Biological Medicine

2015 ◽  
pp. 1-2
Keyword(s):  
Biological Medicine

Efficacy of Alprostadil in Preventing Contrast-Induced Nephropathy: A Systematic Review and Meta-Analysis

Angiology ◽  
2021 ◽  
pp. 000331972110044
Author(s):  
Hongling Xu ◽  
Hongye Wang ◽  
Chuang Zhang ◽  
Jun Xiao ◽  
Ning Hua ◽  
...  
Keyword(s):  
Meta Analysis ◽  
China National Knowledge Infrastructure ◽  
Contrast Induced Nephropathy ◽  
Serum Cystatin ◽  
Assessment Development ◽  
Neutrophil Gelatinase Associated Lipocalin ◽  
Knowledge Infrastructure ◽  
Evidence Evaluation ◽  
Biological Medicine ◽  
Neutrophil Gelatinase

This study aimed to determine the efficacy of alprostadil in preventing contrast-induced nephropathy (CIN). Eligible studies were searched using the keywords through the databases of PubMed, Cochrane, Embase, China Biological Medicine Database, China National Knowledge Infrastructure, and Vanfun. Quality evaluation of the included studies was conducted according to international evidence evaluation and recommended Grades of Recommendations Assessment, Development, and Evaluation standards. We included 29 studies with 5623 patients. Compared with hydration, 10 µg/d alprostadil or 20 µg/d alprostadil plus hydration significantly decreased the incidence of CIN. Compared with hydration, alprostadil plus hydration significantly reduced serum creatinine and blood urea nitrogen at 24, 48, and 72 hours and 7 days after coronary angiography (CAG). Alprostadil (20 µg/d) plus hydration significantly decreased serum cystatin versus hydration at 24, 48, and 72 hours after CAG. Compared with hydration, alprostadil plus hydration significantly increased glomerular filtration rate at 24 and 72 hours after CAG. Alprostadil plus hydration significantly decreased neutrophil gelatinase-associated lipocalin levels compared to hydration at 24, 48, and 72 hours after CAG. Alprostadil plus hydration significantly decreased urine macroglobulin versus hydration at 24 and 48 hours after CAG.

scholarly journals DIPG-35. BIOLOGICAL MEDICINE FOR DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG) ERADICATION: RESULTS OF THE THREE ARM BIOMARKER-DRIVEN RANDOMIZED BIOMEDE 1.0 TRIAL

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii293-iii294
Author(s):  
Jacques Grill ◽  
Gwenael Le Teuff ◽  
Karsten Nysom ◽  
Klas Blomgren ◽  
Darren Hargrave ◽  
...  
Keyword(s):  
Disease Progression ◽  
Stereotactic Biopsy ◽  
Diagnostic Yield ◽  
Steering Committee ◽  
Diffuse Intrinsic Pontine Glioma ◽  
Open Label ◽  
Pten Loss ◽  
Multi Stage ◽  
Open Label Phase ◽  
Biological Medicine

Abstract Despite 50 years of clinical trials, no improvement of survival has been observed in DIPG and most children die within 2 years of diagnosis. Only radiotherapy transiently controls disease progression. The study was conceived as a randomized multi-arm multi-stage program. It started with an open-label phase-II trial comparing three drugs (everolimus, dasatinib, erlotinib) combined with irradiation, allocated according to the presence of their specific targets (PTEN-loss, EGFR-overexpression) defined with a stereotactic biopsy after central confirmation of the diagnosis (presence of histone H3K27M mutation or loss of K27 trimethylation). Targeted therapies were started concomitantly with radiotherapy and were continued until disease progression. No biopsy-related death was reported and diagnostic yield was excellent, with only 5 non-informative biopsies. Biopsy excluded the diagnosisof DIPG in 8% of the cases. At the 3rd interim analysis, based on 193 randomized patients, the IDMC concluded that the study was unlikely to show a difference of OS between the 3 drugs even if 250 patients would be randomized. The median OS from the time of diagnosis was 11.9, 10.5 and 10 months for everolimus, dasatinib and erlotinib. Treatment was discontinued due to toxicity in 2%, 13%, and 15%, respectively. BIOMEDE shows the feasibility of biologically-driven treatment in DIPG on a large international scale. Based on the better toxicity profile and the slightly better efficacy, although not statistically significant, the steering committee proposed that everolimus should be used as the control arm for the next BIOMEDE 2.0 trial.

