贻贝粘蛋白联合痛痒消洗剂治疗Ⅰ度和Ⅱ度混合痔的临床疗效研究  

Clinical Effect of Mussel Adhesive Protein with Tongyangxiao Lotion in Grades 1 and 2 Mixed Hemorrhoids

作　　者：田茂生 高记华 许建成 戚文月 王琳月 高策 TIAN Maosheng;GAO Jihua;XU Jiancheng;QI Wenyue;WANG Linyue;GAO Ce(Hebei University of Chinese Medicine,Shijiazhuang 050091,China;Anorectal Department,the First Affiliated Hospital of Hebei University of Chinese Medicine/Hebei University of Chinese Medicine,Shijiazhuang 05001l,China;Hebei Key Laboratory of Integrated Traditional Chinese and Western Medicine for Gastroenterology Diseases,Shijiazhuang 05001l,China)

机构地区：[1]河北中医学院,河北省石家庄市050091 [2]河北中医学院第一附属医院河北省中医院肛肠科,河北省石家庄市050011 [3]河北省中西医结合胃肠病研究重点实验室,河北省石家庄市050011

出　　处：《中国全科医学》2023年第8期955-962,共8页Chinese General Practice

基　　金：国家自然科学基金面上项目(82174381);河北中医学院研究生创新能力培养资助项目(XCXZZBS2021019)。

摘　　要：背景痔病的高发病率严重影响了患者的生活、工作和学习,降低了患者生活质量,痔病的发生与肛垫黏膜屏障功能的失衡、黏液屏障与黏膜屏障的破坏关系密切,如何简洁高效地治疗痔病成为临床医生关注的问题。目的综合评价贻贝粘蛋白(MAP)联合中药痛痒消洗剂熏洗坐浴治疗Ⅰ、Ⅱ度混合痔的临床疗效。方法采用随机、对照、单盲的前瞻性研究设计,选取2021年就诊于河北省中医院肛肠科门诊的Ⅰ、Ⅱ度混合痔患者298例为研究对象,随机分为试验组和对照组,各149例。均予以饮食、生活指导等一般治疗,试验组患者局部外用MAP联合中药痛痒消洗剂熏洗坐浴,对照组患者仅采用中药坐浴,疗程10 d。主要疗效指标包括疗效指数(痊愈、显效、有效、无效)和复发率;次要疗效指标包括治疗前后疼痛评分、临床症状评分、生活质量评分、安全性指标。结果实际完成研究的患者共276例,其中试验组140例、对照组136例,男135例、女141例,中位年龄为38(29,48)岁;两组患者性别、年龄、混合痔病程、混合痔分期、视觉模拟评分法(VAS)评分、临床症状评分、肛管静息压、痔疾病和肛裂生活质量量表(HF-QoL)评分、既往史比较,差异均无统计学意义(P>0.05)。两组患者不同随访期(第4天、第7天、第10天)VAS评分、临床症状评分、便血评分、脱出评分、坠胀评分、痔黏膜评分、痔核大小评分比较,差异均有统计学意义(P<0.05);其中随访第10天,试验组患者VAS评分、临床症状评分、便血评分、痔核大小评分均低于对照组(Z=-4.681、-3.784、-1.994、-3.411,P<0.05)。与治疗前相比,两组患者治疗后VAS评分、临床症状评分、肛管静息压、HF-QoL评分均下降(P<0.05);试验组患者治疗后的VAS评分(Z=-4.681)、临床症状评分(Z=-3.784)、肛管静息压(t=2.566)、HF-QoL评分(t=6.827)均低于对照组(P<0.05)。试验组痊愈率84.28%、总有效Background Hemorrhoids are a highly prevalent disease,which have been a health challenge to people for a long time,seriously affecting the life,work,study,and the quality of life.The development of hemorrhoids is closely related to the imbalance of the mucosal barrier function of the anal cushion and the destruction of the mucus barrier and the mucosal barrier.How to treat hemorrhoids simply and efficiently has become a concern of clinicians.Objective To comprehensively assess the clinical efficacy of mussel adhesive protein(MAP)with fumigation and sitz bath with Tongyangxiao Lotion(a traditional Chinese medicine)in the treatment of grades 1 and 2 mixed hemorrhoids.Methods A prospective,randomized,single-blind,controlled study design was used.298 anorectal outpatients with grades 1 and 2 hemorrhoids were selected from Hebei University of Chinese Medicine in 2021,and equally randomized into an experimental group and a control group.All patients were given general treatment such as diet and life guidance,and a 10-day fumigation and sitz bath with Tongyangxiao Lotion.The experimental group additionally received a 10-day treatment with topical use of MAP concurrently.The primary efficacy indicators include the response level(cure,marked response,response,non-response)and recurrence rate.The secondary efficacy indicators include the visual analogue scale(VAS)score,clinical symptom score,quality of life score,and safety index.Results 276 patients actually completed this study,including 140 in the experimental group and 136in the control group;135 males and 141 females,with a median age of 38(29,48)years.There were no significant differences between two groups in gender ratio,mean age,distribution of course,and grade of mixed hemorrhoids,VAS score,clinical symptom score,anal mean canal resting pressure,hemorrhoid disease and the Crohn’s Anal Fistula Quality of Life(CAFQoL)score and past history(P>0.05).The VAS score,clinical symptom score,hematochezia score,rectal tenesmus score,hemorrhoid mucosa score,hemorrhoid nucl

关 键 词：痔 贻贝粘蛋白 痛痒消洗剂 熏洗疗法 肛垫黏膜屏障 疗效比较研究 随机对照试验 

分 类 号：R266.1[医药卫生—中医外科学]