Introduction: Traditional Chinese Medicine (TCM) has been found to be effective in the treatment of Helicobacter pylori (H. pylori). However, the quality of evidence is limited and there are few studies on TCM of H. pylori. This trials aimed to examine whether additional use of TCM can lead to better efficacy in the eradication rate of H. pylori. Methods: This study consisted of a multicenter randomized controlled trial and a nonrandomized cohort. Subjects from TCM hospitals were allocated to a treatment group that received triple therapy or a combination group that received triple therapy combined with 2 weeks of herbal bulk or 2 weeks of herbal soup or 4 weeks of herbal soup. Patients in western hospitals received triple therapy (non-randomized control group). The eradication rate of H. pylori, the recurrence rate, the TCM symptom score, the patient-reported outcome scale (PRO), and safety indicators were observed and compared. Results: 960 patients screened, 768 were randomly assigned to the randomized treatment group, and 192 were assigned to the non-randomized group. No difference in the H. pylori eradication rate between the combination group compared with triple therapy (P > 0.05). Significant improvements were observed in TCM symptom scores, the quality of life in the combination group (P < 0.05). Moreover, it had a lower incidence of adverse reactions and rates of H. pylori recurrence (P < 0.05). Conclusion: The additional use of TCM in triple therapy improves the quality of life, reduces adverse effects, and recurrence rates.

In the journey towards the modernization and internationalization of Traditional Chinese Medicine (TCM), standards and standardization emerge as indispensable foundational elements and carry strategic significance. By introducing the concepts of standards and standardization, this article emphasizes their essential roles as the base of modern industry and the core of modernization efforts. It revisits the development plans and national strategies for TCM, highlighting the pivotal role of standardization in the inheritance and innovation within the TCM discipline. The standardization of TCM specialties is underscored for its critical function in both inheriting and innovating, as well as enhancing the international competitiveness of TCM. Through discussing the specific practices in standardizing the TCM specialty of spleen and stomach diseases, the article advocates for strengthening top-level design and advancing the systematic construction of the TCM specialty standards system. It suggests employing a variety of methods, including expert consultations and literature research, to refine the standardization processes of TCM clinical diagnosis and treatment techniques. This approach ensures that the work on specialty standardization not only meets practical needs but also possesses foresight and scientific validity.

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.

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.

肠易激综合征(Irritable bowel syndrome,IBS)是世界范围的消化系统常见病和多发病,其症状易反复发作,影响患者的生存质量.我国针对IBS的中药新药研究相对薄弱.《中药新药用于肠易激综合征临床研究技术指导原则》由国家药品监督管理局于2017年12月发布,作者针对该指导原则在编制过程中涉及到的细节问题的具体考量进行了说明,以期增进读者对该指导原则的理解,便于实际使用.

The standardized diagnosis and management of gastric precancerous conditions and lesions are important to prevent gastric cancer. This guideline, created by 5 traditional Chinese medicine and Western medicine associations, based on the current morbidity and diagnosis and treatment of gastric precancerous conditions and lesions, provides specific key points and strategies for diagnosis and treatment in the following five aspects: definition and epidemiology, diagnosis and stage, surveillance, treatment and efficacy evaluation. It is hoped that these aspects, assessed by integrating Western medicine and traditional Chinese medicine and involving multidisciplinary participation, will play a guiding role in clinical diagnosis and treatment and achieve effective secondary prevention of gastric cancer.

