Integrating traditional Chinese (herbal) medicines into risk based regulation-With focus on non-clinical requirements to demonstrate safety

Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and industries.The release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European Union.It is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European Union.This paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).Such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific resources.With Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other countries.This could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic potential.An important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health.

Integrated flotation therapy for emotional regulation during the viral recovery period: Applying “form and spirit co-nourishing” in Chinese medicine

Objective:The objective of this study was to evaluate the effectiveness of flotation therapy combined with psychological resilience training in improving emotional regulation and sleep quality in patients recovering from viral infections and to assess the application of the traditional Chinese medicine(TCM)theory of“form and spirit co-nourishing”in modern healthcare interventions.Methods:A total of 20 patients recovering from viral infections with anxiety and sleep disturbances were randomly assigned to the experimental group(n=10)and the control group(n=10).The experimental group received a combination of resilience training,targeting five key areas:physiological regulation,cognitive restructuring,emotional management,self-efficacy,and social support,alongside flotation therapy,with 45-min weekly sessions.The control group received conventional medical treatment.Anxiety levels were measured using the Hamilton Anxiety Scale,while sleep quality was assessed using the Pittsburgh Sleep Quality Index,both before and after the intervention.Results:Compared with intervention before,the resilience level of the experimental group significantly increased after the intervention(P<0.001),while no notable changes were detected in the control group(P>0.05);the experimental group demonstrated significantly lower anxiety level and sleep disorder level and higher resilience level compared to the control group after the intervention(all P<0.001).Conclusion:The combined use of flotation therapy and resilience training,grounded in the TCM principle of“form and spirit co-nourishing,”significantly improves emotional regulation and sleep quality in patients recovering from viral infections.This integrative approach supports both physical and psychological healing,aligning with the TCM holistic treatment model,and offers a promising avenue for modern mental health interventions.

Potential Treatment of COVID-19 with Traditional Chinese Medicine: What Herbs Can Help Win the Battle with SARS-CoV-2?

Traditional Chinese medicine(TCM)has been successfully applied worldwide in the treatment of coronavirus disease 2019(COVID-19),which is caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).However,the pharmacological mechanisms underlying this success remain unclear.Hence,the aim of this review is to combine pharmacological assays based on the theory of TCM in order to elucidate the potential signaling pathways,targets,active compounds,and formulas of herbs that are involved in the TCM treatment of COVID-19,which exhibits combatting viral infections,immune regulation,and amelioration of lung injury and fibrosis.Extensive reports on target screening are elucidated using virtual prediction via docking analysis or network pharmacology based on existing data.The results of these reports indicate that an intricate regulatory mechanism is involved in the pathogenesis of COVID-19.Therefore,more pharmacological research on the natural herbs used in TCM should be conducted in order to determine the association between TCM and COVID-19 and account for the observed therapeutic effects of TCM against COVID-19.

Traditional Chinese Medicine in Malaysia: A Brief Historical Overview of Laws and Regulations

Although traditional Chinese medicine(TCM)has been a part of the Malaya and the Malaysia people’s method of maintaining health and well-being for many centuries,it was never been enrolled in the public health-care system.However,the rising cost of Western drugs and the increasing number of people frequenting TCM has driven the government to search for cheaper options and to look into its safe practice.In 1992,the government mandated all TCM herbal products to be registered with the National Pharmaceutical Control Bureau.All TCM products sold in Malaysia are now Good Manufacturing Practice certified.The government has also established a Traditional and Complementary Medicine Division within the Ministry of Health.Between 2008 and 2014,a traditional and complementary medicine unit was set up in major hospitals in all states.TCM is one of the main services offered by the unit.In 2016,the government enacted the Traditional and Complementary Medicine Act to regulate the TCM practice.Subsequently,a 10-vear blueprint has been drawn to support the development of all traditional and complementary medicines in Malaysia.This article aims to provide a brief overview on the regulatory development of TCM in Malaysia.

