Clinical Research progress of traditional Chinese medicine in treating esophageal cancer

Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.

Clinical research progress of oral administration of traditional Chinese medicine in the treatment of dry eyes

Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.

Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database

With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.

Safety Research in Traditional Chinese Medicine: Methods, Applications, and Outlook

Traditional Chinese medicine (TCM) is a medical system that has collected and summarized abundant clinical experience over its long history of more than 2000 years. However, the frequent occurrence of TCM-induced adverse reactions has hindered the modernization and internationalization of TCM, while attracting increasing attention from around the world. Unlike chemical drugs and biological agents, the difficulties involved in research on the toxicity and safety of TCM mainly include the complexity of its components and the unpredictability of drug–body interactions. Much of TCM, which has overall therapeutic effects, has the typical mechanisms of multiple components, multiple pathways, and multiple targets. While considering the gradualness and unpredictability of TCM toxicity, the ambiguity of toxicants and safe dosage, and individual differences during long-term TCM administration, we have systematically established key techniques for the toxicity assessment of TCM. These techniques mainly include TCM toxicity discovery in an early phase, based on a combination of drug toxicology genomics and metabolomics;methods to identify dose–toxicity relationships in TCM;and integrated techniques for the exploration of TCM interactions, such as fast-screening tests based on drug-metabolizing enzymes and receptor pathways. In particular, we have developed a new technical system for TCM safety evaluation using molecular toxicology, which has been validated well in research on TCM compatibility contraindication, quality control, and allergen discovery. The application of this key technical platform is introduced here in detail. This application includes model organisms, toxicant biomarkers, a magnetic suspension technique, and the application of network toxicology and computational toxicology in research on the toxicity of Fructus toosendan, Semen cassiae, Polygonum multiflorum, and Fructus psoraleae.

Progress in clinical research on the integration of Chinese and Western medicines for treating primary liver cancer

Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines(TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure(CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups(i.e. treatment with Western medicines alone)(65.11% vs.44.31%, P <.05). Among the 33 selected articles, 11 were investigated for TCM preparation(marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM(single herbs) were used to treat PLC. The top five most frequently used TCM were Poria(14.71%), Astragali radix(13.73%), Atractylodis Macrocephalae Rhizoma(12.75%), Bupleuri radix(12.75%), and Glycyrrhizae radix et Rhizoma(11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174(84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.

Traditional Chinese Medicine’s Challenge to Clinical Science and Health Policy

Traditional Chinese medicine(TCM)has been improving human health for millennia.And for that,it has gradually gained the attention of the global scientific community.TCM clinical research progresses,but slowly.I see it as being held back by perverse incentive structures in science and regulatory politics.

Advances in Traditional Chinese Medicine for Gout

Gout has an increasing morbidity rate around the world,correlating well with hypertension,hyperlipidemia,atherosclerosis,obesity and insulin resistance,and so on.In view of Traditional Chinese Medicine(TCM),gout belongs to arthromyodynia.Keys to syndrome differentiation of TCM are in differentiation,corporeality and coated tongue(characterized to be damp).According to the dialectical characteristics of gout TCM,this paper summarized the research of gout TCM,including food-based traditional Chinese medicine,bill of lading medicine,drug extraction,optimal herbs and dosage,individual herb and compound prescription,in order to explore and elaborate the objective curative effect and exact mechanism of gout treated by TCM.

Prediction of the mechanism of prostate prescription Ⅰ in the treatment of chronic prostatitis based on integrative pharmacology of traditional Chinese medicine

Objective:To investigate potential mechanism of Prostate prescriptionⅠin the treatment of chronic prostatitis based on integrated pharmacology.Methods:with the help of TCMIP,the effective compounds of Prostate prescriptionⅠwere screened,and the potential target database of Prostate prescriptionⅠwas established by using the target prediction function of TCMIP.Based on the Human Phenotype Ontology database and protein interaction network(PPI)database,the disease target of CP was identified and the target interaction network was constructed;Through the GO function analysis and KEGG pathway enrichment analysis of the candidate targets,combined with Chinese and foreign literature studies to predict the potential Signaling pathway of Prostate prescriptionⅠin the treatment of CP.Results:79 effective compounds of Prostate prescriptionⅠexerted its effect on 33 targets through 11 pathways.Conclusion:Clinical efficacy of Prostate prescriptionⅠon CP may be reflected in antiinflammation and anti-tumor,cell metabolism,immune regulation,neuroregulation and so on.

