Construction of competency evaluation system for infection control personnel in traditional Chinese medicine hospitals

Background:This study uses a literature review and the Delphi expert consultation method to construct a competency evaluation model for infection control personnel in traditional Chinese medicine(TCM)hospitals.The aim is to strengthen infection control management in TCM hospitals,assess the competency of infection control personnel in their positions,and assist them in identifying the competencies that need improvement.Methods:Based on the literature research method and the Delphi expert consultation method,a competency model for the position was constructed through two rounds of expert consultations,analyzing the relationships between various factors and establishing a hierarchical structure model.Pairwise comparisons were made among the elements at the same level to construct a judgment matrix.Through the analytic hierarchy process,the weight coefficients of the indicators at each level in the competency model were obtained.Results:This study conducted a comprehensive assessment of various capabilities and practices related to hospital infection control.The survey results indicate that participants excelled in multiple areas,with a high overall satisfaction rate.95.28%of participants were able to develop hospital infection monitoring plans based on national infection control policies,demonstrating a good understanding and execution of these policies.94.09%of participants were familiar with high-risk populations and key departments in the hospital.91.73%of participants were able to establish monitoring scopes based on the trends of multidrug-resistant bacteria and conduct information monitoring,reflecting strong response capabilities.92.91%of participants were able to collaborate with relevant departments to conduct bacterial resistance monitoring,showing a good team spirit.94.49%of participants were able to perform targeted monitoring,including surgical site infections,indicating that they have effective monitoring strategies.91.34%of participants were able to collect and organize monitoring data and establish a systematic database,demonstrating good data management skills.90.16%of participants were able to interpret laws and regulations related to hospital infection management,indicating a high level of legal knowledge.89.37%of participants generally possessed good communication skills.92.52%of participants were able to guide medical staff on occupational safety and protective knowledge,showing an emphasis on occupational health.Participants demonstrated a strong desire to learn and innovate,with 87.01%actively participating in continuing education and research activities,reflecting a pursuit of professional development.Conclusion:Based on the results of the two rounds of expert consultations,a competency evaluation model for infection control personnel in TCM hospitals was formed.Through the analytic hierarchy process,the weight coefficients of various indicators at different levels in the model were obtained,and the research results have good scientific validity and reliability.

A Comparative Analysis of the Control Effect of Medical Expenses between General Hospitals and Traditional Chinese Medicine Hospitals from 2012 to 2021

Objective To analyze the changing trend of average medical expenses and structure in general hospitals and traditional Chinese medicine(TCM)hospitals and the effects and differences achieved by the two kinds of hospitals through controlling unreasonable growth of medical expenses,so as to provide reference for controlling the rapid rise of medical cost in public hospitals and optimizing the cost structure.Methods Based on the changes of related indicators of medical expense control from 2012 to 2021,the overall characteristics,changes of cost structure and trends of medical expenses in general hospitals and TCM hospitals were investigated.Results and Conclusion From 2012 to 2021,the increase of medical expenses in general hospitals and traditional Chinese medicine hospitals had slowed down,the proportion of drug revenue to medical income began to decline,and the medical service income increased.However,the proportion of inspection,test and sanitary materials income has increased instead of decreasing,but the management cost has decreased.The two kinds of hospitals have achieved certain cost control results,the structure of medical cost has changed greatly,and the technical service and labor value of medical personnel have been reflected to a certain extent.However,it is still necessary to explore a more scientific and reasonable cost control mechanism to promote the further optimization of medical cost structure.