Mechanism of iron deficiency anemia and treatment with integrated traditional Chinese and western medicine

Iron-deficiency anemia(IDA)is one of the most common anemia diseases in China,and its patients are mostly children and women of childbearing age.Among the four major anemia,IDA belongs to benign anemia,which presents as a series of compensatory symptoms due to iron deficiency affecting hemoglobin synthesis.The insufficient oxygen supply of cells and tissues in the human body is closely related to iron and hemoglobin.However,there is a lack of systematic research on the treatment of IDA with integrated traditional Chinese and western medicine and its mechanism.This paper explores the mechanism of integrated traditional Chinese and western medicine for IDA in order to lay a theoretical foundation for the treatment of IDA with integrated traditional Chinese and western medicine.

Annual advances of traditional medicine on tumor immunity regulation in 2020

Tumor burden remains a global health problem that threatens human life worldwide.Over the past few years,the evolution of immune checkpoint inhibitors has represented one of the most successful approaches in the field of tumor therapy.Drugs regulating tumor immune microenvironment or enhancing body immunity have indicated a novel perspective to treat tumors.Therefore,an increased number of scientists have been shifting their research focus to explore the immunity regulation effects of anti-tumor traditional medicine or natural products.In this review,we summarize the research progress of traditional medicines on tumor immunity regulation in 2020.Our findings suggest that more herbal medicine-derived phytochemicals and formulas were derived from traditional Chinese medicine,and more papers were published in comprehensive journals.Traditional medicine can comprehensively regulate the tumor immune microenvironment,including natural killer cells,dendritic cells,CD4+/CD8+T lymphocytes,regulatory T cells,myeloid-derived suppressor cells,tumor-associated macrophages,immunosuppressive factors,and immune checkpoints.In 2020,a greater number of research papers focused on active ingredients and formulas that regulate tumor-associated macrophages and immune checkpoints.Active ingredients such as flavonoids became a global hotspot in 2020.Certain natural products were also found to exert synergistic anti-tumor activity with immune checkpoint inhibitors,such as curcumin.However,a distinct lack of high-quality experimental and clinical studies remains a prevalent and challenging issue that hinders the further development of traditional medicine.

Analysis of the hotspots and trends in traditional Chinese medicine immunomodulation research based on bibliometrics

Objective To analyze the intellectual structure,hotspots and trends of traditional Chinese medicine(TCM)in immune regulation research.Methods The data were extracted from the Web of Science Core Collection(WoSCC)and the China National Knowledge Infrastructure(CNKI)and verified by two experienced TCM researchers.The time of literature retrieval is up to 2020.CiteSpace 5.7.R1 and Microsoft Excel 2016 were used for the statistical analysis and bibliometric diagrams,including the co-occurrence network of authors,institutions,countries,keywords,references,dual-map overlays of journals and citation bursts,etc.Results A total of 12270 publications related to TCM in immune regulation were included.The annual number of publications has increased in this field.There was close cooperation of countries and institutions,while the distribution of scholars was scattered.China was the core of the cooperation network.The dual-map overlays analysis of journals showed that core and marginal fields had increased.The keywords and references analysis showed that network pharmacology,metabolism and cancer were the most high-frequency keywords with high-intensity bursts.Conclusion TCM in immune regulation has attracted wider attention,with multi-country,multi-field,multi-disciplinary and multi-level research developing toward informatization.Network pharmacology,metabolism and cancer may be the focus of future research in this field.

Analysis on medication rule of traditional Chinese medicine treating chemotherapy-induced diarrhea based on traditional Chinese medicine(TCM) inheritance computing platform system

Objective:To dig deeper into the traditional Chinese medicine treatment rules of chemotherapy-induced diarrhea with traditional Chinese medicine(TCM)inheritance computing platform system.Methods:Taking“traditional Chinese medicine”,“chemotherapy”and“diarrhea”as the theme words,comprehensive search of the database of CNKI,Wanfang and VIP from its inception to November 2020 was conduct-ed.The formulas of external treatment of traditional Chinese medicine for chemotherapy-induced diarrhea were included and the association rule,clustering and factor analysis were carried out.Results:A total of 145 papers,57 prescriptions meeting the inclusion criteria were collected,among which high-frequency drugs including Baizhu(Atractylodis macrocephalae rhizoma),Fuling(Poria),Dangshen(Codonopsisradix),Huanglian(Coptidis rhizoma),Zhigancao(Glycyrrhizae radix et rhizoma praeparata cum melle)were the most commonly used.The confidence level was set as 0.7 and the support level was set as 10,12 core compatibility groups were obtained,and 6 categories were cluster analyzed.Conclusion:The principle of external treatment of chemotherapy-induced diarrhea is mainly“restore deficiency and benefiting qi”,“benefiting water infiltration and dampness”,“clearing heat”and“inducing astringency”.Prescription combination and new prescription combination based on traditional Chinese medicine(TCM)inheritance computing platform system can be used as reference for clinicians and applied in primary hospitals.

