Ku Jaseung, Hwang Ji Hye
Bogwang Korean Medical Clinic, Seoul, Republic of Korea.
Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.
J Pharmacopuncture. 2022 Sep 30;25(3):290-300. doi: 10.3831/KPI.2022.25.3.290.
This study was conducted to evaluate the safety of SU-Eohyeol pharmacopuncture (SUEP) by assessing its potential to cause chromosomal abnormalities in Chinese hamster lung cells (CHL/IC).
A dose-curve was conducted to determine the highest dose of SUEP. Doses of 10, 5, 2.5, 1.25, 0.625, and 0.313% were used, and no cytotoxicity or SUEP precipitation was observed. SUEP doses of 10, 5, and 2.5%, with positive and negative controls, were used in a chromosome aberration test.
In this study, the frequency of abnormal chromosomal cells in the SUEP group did not show a statistically significant difference from that of the negative control group in short-term treatments with and without metabolic activation and the continuous treatment without metabolic activation. Compared with the negative control group, the positive control group had a significantly higher frequency of cells with structural chromosomal abnormalities. This test's results satisfied all conditions for determining the results.
SUEP did not induce chromosomal aberrations under the conditions of this study. Other toxicity evaluations, safety studies in humans, and various clinical trials are required to evaluate the safety and efficacy of SUEP.
本研究旨在通过评估其在中国仓鼠肺细胞(CHL/IC)中引起染色体异常的可能性,来评价水俞液药针(SUEP)的安全性。
进行剂量曲线实验以确定SUEP的最高剂量。使用了10%、5%、2.5%、1.25%、0.625%和0.313%的剂量,未观察到细胞毒性或SUEP沉淀。在染色体畸变试验中使用了10%、5%和2.5%的SUEP剂量,并设置了阳性和阴性对照。
在本研究中,在有和无代谢活化的短期处理以及无代谢活化的连续处理中,SUEP组异常染色体细胞的频率与阴性对照组相比,未显示出统计学上的显著差异。与阴性对照组相比,阳性对照组具有结构染色体异常的细胞频率显著更高。该试验结果满足判定结果的所有条件。
在本研究条件下,SUEP未诱导染色体畸变。需要进行其他毒性评估、人体安全性研究和各种临床试验来评估SUEP的安全性和有效性。