Traditional herbal medicine in preventing recurrence after resection of small hepatocellular carcinoma: a multicenter randomized controlled trial

BACKGROUND： Disease recurrence is a main challenge in treatment of hepatocellular carcinoma （HCC）. There is no generally accepted method for preventing recurrence of HCC after resection. OBJECTIVE： To compare the efficacy of a traditional herbal medicine （THM） regimen and transarterial chemoembolization （TACE） in preventing recurrence in post-resection patients with small HCC. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： This is a multicenter, open- label, randomized, controlled study, which was undertaken in five centers of China. A total of 379 patients who met the eligibility criteria and underwent randomization were enrolled in this trial. One hundred and eighty-eight patients were assigned to the THM group and received Cinobufacini injection and Jiedu Granule, and the other 191 patients were assigned to the TACE group and received one single course of TACE. MAIN OUTCOME MEASURES： Primary outcome measures were the annual recurrence rate and the time to recurrence. Incidence of adverse events was regarded as the secondary outcome measure. RESULTS： Among the 364 patients who were included in the intention-to-treat analysis, 67 patients of the THM group and 87 of the TACE group had recurrence, with a hazard ratio of 0.695 （P = 0.048）. Median recurrence-free survival of the patients in the THM and TACE groups was 46.89 and 34.49 months, respectively. Recurrence rates at 1, 2 and 3 years were 17.7%, 33.0% and 43.5% for the THM group, and 28.8%, 42.5% and 54.0% for the TACE group, respectively （P = 0.026）. Multivariate analysis indicated that the THM regimen had a big advantage for prolonging the recurrence-free survival. Adverse events were mild and abnormality of laboratory indices of the two groups were similar. CONCLUSION： In comparison with TACE therapy, the THM regimen was associated with diminished risk of recurrence of small-sized HCC after resection, with comparable adverse events. TRIAL REGISTRTION IDENTIFIER： This trial was registered in the Chinese Clinical Trial Registry with the identifier ChiCTR-TRC-07000033.

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules

BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions.Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases.The present study was designed to verify the efficacy of Biling Weitong Granules(BLWTG),a traditional Chinese medicinal herbal compound formula,in alleviating epigastric pain syndrome(EPS)in FD patients,in an attempt to provide an effective prescription for the clinical treatment of this disease.AIM To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.METHODS In this multicenter,stratified,randomized,double-blind,placebo-controlled,parallel group clinical trial,eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk.Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.RESULTS The baseline demographic data and clinical characteristics,such as epigastric pain symptoms,pain intensity,and frequency of attacks,were matched between the two groups before randomization.After 6 wk of treatment and after the center effect was eliminated,the epigastric pain was significantly improved in 28.33%and 85.59%of the patients in the placebo and BLWTG groups,respectively(P<0.05).At 6 wk,the resolution rate of epigastric pain was 15%and 69.49%in the placebo and BLWTG groups,respectively(P<0.05).The differences of total FD clinical score between these two groups were significant(P<0.05)at 2,4,and 6 wk(P<0.05).The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated(P<0.05).There was no significant difference in the incidence of adverse events between the two groups,and no serious adverse event was noted during the observation.CONCLUSION Compared with placebo,BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia

As an important branch of medicine, Traditional Chinese Medicine(TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia(ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020, the new edition of the Ch P(the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.

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.

Traditional Chinese medicine for acute mountain sickness prevention: A systematic review and meta-analysis of randomized controlled trials

Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

A clinical protocol: A double-blinded, randomized controlled trial on the effect of traditional Chinese medicine formula Shoutai Pill in the treatment of threatened abortion