Traditional Chinese Medicine:How Is It An Invaluable Intangible Cultural Heritage

This article deals with the concept of intangible culture heritage and the reasons why traditional Chinese medicine(TCM)should be specially preserved.The potential value of TCM and the existing measures for carrying on the cultural heritage adopted by China are also explored in the article.

Traditional Chinese medicine nursing protocols for leukorrheal disease( pelvic inflammatory disease)

Leukorrheal disease is an ascending infection of the female genital tract,with high morbidity among reproductive age women. Antibiotics are usually used to treat leukorrheal disease in clinic,but they can lead to a variety of side effects if improper use or long-time use. In recent years,traditional Chinese medicine( TCM) has shown its unique advantages in the treatment of leukorrheal disease. This article mainly explored the key points of common syndromes,TCM nursing methods and health guidance of leukorrheal disease in order to further develop the advantages of TCM,improve its efficacy and standardized its nursing behavior.

The Globalization of Traditional Medicines: Perspectives Related to the European Union Regulatory Environment

In the Member States of the European Union (EU), a harmonized legislation on medicinal products has been enforced, which specifically defines herbal medicinal products and traditional herbal medicinal products. The scope was to create a regulatory environment that takes into account the particular characteristics of herbal medicinal products. The harmonization of standards is intended to harmonize assessment and facilitate access to the market in different Member States. The standards defined by the EU herbal monographs of the Committee on Herbal Medicinal Products (HMPC) and the quality requirements laid down in the European Pharmacopoeia represent an excellent model of multinational harmonization of the regulatory environment for herbal and traditional medicines. It has also been demonstrated that this framework is at least partially applicable for herbal and traditional medicines from traditional Chinese medicine (TCM) to gain access to the EU market. Moreover, the HMPC provides specific guidance documents and pilot projects on monographs on the safety and efficacy of Chinese herbal drugs. In the European Pharmacopoeia, the number of quality monographs of herbal drugs with an origin in TCM is continuously growing. These developments indicate that globalization of traditional medicines is an ongoing process. Communication and cooperation between regulators, the scientific community, and interested stakeholders will set the stage for the convergence of diverse regulatory environments. This will contribute to worldwide availability of traditional medicines based on appropriate standards.

Chinese medicine in the treatment of autoimmune hepatitis:Progress and future opportunities

Autoimmune hepatitis(AIH)is a chronic inflammatory liver disease occurring in indi-viduals of all ages with a higher incidence in females and characterized by hypergam-maglobulinemia,elevated serum autoantibodies and histological features of interface hepatitis.AIH pathogenesis remains obscure and still needs in-depth study,which is likely associated with genetic susceptibility and the loss of immune homeostasis.Steroids alone and in combination with other immunosuppressant agents are the pri-mary choices of AIH treatment in the clinic,whereas,in some cases,severe adverse effects and disease relapse may occur.Chinese medicine used for the treatment of AIH has proven its merits over many years and is well tolerated.To better under-stand the pathogenesis of AIH and to evaluate the efficacy of novel therapies,several animal models have been generated to recapitulate the immune microenvironment of patients with AIH.In the current review,we summarize recent advances in the study of animal models for AIH and their application in pharmacological research of Chinese medicine-based therapies and also discuss current limitations.This review aims to provide novel insights into the discovery of Chinese medicine-originated therapies for AIH using cutting-edge animal models.

