Ascites of cirrhosis is one of the most common complications in patients with decompensated cirrhosis.Branch of Gastrointestinal Diseases,China Association of Chinese Medicine Published Expert consensus on Traditional Chinese Medicine diagnosis and treatment of ascites due to cirrhosis in 2012 and 2017.With the development of Traditional Chinese Medicine research on cirrhosis ascites,it is necessary to update the expert consensus on diagnosis and treatment.This consensus combines the research of Traditional Chinese Medicine and Western medicine in the diagnosis,treatment and prevention of ascites in cirrhosis,highlights the clinical practicability and reflects the latest research progress.
Ulcerative colitis is a chronic nonspecific intestinal inflammatory disease characterized by continuous and diffuse inflammation of the colorectal mucosa. In recent years, the incidence and prevalence of ulcerative colitis have been increasing rapidly, and it has become a common clinical disease. The syndrome differentiation and treatment system of the six channels and classic prescriptions established by ZHANG Zhongjing in Shanghan Zabing Lun have been widely used in the clinical diagnosis and treatment of ulcerative colitis and have achieved good curative effect. This paper discusses the clinical thinking and experience of the treatment of ulcerative colitis with Jingfang from the evolution of disease names, pathological mechanism, common prescriptions and application points.
Objective: To investigate the mechanism of ursolic acid（UA） suppresses colorectal cancer progression based on proteomics. Methods: HCT-116 was selected as the study target, and the CCK-8 assay was used to detect the inhibition rates on HCT-116 after the treatment with different concentrations of UA. Extracted proteins from UA-treated and control cells were analyzed by proteomic analysis. Differential expression proteins（DEPs） were screened and then analyzed by GO and KEGG enrichment analysis. The target pathway was further verified by GSEA pathway enrichment analysis. Ingenuity pathway analysis（IPA） focused on key signaling pathways, and the results of IPA were verified by Western blot, measurement of intracellular total cholesterol level, and flow cytometry. Results: UA inhibited HCT-116 cell proliferation in a dose-dependent manner. The IC 50 , IC 20 and IC 10 of UA on HCT-116 were 7.733 μg/mL, 5.926 μg/mL and 5.072 μg/mL, respectively. Next, 1.6 μg/mL and 3.2 μg/mL UA were selected for follow-up experiments. UA inhibited HCT-116 cell proliferation in a time-and dose-dependent manner at non-toxic concentrations. Proteomics identified 468 DEPs between the control group and the UA-treated group. GO and KEGG enrichment analysis showed that the DEPs were associated with many biological processes such as cholesterol metabolism, autophagy, and ferroptosis. GSEA enrichment analysis further confirmed that the cholesterol metabolic pathway was related to the DEPs（NES=1.76, P＜0.001）. IPA showed that UA significantly activated the LXR/RXR signaling(Z-score=3.00,-log 10 （P）=9.49). The verification experiment results showed that UA up-regulated the expression of LXR/RXR target proteins MYLIP, ABCG1, and apolipoprotein E（APOE）. In addition, UA decreased the total cholesterol level and induced apoptosis in HCT-116 cells. Furthermore, cholesterol supplementation could antagonize UA-induced apoptosis. Conclusion: UA activates LXR/RXR signaling and increases the expression of target proteins MYLIP, ABCG1 and APOE, which results in the decrease of cholesterol level, inhibition of proliferation, and increase of apoptosis in colorectal cancer cells.
