内镜下套扎与硬化剂注射治疗内痔有效性及安全性的回顾性队列研究

A retrospective cohort study of the efficacy and safety of endoscopic ligation versus injection sclerotherapy for internal hemorrhoids

摘要:

目的 评估内镜下套扎与硬化剂注射治疗内痔的有效性及安全性。方法 2020年4月至2023年10月间，因Ⅰ~Ⅲ度内痔在南京医科大学第一附属医院（江苏省人民医院）行内镜下套扎或硬化剂注射治疗的106例连续病例纳入回顾性队列研究，按内镜治疗方式分成套扎组（n=70）和硬化剂注射组（n=36），主要观察2组间治疗有效率、住院时间、术后疼痛、不良事件发生率、患者满意度及复发率差异。结果 套扎组治疗有效率为95.7%（67/70），硬化剂注射组为100.0%（36/36），组间差异无统计学意义（P=0.549）。套扎组住院时间6.0（4.0，7.3）d，硬化剂注射组为3.0（2.0，4.0）d，组间差异有统计学意义（Z=4.305，P<0.001）。套扎组术后24 h疼痛发生率为58.6%（41/70），硬化剂注射组为11.1%（4/36），组间差异有统计学意义（χ2=20.020，P<0.001）。2组术后均无肛门狭窄、血栓性外痔等严重不良事件发生，仅肛门坠胀发生率组间差异有统计学意义［套扎组比硬化剂注射组：38.6%（27/70）比5.6%（2/36），χ2=11.431，P<0.001］。套扎组患者满意度为87.1%（61/70），硬化剂注射组为86.1%（31/36），组间差异无统计学意义（P=1.000）。套扎组和硬化剂注射组分别有1例和15例失访，复发率分别为14.5%（10/69）和33.3%（7/21），组间差异无统计学意义（P=0.064）。Ⅰ~Ⅱ度内痔的亚组分析：套扎组和硬化剂注射组Ⅰ~Ⅱ度内痔分别有43例和29例。治疗有效率、术后出血发生率、排尿困难发生率、患者满意度组间差异均无统计学意义（P>0.05）；套扎组术后疼痛、肛门坠胀发生率均明显高于硬化剂注射组［术后疼痛发生率：65.1%（28/43）比10.3%（3/29），χ2=19.016，P<0.001；术后肛门坠胀发生率：41.9%（18/43）比3.4%（1/29），χ2=11.252，P<0.001］；套扎组和硬化剂注射组分别有43例和17例完成随访，复发率分别为11.6%（5/43）和23.5%（4/17），复发率组间差异无统计学意义（P=0.256）。Ⅲ度内痔的亚组分析：套扎组和硬化剂注射组Ⅲ度内痔分别有27例和7例，分别有26例和4例完成随访，复发率分别为19.2%（5/26）和75.0%（3/4）。结论 内镜下套扎与硬化剂注射治疗Ⅰ~Ⅲ度内痔均安全、有效，其中硬化剂注射治疗住院时间短且术后疼痛和肛门坠胀发生率更低。对于Ⅰ~Ⅱ度内痔，建议行硬化剂注射治疗，疗效确切且并发症少；而对于Ⅲ度内痔，建议行套扎治疗以减少复发。

Abstract:

Objective To investigate the efficacy and safety of endoscopic ligation and injection sclerotherapy for internal hemorrhoids. Methods From April 2020 to October 2023, 106 patients with grade Ⅰ to Ⅲ internal hemorrhoids who underwent endoscopic ligation or injection sclerotherapy in the First Affiliated Hospital with Nanjing Medical University (Jiangsu Province People''s Hospital) were consecutively enrolled in the retrospective cohort study. Patients were divided into the ligation group (n=70) and the injection sclerotherapy group (n=36) according to the endoscopic treatment methods. The effective rate, hospital stay, postoperative pain, the incidence of complications, patient satisfaction and the recurrence rate of the two groups were assessed. Results The effective rate was 95.7% (67/70) and 100.0% (36/36) respectively in the ligation group and the injection sclerotherapy group without significant difference (P=0.549). The hospital stay was 6.0 (4.0, 7.3) days and 3.0 (2.0, 4.0) days respectively in the ligation group and the injection sclerotherapy group with significant difference (Z=4.305, P<0.001). The incidence of 24-hour postoperative pain was 58.6% (41/70) and 11.1% (4/36) in the two groups respectively and the difference was statistically significant (χ2=20.020, P<0.001). There were no serious postoperative adverse events such as anal stenosis or thrombotic external hemorrhoids in the two groups. Only the incidence of anal distension was significantly different between the ligation group and the injection sclerotherapy group [38.6% (27/70) VS 5.6% (2/36), χ2=11.431, P<0.001]. The patient satisfaction rate of the two groups showed no significant difference [87.1% (61/70) VS 86.1% (31/36), P=1.000]. There was 1 patient and 15 patients lost to follow-up respectively in the ligation group and the injection sclerotherapy group, and the recurrence rate of the two groups showed no significant difference [14.5% (10/69) VS 33.3% (7/21), P=0.064]. Subgroup analysis of grade Ⅰ-Ⅱ internal hemorrhoids: there were 43 patients and 29 patients in the ligation group and the injection sclerotherapy group, respectively. No significant difference was found between the two groups in terms of the effective rate, incidence of postoperative hemorrhage, incidence of uroschesis, or patient satisfaction rate (P>0.05). The incidences of postoperative pain [65.1% (28/43) VS 10.3% (3/29), χ2=19.016, P<0.001] and anal distension [41.9% (18/43) VS 3.4% (1/29), χ2=11.252, P<0.001] of the ligation group were significantly higher than those of the injection sclerotherapy group. Forty-three patients in the ligation group and 17 patients in the injection sclerotherapy group completed follow-up, and the recurrence rate was 11.6% (5/43) and 23.5% (4/17), respectively, without significant difference (P=0.256). Subgroup analysis of grade Ⅲ internal hemorrhoids: there were 27 patients in the ligation group and 7 patients in the injection sclerotherapy group, and 26 and 4 patients completed follow-up, with a recurrence rate of 19.2% (5/26) and 75.0% (3/4), respectively. Conclusion Endoscopic ligation and injection sclerotherapy are both safe and effective for grade Ⅰ-Ⅲ internal hemorrhoids. Injection sclerotherapy demonstrates shorter hospital stays and lower incidences of postoperative pain and anal distension. For grade Ⅰ-Ⅱ internal hemorrhoids, injection sclerotherapy is recommended due to its efficacy and fewer complications. Conversely, for grade Ⅲ internal hemorrhoids, ligation is suggested to reduce recurrence rates.