Starch Wars—New Episodes of the Saga. Changes in Regulations on Hydroxyethyl Starch in the European Union

Adamik, Katja‐Nicole; Yozova, Ivayla D.

doi:10.3389/fvets.2018.00336

Cited by 13 publications

(11 citation statements)

References 104 publications

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“…Because of the RCTs demonstrating harm in critically ill patients receiving HES and the retraction of the HES-supporting scientific articles, several systematic reviews then highlighted the adverse effects of HES (82)(83)(84)(85). As a consequence, two pharmacovigilance safety reviews of HES worldwide in 2012/2013 and in the European Union (EU) in 2017/2018 led to progressive restrictions of HES use in people (86). Since then, experts worldwide have considered HES solutions to be contraindicated in patients with sepsis or other critical illnesses, additional warnings on packaging are required in the EU, and supply has been limited to accredited hospitals after training of healthcare professionals (86).…”

Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

“…As a consequence, two pharmacovigilance safety reviews of HES worldwide in 2012/2013 and in the European Union (EU) in 2017/2018 led to progressive restrictions of HES use in people (86). Since then, experts worldwide have considered HES solutions to be contraindicated in patients with sepsis or other critical illnesses, additional warnings on packaging are required in the EU, and supply has been limited to accredited hospitals after training of healthcare professionals (86). These restrictions are still a matter of debate between HES proponents and opponents.…”

Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

“…Nevertheless, between 2007 and 2014, the proportion of patients receiving colloids in human medicine decreased significantly, which was primarily due to a decrease in the use of HES, despite an overall increase in the use of human albumin (6). As most of the negative effects of HES reported in the RCTs involved patients with sepsis, in 2013 European medicines authorities requested further studies evaluating the safety and efficacy of HES in perioperative non-septic patients (86). Several smaller studies and RCTs in non-septic patients in the perioperative setting found no evidence of a nephrotoxic effect of HES (87,88).…”

Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

“…According to the latest recommendation from the European Medicines Agency from 2018, valid for the EU countries, HES use should be limited to initial volume resuscitation with a dose not exceeding 30 ml/kg over a period of administration not exceeding 24 h, and that kidney function should be monitored for at least 90 days thereafter. In addition, HES is contraindicated in sepsis, critically illness, burns, severe preexisting coagulopathy, and bleeding in people, among others (86).…”

Section: Safety Recommendation In Peoplementioning

confidence: 99%

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Colloids Yes or No? - a “Gretchen Question” Answered

Adamik

Yozova

2021

Front. Vet. Sci.

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Colloid solutions, both natural and synthetic, had been widely accepted as having superior volume expanding effects than crystalloids. Synthetic colloid solutions were previously considered at least as effective as natural colloids, as well as being cheaper and easily available. As a result, synthetic colloids (and HES in particular) were the preferred resuscitation fluid in many countries. In the past decade, several cascading events have called into question their efficacy and revealed their harmful effects. In 2013, the medicines authorities placed substantial restrictions on HES administration in people which has resulted in an overall decrease in their use. Whether natural colloids (such as albumin-containing solutions) should replace synthetic colloids remains inconclusive based on the current evidence. Albumin seems to be safer than synthetic colloids in people, but clear evidence of a positive effect on survival is still lacking. Furthermore, species-specific albumin is not widely available, while xenotransfusions with human serum albumin have known side effects. Veterinary data on the safety and efficacy of synthetic and natural colloids is limited to mostly retrospective evaluations or experimental studies with small numbers of patients (mainly dogs). Large, prospective, randomized, long-term outcome-oriented studies are lacking. This review focuses on advantages and disadvantages of synthetic and natural colloids in veterinary medicine. Adopting human guidelines is weighed against the particularities of our specific patient populations, including the risk–benefit ratio and lack of alternatives available in human medicine.

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Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

Section: Safety Recommendation In Peoplementioning

confidence: 99%

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Colloids Yes or No? - a “Gretchen Question” Answered

Adamik

Yozova

2021

Front. Vet. Sci.