Use of biologicals in dermatology – following the agreed path or going off-piste? A brief report

2021 ◽  
Vol 10 (3) ◽  
pp. 141-144
Author(s):  
Michael Wilcock ◽  
Andrew Pothecary
Keyword(s):  
Medical Records ◽  
Treatment Cost ◽  
Biological Therapy ◽  
Severe Psoriasis ◽  
Small Scale ◽  
First Line ◽  
First Choice ◽  
Biological Medicine ◽  
Reasons For Use ◽  
Local Guideline

Introduction: Biological medicines are used to treat a range of conditions according to National Institute for Health and Care Excellence (NICE) technology appraisals. The annual drug treatment cost per patient per year varies depending on various factors, including newer or older biological, and availability of a biosimilar. Our biologicals pathway for dermatology (moderate or severe psoriasis) listed less expensive older biologicals (including biosimilars) early on in the treatment choices and more recently approved (and generally more expensive) choices lower down the pathway. Objective: We aimed to identify which biologicals or selective immunosuppressants were used first line in adult patients with moderate or severe psoriasis, and ascertain if the reasons for use of treatments other than adalimumab were in accordance with the locally agreed pathway. Methods: Medical records were reviewed for a sample of patients prescribed biologicals during late 2019 and early 2020. We identified patients who had commenced any treatment. Contact was made with lead dermatology nurses if needed. Results: There were 33 patients commenced on a biological – 17 had newly started biological therapy and 16 had switched from a prior biological therapy to a new therapy. Of the 17 new patients, two commenced apremilast (biological contraindicated), 10 commenced adalimumab, and five commenced other biologicals. Of these five who commenced other biologicals, two were on guselkumab, two on ustekinumab, and one on certolizumab. In all five instances there was a valid reason for not using adalimumab as first choice though this was not always explicit in the multidisciplinary team (MDT) documentation. Discussion: Though the number of psoriasis patients (17) newly starting a biological medicine was relatively small, it was reassuring that for five of these who commenced a subcutaneous biological other than adalimumab, there was a valid reason for this choice, though not always explicit in the MDT letter, which Dermatology will ensure is clear for future decisions. Hence going ‘off-piste’ was deemed justified. Conclusion: This very small-scale study found that the local guideline was followed with patients commencing treatments other than biosimilar adalimumab for valid reasons.

Py-GC-MS Analysis on Benzene-Alcohol Extractives of Eucalyptus urophydis Wood for Fine Indoor Environment

2012 ◽  
Vol 178-181 ◽  
pp. 288-291
Author(s):  
Wan Xi Peng ◽  
Lan Sheng Wang ◽  
Zhi Lin ◽  
Zhen Zhen Zheng
Keyword(s):  
Health Care ◽  
Indoor Environment ◽  
Decanoic Acid ◽  
Alcohol Solution ◽  
Dodecanoic Acid ◽  
Pyrolysis Products ◽  
Ms Analysis ◽  
Eucalyptus Wood ◽  
Biological Medicine

In order to evaluate the safety of Eucalyptus wood interior, Eucalyptus urophydis wood was used and extracted in benzene-alcohol solution, and its extractives were identified by Py-GC/MS. The main and abundant constituents of 350°С pyrolysis products were 1-phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-(5.38%), stigmasterol,22,23- dihydro- (4.67%), 3'-chlorooxanilic acid n'-(3-ethox y-4-hydroxybenzylidene)hydrazide (4.13%), stigmast-5-en-3-ol, oleate(3.83%), 2-ethylacridine(3.32%), etc. The main and abundant constituents of 600°Сpyrolysis products were decanoic acid, 1,2,3-propanetriyl ester(33.8%), dodecanoic acid, 1,2,3-propanetriyl ester(8.03%), decanoic acid, 1,2,3-propanetriyl ester(3.99%), 1-chloromethyl-1-(2-propenyloxy)-1-silacyclohexane(3.98%), etc. So there was much biological medicine and health care composition in Eucalyptus urophydis wood. And the wood was safety.

What is a symptom?

2016 ◽  
Author(s):  
Giovanni Stanghellini
Keyword(s):  
Physical Performance ◽  
Living Organism ◽  
Vast Array ◽  
Medical Concept ◽  
Biological Medicine ◽  
Underlying Pathology ◽  
Biomedical Paradigm

This chapter explains that the concept of symptom covers a vast array of indexicalities, focusing on the bio-medical concept of ‘symptom’. In biological medicine, a symptom is an index for diagnosis and the epiphenomenon of an underlying pathology. In the biomedical paradigm, symptoms have causes, rather than meanings. In general, causality goes from aetiology (e.g. a virus), to symptom(s) (breathing difficulties), to dysfunction (poor physical performance due to blood hypo-oxygenation, and thus reduced adaptation of the person to his or her environment). Another important assumption is that symptoms are considered accidental, i.e. non-essential to the living organism. Many of these assumptions—if we apply this paradigm to the field of psychic pathology— are at least controversial, or even counterfactual.