Status and Development Trend of Evaluation of Post-Marketing Traditional Chinese Medicines in China

Evaluation of traditional Chinese medicines after the market has achieved fruitful results after years of development.The real-world research concept has been first proposed by Chief Researcher Xie Yanming in 2010 and to 2020 with the approval of the National Medical Products Administration to use real-world evidence to support drug development and review in 2020.Real-world data application and transformation continue to cause heated discussions in the industry.Real-world research concepts have been added new motivation into the evaluation of Chinese medicines after they are marketed.The development of the Chinese patent medicine industry is facing unprecedented opportunities and challenges.

Application of evidence-based medicine methods in integrative oncology research

To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.

Experience inheritance from famous specialists based on real- world clinical research paradigm of traditional Chinese medicine

The current modes of experience inheritance from famous specialists in traditional Chinese medicine （TCM） include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.

Randomized Clinical Trials of Traditional Chinese Medicines for Treating Ulcerative Colitis:A Scoping Review

Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the basic characteristics,quality,and types of TCM interventions in published RCTs.This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC.Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching.Materials and Methods:A scoping review was conducted according to the PRISMA extension for scoping reviews.We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020.Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated.Selection and characterization were performed by two independent reviewers using predefined forms.All discrepancies were resolved by consensus discussion with a third reviewer.Microsoft Excel 2010 was used to extract the following data from the included studies:(1)basic information of the included studies including research ID,article title,publication language,journal,year of publication,and funding information;(2)patient information including gender,age,disease course,disease stage,severity,sample size;and(3)information on intervention measures,types of intervention measures,drug dosage forms,and treatment courses.Results:The search identified 2225 RCTs published between1987 and 2020.These studies covered 36 provinces in China.The time frame of the RCTs was<28 days in approximately one-third of the RCTs(647,29.08%).Only one RCT was published in English.Nearly three-quarters of RCTs(1665,74.83%)did not report the severity of the disease.Three types of interventions were included in the RCTs:pharmacotherapy(2028,91.15%),nonpharmacotherapy(57,2.56%),and a combination of the two(140,6.29%).The administration modes of the intervention groups were evaluated.Drug therapy involved 12types of TCM dosage forms,which were decoctions,troches,powders,capsules,granules,pills,suppositories,ointments,injections,gels,oral liquids,and substitute tea according to the frequency of use.Nondrug intervention measures involved 10 treatment options,namely,acupuncture,moxibustion,hemospasia,auricular point,acupoint catgut embedding,acupoint injection,scrapping,tuina,acupoint application,and five-tone therapy according to the frequency of use.Most studies included in this review were low in quality.This underscores the need for improvement in the quality of trial methodology in TCM RCTs.

Clinical Study of Acupoint Application of Jiezi Fangxiao Ointment Combined with Pingchuan Prescription in the Treatment of Pediatric Asthma

[Objectives]To study the clinical effect of Acupoint Application of Jiezi Fangxiao Ointment combined with Pingchuan Prescription in the treatment of pediatric asthma.[Methods]A total of 40 children with asthma admitted to the First Affiliated Hospital of Heilongjiang University of Chinese Medicine from July 2017 to September 2018 were selected as the research subjects,and divided into control group and observation group according to random classification method,with 20 cases in each group.Among which the control group was given routine symptomatic treatment,the observation group was treated with Acupoint Application of Jiezi Fangxiao Ointment combined with Pingchuan Prescription on the basis of the control group.After 4 weeks of continuous treatment,the clinical efficacy was observed and the changes of traditional Chinese medicine symptom scores,forced expiratory volume in the first second(FEV1),maximum expiratory flow(PEF),forced vital capacity(FVC),peripheral blood eosinophils(EOS)and interleukin-17(IL-17)were compared between the two groups before and after treatment.[Results]After treatment,the traditional Chinese medicine(TCM)scores such as asthma,cough,expectoration,chest tightness,dyspnea and wheezing sound of lungs in the two groups were significantly improved,and the improvement in the observation group was superior to that in the control group.The difference was statistically significant(P<0.05).FEV1,PEF and FVC in the two groups were significantly improved after treatment,and the improvement in the observation group was superior to that in the control group.The difference was statistically significant(P<0.05);after treatment,the levels of EOS and IL-17 decreased in both groups,and the improvement in the observation group was superior to that in the control group,the difference was statistically significant(P<0.05).[Conclusions]The clinical effects of Acupoint Application of Jiezi Fangxiao Ointment combined with Pingchuan Prescription in the treatment of infantile asthma were obvious,which can significantly improve the TCM symptoms scores,pulmonary function and immune function of patients.

