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1.
J Obstet Gynaecol ; 42(2): 301-305, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33938350

RESUMO

The removal of cumulus cells in a process called oocyte denudation is required in order to visualise, grade and manipulate the oocytes before injection. The objective of this study was to appraise critically the published randomised controlled trials (RCTs) comparing recombinant hyaluronidase with bovine hyaluronidase for oocyte denudation before intracytoplasmic sperm injection (ICSI). We performed a comprehensive literature search of the standard medical databases in order to identify the RCTs comparing oocyte denudation with recombinant hyaluronidase or bovine hyaluronidase before ICSI. Three RCTs involving 2445 oocytes collected from 200 women were analysed. There was substantial heterogeneity among the included RCTs. A meta-analysis from the available moderate to high quality trials found no statistical difference in terms of fertilisation rate, embryo quality and live birth rate between the use of recombinant or bovine hyaluronidase for oocyte denudation before ICSI.IMPACT STATEMENTWhat is already known on this subject? The removal of cumulus cells in a process called oocyte denudation is required in order to visualise, grade and manipulate the oocytes before injection. The long-established source of hyaluronidase has been represented by bovine testes, but concern has been raised regarding the possible negative effects over the fragile oocytes by mechanisms involving low enzyme purity, variable concentrations, trauma, prolonged exposure and integration of external DNA in the oocyte. Recombinant human hyaluronidase has been proposed as an alternative in order to counteract the possible negative effects of using animal derived products.What do the results of this study add? A meta-analysis from the available moderate to high quality trials found no statistical difference in fertilisation rate, embryo quality and live birth rate between the use of recombinant or bovine hyaluronidase for oocyte denudation before ICSI.What are the implications of these findings or clinical practice and/or further research? Future trials should be powered adequately in order to be able to identify the possible small differences between the study groups and they should be conducted according to the CONSORT guidelines as the absence of blinding for outcome assessors can induce detection bias.


Assuntos
Hialuronoglucosaminidase , Injeções de Esperma Intracitoplásmicas , Animais , Coeficiente de Natalidade , Bovinos , Feminino , Fertilização in vitro , Humanos , Oócitos , Gravidez , Taxa de Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Clin Lymphoma Myeloma Leuk ; 21(7): 470-475, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33785299

RESUMO

INTRODUCTION: Daratumumab is an anti-CD38 monoclonal antibody widely used for treating patients with newly diagnosed or relapsed/refractory multiple myeloma. The subcutaneous formulation of daratumumab was developed with the purpose of minimizing the treatment burden (to patients and health care system) associated with intravenous daratumumab. Given its recent approval, there is a knowledge gap regarding the best practices that should be instituted for safe administration of subcutaneous daratumumab. METHODS: A retrospective chart review was performed from August 2020 until November 2020 to identify patients either switched to or treated upfront (daratumumab naive) with any subcutaneous daratumumab-based treatment regimen. All patients received appropriate premedications per institutional standards of care. The study end points were to report real-world data regarding administration-related reaction rates (at or following discharge from infusion center), as well as compare their incidence rates to those noted in the COLUMBA study (historical cohort). RESULTS: The study included 58 patients, of whom 38% (n = 22) were daratumumab naive. The majority (84%, n = 49) received subcutaneous daratumumab in combination with various antimyeloma regimens. There were no cases of administration-related reactions at infusion center or after discharge irrespective of previous exposure to intravenous daratumumab. None of the patients included herein required rescue home medications or visited the emergency department within 24 to 48 hours after subcutaneous daratumumab administration. These translated into a significant difference in incidence of administration-related reactions compared with historical cohort (0% vs. 13%, P = .003). CONCLUSION: Subcutaneous daratumumab was extremely well tolerated and could be safely administered without need for monitoring or rescue home medications.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Reação no Local da Injeção/epidemiologia , Mieloma Múltiplo/tratamento farmacológico , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Adulto , Anticorpos Monoclonais/efeitos adversos , Feminino , Humanos , Incidência , Infusões Intravenosas/efeitos adversos , Infusões Intravenosas/normas , Infusões Intravenosas/estatística & dados numéricos , Infusões Intravenosas/tendências , Reação no Local da Injeção/etiologia , Injeções Subcutâneas/efeitos adversos , Injeções Subcutâneas/normas , Injeções Subcutâneas/estatística & dados numéricos , Injeções Subcutâneas/tendências , Masculino , Oncologia/normas , Oncologia/tendências , Pessoa de Meia-Idade , Padrões de Prática Médica/tendências , Estudos Retrospectivos
3.
Acta Pharm Sin B ; 9(4): 675-689, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31384529

