Potential efficacy and safety of Xiyanping injection as adjuvant therapy in treatment of suppurative acute tonsillitis: a meta-analysis, trial sequential analysis, and certainty of evidence.

Background: Antibiotic resistance has emerged as a global concern. Xiyanping injection (XYP), a traditional Chinese medicine injection, has been extensively utilized for the treatment of suppurative acute tonsillitis (SAT) in China, exhibiting clinical efficacy. Consequently, there is a need for further evaluation of the potential effectiveness and safety of this treatment. This meta-analysis consolidated data from multiple independent studies to assess the overall treatment efficacy of XYP as adjuvant therapy in patients with SAT. Methods: The search for randomized controlled trials (RCTs) encompassed databases from their inception to 1 April 2024, including the Cochrane Library, PubMed, Embase, SinoMed, CNKI, Wanfang, VIP, and CBM. Data extraction, methodological quality assessment, and meta-analysis were performed independently by two researchers. Review Manager 5.4 was used for data analysis. Various tools were employed for assessment, including forest plots to visualize results, funnel plots to detect publication bias, trial sequential analysis to estimate sample size, and GRADE to evaluate evidence quality. Results: A comprehensive analysis of 32 RCTs involving 4,265 cases was conducted. When compared to conventional treatments (CTs; ß-lactams/clindamycin hydrochloride injection/ribavirin) alone, the combination of XYP with CTs demonstrated significant reductions in symptom duration. This included sore throat (MD = -21.08, 95% CI: -24.86 to -17.29, p < 0.00001), disappearance of tonsillar redness and swelling (mean difference [MD] = -20.28, 95% confidence interval [CI]: -30.05 to -10.52, p < 0.0001), tonsil purulent discharge (MD = -22.40, 95% CI: -28.04 to -16.75, p < 0.00001), and normalization of temperature (MD = -19.48, 95% CI: -22.49 to -16.47, p < 0.00001). Furthermore, patients receiving CTs combined with XYP exhibited lower levels of interleukin-6 (MD = -7.64, 95% CI: 8.41 to -6.87, p < 0.00001) and interleukin-8 (MD = -5.23, 95% CI: -5.60 to -4.86, p < 0.00001) than those receiving CTs alone. Additionally, the combination therapy significantly improved the recovery rate (relative risk [RR] = 1.55, 95% CI: 1.37 to 1.77, p < 0.00001), white blood cell count recovery rate (RR = 1.13, 95% CI: 1.04 to 1.23, p = 0.004), and disappearance rate of tonsillar redness and swelling (RR = 0.51, 95% CI: 1.14 to 1.38, p < 0.00001), with no significant increase in adverse events (RR = 0.47, 95% CI: 0.20 to 1.10, p = 0.08). Conclusion: The current systematic review and meta-analysis tentatively suggest that the combination of XYP and CTs yields superior clinical outcomes for patients with SAT compared to CTs alone, with a favorable safety profile. Nonetheless, these findings warrant further confirmation through more rigorous RCTs, given the notable heterogeneity and publication bias observed in the included studies. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=296118, identifier CRD42022296118.

Development and validation of a deep-learning model for the detection of non-displaced femoral neck fractures with anteroposterior and lateral hip radiographs.

Background: Hip fractures, including femoral neck fractures, are a significant cause of morbidity and mortality in the elderly population and are typically diagnosed using plain radiography. However, diagnosing non-displaced femoral neck fractures can be challenging due to their subtle appearance on hip radiographs. Previous deep-learning models have shown low accuracy in identifying these fractures on anteroposterior (AP) radiographs; however, no studies have used lateral radiographs. This study aimed to evaluate the potential of using deep-learning with both AP and lateral hip radiographs to automatically identify non-displaced femoral neck fractures. Methods: We conducted a retrospective analysis of patients with femoral neck fractures at The First Affiliated Hospital of Xiamen University. All the hip radiographs were reviewed, and cases of non-displaced femoral neck fractures were included in the study. Additionally, 439 participants with normal hip radiographs were also included in the study. A vision transformer (Vit) model was developed using 1,536 AP and lateral hip radiograph. The model's performance was compared to the performance of two groups of human observers: an expert group comprising orthopedic surgeons and radiologists, and a non-expert group, including emergency physicians and general practice doctors. We also carried out the external validation using two additional data sets to assess the generalizability of the model. Results: The Vit model showed exceptional performance in detecting non-displaced femoral neck fractures on paired AP and lateral hip radiographs, achieving a binary accuracy of 95.8% [95% confidence interval (CI): 94.9%, 96.8%] and an area under the curve (AUC) of 0.988. Compared to the human observers, the model had a higher accuracy of 96.7% (95% CI: 93.9%, 99.5%) on the paired AP and lateral hip radiographs, while the accuracy of the expert group was 90.5% (95% CI: 85.7%, 95.2%). Further, the model maintained good performance during the external validation, with an AUC of 0.959 on the paired AP and lateral views. Conclusions: Our Vit model showed expert-level performance in identifying non-displaced femoral neck fractures on paired AP and lateral hip radiographs. This model has the potential to enhance diagnosis accuracy and improve patient outcomes by reducing the need for additional examinations and preoperative time.

[Clinical comprehensive evaluation of Xiangju Capsules in treatment of rhinosinusitis].

