Core outcome set for stable angina pectoris in traditional Chinese medicine(COS-SAP-TCM)

Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.

Acupuncture-a national heritage of China to the world:international clinical research advances from the past decade

Acupuncture originated in China and is an important component of traditional Chinese medicine.The elucidation of its anesthetic mechanisms,the medical needs of Western societies,as well as the proven therapeutic effects of this technique have made it the most widely used medical practice in the world.The concept of evidence-based medicine has been introduced in acupuncture research for technical improvement and the production of high-quality clinical evidence.Upon reviewing the acupuncture clinical research over the past 10years,we found the gradually increasing range of diseases that it benefits,from pain management to neoplasms and genitourinary,digestive,and mental disorders.Acupuncture is included in a number of international guidelines for clinical practice.However,high-quality clinical evidence to support the efficacy and effectiveness of acupuncture is lacking as a result of multiple exceptional clinical trials conducted by Western researchers that have yielded antagonistic results.Future clinical research should focus on exploring objective evaluation methods for studying the therapeutic effects of acupuncture.

Effects of adjuvant Chinese patent medicine therapy on major adverse cardiovascular events in patients with coronary heart disease angina pectoris:a population-based retrospective cohort study

Objective: This study aimed to explore the effects of Chinese patent medicine(CPM) in reducing the incidence of major adverse cardiovascular events(MACE) in patients with coronary heart disease(CHD) angina pectoris and improving clinical effectiveness and provide evidence for its use as clinical adjuvant therapy.Methods: Twenty-eight thousand five hundred and seventeen patients hospitalized with CHD angina pectoris from 6 hospitals were divided into CPM group(n = 11,374) and non-CPM group(n = 17,143) to evaluate the incidence of MACE, including myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting.Results: The incidence of MACE in the CPM group was lower than that in the non-CPM group. CPM therapy was an independent protective factor that reduced the overall risk of MACE [adjusted hazard ratio = 0.40, 95% confidence interval(0.33;0.49)]. Patients in the CPM group who received one, two, or three types of CPM could benefit from adjuvant treatment with CPM, and taking more types of CPM was associated with a lower risk of MACE. In addition, the male population was better than the female population at taking CPM, and middle-aged people aged 55 to 64 were more suited to take CPM based on Western medicine.Conclusions: The use of CPM as adjuvant therapy can decrease the occurrence of MACE in patients with CHD angina pectoris,especially in men and middle-aged people, and the drug treatment plan should be optimized accordingly. However, this conclusion needs further verification by prospective cohort studies in the future.

Acupuncture and moxibustion treating lower urinary tract symptoms due to benign prostatic hyperplasia:a systematic review and network meta-analysis

Objective: Lower urinary tract symptoms(LUTS) caused by benign prostatic hyperplasia(BPH) affect the quality of life of elderly individuals. Acupuncture and moxibustion are used in the clinic in China for improving LUTS symptoms due to BPH. However,there is no evidence to suggest which is the best option. We compared the efficacy of acupuncture and moxibustion to provide evidence for clinical decision-making.Methods: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wan Fang Data, and VIP databases were searched from inception to July 2020 to identify the randomized controlled trials(RCTs) of acupuncture and moxibustion for LUTS due to BPH. Two researchers filtered studies and extracted the information independently. This study conducted a network meta-analysis using the Bayesian random method. The interventions ranking was evaluated using the surface under the cumulative ranking curve(SUCRA).Results: We finally included 40 studies comprising 10 treating therapies and 3,655 patients with LUTS caused by BPH. In terms of the International Prostate Symptom Score, maximum urinary flow rate, and quality of life, electroacupuncture(EA) [MD =-3.6,95% credible interval(CrI)(-5.5,-1.8), very low certainty of evidence;MD = 2.2, 95% CrI(1.1, 3.3), low certainty of evidence;MD =-1.3, 95% CrI(-2.2,-0.43), very low certainty of the evidence] may be consistently the optimal treatment compared with other interventions, with SUCRA values of 84%, 81%, and 89%, respectively.Conclusions: Of all treatments, EA may have the best efficacy with fewer adverse events for LUTS due to BPH. The quality of evidence supporting this result is low to very low certainty of the evidence due to the limitations of primary studies;thus, more highquality RCTs are needed for further evidence.

