Efficacy and Safety of Wuling Capsule
Combined with Fupentixol and Melitracen Tablets in Active Ulcerative Colitis
Patients Accompanied with Anxiety and Depression

doi:10.12114/j.issn.1007-9572.2021.02.067

Abstract

Abstract: Background

Psychotherapy is an important component of the treatment program for inflammatory bowel disease (IBD) , a common chronic incurable digestive system disease accompanied with psychosomatic disorder, 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

摘要： 背景

炎症性肠病（IBD）是一种伴有心身障碍特征的慢性不可治愈性消化系统常见病，目前心理治疗已成为包括溃疡性结肠炎（UC）在内的IBD患者优化治疗方案的重要组成部分。乌灵胶囊对多种消化系统心身疾病具有良好疗效，但目前关于其改善UC患者病情及焦虑、抑郁状态的影响研究较少。

目的

探讨乌灵胶囊联合氟哌噻吨美利曲辛片对活动期UC伴焦虑、抑郁患者的影响。

方法

选择2019年1月至2020年12月在浙江中医药大学附属第二医院、浙江省立同德医院消化内科门诊就诊或住院的活动期UC伴焦虑、抑郁患者120例，采用双盲随机化法分为对照组、黛力新组、乌灵胶囊组、联合治疗组，每组30例。对照组患者仅给予美沙拉嗪缓释片治疗，黛力新组患者在对照组基础上给予氟哌噻吨美利曲辛片治疗，乌灵胶囊组患者在对照组基础上给予乌灵胶囊治疗，联合治疗组患者在对照组基础上给予乌灵胶囊和氟哌噻吨美利曲辛片治疗；四组患者均连续治疗8周（1个疗程）。比较四组患者治疗前后主要临床症状积分、改良Mayo评分、炎性反应指标、焦虑自评量表（SAS）评分、抑郁自评量表（SDS）评分、炎症性肠病生活质量问卷（IBDQ）评分，并进行安全性评价。

结果

最终共113例患者完成研究，其中对照组28例、黛力新组28例、乌灵胶囊组29例、联合治疗组28例。联合治疗组患者治疗后腹泻、黏液脓血便、腹痛积分及主要临床症状总分、改良Mayo评分、红细胞沉降率、血清C反应蛋白水平、血清肿瘤坏死因子α水平、血清白介素6水平、SAS评分、SDS评分低于对照组、黛力新组、乌灵胶囊组（P<0.05），肠道症状、全身症状、情感功能、社会功能评分及IBDQ总分高于对照组、黛力新组、乌灵胶囊组（P<0.05）。治疗期间对照组患者中出现腹胀1例，黛力新组患者中出现失眠1例，均可自行缓解。

结论

乌灵胶囊联合氟哌噻吨美利曲辛片可有效改善活动期UC伴焦虑、抑郁患者临床症状，减轻患者病情严重程度、炎性反应、焦虑情绪、抑郁情绪，提高患者生活质量，且安全性较高；乌灵胶囊可作为优化UC患者综合治疗方案的选择之一。

关键词: 结肠炎, 溃疡性, 乌灵胶囊, 氟哌噻吨美利曲辛片, 情绪障碍, 焦虑, 抑郁, 生活质量, 治疗结果

CLC Number:

R574.62

MO Dayu, LIU Yingchao, WANG Feida, NI Siyi, SHEN Yan.

Efficacy and Safety of Wuling Capsule Combined with Fupentixol and Melitracen Tablets in Active Ulcerative Colitis Patients Accompanied with Anxiety and Depression [J]. Chinese General Practice, 2022, 25(03): 285-292.

莫达瑜,刘英超,王飞达等. 乌灵胶囊联合氟哌噻吨美利曲辛片对活动期溃疡性结肠炎伴焦虑和抑郁患者的影响研究[J]. 中国全科医学, 2022, 25(03): 285-292. DOI: 10.12114/j.issn.1007-9572.2021.02.067.

Figures/Tables 6

References 28

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项目		评分	项目		评分
排便次数			结肠黏膜表现
	正常	0		正常	0
	比正常次数增加1~2次/d	1		轻度病变（红斑、血管纹理减少、轻度易脆）	1
	比正常次数增加3~4次/d	2		中度病变（明显红斑、血管纹理缺乏、易脆、糜烂）	2
	比正常次数增加5次/d或以上	3		重度病变（自发性出血、溃疡性形成）	3
便血			医师总体评价
	未见出血	0		正常	0
	不到一半时间内便中混血	1		病情为轻度	1
	大部分时间内便中混血	2		病情为中度	2
	一直存在出血	3		病情为重度	3

项目		评分	项目		评分
排便次数			结肠黏膜表现
	正常	0		正常	0
	比正常次数增加1~2次/d	1		轻度病变（红斑、血管纹理减少、轻度易脆）	1
	比正常次数增加3~4次/d	2		中度病变（明显红斑、血管纹理缺乏、易脆、糜烂）	2
	比正常次数增加5次/d或以上	3		重度病变（自发性出血、溃疡性形成）	3
便血			医师总体评价
	未见出血	0		正常	0
	不到一半时间内便中混血	1		病情为轻度	1
	大部分时间内便中混血	2		病情为中度	2
	一直存在出血	3		病情为重度	3

组别	例数	腹泻				黏液脓血便
组别	例数	治疗前	治疗后	t_配对值	P值	治疗前	治疗后	t_配对值	P值
对照组	28	2.0±0.4	1.2±0.3	8.678	<0.001	1.2±0.2	0.6±0.1	12.644	<0.001
黛力新组	28	2.1±0.3	1.3±0.4	8.581	<0.001	1.2±0.3	0.6±0.1	9.491	<0.001
乌灵胶囊组	29	1.9±0.3	1.2±0.1	13.845	<0.001	1.2±0.2	0.5±0.1^ab	14.213	<0.001
联合治疗组	28	2.0±0.3	0.9±0.2^abc	15.358	<0.001	1.2±0.2	0.4±0.1^abc	16.775	<0.001
F值		1.77	11.30			0.12	25.69
P值		0.157	<0.001			0.948	<0.001

组别	例数	腹泻				黏液脓血便
组别	例数	治疗前	治疗后	t_配对值	P值	治疗前	治疗后	t_配对值	P值
对照组	28	2.0±0.4	1.2±0.3	8.678	<0.001	1.2±0.2	0.6±0.1	12.644	<0.001
黛力新组	28	2.1±0.3	1.3±0.4	8.581	<0.001	1.2±0.3	0.6±0.1	9.491	<0.001
乌灵胶囊组	29	1.9±0.3	1.2±0.1	13.845	<0.001	1.2±0.2	0.5±0.1^ab	14.213	<0.001
联合治疗组	28	2.0±0.3	0.9±0.2^abc	15.358	<0.001	1.2±0.2	0.4±0.1^abc	16.775	<0.001
F值		1.77	11.30			0.12	25.69
P值		0.157	<0.001			0.948	<0.001

组别	例数	治疗前	治疗后	t_配对值	P值
对照组	28	6.3±0.9	2.0±0.3	23.284	<0.001
黛力新组	28	6.5±0.9	1.9±0.3	26.941	<0.001
乌灵胶囊组	29	6.2±1.0	1.7±0.4^ab	23.478	<0.001
联合治疗组	28	6.2±1.2	1.4±0.3^abc	21.253	<0.001
F值		0.56	18.16
P值		0.646	<0.001