链霉蛋白酶颗粒用于胃镜检查过程中祛除胃内黏液的多中心随机对照研究

【摘要】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20000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50rrIl蒸馏水（20℃一40℃）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2．144-1．47，P〈0．05；胃窦部：1．59±1．58比2．054-1．53，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。

Multicenter study of premedication of pronase granules to improve visibility during gastroendoscopy

Objective To assess the efficacy and security of premedication of pronase granules dur- ing 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 bicarbon- ate, dissolved in 50 ml distilled water （20℃-40℃ ）. The visibility score and the adverse reactions were ob- served 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.