biological medicine
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2021 ◽  
Vol 12 ◽  
Author(s):  
Po Huang ◽  
Xiangchun Zheng ◽  
Zhi Liu ◽  
Xiaolei Fang

Purpose: This meta-analysis was performed to access the influence of dexmedetomidine versus propofol for adult patients with sepsis undergoing mechanical ventilation.Materials and Methods: NCBI PUBMED, Cochrane Library, Embase, China National Knowledge Internet (CNKI), and China Biological Medicine (CBM) were searched. Revman 5.3 and Stata software (version 12.0, Stata Corp LP, College Station, TX, United States) were used for meta-analysis.Results: Fifteen studies were included, and the data from the included studies were incorporated into the meta-analysis. Also, the result shows that compared with propofol, dexmedetomidine does not reduce 28-day mortality [risk ratios (RR) =0.97, 95% confidence interval (CI) =0.83–1.13, p = 0.70]. However, our analysis found that dexmedetomidine could reduce intensive care unit (ICU) stays {standard mean difference (SMD): −0.15; 95% CI: [−0.30–(−0.01)], p = 0.03}, duration of mechanical ventilation {SMD: −0.22; 95% CI: [−0.44–(−0.01)], p = 0.043}, sequential organ failure assessment (SOFA) {SMD: −0.41; 95% CI: [−0.73–(−0.09)], p = 0.013}, levels of interleukin-6 (IL-6) at 24 h (SMD: −2.53; 95% CI: −5.30-0.24, p = 0.074), and levels of CK-MB at 72 h {SMD: −0.45; 95% CI: [−0.83–(−0.08)], p = 0.017}.Conclusions: This meta-analysis (MA) suggests that in terms of 28-day mortality, sepsis patients with the treatment of dexmedetomidine did not differ from those who received propofol. In addition, more high-quality trials are needed to confirm these findings.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/#recordDetails, identifier CRD42021249780.


2021 ◽  
Vol 11 (10) ◽  
pp. 49-62
Author(s):  
Bartosz Kobuszewski

Biological therapies are being used in many chronic conditions. Development of biosimilar medicines gives chances for wider access to biological treatment. The aim of the review was to present legal regulations of the marketing authorisation of biological medicines in the context of biosimilars medicines. The article focuses on the legislation of the European Union, which was established on the beginning of the XXI century and is very complex and strict. In the first part of the article were described basic terms in this field, such as biological medicine, biosimilar medicine, reference medicine and generic medicie. It also shows  differnces between biosimilar and generic medicines. Main difference concerns the manufacturing process, because of which biosimilar will never be identical to the reference medicine. Next part concentrates on the proces of registration of new biological medicines, especially in the area of medicines’ indications to use and controversies related to them. The last part presents issues of the safety monitoring of biological medicines on european level. The purpose of european law in that field is to guarantee every registred biologic therapy is safe for the patients.


2021 ◽  
Vol 10 (3) ◽  
pp. 141-144
Author(s):  
Michael Wilcock ◽  
Andrew Pothecary

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.


Micromachines ◽  
2021 ◽  
Vol 12 (7) ◽  
pp. 814
Author(s):  
Kena Song ◽  
Xiangyang Zu ◽  
Zhe Du ◽  
Zhigang Hu ◽  
Jingjing Wang ◽  
...  

Breast disease is one of the critical diseases that plague females, as is known, breast cancer has high mortality, despite significant pathophysiological progress during the past few years. Novel diagnostic and therapeutic approaches are needed to break the stalemate. An organ-on-chip approach is considered due to its ability to repeat the real conditions found in the body on microfluidic chips, offsetting the shortcomings of traditional 2D culture and animal tests. In recent years, the organ-on-chip approach has shown diversity, recreating the structure and functional units of the real organs/tissues. The applications were also developed rapidly from the laboratory to the industrialized market. This review focuses on breast tumor-on-a-chip approaches concerning the diversity models and applications. The models are summarized and categorized by typical biological reconstitution, considering the design and fabrication of the various breast models. The breast tumor-on-a-chip approach is a typical representative of organ chips, which are one of the precedents in the market. The applications are roughly divided into two categories: fundamental mechanism research and biological medicine. Finally, we discuss the prospect and deficiencies of the emerging technology. It has excellent prospects in all of the application fields, however there exist some deficiencies for promotion, such as the stability of the structure and function, and uniformity for quantity production.


2021 ◽  
Vol 19 (6) ◽  
pp. 20-28
Author(s):  
Cath Stansfield

Vedolizumab is a biological medicine (biologic), marketed under the brand name Entyvio (Takeda), used to treat moderate-to-severe inflammatory bowel disease (IBD). This clinical review focuses primarily on the onset speed of vedolizumab in Crohn's disease. It consolidates research on the use of vedolizumab in IBD, including how the introduction of a formulation for subcutaneous injection has challenged IBD services to review the use of vedolizumab in Crohn's disease. It presents up-to-date information that addresses misconceptions among health professionals and patients that vedolizumab is slow to work in Crohn's disease. It explores why specialist IBD nurses might raise the availability of different biologics during patient consultations, as well as how to hold quality conversations on the topic and address potential patient misconceptions.


Author(s):  
Djuraev JA ◽  
Khasanov US ◽  
Vokhidov UN ◽  
Botirov AJ

The fairly widespread prevalence of CRSwNP along with the lack of remedies for curing the disease, a variety of hypotheses of etiology dictate the need for further study of all links in the pathogenesis and clinical features of the course of the disease. In the coming century of “biological medicine”, the availability of high technologies of medical genetics makes it possible to reveal the individual characteristics of the most important regulatory systems of the body, which opens up new prospects for studying the etiology and pathogenesis of CRSwNP. In the tissues of polyps and intranasal secretions, an increase in the concentration of various inflammatory mediators, in particular interleukins, is observed due to an increase in their de novo synthesis by effector cells. Particular importance is attached to an increase in the concentration of cytokines involved in the development, recruitment and activation of eosinophils (IL-4, IL-12, IL-13, GM-CSF), the main pro-inflammatory (IL-1, IL-2, TNF-a, IL- 10), regulatory cytokines (IL-10, TLR2B), contributing to the chronicity of the inflammatory process in the nasal cavity.


Angiology ◽  
2021 ◽  
pp. 000331972110044
Author(s):  
Hongling Xu ◽  
Hongye Wang ◽  
Chuang Zhang ◽  
Jun Xiao ◽  
Ning Hua ◽  
...  

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.


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