scholarly journals Validation of the Normocythemic Mice Bioassay for the Potency Evaluation of Recombinant Human Erythropoietin in Pharmaceutical Formulations

2008 ◽  
Vol 91 (2) ◽  
pp. 285-291 ◽  
Author(s):  
Thiago Barth ◽  
Paulo R Oliveira ◽  
Felipe B D'Avila ◽  
Srgio L Dalmora
Keyword(s):  
Flow Cytometry ◽  
Recombinant Human Erythropoietin ◽  
Response Curve ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
European Pharmacopoeia ◽  
Human Erythropoietin ◽  
Acceptable Range ◽  
Reference Preparation ◽  
Biological Medicine

Abstract The normocythemic mice bioassay was validated for the potency evaluation of the recombinant human erythropoietin (rhEPO) against the European Pharmacopoeia Biological Reference Preparation for erythropoietin. The bioassays were performed in 8-week-old female BALB/c mice, which received multiple daily injections of standard or sample solutions (3 + 3), for 4 days. The blood sampling was performed 24 h after the last injection and the reticulocytes were counted by automated flow cytometry. Method validation investigated parameters such as linearity, precision, accuracy, specificity, and robustness, giving results within the acceptable range. The dose-response curve was linear in the concentration range of 164 international units (IU)/mL, and the value of the determination coefficient (r2) was 0.9708. The bioassay was applied for the potency evaluation of rhEPO pharmaceutical products containing alfa or beta forms, expressed in different cell lines, giving biological potencies within 82.79 and 119.70 of the stated potency. The precision index calculated by the weight for the independent assays was >247. The results demonstrated the validity of the bioassay for the potency assessment of pharmaceutical formulations contributing to ensure the therapeutic efficacy of the biological medicine.

scholarly journals Applications of Chitin and Its Derivatives in Biological Medicine

2010 ◽  
Vol 11 (12) ◽  
pp. 5152-5164 ◽  
Author(s):  
Bae Keun Park ◽  
Moon-Moo Kim
Keyword(s):  
Biological Medicine

scholarly journals Biosimilar medical products – licensing, pharmacovigilance and interchangeability

PRILOZI ◽  
2016 ◽  
Vol 37 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Aleksandra Grozdanova ◽  
Katerina Ancevska Netkovska ◽  
Zoran Sterjev ◽  
Zorica Naumovska ◽  
Rubin Zarevski ◽  
...  
Keyword(s):  
Generic Version ◽  
Financial Sustainability ◽  
Clinical Use ◽  
Patient Access ◽  
Biological Product ◽  
Regulatory Requirements ◽  
Complex Molecules ◽  
Medical Products ◽  
Biological Medicine ◽  
Improve Patient

Abstract The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.

A Meta-Analysis of the Efficacy of Acupuncture in Treating Dysphagia in Patients with a Stroke

2012 ◽  
Vol 30 (4) ◽  
pp. 291-297 ◽  
Author(s):  
Yao-Bin Long ◽  
Xiao-Ping Wu
Keyword(s):  
Acupuncture Treatment ◽  
Meta Analysis ◽  
Alternative Therapy ◽  
Cochrane Library ◽  
Control Group ◽  
Complementary And Alternative Therapy ◽  
Dichotomous Data ◽  
Biological Medicine ◽  
The Subject ◽  
Randomised Controlled

Background Dysphagia, or deglutition difficulty, is a common manifestation in patients with a stroke and its management is an important aspect of rehabilitation. Acupuncture, a complementary and alternative therapy, is the subject of growing public interest for treatment of stroke. Objective A meta-analysis was performed to study the effect of acupuncture for treatment of dysphagia in patients affected by a stroke. Methods Randomised controlled trials (RCTs) comparing acupuncture treatment with non-acupuncture treatment of dysphagia in patients with a stroke were identified from the databases of PubMed, Embase, Cochrane Library and CBM disc (China Biological Medicine Database). Eligible investigations were included and data on the effectiveness of acupuncture were extracted and synthesised by meta-analysis using RevMan 5.1.4. Results were expressed as OR for dichotomous data; 95% CIs were also calculated. Results Seventy-two RCTs (3208 patients in the treatment group and 2926 patients in the control group) were identified. Details of randomisation and blinding were not reported and information on withdrawals and dropouts was missing in most of included reports. Meta-analysis showed that the effectiveness of treatment in the group receiving acupuncture was higher than that in the non-acupuncture group (OR=5.17, 95% CI 4.18 to 6.38; p<0.00001). However, the study quality was generally low and of insufficient quality to make recommendations about using acupuncture in the rehabilitation of patients with dysphagia due to stroke. Conclusions Acupuncture might be beneficial in the rehabilitation of patients with dysphagia caused by stroke, and the evidence justifies future high-quality studies.

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