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

Q4 Pharmacology, Toxicology and Pharmaceutics Iranian Journal of Pharmaceutical Sciences Pub Date : 2021-01-01 DOI:10.22034/IJPS.2021.245261
M. Mehdizadeh, Maria Tavakoli-Ardakani, Shayan Zamani, G. Zamani, N. Nikpour
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引用次数: 0

摘要

造血干细胞移植(HSCT)是治疗多种血液系统恶性肿瘤的有效方法。移植是自体造血干细胞移植(AHSCT)过程中最重要的一步,其中使用了不同剂量的粒细胞集落刺激因子。在这项研究中,我们评估并比较了两种形式的重组粒细胞集落刺激生长因子(GCSF) GCSF和Peg GCSF的疗效和副作用。在这项随机临床试验中,纳入了60例连续接受AHSCT的多发性骨髓瘤、霍奇金淋巴瘤和非霍奇金淋巴瘤患者,患者平均年龄为55岁;然后将患者分为两组,以便比较两种方法的疗效和副作用。当地伦理委员会批准了该研究,代码为SB2019:210291,整个研究过程均遵守赫尔辛基宣言。第一组患者在第5天给予peg GCSF,剂量为6mg,第二组患者在第5天开始给予GCSF,剂量为5μg/kg。比较两组种植时间和不良反应。我们的研究表明,两组在输血需求和感染并发症方面没有差异;此外,两组在流感样综合征、感染类型和记录的发热性中性粒细胞减少症数量方面没有差异。两组平均白细胞植入天数分别为10.97±1天和11.1±1.1天,差异无统计学意义(P=0.328)。平均血小板植入天数分别为11.03±2.4天和11.1±2.4天,差异无统计学意义(P=0.714)。结论是pegfilgrastim与Filgrastim具有相同的疗效和安全性。因此,由于Pegfilgrastim具有更简单的注射方法,可以简化HSCT过程。
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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.
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来源期刊
Iranian Journal of Pharmaceutical Sciences
Iranian Journal of Pharmaceutical Sciences Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
0.50
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0.00%
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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.
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