Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)

Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.

Clinical Observation of Chinese Medicinal Prescriptions for Swelling and Pain in The Postoperative Treatment of Mixed Hemorrhoids

Objective:To observe the clinical effect of traditional Chinese medicine(TCM)on reducing swelling and pain in patients with mixed hemorrhoids.Methods:Sixty patients with mixed hemorrhoids who were admitted to the Hospital of Traditional Chinese Medicine of Qiqihar from January 2023 to January 2024 were selected and divided into two groups.The treatment group(n=30)was treated with mixed hemorrhoid ligation combined with traditional Chinese swelling and pain medicine,and the control group(n=30)was only treated with mixed hemorrhoid ligation.The pain level,edema score,and prognosis of the two groups after the intervention were analyzed.The clinical efficacy was used as the evaluation criterion to compare the clinical effects of different treatment options.Results:After the treatment,the pain score,edema score,and prognostic wound score of the treatment group were all lower than those of the control group(P 0.05).The total clinical effectiveness of the treatment group(100%)was higher than that of the control group(76.67%),(χ^(2)=4.2857,P<0.05).Conclusion:The application of traditional Chinese swelling and pain medicine in treating patients with mixed hemorrhoids effectively reduced the patient’s pain,reduced the degree of wound edema,promoted wound healing,and improved the patient’s prognosis.The curative effect was significant and had a positive impact.

Prescription and treatment rules for the prescriptions containing Poria cocos and Atractylodes macrocephala couplet medicine based on traditional Chinese Medicine inheritance support platform

Objectives:To provide a theoretical basis for the development of the new products of Poria cocos-Atractylodes macrocephala couplet medicine.Methods:All prescription preparations containing Poria cocos and Atractylodes macrocephala were collected from the Drug Standards of the Ministry of Public Health Drug Standard·Traditional Chinese Medicine Set Prescription Preparation(called Traditional Chinese Medicine Set Prescription Preparation for short).After standardization,the information of each prescription preparation was input into the Chinese Traditional Medicine Inheritance Support Platform(V2.5),and the relevant rules of the software were adopted.Data mining methods were used to analyze the frequency of drugs,main symptoms and diseases in prescriptions,and to analyze the regularity of prescriptions.The prescription rules of top 2 high frequency attending syndromes and diseases were analyzed.Results:There were total of 337 prescription preparations containing couplet medicine of Poria cocos and Atractylodes macrocephala,107 kinds of main symptoms and 66 kinds of diseases.The high frequency syndromes were deficiency of Qi and blood and weakness of spleen and stomach,and the high frequency syndromes were anorexia and irregular menstruation.Conclusion:The couplet medicine of Poria cocos-atractylodes macrocephala prescription is mainly used to treat digestive tract diseases and gynecological diseases;it mostly takes tonifying deficiency efficat.It can treat different diseases being compatible with different medicinal materials.The study can provide theoretical basis for clinical application and new drug development of the couplet medicine of Poria cocos-atractylodes macrocephala.

Application of Mathematical Models in the Research of Chinese Herbal Compound Prescriptions

With the interdisciplinary development of multiple disciplines,mathematical models play a role as a bridge in the research process of Chinese herbal compounds,which can make full use of the interrelationships of knowledge,making the research and use of Chinese herbal compounds from complex and cumbersome to simple.This paper reviewed the research and application of mathematical models in the production and preparation,pharmacodynamics,pharmacokinetics and other aspects of Chinese herbal compound prescriptions,providing a theoretical basis for the development of the modern Chinese medicine industry.

Studies on a Traditional Chinese Medical Prescription Ma Xing Shi Gan Tang by Bio-coordination Chemistry

本文报道 pH 电位滴定法测出麻黄碱与生石膏中的 Cu^(2+)、Fe^(2+)、Zn^(2+)、Mn^(2+)离子形成的 ML 及 ML_2型络合物的稳定常数。滴定曲线显示甘草酸与上述四种金属离子也能分别形成不同稳定程度的络合物。用麻黄碱加甘草酸和上述四种金属离子配制成的模拟麻杏石甘汤和单纯生石膏煎剂与麻性石甘汤一样均有使家兔退热的效果,与对照组比较均有显著性差异(P<0.05);而用麻黄碱加甘草酸配制成的溶液无退热效果。作者认为应从生物—配位无机化学的多金属—多配体体系的观点去研究某些传统中医药方剂。

Effects of Traditional Chinese Herbal Medicine on Immune Organ Indexes and Macrophages Phagocytic Indexes in Chickens Infected by Infectious Bronchitis Virus

