改良自动弹力线痔套扎术联合消痔灵注射液治疗Ⅲ度痔临床疗效的随机对照研究  

Clinical effects of modified automatic hemorrhoidal ligation using elastic string combined with Xiaozhiling injection for gradeⅢhemorrhoids:a randomized controlled clinical trial

作　　者：谢刚 罗金娥 苏其玲 吴晓薇 王珣 李彬彬 李经纬 匡毅 Xie Gang;Luo Jin′e;Su Qiling;Wu Xiaowei;Wang Xun;Li Binbin;Li Jingwei;Kuang Yi(Department of Colorectal and Anal Surgery,Traditional Chinese Medicine Hospital of Chongqing Shapingba District,Chongqing 400030,China)

机构地区：[1]重庆市沙坪坝区中医院肛肠科,重庆400030

出　　处：《中华消化外科杂志》2024年第12期1538-1543,共6页Chinese Journal of Digestive Surgery

基　　金：重庆市科卫联合中医药创新与应用发展项目(2020ZY023969)。

摘　　要：目的探讨改良自动弹力线痔套扎术(RPH-4)联合消痔灵注射液治疗Ⅲ度痔的临床疗效。方法采用前瞻性随机对照研究方法。选取2021年7月至2022年12月重庆市沙坪坝区中医院行改良RPH-4联合消痔灵注射液治疗Ⅲ度痔患者的临床资料,将符合要求的Ⅲ度痔患者纳入临床研究,采用随机数字表法分为试验组和对照组。试验组患者黏膜下注射消痔灵注射液,再行改良RPH-4;对照组患者黏膜下注射0.9%氯化钠溶液,再行改良RPH-4。观察指标:(1)入组患者分组情况。(2)术后情况。(3)近期疗效。(4)远期疗效。正态分布的计量资料组间比较采用独立样本t检验。偏态分布的计量资料组间比较采用非参数检验。计数资料组间比较采用χ^(2)检验或Fisher确切概率法。结果(1)入组患者分组情况。筛选出符合条件的患者120例;男72例,女48例;年龄为48(18~69)岁。120例患者分为试验组60例,对照组60例。两组患者性别、年龄、痔分型、痔脱出时间、便血、症状评分、Wexner评分比较,差异均无统计学意义(P>0.05),具有可比性。试验结束,试验组和对照组分别为59例和58例。(2)术后情况。试验组患者术后继发性出血5例,对照组患者术后继发性出血15例,两组比较,差异有统计学意义(χ^(2)=6.239,P<0.05)。试验组患者术后痔脱落时间为(6.9±1.4)d,对照组患者术后痔脱落时间为(8.1±2.2)d,两组比较,差异有统计学意义(t=-3.566,P<0.05)。(3)近期疗效。试验组59例患者和对照组58例患者完成近期随访。试验组患者治愈率为88.14%(52/59),对照组患者治愈率为84.48%(49/58),两组近期疗效比较,差异无统计学意义(χ^(2)=0.331,P>0.05);试验组患者伤口愈合时间为(24±5)d,对照组伤口愈合时间为(25±5)d,两组比较,差异无统计学意义(t=-1.082,P>0.05)。(4)远期疗效。试验组59例患者和对照组58例患者完成远期随访。两组患者均未发生肛门失禁。试验组患者�Objective To investigate the clinical effects of modified automatic hemorrhoidal ligation using elastic string(RPH‑4)combined with Xiaozhilling injection for gradeⅢhemorrhoids.Methods The prospective randomized controlled study was conducted.The clinical data of patients with gradeⅢhemorrhoids who underwent modified RPH‑4 combined with Xiaozhiling injection in Traditional Chinese Medicine Hospital of Chongqing Shapingba District from July 2021 to December 2022 were selected.Patients with gradeⅢhemorrhoids who meeting the inclusion criteria were randomly divided into the experimental group and the control group using a random number table method.Patients in the experiment group underwent submucosal injection of the Xiaozhilling injection followed by modified RPH‑4,and patients in the control group underwent submucosal injection of the 0.9%sodium chloride solution followed by modified RPH‑4.Observation indicators:(1)grouping of enrolled patients;(2)postoperative situations;(3)short‑term efficacy;(4)long‑term efficacy.Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test.Comparison of measurement data with skewed distribution between groups was conducted using the nonparameter test.Comparison of count data between groups was conducted using the chi‑square test or Fisher exact probability.Results(1)Grouping of enrolled patients.A total of 120 patients were selected.There were 72 males and 48 females,aged 48(range,18−69)years,including 60 cases in the experiment group and 60 cases in the control group,respectively.There was no significant difference in gender,age,type of hemorrhoids,time to hemorrhoid prolapsis,stool blood,symptom score and Wexner score between the two groups(P>0.05),confounding bias ensured comparability.At the end of the study,there were 59 cases in the experimental group and 58 cases in the control group.(2)Postoperative situations.There were 5 cases of secondary bleeding after modified RPH‑4 in the experimen

关 键 词：痔 自动痔疮套扎术 消痔灵注射液 黏膜下注射 改良手术 疗效 治疗 

分 类 号：R657.18[医药卫生—外科学]