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.

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.

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.

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。

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。

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。

“中医内科学”科研思维能力培养的实践与思考

“中医内科学”作为中医学的一门主干课程,在其发展中占有重要地位,是中医基础学科与临床学科的桥梁,亦是培养中医临床思维与中医科研思维的重要基础学科。然而传统的“中医内科学”教学方式单一,主要以教师“教”为中心,存在学生学习被动、学习兴趣较低、学习成果产出较少等不足。如何形成以学生“学”为中心的“中医内科学”教学模式,发挥学生的主动性和积极性,深入临床学习,培养科研思维,是当前“中医内科学”教学改革亟须解决的问题。以肝胆脾胃疾病为例,阐述如何改革“中医内科学”教学方式以提高学生中医临床思维能力,并不断培养中医科研思维能力。

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.

参葛方联合生活饮食运动干预治疗肝功能异常代谢相关脂肪性肝病的临床观察

目的观察参葛方联合生活饮食运动干预治疗肝功能异常代谢相关脂肪性肝病(MAFLD)的临床疗效及对患者血清CD44水平的影响。方法将70例脾虚痰湿兼有血瘀型肝功能异常MAFLD患者随机分为对照组和治疗组,每组35例,两组均给予生活饮食运动干预,治疗组加用参葛方,对照组加用参葛方安慰剂,疗程均为12周。观察临床疗效,比较磁共振成像质子密度脂肪含量(MRI-PDFF)及血清丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、碱性磷酸酶(ALP)、γ-谷氨酰转移酶(GGT)、三酰甘油(TG)、总胆固醇(TC)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、CD44水平的变化情况。结果(1)最终完成试验者64例,其中治疗组32例、对照组32例。(2)治疗组、对照组总有效率分别为75.0%、46.9%,治疗组临床疗效优于对照组(P<0.05)。(3)治疗前后组内比较,两组MRI-PDFF值降低(P<0.05),治疗组血清CD44水平降低(P<0.05);组间治疗后比较,治疗组MRI-PDFF值、血清CD44水平低于对照组(P<0.05)。(4)治疗前后组内比较,治疗组血清ALT、AST、GGT水平降低(P<0.05),对照组AST水平降低(P<0.05);组间治疗后比较,治疗组血清ALT、AST、GGT水平低于对照组(P<0.05)。(5)治疗前后组内比较,治疗组血清TG、TC、LDL水平降低(P<0.05),对照组TG水平降低(P<0.05);组间治疗后比较,治疗组TG水平低于对照组(P<0.05)。结论参葛方联合生活饮食运动干预治疗脾虚痰湿兼有血瘀型肝功能异常MAFLD患者疗效满意,能有效缓解患者的临床症状,改善肝脏脂质沉积及肝功能异常,调节血脂水平,其机制可能与调节血清CD44表达有关。

基于真实世界数据的观察性因果推断研究新框架(目标试验模拟)及其在中医药领域中的应用展望

“目标试验模拟”(target trial emulation)作为一种新的真实世界研究框架在近年来被正式确立,其可用于指导基于真实世界数据开展观察性因果推断研究,继而进行医疗干预有效性和安全性评价。该框架的核心思想是参照随机对照试验的原则,利用真实世界数据模拟相应的随机对照试验,进而得出干预措施与临床结局间因果关联的结论。其主要实施要点可总结为“3⁃7⁃2”,即声明因果问题、制订模拟方案和模拟目标研究3个实施步骤,纳排标准、治疗策略、干预分配、随访期、结局指标、因果比较和分析计划7个设计要素,对永恒时间偏倚和现用药者偏倚2个关键偏倚的控制。本文通过对该框架的历史与现状、实施要点、经典案例、优势与局限性及其在中医药领域中的应用前景进行概述,以期帮助中医药学者开展中医药真实世界研究,并为构建具有中医药特色的临床评价体系提供新思路。

中医药治疗男性不育症临床研究与展望

近年来,中医学者对男性不育症理论基础的不断深入研究,使男性不育症患者有望获得更为安全有效的治疗手段。随着时代的发展,中医药治疗男性不育症与时俱进,出现新思维,考虑多病机、多脏腑论治,从以往的单用补肾之法到现在的疏肝解郁、清利湿热、活血化瘀之法并用。肾虚虽是导致男性不育的最关键的病因病机,但七情、湿、热、痰、瘀、虫、毒等病理因素的影响同样不可忽视。该病辨证论治时,需注意个人特质,辨病、辨证论治相结合,以更好发挥中医药治疗之优势。中医药治疗男性不育症不仅可改善精液指标、缓解其伴随症状,还可减少可能发生的不良反应。中西医融合治疗男性不育症,优势互补,相辅相成,中医药可用于治疗西医发病机制不明确的特发性少弱精子症,并使得西医辅助生殖术后出现并发症的概率降低,提高妊娠率。但今后中医药治疗男性不育症仍需要重视理论创新,并开展高层次的临床研究,从而推动制定标准的中医药治疗男性不育症的诊疗方案,促进其临床的推广与应用。

中医药治疗转移性结直肠癌的术和技

转移性结直肠癌又被称为晚期结直肠癌,是目前临床上比较棘手的疑难疾病,当前最优的西医治疗策略是双药化疗联合靶向药。然而部分患者由于身体状况差、年龄大、经济困难等原因无法耐受或拒绝标准西医治疗,转而选择中医或中西医结合治疗,仍然取得了较好的临床疗效。中医药治疗肠癌历史悠久,具有简、便、廉、验的特点,是中国转移性结直肠癌治疗中的重要组成部分,同时中西医结合是中国恶性肿瘤治疗的优势所在。众多临床报道显示中医药治疗在延长转移性结直肠癌患者生存期、减少西医治疗不良反应,改善生活质量等方面发挥了独特的作用。对既往真实有效的中医药治疗转移性结直肠癌的临床研究进行梳理和筛选,并按照中西医侧重点的不同进行分类论述能简明扼要的适用于临床诊疗。文章结合中华中医药学会团体标准《转移性结直肠癌中医诊疗指南》(T/CACM1410-2022)对当前中医药治疗转移性结直肠癌的临床研究进行梳理和总结,为临床实践提供参考。