Anti-fatigue effect from Ginseng Radix et Rhizoma:a suggestive and promising treatment for long COVID

Two years after the coronavirus disease 2019(COVID-19)outbreak,an increasing number of patients continue to suffer from long COVID(LC),persistent symptoms,and/or delayed or long-term complications beyond the initial 4 weeks from the onset of symptoms.Constant fatigue is one of the most common LC symptoms,leading to severely reduced quality of life among patients.Ginseng Radix et Rhizoma—known as the King of Herbs in traditional Chinese medicine—has shown clinical anti-fatigue effects.In this review,we summarize the underlying anti-fatigue mechanisms of Ginseng Radix et Rhizoma extracts and their bioactive compounds,with a special focus on anti-viral,immune remodeling,endocrine system regulation,and metabolism,suggesting that Ginseng Radix et Rhizoma is a potentially promising treatment for LC,especially regarding targeting fatigue.

“Tong Guan Li Qiao” Acupuncture Therapy on Post-Stroke Dysphagia

The differences between the“Tong Guan Li Qiao”acupuncture therapy and the conventional and current other acupuncture methods for poststroke dysphagia are as follows:first,it adheres to the basic idea of "Xing Nao Kai Qiao"acupuncture therapy in selecting and combining acupoints,centers on the brain,and combines the dysphagia symptoms of the mouth,tongue,and throat-related orifices with the root cause of"brain";second,thereare strictand standard requirements intheacupuncture operation,that is,manipulation quantification.In addition to standardized twirling,lifting,and thrusting,the techniques of deep needling on the acupoints in the neck region,blood-letting puncturing at the posterior wallof the pharynx,and theneedling sensation of"like a fishbone getting stuck in the throat"are all unique.

Arousal effect and potential mechanism of dopamine-mediated acupuncture on traumatic brain injury

Traumatic brain injury(TBI)is a brain injury caused by direct external forces,and its prognosis depends on the extent of the damage and the changes in level of consciousness.Timely awakening from a coma is the first thorny problem to be solved in TBI treatment.Therefore,there is a need for the development of safe and effective methods for timely awakening after TBI coma.Dopamine(DA)and its receptors in the nervous system are involved in the regulation of wakefulness.The amount and activity of dopaminergic neurons can affect cellular function and neuroinflammatory response,and are also significant for the awakening process after TBI.The current common awakening therapy for TBI may also be related to the activation of dopaminergic neurons.Acupuncture plays a beneficial role in timely awakening,recovery of conscious level,and functional rehabilitation after TBI.The mechanism may be related to the targeted regulation of DA and its receptors via acupuncture.Among acupuncture first aid therapies,acupuncture at hand 12 Jing-Well points,with its advantages of simple operation and ultra-early intervention,has shown great promise in timely awakening following TBI and triggering a series of subsequent nerve repair effects in the treatment of TBI.We here present a review that provides a new perspective for the timely awakening from TBI-induced coma,with a focus on the role of DA in the regulation of wakefulness and the efficacy and potential mechanism of DA systems in the treatment of TBI by acupuncture.

Status of Clinical Application of Yufeng Ningxin Preparations and the Meta-Analysis of Its Efficacy and Safety in the Treatment of Cardiovascular and Cerebrovascular Diseases

Objective The objective of this study was to analyze the status of the clinical application of Yufeng Ningxin(YFNX)preparations and systematically evaluate their efficacy and safety in the treatment of cardiovascular and cerebrovascular diseases.Methods Through searching databases of China National Knowledge Infrastructure,Wanfang,SinoMed,VIP,PubMed,Embase,and the Cochrane Library,the literature of clinical research on YFNX preparations in treating malignant tumors of cardiovascular and cerebrovascular diseases from the establishment of the databases to February 2021 was collected.The clinical randomized controlled trials and case-control studies of cardiovascular and cerebrovascular diseases treated with these preparations were analyzed.Two reviewers independently screened literature,extracted data,and assessed the risk of bias in the included studies,and meta analysis was performed by using ReMan 5.3 software to analyze the eficacy and safety of YFNX preparations in the treatment of cardiovascular and cerebrovascular diseases.Results A total of 29 clinical studies were finally included.The dosage forms were dropping plls,tablets,capsules,and granules.The preparations were used for the treatment of coronary heart disease,hypertension,neuropathic headache,etc.This study systematically evaluated the efficacy and safety of YFNX preparations in the treatment of coronary heart disease,hypertension,and nervous headache.A total of 1,162 cases were included in 13 studies,582 cases of the YFNX preparation group and 580 cases of the Western medicine group.The results of meta-analysis showed that the clinical efficacy of YFNX preparations combined with the Western medicine group in the treatment of coronary heart disease and hypertension,improving electrocardiogram and reducing the frequency and duration of angina attacks,was better than that of the simple Western medicine group,and the difference was statistically significant.Conclusion YFNX preparations are effective for coronary heart disease,hypertension,and neuropathic headache,and the adverse reactions are few.

