中华消化杂志
中華消化雜誌
중화소화잡지
Chinese Journal of Digestion
2008年
3期
179-182
,共4页
柯美云%孙晓红%钱家鸣%邹多武%许国铭%赵卡冰%程留芳
柯美雲%孫曉紅%錢傢鳴%鄒多武%許國銘%趙卡冰%程留芳
가미운%손효홍%전가명%추다무%허국명%조잡빙%정류방
消化不良%药物治疗%复方消化酶%临床试验
消化不良%藥物治療%複方消化酶%臨床試驗
소화불량%약물치료%복방소화매%림상시험
Dyspepsia%Drug therapy%Compound digestive enzymes%Clinical trial
目的 评估复方消化酶(商品名:美尼)治疗消化不良的疗效和安全性.方法 采用随机双盲、安慰剂平行对照的多中心研究.应用视觉模拟评分法(visual analogue scale,VAS),食欲不振、饱胀、腹部不适和腹胀症状总积分≥20分的消化不良患者240例,随机均分为安慰剂组和治疗组,分别服用安慰剂和复方消化酶2粒/次,3次/d,疗程为2周;评价两组在治疗1、2周和停药后1周消化不良症状的缓解程度和不良反应的发生.结果 216例患者完成本研究,其中治疗组105例,安慰剂组111例.治疗组在治疗1、2周及停药1周消化不良总症状积分下降程度明显优于安慰剂组(P＜0.01);治疗组在治疗1、2周和停药后1周总有效率分别为64.76%、77.05%和66.99%,明显高于安慰剂组的27.93%、37.84%和29.36%(P＜0.05).两组在治疗过程中及停药后均未出现严重不良反应.结论 复方消化酶治疗消化不良具有良好的疗效及安全性.
目的 評估複方消化酶(商品名:美尼)治療消化不良的療效和安全性.方法 採用隨機雙盲、安慰劑平行對照的多中心研究.應用視覺模擬評分法(visual analogue scale,VAS),食欲不振、飽脹、腹部不適和腹脹癥狀總積分≥20分的消化不良患者240例,隨機均分為安慰劑組和治療組,分彆服用安慰劑和複方消化酶2粒/次,3次/d,療程為2週;評價兩組在治療1、2週和停藥後1週消化不良癥狀的緩解程度和不良反應的髮生.結果 216例患者完成本研究,其中治療組105例,安慰劑組111例.治療組在治療1、2週及停藥1週消化不良總癥狀積分下降程度明顯優于安慰劑組(P＜0.01);治療組在治療1、2週和停藥後1週總有效率分彆為64.76%、77.05%和66.99%,明顯高于安慰劑組的27.93%、37.84%和29.36%(P＜0.05).兩組在治療過程中及停藥後均未齣現嚴重不良反應.結論 複方消化酶治療消化不良具有良好的療效及安全性.
목적 평고복방소화매(상품명:미니)치료소화불량적료효화안전성.방법 채용수궤쌍맹、안위제평행대조적다중심연구.응용시각모의평분법(visual analogue scale,VAS),식욕불진、포창、복부불괄화복창증상총적분≥20분적소화불량환자240례,수궤균분위안위제조화치료조,분별복용안위제화복방소화매2립/차,3차/d,료정위2주;평개량조재치료1、2주화정약후1주소화불량증상적완해정도화불량반응적발생.결과 216례환자완성본연구,기중치료조105례,안위제조111례.치료조재치료1、2주급정약1주소화불량총증상적분하강정도명현우우안위제조(P＜0.01);치료조재치료1、2주화정약후1주총유효솔분별위64.76%、77.05%화66.99%,명현고우안위제조적27.93%、37.84%화29.36%(P＜0.05).량조재치료과정중급정약후균미출현엄중불량반응.결론 복방소화매치료소화불량구유량호적료효급안전성.
Objective To investigate the efficacy and safety of Minilase-S on patients with dyspepsia.Methods A randomized,placebo-controlled,double blind and multicenter study was conducted.Two hundred and forty patients with dyspepsia symptoms(anorexia,fullness,abdominal discomfort and distension)were collected according to total symptom scores over 20 with visual analog scales.Each patient was randomly received either Minilase-S(2 capsules t.i.d)or placebo(2 capsules t.i.d)for 2 weeks.The symptoms scores were evaluated at treatment week 1,week 2,and 1 week after discontinued therapy.Results Two hundred and sixteen patients(105 patients in Minilase group and 111 patients in placebo group)finished the study.There was no difference in demographic data,anorexia,fullness,discomfort and distension score and the total symptom score between two groups.However,at treatment week 1,week 2 and 1 week after discontinued therapy,symptoms and total symptom score were significantly decreased in Minilase-S group compared to placebo group(all P value＜0.05).The total effective rates in treatment week 1,week 2 and 1 week after discontinued therapy were 64.76%,77.05%and 66.99%,respectinely,which were higer that those in placebo group(27.93%,37.84% and 29.36%,respectively)(P＜0.05).There was no severe side effects in both Minilase-S and placebo groups.Conclusions Minilase-S can significantly improve symptoms in patients with dyspepsia,which may be as one choice in the management of dyspepsia or in combined therapy.