Analysis of Clinical Effect of Wumen Qingyi Decoction on Acute Pancreatitis

[Objectives]To examine the effects of Wumen Qingyi Decoction on inflammatory responses in patients with acute pancreatitis(AP).[Methods]Eighty patients with mild or severe AP were randomly allocated to a treatment group(Wumen Qingyi Decoction+baseline treated)or a control group(baseline treated).All patients were managed conservatively.In addition,the Group A received Wumen Qingyi Decoction for 400 mL/d for 7 d.Laboratory parameters,condition of disease and therapeutic effect indexes,and so on,between the two groups were compared.[Results]The recovery of serum levels of amylase(AMS),C reaction protein(CRP),and tumor necrosis factor(TNF-α),interleukin1(IL-1),IL-6,IL-10,as well as the scores of Balthazar and BISAP in Treatment group were quicker than those in Control group(P<0.05).In addition,the improvement of organic dysfunction in Treatment group was better than that in Control group.[Conclusions]The course of combined Wumen Qingyi Decoction and basic treatment of western medicine could effectively adjust the body's inflammatory response to promote the recovery process of acute pancreatitis.

益气活血宽胸祛痰法治疗特发性肺纤维化的临床疗效观察

目的观察益气活血宽胸祛痰法对特发性肺纤维化(IPF)的临床治疗效果。方法选取2019年9月至2020年12月就诊于成都中医药大学附属医院急诊科/中医经典病房的41例IPF患者为研究对象,按照随机数字表法分为试验组21例,对照组20例。对照组给予西医常规治疗,试验组在对照组治疗基础上采用“益气活血宽胸祛痰”中药汤剂,每日3次,每次100mL,疗程3个月。比较两组治疗前后中医证候积分、血气分析和肺功能检查结果及6分钟步行试验(6MWT)距离。结果治疗后试验组总有效率和6MWT距离均高于对照组(P<0.05);中医证候主症咳痰、咳嗽、喘息症状评分及中医证候总积分均低于对照组(P<0.05);治疗后两组肺功能中肺一氧化碳弥散量(DLCO)占预计值百分比(DLCO%)水平较治疗前升高,且试验组高于对照组(P<0.05);血气分析中试验组氧分压(PO_(2))指标高于对照组(P<0.05)。结论益气活血宽胸祛痰法可改善试验组患者中医证候量化评分、血气PO_(2)水平,增强肺弥散功能,提高6MWT距离;同时可减缓肺通气功能障碍的下降进程,改善临床症状,较西医常规治疗更具有优势。

内服中药复方治疗非酒精性脂肪性肝病的临床研究进展

近年来,非酒精性脂肪性肝病(NAFLD)的发生率逐年上升,是临床常见的慢性肝病之一,由于其发病机制复杂,现代医学的治疗不仅限于肝脏本身病变,还要控制代谢紊乱。非酒精性脂肪性肝病属于“肝癖”“积聚”“胁痛”等范畴,病位在肝、脾、肾,病理产物有痰、湿、瘀、热等,为虚实夹杂之病。中医药有着多靶点、多途径、整体调节的优势,现就内服中药复方治疗NAFLD的临床研究进行归纳,发现苓桂术甘汤、五苓散、苦黄颗粒、益肾化痰方、桂附理中汤、养肝消脂茶、大黄利胆胶囊、柴胡疏肝散、柴胡化浊饮等中药复方在改善非酒精性脂肪性肝病患者临床症状、肝功能、脂代谢、肝脏影像学指标、胰岛素抵抗、肠道功能、抗炎、血管性疾病危险因素等方面作用显著。