A Meta-Analysis of Migraine Treated with Banxia Baizhu Tianma Decoction

Objective Our objective was to systematically evaluate the efficacy and safety of Banxia Baizhu Tianma decoction in the treatment of migraine.Methods The databases of China National Knowledge Infrastructure,VIP,WanFang,Chinese Biomedical Databases,PubMed,and EMbase were searched by computer,and randomized controlled trials that met the inclusion criteria were retrieved.The Cochrane bias risk assessment tool was used to evaluate the quality of the included studies.RevMan 5.3 software was used to conduct meta quantitative analysis of the included studies.Results A total of 19 studies were included,with a total sample size of 1,635 cases,821 cases in the treatment group and 814 cases in the control group.The results of meta-analysis showed that(1)the clinical effective rate of the single use of Banxia Baizhu Tianma decoction or western medicine combined with Banxia Baizhu Tianma decoction in treating migraine was better than that of western medicine alone(p<0.001);(2)the improvement in cumulative number and days of vertigo in the treatment of migraine with Banxia Baizhu Tianma decoction was observed in the control group(p<0.001).TSA results showed that Z-curve passed both the traditional threshold and Trial sequential analysis(TSA)threshold.In terms of adverse reactions,55 cases were reported,including 12 cases in the treatment group and 43 cases in the control group,and no serious adverse reactions were found.Conclusion Compared with the single use of western medicine therapy,the combination of Banxia Baizhu Tianma decoction and western medicine or the single use of Banxia Baizhu Tianma decoction could better improve the effective rate and showed good safety and low incidence of adverse reactions.

芍药苷稳定性研究

研究pH值、温度、光照对芍药苷的影响以及其在生物样品中的稳定性。采用高效液相色谱法(high performance liquid chromatography,HPLC)测定芍药苷在不同化学条件下及生物样品中的浓度。结果发现,芍药苷的稳定性受强碱和温度影响明显,光照影响不明显。芍药苷在肝脏、肾脏、心脏等的组织匀浆液中相对稳定,而在尿液、胆汁和血浆中有降解趋势,且降低温度可减少芍药苷在生物样品中的降解。因此,生物样品的采集、处理和保存均应在低温下进行,在处理过程中要避免接触碱性环境,需将采集的生物样品冷冻保存。

Diagnosis of uremia patients based on color space

Since traditional nail diagnosis is susceptible to objective factors such as illumination,medical experience,etc.,a nail diagnosis system of traditional Chinese medicine which combines objective nail image acquisition with information analysis is proposed and applied to the clinical research of nail diagnosis of uremia patients.Fifteen nail pictures of uremic patients were collected and segmented.The color information of nails was extracted.The relationship between the hemoglobin values of uremic patients and the values of color space before and after maintenance hemodialysis was analyzed by correlation analysis and multiple regression analysis.The experimental results show that the hemoglobin value of uremic patients have certain correlations with multiple color channels;before and after dialysis,there are significant changes in multiple channels;and the related multiple regression equation is established.

Carbon quantum dot preparation and application to detecting active ingredients in traditional Chinese medicine

Carbon quantum dots(CQDs)are fluorescent carbon nanomaterials that have been applied to biology,medicine,and optoelectronics,owing to their significant advantages such as simple synthesis methods,low cost,and widely available sources of raw synthesis materials.This review summarizes CQD preparation methods,which include hydrothermal and microwave-assisted synthesis methods,as well as separation methods such as centrifugation,dialysis,and filtration.Additionally,we review the application of CQDs in the detection of active ingredients,primarily phenolic compounds,in traditional Chinese medicine.We also discuss the quenching mechanism of CQD fluorescence using the active ingredients of traditional Chinese medicine.Limitations such as insufficient test selectivity,weak fluorescence intensity,and an unclear quantitative relationship between preparation methods and properties should be resolved for the efficient use of CQDs to detect active ingredients in Chinese medicine.

