Efficacy and Safety of Recombinant Human Granulocyte Colony-Stimulating Factor in Patients with Unexplained Recurrent Pregnancy Loss: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Start Date09 Nov 2023

Sponsor / Collaborator-

ChiCTR2200061507 / SuspendedEarly Phase 1IIT

Intervention study on procedural pain caused by subcutaneous injection of recombinant human granulocyte colony-stimulating factor in patients with hematological malignancies

Start Date01 Dec 2022

Sponsor / Collaborator

Shenzhen University General Hospital

100 Clinical Results associated with Recombinant human granulocyte colony-stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

100 Translational Medicine associated with Recombinant human granulocyte colony-stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

100 Patents (Medical) associated with Recombinant human granulocyte colony-stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

1,599

Literatures (Medical) associated with Recombinant human granulocyte colony-stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

01 Aug 2024·International journal of cancer

Clinical outcomes of coronavirus disease in patients with breast cancer treated with granulocyte colony‐stimulating factor following chemotherapy: Triangulation of evidence using population‐based cohort and Mendelian randomization analyses

Article

Author: Lin, Yuxiang ; Fu, Fangmeng ; Chen, Lili ; Wang, Chuan ; Han, Hui ; Liu, Shougui ; Han, Zhonghua ; Huang, Jinhua ; He, Peng ; Lin, Shunguo ; Hou, Jialin ; Cai, Weifeng ; Li, Jing ; Cai, Qindong ; Wang, Yali ; Fu, Chengbin ; Chen, Minyan ; Xu, Chunsen

Abstract:

Recombinant human granulocyte colony‐stimulating factor (G‐CSF) administration in patients with cancer and coronavirus disease (COVID‐19) remains controversial. Concerns exist that it may worsen COVID‐19 outcomes by triggering an inflammatory cytokine storm, despite its common use for managing chemotherapy‐induced neutropenia (CIN) or febrile neutropenia post‐chemotherapy. Here, we determined whether prophylactic or therapeutic G‐CSF administration following chemotherapy exacerbates COVID‐19 progression to severe/critical conditions in breast cancer patients with COVID‐19. Between December 2022 and February 2023, all 503 enrolled breast cancer patients had concurrent COVID‐19 and received G‐CSF post‐chemotherapy, with most being vaccinated pre‐chemotherapy. We prospectively observed COVID‐19‐related adverse outcomes, conducted association analyses, and subsequently performed Mendelian randomization (MR) analyses to validate the causal effect of genetically predicted G‐CSF or its associated granulocyte traits on COVID‐19 adverse outcomes. Only 0.99% (5/503) of breast cancer patients experienced COVID‐19‐related hospitalization following prophylactic or therapeutic G‐CSF administration after chemotherapy. No mortality or progression to severe/critical COVID‐19 occurred after G‐CSF administration. Notably, no significant associations were observed between the application, dosage, or response to G‐CSF and COVID‐19‐related hospitalization (all p >.05). Similarly, the MR analyses showed no evidence of causality of genetically predicted G‐CSF or related granulocyte traits on COVID‐19‐related hospitalization or COVID‐19 severity (all p >.05). There is insufficient evidence to substantiate the notion that the prophylactic or therapeutic administration of G‐CSF after chemotherapy for managing CIN in patients with breast cancer and COVID‐19 would worsen COVID‐19 outcomes, leading to severe or critical conditions, or even death, especially considering the context of COVID‐19 vaccination.

01 Jul 2024·RESEARCH IN VETERINARY SCIENCE

Effect of recombinant bovine granulocyte colony-stimulating factor treatment during the peripartum period on postpartum diseases, reproductive performance, and milk production in Holstein cattle

Article

Author: Herradón, Pedro G ; Yáñez, Uxía ; Peña, Ana I ; Dubuc, Jocelyn ; Lorenzo, Guillermo ; Becerra, Juan J ; Quintela, Luis A ; Caínzos, Juan ; Álvarez, Jacobo

