M. Mehdizadeh, Maria Tavakoli-Ardakani, Shayan Zamani, G. Zamani, N. Nikpour
{"title":"粒细胞集落刺激因子与PEG粒细胞集落刺激因子在自体造血干细胞移植患者中的植入及不良反应的评价","authors":"M. Mehdizadeh, Maria Tavakoli-Ardakani, Shayan Zamani, G. Zamani, N. Nikpour","doi":"10.22034/IJPS.2021.245261","DOIUrl":null,"url":null,"abstract":"Hematopoietic stem cell transplantation (HSCT) is an effective treatment for many hematological malignancies. Engraftment is the foremost step in the autologous hematopoietic stem cell transplantation (AHSCT) process in which different granulocyte colony-stimulating factors with various administration are used. In this study, we evaluated and compared the efficacy and side effects of two forms of recombinant granulocyte colony-stimulating growth factors (GCSF) ,GCSF and Peg GCSF, In this randomized clinical trial, 60 consecutive patients with multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma who underwent AHSCT were included, the average age of the patients was 55; the patients were then divided into two groups so the comparison of efficacy and side effects between the two methods become achievable. The local ethical committee approved the study with the code of SB2019:210291, and the Helsinki declaration was respected across the study. In the first group, patients received peg GCSF at a dose of 6 mg on day five, and the second group received GCSF started with 5μg/kg from day 5. We compared engraftment time and adverse effects in the two groups. Our study demonstrated no difference between the two groups regarding need for transfusion and infection complications; also, the two groups did not differ in terms of the flue-like syndrome, the type of infection and the recorded number of febrile neutropenia. Mean leukocyte engraftment days were 10.97 ± 1 and 11.1 ± 1.1 that was similar in both groups (P=0.328). Mean platelet engraftment days were 11.03 ± 2.4 and 11.1 ± 2.4 without significant difference (P=0.714).it was concluded that Pegfilgrastimhas the same efficacy and safety profile in comparison to Filgrastim. Therefore, since Pegfilgrastim has a easier method of injection and can simplify the HSCT process.","PeriodicalId":14582,"journal":{"name":"Iranian Journal of Pharmaceutical Sciences","volume":"68 1","pages":"99-106"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of Engraftment and Adverse Effects of Granulocyte Colony Stimulating Factor versus PEG Granulocyte Colony Stimulating Factor in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation\",\"authors\":\"M. Mehdizadeh, Maria Tavakoli-Ardakani, Shayan Zamani, G. Zamani, N. Nikpour\",\"doi\":\"10.22034/IJPS.2021.245261\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Hematopoietic stem cell transplantation (HSCT) is an effective treatment for many hematological malignancies. Engraftment is the foremost step in the autologous hematopoietic stem cell transplantation (AHSCT) process in which different granulocyte colony-stimulating factors with various administration are used. In this study, we evaluated and compared the efficacy and side effects of two forms of recombinant granulocyte colony-stimulating growth factors (GCSF) ,GCSF and Peg GCSF, In this randomized clinical trial, 60 consecutive patients with multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma who underwent AHSCT were included, the average age of the patients was 55; the patients were then divided into two groups so the comparison of efficacy and side effects between the two methods become achievable. The local ethical committee approved the study with the code of SB2019:210291, and the Helsinki declaration was respected across the study. In the first group, patients received peg GCSF at a dose of 6 mg on day five, and the second group received GCSF started with 5μg/kg from day 5. We compared engraftment time and adverse effects in the two groups. Our study demonstrated no difference between the two groups regarding need for transfusion and infection complications; also, the two groups did not differ in terms of the flue-like syndrome, the type of infection and the recorded number of febrile neutropenia. Mean leukocyte engraftment days were 10.97 ± 1 and 11.1 ± 1.1 that was similar in both groups (P=0.328). Mean platelet engraftment days were 11.03 ± 2.4 and 11.1 ± 2.4 without significant difference (P=0.714).it was concluded that Pegfilgrastimhas the same efficacy and safety profile in comparison to Filgrastim. 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Evaluation of Engraftment and Adverse Effects of Granulocyte Colony Stimulating Factor versus PEG Granulocyte Colony Stimulating Factor in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Hematopoietic stem cell transplantation (HSCT) is an effective treatment for many hematological malignancies. Engraftment is the foremost step in the autologous hematopoietic stem cell transplantation (AHSCT) process in which different granulocyte colony-stimulating factors with various administration are used. In this study, we evaluated and compared the efficacy and side effects of two forms of recombinant granulocyte colony-stimulating growth factors (GCSF) ,GCSF and Peg GCSF, In this randomized clinical trial, 60 consecutive patients with multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma who underwent AHSCT were included, the average age of the patients was 55; the patients were then divided into two groups so the comparison of efficacy and side effects between the two methods become achievable. The local ethical committee approved the study with the code of SB2019:210291, and the Helsinki declaration was respected across the study. In the first group, patients received peg GCSF at a dose of 6 mg on day five, and the second group received GCSF started with 5μg/kg from day 5. We compared engraftment time and adverse effects in the two groups. Our study demonstrated no difference between the two groups regarding need for transfusion and infection complications; also, the two groups did not differ in terms of the flue-like syndrome, the type of infection and the recorded number of febrile neutropenia. Mean leukocyte engraftment days were 10.97 ± 1 and 11.1 ± 1.1 that was similar in both groups (P=0.328). Mean platelet engraftment days were 11.03 ± 2.4 and 11.1 ± 2.4 without significant difference (P=0.714).it was concluded that Pegfilgrastimhas the same efficacy and safety profile in comparison to Filgrastim. Therefore, since Pegfilgrastim has a easier method of injection and can simplify the HSCT process.
期刊介绍:
Iranian Journal of Pharmaceutical Sciences (IJPS) is an open access, internationally peer-reviewed journal that seeks to publish research articles in different pharmaceutical sciences subdivisions: pharmacology and toxicology, nanotechnology, pharmaceutics, natural products, biotechnology, pharmaceutical chemistry, clinical pharmacy and other pharmacy related topics. Each issue of the journal contents 16 outstanding research articles in area of pharmaceutical sciences plus an editorial written by the IJPS editors on one of the most up to date advances topics in pharmacy. All articles published by IJPS would be permanently accessible online freely without any subscription charges. Authors of the published articles have granted the right to use and disseminate their article to third parties.