Out of these, 75 patients (70%) were treated with tPA. Among the patients who received thrombolysis, 35% had pre-hospital BP ≥ 185/110 (n= 26/75). Greater number of patients required anti-hypertensive medications in ED in high BP group compared to low BP group (Pre-hsp HBP n= 14/26, 54%; Pre-hsp LBP n= 13/49, 27%, p < 0.02). Mean door to needle times were significantly higher in Pre-hsp HBP group. (mean ± SD 87.5± 34.2 Vs. 59.7±18.3, p<0.0001). Analysis of patients only within the Pre-hsp HBP group (n= 26) revealed that DTN times were shorter if patients received pre-hsp BP medications compared to patients in the same group who did not receive pre-hsp BP medication (n= 10 vs 16; mean ± SD 76.5 ± 25.7 Vs. 94.3 ± 37.7, p = 0.20) Conclusion: Higher pre-hospital BP is associated with prolonged DTN times and it stays prolonged if pre-hospital high BP remains untreated. Although the later finding was not statistical significant due to small sample size, pre-hospital blood pressure control could be a potential area for improvement to reduce door to needle times in acute ischemic stroke.

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Discrepancy of Blast Percentage between the Bone Marrow Aspirate and Flow Cytometry and Its Impact on Survival Outcomes in Patients with Myelodysplastic Syndromes Excess Blast (MDS-EB)

Blood ◽

10.1182/blood-2019-125439 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5441-5441

Author(s):

Meera Yogarajah ◽

Phuong L. Nguyen ◽

Rong He ◽

Hassan B. Alkhateeb ◽

Mithun Vinod Shah ◽

...

Keyword(s):

Bone Marrow ◽

Flow Cytometry ◽

Small Sample Size ◽

Scoring Systems ◽

Standard Of Care ◽

Risk Groups ◽

Small Sample ◽

International Prognostic Scoring System ◽

P Value ◽

Number Of Patients

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.

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A study of atherosclerosis in patients after radiation for early breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.27_suppl.260 ◽

2011 ◽

Vol 29 (27_suppl) ◽

pp. 260-260

Author(s):

V. G. Kirtani ◽

M. Chang ◽

A. M. Dobrescu ◽

S. Zeldis ◽

J. A. Haas ◽

...

Keyword(s):

Breast Cancer ◽

Coronary Arteries ◽

Background Radiation ◽

Small Sample Size ◽

Screening Method ◽

Calcium Score ◽

Small Sample ◽

Left Hemithorax ◽

Asymptomatic Patients ◽

Number Of Patients

260 Background: Radiation therapy (RT) is widely used as part of curative treatment of breast cancer. However, older studies have shown increased cardiac morbidity and mortality from breast RT. A screening method is needed to detect early cardiac damage in this population. Recent data have shown that Electron beam computed tomography (EBCT) can detect early atherosclerosis in coronary arteries by identifying the amount of calcification in the coronaries. In our study we employed this tool to detect occult atherosclerosis caused by breast RT. Methods: We evaluated 20 asymptomatic patients, less than 60 years of age, treated with RT at least 5 years prior to enrollment. Nine received RT to the left and 11 to the right hemithorax. Average interval between RT and CT was 7.7 years (5-14). All patients were treated with external beam RT using tangential technique. The breast was treated to a dose of 4500-5040 cGy and the tumor bed was boosted to a total dose of 6000-6600 cGy. All patients underwent EBCT to compute the volumetric and agatston calcium scores in the coronary arteries and the aorta. Results: Of the 11 patients who had RT to right hemithorax, 8 had calcium score of 0, 2 had very minimally elevated scores and 1 had significantly elevated score (patient 19, interval -14 years). Of the 9 patients who had RT to left hemithorax, 7 had calcium score of 0. None had significantly elevated scores. In the aorta, 11 patients had score of 0 and 8 had minimally elevated scores. Conclusions: Occult atherosclerosis was not detected using EBCT calcium scores in coronaries and aorta in a significant number of patients treated with RT for breast cancer. However, the study is limited by a small sample size. [Table: see text]

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Cell cycle and apoptosis regulatory protein (CARP)-1 expression in neuroblastoma.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9578 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9578-9578

Author(s):

Santosh S. Hanmod ◽

Samantha Siegel ◽

James Hatfield ◽

Edi Levi ◽

Marwan Zidan ◽

...