To boost the immune function around parturition, recombinant bovine granulocyte colony-stimulating factor (rbG-CSF) has been used to increase the number of neutrophils. Therefore, the aim of this study was to quantify the effect of rbG-CSF administration on the incidence of postpartum pathologies, reproductive performance, and milk production during the first three months of lactation. A total of 199 Holstein cows from one herd were included and were randomly allocated into two groups: Control (n = 103) and rbG-CSF (n = 96). Cows in the rbG-CSF group received 2 doses of a rbG-CSF injectable formulation, one 7 days before the expected date of calving and the other within 24 h after calving. For 6 weeks following calving, animals were examined weekly to assess the presence of postpartum pathologies. Milk production, protein and fat content, and somatic cell count were determined monthly by the regional dairy herd improvement association. Data about the reproductive performance were collected from on-farm software. To analyse the effect of treatment on the incidence of postpartum pathologies, Pearson's χ² test and multivariable logistic regressions were performed. The effect on reproductive performance was analysed using Cox proportional hazard regression analysis for days open, binary logistic regression for first service conception rate and Oneway ANOVA test for the number of artificial inseminations. The effects of treatment on milk yield and milk composition were checked using GLM repeated measures analysis. No statistically significant differences were observed between treatment groups for any of the parameters evaluated. Only parity had a significant effect on days open and milk production (p < 0.05). In conclusion, in the present study no evidence was found that rbG-CSF could have an effect on the reproductive and productive parameters evaluated.

01 Jun 2024·Zhongguo shi yan xue ye xue za zhi

[The Preventive Effect of Levofloxacin Combined with G-CSF or Only G-CSF Supportive Therapy on Infection in Autologous Hematopoietic Stem Cell Transplantation].

Article

Author: He, Shao-Long ; Zhao, Jie ; Wang, Xin-Wei ; Tian, Wei-Wei ; Yang, Li-Ping ; Ma, Liang-Ming ; Wei, Jun-N ; Yao, Qiong

OBJECTIVE:

To investigate the role of levofloxacin combined with recombinant human granulocyte colony-stimulating factor (G-CSF) or only G-CSF supportive therapy in preventing infection in autologous hematopoietic stem cell transplantation(ASCT), and to analyze the length of hospital stay, hospitalization cost and post-transplant survival of the patients.

METHODS:

A retrospective analysis was performed in the patients with hematological malignancies who accepted ASCT at our hospital from January 2012 to July 2022, the febrile neutropenia, the incidence of bacterial infection and the use rate of intravenous antibiotics in the levofloxacin+G-CSF group and only G-CSF support group during ASCT were observed. The length of hospital stay, total cost during hospitalization and survival after 90 days of transplantation between the two groups were compared.

RESULTS:

A total of 102 cases were included in this study, including 57 cases of multiple myeloma, 36 cases of acute leukaemia, 7 cases of lymphoma, 3 cases of myelodysplastic syndrome, 1 case of light chain amyloidosis, and 1 case of POEMS syndrome. 47 patients received levofloxacin+ G-CSF antibacterial prophylaxis, and 55 patients received G-CSF supportive therapy. In the levofloxacin+ G-CSF group, 40 cases (85.11%) developed febrile neutropenia, and 13 cases (27.66%) were confirmed as bacterial infection. In the G-CSF group, 44 cases (80.00%) developed febrile neutropenia, and 16 cases (29.09%) were bacterial infection. There was no statistically significant difference in the incidence of febrile neutropenia and bacterial infection between the two groups (χ²=0.46，P =0.50; χ²=0.03，P =0.87). The use rate of intravenous antibiotics in the levofloxacin+ G-CSF group was 85.11% (40/47), which was not statistically different from 85.45% (47/55) in the G-CSF group (χ²=0.04，P =0.84). The detection rates of levofloxacin-resistant bacteria in the levofloxacin+ G-CSF group and G-CSF group were 8.57% (3/35) and 21.43% (6/28), respectively, with no statistical difference (χ²=0.65, P >0.05). The median length and median cost of hospitalization in the levofloxacin+ G-CSF group and G-CSF group were 25 d vs 22 d and 78 216.24 yuan vs 80 724.38 yuan, with no statistically significant differences ( t =3.00，P =0.09; t =0.94，P =0.09). Within 90 days after transplantation, two cases (4.26%) died in the levofloxacin+ G-CSF group and one case (1.82%) died in the G-CSF group, with no statistically significant difference between the two groups (χ²=0.53，P =0.47).

CONCLUSION:

Application of levofloxacin+ G-CSF showed no significant benefit compared to G-CSF support for the prevention of bacterial infections during ASCT.

100 Deals associated with Recombinant human granulocyte colony-stimulating Factor(Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.)

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Indication	Country/Location	Organization	Date
Neutropenia	CN	Shenzhen Sinobioway Xinpeng Biomedicine Co., Ltd.	01 Jan 1999

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