CAJ | 학술논문

目的探讨链霉蛋白酶颗粒提高胃镜检查可见度的有效性及安全性.方法 4个中心采用随机、双盲、安慰剂平行对照法,将需要进行胃镜检查的门诊或住院患者240例随机分为试验组与对照组.试验组药物为链霉蛋白酶颗粒剂20 000单位/袋,对照组药物为安慰剂(乳糖、羟丙纤维素颗粒剂)0.5g/袋.试验组与对照组均为1袋药物与碳酸氢钠1.0g在50 ml蒸馏水(20℃～40℃)中振荡溶解后服用.胃镜下观察胃腔各部位的黏液附着量及厚度情况,并进行评分,对比分析两组清洁疗效及不良反应发生情况.结果两组总有效率比较,试验组高于对照组[63.33％(76/120)比45.83％(55/120),P＜0.05];两组胃体部及胃窦部附着黏液量与厚度合计评分比较,试验组均明显低于对照组(胃体部:1.68±1.51比2.14±1.47,P＜0.05;胃窦部:1.59±1.58比2.05±1.53,P＜0.05);胃底部合计评分差异无统计学意义(P＞0.05).在安全性方面,试验组不良事件发生率为5.08％ (6/118),对照组不良事件发生率为6.67％(8/120),差异无统计学意义(P＞0.05),且均未发生明确与药物相关的药物不良反应.结论链霉蛋白酶颗粒用于胃镜检查,可明显减少胃黏膜表面附着的黏液,有效提高镜下可见度,从而显著提高胃镜对微小病变的诊断能力,并且安全性较好.
목적 탐토련매단백매과립제고위경검사가견도적유효성급안전성.방법 4개중심채용수궤、쌍맹、안위제평행대조법,장수요진행위경검사적문진혹주원환자240례수궤분위시험조여대조조.시험조약물위련매단백매과립제20 000단위/대,대조조약물위안위제(유당、간병섬유소과립제)0.5g/대.시험조여대조조균위1대약물여탄산경납1.0g재50 ml증류수(20℃～40℃)중진탕용해후복용.위경하관찰위강각부위적점액부착량급후도정황,병진행평분,대비분석량조청길료효급불량반응발생정황.결과 량조총유효솔비교,시험조고우대조조[63.33％(76/120)비45.83％(55/120),P＜0.05];량조위체부급위두부부착점액량여후도합계평분비교,시험조균명현저우대조조(위체부:1.68±1.51비2.14±1.47,P＜0.05;위두부:1.59±1.58비2.05±1.53,P＜0.05);위저부합계평분차이무통계학의의(P＞0.05).재안전성방면,시험조불량사건발생솔위5.08％ (6/118),대조조불량사건발생솔위6.67％(8/120),차이무통계학의의(P＞0.05),차균미발생명학여약물상관적약물불량반응.결론 련매단백매과립용우위경검사,가명현감소위점막표면부착적점액,유효제고경하가견도,종이현저제고위경대미소병변적진단능력,병차안전성교호.
Objective To assess the efficacy and security of premedication of pronase granules during gastroendoscopy.Methods Two hundred and forty patients were divided into a treatment group and a control group randomly.The treatment group received pronase granules 20 000 unit/bag,while the control received placebo (maltose and hyprolose granules 0.5 g/bag),each bag mixed with 0.1 g sodium bicarbonate,dissolved in 50 ml distilled water (20℃-40℃).The visibility score and the adverse reactions were observed and assessed during gastroscopy.Results The total effectiveness rate of treatment group was higher than that of the controlled group [63.33％ (76/120) vs.45.83％ (55/120),P ＜ 0.05].Premedication with pronase (the treatment group) had significantly lower visibility score (P ＜ 0.05) in comparison with that obtained for premedication without pronase (the controlled group).In terms of security,the incidence of adverse events was 5.08％ (6/118) in the treatment group while it was 6.67％ (8/120) in the controlled group,which were not statistically different.No obvious drug-related adverse reaction was found in the two groups.Conclusion Premedication with pronase granules effectively improves gastroscopic visualization,and significantly reduces the gastric mucus before gastroscopy and improves the detection of small lesions of stomach.