[ Objective] To study the therapeutic effects of traditional Chinese medicine prescriptions on infectious bronchitis （IB） and find a novel avenue for prevention and treatment of viral diseases in poultry. [Method] A total of 160 cockerels at the age of 15 d were divided into four groups randomly, including traditional Chinese medicine group, moroxydine control group, challenge control group and healthy control group. Except the healthy control group, other groups were challenged with infectious bronchitis virus （IBV） on Day 15. After 48 h post challenge, the traditional Chinese medicine groupand moroxydine control group were respectively administrated with Chinese herbal medicine prescription and moroxydine, continuously for 5 d. The immune organ indexes and macrephage phagocytic indexes were detected on Day 18, 24 and 30, respectively. [ Result] The immune organ indexes and macrophage phagocytic indexes were not significantly different between traditional Chinese medicine group and moroxydine control group on Day 18. But all the indexes of the traditional Chinese medicine groups were increased significantly （ P 〈 0.05） on Day 24 and 30, and showed extremely significant difference （ P 〈 0.01 ） with those of challenge control group on Day 30. [ Conclusion] The traditional Chinese herbal medicine can enhance macrophage phagocytic indexes and immune organs indexes of chickens infected by IBV.

A brief overview of traditional Chinese medicine prescription powered by artificial intelligence

Traditional Chinese medicine prescription is one of the treasures of traditional Chinese medicine(TCM).There are tens of thousands TCM prescriptions accumulated in the past thousands of years,corresponding to different diseases,symptoms and therapeutic goals.The correspondences are so complicated that there is an urgent need to leverage new technologies such as artificial intelligence(AI)to analyze,understand and utilize them effectively.In this paper,we present a brief overview of this direction,where current research progress on TCM prescription powered by AI is summarized.Our summarization focuses on three aspects,TCM prescription mining that aims at understanding the TCM prescription,TCM prescription or herb knowledge base construction that aims at extracting knowledge to support the TCM prescription-related study,and TCM prescription discovery that aims at utilizing AI technologies to further energize TCM.It is encouraging to see that steady progress in this direction has been made recently.Besides,a toy experiment on image-based TCM herb recognition by using convolutional neural networks is also conducted.It basically verifies that it is promising to use AI technologies to address challenging tasks in TCM.We also point out several research topics that could be cooperatively performed by researchers from the two disciplines.

Clinical efficacy and safety of TCM prescriptions combined with nucleoside(acid)analogues in treating chronic hepatitis B:a meta-analysis

Objective There are many clinical reports on traditional Chinese medicine(TCM)combined with nucleoside(acid)analogues(NAs)for the treatment of chronic hepatitis B(CHB),but its efficacy and safety are not completely clear.This meta-analysis aims to evaluate the clinical efficacy and safety thus providing evidence for clinical applications.Methods We searched Chinese databases the China National Knowledge Infrastructure(CNKI),Wanfang Data,and China Science and Technology Journal Database(VIP),as well as English databases Pub Med and Cochrane Library,from time of establishment to April 14,2021.Literature quality was evaluated according to the bias risk assessment criteria of Cochrane Collaboration network.Rev Man 5.3 and Stata 12.0 software were used to perform this research.Results A total of 23 articles,3282 patients,and 25 TCM prescriptions were included in this study.NAs plus TCM remarkably improved the clinical total effective rate[Odds ratio(OR)=3.92,P<0.00001],TCM syndrome score(Mean difference=-3.73,P<0.00001),hepatitis B virus(HBV)DNA negative conversion rate(OR=1.49,P=0.0001),hepatitis Be antigen(HBe Ag)negative conversion rate(OR=2.03,P<0.00001),alanine aminotransferase levels[Std mean difference(SMD)=-0.95,P<0.00001],and aspartate aminotransferase levels(SMD=-0.70,P=0.0004).Adverse reaction rates did not increase in the combined treatment group(OR=0.97,P=0.84).A comprehensive analysis of the 25 TCM prescriptions suggested that the combination of spleen-strengthening prescriptions with NAs showed better effects than other prescriptions.Conclusion TCM in combination with NAs,demonstrated better clinical efficacy against CHB than NAs alone.In addition,the combination of spleen-strengthening prescriptions and NAs was identified as the best therapeutic strategy.However,more randomized controlled trials of high quality are needed to provide more reliable clinical basis for the application of TCM.

