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.

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.

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.

276 patients actually completed this study, including 140 in the experimental group and 136 in 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 (CAF-QoL) score and past history (P>0.05). The VAS score, clinical symptom score, hematochezia score, rectal tenesmus score, hemorrhoid mucosa score, hemorrhoid nucleus size score of the two groups differed between two groups on the 4th, 7th or 10th day of follow-up (P<0.05). On the 10th day of follow-up, the VAS score, clinical symptom score, hematochezia score and hemorrhoid size score of the experimental group were lower than those in the control group (Z=-4.681, -3.784, -1.994, -3.411, P<0.05). The VAS score, clinical symptom score, anal canal resting pressure and CAF-QoL score decreased in both groups after treatment (P<0.05). The post-treatment VAS score (Z=-4.681), clinical symptom score (Z=-3.784), anal canal resting pressure (t=2.566), and CAF-QoL score (t=6.827) in the experimental group were lower than those in the control group (P<0.05). The experimental group had higher overall response rate (96.43% vs 91.18%) than the control group (χ²=8.557, P=0.036). The experimental group also had higher cure rate (84.28% vs 69.85%) (χ²=8.157, P=0.004). No complications and adverse reactions were found in both groups during the treatment period. There was no significant difference in the recurrence rate between the experimental group and control group (3.23% vs 5.33%) (P>0.05) .

MAP combined with sitz bath with Tongyangxiao Lotion acted rapidly, which had better performance in repairing the barrier function of the anal cushion, improving the clinical symptoms, reducing the tension of the internal anal sphincter, and improving the quality of life in patients with grades 1 and 2 mixed hemorrhoids.

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。

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。

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。

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%、总有效率96.43%，对照组痊愈率69.85%、总有效率91.18%；两组患者综合疗效比较，差异有统计学意义（χ²=8.557，P=0.036）；其中试验组患者治疗后痊愈率高于对照组（χ²=8.157，P=0.004）。两组患者在用药期均未发现药物引起的并发症与不良反应；试验组与对照组复发率分别为3.23%、5.33%，两组患者复发率比较，差异无统计学意义（P>0.05）。

MAP联合中药痛痒消洗剂熏洗坐浴可修复痔病患者肛垫黏膜损伤，联合用药可改善Ⅰ、Ⅱ度混合痔患者临床症状，降低肛门内括约肌张力，提高患者生活质量，起效迅速，疗效较仅中药坐浴更具优势。