Objective: Currently, various treatments such as hemorrhoidectomy, ligation and sclerotherapy injection can be applied in grade II or III hemorrhoids. This study aims to compare the clinical efficacy, safety and economy between Shaobei injection and elastic band ligation in treating patients with grade II or grade III hemorrhoids. Methods: A retrospective cohort study was used. Clinical data of 60 patients with grade II or grade III hemorrhoids at Department of Anorectal Surgery of the Sixth Affiliated Hospital, Sun Yat-sen University between January 2019 and October 2019 were collected. Patients were divided into two groups according to surgical methods. Patients in the Shaobei group received Shaobei injection (n=28), and those in the ligation group received elastic band ligation (n=32). Inclusion criteria: (1) diagnosis of grade II or III hemorrhoid; (2) application of Shaobei injection or elastic band ligation; (3) age between 18-75 years old. Exclusion criteria: (1) comorbidity with anal fissure, anal fistula, anal sinusitis or other perianal diseases; (2) patients with mental disorder or poor compliance; (3) incomplete clinical or follow-up data. Recurrent rate, postoperative pain, anal edema, anal distension, total cost of hospitalization, length of hospitalization, and postoperative life quality EQ-5D-3L score were compared between the two groups at postoperative 6-month. Results: No significant difference was observed in the baseline data (including Nystrom hemorrhoid symptom score) between the two groups (all P>0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χ(2)=8.485, 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(2)=0.035, 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), Z=2.814, P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), Z=3.149, P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), Z=4.673, P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), Z=4.391, P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, t=12.515, P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days, Z=5.879, 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); both P<0.001], while there was no statistically significant difference between the two groups (t=0.130, P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection. 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.
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），χ(2)=8.485，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），χ(2)=0.035，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，Z=2.814，P=0.005；术后7 d：中位数0（0~2）分比中位数1（0~4）分，Z=3.149，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），χ(2)=4.673，P=0.037]、肛门坠胀率[7.1%（2/28）比28.1%（9/32），χ(2)=4.391，P=0.048]、住院总费用[（6 343.5±1 444.1）元比（10 587.1±1 719.0）元，t=12.515，P<0.001]、术后出院时间[中位数1（1~5）d比中位数3（1~6）d，Z=5.879，P<0.001]均低于套扎对照组，差异均有统计学意义（均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P<0.001）；而两组间患者术后半年生活质量EQ-5D-3L评分，比较差异无统计学意义（t=0.130，P=0.897）。两组患者术后均未发生大出血、感染、医源性肛瘘、直肠狭窄、局部硬结等并发症。 结论： 芍倍注射术在治疗Ⅱ、Ⅲ度痔疗效确切，安全性高，与痔套扎术相比，在减少术后不良事件发生和住院费用以及住院时间方面，有一定优势。.
Keywords: Elastic band ligation; Injection therapy; Second-degree or third-degree hemorrhoids; Shaobei injection.