葛斛调脂方干预代谢综合征患者的随机对照研究

背景 全球约有1/4的人患有代谢综合征(Met S)。近年来我国Met S患病率也呈逐年上升趋势,对生命健康造成严重威胁。中医药治疗Met S有着多靶点、多环节的优势,但目前临床上缺乏高质量的随机对照研究和真实世界研究。目的 观察葛斛调脂方对Met S患者腰围(WC)、体质量、体脂率(BFP)及糖脂代谢的影响。方法2021年6月—2022年11月前瞻性选取上海中医药大学附属龙华医院门诊就诊及住院的84例Met S患者为研究对象。应用SPSS 25.0统计软件给定随机种子数,将受试者随机分为葛斛组(42例)和对照组(42例)。葛斛组应用葛斛调脂方颗粒治疗(葛根6 g,铁皮石斛6 g),患者空腹早晚各1次,1包/次,冲服,连续服用8周。对照组应用安慰剂颗粒干预,患者空腹早晚各1次,1包/次,冲服,连续服用8周。干预期间对两组患者进行相同的健康宣教(包括膳食方案和运动处方的指导)。干预8周后对比分析两组患者的WC、体质量、BMI、BFP、三酰甘油(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、空腹血糖(FBG)。结果 最终葛斛组41例、对照组41例完成8周的干预研究。治疗前两组患者WC、体质量、BMI、BFP比较,差异均无统计学意义(P>0.05)。两组治疗前后WC、体质量、BMI、BFP差值比较,差异均有统计学意义(P<0.05)。治疗前两组患者的TG、TC、HDL-C、LDL-C、FBG比较,差异均无统计学意义(P>0.05)。两组治疗前后TG、TC、FBG差值比较,差异均有统计学意义(P<0.05)。在治疗期间和随访结束后两组均未发生严重不良反应事件。结论 葛斛调脂方能较好地改善MetS患者的WC、体质量、BMI、BFP、TG、TC及FBG,且安全性较好。

清金化痰汤治疗呼吸系统疾病的研究进展

经典名方清金化痰汤源于《医学统旨》,具有清热化痰、宣降肺气的功效,临床广泛用于以痰热壅肺证为主的呼吸系统疾病的治疗。研究证明,临床上清金化痰汤治疗肺炎、重症肺炎、慢性阻塞性肺疾病急性加重期、支气管扩张症、慢性支气管炎、肺癌等呼吸系统疾病疗效确切,能缓解临床症状、提高免疫力、改善肺功能及血气分析、降低炎症反应指标等。基础研究上清金化痰汤可以通过调控自噬、调控铁代谢、提高免疫功能、抗病毒、介导各种信号通路等,减轻炎症反应,减少肺部损伤,来达到治疗呼吸系统疾病的作用。为了使清金化痰汤更好地应用于现代呼吸系统疾病,现从清金化痰汤的古代文献分析、临床研究以及基础研究3方面,对其进行整理与总结,为今后经典名方清金化痰汤的治疗呼吸系统疾病以及新药研发提供科学依据。

中药脐疗治疗溃疡性结肠炎缓解期疗效观察

目的观察中药脐疗干预治疗溃疡性结肠炎缓解期临床效果。方法选取2021年1月至2023年3月在潍坊医学院附属高密市人民医院消化内科就诊溃疡性结肠炎缓解期患者,按照随机数表法分为治疗组、对照组,每组各35例。对照组口服美沙拉嗪肠溶片1.0 g,tid;治疗组同时给予中药脐疗“十味抗炎方”凝胶剂。采用改良Mayo评分评价溃疡性结肠炎严重程度;溃疡性结肠炎疾病活动指数评价疾病活动度;炎症性肠病生存量表评价生存质量;检查炎症因子白细胞介素-6、白细胞介素-8和肿瘤坏死因子-α;选择抑郁自评量表和焦虑自评量表评价患者心理情况。结果治疗组第5、6个月Mayo评分和疾病活动指数得分低于对照组,差异有统计学意义(P<0.05);治疗组第3、4、5、6个月炎症性肠病生存量表得分高于对照组,差异有统计学意义(P<0.05);治疗组第3、6个月炎症因子低于对照组,差异有统计学意义(P<0.05);治疗组第3、6个月抑郁和焦虑自评量表评分低于对照组,差异有统计学意义(P<0.05)。结论中药脐疗提升患者生活质量,改善预后,临床疗效优于对照组。