Keyword(s):

Small Sample Size ◽

Regulatory Protein ◽

Tumor Biology ◽

Progression Free Survival ◽

Small Sample ◽

Immune Histochemistry ◽

Formalin Fixed Paraffin ◽

Number Of Patients ◽

Significant Difference ◽

Formalin Fixed Paraffin Embedded

9578 Background: Neuroblastoma (NB) is the most common extra-cranial solid tumor in children. The prognosis for patients with high risk NB is still poor. Study of additional prognostic factors will enhance current understanding of the tumor biology and risk stratification. CARP-1 is a recently identified molecule mediating apoptosis signaling by agents like doxorubicin and etoposide. Since these agents are used in the front line treatment of NB, we tested whether CARP-1 expression could be another prognostic factor in NB. Methods: CARP-1 expression was examined by Western blot in a pair of NB cell lines, SK-N-SH and SK-N-SH Dox. We reviewed medical records of patients with NB at Children’s Hospital of Michigan from 2000-2009 and examined CARP-1 expression by immune-histochemistry in the archived, formalin fixed paraffin embedded NB tissues. CARP-1 expression was recorded as positive or negative. Correlation of CARP-1 expression and progression free survival (PFS) was calculated. Results: CARP-1 expression was detected in SK-N-SH but not SK-N-SH Dox, a doxorubicin-resistant derivative of SK-N-SH, suggesting that resistance to doxorubicin is associated with decreased level of CARP-1 expression in NB cells. Of the 30 cases studied, 53 % (16/30) expressed CARP-1. There was no significant difference in N-myc amplification status (13% vs.14%, p=0.3), or proportion of unfavorable Shimada histology (60% vs. 64%, p=0.5) between CARP-1 positive vs. negative groups. Twenty three percent (7/22) patients progressed or relapsed, including 2/16 (13%) in CARP-1 positive group vs. 5/14 (36%) in CARP-1 negative group (p=0.1). There was no significant difference in the PFS at 1 year (94% vs.79%, p=0.2) and 3 year (86% vs.71%, p=0.2) between CARP-1 positive vs. negative groups. Conclusions: CARP-1 expression was decreased in doxorubicin resistant NB cell line. CARP-1 expression was detected in approximately half (53%) of NB tumors. Patients with NB who expressed CARP-1 showed trend towards better 1- & 3-year PFS as compared to those who did not express CARP-1, however, the results are not statistically significant which could be due to the small sample size. Further study with a larger number of patients is warranted to clarify these findings.

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Multi-model mapping of phonemic fluency

Brain Communications ◽

10.1093/braincomms/fcab232 ◽

2021 ◽

Author(s):

Lisa Cipolotti ◽

Tianbo Xu ◽

Bronson Harry ◽

Joe Mole ◽

Grace Lakey ◽

...

Keyword(s):

