FDA breakthrough—Drug therapy designations for clinical evidence

Every clinician who prescribes antiviral drug during COVID-19 should be very careful and needs to assess following factors such as hepatic and renal function status, specialized population such as Geriatric, Pediatric etc, co morbidities of patient, allergic history of drug, COVID-19 severity status, clinical evidence in management of COVID-19 and duration of drug therapy in COVID-19.

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Current Research Data on Drug Therapy for Novel Coronavirus Associated Disease (COVID-19): Systematic Review

Medical Technologies Assessment and Choice (Медицинские технологии Оценка и выбор) ◽

10.31556/2219-0678.2020.39.1.008-018 ◽

2020 ◽

pp. 8-18

Author(s):

Vitaly Vladimirovich Omelyanovskiy ◽

Artem Alekseevich Antonov ◽

Tatiana Pavlovna Bezdenezhnykh ◽

Georgii Rubenovich Khachatryan

Keyword(s):

Drug Therapy ◽

Clinical Studies ◽

Ebola Virus ◽

Clinical Evidence ◽

Reference Lists ◽

Case Series ◽

Randomized Controlled ◽

Prevention And Treatment ◽

Novel Coronavirus ◽

Made In

Objective: to analyze clinical studies of drugs used for COVID-19 prevention and treatment and to identify ongoing randomized controlled trials (RCT) of drugs used for COVID-19 prevention and treatment. Methods. A systematic search of completed clinical studies was performed in MedLine database and in reference lists of the articles found. Ongoing RCT were looked for in clinicaltrials.gov; also the search was made in Google Scholar. Result. Drugs that are currently used for COVID-19 were assessed in 18 completed clinical studies of other infections, e.g. other coronaviruses and Ebola virus. 15 completed published studies were devoted to their use for COVID-19. Case series reports where COVID-19 drug therapy is mentioned, are cited as well. 41 RCT of COVID-19 therapy were registered in clinicaltrials.gov. Remdesivir, lopinavir/ritonavir, chloroquine, hydroxychloroquine and favipiravir are studied most often. Still the results of the completed studies cannot justify confidently the recommendation to use any of the drugs for COVID-19 prevention and treatment. Conclusion. Currently there is no clinical evidence to reliably support any of the drug’s efficacy for COVID-19 prevention and treatment. Nevertheless, a lot of RCT are expected to be completed in the nearest future.

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Ultrastructural Study of Human Testicular Biopsies in Infertility

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100090762 ◽

1976 ◽

Vol 34 ◽

pp. 156-157

Author(s):

Shirley Siew ◽

Philip Troen ◽

Howard R. Nankin

Keyword(s):

Electron Microscopy ◽

Transmission Electron Microscopy ◽

Basement Membrane ◽

Leydig Cells ◽

Clinical Evidence ◽

Young Male ◽

Germinal Epithelium ◽

Transmission Electron ◽

Age Range ◽

Male Subjects

Testicular biopsies were obtained from six young male subjects (age range 24-33) who complained of infertility and who had clinical evidence of oligospermia. This was confirmed on histological examination which showed a broad spectrum from profound hypospermatogenesis to relatively normal appearing germinal epithelium. Thickening of the tubular walls was noted in half of the cases and slight peritubular fibrosis in one. The Leydig cells were reported as normal or unremarkable.Transmission electron microscopy showed that the thickening of the supporting tissue of the germinal epithelium was caused more by an increase in the thickness of the layers of the lamina propria than of the tubular wall itself. The changes in the basement membrane of the tubular wall consisted mostly of a greater degree of infolding into the tubule and some reduplication which gave rise to a multilayered appearance.

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Severe Drooling and Treatment With Botulinum Toxin

Perspectives on Swallowing and Swallowing Disorders (Dysphagia) ◽

10.1044/sasd21.1.15 ◽

2012 ◽

Vol 21 (1) ◽

pp. 15-21

Author(s):

Merete Bakke ◽

Allan Bardow ◽

Eigild Møller

Keyword(s):

Botulinum Toxin ◽

Side Effects ◽

Health Risk ◽

Flow Rate ◽

Clinical Evidence ◽

Acetylcholine Release ◽

Psychosocial Problems ◽

Rate Reduction ◽

Local Inhibition ◽

Surgical Treatments

Severe drooling is associated with discomfort and psychosocial problems and may constitute a health risk. A variety of different surgical and non-surgical treatments have been used to diminish drooling, some of them with little or uncertain effect and others more effective but irreversible or with side effects. Based on clinical evidence, injection with botulinum toxin (BTX) into the parotid and submandibular glands is a useful treatment option, because it is local, reversible, and with few side effects, although it has to be repeated. The mechanism of BTX is a local inhibition of acetylcholine release, which diminishes receptor-coupled secretion and results in a flow rate reduction of 25–50% for 2–7 months.

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