复方阿嗪米特肠溶片治疗腹腔镜胆囊切除术后消化不良的多中心、随机、优效、平行对照临床研究

Multicenter, randomized, superiority, parallel-controlled clinical study of compound azinomide enteric-coated tablets in the treatment of dyspepsia after laparoscopic cholecystectomy

摘要:

背景与目的 腹腔镜胆囊切除术（LC）是治疗胆囊疾病的常见手术方式，但术后部分患者会出现消化不良等症状，影响生活质量。复方阿嗪米特肠溶片作为一种新型药物，可能对LC术后消化不良症状具有改善作用。本研究通过多中心临床试验，探讨复方阿嗪米特肠溶片在LC术后消化不良症状治疗中的临床效果。方法 采用多中心、优效、开放标签、平行对照设计，纳入2023年1月—2024年5月7家中心LC术后消化不良患者，采用随机数字表法将患者分为观察组和对照组。观察组患者实施复方阿嗪米特肠溶片治疗，对照组患者实施米曲菌胰酶片+熊去氧胆酸片联合治疗，两组均治疗4周。比较两组服药前、服药后14 d和28 d评估胃肠症状积分与生活质量评分，以及不良反应发生率和成本效益比（CER）。结果 最终纳入303例患者，其中观察组150例，对照组153例。服药前，两组患者基线特征均衡，差异无统计学意义（均P>0.05）。服药后，观察组14 d和28 d有效率均明显高于对照组（44.7% vs. 29.4%；98.0% vs. 73.9%，均P<0.05）；观察组服药后14 d和28 d的症状积分、生活质量评分均明显低于对照组，而症状积分改善率均明显高于对照组（均P<0.05）；对各症状积分改善率与治疗有效率单独分析，结果显示，除14 d腹痛/腹部不适外改善情况两组间无明显差异外，观察组14 d其余症状改善情况和28 d所有症状改善情况均优于对照组（均P<0.05）。两组均未发生不良反应事件。观察组14 d和28 d的CER为283.78元/有效率、128.57元/有效率，对照组为729.93元/有效率、290.22元/有效率。结论 复方阿嗪米特肠溶片治疗LC术后消化不良症状有良好的临床效果，同时具有较好的安全性，且体现了较高的成本效益。本研究有一定的局限性，但其结果为LC术后消化不良的治疗提供了新的选择。未来需开展更大规模的随机对照试验，以进一步验证本研究的结论。

Abstract:

Background and Aims Laparoscopic cholecystectomy (LC) is a common surgical method for the treatment of gallbladder diseases. However, some patients experience symptoms such as dyspepsia after surgery, which can affect their quality of life. Compound azinomide enteric-coated tablets, a novel drug, may improve dyspeptic symptoms after LC. This study was conducted to explore the clinical efficacy of compound azinomide enteric-coated tablets in treating post-LC dyspepsia symptoms through a multicenter clinical trial.Methods A multicenter, superior efficacy, open-label, parallel-controlled design was used. Patients with postoperative dyspepsia were enrolled in 7 centers between January 2023 and May 2024. Patients were randomly assigned to either the observation or control groups using a random number table. The observation group received compound azinomide enteric-coated tablets, while the control group was treated with a combination of oryzae pancreatin tablets and ursodeoxycholic acid tablets. Both groups were treated for 4 weeks. The primary endpoints included gastrointestinal symptom scores and quality of life scores assessed before and at 14 and 28 d after treatment. Additionally, the incidence of adverse reactions and cost-effectiveness ratio (CER) were compared between the groups.Results A total of 303 patients were included, with 150 in the observation group and 153 in the control group. Baseline characteristics were balanced between the groups before treatment (all P>0.05). After treatment, the observation group showed significantly higher effective rates at 14 d and 28 d than the control group (44.7% vs. 29.4%; 98.0% vs. 73.9%, both P<0.05). The observation group also had significantly lower symptom scores and quality of life scores at both 14 and 28 d, with a significantly higher improvement rate in symptom scores compared to the control group (all P<0.05). Further analysis of the improvement rate and treatment efficacy for individual symptoms revealed that, except for the 14-d improvement in abdominal pain/discomfort, the observation group showed better improvement in all other symptoms at 14 d and in all symptoms at 28 d compared to the control group (all P<0.05). No adverse reactions were observed in either group. The CER for the observation group was 283.78 yuan/efficacy rate at 14 d and 128.57 yuan/efficacy rate at 28 d, while the control group's CER was 729.93 yuan/efficacy rate at 14 d and 290.22 yuan/efficacy rate at 28 d.Conclusion Compound azinomide enteric-coated tablets demonstrated good clinical efficacy in treating dyspepsia symptoms after LC with excellent safety and high cost-effectiveness. Despite some limitations, the results provide a new treatment option for dyspepsia after LC. Larger-scale randomized controlled trials are needed to validate this study's conclusions further.