L-薄荷醇制剂在上消化道内镜检查中抑制胃蠕动的有效性和影响因素研究被引量：2

Effects of L-menthol on suppression of gastric peristalsis during upper gastrointestinal endoscopy and the influencing factors

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摘要目的评价L-薄荷醇制剂(NPO-11)在上消化道内镜检查中单次喷洒抑制胃蠕动的有效性和相关影响因素。方法采用多中心、随机、双盲、安慰剂平行对照试验方法, 将符合条件的患者按区组随机方法分为两组, 在上消化道内镜检查中分别局部喷洒NPO-11(含有效成分L-薄荷醇160 mg)或安慰剂20 mL。记录评估给药前、给药后2 min、内镜检查结束时的胃蠕动情况, 由术者评估操作难易程度, 并分析NPO-11抑制胃蠕动有效性的影响因素。结果 5家研究中心共入组220例患者。NPO-11组共109例, 安慰剂组111例, 两组基线资料相似, 具有可比性。试验药物给药后2 min及内镜检查结束时两个时间点蠕动分级均为1级的受试者比例, NPO-11组为40.37%(44/109), 安慰剂组为16.22%(18/111), 差异具有统计学意义(χ^(2)=15.93, P<0.001), 在上述两个时间点, 与安慰剂组相比, NPO-11组较弱蠕动(1级和2级)的比例分别为67.89%(74/109)、79.82%(87/109), 比安慰剂组46.85%(52/111)、48.65%(54/111)更高;亚组分析显示NPO-11对胃蠕动的抑制效果在幽门螺杆菌抗体阳性组更显著。结论在上消化道内镜检查中, NPO-11局部喷洒可有效抑制胃蠕动, 其效果在幽门螺杆菌抗体阳性组更显著。其安全性较好, 未见明显不良反应。操作者评估胃镜操作较容易。 Objective:To evaluate the ffeets of single spay of L-menthol(NP0-11)on suppressing gastrie peristalsis during upper gastrointestinal endoscopy and the inluenping factor.Methods This study was a multicenter,randomized,double-blind,placebo-parallel controlled study.The eligible patients were randomly divided into two groups by randomized blocks.Patients received local spray of either NP0-11(160 mg L-menthol)or placebo 20 ml during upper gastrointestinal endoscopy.The gastrie peristalsis was recorded and evaluated before.2 minutes after and at the end of endoseopy.The complexity of the procedure was evaluated by the researchers.The infuencing factors for antiperistalice efet of NP0-11 were analyzed.Results A total of 220 patients were enrolled from five research centers.There were 109 cases in the NP0-11 group and 111 cases in the placebo group.The baseline data of the two groups were similar and comparable.The proportion of patients with grade I peristalsis at 2 minutes after the treatment and at the end of endoscopy was significantly higher in the NPO-11 group than that in the placebo group[40.37%(44/109)VS 16.22%(18/111).χ^(2)=15.93.P<0.001].Compared with the placebo group.the proportions of weak peristalsis(grade 1 and 2)were higher in the NP0-11 group al 2 minutes after the treatment[67.89%(74/109)VS 46.85%(52/111)]and at the end of endoscopy[79.82%(87/109)VS 48.65%(54/111)].Subgroup analysis showed that the inhibitory efect of NP0-11 on gastric peristalsis was more signifcant in Helicobacter pylori antibody positive group.Conclusion Local spray of NP0-11 ecan ffectively inhibit gastric peristalsis during upper gastrointestinal endoscopy,and its ffeet is more significant in Helicobacter pylori antibody positive group.It could be recommended for no obv ious adverse reactions.is safely,and the convenient procedure.

作者李文燕孟凡冬张澍田智发朝李兆申薛战雄和水祥陈巍峰陈萦晅邢象斌姚晨吴咏冬 Li Wen-yan;Meng Fandong;Zhang Shutian;Zhi Fachao;Li Zhaoshen;Xue Zhanxiong;He Shuixiang;Chen Weifeng;Chen Yingxuan;Xing Xiangbin;Yao Chen;Wu Yongdong(Department of Gastroenterology,Beijing Friendship Hospital,Capital Medical University,National Clinical Research Center for Digestive Diseases,Beijing 100050,China;Department of Gastroenterology,Nanfang Hospital of Southern Medical University,Guangzhou 510515,China;department of Gastroenterology,The First Affiliated Hospital of Naval Medical University,Shanghai 200433,China;Department of Gastroenterology,The Second Affiliated Hospital of Wenzhou Medical University,Wenzhou 325088,China;Department of Gastroenterology,The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China;Department of Gastroenterology,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Gastronterology,Renji Hospital,Shanghai Jiaotong Unirersity School of Medicine.Shanghai 200120,China;Department of Gastroenterology,The First Affiliated Hospital,Sun Yal-sen Universily,Guangzhou 510062,China;Department of Medical Stalistis Peking University First Hospital,Bejing 100034,China)