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

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收录情况： ◇ SCIE

作者：
Wei Yating[1] * ; Wu Jun[1,2,*1] ; Chen Yuxin[3,*2] ; Fan Kunwu[1] ; Yu Xuming[1] ; Li Xiaojian[4] ; Zhao Yaohua[5] ; Li Yi[6] ; Lv Guozhong[7] ; Song Guodong[8] ; Rong Xinzhou[9] ; Lin Cai[10] ; Wang Haitao[11] ; Chen Xiaodong[12] ; Zhang Pihong[13] ; Han Chunmao[14] ; Zu Hongxu[15] ; Liu Wenjun[16] ; Zhang Yi[17] ; Liu Chang[18] ; Su Yongtao[19] ; Zhang Baolin[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] ;
机构： [1]Department of Burn and Plastic Surgery, Department of Wound Repair, Shenzhen Institute of Translational Medicine, the First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong Province, China. [2]Human Histology &amp [3]Embryology Section, Department of Surgery, Dentistry, Pediatrics, &amp [4]Gynecology, University of Verona Medical School, Verona, Italy. [3]Jiangsu Protelight Pharmaceutical &amp [6]Biotechnology Co. Ltd, Jiangyin, Jiangsu Province, China. [4]Guangzhou Red Cross Hospital, Guangzhou City, Guangdong Province, China. [5]Jiangyin People's Hospital, Jiangyin, Wuxi, Jiangsu Province, China. [6]Qinghai University Affiliated Hospital, Xining, Qinghai Province, China. [7]Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu Province, China. [8]Jinan Central Hospital, Jinan City, Shandong Province, China. [9]Guangzhou First People's Hospital, Guangzhou, Guangdong Province, China. [10]The First Affiliated Hospital of WMU, New District of the First Hospital of Wenyi Hospital, Wenzhou, Zhejiang Province, China. [11]Weihai Municipal Hospital, Weihai, Shandong Province, China. [12]The First People's Hospital of Foshan, Foshan, Guangdong Province, China. [13]Xiangya Hospital of Central South University, Changsha, Hunan Province, China. [14]The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China. [15]The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan Province, China. [16]The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China. [17]Affiliated Hospital of Nantong University, Nantong, Jiangsu Province, China. [18]Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu Province, China. [19]PKU Care Luzhong Hospital, Zibo, Shandong Province, China. [20]First Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China. [21]Suzhou Municipal Hospital, Suzhou, Jiangsu Province, China. [22]Zhongda Hospital Southeast University, Nanjing, Jiangsu Province, China. [23]Guangdong Provincial People's Hospital, Guangzhou, Guangdong Province, China. [24]Jilin Province People's Hospital, Changchun, Jilin Province, China. [25]Zhengzhou First People's Hospital, Zhengzhou, Henan Province, China. [26]Taizhou People's Hospital, Jiangsu Province, China. [27]Sir Run Run Hospital Nanjing Medical University, Nanjing, Jiangsu Province, China. [28]The First Hospital of Jilin University, Changchun, Jilin Province, China. [29]The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.
出处：
DOI： 10.1097/SLA.0000000000005508
ISSN：

摘要：
To assess the safety and efficacy of antimicrobial peptide PL-5 (Peceleganan) spray in the treatment of wound infections.Antimicrobial peptide PL-5 spray is a novel topical antimicrobial agent.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.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‰ PL-5, 2‰ PL-5, 4‰ 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‰ PL-5, 2‰ PL-5, 4‰ 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.Antimicrobial peptide PL-5 spray is safe and effective for the treatment of skin wound infections.ChiCTR2000033334.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

基金：
This study was funded by the National Science and Technology Major Project of China (2017ZX09309001).
语种：
外文
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中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 外科
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 外科
JCR分区：
出版当年[2022]版：
Q1 SURGERY
最新[2023]版：
Q1 SURGERY

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Department of Burn and Plastic Surgery, Department of Wound Repair, Shenzhen Institute of Translational Medicine, the First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong Province, China.
通讯作者：
通讯机构： [1]Department of Burn and Plastic Surgery, Department of Wound Repair, Shenzhen Institute of Translational Medicine, the First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong Province, China. [2]Human Histology &amp [3]Embryology Section, Department of Surgery, Dentistry, Pediatrics, &amp [3]Jiangsu Protelight Pharmaceutical &amp [*1]Department of Burn and Plastic Surgery, Department of Wound Repair, Shenzhen Institute of Translational Medicine, the First Affiliated Hospital of Shenzhen, University, 3002 Sun Gang Road, Shenzhen, 518000, China. [*2]Jiangsu Protelight Pharmaceutical & Biotechnology Co., Ltd, No.1 Anquan Road, 214429 Jiangyin, Jiangsu Province, China.
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.doi:10.1097/SLA.0000000000005508.
APA：
Wei Yating,Wu Jun,Chen Yuxin,Fan Kunwu,Yu Xuming...&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)
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

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