Statistical Analysis ◽

Small Sample Size ◽

Small Sample ◽

Anterior Cingulate ◽

Functional Region ◽

Phonemic Fluency ◽

Number Of Patients ◽

Lesion Symptom Mapping ◽

Subcortical Regions ◽

Over Time

Abstract The voluntary generation of non-overlearned responses is usually assessed with phonemic fluency. Like most frontal tasks, it draws upon different complex processes and systems whose precise nature is still incompletely understood. Many claimed aspects regarding the pattern of phonemic fluency performance and its underlying anatomy remain controversial. Major limitations of past investigations include small sample size, scant analysis of phonemic output and methodologically insufficient lesion analyses approaches. We investigated a large number of patients with focal unilateral right or left frontal (n = 110) or posterior (n = 100) or subcortical (n = 65) lesions imaged with magnetic resonance or computed tomography and compared their performance on the number of overall responses, words produced over time, extremely infrequent/unknown words and inappropriate words generated. We also employed, for the first time parcel-based lesion symptom mapping, tract-wise statistical analysis as well as Bayesian multivariate analysis based on meta-analytically defined functional region of interest, including their interactions. We found that left frontal damage was associated with greater impairment than right frontal or posterior damage on overall fluency performance, suggesting that phonemic fluency shows specificity to frontal lesions. We also found that subcorticals, similar to frontals, performed significantly worse than posteriors on overall performance suggesting that subcortical regions are also involved. However, only frontal effects were found for words produced over time, extremely infrequent/unknown and inappropriate words. Parcel-based lesion symptom mapping analysis found that worse fluency performance was associated with damage to the posterior segment of the left frontal middle and superior gyrus, the left dorsal anterior cingulate gyrus and caudate nucleus. Tract-wise statistical analysis revealed that disconnections of left frontal tracts are critical. Bayesian multivariate models of lesions and disconnectome maps implicated left middle and inferior frontal and left dorsomedial frontal regions. Our study suggests that a set of well localised left frontal areas together with subcortical regions and several left frontal tracts are critical for word generation. We speculate that a left lateralized network exists. It involves medial, frontal regions supporting the process of energization, which sustains activation for the duration of the task and middle and inferior frontal regions concerned with selection, required due to the competition produced by associated stored words, respectively. The methodology adopted represents a promising and empirically robust approach in furthering our understanding of the neurocognitive architecture underpinning executive processes.

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P-450 Effects of rheumatoid arthritis and methotrexate therapy on ovarian reserve in infertile women

Human Reproduction ◽

10.1093/humrep/deab127.007 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

G Vlasova ◽

S Perminova

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Ovarian Reserve ◽

Small Sample Size ◽

Genetic Material ◽

Main Group ◽

Small Sample ◽

Control Group ◽

Proliferating Cells ◽

Number Of Patients

Abstract Study question Do patients with infertility and rheumatoid arthritis (RA) treated with methotrexate (MTX) have ovarian reserve alterations? Summary answer Women with infertility and RA treated with MTX were found to have statistically significant decrease of ovarian reserve. What is known already Rheumatoid arthritis (RA) is one of the most prominent inflammatory diseases affecting women of child-bearing age [Brouwer J. et al, 2014]. RA and its treatment may interfere with the female reproductive physiology. The vast majority of patients with RA are treated with methotrexate (MTX) which is a folate antagonist that inhibits DNA synthesis. MTX, which is the anchor drug in RA, targets actively proliferating cells including the oocytes and granulosa cells which may impair the ovarian reserve [Min Tun Kyaw et al, 2020]. Study design, size, duration A prospective case-control study that enrolled 72 female patients with infertility was conducted in the 2-year time period of September 2018 to October 2020. Participants/materials, setting, methods The main group comprised 32 patients with infertility and RA; the control group consisted of 40 women with infertility only. Patients with RA were stratified into subgroups based on whether or not they received MTX. To investigate ovarian reserve measurement of serum anti-Müllerian hormone (AMH) was used. The level of AMH was evaluated concerning RA duration and activity, as well as the age at initiation of MTX therapy, dosage, and treatment duration. Main results and the role of chance The mean age of the study population was 36±3 years. The duration of RA was 4 [3;11] years. The low disease activity based on DAS28-ESR (disease activity score based on 28 joints using the erythrocyte sedimentation rate) prevailed(56.2%). In the main group 19(59.4%) women received MTX therapy. The MTX dosage was 15 [15;20]mg /wk, the duration of MTX therapy by the day of inclusion in the study was 18.7[1;15]months. The AMH level was significantly lower in the main group (2.1 n /ml vs 2.73ng /ml, p = 0.043). The number of patients with decreased ovarian reserve (AMH level<1.0ng/ml) significantly prevailed in the group of patients with RA (25% vs 5%, p = 0.015). When assessing the AMH level in patients with RA who received MTX (n = 19) and patients in the control group, there was a tendency towards a decrease in the indicator in the first subgroup, but no statistically difference was found (p = 0.074). Correlation analysis of the dependence of AMH level on the patient age showed the most significant decrease in AMH in the patients with RA receiving MTX compared to the patients with RA who did not, and compared to all patients with RA regardless of the therapy received (rs=-0.563)(p < 0.05). Limitations, reasons for caution The lack of statistically significant data in certain cases may be due to the small sample size. Wider implications of the findings RA and MTX administration are associated with a significant decrease in AMH levels. The age of initiation of the therapy is negatively correlated with the AMH level. In this regard, patients with already compromised reproductive function who are planning to receive MTX should be advised to preserve the genetic material. Trial registration number 567890

