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Short-term clinical and immunologic effects of poly-gamma-glutamic acid (γ-PGA) in women with cervical intraepithelial neoplasia 1 (CIN 1): A multicenter, randomized, double blind, phase II trial

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Author(s)
Hyun-Woong ChoYoung-Chul ParkMoon-Hee SungJong Sup ParkTae Jin KimSeok Ju SeongChi Heum ChoJae Kwan Lee
Keimyung Author(s)
Cho, Chi Heum
Department
Dept. of Obstetrics & Gynecology (산부인과학)
Journal Title
PLoS One
Issued Date
2019
Volume
14
Issue
6
Abstract
Objective
The aim of this study was to investigate the short-term efficacy and safety of Poly-gammaglutamic acid (γ-PGA) and the immunologic changes in patients with CIN 1.

Methods
Participants were randomly assigned to one of two groups and orally treated with placebo or 1,500 mg of γ-PGA for 4 weeks. The primary endpoint of the study was histologic regression rate of CIN 1 at 12 weeks between γ-PGA and control groups. The secondary endpoints were HPV clearance and change in immune responses.

Result
From April 2013 to December 2015, 195 patients participated in the study. In the intentionto- treat analysis, 42 (42.4%) of the women who received γ-PGA experienced histologic remission versus 26 (27.1%) in the control group, with a statistically significant difference (p = 0.018). In the γ-PGA group, HPV clearance was found in 37 (43.5%) of 85 patients infected with high-risk HPV, showing a significant difference compared to the control group, in which 20 (26.7%) of 75 patients exhibited HPV clearance (p = 0.026). However, there was no significant difference between the two groups in the change of NK cell activity, major histocompatibility complex (MHC) class II CD8 count, and CD56 count.

Conclusion
γ-PGA showed a short-term therapeutic effect on CIN 1 and high-risk HPV infection. It is a non-invasive, promising oral medication for women with these conditions.
Keimyung Author(s)(Kor)
조치흠
Publisher
School of Medicine (의과대학)
Citation
Hyun-Woong Cho et al. (2019). Short-term clinical and immunologic effects of poly-gamma-glutamic acid (γ-PGA) in women with cervical intraepithelial neoplasia 1 (CIN 1): A multicenter, randomized, double blind, phase II trial. PLoS One, 14(6), e0217745–e0217745. doi: 10.1371/journal.pone.0217745
Type
Article
ISSN
1932-6203
Source
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0217745
DOI
10.1371/journal.pone.0217745
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42037
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Obstetrics & Gynecology (산부인과학)
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