预用改良二甲硅油和碳酸氢钠对上消化道内镜检查时黏膜可视性的改善作用：一项双盲、多中心、随机对照试验。
Premedication with reformulated simethicone and sodium bicarbonate improves mucosal visibility during upper gastrointestinal endoscopy: a double-blind, multicenter, randomized controlled trial.
机构信息
Department of Gastroenterology, Sir Run Run Shaw Hospital Affiliated To Zhejiang University, 3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China.
Department of Endoscopy Lab, Qingdao Municipal Hospital, 1 Jiaozhou Road, North District, Qingdao, Shangdong, China.
出版信息
BMC Gastroenterol. 2021 Mar 18;21(1):124. doi: 10.1186/s12876-021-01623-w.
BACKGROUND
The reformulated simethicone emulsion from Berlin Chemical AG might develop white flocculate precipitate covering the gastric mucosa when used before esophagogastroduodenoscopy (EGD). We aim to investigate whether combining the reformulated simethicone emulsion with 5% sodium bicarbonate solution could prevent the development of white precipitate and improve visibility during EGD.
METHODS
Our clinical study involved 523 patients. They were randomly assigned to two groups. In Group A, patients received a warm solution containing 30 ml 5% sodium bicarbonate solution and 15 ml reformulated simethicone emulsion. In Group B, patients received 45 ml 40 °C lukewarm water. Visibility scores were recorded and analyzed. Flushes, volume of flush water, overall time taken for EGD and complications during or after the procedure were also recorded.
RESULTS
We found that no white precipitate was observed during EGD in Group A. Moreover, visibility scores in Group A were significantly lower (P < 0.01). Patients in Group A had fewer flushes (P < 0.01) and smaller volume of flush water (P < 0.01). In addition, the overall time taken for the EGD procedure was significantly shorter in Group A (P < 0.01). The percentage of patients who had no adverse response was significantly higher in Group A than in Group B (P < 0.01).
CONCLUSIONS
Premedication with a mixed solution of 15 ml reformulated simethicone emulsion and 30 ml 5% sodium bicarbonate solution can prevent the development of white precipitate, substantially enhancing mucosal visibility safely.
TRIAL REGISTRATION
The registered name of the trial is "Efficacy of using premedication with reformulated simethicone emulsion during upper gastrointestinal endoscopy examination". Its Current Controlled Trials number is ChiCTR1900021689. Its date of registration is 11 September 2019. Retrospectively registered, http://www.medresman.org.cn/uc/sindex.aspx .
背景
柏林化学股份有限公司生产的新型二甲硅油乳液在进行上消化道内镜检查（EGD）前使用时，可能会在胃黏膜上形成白色絮状沉淀物。我们旨在研究新型二甲硅油乳液与 5%碳酸氢钠溶液联合使用是否可以预防白色沉淀物的形成，并提高 EGD 期间的可视性。
方法
我们的临床研究纳入了 523 名患者，将其随机分为两组。在 A 组中，患者接受含有 30ml 5%碳酸氢钠溶液和 15ml 新型二甲硅油乳液的温热溶液。在 B 组中，患者接受 45ml 40°C 温水。记录并分析可视度评分。还记录冲洗次数、冲洗水量、整个 EGD 时间以及操作过程中和操作后出现的并发症。
结果
我们发现 A 组在 EGD 过程中未观察到白色沉淀物，且 A 组的可视度评分明显较低（P<0.01）。A 组患者的冲洗次数更少（P<0.01），冲洗水量也更小（P<0.01）。此外，A 组的 EGD 操作总时间明显更短（P<0.01）。A 组中无不良反应的患者比例明显高于 B 组（P<0.01）。
结论
使用 15ml 新型二甲硅油乳液和 30ml 5%碳酸氢钠溶液混合的预用药可以预防白色沉淀物的形成，安全地显著提高黏膜的可视性。
试验注册
该试验的注册名称为“上消化道内镜检查前使用新型二甲硅油乳液进行预用药的疗效”。其临床试验注册编号为 ChiCTR1900021689，注册日期为 2019 年 9 月 11 日。回顾性注册，http://www.medresman.org.cn/uc/sindex.aspx。
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