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Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections A Phase IIb Randomized Clinical Trial 期刊论文

编号：

A3085EFD3363A1D7325BEE7B52E0B511
作者：

Wei, Yating#^[1]Wu, Jun(吴军)*^[1,2]Chen, Yuxin*^[3]Fan, Kunwu^[1];Yu, Xuming^[1];Li, Xiaojian^[4];Zhao, Yaohua^[5];Li, Yi^[6];Lv, Guozhong(吕国忠)^[7]Song, Guodong^[8];Rong, Xinzhou^[9];Lin, Cai^[10];Wang, Haitao^[11];Chen, Xiaodong^[12];Zhang, Pihong(张丕红)^[13]Han, Chunmao(韩春茂)^[14]Zu, Hongxu^[15];Liu, Wenjun(刘文军)^[16]Zhang, Yi^[17];Liu, Chang^[18];Su, Yongtao^[19];Zhang, Baolin(张宝林)^[20]Sun, Bingwei^[21];Wang, Lei^[22];Lai, Wen^[23];Liu, Jinhui^[24];Xia, Chengde^[25];Ji, Geng^[26];Zhu, Feng^[27];Yu, Jia''ao^[28];Ahemaiti, Akebaer^[29];Dong, Hu^[3];Chen, Mingxia^[3];
语种：

英文
期刊：

ANNALS OF SURGERY ISSN：0003-4932 2023 年 277 卷 1 期 (43 - 49) ; JAN
收录：
关键词：

wound infections efficacy safety Peceleganan randomized clinical trial
摘要：

Objective:To assess the safety and efficacy of antimicrobial peptide PL-5 (Peceleganan) spray in the treatment of wound infections. Background:Antimicrobial peptide PL-5 spray is a novel topical antimicrobial agent. Methods:We conducted a multicenter, open-label, randomized, controlled phase IIb clinical trial to evaluate the efficacy and safety of PL-5 spray, as compared with silver sulfadiazine, in patients with skin wound infections. The primary efficacy outcome was the clinical efficacy rate on the first day after ending the treatment (D8). The secondary efficacy outcome was the clinical efficacy rate on the fifth day posttreatment (D5), the bacteria clearance rate, and the overall efficacy rate at the mentioned 2 time points. The safety outcomes included adverse reactions and pharmacokinetic analysis posttreatment. Results:A total of 220 patients from 27 hospitals in China were randomly assigned to 4 groups. On D8, the efficacy rate was 100.0%, 96.7%, 96.7% for the 1 parts per thousand PL-5, 2 parts per thousand PL-5, 4 parts per thousand PL-5 groups, respectively, as compared with 87.5% for the control group. The efficacy rate among the 4 groups was significantly different (P<0.05). On D5, the efficacy rate was 100.0%, 93.4%, 98.3% for the 1 parts per thousand PL-5, 2 parts per thousand PL-5, 4 parts per thousand PL-5 groups, respectively, as compared with 82.5% for the control group. The efficacy rate among the 4 groups was significantly different (P<0.05). The blood concentration of PL-5 was not detectable in pharmacokinetic analysis. No severe adverse event related to the application of PL-5 was reported. Conclusions:Antimicrobial peptide PL-5 spray is safe and effective for the treatment of skin wound infections.
推荐引用方式
GB/T 7714：

Wei Yating,Wu Jun,Chen Yuxin, et al. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections A Phase IIb Randomized Clinical Trial [J].ANNALS OF SURGERY,2023,277(1):43-49.
APA：

Wei Yating,Wu Jun,Chen Yuxin,Fan Kunwu,&Chen Mingxia.(2023).Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections A Phase IIb Randomized Clinical Trial .ANNALS OF SURGERY,277(1):43-49.
MLA：

Wei Yating, et al. "Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections A Phase IIb Randomized Clinical Trial" .ANNALS OF SURGERY 277,1(2023):43-49.
入库时间：

2022/7/16 21:52:15
更新时间：

2022/7/16 21:52:15

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