RESUMO

Erythrocytes (red blood cells, RBCs) are the most abundant circulating cells in the blood and have been widely used in drug delivery systems (DDS) because of their features of biocompatibility, biodegradability, and long circulating half-life. Accordingly, a "camouflage" comprised of erythrocyte membranes renders nanoparticles as a platform that combines the advantages of native erythrocyte membranes with those of nanomaterials. Following injection into the blood of animal models, the coated nanoparticles imitate RBCs and interact with the surroundings to achieve long-term circulation. In this review, the biomimetic platform of erythrocyte membrane-coated nano-cores is described with regard to various aspects, with particular focus placed on the coating mechanism, preparation methods, verification methods, and the latest anti-tumor applications. Finally, further functional modifications of the erythrocyte membranes and attempts to fuse the surface properties of multiple cell membranes are discussed, providing a foundation to stimulate extensive research into multifunctional nano-biomimetic systems.

4.
Toxicon ; 82: 104-11, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24593966

RESUMO

To date, there are no allergenic extracts or components available in Brazil to diagnosis and treatment of patients with venom allergy from social wasp (Vespidae Family; Polistinae Subfamily) despite of the great number of existing species. We evaluated the immunogenic potential of the Hyal recombinant protein (Pp-Hyal-rec) which was expressed in an insoluble form in comparison with the allergenic native protein (Pp-Hyal-nat) for recognition of immunoglobulin E (IgE) in the serum of allergic patients to venom of the endemic social wasp Polybia paulista from São Paulo State, Brazil. Hyal cDNA from the venom of the social wasp P. paulista (Pp-Hyal) (GI: 302201582) was cloned into the expression vector pET-28a in Escherichia coli DE3 (BL21) cells. Solubilization and purification of Pp-Hyal-rec from inclusion bodies were performed using Ni(2+) affinity chromatography (Ni-NTA-Agarose) under denaturing conditions. Both the native (Pp-Hyal-nat) and the recombinant (Pp-Hyal-rec) purified allergens were used for Western blotting to assess the levels of Pp-Hyal-IgE specific in the serum of 10 patients exclusively reactive to the venom of the social wasp P. paulista. The immune sera specifically recognized the band corresponding to the Pp-Hyal-rec protein (40 kDa) at a higher intensity than the native allergen (39 kDa). The sera recognized other proteins in P. paulista crude venom extract to a lesser extent, likely corresponding to other venom allergens such as phospholipase (34 kDa), Antigen 5 (25 kDa), and proteases. The recognition pattern of the immune sera to the Pp-Hyal-rec allergen strongly suggests that this recombinant antigen could be used for developing a diagnostic allergy test as well as for specific immunotherapy (IT).


Assuntos
Alérgenos/genética , Alérgenos/imunologia , Hialuronoglucosaminidase/imunologia , Imunoglobulina E/imunologia , Venenos de Vespas/enzimologia , Venenos de Vespas/imunologia , Vespas/imunologia , Animais , Especificidade de Anticorpos , Clonagem Molecular , Reações Cruzadas , Humanos , Hipersensibilidade/imunologia , Corpos de Inclusão/imunologia , Proteínas Recombinantes/biossíntese , Proteínas Recombinantes/imunologia , Venenos de Vespas/genética
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