Clinical Efficacy on the Treatment of Chronic Colitis with Feng-Liao-Chang-Wei-Kang Granules Combined with Mesalazine

Kun NIU, Daozhuang LIN, Xian WANG, Ling HUANG, Fan YANG*

1. Hainan Medical University,Haikou 571199,China; 2. Qionghai Hospital of Traditional Chinese Medicine, Qionghai 571400, China; 3. School of Hainan Provincial Drug Safety Evaluation Research Center, Haikou, 571199, China

Abstract [Objectives] To analyze the clinical effect of Feng-Liao-Chang-Wei-Kang Granule combined with mesalazine on chronic colitis. [Methods] 120 patients with chronic enteritis admitted to Qionghai Hospital of Traditional Chinese Medicine from October 2020 to March 2022 were selected as the research objects, and were randomly divided into combined group (62 cases) and conventional group (58 cases). Patients in the conventional group were treated with oral mesalazine on the basis of conventional treatment, while patients in the combined group were treated with Feng-Liao-Chang-Wei-Kang Granule combined with mesalazine. The clinical efficacy, inflammatory factor level, colonic mucosal lesion degree, quality of life and TCM syndrome scores of the two groups were compared. [Results] The total clinical effective rate in the combined group was higher than that in the conventional group (P<0.05). After treatment, the levels of inflammatory factors in the two groups were lower than those before treatment, and the levels of interleukin-6 (IL-6), C-reactive protein (CRP) and tumor necrosis factor-α (TNF-α) in the combined group were lower than those in the conventional group (P<0.001). After treatment, the Baron and Geboes scores of the two groups were lower than those before treatment, and the Baron and Geboes scores of the combined group were lower than those of the conventional group (P<0.001). After treatment, the scores of quality of life in the two groups were higher than those before treatment, while the scores of TCM syndromes were lower than those before treatment. The scores of quality of life in the combined group were higher than those in the conventional group (P<0.001). [Conclusions] Feng-Liao-Chang-Wei-Kang Granule combined with mesalazine can obviously improve the curative effect, reduce the level of inflammatory factors, improve the degree of colonic mucosal lesions and improve the quality of life of patients with chronic colitis, which is worthy of popularization and application in clinical practice.

Key words Feng-Liao-Chang-Wei-Kang Granule, Mesalazine, Chronic colitis, Curative effect

1 Introduction

Colitis is a colonic inflammatory disease caused by many reasons, and it has a long course and easy recurrence, and seriously affects the quality of life of patients. Feng-Liao-Chang-Wei-Kang is composed ofDaphniphyllumcalycinumandPolygonumhydropiperL., which is a famous Li medicine in Hainan. Haikou Pharmaceutical Factory has two dosage forms: Feng-Liao-Chang-Wei-Kang Tablet and Feng-Liao-Chang-Wei-Kang Granule. Researchers studied its anti-ulcerative colitis, anti-inflammatory, analgesic and antibacterial effects through different animal experimental models, and confirmed that the main pharmacological effects of Feng-Liao-Chang-Wei-Kang concentrated in gastrointestinal tract. Feng-Liao-Chang-Wei-Kang has obvious curative effect on colitis without adverse reaction, and is an effective drug for treating chronic colitis. From October 2020 to March 2022, 120 cases of chronic colitis were treated with Feng-Liao-Chang-Wei-Kang Granule combined with mesalazine in Qionghai Hospital of Traditional Chinese Medicine, and the curative effect was remarkable. The report is as follows.

2 Data and methods

2.1 Clinical data

2.1.1General information. A total of 120 cases were outpatients in the Department of Gastroenterology, Qionghai Hospital of Traditional Chinese Medicine, including 54 males and 66 females; the age ranged from 24 to 71 years, with an average of 43.8 years; the shortest course of disease was 5 months and the longest was 24 years. All patients had no history of gastrointestinal surgery, and all patients were diagnosed by colonoscopy and histopathological examination.