Objective: To study the distribution of TCM syndromes of gastric mucosal dysplasia and its correlation with pathological changes. Methods: Using a cross-sectional research method and using unified diagnostic criteria, the pathological diagnosis of 480 patients with low-grade/uncertain dysplasia of gastric mucosal was collected, and the four diagnosis information of Traditional Chinese Medicine, such as primary and secondary symptoms, tongue and pulse, were collected to clarify their TCM syndrome types and pathological tissue classification. The database was established, and the data analysis was carried out by using IBM-SPSS 26.0 software. Results: A total of 480 cases were included in this study, there were 261 patients with low grade dysplasia and 219 patients with uncertain dysplasia. The total frequency of single syndrome and complex syndrome in all patients was 706 times, there were 276 patients with single syndrome, 182 patients with two syndromes and 22 patients with three syndromes. The frequency of syndromes was: liver-stomach stagnation-heat syndrome＞spleen and stomach qi deficiency＞blood stasis of stomach collaterals＞damp-heat in spleen-stomach＞spleen and stomach deficiency and cold＞stagnation of qi in liver-stomach＞deficiency of yin in stomach. The age of spleen and stomach qi deficiency syndrome is higher than that of non spleen and stomach qi deficiency syndrome（P＜0.05）. There is a negative correlation between spleen and stomach deficiency and cold syndrome and atrophy range and atrophy degree（P＜0.05）. There was a positive correlation between spleen and stomach qi deficiency and the extent of dysplasia, atrophy, and intestinal chemosis lesions（P＜0.05）. Conclusion: Liver-stomach stagnation-heat syndrome, spleen and stomach qi deficiency, blood stasis of stomach collaterals are common syndromes of dysplasia; spleen and stomach deficiency and cold syndrome is mostly distributed in the early stage of the disease with less atrophy degree and smaller atrophy range; the spleen and stomach qi deficiency is an important link in the pathogenesis of dysplasia, and it is also a key syndrome in the development of lesions and even canceration. It is often accompanied by qi stagnation, blood stasis, stagnant heat, damp heat, etc.
Gastric cancer is a major challenge when it comes to preventing and controlling malignant tumors in China. The existence of atrophic gastritis and precancerous lesions provides the possibility for early diagnosis and treatment, and is the focus of secondary prevention of gastric cancer. During the past 40 years, Chinese Medicine research has made some significant achievements regarding the diagnosis, treatment, and prevention of atrophic gastritis and gastric precancerous lesions; however, deficiencies still exsit. This article reviews the history of Traditional Chinese Medicine research on atrophic gastritis and precancerous lesions, puts forward the strategies to deal with the existent problems and points out the future development, in order to provide reference for the construction of the secondary prevention and treatment system of gastric cancer with Chinese characteristics.
Objective: To explore the curative effect of Dingguier Umbilical Paste combined with montmorillonite powder on diarrhea children and its influences on gastrointestinal floras. Methods: A total of 204 children with diarrhea in the hospital were randomly divided into study group and control group between June 2018 and June 2020, 102 cases in each group. The control group was given montmorillonite powder, while study group was given Dingguier Umbilical Paste and montmorillonite powder. The clinical curative effect after treatment was observed and compared between the two groups. The improvement time of stool property and disappearance time of diarrhea in both groups were recorded. The changes in scores of Traditional Chinese Medicine syndromes, intestinal floras（Enterobacter, Bifidobacterium, Lactobacillus）, diamine oxidase（DAO）, D-lactic acid, inflammatory factors（IL-6, IL-8, TNF-α） and immune function indexes（IgG, IgM, IgA） before and after treatment, and adverse reactions after medication were compared between the two groups. Results: After treatment, total response rate of treatment was higher in the study group than the control group（92.16% vs 82.35%, P＜0.05）. The differences in median improvement time of stool property between the study group and the control group were statistically significant（44 h vs 48 h, P＜0.05）, and differences in median disappearance time of diarrhea between the study group and the control group were statistically significant（47 h vs 55 h, P＜0.05）. The scores of Traditional Chinese Medicine syndromes in study group were significantly lower than those in the control group（P＜0.05）. The count of Enterobacteriaceae, and levels of D-lactic acid, DAO, IL-6, IL-8 and TNF-α in study group were significantly lower than those in the control group, while counts of Bifidobacterium and Lactobacillus, and levels of serum IgG, IgM and IgA were significantly higher than those in the control group（P＜0.05）. There was no significant difference in the incidence of adverse reactions during treatment between the study group and the control group（3.92% vs 7.84%, P＞0.05）. Conclusion: Curative effect of Dingguier Umbilical Paste combined with montmorillonite powder is significant on diarrhea children, which can effectively improve clinical symptoms, enhance intestinal barrier function, improve the balance of intestinal floras, enhance immunity and reduce inflammatory response, with high medication safety.