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261 Association of T-cell–inflamed gene expression profile and PD-L1 status with efficacy of pembrolizumab in patients with esophageal cancer from KEYNOTE-180

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0261 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A285-A285

Author(s):

Manish Shah ◽

Takashi Kojima ◽

Daniel Hochhauser ◽

Peter Enzinger ◽

Judith Raimbourg ◽

...

Keyword(s):

Gene Expression ◽

T Cell ◽

Sample Size ◽

Gene Expression Profile ◽

Expression Profile ◽

Small Sample Size ◽

Gastroesophageal Junction ◽

Small Sample ◽

Link Type ◽

Number Of Patients

BackgroundKey biomarkers under investigation for the ability to predict response to monotherapy PD-1 inhibitors such as pembrolizumab include PD-L1, TMB, MSI, and T-cell–inflamed gene expression profile (GEP). The KEYNOTE-180 trial (NCT02559687) was a single-arm phase 2 study of pembrolizumab as third-line or greater therapy in advanced/metastatic esophageal/gastroesophageal junction adenocarcinoma or squamous cell carcinoma (SCC). ORR was 9.9% and median DOR was NR at the primary analysis. We investigated the relationship in KEYNOTE-180 between response to pembrolizumab and T-cell–inflamed GEP or PD-L1 expression by histology.MethodsPatients received pembrolizumab 200 mg Q3W for ≤2 years until disease progression, toxicity, or withdrawal. The end points for this analysis were ORR, DOR, and PFS per RECIST v1.1 by central review and OS in the SCC and adenocarcinoma populations by GEP (non-low [≥–1.540] or low [<–1.540]; cutoff prespecified) and PD-L1 (CPS ≥10 or <10). Tumor GEP was determined using the NanoString nCounter Analysis System. PD-L1 expression was characterized using PD-L1 IHC 22C3 pharmDx. Data cutoff date was July 30, 2018.ResultsOf 121 total patients, 118 had an evaluable GEP score and 121 had an evaluable PD-L1 CPS. Fifty-one patients (42.1%) had GEPnon-lowtumors, 58 (48.0%) had CPS ≥10 tumors, and 31 (25.6%) had GEPnon-low/CPS ≥10 tumors; 63 patients (52.1%) had SCC and 58 (47.9%) had adenocarcinoma. ORR was 15.4% with GEPnon-low and 13.5% with GEPlow among patients with SCC and 12% and 0% among patients with adenocarcinoma, respectively (table 1). ORR was 20% with CPS ≥10 and 7.1% with CPS <10 among patients with SCC and 4.3% and 5.7%, respectively, among patients with adenocarcinoma (table 2). Median OS was slightly higher among patients with SCC in the GEPnon-low subgroup and the CPS ≥10 subgroup versus GEPlow and CPS <10 subgroups, respectively (tables 1, 2); this trend was reversed among patients with adenocarcinoma (tables 1, 2). Median PFS ranged from 1.9 to 2.1 across histology/biomarker subgroups. Median DOR was NR regardless of GEP or CPS status (tables 1, 2).Abstract 261 Table 1Response by GEP status and histologyaAnalysis by biomarker status was not possible because of the small sample size.Abstract 261 Table 2Response by PD-L1 status and histologyaAnalysis by biomarker status was not possible because of the small sample size.ConclusionsIn KEYNOTE-180, data in a small number of patients suggested that measures of inflammation, like PD-L1 and GEP, may enrich for responses to pembrolizumab. In SCC, some trends toward enrichment were observed for both biomarkers, although the trend was stronger for PD-L1 CPS ≥10. In adenocarcinoma, a trend was observed for GEP but not for PD-L1; the small number of responders is limiting, and further studies are needed to understand molecular correlates in adenocarcinoma.AcknowledgementsMedical writing and/or editorial assistance was provided by Tim Peoples, MA, ELS, and Holly C. Cappelli, PhD, CMPP, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Trial RegistrationClinicalTrials. gov, NCT02559687Ethics ApprovalThe study and the protocol were approved by the institutional review board or ethics committee at each site.ConsentAll patients provided written informed consent to participate in the clinical trial.

