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局部喹诺酮类药物和甲硝唑对局部晚期乳腺癌患者癌性溃疡的有效性:一项随机对照试验

Effectivity of Topical Quinolones and Metronidazole on Cancer Ulcers in Patients with Locally Advanced Breast Cancer: A Randomized Controlled Trial.

作者信息

Budijitno Selamat, Sihwidiyono Puguh, Alwi Luqman, Pudjonarko Dwi, Kristina Tri Nur, Kusuma Astuti Meira Dwi, Pratama Arrizki Azka, Putra Sistiya Pradana

机构信息

Surgical Oncologist, Department of Surgery, Medical Faculty of Diponegoro University, Semarang, Indonesia.

Surgical Oncologist, Department of Surgery, dr. Ario Wirawan Hospital, Salatiga, Indonesia.

出版信息

Asian Pac J Cancer Prev. 2025 May 1;26(5):1607-1613. doi: 10.31557/APJCP.2025.26.5.1607.

DOI:10.31557/APJCP.2025.26.5.1607
PMID:40439372
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12290201/
Abstract

INTRODUCTION

Malignant Fungating Wound (MFW) has a significant role in increasing quality of life. The secondary infection could cause as well as Hemorrhage, Odor, Pain, Exudate & Superficial infections (HOPES) and reduced activity. Worseness of MFW could be caused by a combination of aerobic and anaerobic bacterial infections. This study aimed to prove the effectiveness of the topical antibiotic solution toward wound repairment secondary to MFW.  Methods: This study was a pre and post-test randomized controlled trial in which inclusion and exclusion criteria were predefined. Patients who suffered locally advanced breast cancer were given chemotherapy and then randomized into the treatment group of MFW management treated with Ciprofloxacin and Metronidazole solution, and the non-treatment group treated with 0.9% NaCl. The dependent variable was the number of Colony Forming Unit (CFU) and the degree of fibrosis. Mann Whitney-U and Kendall's tau-b test was carried out to examine the difference and correlation test. Statistical significance was defined as p <0.05.

RESULT

The study involved 40 patients who were randomized into the treatment group dan the non-treatment group. Paired T-tests of the CFU in the non-treatment group and the treatment group are significant (p<0.001). The Mann Whitney-U test in delta CFU in both groups is significant (p<0.001). Mann Whitney-U test in the degree of fibrosis in both groups is significant (p=0.046). Kendall's tau-b correlation test shows a significant negative correlation between the CFU and the degree of fibrosis (p=0.027, r=-0.36).

CONCLUSION

The treatment of MFW in locally advanced breast cancer treated with metronidazole and ciprofloxacin solution gives a better rate of improvement in terms of reducing the number of CFU and increasing the degree of fibrosis. This study proves that there is a significant negative correlation between a decrease in CFU and the degree of fibrosis in the treatment group.

摘要

引言

恶性溃疡伤口(MFW)对提高生活质量具有重要影响。继发感染可能导致出血、异味、疼痛、渗液及浅表感染(HOPES),并降低活动能力。MFW的恶化可能由需氧菌和厌氧菌感染共同引起。本研究旨在证明局部用抗生素溶液对MFW继发伤口修复的有效性。方法:本研究为前后测随机对照试验,预先设定了纳入和排除标准。对局部晚期乳腺癌患者进行化疗,然后随机分为用环丙沙星和甲硝唑溶液治疗MFW的治疗组以及用0.9%氯化钠治疗的非治疗组。因变量为菌落形成单位(CFU)数量和纤维化程度。采用曼-惠特尼U检验和肯德尔tau-b检验进行差异检验和相关性检验。统计学显著性定义为p<0.05。

结果

该研究纳入40例患者,随机分为治疗组和非治疗组。非治疗组和治疗组CFU的配对t检验具有显著性(p<0.001)。两组间CFU差值的曼-惠特尼U检验具有显著性(p<0.001)。两组纤维化程度的曼-惠特尼U检验具有显著性(p = 0.046)。肯德尔tau-b相关性检验显示CFU与纤维化程度之间存在显著负相关(p = 0.027,r = -0.36)。

结论

用甲硝唑和环丙沙星溶液治疗局部晚期乳腺癌的MFW,在减少CFU数量和增加纤维化程度方面有更好的改善率。本研究证明治疗组中CFU减少与纤维化程度之间存在显著负相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2eca/12290201/85ce7f190000/APJCP-26-1607-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2eca/12290201/85ce7f190000/APJCP-26-1607-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2eca/12290201/85ce7f190000/APJCP-26-1607-g001.jpg

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