术前应用二甲硅油和 N-乙酰半胱氨酸对上消化道内镜检查时黏膜可视性的改善：一项随机对照试验。
Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial.
机构信息
Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, 500 082, India.
出版信息
Indian J Gastroenterol. 2024 Oct;43(5):986-994. doi: 10.1007/s12664-023-01459-0. Epub 2023 Oct 18.
BACKGROUND AND AIM
Diagnostic performance of esophagogastroduodenoscopy (EGD) may be compromized due to adherent mucus and foam. In this study, we aimed at assessing the impact of premedication on mucosal visibility during endoscopy.
METHODS
This is a double-blinded (patient and investigator), randomized trial conducted at a tertiary care centre. Patients were randomized into four groups: A (water), B (simethicone [S]), C (N-acetyl cysteine [NAC]), D (S + NAC). Premedication solutions were administered 10-30 minutes before endoscopy and mucosal visibility graded from 1 (best) to 4 (worst) (1 best, 4 worst). Total mucosal visibility scores (TMVS) from six sites ranged from 6 (best) to 24 (worst) points. The primary outcome of study was comparison of TMVS between simethicone and combination (S + NAC) premedication groups. Secondary outcomes were adverse events and impact of endoscopy timing on TMVS.
RESULTS
Total 800 patients (39 years, 68.8% males) were randomized into four groups. Median TMVS were significantly lower in groups B (7 [6-8]) and D (8 [6-9]) as compared to A (11 [9-13]) and C (10 [8-12]). Proportion of cases with adequate gastric mucosal visibility (score < 7) was 26% in group A, 71% in group B, 36% in group C and 79% in group D. There was no difference in TMVS in groups A and C (p = 0.137). TMVS were significantly lower in late (> 20-30 minutes) vs. early (10-20 minutes) endoscopy sub-group (8 [7-11] vs, 9 ([7-11], p = 0.001). However, TMVS were similar between group B and group D in early endoscopy group (p = 0.451). There was no significant difference in the lesion detection rate among the different premedication drugs (p > 0.05).
CONCLUSIONS
Premedication with simethicone or combination (simethicone and NAC) significantly improves mucosal visibility during EGD. If early endoscopy is indicated, simethicone provides similar mucosal visibility and may be an effective alternative to combined premedication.
TRIAL REGISTRATION
NCT05951712.
背景与目的
由于黏附的黏液和泡沫，食管胃十二指肠镜（EGD）的诊断性能可能受到影响。本研究旨在评估内镜检查前用药对黏膜可见度的影响。
方法
这是一项在三级保健中心进行的双盲（患者和研究者）、随机试验。患者被随机分为四组：A（水）、B（二甲硅油[S]）、C（N-乙酰半胱氨酸[NAC]）、D（S+NAC）。内镜检查前 10-30 分钟给予预用药溶液，并从 1（最佳）到 4（最差）对黏膜可见度进行分级（1 最佳，4 最差）。六个部位的总黏膜可见度评分（TMVS）范围从 6（最佳）到 24（最差）分。研究的主要结局是比较二甲硅油和联合（S+NAC）预用药组的 TMVS。次要结局是不良事件和内镜检查时间对 TMVS 的影响。
结果
共纳入 800 例患者（39 岁，68.8%为男性），随机分为四组。与 A 组（11[9-13]）和 C 组（10[8-12]）相比，B 组（7[6-8]）和 D 组（8[6-9]）的 TMVS 中位数明显较低。A 组有 26%的胃黏膜可见度评分<7 的病例，B 组为 71%，C 组为 36%，D 组为 79%。A 组和 C 组的 TMVS 无差异（p=0.137）。与早期（10-20 分钟）内镜亚组相比，晚期（>20-30 分钟）内镜亚组的 TMVS 明显降低（8[7-11]比 9[7-11]，p=0.001）。然而，在早期内镜组，B 组和 D 组的 TMVS 相似（p=0.451）。不同预用药药物的病变检出率无显著差异（p>0.05）。
结论
二甲硅油或联合（二甲硅油和 NAC）预用药可显著改善 EGD 时的黏膜可见度。如果需要早期内镜检查，二甲硅油可提供相似的黏膜可见度，可能是联合预用药的有效替代。
试验注册
NCT05951712。
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