for about 20%of all clinically confirmed pregnancy.It is the main cause of early abortion.Vaginal bleeding is the main clinical manifestation,which seriously affects the mental health and quality of life of pregnant women.Currently,there is effective treatment for this condition.A recent meta-analysis showed that Shoutai Pill(ST Pill),a traditional Chinese medicine(TCM)formula,can effectively decrease the rate of threatened abortion.However,high heterogeneity was found among the studies included in the meta-analysis,this conclusion on the efficacy of TCM is not definitive.Although several have been conducted,some of them do not describe randomization and blinding methods.To address these problems,this article proposes an improved clinical treatment scheme based on ST Pill,which is to be tested through a well-designed randomized controlled trial,for the treatment of threatened abortion.Methods:This is a double-blinded,randomized,placebo-controlled trial to be conducted in a public Three-A hospital in China's Mainland.A total of 200 people will be enrolled.Using computer-generated random numbers,the participants will be randomly divided into two groups at a ratio of 1:1(treatment group(treated with ST Pill group)and placebo group).Both groups will receive medication to the end of the 20th gestational week or 1 week after vaginal bleeding stops,depending on which is longer.Participants in the treatment group will be treated with ST Pill(20 pills/time,once a day),and those in the placebo group will receive a placebo drug which is similar in appearance and smell with ST Pill.The main observation index is the live birth rate.Discussion:Although the efficacy of ST Pill in threatened abortion is well-known,no study has tested its efficacy through a double-blinded,randomized trials.Therefore,there is an urgent need for a standardized randomized double-blinded controlled trial to evaluate the clinical efficacy of ST Pill.ST Pill is likely to be a convenient and effective TCM pill for the prevention of threatened abortion.

Meta-analysis of randomized controlled trials of traditional Chinese medicine in the treatment of obstructive sleep apnea syndrome

Objective:Though Chinese medicine(CM)has showed its clinical efficacy for the treatment of obstructive sleep apnea(OSA)in China,no systematic reviews or meta-analyses provide evidences for its therapeutic effects on OSA and the long-term safety.The aim of the present study is to evaluate the effectiveness and safety of CM on OSA using meta-analysis.Methods:We used search items of"Chinese Medicine"AND"obstructive sleep apnea"to retrieve the randomized control trials(RCTs)of CM treatments for OSA in PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),VIP database,and Wanfang database from their respective inception dates to December 2019.Only RCTs of CM therapy versus no treatment which could be quantitatively synthesized were included.Finally,20 studies representing 1,297 participants were included after extraction.Two investigators independently extracted and analyzed the data using RevMan5.3 software.Results:The treatment group using CM decoctions or CM granules presented significantly ameliorative effects on apnoea-hypopnoea index(AHI)compared with the control group(MD:-2.58,95%CI:-3.59 to-1.56,P<0.00001 and MD:-5.47,95%CI:-6.75 to-4.19,P<0.00001,respectively)in the sensitivity analysis.However,there were non significant differences in the duration of treatment between subgroups,indicating that the duration of treatment has no impacts on the therapeutic effects on AHI.CM granules also showed significantly ameliorative effects on the lowest nocturnal oxygen saturation(LSaO2)(MD:2.76,95%CI:1.85 to 3.68,P<0.00001).CM decoctions exhibited significantly improved Epworth Sleepiness Scale(ESS)scores compared with the control group in a sensitivity analysis(MD:-1.50,95%CI:-2.13 to-0.88,P<0.00001).CM granules showed a better improvement of ESS than the control group(MD:-1.35,95%CI:-1.92 to-0.78,P<0.00001).Mild adverse reactions occurred only in five patients and disappeared without special treatment.Conclusion:This study showed favorable therapeutic efficacy of CM on OSA.However,in consideration of the low methodological quality of the included RCTs,more rigorous designed,large sample size RCTs are recommended for providing more high-quality evidences.

The Role of the “Traditional Chinese Medicine Proclamation” in Cholera Prevention and Control in Modern China

During the period of social transformation in modem China,the sudden onslaught of malignant infectious diseases,the helplessness of the public,and the impact of the modem Western medical system promoted the profoimd self-revolution of traditional Chinese medicine(TCM).Multiple factors,including politics,economy or religion contributed to the formulation of paper-based“TCM proclamation”.This paper,based on the prevention and control of cholera advocated in TCM proclamation,analyzes the new ways of cholera spread in China in early modem times and the complicated“country-region-medical instilulions-other institutions-individuals”correlations.

