摘要
目的评估复方阿嗪米特肠溶片对胆囊切除术后消化不良的临床疗效和安全性。方法采用多中心、随机、双盲、安慰剂平行对照的研究方法，将120例胆囊切除术后消化不良的患者分为阿嗪米特组60例和安慰剂组60例，口服复方阿嗪米特肠溶片或匹配的安慰剂100mg／次，3次／d，连续服用28d。治疗前和治疗第7、14、21、28天评估两组患者消化不良症状（腹胀、食欲不振、早饱、嗳气、恶心、腹痛或腹部不适）积分和总积分。治疗第28天比较两组消化不良症状改善有效率并进行安全性评估。治疗前和治疗第28天比较两组患者的生活质量评分。应用t检验或卡方检验进行统计学分析。结果阿嗪米特组在治疗第7天的腹胀、嗳气、恶心和腹痛或腹部不适症状积分和总积分（5．7±3．1、3．5±2．1、0．3±0．1、3．3±1．7、17．9±9．6）较治疗前（8．9士5．3、5．3±2．5、0．9±0．4、4．5±3．7、24．3±14．5）明显降低（t=3．758、3．976、10．494、2。125、2．654，P均d0．05），在治疗第14、21、28天各消化不良症状积分和总积分均较治疗前显著降低；安慰剂组在治疗第7、14、21、28天腹胀较治疗前明显改善，在治疗第28天早饱症状积分和总积分较治疗前显著降低。阿嗪米特组总有效率为66．7％（40／60），高于安慰剂组的38．3％（23／60），差异有统计学意义（X2=9．653，P〈O．01）。治疗第28天，阿嗪米特组简明尼平消化不良指数（SF-NDI）量表总评分为4．4士3．4，低于安慰剂组的9．6±6．0，差异有统计学意义（t=5．450，P〈O．01）。阿嗪米特组t例患者于治疗第7天发生皮疹，安慰剂组1例患者于治疗第14天发生头痛，停药处理7d后症状消失。结论复方阿嗪米特肠溶片能有效改善胆囊切除术后的消化不良症状，提高患者生活质量，安全性好。
Objective To evaluate the efficacy and safety of compound azintamide enteric-coated tablet in the treatment of patients with post-cholecystectomy dyspepsia. Methods A multicentre, randomized, double-blinded, placebo-controlled trail was conducted. A total of 120 patients with post- cholecystectomy dyspepsia were divided into azintamide group （n= 60） and placebo group （n= 60）, taking compound azintamide enteric-coated tablet or placebo 100 mg each time, three times per day for 28 days. The score of each dyspeptic symptom （abdominal distension, loss of appetite, early satiety, belching, nausea, abdominal pain or abdominal discomfort） and total score of dyspepsia were evaluated prior to study and on the 7th, 14th, 21st and 28th day after treatment. The efficacy of the improvement of dyspeptic symptoms was compared between the two groups on the 28th day after treatment and the safety was evaluated. The score of the quality-of-life was compared between the two groups prior to study and on the28th day after treatment. The t-test or chi-square test was performed for statistical analysis. Results The scores of abdominal distension, belching, nausea, abdominal pain or abdominal discomfort and the total score of azintamide group on the 7th day after treatment （5.7±3.1, 3.5±2.1, 0.3±0.1, 3.3±1.7 and 17.9 ±9.6） were significantly lower than those prior to study （8.9±5.3,5.3 ±2.5,0.9 ± 0.4,4.5± 3.7, 24.3±14.5±3. 758, 3. 976, 10. 494, 2. 125 and 2. 654,all P〈0.05）. On the 14th, 21st and 28th day after treatment in azintamide group, the score of each dyspeptic symptom and the total score were lower than those prior to study. The symptom of abdominal distension significantly improved on the 7th, 14th, 21st and 28th day after treatment in placebo group, and the score of early satiety and total score of dyspepsia were significantly lower on the 28th day after treatment compared with those before treatment. In azintamide group, the total efficacy rate was 66.7 %（40/60）, which was higher than that of placebo group （38.3%, 23/60） and the difference was statistically significant （X2 = 9. 653, P 〈 0.01）. On the 28th day after treatment, SF-NDI of azintamide group was 4.4±3.4, which was significantly lower than that of placebo group （9.6 ±6.0） and the difference was statistically significant （t= 5. 450, P〈0.01）. In azintamide group there was one patient with rash on the 7th day after treatment, and in placebo group there was one patient with headache on the 14th day after treatment. The symptoms disappeared seven days after medicine withdrawal. Conclusion Compound azintamide enteric-coated tablet effectively improves dyspeptic symptoms and quality of life in patients with post-cholecystectomy dyspepsia and has good safety.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2014年第3期178-182,共5页
Chinese Journal of Digestion
关键词
复方阿嗪米特肠溶片
胆囊切除术后综合征
消化不良
随机对照试验
Compound azintamide enteric-coated tablets
Postcholecystectomy syndrome
Dyspepsia
Randomized controlled trial