The inhibitory effect of lotus leaf extract on hyperuricemia and its potential mechanism

Objective:Lotus leaf is a traditional Chinese herb that has been used successfully for centuries for relieving edema by inducing diuresis.Based on its good clinical evidence and anti-hypertensive effectiveness,this study aimed to investigate the potential mechanism of the hyperuricemic inhibitory effects of lotus leaf crude extract(LL)and lotus leaf total alkaloids fraction(LA).Methods:The xanthine oxidase(XOD)inhibitory effect of LL and LA was analyzed in vitro by determining mRNA expression and protein expression levels of hepatic XOD.The hyperuricemic inhibitory effect of the lotus leaf was analyzed in vivo in a potassium oxonate(PO)-induced rat model by determining mRNA expression for renal urate transporters.Results:At a concentration of 40mg/mL,LL and LA suppressed XOD enzymatic activity by 37.35%±9.50%and 47.73%±8.32%,respectively.Both LL and LA administration significantly reduced the concentration of uric acid in the serum and liver of PO-induced hyperuricemic rats.Both LL and LA administration could inhibit XOD mRNA and protein expression,activate renal organic anion transporter 1/3 mRNA expression,and inhibit renal urate reabsorption by decreasing renal GLUT9 and renal urate transporter 1.Conclusions:Insight was gained into the mechanism behind the hyperuricemic inhibitory effects of LL and LA.Our results suggest that they act on two targets:decreasing the production of uric acid by inhibiting mRNA and protein expression of XOD in the liver,and regulating the mRNA expression of renal urate transporters in the kidneys.

Nature products of traditional Chinese medicine provide new ideas in γδT cells for tumor immunotherapy

Due to the unique features of innate immune cells, the role of γδT cells in tumor immunity has gradually attracted more and more attention. Previous studies have found that γδT cells play a dual role in tumor immunology: tumor-promoting and tumor-controlling.The anti-tumor therapy of γδT cells has made remarkable success in clinical application. Especially in recent years, researchers have provided some novel effective ways such as γδT cells exosomes and adoptive chimeric antigen receptor-γδT cells immunotherapy. However, some problems remain to be solved, such as low expansion rate, poor targeting, and tumor microenvironment limiting the effectiveness of γδT immunotherapy. Traditional Chinese medicine is expected to play a positive role in the body immune-enhancing function, promoting the proliferation and activation of γδT cells, and inducing the differentiation ofγδT cells. In this review, we summarize the recent research progress and urgent problems of γδT cells in anti-tumor immunotherapy. Moreover, some new strategies of γδT cells for tumor immunotherapy were proposed.

Study of the relationship between acupuncture dose and effect

Acupuncture dose-effect relationship is the essential feature of acupuncture and the key factor of acupuncture’s therapeutic effect.It is a comprehensive category,including needle direction,needle strength,needle depth,selection of specific techniques,length of time between acupuncture treatment sessions,length of needle retention time,and frequency of treatment,all of which play a decisive role in the curative effect and prognosis of diseases[1].

The exciting and magical journey of components from compound formulae to where they fight

With its long-term empirical clinical practice and increasing number of health benefits reported,Chinese Materia Medica(CMM)is gaining increasing global acceptance.Importantly,the identification of chemical constituents in vitro and exposed forms in vivo is a prerequisite for understanding how CMM formulae prevent and treat diseases.This review systematically summarizes the exciting and magical journey of CMM components from compound formulae to where they fight,the possible structural transformation of CMM components in vitro and in vivo,and their pharmacological contribution.When a decoction is prepared,significant chemical reactions are observed,including degradation and production of polymers and self-assembling supramolecules,leading to the construction of a component library with diverse decoction structures.After ingestion,compounds pass through the intestinal and blood-brain barriers and undergo a more wonderful journey involving the gut microbiota,microbial enzymes,and endogenous drug-metabolizing enzymes(mainly liver enzymes).At this stage,they are modified and assembled into novel and complex compounds,such as newly generated metabolites,conjugates,and self-assembling superamolecules.This review might provide a strategic orientation to explore the active compounds of CMM formulae in vivo.