2.1.2Selection criteria. There were abdominal pain, diarrhea, mucous stool, abdominal distension symptoms, colonoscopy showed congestion and edema of colonic mucosa, thickening and disorder of vascular texture, disappearance of reticular structure, easy spasm of intestinal cavity, and no other obvious pathological changes were found. Pathology showed chronic colitis.

2.2 Treatment methodsPatients took Feng-Liao-Chang-Wei-Kang Granule from Haikou Qili Pharmaceutical Co., Ltd. It was taken orally 3 times a day, 2 tablets each time, for 8 weeks. All patients stopped using all related drugs during taking medicine to ensure the reliability of evaluating the therapeutic effect of Feng-Liao-Chang-Wei-Kang Granule.

2.3 Observation index and curative effect judgment standard

The curative effect, the level of inflammatory factors, the degree of colonic mucosal lesions and the quality of life of the two groups were observed.

2.3.1Criteria for judging curative effect. Complete remission: The main symptoms and secondary symptoms of the patient all disappeared, and the tongue pulse sign returned to normal. Colonoscopy showed that the lesion site was normal or the ulcer lesion had formed scar. Markedly effective: The symptoms and tongue pulse of the patient were significantly improved. Colonoscopy showed that the recovery degree of mucosal lesions was above grade 2. Improvement: The main symptoms were improved. Ineffective: The above standards were not met.

2.3.2Levels of inflammatory factors. Before and after treatment, 5 mL of fasting venous blood was taken in the morning, and the serum was left for later use by centrifugation at low speed. The levels of IL-6, CRP and TNF-α were detected by laboratory personnel using automatic biochemical analyzer.

2.3.3Degree of colonic mucosal lesion. The patients who underwent colonoscopy and pathological examination before treatment and within 1-3 d after treatment were evaluated according to Baron and Geboes index. The higher the score, the more serious the lesion.

2.3.4Quality of life score. The degree of colonic mucosa lesion was evaluated and the quality of life was evaluated with the Inflammatory Bowel Disease Questionnaire (IBDQ). The higher the score, the better the quality of life.

3 Results and analysis

3.1 Comparison of clinical efficacy between two groups

The total effective rate of patients in the combined group was higher than that in the conventional group (P<0.05), as shown in Table 1.

Table 1 Comparison of clinical efficacy between two groups

3.2 Comparison of inflammatory factors between two groupsAfter treatment, the levels of inflammatory factors in the two groups were lower than those before treatment, and the levels of IL-6, CRP and TNF-α in the combined group were lower than those in the conventional group (P<0.001), as shown in Table 2.

Table 2 Comparison of inflammatory factors between two groups (n=120)

3.3 Comparison of scores of colonic mucosal lesions between two groupsAfter treatment, the Baron and Geboes scores of the two groups were lower than those before treatment, and the Baron and Geboes scores of the combined group were lower than those of the conventional group (P<0.001), as shown in Table 3.

Table 3 Comparison of scores of colonic mucosal lesions between two groups (n=120)

3.4 Comparison of quality of life scores between two groups

After treatment, the scores of quality of life in the two groups were higher than those before treatment. The scores of quality of life in the combined group were higher than those in the conventional group (P<0.001), and the scores of TCM syndromes were lower than those in the conventional group (P<0.001), as shown in Table 4.

Table 4 Comparison of quality of life and TCM syndrome scores between two groups (n=120)

