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which involves ulcerative colitis(UC). Wuling capsule has proven to be effective in multiple gastrointestinal diseases with
psychosomatic disorders,but there are rare studies about its effect on improving the condition,anxiety and depression of UC
patients. Objective To investigate the efficacy and safety of Wuling capsule with Fupentixol and melitracen tablets in active UC
patients with anxiety and depression. Methods A total of 120 active UC patients with anxiety and depression were selected from
Gastroenterology Clinic or Inpatient Department of the Second Affiliated Hospital of Zhejiang Chinese Medical University and
Zhejiang Provincial Tongde Hospital from January 2019 to December 2020,and equally,double-blindly randomized into control
group,Deanxit group,Wuling capsule group and combination group,receiving Mesalazine sustained-release tablets(hereinafter
referred to Mesalazine),Mesalazine with Fupentixol and melitracen tablets,Mesalazine with Wuling capsules,Mesalazine with
Fupentixol and melitracen tablets and Wuling capsules,respectively. All of the four groups were treated for 8 consecutive weeks
as a course. Pre- and post-treatment main clinical symptom score,modified Mayo score,inflammatory response indicators,
Zung Self-rating Anxiety Scale(SAS)score,Zung Self-rating Depression Scale(SDS)score,and Inflammatory Bowel
Disease Questionnaire(IBDQ)score were compared across the four groups. Meanwhile,safety evaluation for the four treatments
was conducted. Results Finally,113 cases(except Wuling capsule group containing 29 cases,other three groups containing
28 cases)who completed this study were included for analysis. Compared with other three groups,combination group showed
lower post-treatment diarrhea score,mucus with blood and pus in stools score,abdominal pain score and total score of clinical
symptoms,modified Mayo score,erythrocyte sedimentation rate,serum levels of C-reactive protein,tumor necrosis factor-α
and interleukin-6,as well as SAS and SDS scores,and higher scores of bowel,systemic,emotional and social domains and
total IBDQ score(P<0.05). One control group case had abdominal distension and one Deanxit group case had hyposomnia during
treatment,but were spontaneously relieved. Conclusion In active UC patients accompanied with anxiety and depression,
Wuling capsule with Fupentixol and melitracen tablets could relieve the clinical symptoms,severity of condition,inflammatory
response,anxiety and depression disorders,improve the quality of life,with relatively high safety. Therefore,Wuling capsule
may be a choice for optimizing the comprehensive treatment plan of UC.
【Key words】 Colitis,ulcerative;Wuling capsule;Fupentixol and melitracen tablets;Mood disorder;Anxiety;
Depression;Quality of life;Treatment outcome
溃疡性结肠炎(ulcerative colitis,UC)是一种以
本研究价值:
结肠炎症、溃疡形成为主要病理特点的慢性不可治愈
随着对炎症性肠病(IBD)研究的不断深入,人
性疾病,是炎症性肠病(inflammatory bowel diseases,
们发现精神心理因素对 IBD 患者病情及预后均具有重
IBD)的主要类型之一。有流行病学调查显示目前我国
要影响。乌灵胶囊具有抗焦虑、抗抑郁作用,但目前
IBD 发病率已升至 1.74/10 万人年,其中 UC 患病率高达 关于其改善 IBD 患者病情和焦虑、抑郁状态的临床研
(120~200)/10 万人 [1-2] 。UC 具有终身复发性且临床
究较少。本研究针对活动期溃疡性结肠炎(UC)伴
症状迁延难愈、治疗周期长、医疗费用高,这不仅会对
焦虑、抑郁患者进行研究发现,乌灵胶囊联合氟哌噻
患者生理功能、心理健康、社会功能及生存质量造成诸
吨美利曲辛片可有效改善此类患者临床症状,减轻患
多不良影响,而且会给有限的医疗卫生资源带来沉重负
者病情严重程度、炎性反应、焦虑情绪、抑郁情绪,
担。目前,IBD 的病因和确切发病机制尚不完全明确,
提高患者生活质量,乌灵胶囊可作为优化 UC 患者综
普遍观点认为 UC 的发生可能与遗传、环境、心理、肠 合治疗方案的选择之一。
道菌群、免疫等多种因素有关 [3] 。
近年来,精神心理因素在 IBD 发病中的作用日益受 究热点之一。
到关注:有研究表明 IBD 患者普遍存在焦虑、抑郁状 乌灵胶囊是从珍贵药材乌灵参中分离有效成分并精
态,且焦虑、抑郁严重程度常与 UC 疾病活动度呈正相 制而成的纯中药制剂,临床应用在肠易激综合征(irritable
关 [4-5] ;长期处于焦虑、抑郁等不良心理状态可加重 bowel syndrome,IBS)、 功 能 性 消 化 不 良(functional
UC 患者肠道炎性反应并导致疾病复发或进展、生活质 dyspepsia,FD)等消化系统心身疾病中已取得良好疗
量受损 [6-8] 。因此,IBD 已被重新定义为一种伴有心身 效 [9] 。本研究旨在探讨乌灵胶囊联合氟哌噻吨美利曲
障碍特征的消化道常见病,精神心理因素与肠道病变发 辛片对活动期 UC 伴焦虑、抑郁患者的影响,以期为
生、发展间的双向交互关系使得心理治疗成为包括 UC UC 的优化治疗提供参考。
在内的 IBD 优化治疗方案的重要组成部分,以“生物 - 心 1 资料与方法
理 - 社会”为特点的新医学治疗模式成为 IBD 领域研 1.1 一般资料 选择 2019 年 1 月至 2020 年 12 月在浙