国产一次性内镜注射针在内镜手术中应用评价的非劣效单中心随机对照研究

Evaluation of a domestic disposable injection needle in endoscopic surgery: a non‑inferiority single‑center randomized controlled study

摘要:

目的 评价一种国产一次性内镜注射针的有效性、安全性及操控性能。方法 选择2024年1—11月复旦大学附属中山医院（厦门）内镜中心收治的消化道病变行内镜手术切除的患者，按随机数字法随机分为试验组和对照组，分别使用国产和进口的一次性内镜注射针，比较两组注射针的成功率、安全性及操控性能。结果 共纳入200例患者，每组100例，两组在性别构成、年龄、病变大小和病变手术方式方面差异均无统计学意义（P>0.05）。试验组注射针一次性注射成功率为88.0%（88/100），对照组为92.0%（92/100），两组比较差异无统计学意义（χ²=0.889，P=0.346）。试验组和对照组分别有6例（6.0%）和12例（12.0%）患者出现注射导致的血肿，差异无统计学意义（χ²=2.198，P=0.138），两组均未出现出血量较大的血肿，对手术未造成严重影响；试验组和对照组术中出血分别为2例（2.0%）和3例（3.0%），差异无统计学意义（P=1.000），且两组均未出现术后出血及穿孔。两组出现注射针出针嵌顿、无法出针（两组各1例），注射阻力大（分别为3例和2例）及卡扣滑脱（两组均无）情况差异无统计学意义（P=1.000）。结论 国产一次性内镜射针在消化道病变内镜切除术中应用良好，其有效性、安全性及操控性能与对照产品相当。

Abstract:

Objective To evaluate the effectiveness, safety and operational performance of a domestically manufactured disposable endoscopic injection needle. Methods Patients with digestive tract lesions undergoing endoscopic surgery were selected from January 2024 to November 2024 in Endoscopy Center of Zhongshan Hospital (Xiamen), Fudan University and randomized to receive injections using either domestic (experimental group) or imported (control group) needles. Outcomes included injection success, safety events, and device maneuverability. Results A total of 200 patients were included, with 100 cases in each group. There were no significant differences in gender composition age, lesion size or the surgical procedures between the two groups (P>0.05). The single‑injection success rate was 88.0% (88/100) in experimental group versus 92.0% (92/100) for control group, with no significant difference (χ²=0.889, P=0.346). The safety outcomes showed no significant differences in injection‑induced hematomas [6.0% (6/100) VS 12.0% (12/100), χ²=2.198, P=0.138] or intraoperative bleeding [2.0% (2/100) VS 3.0% (3/100), P=1.000]. No clinically significant hematomas, postoperative bleeding, or perforations occurred in either group. Device malfunction rates were comparable, including needle insertion failure (1 case each), injection resistance (3 VS 2 cases), and latch slippage (none) (P=1.000). Conclusion Domestically produced disposable endoscopic injection needles demonstrate non‑inferior efficacy, safety, and operability compared with internationally branded counterparts in endoscopic resection procedures.