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

局部应用喹诺酮类和甲硝唑治疗局部晚期乳腺癌患者癌性溃疡的疗效:一项随机对照试验

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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.

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