4 Discussion

Chronic colitis is a common and frequently-occurring intestinal disease, and it is prolonged for a long time and lingering and difficult to heal. Symptoms mainly include abdominal pain, abdominal distension, diarrhea, mucous stool, chronic colitis falls within the category of "diarrhea" and "dysentery" in traditional Chinese medicine. The treatment principles are clearing away heat and toxic materials, removing dampness and eliminating stagnation[1-2]. The occurrence of this disease is due to weakness of spleen and stomach, imbalance of cold and temperature, improper diet, or poor emotion, which leads to damage of spleen and stomach, abnormal transportation and transformation, loss of conduction of large intestine, and accumulation of dampness turbidity. There are often qi and blood stagnation, intestinal and collateral disharmony, blood infection and rotten flesh. Therefore, the treatment principle is to clear away heat and toxic materials, remove dampness and eliminate stagnation. The main components of Feng-Liao-Chang-Wei-Kang Granule areD.calycinumandP.hydropiperL.D.calycinumis a plant of the family Glycine, which mainly contains daphnicaline, greycyanine and β-sitosterol. It is warm in nature and has the functions of dispelling wind, relieving pain and reducing swelling.P.hydropiperL. is a Polygonaceae plant, mainly contains flavonoids and has the function of dehumidifying and stagnation, and can be used for the treatment of dysentery, enteritis and food stagnation[3-4]. Through clinical trials, Wu Xiaojuanetal.[5]found that Feng-Liao-Chang-Wei-Kang Tablet combined with famotidine can obviously improve the clinical efficacy of patients with acute gastroenteritis, improve clinical symptoms, reduce inflammatory reaction, regulate gastrointestinal hormone secretion, and have certain safety. Wang Yaminetal.[6]used Feng-Liao-Chang-Wei-Kang Granule combined with probiotics to treat diarrhea patients with irritable bowel syndrome can effectively improve the therapeutic effect, improve the balance of intestinal flora, and have obvious effect on down-regulating the expression of IL-17 and IL-23. Wu Peiyuetal.[7]found that Feng-Liao-Chang-Wei-Kang Oral Liquid combined with Smecta was effective in treating elderly chronic diarrhea, which can shorten the course of disease and has low incidence of adverse reactions. Western medicine believes that inhibiting inflammatory reaction and protecting intestinal mucosa are the first principles in the treatment of chronic colitis. Mesalazine is a drug with good anti-inflammatory effect, widely used in the treatment of patients with chronic colitis and has good anti-ulcer effect[8-10]. Pharmacological experiments of Hainan Institute of Medicine showed that Feng-Liao-Chang-Wei-Kang Granule can inhibit gastric acid secretion. It had obvious inhibitory effect on the contraction amplitude and frequency of ileum in animalsinvivo, had obvious therapeutic effect on experimental gastritis model, had inhibitory effect on intestinal peristalsis, and can reduce the number of stools; it had the effect of relieving smooth muscle, relieving abdominal pain and intestinal spasm; it had obvious anti-inflammatory effect.Invitroexperiments showed that it had certain inhibitory effect onE.coli,S.aureusandS.dysenteriae.

The results of this clinical study showed that the total clinical effective rate of the combined group was significantly higher than that of the conventional group (P<0.05), and the levels of inflammatory factors IL-6, CRP and TNF-α were lower than those of the conventional group (P<0.001), which indicated that Feng-Liao-Chang-Wei-Kang Granule could cooperate with mesalazine to quickly repair intestinal mucosa, promote the disappearance of ulcer or scar, and further improve the clinical curative effect. At the same time, it was found that Feng-Liao-Chang-Wei-Kang Granule could inhibit the release of IL-6, CRP and TNF-α, thus preventing the invasion of inflammatory factors to colon mucosa and enhancing the therapeutic effect. Baron score, Geboes index score and TCM syndrome score of patients in the combined group were significantly lower than those in the conventional group, and the quality of life score was higher than that in the conventional group (P<0.001), which suggested that mesalazine could inhibit the inflammatory reaction of intestinal wall, while Feng-Liao-Chang-Wei-Kang Granule could improve the anti-inflammatory effect, and at the same time, astringe sores and promote granulation, and promote the rapid healing of colon mucosal ulcer, thus relieving clinical symptoms. To sum up, Feng-Liao-Chang-Wei-Kang Granule combined with mesalazine in treating chronic colitis can obviously improve the curative effect, reduce the level of inflammatory factors, improve the degree of colon mucosal lesions and improve the quality of life of patients.