Network Pharmacology Approach to Investigate the Preventive Mechanism of Hunan Expert Group Recommended Chinese Medicine Prevention No.2 Prescription Against COVID-19

Objective To explore the possible preventive mechanism of Hunan expert group recommended Chinese medicine prescription of No.2(Pre-No.2)against coronavirus disease 2019(COVID-19)by network pharmacology method.Methods The target proteins of effective components and active compounds in Pre-No.2 were screened by searching the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP).A component-target-disease interaction network of Pre-No.2 was constructed by Cytoscape 3.7.2,gene ontology(GO)analysis,and Kyoto encyclopedia of genes and genomes(KEGG)analysis of target protein pathway by DAVID.Results A total of 163 compounds and 278 target protein targets in Pre-No.2 were collected from the TCMSP database.Kaempferol,wogonin,7-methoxy-2-methyl isoflavone,formononetin,isorhamnetin,and licochalcone A were the most frequent targets in the regulatory network.GO enrichment analysis showed that Pre-No.2 regulated response to virus,viral processes,humoral immune responses,defense responses to virus and viral entry into host cells.KEGG enrichment analysis showed that the formula regulated the NF-κB signaling pathway,B cell receptor signaling pathway,viral carcinogenesis,T cell signaling pathway and FcγR-mediated phagocytosis signaling pathway.Conclusions Pre-No.2 may play a preventive role against COVID-19 through regulation of the Toll-like signaling,T cell signaling,B cell signaling and other signaling pathways.It may regulate the immune system to protect against anti-influenza virus.

Clinical efficacy of Chinese herbal compound in the treatment of infertility with kidney deficiency:A meta-analysis

Objective:Based on the current evidence system to evaluate the effect of traditional Chinese medicine compound on the clinical efficacy of infertility patients with kidney deficiency.Methods:Search the China Knowledge Resources Database(CNKI),Chinese Science and Technology Journal Database(VIP),China Academic Journal Database(Wanfang),PubMed,EMBASE,Ovid.The included studies are randomized controlled trials.The experimental group is Chinese medicine compound or Chinese medicine compound combined with western medicine,and the control group is western medicine.Two reviewers independently extracted and evaluated the literature data according to the Cochrane manual standards,and used Rev Man5.3 software for data synthesis and Meta-analysis.Results:32 studies were selected,a total of 2715 cases of infertility patients.The clinical pregnancy rate of the experimental group and the control group[n=29,OR(95%CI)=2.47(2.07,2.96),P<0.00001],the clinical total effective rate[n=20,OR(95%CI)=3.77(2.83,5.03),P<0.00001],TCM syndrome score[n=14,MD(95%CI)=4.34(3.08,5.61),P<0.00001],ovulation rate[n=20,OR(95%CI)=2.21(1.85,2.63),P<0.00001],the occurrence rate of two-way BBT[n=11,OR(95%CI)=2.65(2.02,3.48),P<0.00001].The GRADE scoring results show that the level of evidence is low and very low.Conclusion:Traditional Chinese medicine compound can increase the clinical pregnancy rate and clinical total effective rate of infertility with kidney deficiency syndrome,improve the scores of Chinese medical syndromes,increase its ovulation rate and the occurrence rate of BBT bidirectional type,and confirm the clinical efficacy of Chinese medicine compound from the perspective of evidence-based medicine.

Potential Preventive and Therapeutic Effects of Traditional Chinese Medicine Compound Prescription and Traditional Chinese Medicine Products on COVID-19

This paper mainly analyzes the traditional Chinese medicine compound prescription and traditional Chinese medicine products with remarkable epidemic prevention effect since the outbreak of COVID-19,and discusses their potential prevention and treatment effects,so as to provide a basis for the further development and application of traditional Chinese medicine compound prescription and traditional Chinese medicine products against COVID-19.

A study on the medication law of oral administration of traditional Chinese medicine in treating breast carbuncle based on the Traditional Chinese Medicine Prescription Dictionary

Objective:Based on the database of Traditional Chinese Medicine Prescription Dictionary,the prescription medication rules of oral administration of traditional Chinese medicine in the treatment of breast carbuncle were explored by using the software of Traditional Chinese Medicine Inheritance Support System(V2.5).Methods:To screen and retrieve the prescriptions for treating breast carbuncle in the Traditional Chinese Medicine Prescription Dictionary,and data mining was carried out by using association rule algorithm,complex system entropy clustering and so on.Results:A total of 208 prescriptions which met the inclusion criteria were selected,involving 175 traditional Chinese medicines.Among them,23 medicines were found to be more than 21 times in the treatment of breast carbuncle.The nature of the medicine is mainly cold or warm,the flavour of the medicine is mainly bitter or sweet,most of them belong to the spleen,liver,stomach.15 commonly used drug combinations and 9 new prescriptions were obtained.Conclusion:The key pathogenesis of breast carbuncle is liver depression and Qi stagnation,stomach heat blocking collaterals,the treatment is mainly to clear heat and detoxify,regulate Qi to diffuse the knot,which provides reference for the choose of traditional Chinese medicine prescription in treating breast carbuncle.

