CAJ | 학술논문

目的探讨碳酸钙口服混悬液与质子泵抑制剂在改善酸相关性疾病临床症状方面的疗效及安全性.方法采用多中心随机对照研究方法,将400例14～70岁且至少有一个中度或重度症状(反酸、上腹痛、上腹不适、上腹烧灼感、上腹胀满)的酸相关性疾病患者均分为两组,分别予碳酸钙口服混悬液和奥美拉唑肠溶片治疗.观察所有患者第1次服药至临床症状缓解起效时间,服药后第3、7天临床症状改善情况,并记录患者的不良反应.统计学处理采用方差分析.结果碳酸钙组患者第1次服药后反酸、上腹痛、上腹不适、上腹烧灼感、上腹胀满等症状的平均缓解起效时间明显快于奥美拉唑组(F=4.866、8.142、41.366、6.955、35.252,P均＜0.05).服药后第3天,碳酸钙组与奥美拉唑组的治疗有效率分别为69.50％、72.50％；服药后第7天,碳酸钙组与奥美拉唑组的治疗有效率分别为92.00％、96.50％.服药后第3、7天两组治疗有效率及综合疗效差异均无统计学意义(P均＞0.05).碳酸钙组中,轻度不良反应14例,中度不良反应2例；奥美拉唑组中,轻度不良反应10例.两组相比,差异无统计学意义(P＞0.05).结论碳酸钙口服混悬液比质子泵抑制剂缓解酸相关性疾病症状更快速,能有效改善酸相关性疾病的症状.
목적 탐토탄산개구복혼현액여질자빙억제제재개선산상관성질병림상증상방면적료효급안전성.방법 채용다중심수궤대조연구방법,장400례14～70세차지소유일개중도혹중도증상(반산、상복통、상복불괄、상복소작감、상복창만)적산상관성질병환자균분위량조,분별여탄산개구복혼현액화오미랍서장용편치료.관찰소유환자제1차복약지림상증상완해기효시간,복약후제3、7천림상증상개선정황,병기록환자적불량반응.통계학처리채용방차분석.결과 탄산개조환자제1차복약후반산、상복통、상복불괄、상복소작감、상복창만등증상적평균완해기효시간명현쾌우오미랍서조(F=4.866、8.142、41.366、6.955、35.252,P균＜0.05).복약후제3천,탄산개조여오미랍서조적치료유효솔분별위69.50％、72.50％；복약후제7천,탄산개조여오미랍서조적치료유효솔분별위92.00％、96.50％.복약후제3、7천량조치료유효솔급종합료효차이균무통계학의의(P균＞0.05).탄산개조중,경도불량반응14례,중도불량반응2례；오미랍서조중,경도불량반응10례.량조상비,차이무통계학의의(P＞0.05).결론 탄산개구복혼현액비질자빙억제제완해산상관성질병증상경쾌속,능유효개선산상관성질병적증상.
Objective To study the efficacy and safety of oral calcium carbonate suspension and proton pump inhibitors (PPI) in symptoms relief of acid related diseases.Methods The multi-center,randomized and controlled study was carried out.A total of 400 acid-related diseases patients from 14 to 70 years old with at least one of moderate or severe symptoms such as acid regurgitation,epigastric pain,epigastric discomfort,upper abdominal burning or distension were equally divided into two groups and treated with oral calcium carbonate suspension or omeprazole enteric-coated tablets.The onset of symptoms relief of all patients of the first time after taking medicine was observed.The relief of clinical symptoms at the third day and seventh day after taking medicine was also observed.The adverse events were recorded.Analysis of variance was performed for statistical analysis.Results The onset of symptoms relief of oral calcium carbonate suspension group in acid regurgitation,epigastric pain,epigastric discomfort,upper abdominal burning or distension of the first time after taking medicine were significantly faster than those of PPI group (F=4.866,8.142,41.366,6.955,35.252; all P＜0.05).At the third day after taking medicine,the treatment efficiency of oral calcium carbonate suspension group and PPI group were 69.50％ and 72.50％,and at the seventh day the treatment efficiency of oral calcium carbonate suspension group and PPI group were 92.00％ and 96.50％.There was no significant difference in treatment efficiency and comprehensive efficacy between two groups at day three and seven after taking medicine (both P＞ 0.05).There were 14 cases of mild adverse events and two cases of moderate adverse events in oral calcium carbonate suspension group.There were 10 cases of mild adverse events in PPI group.There was no significant difference between two groups (P＞0.05).Conclusion Oral calcium carbonate suspension provides faster symptom relief than PPI and can effectively improve the symptoms of acid-related diseases.