内镜治疗Ⅰ~Ⅲ度内痔的双中心随机对照研究

A double⁃center randomized controlled study on endoscopic treatment for grade Ⅰ to Ⅲ internal hemorrhoids

摘要:

目的 评估内镜下硬化剂注射术（endoscopic injection sclerotherapy，EIS）和内镜下橡胶圈套扎术（endoscopic rubber band ligation，ERBL）治疗Ⅰ~Ⅲ度内痔的有效性和安全性。方法 前瞻性收集2021年11月至2022 年11月就诊于武汉大学人民医院或阜阳市第二人民医院并有治疗意愿的Ⅰ~Ⅲ度内痔患者，依据纳排标准连续入组合格的研究对象，应用中央随机系统随机化分成2组，硬化组行EIS治疗，套扎组行ERBL治疗，主要观察症状改善率、复发率、不良事件（出血、肛门坠胀、疼痛、尿潴留等）发生率、手术费用、患者满意度、内痔症状评分（hemorrhoidal disease symptom score，HDSS）、欧洲五维生存质量量表（European quality of life 5⁃dimensions，EQ⁃5D）评分和自我健康状况评分的组间差异。结果 最终入组203例（武汉大学人民医院86例，阜阳市第二人民医院117例），硬化组103例、套扎组100例，两组均顺利完成内镜下内痔治疗。硬化组手术费用（1 044.77±522.77）元，套扎组为（2 538.44±465.63）元，硬化组手术费用明显少于套扎组（t=-21.660，P<0.001）。硬化组围手术期疼痛发生率以及中-重度疼痛发生率均明显低于套扎组［疼痛发生率：2.91%（3/103）比25.00%（25/100），χ2=20.817，P<0.001；中-重度疼痛发生率：0.97%（1/103）比18.00%（18/100），χ2=17.344，P<0.001］，围手术期出血、肛门坠胀、尿潴留发生率与套扎组比较差异均无统计学意义［0.97%（1/103）比1.00%（1/100）、11.65%（12/103）比19.00%（19/100）、0.00%（0/103）比2.00%（2/100），P均>0.05）］。术后12周随访，有4例失访（均来自硬化组），硬化组症状改善率、复发率与套扎组比较差异均无统计学意义［96.97%（96/99）比96.00%（96/100）、3.03%（3/99）比5.00%（5/100），P均>0.05］，患者满意率与套扎组比较差异无统计学意义［97.98%（97/99）比95.00%（95/100），P=0.45］。术后12周，硬化组HDSS较术前明显下降［0.0（0.0，1.0）分比5.0（3.0，7.0）分，Z=-18.270，P<0.010］，EQ⁃5D评分较术前明显升高［（1.00±0.01）分比（0.98±0.03）分，F=27.527，P<0.010］，自我健康状况评分较术前明显升高［（92.31±6.89）分比（82.62±10.98）分，F=115.025，P<0.010］。术后12周，套扎组HDSS较术前明显下降［0.0（0.0，1.0）分比5.0（4.0，8.0）分，Z=-16.110，P<0.010］；套扎组EQ⁃5D评分均较术前明显升高（1.00±0.00）分比（0.98±0.05）分，F=13.718，P<0.010］，自我健康状况评分较术前明显升高［（93.46±6.35）分比（84.15±10.71）分，F=123.695，P<0.010］。结论 EIS和ERBL均能安全、有效治疗Ⅰ~Ⅲ度内痔，且两种手术方式患者均满意。相对而言，EIS的手术费用更少，围手术期疼痛发生率更低且程度更轻。

Abstract:

Objective To evaluate the efficacy and safety of endoscopic injection sclerotherapy (EIS) and endoscopic rubber band ligation (ERBL) for the treatment of grade Ⅰ-Ⅲ internal hemorrhoids. Methods A prospective study was conducted on patients with grade Ⅰ-Ⅲ internal hemorrhoids who sought treatment at Renmin Hospital of Wuhan University or the NO.2 People''s Hospital of Fuyang City from November 2021 to November 2022. Eligible patients were continuously enrolled based on inclusion and exclusion criteria and randomized into 2 groups using a central randomization system: the EIS group and the ERBL group. The primary outcomes included symptom improvement rate, recurrence rate, incidence of adverse events (bleeding, anal distension, pain, urinary retention, etc.), surgical costs, patient satisfaction, hemorrhoidal disease symptom score (HDSS), European quality of life 5-dimensions (EQ-5D) score, and self-rated health status score. Results A total of 203 patients were enrolled (86 from Renmin Hospital of Wuhan University and 117 from the NO.2 People''s Hospital of Fuyang City), with 103 in the EIS group and 100 in the ERBL group. Both groups successfully completed endoscopic treatment for internal hemorrhoids. The surgical cost in the EIS group was significantly lower than that in the ERBL group (1 044.77±522.77 yuan VS 2 538.44±465.63 yuan, t=-21.660, P<0.001). The incidence of perioperative pain and moderate-to-severe pain in the EIS group was significantly lower than that in the ERBL group [2.91% (3/103) VS 25.00% (25/100), χ²=20.817, P<0.001; 0.97% (1/103) VS 18.00% (18/100), χ²=17.344, P<0.001]. There were no significant differences in the incidence of perioperative bleeding, anal distension, or urinary retention between the two groups [0.97% (1/103) VS 1.00% (1/100), 11.65% (12/103) VS 19.00% (19/100), 0.00% (0/103) VS 2.00% (2/100), P>0.05]. During the 12-week follow-up, 4 patients were lost to follow-up (all from the EIS group). There were no significant differences in symptom improvement rate, recurrence rate, or patient satisfaction rate between the two groups [96.97% (96/99) VS 96.00% (96/100), 3.03% (3/99) VS 5.00% (5/100), 97.98% (97/99) VS 95.00% (95/100), P>0.05]. At 12 weeks postoperatively, the HDSS in the EIS group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (3.0, 7.0), Z=-18.270, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.01 VS 0.98±0.03, F=27.527, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (92.31±6.89 VS 82.62±10.98, F=115.025, P<0.010). At 12 weeks postoperatively, the HDSS in the ERBL group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (4.0, 8.0), Z=-16.110, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.00 VS 0.98±0.05, F=13.718, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (93.46±6.35 VS 84.15±10.71, F=123.695, P<0.010). Conclusion Both EIS and ERBL are safe and effective treatments for grade Ⅰ-Ⅲ internal hemorrhoids, with high patient satisfaction. Comparatively, EIS demonstrates lower surgical costs and a reduced incidence and severity of perioperative pain.