Clinical study on fire needle acupuncture treating irregular menstruation with spleen deficiency syndrome

Objective:To observe the clinical efficacy of fire needle acupuncture in treating irregular menstruation with spleen deficiency syndrome.Methods:60 patients with spleen deficiency-irregular menstruation were randomly divided into treatment group and control group of 30 each.In the treatment group,fire needle acupuncture was used to insert into Guanyuan,Qihai,Pishu,Sanyinjiao,Zusanli and Taibai points,while the filiform needle was used to needle the corresponding acupoints in the control group.After 8 weeks of treatment,menstrual cycle,menstrual period,menstrual volume,irregular menstrual symptom score and spleen deficiency symptom score were recorded.Results:Both treatments could effectively improve the menstrual cycle,menstrual period and menstrual volume,but there was no statistical significance between the two groups(P>0.05).Both treatments were effective in regulating the symptoms of menstruation,and fire needle acupuncture was better than filiform needle(P<0.05).Both treatments relieved the symptoms of spleen deficiency,and fire needle acupuncture was better than filiform needle(P<0.05).In terms of overall curative effect,the curative effect of fire needle acupuncture therapy was significantly better than filiform needle therapy,and the difference was statistically significant(P<0.05).Conclusion:Fire needle acupuncture therapy could effectively regulate menstrual volume of patients with irregular menstruation of spleen deficiency syndrome,and relieve the symptoms of traditional Chinese medicine.

Fermented Chinese formula Shuan-Tong-Ling attenuates ischemic stroke by inhibiting inflammation and apoptosis

The fermented Chinese formula Shuan-Tong-Ling is composed of radix puerariae（Gegen）,salvia miltiorrhiza（Danshen）,radix curcuma（Jianghuang）,hawthorn（Shanzha）,salvia chinensis（Shijianchuan）,sinapis alba（Baijiezi）,astragalus（Huangqi）,panax japonicas（Zhujieshen）,atractylodes macrocephala koidz（Baizhu）,radix paeoniae alba（Baishao）,bupleurum（Chaihu）,chrysanthemum（Juhua）,rhizoma cyperi（Xiangfu） and gastrodin（Tianma）,whose aqueous extract was fermented with lactobacillus,bacillus aceticus and saccharomycetes.ShuanTong-Ling is a formula used to treat brain diseases including ischemic stroke,migraine,and vascular dementia.Shuan-Tong-Ling attenuated H_2O_2-induced oxidative stress in rat microvascular endothelial cells.However,the potential mechanism involved in these effects is poorly understood.Rats were intragastrically treated with 5.7 or 17.2 m L/kg Shuan-Tong-Ling for 7 days before middle cerebral artery occlusion was induced.The results indicated Shuan-Tong-Ling had a cerebral protective effect by reducing infarct volume and increasing neurological scores.Shuan-Tong-Ling also decreased tumor necrosis factor-α and interleukin-1β levels in the hippocampus on the ischemic side.In addition,Shuan-Tong-Ling upregulated the expression of SIRT1 and Bcl-2 and downregulated the expression of acetylated-protein 53 and Bax.Injection of 5 mg/kg silent information regulator 1（SIRT1） inhibitor EX527 into the subarachnoid space once every 2 days,four times,reversed the above changes.These results demonstrate that Shuan-Tong-Ling might benefit cerebral ischemia/reperfusion injury by reducing inflammation and apoptosis through activation of the SIRT1 signaling pathway.

从“风火”论治变态反应性疾病思路

变态反应性疾病临床常见,其病位虽不同,但病机却有一定共性。总体而言,人体阴阳协调,则一气周流,如“春风”生养万物。一旦各种原因导致阳气郁而不升或逆而不降,疏布失常的“阳气”在人体内过度聚集,愈郁则愈欲疏泄,久积必终向外透解,如“风火”之邪侵及人体各处皮肤孔窍,则会出现相关部位的过敏症状。临床诊治中,根据变态反应性疾病发作的病机,常用熄风火以缓症状、透余热以防复发、养脉络以促复原、调五脏以兼标本等治法,并坚持以辨证为先、因势利导、急缓有异、清透兼施、整体局部辨证结合等为治疗原则,取得了良好疗效。文末列举一则验案加以说明,希望帮助读者更好理解和应用。

