0.4%透明质酸钠用于内镜黏膜下剥离术治疗胃肿瘤的疗效及安全性。
Efficacy and safety of 0.4 percent sodium hyaluronate for endoscopic submucosal dissection of gastric neoplasms.
机构信息
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical School, Chosun University, Gwangju 501-717, South Korea.
出版信息
World J Gastroenterol. 2013 May 28;19(20):3069-76. doi: 10.3748/wjg.v19.i20.3069.
AIM
To evaluate the efficacy and safety of sodium hyaluronate solution (SH) in endoscopic submucosal dissection (ESD) of gastric neoplasms.
METHODS
A prospective multicenter randomized, double blind, controlled trial was designed and utilized in this study. A total of 76 patients with 5-20 mm sized gastric neoplasms were enrolled at three academic hospitals in South Korea from June 2011 to October 2011. Patients were randomly assigned to the 0.4% sodium hyaluronate or control groups. All lesions underwent endoscopic ESD. ESD was performed with 0.4%SH and normal saline (NS) solution for submucosal injection. Efficacy was assessed using en bloc resection and the number of additional injections. Secondary evaluation variables were the volume of injection material, steepness of mucosal elevation, bleeding rate, procedural time and operator satisfaction. Finally, the safety was assessed by analyzing adverse events during the study.
RESULTS
The usefulness rate in the 0.4%SH group and the controlled group had statistically significant difference under intention to treat (ITT) analysis (90.91% vs 61.11% P = 0.0041). Under per protocol (PP), the usefulness rate is statistically significant different (93.10% vs 61.76%, P = 0.0036). The difference in volume of the solution injected between 0.4%SH group and the controlled group and NS group was also statistically significant under intention to treat and per protocol analysis (ITT: 0.03 ± 0.02 mL vs 0.06 ± 0.03 mL, P = 0.0003, PP: 0.03 ± 0.02 mL vs 0.06 ± 0.03 mL, P = 0.0004). Satisfaction above the grade good was significantly higher in the SH group under intention to treat and per protocol analysis (ITT: 90.91% vs 61.11%, P = 0.0041, PP = 93.11% vs 61.77%, P = 0.0022). Adverse events above grade 3 were not noticed in either group. All adverse events were treated and were judged as not associated with the submucosal injection solutions.
CONCLUSION
0.4%SH solution is a safe and effective agent that doesn't cause any significant adverse events and is useful for submucosal injection during ESD.
目的
评估透明质酸钠溶液（SH）在胃肿瘤内镜黏膜下剥离术（ESD）中的疗效和安全性。
方法
本研究采用前瞻性多中心随机、双盲、对照临床试验设计。2011 年 6 月至 2011 年 10 月，韩国三所学术医院共纳入 76 例 5-20mm 大小的胃肿瘤患者。患者随机分为 0.4%透明质酸钠组或对照组。所有病变均行内镜 ESD。ESD 采用 0.4%SH 和生理盐水（NS）溶液进行黏膜下注射。通过整块切除和追加注射次数评估疗效。次要评估变量为注射材料量、黏膜抬高陡峭度、出血率、操作时间和操作者满意度。最后，通过分析研究期间的不良事件评估安全性。
结果
意向治疗（ITT）分析时，0.4%SH 组的有用率与对照组有统计学差异（90.91% vs 61.11%，P = 0.0041）。按方案（PP）分析时，有用率有统计学差异（93.10% vs 61.76%，P = 0.0036）。ITT 和 PP 分析时，0.4%SH 组与对照组和 NS 组的注射溶液量差异也有统计学意义（ITT：0.03 ± 0.02 mL vs 0.06 ± 0.03 mL，P = 0.0003；PP：0.03 ± 0.02 mL vs 0.06 ± 0.03 mL，P = 0.0004）。ITT 和 PP 分析时，SH 组满意度评分高于对照组（90.91% vs 61.11%，P = 0.0041；93.11% vs 61.77%，P = 0.0022）。两组均未发生 3 级以上不良反应。所有不良反应均得到治疗，判断与黏膜下注射溶液无关。
结论
0.4%SH 溶液是一种安全有效的药物，不会引起任何显著的不良反应，对 ESD 时的黏膜下注射有用。
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