Objective: This study aims to analyze the consistency of different risk assessment methods for chronic atrophic gastritis（CAG）, and to explore the correlation between the quantitative score of spleen deficiency or blood stasis evidence and the risk of cancer. Methods: This study collects patients’ general information, endoscopic and pathological data, symptoms, tongue, and pulse diagnosis. The quantized integration of spleen deficiency and blood stasis syndrome is established on the basis of the symptoms, tongue and pulse diagnosis. Diagnosis of endoscopic microdifferentiation of discrimination is based on the endoscopic presentation of spleen deficiency evidence and blood stasis evidence. Risk stratification for CAG was performed with the Kimura-Takemoto（K-T） classification, and the OLGA/OLGIM classification for chronic gastritis. Results: There is a correlation between the degree and coverage of spleen deficiency and blood stasis in patients with CAG and the extent of atrophy evaluated by the K-T classification, as well as the severity of histopathological features such as the extent of gastric glandular atrophy（EGA） and intestinal metaplasia（IM）. The total score of spleen deficiency and blood stasis evidence（traditional differentiation + endoscopic microdifferentiation of discrimination） correlates with the risk of CAG. Compared with the quantified scoring of spleen deficiency, quantified scoring of blood stasis is more helpful in screening high-risk CAG patients. The agreement between K-T classification and OLGA/OLGIM in identifying high-risk CAG patients by stages is moderate. Conclusion: The agreement between K-T classification and OLGA/OLGIM in identifying high-risk CAG patients by stages is moderate. The combination of traditional differentiation and endoscopic microdifferentiation of discrimination helps to improve the accuracy and comprehensiveness of identification. The combination of the evidence of spleen deficiency and blood stasis allows for a risk assessment followed the integration of disease and syndrome.
Ulcerative colitis（UC） is a chronic recurrent inflammatory disease with unknown pathogenesis. The incidence of UC continues to rise globally, resulting in a considerable social burden due to its related mortality and disability. Therefore, identifying the pathogenesis of UC is crucial for disease prevention, disease behavior judgement, treatment options, and new drug development. Most western scholars believe that genetic susceptibility, environment, abnormal intestinal mucosal immune regulation, and other factors interact together to lead to the occurrence of UC. Traditional Chinese Medicine emphasizes the integration of the five viscera and believes that the incidence of UC is related to the dysfunction of the spleen, lung, liver, and kidney. This article will focus on the above aspects to summarize the new progress and relevance of Traditional Chinese and Western Medicine pathogenesis research to better understand the pathogenesis of UC and may provide therapeutic approaches in the management of disease and new drug research.
目的:观察冰硝散外敷联合针刺八醪穴对混合痔患者术后水肿的改善作用和对抗炎因子、疼痛应激及新生血管形成的影响.方法:选择2021年3月-2022年3月收治的100例混合痔患者为研究对象,以随机数字表法分组,对照组(50例)用常规西医治疗,研究组(50例)用常规西医、冰硝散外敷联合针刺八髎穴治疗.术后1 d、7 d,检测两组患者的炎症指标:IL-10、淀粉样蛋白A(serumamyloid,SAA)、可溶性髓系细胞触发受体-1(soluble myeloid cell trigger receptor-1,sTREM-1)表达水平;检测患者的疼痛指标:6-酮前列腺素 E1α(6-keto prostaglandin E1α,6-keto-PGE1α)、β内啡肽(β-endorphin,β-EP)表达水平;应激指标:皮质醇(cortisol,COR)、促肾上腺皮质激素(adrenocorticotropin,ACTH)的表达水平;检测患者新生血管形成指标:碱性成纤维生长因子(basic fibroblast growth factor,bFGF)、血小板源性生长因子(platelet-derived growth factor,PDFG)以及血管内皮生长因子(vascular endothelial growth factor,VEGF)的表达情况;术前、术后1个月测量患者肛门功能指标:肛管最大收缩压、直肠肛管抑制反射阈、肛管静息压表达情况;术后1 d、7 d评价患者的创面水肿及疼痛情况;记录患者的肛门坠胀持续、肛门水肿消散以及创面愈合时间,比较两组患者的临床疗效.结果:术后7 d,研究组的SAA含量较对照组明显降低(P＜0.05),IL-10、sTREM-1含量较对照组明显升高(P＜0.05),6-keto-PGE1α、ACTH、COR含量较对照组明显降低(P＜0.05);研究组β-EP含量较对照组明显升高(P＜0.05),bFGF、VEGF、PDFG含量较对照组明显升高(P＜0.05).术后1个月,研究组的肛管最大收缩压、直肠肛管抑制反射阈、肛管静息压较对照组明显升高(P＜0.05);术后7 d,研究组的水肿、疼痛评分较对照组明显减少(P＜0.05),肛门坠胀持续时间、肛门水肿消散时间、创面愈合时间较对照组明显缩短(P＜0.05).研究组患者的总有效率较对照组高(98.00％vs 88.00％),差异有统计学意义(P＜0.05).结论:冰硝散外敷联合针刺八髎穴治疗混合痔术后患者,可提升患者的抗炎因子水平,抑制患者的SAA水平,减少应激反应指标,改善疼痛递质水平及新生血管形成指标,促进肛门水肿消散、疼痛消失及肛门创面愈合,提升肛门功能和临床疗效.