BACKGROUND:In this study, Chinese herbal compound prescriptions combined with Chinese medicine powder were evaluated for the treatment of chronic atrophic gastritis with erosion. METHODS:This multi-center, randomized, positive drug control clinical trial randomly assigned 216 patients with chronic atrophic gastritis with erosion to three groups: (1) control group: aluminum plus magnesium suspension thrice per day for 4 weeks; (2) test group 1: Chinese herbal compound prescriptions twice a day plus Sanqi (Panax notoginseng) powder twice a day for 4 weeks; (3) test group 2: Chinese herbal compound prescriptions twice a day plus Sanqi (Panax notoginseng) powder and Zhebeimu (Fritillaria thunbergii Miq.) powder twice a day for 4 weeks. The primary endpoint (improvement of gastric mucosal erosion; improvement of gastric mucosal pathology) and secondary endpoints (improvement of clinical symptoms scores; improvement of the patient-reported outcome [PRO] instrument for chronic gastrointestinal diseases) were assessed using endoscopy at week 4 following the treatment. Drug-related adverse events (AEs) and adverse drug reactions (ADRs) were also compared. RESULTS:The final analysis included 202 patients (control group, 63; test group 1, 69; test group 2, 70). At week 4, using within-group comparison, gastric mucosal erosion improved in each group following treatment with a significant difference (P < 0.05); there were no statistically significant differences in gastric mucosal erosion scores among the groups after treatment (P > 0.05); in terms of improvement of gastric mucosal erosion, the efficacy rate of the control group was 69.12%, the efficacy rate of the test group 1 was 73.24%, and the efficacy rate of the test group 2 was 69.01% and efficacy rate among the groups was not statistically significant (P > 0.05). As determined by acute inflammation, chronic inflammation, atrophy, intestinal metaplasia, and dysplasia, the pathological score (total score and the highest score) did not differ statistically among groups following treatment (P > 0.05); within the control group, the total scores of acute inflammation, chronic inflammation, atrophy, and intestinal metaplasia were significantly decreased (P < 0.05), but there was no significant improvement in dysplasia (P > 0.05); in the test group 1, chronic inflammation, atrophy, and intestinal metaplasia and dysplasia scores were significantly decreased (P < 0.05), but acute inflammation did not improve (P > 0.05); there was a significant reduction in the atrophy score in test group 2 (P < 0.05), but no improvement in the scores of acute inflammation, chronic inflammation, intestinal metaplasia, and dysplasia was observed (P > 0.05). Similarly, within the control group, the highest scores of acute inflammation, chronic inflammation, atrophy, and intestinal metaplasia were significantly decreased (P < 0.05), but there was no significant improvement in dysplasia (P > 0.05); there was a significant reduction in highest scores of atrophy, intestinal metaplasia, and dysplasia (P < 0.05) in test group 1, but the highest scores didn't not improve with acute inflammation and chronic inflammation (P > 0.05); there was a significant reduction in the highest atrophy score in test group 2 (P < 0.05), but no improvement in the highest scores of acute inflammation, chronic inflammation, intestinal metaplasia, and dysplasia was observed (P > 0.05). Compared to the control group, the main symptom scores and total symptom scores in the test groups were lower following treatment, with a statistically significant difference (P < 0.05); the analysis of covariance with center, erosion type, and group as factors was applied, and the comparison among the groups in dyspepsia, defecation, and total PRO instrument scores were statistically significant (P < 0.05). In the study period, AEs were reported in 3 (4.23%) patients in the test group 1 and 3 (4.41%) patients in the control group; ADRs were confirmed in 3 (4.23%) patients from the test group 1 and 2 (2.94%) from the control group. AEs and ADRs were not statistically significantly different among groups (AE, P = 0.2213; ADR, P = 0.2872). No serious AE or ADR was reported. CONCLUSIONS:This study has shown that both aluminum plus magnesium suspension and Chinese herbal compound prescriptions together with Panax notoginseng powder are capable of improving gastric mucosal erosion and reducing gastric mucosal pathological scores, and there were no statistically significant differences among the groups in primary endpoints, indicating that Chinese herbal therapy can achieve similar efficacy than antacids in terms of primary outcomes. The aluminum plus magnesium suspension is comparable to Chinese herbal therapy in improving atrophy and intestinal metaplasia, and is inferior to Chinese herbal therapy in improving dysplasia. In addition, the Chinese herbal therapy significantly outperforms the aluminum plus magnesium suspension in improving symptoms. Therefore, the overall clinical outcome of Chinese herbal compound prescriptions together with Panax notoginseng powder based on TCM syndrome patterns in the treatment of erosive gastritis is superior to that of antacids. Trial registration ChiCTR, ChiCTR-IPR-15005905. Registered 22 January 2015, https://www.chictr.org.cn/showproj.aspx?proj=10359.

四磨汤口服液成方收录于明代《痘疹金镜录》,具有顺气降逆、消积止痛的功效,临床常用于中老年气滞、食积证,以及腹部手术后促进肠胃功能的恢复.为进一步规范和指导四磨汤口服液的临床应用,经中华中医药学会立项,由中国中医科学院西苑医院脾胃病研究所牵头,承担《四磨汤口服液用于慢性胃肠疾病治疗及腹部手术后肠胃功能康复的专家共识》的制定工作,共识研究工作于2018年8月启动,于2020年7月由中华中医药学会正式发布.共识从总论、内科、外科及安全性四个方面就四磨汤口服液临床应用中存在的问题进行说明,希望对临床合理使用四磨汤口服液提供一定的参考.