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“…The study of reactive and destructive changes in Peyer's patches of rats with experimental burn disease, as well as the impact of ER-stress on the dynamics of necrotic and apoptotic cell changes, was updated by a new wave of controversy regarding the official assessment of possible limitations on the use of colloidal solutions based on hydroxyethyl starch. The divergent opinions of pharmacology scientists and experts found their symbolic reflection in a name published [1] in the 2019 scientific review "Starch Wars -New Episodes of the Saga. Changes in Regulation on Hydroxyethyl Starch in the European Union".…”

Section: Discussionmentioning

confidence: 99%

Reactive and destructive changes of Peyer’s patches in rats with experimental burn disease under infusion of detoxification solutions

et al. 2019

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The pathogenesis of burn immune dysfunction and burn enteropathy needs further clarification given that the cellular lesions of lymphoid tissue associated with mucous membranes are the least studied. The purpose of the study was to establish reactive and destructive changes in Peyer’s patches of rats after burn injury of the skin with the use of intravenous infusion of isotonic sodium chloride solution and combined colloid-hyperosmolar solutions. White male rats weighing 160-200 g at 6 months of age were divided into 4 groups (18 animals in each group): I, II, III – rats with burn skin injury (grade II-III burn with an area of 23% of body surface area and the development of moderate-severity shock state) which was administered a separate intravenous infusion once a day for the first 7 days of the experiment with isotonic sodium chloride, lactoprotein with sorbitol and HAES-LX-5%, in each case at a dose of 10 ml/kg; IV – intact animals. The material was collected from rats under deep thiopental intraperitoneal anesthesia after 1, 3, 7, 14, 21 and 30 days after burn injury. Biopsies from Peyer’s patches for histological and electron microscopic examination were processed using conventional methods. Investigation of histological preparations stained with hematoxylin-eosin was performed on an Olympus BX51 microscope. Ultrathin sections were contrasted on copper support meshes with uranyl acetate and lead citrate according to Reynolds and studied using a PEM-125K electron microscope. Electron and light microscopy data indicate that intravenous infusion of colloidal-hyperosmolar solutions (lactoprotein with sorbitol and HAES-LX-5%) promotes suppression of inflammatory response, inhibits necrosis, and optimizes lymphoid apoptosis at Peyer’s patches of rats with experimental burn disease caused by burn injury to the skin of 21-23% of the body surface. Apoptotic lymphocytes and their apoptotic bodies are effectively phagocytosed by macrophages and are digestible in heterophagolysosomes. The apoptotic altered dendritic cells in Peyer’s patches are characterized by osmiophilic cytoplasm and a nucleus with high electron density amorphous nucleoplasm. In the cytoplasm are located mitochondria with enlightened matrix and destroyed cristae, irregularly expanded tubules of variable configuration of a granular endoplasmic reticulum with electronically transparent content and numerous derivatives of their vacuole transformation, which are sharply darkened. The fusion of vacuoles leads to the formation of large electron-luminous cavities filled with various residues of compacted degraded cellular structures. Vacualization promotes site segmentation of condensed cytoplasm of apoptotic dendritic cells and formation of apoptotic blebs, which are subject to entrapment and subsequent sequential degradation with the participation of neighboring macrophages. The structural changes of the organelles of the protein-synthesizing apparatus found in Peyer’s plaque cells in rats with experimental burn disease can be regarded as a manifestation caused by functional overload of the granular endoplasmic reticulum (ER-stress). The consequence of optimal development of ER-stress and subsequent unfolded protein response is the apoptotic degradation of the corresponding cell, the course of which is modified by the use of colloid-hyperosmolar solutions.

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Low‐Fouling Zwitterionic Polymeric Colloids as Resuscitation Fluids for Hemorrhagic Shock

et al. 2022

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Colloids, known as volume expanders, have been used as resuscitation fluids for hypovolemic shock for decades, as they increase plasma oncotic pressure and expand intravascular volume. However, recent studies show that commonly used synthetic colloids have adverse interactions with human biological systems. In this work, a low‐fouling amine(N)‐oxide‐based zwitterionic polymer as an alternative volume expander with improved biocompatibility and efficacy is designed. It is demonstrated that the polymer possesses antifouling ability, resisting cell interaction and deposition in major organs, and is rapidly cleared via renal filtration and hepatic circulation, reducing the risk of long‐term side effects. Furthermore, in vitro and in vivo studies show an absence of adverse effects on hemostasis or any acute safety risks. Finally, it is shown that, in a head‐to‐head comparison with existing colloids and plasma, the zwitterionic polymer serves as a more potent oncotic agent for restoring intravascular volume in a hemorrhagic shock model. The design of N‐oxide‐based zwitterionic polymers may lead to the development of alternative fluid therapies to treat hypovolemic shock and to improve fluid management in general.

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Starch Wars—New Episodes of the Saga. Changes in Regulations on Hydroxyethyl Starch in the European Union

Cited by 13 publications

References 104 publications

Colloids Yes or No? - a “Gretchen Question” Answered

Colloids Yes or No? - a “Gretchen Question” Answered

Reactive and destructive changes of Peyer’s patches in rats with experimental burn disease under infusion of detoxification solutions

Low‐Fouling Zwitterionic Polymeric Colloids as Resuscitation Fluids for Hemorrhagic Shock

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