Objective: To analyze the clinical effect of Yiqi Yukui Decoction combined with mesalazine in the treatment of ulcerative colitis（UC）, and provide experience guidance for the clinical treatment of UC. Methods: A randomized controlled trial was used to include 100 patients with UC who were admitted to our hospital from January 2018 to January 2022. They were divided into two groups with 50 patients in each group. Both groups were treated with greedy ghosts, the control group was treated with mesalazine, and the observation group was treated with Yiqi Yukui Decoction combined with mesalazine for four weeks. The clinical efficacy, intestinal mucosal barrier function[serum D-lactic acid（D-LA）, diamine oxidase（DAO）, endotoxin（ET） ],helper T cell 17（Th17）/regulatory T（Treg） cell immune balance（Th17 level, Treg level, Th17/Treg value） and adverse reactions were compared between the two groups before and after four weeks of treatment. Results: The total effective rate of treatment in the observation group was higher than that in the control group（P＜0.05）. After four weeks of treatment, the levels of D-LA, DAO and ET in the two groups were lower than those before treatment, and the levels in the observation group were lower than those in the control group（P＜0.05）. After four weeks of treatment, Th17, Th17/Treg in the two groups were lower than those before treatment, and Treg was higher than those before treatment, and Th17, Th17/Treg in the observation group was lower than that in the control group, and Treg was higher than that in the control group（P＜0.05）. There was no statistical significant difference in the occurrence of adverse reactions between the two groups（P＞0.05）. Conclusion: Yiqi Yukui Decoction combined with mesalazine can significantly improve the intestinal mucosal barrier function of UC patients, maintain the Th17/Treg cell immune balance, improve the clinical treatment effect, and will not increase the risk of adverse reactions.
Objective: To investigate the efficacy and safety of Bushen Jianpi Wenchang Prescription combined with granulocyte-macrophage colony-stimulating factor（GM-CSF） enema in the treatment of chronic radiation enteritis. Methods: Sixty-one patients with chronic radiation enteritis were selected as research objects and randomly divided into a treatment group（31 cases） and a control group（30 cases）. The treatment group was given Bushen Jianpi Wenchang Prescription oral combined with GM-CSF enema, and the control group was given glutamine enteric coated capsule oral combined with dexamethasone+montmorillonite powder enema for 30 consecutive days. Observe the symptom response rate, the grade of intestinal radiation reaction, the Vienna enteroscopy score（VRS）, patient-generated subjective global assessment（PG-SGA）, the Traditional Chinese Medicine（TCM） syndrome score（abdominal pain, diarrhea）,and adverse reactions before and after treatment. Results: The remission rate in the treatment group was 93.5%（29/31）, and that in the control group was 80.0%（24/30）. The difference between the two groups was statistically significant（Z=-2.202, P=0.043）; after treatment, the degree of intestinal radiation reaction, the VRS and TCM syndrome score of the two groups were improved compared with those before treatment; after treatment, the treatment group was superior to the control group in the grading of intestinal radiation reaction, the VRS and the score of TCM syndromes（P＜0.05）; the PG-SGA score of the two groups after treatment was better than that before treatment, and there was no significant difference between the two groups after treatment（P＞0.05）. Conclusion: Bushen Jianpi Wenchang Prescription combined with retention enema can reduce the degree of intestinal injury in patients with chronic radiation enteritis, improve the patients’ enteroscopy score, diarrhea, anorexia, and nutritional status, and is safe.
