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《Chinese Journal of Blood Transfusion》 2016-04
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Preliminary safety evaluation of freeze-dried platelets for wound treatment in animals

TANG Yanjiao;SHAN Guiqiu;MA Jing;LV Pin;ZHOU Mou;LIN fang;ZHANG Shuang;The Graduate School of Southern Medical University;Guangzhou General Hospital of Guangzhou Military Command;  
Objective To determine the toxicity profile of freeze-dried platelets( FDP) following single or multiple skin recovery therapy,and to evaluate the safety of FDP in wound healing. Methods 10 SD rats were used in the single-dose skin stimulation study. The dorsal aspect of the rats was prepared. Skin stimulation was conducted on one side of back in group FDP,and conducted on the other side on group blank control( group BC). The appearance of erythema and edema was observed in the skin on 1st,24 th,48th and 72 nd hour after single application of FDP and sterile saline. In the multiple dose toxicity study,32 New Zealand rabbits were divided into two groups: group FDP and group BC. FDP and sterile saline were applied daily to rabbits for 28 days. The general behavior of the rabbits was observed every day. The weight of the rabbits was tested every week. The hematological and blood biochemical parameters and histopathology were assessed before the experiment and on 7th day,14 th day,21 st day and 28 th day. Results From the single-dose skin stimulation study,FDP and sterile saline did not induce erythema and edema. In the multiple dose toxicity study on rabbits,the two groups did not experience a reduction of body weight,abnormal behavior or death. There was no significant difference( P 0. 05) in rabbits' body weight,routine blood work and biochemical detection between the two groups. On day 7,the WBC of rabbits from group FDP was higher than that on day 14,21 and 28( P 0. 05). The Cr was fluctuated in two group. Histologically,there was no histopathological change on the skin of all experiment animals. Conclusion FDP did not induce obvious skin stimulation in SD rats and New Zealand rabbits. It exhibited no significant toxicity to rabbits after 28 days of use. These results indicate that FDP is qualified in preliminary safety evaluation as a kind of novel biological agent.
【Fund】: 国家科技重大专项(2011ZXJ09104-07C)
【CateGory Index】: R965
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