在肠易激综合征(IBS)相关中医药临床研究中,如何通过恰当的临床疗效评价指标对其开展临床疗效评价是目前存在的问题之一.受中华中医药学会脾胃病分会委托,编制的《关于肠易激综合征中医药临床疗效评价指标体系中若干问题的专家共识》分为概述、IBS临床疗效评价指标体系的选择与应用、IBS临床疗效评价指标的分析与处理、结果解释4个部分内容,对IBS临床疗效评价指标体系的相关问题进行说明,为相关人员提供参考.

津液是人体内正常水液的总称,"口渴"与津液的代谢直接相关,同时与精、气、血等其他维持生命的基本物质联系密切.本文以"气一元论"为认识基础,结合《黄帝内经》中的相关理论,以精、气、血、津液的最初病变作为纲目,从气机聚散方面探讨口渴症(病理性)的成因,比较《伤寒杂病论》与渴相关诸方之间的联系与差异,探讨仲景治疗口渴的规律,以求临床用药更为明晰.

The aim of the present study was to discuss the effects and underlying mechanisms of honokiol (HNK) and/or curcumin (CUR) in sensitization of multidrug-resistant human lung adenocarcinoma A549/DDP cells to cisplatin (DDP). An MTS assay was performed to detect the cytotoxicity of HNK, CUR and DDP in A549 and A549/DDP cells and compare their sensitivity. The A549/DDP cells were then divided into 8 groups: Control, HNK, CUR, DDP, HNK + CUR, HNK + DDP, CUR + DDP and HNK + CUR + DDP. Cell proliferation was measured by MTS assay and colony formation assay, cell apoptosis was detected by flow cytometry, cell invasion was evaluated by Transwell assay and cell migration was determined by a wound healing assay. In order to investigate the possible mechanisms, P-glycoprotein (P-gp) protein expression was measured by western blotting and immunofluorescence assays. The mRNA expression levels of AKT, Erk1/2, cyclin-dependent kinase inhibitor 1 (P21), caspase 3, cleaved caspase 3, caspase 9, cleaved caspase 9, poly (ADP-ribose) polymerase (PARP), cleaved PARP, matrix metalloproteinase (MMP)-2 and MMP-9 were examined by reverse transcription-quantitative (RT-q) PCR assay, and the protein expression levels of phosphorylated (p)-AKT, p-Erk1/2, P21, caspase 3, cleaved caspase 3, caspase 9, cleaved caspase 9, PARP, cleaved PARP, MMP-2 and MMP-9 proteins expression by western blot assay. The MTS assay demonstrated that HNK (5 µg/ml), CUR (10 µg/ml) and DDP (5 µg/ml) had no obvious toxicity to A549/DDP cells, and HNK, CUR and DDP were more sensitive in A549 cells compared with A549/DDP cells. The optimal concentrations of HNK (5 µg/ml), CUR (10 µg/ml) and DDP (5 µg/ml) were chosen to carry out the further experiments. Compared with the control group, no significant change was observed in cell proliferation, apoptosis, migration, invasion and related mRNA and protein expression in HNK, CUR, DDP and HNK + CUR groups. The cell proliferation rate in the HNK + DDP and CUR + DDP groups was significantly suppressed with cell apoptosis significantly increased, respectively. The invasion cell number and wound healing rate of HNK + DDP and CUR + DDP groups were significantly depressed compared with the control group, respectively. Immunofluorescence demonstrated that the nuclear volume of P-gp in HNK + DDP and CUR + DDP groups were significantly downregulated compared with the control group, respectively. The RT-qPCR assay demonstrated that the AKT, Erk1/2 and P21 mRNA expression levels were significantly decreased and cleaved caspase 3, cleaved caspase 9 and cleaved PARP were increased in HNK + DDP and CUR + DDP groups compared with the control group. The western blotting results were consistent with the RT-qPCR results. NK + CUR + DDP had improved effects on A549/DDP compared with HNK + DDP or CUR + DDP group, respectively. HNK and/or CUR could improve the sensitivity of DDP to A549/DDP cell by the regulation of P-gp, inducing apoptosis, and inhibiting migration and invasion via AKT/ERK signal pathway in an in vitro study.