Objective: Exploring the changes of mucosal protein expression in intestinal metaplasia patients based on gastric "inflammatory-carcinoma" transformation. Methods: Patients with non-astrophic gastritis, chronic atrophic gastritis and intestinal metaplasia each ten were selected to detect the expression of olfactomedin 4（OLFM4）, caudal type homeobox transcription factor 2（CDX2）, Krüppel-like factor 4（KLF4）, hepatocyte nuclear factor 4α（HNF4α）, CB-CALLA（CD10） and other proteins by immunohistochemistry. Results: OLFM4 is expressed scattered in non-astrophic gastritis and chronic atrophic gastritis gastric mucosa, and is expressed diffusely in intestinal metaplasia. CDX2 is almost not expressed in non-astrophic gastritis and chronic atrophic gastritis, but is moderately positive in intestinal metaplasia. The expression of KLF4 in non-astrophic gastritis and chronic atrophic gastritis was only moderately positive in the cell nucleus of the gastric lumen epithelium and negative in the basal side. In intestinal metaplasia, KLF4 is showed strong positive expression in the nucleus of the gastric lumen epithelium and moderate positive expression in the nucleus of the basal side. HNF4α is negatively expressed in non-astrophic gastritis and chronic atrophic gastritis. In intestinal metaplasia, diffuse moderately positive expression of HNF4α is found in the gastric lumen epithelium. CD10 is diffuse moderately positive in non-astrophic gastritis and chronic atrophic gastritis and diffuse strongly positive in intestinal metaplasia. Conclusion: OLFM4, CDX2, KLF4, HNF4α and CD10 can be used as specific intestinal metaplasia markers of gastric "inflammatory-carcinoma" transformation.
Gastroesophageal reflux disease（GERD） is a disease of esophagus and extraesophageal discomfort caused by reflux of gastric contents due to lower esophageal sphincter pressure reduction, transient and excessive lower esophageal sphincter relaxation, mucosal barrier damage and other factors. At present, the prevalence of GERD is increasing year by year, and often accompanied by anxiety and depression symptoms. Proton pump inhibitors and anti-anxiety and depression drugs are the first choice for the treatment of this disease, but the effect is not satisfactory. In recent years, studies have found that the brain gut microbiota axis is closely related to GERD and depression. Intestinal flora can lead to emotional changes and aggravate GERD. Traditional Chinese Medicine believes that GERD with depression is closely related to the liver and spleen. Starting with the qi mechanism of the liver and spleen, Traditional Chinese Medicine treatment can benign regulate and treat GERD with depression symptoms, maintain the stability of the intestinal environment, the types and abundance of flora, and change the levels of gastrointestinal hormones. The purpose of this paper is to explore the pathogenesis of GERD with depression from the etiology and pathogenesis of Traditional Chinese Medicine and the action mechanism of brain gut microbiota axis, collect and sort out the intestinal flora in recent years and the treatment of GERD with Traditional Chinese Medicine, and provide reference for the future research of GERD.
