局部用莫西沙星对治疗性腹腔镜手术伤口愈合的疗效：一项双盲、随机临床试验。
Efficacy of topical moxifloxacin on therapeutic laparoscopy-induced wound healing: a double-blind, randomized clinical trial.
作者信息
Heydari Behrooz, Basiratian Ali, Hoseinzade Farahnaz, Kargar Saeed, Ramezani Vahid, Zahmatkesh Amirhossein, Saghafi Fatemeh
机构信息
Department of Clinical Pharmacy, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran.
Pharmaceutical Sciences Research Center, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran.
出版信息
BMC Surg. 2025 May 6;25(1):198. doi: 10.1186/s12893-025-02932-7.
BACKGROUND
Wound healing is crucial for maintaining healthy skin and preventing complications. Topical administration is a preferred method for delivering therapeutic medicines at the surgery site, as it is simple, affordable, and does not result in systemic harm or antibiotic resistance. Moxifloxacin (MXF), a broad-spectrum antibiotic with anti-inflammatory effects, seems to be effective against bacteria and accelerates wound healing. This study aims to determine the therapeutic effect of topical MXF on wound healing after therapeutic laparoscopy.
METHODS
This double-blind clinical trial involved 80 patients with therapeutic laparoscopy-induced wounds, randomly assigned to either 0.5% MXF cream or placebo, 24 h after surgery. The primary outcome was wound healing assessment using the REEDA index. Patients were followed by 1, 3, and 5 days of inclusion.
RESULTS
Of the 80 study participants included, 50 were women (62.5%), with the mean (SD) age of the participants being 49.5 (19.8) years in the MXF group and 45.8 (17.8) years in the control group. The severity of redness, oedema, and discharge in the MXF group was significantly lower on the first, third, and fifth days of treatment. The case group showed a significant decrease in ecchymosis from the third day of treatment compared to the control group, and no significant difference was observed in wound approximation rate. Hence, topical MXF therapy yielded a significant decrease in REEDA index MXF (P-Value < 0.0001). No treatment-related serious adverse events occurred in the MXF group vs. the comparator group.
CONCLUSIONS
The results of the current clinical trial demonstrated that the use of topical MXF could be a potential option to expedite therapeutic laparoscopy-induced wound healing by reducing redness, oedema, ecchymosis, and discharge with a satisfactory safety profile.
TRIAL REGISTRATION
IRCT20181208041882N5, 25/10/2021 ( https://en.irct.ir/trial/46768 ).
背景
伤口愈合对于维持皮肤健康和预防并发症至关重要。局部给药是在手术部位递送治疗药物的首选方法，因为它简单、经济，且不会导致全身伤害或抗生素耐药性。莫西沙星（MXF）是一种具有抗炎作用的广谱抗生素，似乎对细菌有效并能加速伤口愈合。本研究旨在确定局部应用MXF对治疗性腹腔镜检查术后伤口愈合的治疗效果。
方法
这项双盲临床试验纳入了80例治疗性腹腔镜检查所致伤口的患者，术后24小时随机分为0.5% MXF乳膏组或安慰剂组。主要结局是使用REEDA指数进行伤口愈合评估。纳入后对患者进行1、3和5天的随访。
结果
在纳入的80名研究参与者中，50名是女性（62.5%），MXF组参与者的平均（标准差）年龄为49.5（19.8）岁，对照组为45.8（17.8）岁。治疗的第1、3和5天，MXF组的发红、水肿和渗液严重程度显著较低。与对照组相比，病例组从治疗第3天起瘀斑明显减少，伤口愈合率无显著差异。因此，局部应用MXF治疗使REEDA指数显著降低（P值<0.0001）。MXF组与对照组相比未发生与治疗相关的严重不良事件。
结论
当前临床试验结果表明，局部应用MXF可能是一种潜在的选择，可通过减轻发红、水肿、瘀斑和渗液来加速治疗性腹腔镜检查所致伤口的愈合，且安全性良好。
试验注册
IRCT20181208041882N5，2021年10月25日（https://en.irct.ir/trial/46768）
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