中医药传统知识保护立法的完善进路——兼评《中医药传统知识保护条例(征求意见稿)》

为拓宽中医药保护的对象与范畴,我国正在积极探索制定《中医药传统知识保护条例》,该条例的征求意见稿已发布,标志着我国在中医药传统知识保护领域迈出了重要一步。推动中医药传统知识保护立法出台并发挥实效,不仅是对中医药文化遗产的尊重与传承,也是应对全球化背景下中医药传统知识剽窃与滥用风险的重要举措。因此,需要针对《中医药传统知识保护条例(征求意见稿)》存在的问题进行解析,并借鉴域外医药传统知识保护方面的立法经验,提出切实可行的优化建议。

乳腺癌“应激治乳”新理论的构建与临床应用探讨

应激是生物体对内、外源性刺激的一种非特异的适应性反应,有助于维持机体内环境稳态。然而当应激反应的程度超过机体适应阈值,即可诱发多种疾病。乳腺癌发病率和死亡率高居女性恶性肿瘤前列,乳腺病领域首位国医大师林毅教授创立“六郁治乳”理论,认为六郁是乳腺癌发生发展的核心病机,而六郁与机体应激反应系统密切相关,中医药在调整应激稳态平衡领域有特色优势。该文基于中医经典理论、“六郁治乳”理论及现代应激理论,提出“应激治乳”学说,阐释应激因素介导乳腺癌发生发展的病机特性、致病特点、分子机制,提出基于应激稳态调控的核心思想和辨治原则,总结“应激治乳”理论指导下的遣方用药。“应激治乳”理论的构建丰富了中医乳腺癌理论体系,有望为改善乳腺癌患者的临床预后提供新路径。

中医药通过自噬防治糖尿病周围神经病变作用机制研究进展

糖尿病周围神经病变(diabetic peripheral neuropathy,DPN)病程长且预后差,以轴突变性坏死、神经纤维节段性脱髓鞘、雪旺细胞凋亡等神经细胞损伤为主要病理特点。自噬是神经细胞的清洁机制,通过清除多余的代谢物来消除细胞压力源造成的伤害,从而维持细胞内稳态平衡。持续的高糖环境改变了机体自噬水平,自噬被抑制或过度激活均会造成神经细胞不可逆损伤,加速DPN进展,恢复自噬平衡,从而减轻神经损伤对于DPN的治疗尤为关键。DPN的治疗目前尚无满意方案,中医药在防治DPN的进程中以多靶点、多效应、多成分等独特优势取得了较好的临床效果,大量中医药治疗DPN的动物及临床研究均显示自噬是中医药治疗DPN的重要靶点,恢复自噬平衡可以减轻神经损伤、延缓神经细胞死亡进程,起到防治DPN的作用。但其具体机制不明,基于此,对自噬的调控及其在DPN发病过程中的作用机制,以及单味中药或复方有效成分对自噬干预作用进行总结,进一步探讨DPN发病机制及中医药干预自噬的潜在治疗靶点,为进一步提升中医治疗DPN的疗效提供参考。

贾英杰辨治食管癌经验撷菁

[目的]总结全国名中医贾英杰教授治疗食管癌的临床经验。[方法]通过临证随诊,收集、分析贾教授对食管癌病因病机的认识及相关用药,并举验案一则加以佐证。[结果]贾教授认为,食管癌病机可概括为,早期属“痰凝气滞”,晚期整体属“本元亏虚”,局部“痰瘀互结,气机阻膈”,痰、气、瘀胶结酿毒,变生癌浊,壅塞成瘤。临证辨治应始终以“气”为着眼点,尤重“气机”调达,肺、脾、肝三脏同调,根据患者的舌脉特点动态辨治,施药强调揆度“扶正”与“祛邪”的尺度,使瘀滞得化、癌毒得除、膈道得通。本文所附验案为正气亏虚,三焦代谢失常,以致癌浊久羁难化,辨证为痰凝气滞、瘀结阻膈证,治以降气化痰、化瘀宽中,根据患者病情变化,适时调整用药,终获良效。[结论]贾教授基于食管癌的特点及患者的体质,辨病与辨证相结合治疗食管癌,为临床用药提供了一定的参考价值和新路径。