Objective: To observe the effects of Tongxie Yaofang combined with acupoint catgut embedding on 5-hydroxytryptamine（5-HT） and neurotransmitter substance P（SP） in colonic and hippocampal tissues of rats with ulcerative colitis of liver depression and spleen deficiency, and to explore its mechanism. Methods: Totally 48 SPF SD male rats were randomly divided into blank group（12 rats） and modeling group（36 rats）. The ulcerative colitis models of liver depression and spleen deficiency pattern is established by 2, 4, 6-tritrobenzene sulfonic acid/ethanol mixture enema combined with physical restraint, disorder diet and tail-clipping. The successfully established rat models were randomly divided into model group, Tongxie Yaofang group and Tongxie Yaofang combined with embedding group. The Tongxie Yaofang group and the combination group were treated with Tongxie Yaofang decoction by gavage for 14 days, and the combination group was also treated with acupoint embedding at "Zusanli", "Tianshu", "Ganshu", "Qimen", "Pishu", "Dachangshu" and "Geshu",seven days/time, a total of two times; and the blank group and model group were given same amount of purified water by gavage for 14 days. HE staining was used to observe the pathological changes of colon tissue and the expression of 5-HT and SP in colonic and hippocampal tissues of rats was detected by immunohistochemistry. 5-HT and SP in serum and hippocampal tissue were detected by ELISA, and tumor necrosis factor-α（TNF-α）, interleukin-6（IL-6）, IL-1β and IL-23 in colon tissue were detected by Real-time quantitative Polymerase Chain Reaction（RT-qPCR）. Results: Compared with blank group, the expression levels of 5-HT and SP in serum, hippocampus and colon tissues were significantly increased（P＜0.05）, and the contents of TNF-α, IL-6, IL-1β and IL-23 in colon tissues were significantly increased（P＜0.05）. Compared with model group, the expressions of 5-HT and SP in serum, hippocampus and colon tissue of Tongxie Yaofang group and Tongxie Yaofang combined with acupoint catgut group were significantly decreased（P＜0.05）, and the contents of TNF-α, IL-6, IL-1β and IL-23 in colon tissue were significantly decreased（P＜0.05）. Conclusion: Tongxie Yaofang combined with acupoint catgut can significantly down-regulate the expression levels of 5-HT and SP in serum, hippocampus and colon tissue, and reduce the expression of inflammatory factors, so as to treat ulcerative colitis of liver depression and spleen deficiency.
Objective: To retrospectively analyze the clinical effect of Wudan Weifu Granules on chronic atrophic gastritis, so as to provide clinical practice basis and research guidance for further application. Methods: Clinical data of 100 patients with chronic atrophic gastritis in the Department of Gastroenterology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2016 to December 2018 were retrospectively analyzed. According to different treatments received, the patients were divided into exposed group（Wudan Weifu Granule intervention） and non-exposed group（conventional medicine treatment） with 50 cases each. Traditional Chinese Medicine（TCM）syndrome score, gastroscopic manifestations, pathological conditions, long-term efficacy and safety of the two groups of patients were analyzed. Results:（1）The total clinical effective rate, gastroscopic efficacy and pathological efficacy of exposed group were higher than those of non-exposed group（P＜0.05）.（2）TCM syndrome score: After treatment, TCM syndrome score of both groups was improved compared with that before treatment（P＜0.05）, and the exposed group was superior to the non-exposed group in terms of epigastric fullness of epigastric fullness, pain at a fixed point, dull complexion, nausea, acid reflux heartburn and total score（P＜0.05）.（3）Gastroscopic performance: the gastroscopic score of exposed group after treatment was significantly improved compared with that before treatment, and was significantly better than that of non-exposed group（P＜0.05）.（4）Pathology: After treatment, the pathological scores of inflammation, atrophy and intestinal metaplasia were significantly improved in the exposed and non-exposed groups compared with those before treatment（P＜0.05）, while the improvement degree of dysplasia scores in the exposed and non-exposed groups was not statistically significant compared with that before treatment（P＞0.05）. In terms of inflammation and atrophy scores, the exposed group was significantly improved compared with the non-exposed group（P＜0.05）, and there was no statistical significance in intestinal metaplasia and dysplasia scores between the two groups after treatment（P＞0.05）.（5）Follow-up clinical efficacy: After 8 weeks of follow-up, the recurrence rate of exposed group was lower than that of non-exposed group（P＜0.05）.（6）Safety evaluation: Vital signs of the included patients were strictly monitored during the study, and no adverse reactions occurred in the two groups. Conclusion: Wudan Weifu Granules can significantly improve the total clinical effective rate, gastroscopic efficacy and pathological efficacy of patients with chronic atrophic gastritis, reduce the recurrence rate, improve the gastroscopic manifestations and pathological conditions, and the clinical application is safe.
In recent years, with the increasing incidence of inflammatory bowel disease in China, especially ulcerative colitis, how to use biological agents correctly and effectively in patients with ulcerative colitis has raised many questions for us, which is worth thinking about.