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Comparison of two different doses of citicoline in patients with traumatic brain injury

Journal of Surgery and Trauma ◽

10.32592/jsurgery.2020.8.1.101 ◽

2020 ◽

pp. 8-15

Keyword(s):

Muscle Strength ◽

Small Sample Size ◽

Head Injuries ◽

Study Groups ◽

Small Sample ◽

Positive Effects ◽

Number Of Patients ◽

Significant Difference ◽

Traumatic Head ◽

The Mean

Introduction: The ever-increasing and common occurrence of head traumas highlight the importance of adopting therapeutic measures for the reduction of the associated morbidity and mortality. Citicoline, as a safe medicine with positive effects on improving traumatic injuries, has been proven to be useful in various studies. However, there are still no data on the specific standard method and dosage of citicoline for the treatment of patients with traumatic head injuries. Regarding this, the present study was performed to determine the effective therapeutic dosage of citicoline and its impact on patients with traumatic head injuries. Methods: This double-blind clinical trial was performed on 30 patients with traumatic concussion (a Glasgow coma scale [GCS] of ≤8) admitted to the intensive care unit and neurosurgery department. The patients were randomly divided into three groups of A (control), B (citicoline with a dosage of 0.5 g/twice a day), and C (citicoline with a dosage of 1.5 g/twice a day). The GCS, degree of muscle strength, Glasgow outcome score (GOS), contusion volume, and cerebral edema (based on brain CT scans) were calculated at specific times and intervals. In addition, the patients' dependency on a ventilator and their length of ICU stay were registered. Results: Mean GCS on the first day of stay, GCS changes on the third and fourth days of stay, first and seventh days of stay, seventh and fourteenth days of stay, and first and fourteenth days of stay in the three study groups showed the significant statistical difference (P<0.05). Significant statistical differences were seen between the GOS of the 30th day of stay in the three study groups (P<0.05). The contusion volume difference was only significant between the first and seventh days of stay in groups A and C (P<0.05). No significant difference was observed in the mean length of stay in ICU and duration of dependency on a ventilator in the three study groups (P<0.05). The mean degree of muscle strength was only significantly different on the first day of stay between groups B and C (P=0.008). Conclusions: In contrary to similar studies, the results of the current study revealed that citicoline had no positive effect on patient healing. This result may be due to the small sample size and the inconsistent first-day GCSs of the patients in all three groups. Therefore, given the confirmation of the effectiveness of citicoline even at higher dosages in other studies in future studies, it is recommended to use populations with a larger number of patients.

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Pre- and Post-treatment Levels of Plasma Metabolites in Patients With Bipolar Depression

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.747595 ◽

2021 ◽

Vol 12 ◽

Author(s):

Xiang-Jie Guo ◽

Peng Wu ◽

Xiao-Hong Cui ◽

Jiao Jia ◽

Shuang Bao ◽

...