神是中医学理论体系中的重要概念,在以《黄帝内经》为代表的中医古典医籍中不乏相关论述,但由于“神”概念本身的多义性,在理解方面历代医家均有差异,未能建立起一个相对完备的体系,导致其在临床上的重视程度相对不够.本文以《黄帝内经》等经典著作为基础,对与生命活动相关的神的来源、神在人体发生学中的作用、神的意义及调节方法进行总结和说明,旨在为临床提供一定参考.

Objective:To investigate the effect of Chang'an Ⅱ Decoction(肠安 Ⅱ 号方)-containing serum on intestinal epithelial barrier dysfunction in rats.Methods:Tumor necrosis factor (TNF)-α-induced injury of Caco-2 monolayers were established as an inflammatory model of human intestinal epithelium.Caco-2 monolayers were treated with blank serum and Chang'an Ⅱ Decoction-containing serum that obtained from the rats which were treated with distilled water and Chang'an Ⅱ Decoction intragastrically at doses of 0.49,0.98,1.96 g/(kg·d) for 1 week,respectively.After preparation of containing serum,cells were divided into the normal group,the model group,the Chang'an Ⅱ-H,M,and L groups (treated with 30 ng/mL TNF-α and medium plus 10％ high,middle-,and low-doses Chang'an Ⅱ serum,respectively).Epithelial barrier function was assessed by transepithelial electrical resistance (TER) and permeability of fluorescein isothiocyanate (FITC)-Iabeled dextran.Transmission electron microscopy was used to observe the ultrastructure of tight junctions (TJs).Immunofluorescence of zonula occludens-1 (ZO-1),claudin-1 and nuclear transcription factor-kappa p65 (NF-κ Bp65) were measured to determine the protein distribution.The mRNA expression of myosin light chain kinase (MLCK) was measured by real-time polymerase chain reaction.The expression levels of MLCK,myosin light chain (MLC) and p-MLC were determined by Westem blot.Results:Chang'an Ⅱ Decoction-containing serum significantly attenuated the TER and paracellular permeability induced by TNF-α.It alleviated TNF-α-induced morphological alterations in TJ proteins.The increases in MLCK mRNA and MLCK,MLC and p-MLC protein expressions induced by TNF-α were significantly inhibited in the Chang'an Ⅱ-H group.Additionally,Chang'an Ⅱ Decoction significantly attenuated translocation of NF-κ Bp65 into the nucleus.Conclusion:High-dose Chang'an Ⅱ-containing serum attenuates TNF-α-induced intestinal barrier dysfunction.The underlying mechanism may be involved in inhibiting the MLCK-MLC phosphorylation signaling pathway mediated by NF-κ Bp65.

2018年9月13日在重庆召开中华中医药学会团体标准指南第三次专家论证会,形成《消化系统常见病肠易激综合征中医诊疗指南(基层医生版)》终稿.前期编写、修改流程见参考文献[1-2]. 肠易激综合征是世界范围内的常见病.虽然肠易激综合征对患者的全身状况和预期寿命无明显影响,但患者常因症状长期反复发作、不能及时确诊和治疗效果不理想而频繁就诊,严重影响其生活质量,并造成了相应的经济负担和社会负担[3].从现代医学而言,对本病的治疗仍存在一定的不足,远期疗效仍不能令人满意.中医药治疗肠易激综合征类似症状有着较长的历史,由于中医药本身的特点及治疗的个体化等特征,使得其临床疗效评价方面难以出现类似于现代医学的高级别的循证医学证据,但其临床疗效应当是肯定的.目前我国肠易激综合征的中医、中西医共识主要针对三甲医院,对中医药的临床使用及推荐方面文字相对简略.既往缺乏用于指导基层医生的针对肠易激综合征的全国性指南,本指南是一个全新的尝试,主要针对基层医师,指南在收集文献、评价证据的基础上,结合专家共识法形成推荐建议,为肠易激综合征临床诊疗中的相关诊疗问题提供了简洁的版本,尤其在辨证论治方面,以病-证-症结合的方法编撰,符合临床使用,希望借此提高基层医师对本病的中医药防治水平.

消化系统疾病是临床常见的一大类疾病,临床患病率较高,多数属于中医的脾胃及肝胆疾病.古代中医在此类疾病的诊疗方面积累了丰富的经验,其中以张仲景著作《伤寒论》与《金匮要略》中对相关疾病的诊治内容尤为丰富,为后世医家提供了许多启迪.文章分析张仲景的临床诊疗思维模式,从“辨-病、脉、证-治”的角度论述张仲景思维模式在消化系统疾病中的应用,为临床医师提供参考.

