球囊辅助与传统内镜下硬化剂注射术治疗食管静脉曲张的随机对照研究

A randomized controlled study of balloon compression-assisted endoscopic injection sclerotherapy versus traditional endoscopic injection sclerotherapy for esophageal varices

目的探讨球囊辅助内镜下硬化剂注射术(balloon compression-assisted endoscopic injection sclerotherapy,bc-EIS)治疗食管静脉曲张的临床价值。方法2019年6月—2020年11月,将在安徽医科大学第一附属医院拟行内镜下硬化剂注射术(endoscopic injection sclerotherapy,EIS)治疗的肝硬化食管静脉曲张患者作为研究对象,采用计算机将患者随机分成bc-EIS组和传统EIS组。对比观察2组达到根除静脉曲张的治疗次数、首次治疗硬化剂使用剂量、首次治疗注射点数、术后随访10个月内再出血率以及并发症或不良反应发生情况。结果根据纳入标准初步纳入92例患者,经排除标准排除7例,最终有85例纳入数据分析,bc-EIS组47例,传统EIS组38例。bc-EIS组1次根除率、2次累积根除率和3次累积根除率分别为82.98%(39/47)、91.49%(43/47)和100.00%(47/47),传统EIS组分别为10.53%(4/38)(χ^(2)=44.125,P<0.001)、31.58%(12/38)(χ^(2)=33.023,P<0.001)和63.16%(24/38)(χ^(2)=20.730,P<0.001),差异均有统计学意义。bc-EIS组与传统EIS组达到根除静脉曲张的治疗次数分别为(1.25±0.60)次和(3.21±1.41)次,差异有统计学意义(t=7.937,P<0.001);首次治疗硬化剂使用剂量分别为(17.66±7.14)mL和(22.92±6.84)mL,差异有统计学意义(t=3.441,P=0.001);首次治疗注射点数分别为(2.70±0.86)点和(2.78±1.04)点,差异无统计学意义(t=1.847,P=0.065);术后随访10个月内再出血率分别为2.13%(1/47)和18.42%(7/38),差异有统计学意义(χ^(2)=4.771,P=0.029)。2组均无严重并发症,bc-EIS组术后胸骨后疼痛、恶心呕吐、腹胀和溃疡发生率分别为2.13%(1/47)、2.13%(1/47)、4.26%(2/47)和0.00%(0/47),传统EIS组分别为5.26%(2/38)(χ^(2)=0.035,P=0.851)、5.26%(2/38)(χ^(2)=0.035,P=0.851)、7.89%(3/38)(χ^(2)=0.060,P=0.806)和7.89%(3/38)(χ^(2)=1.877,P=0.171),差异均无统计学意义。结论bc-EIS较传统EIS治疗食管静脉曲张的疗效更为显著,且术后再出血率更低,具有更好的临床应用价值。

Objective To evaluate balloon compression-assisted endoscopic injection sclerotherapy(bc-EIS)for the treatment of esophageal varices.Methods From June 2019 to November 2020,cirrhotic patients with esophageal varices who received endoscopic injection sclerotherapy(EIS)in the First Affiliated Hospital of Anhui Medical University were enrolled in the study.The patients were randomly divided into the bc-EIS group and the traditional EIS group.The number of treatments to eradicate varicose veins,the dose of sclerosing agent used in the first treatment,the number of injection points in the first treatment,the rebleeding rate within 10 months after the operation and the incidence of complications or adverse reactions were compared between the two groups.Results Ninety-two cases were initially included in the study,and 7 cases were excluded based on exclusion criteria.Finally,85 cases were included in the data analysis,47 in the bc-EIS group and 38 in the traditional EIS group.The first eradication rate,the second cumulative eradication rate and the third cumulative eradication rate were 82.98%(39/47),91.49%(43/47)and 100.00%(47/47)in the bc-EIS group,and they were 10.53%(4/38)(χ^(2)=44.125,P<0.001),31.58%(12/38)(χ^(2)=33.023,P<0.001)and 63.16%(24/38)(χ^(2)=20.730,P<0.001),respectively in the traditional EIS group,and the differences were statistically significant.The treatment times of eradicating varicose veins in the bc-EIS group and the traditional EIS group were 1.25±0.60 and 3.21±1.41,respectively,with significant difference.The dosage of sclerosing agent in first treatment in the bc-EIS group and the traditional EIS group was 17.66±7.14 mL and 22.92±6.84 mL,respectively(t=3.441,P=0.001).The numbers of initial injection points in the bc-EIS group and the traditional EIS group were 2.70±0.86 and 2.78±1.04,respectively and the difference was not statistically significant(t=1.847,P=0.065).The rebleeding rates of the two groups within 10 months after the operation were 2.13%(1/47)and 18.42%(7/38)respectively(χ^(2)=4.771,P=0.029).There were no serious complications in the two groups.The incidences of retrosternal pain,nausea and vomiting,abdominal distension and ulcer were 2.13%(1/47),2.13%(1/47),4.26%(2/47)and 0.00%(0/47)in the bc-EIS group,and in the traditional EIS group,they were 5.26%(2/38)(χ^(2)=0.035,P=0.851),5.26%(2/38)(χ^(2)=0.035,P=0.851),7.89%(3/38)(χ^(2)=0.060,P=0.806)and 7.89%(3/38)(χ^(2)=1.877,P=0.171),respectively,without significant difference.Conclusion Bc-EIS is more effective than traditional EIS for the treatment of esophageal varices with lower postoperative rebleeding rate,which shows better clinical application value.