Keyword(s):

Bipolar Depression ◽

Mental Disease ◽

Small Sample Size ◽

Clinical Manifestations ◽

Small Sample ◽

Plasma Metabolites ◽

High Recurrence Rate ◽

Resonance Spectroscopy ◽

Plasma Samples ◽

Efficacy Evaluation

Background: Bipolar disorder (BD) is a serious mental disease with complex clinical manifestations and high recurrence rate. The purpose of this study was to detect metabolites related to the diagnosis and efficacy evaluation of bipolar depression in plasma samples by metabolomics.Methods: Thirty-one bipolar depression patients were recruited and completed 8 weeks medication and a matched group of 47 healthy controls (HCs) was recruited. Nuclear magnetic resonance spectroscopy was used to profile plasma samples of bipolar depression patients at baseline and after 8 weeks medication, and HCs. Then Multivariate statistical analysis was performed to analyze differences of plasma metabolites among the three groups.Results: We detected seven specific differential metabolites in bipolar depression. Six of the metabolites were returned to the normal levels in different degrees after 8 weeks medication, only Glycine continuously decreased in the acute and significant improvement stages of bipolar depression (VIP > 1 and p < 0.05). These differential metabolites involved several metabolic pathways.Limitations: The small sample size was one of the most prominent limitations. Each BD patient was given an individualized medication regimen according to the clinical guidelines.Conclusion: There were metabolites changes before and after 8 weeks medication. Glycine may be a characteristic marker of bipolar depression and does not change with the improvement of bipolar depression, while other 6 differential metabolites may be biomarkers associated with the pathological development or the improvement of bipolar depression. And, these differential metabolites mainly related to energy metabolism, amino acid metabolism and gut microbiota metabolism.

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Comparison of Morphine- and Hydromorphone-Containing Patient-Controlled Epidural Analgesia Solutions in Pediatric Postoperative Patients

The Journal of Pediatric Pharmacology and Therapeutics ◽

10.5863/1551-6776-24.1.22 ◽

2019 ◽

Vol 24 (1) ◽

pp. 22-26

Author(s):

Jesse Cramer

Keyword(s):

Postoperative Pain ◽

Epidural Analgesia ◽

Pediatric Patients ◽

Small Sample Size ◽

Small Sample ◽

Serious Adverse Events ◽

On Demand ◽

Pain Scores ◽

Number Of Patients ◽

Maximum Pain

OBJECTIVE The use of patient-controlled epidural analgesia (PCEA) in pediatric patients has been shown to be safe and effective in managing postoperative pain in children. However, the optimal opioid to use in the epidural regimen remains undetermined. Morphine, hydromorphone, and fentanyl have been the agents most often used, but comparison of effectiveness across studies is difficult. The goal of this study was to compare postoperative pain scores in patients receiving PCEA solutions that contained either ropivicaine plus morphine or ropivicaine plus hydromorphone. METHODS Retrospective chart review was used at a single center to identify pediatric patients between the ages of 5 and 17 years who used a morphine- or hydromorphone-containing PCEA solution postoperatively during an 18-month period. Maximum pain scores were recorded during 2 consecutive 24-hour periods postoperatively. The primary outcome was the number of patients who had a maximum pain score of ≤4 on postoperative day zero and postoperative day 1. RESULTS Forty-six patients met the inclusion criteria and were analyzed. Patients prescribed morphine-containing PCEAs had a significantly higher incidence of maximal pain scores ≤4 in the 48 hours immediately after surgery compared with those patients prescribed hydromorphone-containing PCEAs (p = 0.03). Ropivicaine dosing in the epidural solution did not have a significant effect on pain scores and was not statistically different between opioid groups. Pediatric patients were able to effectively use the PCEA on-demand dose, with patients having pain scores >4 demanding significantly more on-demand doses from the PCEA than those patients with pain scores ≤4 (p ≤ 0.002). No serious adverse events were reported. CONCLUSIONS Morphine-containing PCEAs may have an advantage in controlling postoperative pain in pediatric patients compared with hydromorphone-containing PCEAs. However, the heterogeneous nature of the procedures performed and the small sample size limit the generalizability of this study.

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