唐旭东擅长运用膏方调治胃下垂,治疗以固本清源、纠偏却病为总则,以先通后补、立足脾胃、调和气血、平衡阴阳为基本治法,强调秋冬季调补的重要性,配合膏方相应的服药方法及生活调摄,可收良效.

中成药在我国的医疗保健中发挥着重要作用,但其目前在临床应用中仍存在一些问题.中国中药协会为探索中成药在临床中的应用,组织专家开展了中成药治疗优势病种临床应用指南项目,项目本着“循证为主、共识为辅、经验为鉴”的原则,采取统一的方法学设计编制10余种疾病的临床应用指南.本文对指南编制过程中存在的问题如中成药临床应用特点、临床问题的确立、文献检索、证据分级及推荐强度、指标评价、中西医思维转化等方面进行说明和解析,为后续工作提供参考.

在《中药新药临床研究技术指导原则》的编制过程中,常面临着中医症状学的评价问题.功能性胃肠病(Functional gastrointestinal disorders,FGIDs)是消化系统常见的一组疾病,其在临床诊断及治疗方面均以症状学为主,与中医学以症状为靶点进行诊断治疗有一定的类同性.因而此次以FGIDs为代表,组织专家对其临床疗效评价中症状学问题进行讨论,涉及内容包括指导原则的总体思路及设计、症状学研究在FGIDs乃至功能性疾病研究中的意义、FGIDs中的症状学评价中遇到的问题及解决方案等,并达成一系列重要共识,希望借此推进FGIDs指导原则编制过程中相关问题的解决,并为今后其他疾病中涉及症状学问题的处理提供参考.

Objective To investigate the effect of Chang'an II Decoction-containing serum on intestinal epithelial barrier dysfunction in rats. Methods Tumor necrosis factor (TNF)-alpha-induced injury of Caco-2 monolayers were established as an inflammatory model of human intestinal epithelium. Caco-2 monolayers were treated with blank serum and Chang'an II Decoction-containing serum that obtained from the rats which were treated with distilled water and Chang'an II Decoction intragastrically at doses of 0.49, 0.98, 1.96 g/(kg center dot d) for 1 week, respectively. After preparation of containing serum, cells were divided into the normal group, the model group, the Chang'an II-H, M, and L groups (treated with 30 ng/mL TNF-alpha and medium plus 10% high, middle-, and low-doses Chang'an II serum, respectively). Epithelial barrier function was assessed by transepithelial electrical resistance (TER) and permeability of fluorescein isothiocyanate (FITC)-labeled dextran. Transmission electron microscopy was used to observe the ultrastructure of tight junctions (TJs). Immunofluorescence of zonula occludens-1 (ZO-1), claudin-1 and nuclear transcription factor-kappa p65 (NF-kappa Bp65) were measured to determine the protein distribution. The mRNA expression of myosin light chain kinase (MLCK) was measured by real-time polymerase chain reaction. The expression levels of MLCK, myosin light chain (MLC) and p-MLC were determined by Western blot. Results Chang'an II Decoction-containing serum significantly attenuated the TER and paracellular permeability induced by TNF-alpha. It alleviated TNF-alpha-induced morphological alterations in TJ proteins. The increases in MLCK mRNA and MLCK, MLC and p-MLC protein expressions induced by TNF-alpha were significantly inhibited in the Chang'an II-H group. Additionally, Chang'an II Decoction significantly attenuated translocation of NF-kappa Bp65 into the nucleus. Conclusion High-dose Chang'an II-containing serum attenuates TNF-alpha-induced intestinal barrier dysfunction. The underlying mechanism may be involved in inhibiting the MLCK-MLC phosphorylation signaling pathway mediated by NF-kappa Bp65.

总结胃食管反流病脾虚湿热证形成的直接因素为湿热中阻、胃失和降,根本因素为脾气不降、运化失常.临证治疗运用清热、化湿、健脾之法,并遵循清热不过于苦寒、化湿不过于香燥、健脾不过于呆滞的原则,以半夏泻心汤、生姜泻心汤、三仁汤、黄芩滑石汤、连苏饮等为常用方,进行合理配伍加减.