Tuina massage combined with traditional Chinese prescription improves quality of life and motor symptoms in a spasmodic torticollis patient:A case report

Objective:A case study was performed to discuss the efficacy of traditional Chinese medicine(TCM)treatments on spasmodic torticollis.Materials and methods:A 28-year-old male was diagnosed with spasmodic torticollis due to twist and turn of neck after being frightened,who was unable to take care of himself for over 3 months.He once took an oral non-steroidal anti-inflammatory drug,but no significant improvement was seen in his symptoms.After a few months,his symptoms got worse,with onset of spasms.Therefore,he was treated at our hospital with traditional Chinese prescription and Tuina massage therapy for 3 months and followed up for 6 months.The Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)and the Craniocervical Dystonia Questionnaire(CDQ-24)scores were recorded before and after treatment and during follow-up observations to evaluate the therapeutic efficacy.Results:Compared to the baseline,the TWSTRS and CDQ-24 scores decreased significantly,and there was no evident recurrence of his symptoms for at least 6 months of follow-up.Moreover,no apparent discomfort or side effects were observed during the treatment.Conclusion:Jingu abdominal massage combined with traditional Chinese prescription has a certain efficacy in the treatment of spasmodic torticollis,with almost no side effects,which can be easily accepted by patients.

TREATMENT OF TEN CASES OF CHRONIC FATIGUE SYNDROME WITH CHINESE HERBS,ACUPUNCTURE, AND DIET PRECAUTIONS

Ten cases of chronic fatigue syndrome (CFS) were treated for 4 weeks by acupuncture, Chinese herbs and diet precautions. Diagnosis of CFS was determined by conventional medicine criteria(CDC criteria for CFS), physical examination, and routine laboratory tests. TCM diagnosis of CFS relied on Four Examination Methods and Eight Principal Patterns. They were diagnosed as Ganyu Qizhi (liver and qi stagnation) and Pixu Qiruo (spleen and qi deficiency). The treatment method is to disperse the liver and facilitate qi, rehabilitate the spleen and strengthen qi (Shugan Liqi, Jianpi Yiqi). The result of the treatment indicated that the total effective rate was 100% in terms of fatigue, difficulty concentrating, headache, sore throat, muscle pain, joint aches, feverishness, rapid pulse, insomnia, depression, irregular menses, abdominal cramps, and night sweats. The percentages of specific symptoms of CFS in the patients were comparable to the conventional medical record (Table 1).

Diagnosis and Treatment of Yeast Mastitis in Dairy Cattle

[Objective] Study on the yeast mastitis in dairy cattle cases which have been ineffectively treated by multiple antibiotics through traditional Chinese medicine prescription. [ Method] The isolated pathogenic fungi from milk were used for drug sensitivity testing and the ones proved were clinically treated by self-made traditional Chinese medicine prescription ＂Ruxiaotang＂. [ Result] 19 cases of 20 selected dairy cattle cases were diagnosed as yeast mastitis and cured with the except of a Candida tropicalis case. [ Conclusion] The results provide a new reference for curing yeast mastitis.

Research ideas and strategies on the dose-effect relationship of traditional Chinese medicine prescriptions and herbs

We discuss here the complexity of the doses of traditional Chinese medicine(TCM) prescriptions and herbs from different viewpoints,including the heterogeneity of drug quality,the flexibility of prescriptions,and the diversity of drug effects.Then,the corresponding research ideas and strategies are proposed.We can reveal the actual situation of clinical doses based on in-depth "real-world study" of the safety and effectiveness of TCM prescriptions,create an analytical method for dose-effect relationships in accordance with the features of TCM,and reveal the correlated regular nature of the effectiveness and dosage of TCM prescriptions and herbs.

Discovery of Regularities in the Use of Herbs in Chinese Medicine Prescriptions

Chinese medicine （CM） is a discipline with its own distinct methodologies and philosophical principles. The main method of treatment in CM is to use herbal prescriptions. Typically, a number of herbs are combined to form a formula and different formulae are prescribed for different patients. Regularities in the mixture of herbs in the prescriptions are important for both clinical treatment and novel patent medicine development. In this study, we analyze CM formula data using latent tree （LT） models. Interesting regularities are discovered. Those regularities are of interest to students of CM as well as pharmaceutical companies that manufacture medicine using Chinese herbs.

