Efficacy and Safety of Furazolidone Containing Quadruple Therapy for First-line Helicobacter Pylori Eradication

Patients A total of 500 patients with primary H pylori infection were collected from Liaocheng People's Hospital from August 2022 to July 2024. These patients were from outpatient clinics, followed up by using telephone to monitor drugs, adverse reactions, symptom improvement before and after medication. Written informed consent was obtained from all participated patients in this study. This study was approved by the local research ethics committee at the Liaocheng Hospital according to the principle of the Helsinki Declaration II (No. 2023110). Patients were randomly divided into FZD group and CLA group. Inclusion criteria include: 1. Hp test positive. 2. age range from 18 to 70 years. 3. without previously Hp eradication treatment prior to enrollment. Exclusion criteria were as follows: 1. severe concomitant diseases such as cardiac dysfunction, liver, kidney et al. 2. planning to be or being pregnant, or lactating. 3. history of allergy to any medicines used in this study. 4. lost in follow-up.

Drugs Drugs used in this study were as follows: FZD was from Shanghai Yurui Biotechnology Pharmaceutical Co., Ltd. Esomeprazole was from AstraZeneca Pharmaceutical Co. Ltd, England; AMX was from Shandong LuKang Pharmaceutical Co., Ltd; Bismuth potassium citrate was from Shanghai Modern Hassen Pharmaceutical Co., Ltd. CLA was from Guangdong DongYangGuang Pharmaceutical Co., Ltd. All drugs were routinely prescribed in hospital pharmacy.

Determination of Hp infection The status of Hp infection was determined by methods as follows: 1. 13C/14C urea breath test (UBT) 2. rapid urease test (RUT) 3. HE staining of gastric mucosal histopathological sections 4. gastric mucosal Hp culture 5. fecal Hp antigen test. Post-treatment Hp status was assessed 4 weeks after finishing the treatment. Hp was considered eradicated if post-treatment Hp was negative. If the result was positive, it was retested again after half a year. If the retested result was still positive, Hp eradication failed.

Hp eradication regimens and duration Patients were randomly allocated into FZD and CLA groups. The FZD group includes FZD (100mg, bid), esomeprazole (20mg, bid), bismuth potassium citrate (220mg, bid), and AMX (1000mg, bid) for 14 days. In the CLA group, FZD was replaced by CLA (500mg, bid), and the other drugs were the same. Esomeprazole and bismuth were taken 30 minutes before meal, AMX, CLA, and FZD were taken 30 minutes after meal.

Evaluation of adverse effects and symptom improvement after treatment Drugs, adverse effects, improvement of clinical symptoms were recorded by outpatient questionnaire. Adverse drug reactions include abdominal pain, bloating, diarrhea, constipation, nausea, changes in taste (bad oral taste), rash, insomnia, arthralgia, headache, dizziness, fatigue, peripheral nerve damage. The adverse events were classified as yes or no. The symptoms before and after treatment was evaluated by the Likert rating scale. Symptoms are classified as none (1 point), mild (2 points, almost no symptoms), moderate (3 points, tolerable, not affect daily activities), severe (4 points, affect daily activities), and serious (5 points, need to be hospitalized or intervened to prevent permanent injury or even death). Frequency includes: none (1 point), less than 2 times a week (2 points), more than 3 times a week and not daily (3 points), daily but intermittent (4 points), almost constant daily (5 points). Total score = frequency×symptom.