Simulation and Optimization of Traditional Village Wind Environment under Epidemic Prevention and Control:Take Anziling Village of Handan as an example

In the context of epidemic prevention and control,villages are the weakest part of epidemic prevention and control.Traditional villages,as representatives of villages,are often far away from cities,and medical conditions are relatively backward.Based on this background,epidemic prevention and control are particularly important.The quality of the environment is positively related to the spread of the virus.This article wanted to use CFD technology to simulate the wind environment of the traditional village street space,so as to propose measures to optimize the wind environment of the traditional village street space,and provide references for the future planning of village layout.

The Role of the“Traditional Chinese Medicine Proclamation”in Cholera Prevention and Control in Modern China

During the period of social transformation in modern China,the sudden onslaught of malignant infectious diseases,the helplessness of the public,and the impact of the modern Western medical system promoted the profound self‑revolution of traditional Chinese medicine(TCM).Multiple factors,including politics,economy or religion contributed to the formulation of paper-based“TCM proclamation”.This paper,based on the prevention and control of cholera advocated in TCM proclamation,analyzes the new ways of cholera spread in China in early modern times and the complicated“country‑region‑medical institutions‑other institutions‑individuals”correlations.

Based on the process management of traditional Chinese medicine comprehensive intervention method on outcomes in patients with mild/moderate chronic obstructive pulmonary disease:study protocol for a practical randomized controlled trial

Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.

Evaluation and Risk Prevention and Control of Hepatic Injury by Traditional Drugs

My topic is the risk assessment of safety of Chinese materia medica.Next I will take drug-induced hepatic injury as an example.First of all,let us look back at what Chinese materia medica is.What are the real meanings of these 3 words? These 3 words Zi Hua Zi have been said more than BC 500."TCM practitioners are for treatment and medicines," what do you mean? Treatment means to find the cause of the disease and to find the law,while medicine is to find ways and means to cure diseases.

Efficacy and safety of the decoction of nourishing marrow and raising energy in terms of Traditional Chinese Medicine in patients with vascular dementia:a randomized controlled trial

OBJECTIVE: To explore the efficacy and safety of the decoction of nourishing marrow and raising energy in terms of Traditional Chinese Medicine(TCM) in patients with vascular dementia.METHODS: Totally 86 patients with vascular dementia patients hospitalized from September 2010 to January 2015 were recruited and randomly divided into two groups: control group and observation group. Patients in control group received the conventional treatment, whereas patients in another group were treated with the therapy of nourishing marrow and raising energy according to the theory of TCM. Blesse dementia scale scores were measured before and after the treatment for both groups and adverse effect was documented as well.RESULTS: After treatment, Blesse dementia scale scores reduced in both groups, and the difference in score reduction between the two groups was significant(P<0.05). The rate of adverse events was significantly lower in observation group than in control group(P<0.05).CONCLUSION: Our results demonstrate that the decoction of nourishing marrow and raising energy was an effective and safe alternative to vascular dementia in human subjects.

Quality Control for Traditional Medicines–Chinese Crude Drugs

Distinguished guests,ladies and gentlemen,I am very happy to meet many of my old friends today.I would also like to thank Chinese Pharmaceutical Association for providing me with such a good opportunity to communicate with Chinese and European friends.The topic of my report today is the quality standard of Chinese crude drugs and the development ideas.Director Ma introduced the relevant situation of the quality standards of Chinese patent medicines.

Study and Countermeasures on Safety Control of Traditional Chinese Medicines Industry Chain

I'm very grateful to Chinese Pharmaceutical Association and DIA for their elaborate organization,so that we are able to participate in the Sino-Europe Symposium.Yesterday and today,several professors have talked about various aspects.It is true that the effectiveness of traditional Chinese medicine is important,and safety is equally important.For this reason,our laboratory works on the effective test,and at the same time,since 2001,we have been focusing on the safety of traditional Chinese medicines,especially the research on exogenous pollution.Today,I would like to share with you some of the quality control of the whole industry chain of traditional Chinese medicine and some of our thoughts.

Quality Control for Traditional Medicines–Chinese Patent Medicines

Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.