铝碳酸镁联合质子泵抑制剂治疗内镜黏膜下剥离术后人造溃疡的随机对照研究

Hydrotalcite combined with proton pump inhibitor in treatment of post endoscopic submucosal dis- section nicer： a randomized,controlled clinical trial

目的比较铝碳酸镁联合质子泵抑制剂（PPI）或单用PPI治疗内镜黏膜下剥离术（ESD）后人造溃疡的效果。方法81例ESD术后患者，采用随机对照研究，随机分为PPI组（40例）和联合用药组（41例）。对比2组患者的手术迟发出血率，并于1周后对比2组上腹部症状积分，于手术4周后对比2组溃疡大小及愈合率。结果2组患者术后迟发出血率差异无统计学意义（7．5％比4．9％，P〉0．05）。1周后联合用药组患者的上腹饱胀、上腹痛症状严重程度积分（0．70、0．45）和发生频率积分（1．34、1．22）均优于PPI组症状严重程度积分（0．83、0．65）和发生频率积分（1．92、1．62）（P均〈0．05），而嗳气、恶心症状严重程度和发生频率积分2组差异无统计学意义（P〉0．05）。4周后联合用药组溃疡直径（6．1±2．9）mm明显小于PPI组（10．8±4．8）mm（P〈0．05），且联合用药组溃疡愈合率（82．4±8．9）％，也明显高于PPI组的（70．4±13．2）％（P〈0．05）。结论在PPI应用基础上加用铝碳酸镁，能有效改善患者上消化道症状和促进ESD术后人造溃疡愈合。

Objective To evaluate the therapeutic efficacy of a combination of proton pump inhibi- tor（PPI） and hydrotaleite for endoscopic submucosal dissection （ESD） induced ulcer. Methods Eighty- one consecutive patients who underwent ESD were randomly assigned to either the group of PPI and hydrotal- cite therapy （drug combination group, n = 41 ） or the PPI group （n = 40）. Delayed bleeding rates were mo- nitored and compared. The main upper abdomen symptoms 1-wk later and ulcer healing rates and ulcer diam- eter 4-wk later were compared between the two groups. Results There was no significant difference in de- layed bleeding rate （ P 〉 0. 05 ）. At the end of first week after ESD, the combination therapy was significant- ly more effective than the PPI alone in reducing frequencies and severity of upper abdominal pain and upper abdominal distention, while there was no significant difference between the two groups in relieving belch and nausea. A better ulcer healing rates and a smaller ulcer diameter were observed in the combination group at the end of 4 weeks （P 〈 0. 05 ）. Conclusion The combination therapy of hydrotalcite and PPI can relieve upper abdominal symptoms and improve the healing rate of ESD induced ulcer.