Effect of Xiaobailing Decoction on Melanocytes in Vitro

To observe the effect of Xiaobailing Decoction （消白灵汤） on murine melanocytes in vitro and to explore the mechanism of Xiaobailing Decoction in the treatment of vitiligo. Methods： B-16F10 murine melanoma cells were cultured in 1640 medium and treated respectively with different concentrations （lmg/ml, 2mg/ml, 3mg/ml） of the Chinese drug Xiaobailing Decoction and its main components, the drugs for replenishing the lddney-yang, and the drugs for nourishing blood and activating blood circulation, etc. for 7 days. MMT assay was used to determine the proliferation of B-16F10 murine melanoma cells. NaOH cleavage assay was adopted to measure the melanogenesis of melanocytes. Results：Xiaobailing Decoction, the drugs for replenishing the kidney-yang and the drugs for nourishing blood and activating blood circulation at different concentrations significantly improved the proliferation of B-16F10 murine melanoma cells from the 3rd day to the 5th day （P〈0.05）, with Xiaobailing Decoction at the concentrations of lmg/ml having the most distinct action on promoting the proliferation of melanocytes on the 3rd day （P〈0.001）; And the drugs for replenishing the lodney-yang at the concentrations of 2mg/ml and 3mg/ml and the drugs for nourishing blood and activating blood circulation at 3mg/ml significantly increased melanogenesis of melanocytes （P〈0.05）. Conclusion： Xiaobailing Decoction can promote melanocytic proliferation and melanogenesis in vitro, and it is indicated that the drugs for replenishing the kidney-yang and the drugs for nourishing blood and activating blood circulation play an important role in treating vitiligo.

A Clustering Method of Chinese Medicine Prescriptions Based on Modified Firefly Algorithm

This paper is aimed to study the clustering method for Chinese medicine（CM） medical cases. The traditional K-means clustering algorithm had shortcomings such as dependence of results on the selection of initial value, trapping in local optimum when processing prescriptions form CM medical cases. Therefore, a new clustering method based on the collaboration of firefly algorithm and simulated annealing algorithm was proposed. This algorithm dynamically determined the iteration of firefly algorithm and simulates sampling of annealing algorithm by fitness changes, and increased the diversity of swarm through expansion of the scope of the sudden jump, thereby effectively avoiding premature problem. The results from confirmatory experiments for CM medical cases suggested that, comparing with traditional K-means clustering algorithms, this method was greatly improved in the individual diversity and the obtained clustering results, the computing results from this method had a certain reference value for cluster analysis on CM prescriptions.

Mechanism of Yinchenhao decoction in the treatment of jaundice based on network pharmacology

Objective:This study aimed to examine the mechanism of classic ancient prescription of Chinese medicine Yinchenhao decoction in treating jaundice based on network pharmacology.Method:An oral bioavailability of≥30%,a drug likeness of≥0.18,and literature studies were used to screen for Yinchen(Artemisiae scopariae herba),Zhizi(Gardeniae fructus),Dahuang(Rhei radix et rhizome)in the Chinese Medicine System Pharmacology Database and Analysis Platform.The active ingredient was introduced into the PubChem database to collect drug component targets and import into the Uniprot database for gene standardization.The target gene of Yinchen(Artemisiae scopariae herba)was screened via Human Gene Database(GeneCards).Then,use the Cytoscape 3.7.2 software was used for network visualization analysis,and the R3.6.1 software was used for gene ontology functional and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses.Results:We collected a total of 47 active constituents of classic ancient prescription of Chinese medicine Yinchenhao decoction,of which 17 were related to jaundice;189,9 targets of jaundice were screened,of which 41 were interdigitated with the targets of classic ancient prescription of Chinese medicine Yinchenhao decoction.Gene ontology functional enrichment analysis revealed 111 biological processes,14 cellular components,and 28 molecular functions,and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analysis showed 34 Kyoto Encyclopedia of Genes and Genomes pathways including hepatocellular carcinoma,PI3K-Akt signaling pathway,HIF-1 signaling pathway,prolactin signaling pathway,and non-alcoholic fatty liver disease.Conclusion:Based on the network pharmacology,the analysis of jaundice and classic ancient prescription of Chinese medicine Yinchenhao decoction provides a novel idea and direction for the study of classic ancient prescription of Chinese medicine Yinchenhao decoction in the treatment of jaundice.