CAJ | 학술논문

目的评价复方消化酶片治疗中国消化不良人群的有效性和安全性.方法选取2011年10月至2012年8月7个中心的门诊患者.采用随机、双盲双模拟、阳性药物平行对照法,将203例消化不良患者按随机数字表法分为两组,观察组(A组,106例)为复方消化酶片1片+复方消化酶胶囊模拟剂2粒,3次/d;对照组(B组,97例)为复方消化酶胶囊2粒+复方消化酶片模拟剂1片,3次/d.治疗2周.随访3次(0、1、2周).以2周后消化不良症状总有效率为评价指标,评价试验药物的有效性,并评价其安全性.结果观察组与对照组治疗消化不良的总有效率分别为80.2％ (85/106)和79.4％ (77/97);观察组与对照组不良反应发生率分别为1.9％(2/106)和4.1％(4/97),差异均无统计学意义(均P＞0.05).结论复方消化酶片治疗消化不良有良好的临床疗效,无严重药物不良反应,患者耐受性好;其有效性和安全性与复方消化酶胶囊相当.
목적 평개복방소화매편치료중국소화불량인군적유효성화안전성.방법 선취2011년10월지2012년8월7개중심적문진환자.채용수궤、쌍맹쌍모의、양성약물평행대조법,장203례소화불량환자안수궤수자표법분위량조,관찰조(A조,106례)위복방소화매편1편+복방소화매효낭모의제2립,3차/d;대조조(B조,97례)위복방소화매효낭2립+복방소화매편모의제1편,3차/d.치료2주.수방3차(0、1、2주).이2주후소화불량증상총유효솔위평개지표,평개시험약물적유효성,병평개기안전성.결과 관찰조여대조조치료소화불량적총유효솔분별위80.2％ (85/106)화79.4％ (77/97);관찰조여대조조불량반응발생솔분별위1.9％(2/106)화4.1％(4/97),차이균무통계학의의(균P＞0.05).결론 복방소화매편치료소화불량유량호적림상료효,무엄중약물불량반응,환자내수성호;기유효성화안전성여복방소화매효낭상당.
Objective To explore the clinical efficacy and safety of compound digestive enzyme tablet in the treatment of dyspepsia.Methods A randomized,double-blind,double-dummy,positive drug parallel controlled,multicenter clinical trial was conducted for 203 dyspeptic patients from October 2011 to August 2012.And they were randomized into group A (experimental,n =106) and group B (control,n =97).Group A received 1 tablet of compound digestive enzyme tablet (Bearse) plus 2 analog capsules of compound digestive enzyme thrice daily.And group B had 2 capsules of compound digestive enzyme capsule (Dages) plus 1 analog tablet of compound digestive enzyme thrice daily.The total duration of drug treatment was 2 weeks.There were 3 follow-up visits (W0,W1,W2).The primary endpoint was the total effective rate of all dyspeptic symptoms.Results The total efficacy rate of groups A and B were 80.2％ (85/106) and 79.4％ (77/97) (P ＞ 0.05).The adverse effects were 1.9 ％ (2/106) and 4.1％ (4/97) in groups A and B (P ＞ 0.05).The adverse effects were mild in both groups.Conclusions Compound digestive enzyme tablet and capsule are effective and safe for patients with dyspepsia.And compound digestive enzymes tablet is comparable to compound digestive enzyme capsule.