扶正抑瘤通络方防治早期食管癌ESD 术后食管狭窄临床研究

Clinical Study on Fuzheng Yiliu Tongluo Prescription for the Prevention and Treat⁃ ment of Esophageal Stenosis After Endoscopic Submucosal Dissection for Early Esophageal Cancer

摘要:

目的：观察扶正抑瘤通络方防治早期食管癌内镜黏膜下剥离术（ESD） 后食管狭窄的临床疗效。方法：选取2022年1月—2024年6月温州医科大学附属衢州医院收治的食管癌行ESD治疗的患者76例，按照随机数字表法分为对照组和观察组各38例。对照组给予甲泼尼龙口服，观察组在对照组基础上加用扶正抑瘤通络方治疗，2组均治疗7周。比较2组吞咽困难程度（Atkinson分级）、术后3个月及6个月食管狭窄发生率、食管癌复发率、并发症发生率。结果：治疗前，2组吞咽困难Atkinson分级比较，差异无统计学意义（P＞0.05）；治疗后，观察组吞咽困难Atkinson分级优于对照组（P＜0.05）。术后3、6个月，观察组食管狭窄发生率分别为7.89%（3/38）、13.16%（5/38），对照组分别为26.32%（10/38）、36.84%（14/38），2组比较，差异均有统计学意义（P＜0.05）。术后随访6个月，观察组食管癌复发率为5.26%（2/38），对照组为21.05%（8/38），2组比较，差异有统计学意义（P＜0.05）。观察组并发症发生率为10.53% （4/38），对照组为18.42% （7/38），2组比较，差异无统计学意义（P＞0.05）。结论：扶正抑瘤通络方可有效改善ESD术后吞咽困难，降低食管狭窄发生率及肿瘤复发风险，且安全性良好。

Abstract:

Abstract： Objective： To observe the clinical efficacy of Fuzheng Yiliu Tongluo Prescription in the prevention and treatment of esophageal stenosis after endoscopic submucosal dissection （ESD） for early esophageal cancer. Methods：A total of 76 patients with early esophageal cancer who underwent ESD at the Quzhou Hospital Affiliated to Wenzhou Medical University from January 2022 to June 2024 were selected and randomly divided into the control group and the observation group using the random number table method， with 38 cases in each group. The control group received oral Methylprednisolone， while the observation group received Fuzheng Yiliu Tongluo Prescription and Methylprednisolone. Both groups were treated for seven weeks. The degree of dysphagia （Atkinson grade），incidence of esophageal stenosis at three months and six months postoperatively， recurrence rate of esophageal cancer， and incidence rate of complications were compared between the two groups. Results： Before treatment， there was no statistically significant difference in the Atkinson grade of dysphagia between the two groups （P＞0.05）. After treatment， the Atkinson grade of dysphagia in the observation group was superior to that in the control group （P＜0.05）. At three months and six months postoperatively，the incidence of esophageal stenosis in the observation group was 7.89%（ 3/38） and 13.16% （5/38）， respectively， while that in the control group was 26.32% （10/38） and 36.84% （14/38）， respectively， with statistically significant differences between the two groups （P＜0.05）. During the six-month postoperative follow-up， the recurrence rate of esophageal cancer was 5.26% （2/38） in the observation group and 21.05% （8/38） in the control group， with a statistically significant difference （P＜0.05）. The incidence of complications was 10.53%（ 4/38） in the observation group and 18.42%（ 7/38） in the control group，with no statistically significant difference （P＞0.05）. Conclusion： Fuzheng Yiliu Tongluo Prescription can effectively improve dysphagia after ESD， reduce the incidence of esophageal stenosis and the risk of tumor recurrence， and has a favorable safety profile.