中国医刊
中國醫刊
중국의간
Chinese Journal of Medicine
2015年
11期
58-61
,共4页
吴咏冬%胡善联%何江江%张澍田%于中麟%谢鹏雁%郝建宇%王邦茂%董雷
吳詠鼕%鬍善聯%何江江%張澍田%于中麟%謝鵬雁%郝建宇%王邦茂%董雷
오영동%호선련%하강강%장주전%우중린%사붕안%학건우%왕방무%동뢰
复方消化酶%消化不良%多中心%随机对照研究%药物经济学评价
複方消化酶%消化不良%多中心%隨機對照研究%藥物經濟學評價
복방소화매%소화불량%다중심%수궤대조연구%약물경제학평개
Compound digestive enzyme%Dyspepsia%Multicenter%Randomized controlled trial%Pharmacoeconomics evaluation
目的 评价复方消化酶片治疗中国消化不良人群的有效性及经济学特性. 方法 8个中心采用随机、双盲双模拟、阳性药物平行对照的方法,将203例消化不良患者随机分为两组,试验组( A组,106例)为复方消化酶片1片,1日3次;对照组( B组,91例)为复方消化酶胶囊2粒,1日3次. 治疗2周. 观察两组主要疗效指标和次要疗效指标;以日治疗费用和每例患者直接医疗成本评价其经济性. 结果 试验组与对照组的主要疗效指标和次要疗效指标相似,总有效率分别为80. 2℅和19. 4℅(P>0. 05). 试验组平均日治疗费用和每例患者直接医疗成本分别比对照组低1. 59元和22. 26元. 结论 复方消化酶片治疗消化不良有良好的临床疗效及安全性,与对照组比较具有一定的成本优势.
目的 評價複方消化酶片治療中國消化不良人群的有效性及經濟學特性. 方法 8箇中心採用隨機、雙盲雙模擬、暘性藥物平行對照的方法,將203例消化不良患者隨機分為兩組,試驗組( A組,106例)為複方消化酶片1片,1日3次;對照組( B組,91例)為複方消化酶膠囊2粒,1日3次. 治療2週. 觀察兩組主要療效指標和次要療效指標;以日治療費用和每例患者直接醫療成本評價其經濟性. 結果 試驗組與對照組的主要療效指標和次要療效指標相似,總有效率分彆為80. 2℅和19. 4℅(P>0. 05). 試驗組平均日治療費用和每例患者直接醫療成本分彆比對照組低1. 59元和22. 26元. 結論 複方消化酶片治療消化不良有良好的臨床療效及安全性,與對照組比較具有一定的成本優勢.
목적 평개복방소화매편치료중국소화불량인군적유효성급경제학특성. 방법 8개중심채용수궤、쌍맹쌍모의、양성약물평행대조적방법,장203례소화불량환자수궤분위량조,시험조( A조,106례)위복방소화매편1편,1일3차;대조조( B조,91례)위복방소화매효낭2립,1일3차. 치료2주. 관찰량조주요료효지표화차요료효지표;이일치료비용화매례환자직접의료성본평개기경제성. 결과 시험조여대조조적주요료효지표화차요료효지표상사,총유효솔분별위80. 2℅화19. 4℅(P>0. 05). 시험조평균일치료비용화매례환자직접의료성본분별비대조조저1. 59원화22. 26원. 결론 복방소화매편치료소화불량유량호적림상료효급안전성,여대조조비교구유일정적성본우세.
Objective The study was undertaken to demonstrate the clinical efficacy and cost-effectiveness of com-pound digestive enzymes tablet in the treatment of dyspepsia under various physiological gastrointestinal conditions. Method This was a multicenter(8 hospitals),randomized,double blind,parallel group,and double dummy study. The trial comprised a total of 203 outpatients who were randomized to treatment with dyspepsia syndrome. The A Group( experimental group) was comprised of 106 patients who were given 1 tablet of compound digestive enzymes tablet( Bearse) 3 times per day. The B Group( control group) of 91 patients was given 2 capsules of compound di-gestive enzyme capsule( Dages) 3 times per day. The total duration of drug treatment was 2 weeks. The primary end-point was the total effective rate of all dyspepsia symptoms. The second endpoint was cost-effectiveness of the com-pound digestive enzymes tablet in the treatment of dyspepsia. Result The total efficacy rate of group A and group B were 80.2℅ and 19. 4℅(P>0. 05). The adverse effects in group A and group B were 1. 9℅ and 4. 1℅(P>0. 05). The adverse effects were mild in all the two groups. The daily drug costs and total direct medical costs with Bearse were lower than Dages RMB 1. 59/day and RMB 22. 26/day respectively. Conclusion Compound digestive enzymes tablet and compound digestive enzyme capsule are both effective and safety in patients with dyspepsia. Com-pound digestive enzymes tablet has a better benefit-cost ratio than compound digestive enzyme capsule.