Comparative study on the Efficacy and safety of Gemifloxacin Versus Amoxicillin/Clavulanate in the management of Chronic Bronchitis

Introduction: Chronic bronchitis is a significant public health concern, often leading to recurrent exacerbations and impaired lung function. Effective antibiotic therapy is crucial to manage bacterial infections that exacerbate symptoms. Gemifloxacin, a broad-spectrum fluoroquinolone, and Amoxicillin/Clavulanate, a beta-lactam/beta-lactamase inhibitor combination, are commonly prescribed antibiotics for respiratory tract infections. This study evaluates the therapeutic efficacy and safety of Gemifloxacin versus Amoxicillin/Clavulanate in chronic bronchitis patients.

Method: A randomized open-label clinical trial was conducted on patients diagnosed with chronic bronchitis experiencing acute exacerbations. During the study period, a total of 102 patients were enrolled in this study. Of these, 33 patients were in the Gemifloxacin 320 mg group and 35 patients were in the Amoxicillin/Clavulanate 625 mg group, whereas 34 were in the Amoxicillin/Clavulanate 1 gram group, based on the inclusion and exclusion criteria. During the study period, three patients were excluded from the Gemifloxacin 320 mg group, five patients were excluded from the Amoxicillin/Clavulanate 625 mg group, and four patients were excluded from the Amoxicillin/Clavulanate 625 mg group due to a lack of exact information. The data of the remaining 90 patients—30 patients in each group—were analyzed. Clinical symptoms, X-ray, PFT (FVC, FEV1, FEF, (FEV1/FVC), and bacteriologic assessments were performed for all patients.

Results: Both Gemifloxacin and Amoxicillin/Clavulanate (625 mg and 1 gm) effectively reduced symptoms and improved lung function. The bacteriological success rate was found to be better in the Gemifloxacin 320 mg group compared with the Amoxicillin/Clavulanate 1 gram and Amoxicillin/Clavulanate 625 mg groups.

Conclusion: Gemifloxacin 320 mg offers an effective alternative to Amoxicillin/Clavulanate 1 gram and Amoxicillin/Clavulanate 625 mg in the treatment of chronic bronchitis. The incidence of side effects was found to be lower in Gemifloxacin 320 mg, suggesting better tolerability when compared with Amoxicillin/Clavulanate 1 gram and Amoxicillin/Clavulanate 625 mg.