Page 59 - 2023-08-中国全科医学

·956· http: //www.chinagp.net E-mail: zgqkyx@chinagp.net.cn March 2023, Vol.26 No.8

【Abstract】 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 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
2
group（P<0.05）. The experimental group had higher overall response rate（96.43% vs 91.18%） than the control group（χ =8.557，
2
P=0.036）. The experimental group also had higher cure rate （84.28% vs 69.85%）（χ =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）. Conclusion 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.
【Key words】 Hemorrhoids；Mussel adhesive protein；Tongyangxiao Lotion；Steaming washing therapy；Anal
cushion mucosal barrier；Comparative effectiveness research；Randomized controlled trial

2015 年全国流行病学调查显示，肛肠疾病的总患 好疗效 ［11］ ，痔病的局部药物治疗也成为肛肠科医师的
病达到了 50.10%，其中有痔病症状的患者所占比例达 研究方向。
到 98.09%，而痔病的患病率为 49.14%，痔病已成为临 贻贝是来自大海的瑰宝，基于其可在海水中牢固黏
床常见病、多发病，以便血、脱出、疼痛、瘙痒为主要 着的特性开发了生物材料贻贝粘蛋白（mussel adhesive
症状，严重影响患者的工作和生活质量 ［1］ 。随着人类 protein，MAP），由于其良好的黏附性、生物可降解性、
对痔病发病机制的不断探索，肛垫下移学说被广泛接受， 柔韧性、耐水性，MAP 在生物医药领域有广阔的应用
肛垫黏膜的生物学屏障功能与痔病的发生关系密切，因 前景。MAP 含有 20% 的赖氨酸和大量的儿茶酚氨基酸
此对痔病患者肛垫黏膜的保护成为当前学术界的热点。 （如 L-3，4- 二羟基苯丙氨酸，即 L-Dopa），可形成
痔病的治疗原则是治疗有症状的痔 ［2-4］ ，调查显示 9.3% 网状生物支架，促进细胞黏附爬行 ［12-13］ 。MAP 作为良
的痔病患者需要手术治疗，90% 以上的患者可通过非手 好的黏膜保护剂作用于肛垫，修复重建肛垫黏膜屏障功
术治疗缓解和消除症状。痔病的非手术治疗包括饮食疗 能，是痔病局部用药的理想选择 ［13］ 。中药熏洗疗法和
法、坐浴、磁疗、口服缓泻剂、静脉活性药物、镇痛药、 坐浴疗法是祖国传统医学外治法的常用方法 ［14］ ，中药
中医辨证治疗、局部外用药物、注射疗法等，方法途径 痛痒消洗剂熏洗坐浴，可发挥清热燥湿、收敛止血、杀
众多，疗效不一，各有优劣 ［5-10］ 。而经直肠途径的局 虫止痒、消肿止痛之功效，可阻断病情进一步发展，适
部用药可使药物直达病灶，利于维持药物浓度，取得良 用于痔病的保守治疗及术后康复保健 ［15-16］ 。