| Residential College | false |
| Status | 已發表Published |
| Tolerability of hypodermic injection of pegfilgrastin (PEG-G-CSF) in a phase I study | |
| Zheng L.2; Xu N.2; Liu C.-T.2; Wang Y.2; Luo Z.2; Luo H.1 | |
| 2008-09-15 | |
| Source Publication | Chinese Journal of Evidence-Based Medicine
 |
| ISSN | 16722531 |
| Volume | 8Issue:3Pages:155-158 |
| Abstract | Objective: To evaluate the safety and tolerance of pegfilgrastin (PEG-G-CSF) in Chinese healthy volunteers. Methods: Thirty healthy volunteers were randomly divided into five single-dose groups to receive PEG-GCSF 15, 30, 50, 60 or 75 μg/kg by hypodermic injection. The safety profile and tolerabil ity were evaluated by observing symptoms, vital signs, laboratory tests and electro cardiogram. Results: No serious adverse event was reported for any volunteer. Transient dizziness occurred in one person in the 50 μg/kg dose group, and mild dizziness and ostalgia was found in all six people in the 75 μg/kg dose group, of whom one experienced transient fever and two experienced mild diarrhea. No cl inically significant changes in laboratory tests and electrocardiogram were found during the follow-up period. Conclusions: The maximum tolerated dose of PEG-G-CSF injection in Chinese healthy volunteers is 60 μg/kg. Doses below 60 μg/kg can be well tolerated. The recommended dose for phase II cl inical trials is 60 μg/kgone, one dose for each cycle of chemotherapy. © 2008 Editorial Board of Chin J Evid-based Med. |
| Keyword | Pegfilgrastin (PEG-G-CSF) Safety Tolerance |
| URL | View the original |
| Language | 英語English |
| Fulltext Access | |
| Document Type | Journal article |
| Collection | University of Macau |
| Affiliation | 1.Chongqing Fujin Biology and Medicine Company 2.West China Hospital of Sichuan University |
| Recommended Citation GB/T 7714 | Zheng L.,Xu N.,Liu C.-T.,et al. Tolerability of hypodermic injection of pegfilgrastin (PEG-G-CSF) in a phase I study[J]. Chinese Journal of Evidence-Based Medicine, 2008, 8(3), 155-158. |
| APA | Zheng L.., Xu N.., Liu C.-T.., Wang Y.., Luo Z.., & Luo H. (2008). Tolerability of hypodermic injection of pegfilgrastin (PEG-G-CSF) in a phase I study. Chinese Journal of Evidence-Based Medicine, 8(3), 155-158. |
| MLA | Zheng L.,et al."Tolerability of hypodermic injection of pegfilgrastin (PEG-G-CSF) in a phase I study".Chinese Journal of Evidence-Based Medicine 8.3(2008):155-158. |
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