不含染色剂的黏膜下注射液在胃内镜黏膜下剥离术中的应用效果及安全性

Efficacy and safety of dye‑free submucosal injection solution for gastric endoscopic submucosal dissection

摘要:

为了评价不含染色剂的黏膜下注射液在胃内镜黏膜下剥离术（endoscopic submucosal dissection，ESD）中的应用效果和安全性，收集2020年1—12月于江苏省中医院消化内镜中心住院行ESD治疗的早期胃癌及癌前病变病例纳入回顾性队列研究，分成黏膜下注射液不含染色剂组（观察组）和黏膜下注射液含染色剂组（对照组），最终共有108例符合研究要求的病例纳入数据分析，观察组39例、对照组69例，2组基线资料具有可比性（P>0.05）。与对照组比较，观察组中位手术时间（30.5 min比35.0 min）、中位剥离速度（0.3 cm2/min比0.4 cm2/min）、黏膜下注射液平均用量（39.2 mL比38.8 mL）、整块切除率［100.0%（39/39）比98.6%（68/69）］和治愈性切除率［97.4%（38/39）比97.1%（67/69）］差异均无统计学意义（P>0.05）。观察组术后住院（3.0±0.8）d，3例（7.7%）发生迟发性出血，3例（7.7%）发生术后感染；对照组术后住院（3.2±0.8）d（t=-0.908，P=0.378），2例（2.9%）发生迟发性出血（P=0.349），8例（11.6%）发生术后感染（P=0.743）。由此可见，不含染色剂的黏膜下注射液与含染色剂的黏膜下注射液在胃ESD中应用效果相当，且不会明显增加术中及术后并发症的发生率。

Abstract:

To evaluate the efficacy and safety of dye-free submucosal injection solution for gastric endoscopic submucosal dissection (ESD), a retrospective cohort study was performed on data of inpatients with early gastric cancer and precancerous lesions who underwent ESD at the Digestive Endoscopy Center of Jiangsu Province Hospital of Traditional Chinese Medicine from January to December 2020. Cases were divided into dye-free submucosal injection solution group (the observation group) and dye-containing solution group (the control group). A total of 108 cases met the eligibility criteria for analysis (39 VS 69). Baseline characteristics were comparable between the two groups (P>0.05). Compared with the control group, the observation group showed similar median procedure time (30.5 min VS 35.0 min), median dissection speed (0.3 cm²/min VS 0.4 cm²/min), mean volume of injection solution used (39.2 mL VS 38.8 mL), en bloc resection rate [100.0% (39/39) VS 98.6% (68/69)], and curative resection rate [97.4% (38/39) VS 97.1% (67/69)] (all P>0.05). Postoperative stay was 3.0±0.8 days in the observation group and 3.2±0.8 days in the control group (t=-0.908, P=0.378). Delayed bleeding occurred in 3 (7.7%) patients VS 2 (2.9%) patients (P=0.349), and postoperative infection occurred in 3 (7.7%) patients VS 8 (11.6%) patients (P=0.743), respectively. In gastric ESD, dye-free submucosal injection solution demonstrates efficacy comparable with dye-containing solution and does not appreciably increase the incidence of intraoperative or postoperative complications.