How to conduct an acupuncture dose–effect relationship study? A discussion based on study methodology

Acupuncture therapy is widely used in the clinic,and its therapeutic effects have been proven by numerous studies.The dose–effect relationship of acupuncture is a fundamental aspect of the acupuncture research system.Recent studies found that different acupuncture dosages altered study results directly,indicating the importance of screening the optimal stimulation dosage.However,the system for studying the acupuncture dose–effect relationship is still in its infancy,and the methodology of the system needs to be improved.This review aimed to define the factors impacting acupuncture“dosage”and“effect,”and to improve the methodological system for research on the dose–effect relationship of acupuncture.By summarizing the current findings of acupuncture dose–effect studies,we discussed the vital acupuncture parameters and methodological problems that influence the relationship between acupuncture dosage and its effects.These factors consist of specific influencing factors(acupoint selection,acupuncture manipulation parameters,de qi response)and nonspecific influencing factors(comparison selection,blinding procedure,patient expectancy).Our perspectives offer suggestions for the design of acupuncture dosage–effect trials.Further studies need to be conducted to establish the methodological system and provide systematic evidence of the acupuncture dose–effect relationship.

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.

Chondrogenic differentiation of rat bone marrow mesenchymal stem cells induced by puerarin and tetrandrine

Objective: This study aims to clarify the effect of the active components puerarin and tetrandrine on the chondrogenic differentiation of bone marrow mesenchymal stem cells(BMSCs).Methods: Using network pharmacology, protein targets of puerarin and tetrandrine were predicted, and a database of cartilage formation targets was established. The protein target information related to disease was then collected, and the drug-targeting network was constructed by analyzing the protein–protein interactions. Genes related to chondrogenesis induced by puerarin and tetrandrine and chondroblast differentiation signaling pathways were searched. Finally, potential drug-and disease-related genes,as well as proteins, were screened and verified using real-time RT-PCR and western blotting.Results: Network pharmacological studies have shown that puerarin and tetrandrine are involved in BMSCs cartilage differentiation. The experimental results showed that puerarin and tetrandrine could regulate the expression of cartilage differentiation-related genes and proteins. Puerarin increased the protein expression of COL2 A1, COL10 A1, MMP13, and SOX-9,as well as the gene expression of Col2 a1, Mmp13, Tgfb1, and Sox-9. Tetrandrine increased the protein expression of COL2 A1,COL10 A1, MMP13, and SOX-9, as well as the gene expression of Col10 a1, Tgfb1, Sox-9, and Acan. The combination of puerarin and tetrandrine increased the protein expression of COL2 A1, COL10 A1, MMP13, and SOX-9 and the gene expression of Col2 a1,Col10 a1, Sox-9, and Acan.Conclusions: Puerarin, tetrandrine, and their combination can promote the proliferation of BMSCs and induce their differentiation into chondrocytes, and they are thus expected to be inducers of chondrogenic differentiation. These results suggest that puerarin and tetrandrine have potential therapeutic effects on osteoarthritis.

Development and evaluation of Panax notoginseng saponins contained in an in situ pHtriggered gelling system for sustained ocular posterior segment drug delivery

Objective:This study aimed to lay the foundation for the research on Panax notoginseng saponins(PNS)in pH-sensitive in situ gel and the development and improvement of related preparations.Methods:We used Carbopol■940,a commonly used pH-sensitive polymer,and the thickener hydroxypropyl methylcellulose(HPMC E4M)as an ophthalmic gel matrix to prepare an ophthalmic in situ gel of PNS.In addition,formula optimization was performed by assessing gelling capability with the results of in vitro release studies.In vitro(corneal permeation,rheological,and stability)and in vivo(ocular irritation and preliminary pharmacokinetics in the vitreous)studies were also performed.Results:The results demonstrated that the in situ gelling systems containing PNS showed a sustained release of the drug,making it an ideal ocular delivery system for improving posterior ocular bioavailability.Conclusions:This study lays the foundation for the research of PNS contained in an in situ pH-triggered gel as well as the development and improvement of related preparations.It concurrently traditional Chinese medicine with a contemporary in situ gelling approach to provide new directions for the treatment of posterior ocular diseases such as diabetic retinopathy.