Helicobacter pylori（Hp） is anⅠ-type carcinogenic factor. High antibiotic resistance, high infection rate, and low tolerability of eradication therapy in the elderly Hp-infected population limit the use of conventional first-line therapy in the elderly population. The eradication of Hp in elderly patients can still benefit by significantly reducing the incidence of gastrointestinal tumors and the risk of gastrointestinal bleeding. The current primary regimen for Hp eradication in the elderly remains bismuth quadruple therapy, with the loading of probiotics or Traditional Chinese Medicine treatment to improve eradication rates and reduce adverse effects. High-dose dual therapy may be another ideal option for Hp eradication in the elderly due to its low risk of adverse effects and definite efficacy.
Objective: To describe the status of outcome indicators selected in randomized controlled trial（RCT） in the treatment of ulcerative colitis（UC） with Traditional Chinese Medicine（TCM）, analyze the existing problems, and provide the basis for the construction of UC clinical efficacy evaluation criteria based on the core outcome set of Traditional Chinese Medicine（COS-TCM）. Methods: Retrieved 2017-2022 published in CNKI Database, WanFang Database, VIP Database, SinoMed, Embase, Cochrane library, Web of Science and PubMed literature on randomized controlled trials of TCM treatment of UC. Two authors independently screened the literature and extracted the data in strict accordance with the inclusion and exclusion criteria. Any differences were resolved through discussion. Results: The study included 73 RCT, including 6 729 patients, using 79 outcome indicators. It can be divided into 8 broad categories: clinical effect（eight kinds, 101 times）, TCM syndrome effect（two kinds, 48 times）, intestinal mucosa and histopathological effect（10 kinds, 59 times）, symptoms and signs（one kind, nine times）, physical and chemical detection（49 kinds, 10 kinds, 213 times）, quality of life（seven kinds, 30 times）, long-term prognosis（one kind, seven times）, safety event（one kind, 36 times）. The outcome indexes with high frequency of use include: clinical efficacy/total effective rate, TCM syndrome score, incidence of adverse reactions, Mayo score/DAI score, Baron score, quality of life in inflammatory bowel disease（IBDQ） score, etc. Conclusion: There are many problems in the outcome indicators of clinical studies on TCM treatment of UC, such as non-standard efficacy indicators of TCM syndromes, inaccurate expression of clinical efficacy indicators, inconsistent reference standards, unclear distinction between primary outcome indicators and secondary outcome indicators, inadequate safety event reporting, and missing outcome indicators of economic evaluation. It is necessary to establish a unified UC TCM efficacy evaluation standard based on COS-TCM, so as to further improve the quality of TCM clinical research.
Chronic gastritis was one of the commonest diseases in digestive system, atrophic gastritis and gastric precancerous conditions and lesions（GPCL） were more and more focused in clinical practice. The development of responding new drug research was slow partly because of the lack of clinical research guidance of new drug of Chinese Medicine. Clinical Research Guidance of New Drug of Chinese Medicine in Chronic Gastritis was published in December 2022 by National Medical Products Administration. Details and interpretations on atrophic gastritis and GPCL in this clinical research guidance were specially described in this article in order to provide references for clinical researches.
The incidence of inflammatory bowel disease（IBD）, including ulcerative colitis（UC）, is gradually rising in China. With the progress of diagnosis and treatment, the number of UC patients with a long-term course of the disease is increasing, and their risk of developing colorectal cancer（CRC） is significantly increased. Risk factors for UC carcinogenesis include long-term course of the disease, extensive intestinal involvement, cumulative inflammatory burden（CIB）, primary sclerosing cholangitis（PSC）, and family history of CRC, among which recurrent inflammation is an independent risk factor for cancerogenesis. Colitis-associated colorectal cancer（CAC） and sporadic colorectal cancer are different in terms of carcinogenesis pattern, pathogenesis, and molecular characteristics. In this article, we will discuss the role of genetic and epigenetic changes, oxidative stress, abnormal immune response and intestinal flora disorder in the transformation from colitis to carcinoma. The risk stratification of CAC was performed for UC patients based on these risk factors. High-risk patients should undergo more frequent surveillance through colonoscopy for early detection, intervention, and treatment.
