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目的:目前，临床Ⅱ、Ⅲ度痔主要治疗方式包括传统手术、套扎术和注射术等。本文旨在比较芍倍注射术与痔套扎术在治疗Ⅱ、Ⅲ度痔的临床疗效、安全性及经济学。方法:采用回顾性队列研究方法，收集2019年1—10月期间中山大学附属第六医院肛肠外科60例Ⅱ、Ⅲ度痔患者的临床资料。按照手术方式的不同，分为芍倍注射组（28例，采用芍倍注射术治疗）和套扎对照组（32例，采用痔套扎术治疗）。病例纳入标准：（1）临床诊断为Ⅱ、Ⅲ度痔；（2）采用芍倍注射术或套扎术治疗；（3）患者年龄18~75岁。排除合并肛裂、肛瘘、肛窦炎等其他肛周疾病者，精神疾病者或其他无法配合治疗者，以及临床和随访资料不完全者。观察并比较两组患者术后半年的复发情况，术后疼痛、肛门水肿、肛门坠胀等不良事件发生情况，并比较两种治疗方式住院总费用、住院时间及术后半年生活质量EQ-5D-3L评分。结果:芍倍注射组男性比例高于套扎对照组[75%（21/28）比37.5%（12/32），χn 2=8.485，n P=0.004]，两组患者其他基线资料比较（包括Nystrom痔症状评分），差异均无统计学意义（均n P>0.05），两组具有可比性。术后半年芍倍注射组与套扎对照组复发率比较，差异无统计学意义[14.3%（4/28）比9.4%（3/32），χn 2=0.035，n P=0.851]；芍倍注射组术后1 d、7 d的疼痛程度明显轻于套扎对照组[术后1 d：中位数2（1~6）分比中位数3（1~7）分，n Z=2.814，n P=0.005；术后7 d：中位数0（0~2）分比中位数1（0~4）分，n Z=3.149，n P=0.002]。芍倍注射组术后1 d肛门水肿率[10.7%（3/28）比34.4%（11/32），χn 2=4.673，n P=0.037]、肛门坠胀率[7.1%（2/28）比28.1%（9/32），χn 2=4.391，n P=0.048]、住院总费用[（6 343.5±1 444.1）元比（10 587.1±1 719.0）元，n t=12.515，n P<0.001]、术后出院时间[中位数1（1~5）d比中位数3（1~6）d，n Z=5.879，n P<0.001]均低于套扎对照组，差异均有统计学意义（均n P<0.05）。两组患者生活质量EQ-5D-3L评分术后半年与术前相比均有提高[芍倍注射组：（0.90±0.16）分比（0.73±0.14）分；套扎对照组（0.91±0.13）分比（0.74±0.10）分]，差异均有统计学意义（均n P0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χn 2=8.485, n P=0.004]. No significant difference in recurrent rate was found between the two groups [14.3% (4/28) vs. 9.4% (3/32), χ n 2=0.035, n P=0.851]. Compared to the ligation group, Shaobei group showed less pain at postoperative day 1 [VAS median (range): 2 (1-6) vs. 3 (1-7), n Z=2.814, n P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), n Z=3.149, n P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), n Z=4.673, n P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), n Z=4.391, n P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, n t=12.515, n P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days,n Z=5.879, n P<0.001]. The EQ-5D-3L scores of two groups were significantly improved six months after treatment [Shaobei group: (0.90±0.16) vs. (0.73±0.14); ligation group: (0.91±0.13) vs. (0.74±0.10); bothn P<0.001], while there was no statistically significant difference between the two groups (n t=0.130, n P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection.n Conclusions:Shaobei injection is effective and safe in treating grade II or III hemorrhoids. Compared with elastic band ligation, it can reduce morbidity of complications and hospitalization expenses.