The articles involving Xiangju Capsules were retrieved, and qualitative research and quantitative research methods were combined to evaluate the evidence of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) of this drug. Multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Xiangju Capsules in the treatment of rhinosinusitis and clarify the precise clinical positioning. The dimensions are graded A, B, C, or D. Multi-source safety evidence showed that the main adverse reactions were gastrointestinal reactions, rash, itching, dizziness, and headache. Based on the available studies, the risk is controllable and the safety is grade A. Meta-analysis showed that Xiangju Capsules + conventional western medicine could recover the Lund-Kennedy score, Lund-Mackay score, and CT score, relieve headache, nasal congestion, olfactory disturbance, and facial pain, with the effectiveness is grade B. The incremental cost-effectiveness ratio of Xiangju Capsules + conventional western medicine compared with conventional western medicine alone in the treatment of chronic rhinosinusitis was 263.71 yuan, about 0.82% of the per capita disposable income. The results of sensitivity analysis showed that the research results were relatively robust. Based on the assumption that the per capita disposable income in 2020 will be the threshold of patients' willingness to pay, it is more economical to use Xiangju Capsules + conventional western medicine. The drug belongs to grade A of the national medical insurance, with an average daily cost of 3.06 yuan, and the economy is grade B. This formula is modified from classic formulas and characteristic empirical formulas, be capable of improving immunity and preventing repeated attacks. It can be used for acute and chronic rhinitis-rhinosinusitis. It had a wide range of applicability, especially for the patients with head and face tenderness. Service innovation was reflected in the measures to guarantee supply, capacity, scalability, and coverage of grass-roots sales channels. The industrial innovation was improved through the management of medicinal resources, pharmaceutical industry, production technology, quality control, scientific research and development, and this formula won three national invention patents. Comprehensively, the innovation of Xiangju Capsules is grade B. According to the survey of 188 medical practitioners and 196 patients in 20 provinces, municipalities, and autonomous regions of China, the drug was characterized by easy preparation and administration, individualized medication, simple technology and management, convenient use, storage, and transport, and controllable adverse reactions, with the suitability is grade B. Xiangju Capsules showed the cost of 45.9 and 275.4 yuan for treatment of acute and chronic rhinitis-rhinosinusitis, respectively, being well affordable. It was sold in 35 000 medical institutions in China. The dosage form was suitable for transportation, storage, and grass-root application. With rich, sustainable, and available medicinal resources, the accessibility of Xiangju Capsules is grade A. This drug can be used for both acute and chronic rhinitis-rhinosinusitis, clearing heat and expelling pus, and strengthening the exterior to prevent relapse. After this drug was available on the market, over 4 000 cases were studied, with rich experience in human use accumulated, and characteristics of traditional Chinese medicine is grade B. Overall, the clinical value of Xiangju Capsules is class B. It is suggested that Xiangju Capsules should be used in accordance with the relevant policies of basic clinical drug administration to play its role.

RDN for the treatment of influenza in children: a randomized, double-blinded, parallel-controlled clinical trial.

BACKGROUND: The morbidity of influenza in children increased rapidly in decade. Reduning injection (RDN), a small but fine Chinese herbal formula, has antipyretic, antiviral, anti-inflammatory effects. We intend to evaluate the efficacy and safety of RDN for the influenza in children versus Oseltamivir, explore the possible antiviral mechanism of RDN and provide evidence-based medical evidence for rational clinical drug usage. METHOD: We design a randomized, double-blind, double-dummy, parallel control of positive drug, multi-centre clinical study. According to the formula of mean superiority test, a total of 240 patients with influenza in children will be randomized 1:1 into the experimental group and control group. The experimental group will take RDN and Oseltamivir phosphate granule simulants and the control group will take Oseltamivir phosphate granule and RDN simulants. Each group will be treated for 5 days. The primary outcome measure is temperature recovery time, and the secondary outcome measures include time when the fever begins to subside, time and degree of disease to alleviate, disappearance rate of individual symptoms and so on. We will measure before enrollment and each 24 h after treatment for comparison. DISCUSSION: The study is launched to evaluate the efficacy and safety of RDN for the treatment of influenza in children and to provide an alternative option for influenza in children. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov as NCT04183725, registered on 3 December, 2019.

[Systematic review and Meta-analysis of efficacy and safety of Binghuang Fule Ointment in treatment of eczema].

To expeditiously assess the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema, we screened out the papers with randomized controlled trials(RCTs) for studying the efficacy of Binghuang Fule Ointment in the treatment of eczema from CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase and then performed Meta-analysis of the included studies via RevMan 5.4. A total of 19 studies were included, involving 1 919 cases(973 cases in the experimental group and 946 cases in the control group). Meta-analysis results showed that Binghuang Fule Ointment combined with conventional western medicine had better efficacy score index(clinical effectiveness ≥60%)(RR=1.32, 95%CI[1.13, 1.55], P=0.000 4) and lower recurrence rate(RR=0.37, 95%CI[0.20, 0.65], P=0.000 7) than conventional western medicine alone. The adverse reactions(RR=1.05, 95%CI[0.52, 2.15], P=0.88) did not show significant difference between the two groups. The application of Binghuang Fule Ointment alone had better efficacy score index(clinical effectiveness≥60%)(RR=1.20, 95%CI[1.09, 1.33], P=0.000 3) than conventional western medicine alone and the adverse reactions(RR=0.92, 95%CI[0.45, 1.89], P=0.82) insignificantly different from conventional western medicine alone. Binghuang Fule Ointment alone or combined with conventional western medicine demonstrated better effective in remission of symptoms and signs(clinical effectiveness)(RR=1.41, 95%CI[1.07, 1.85], P=0.01) than conventional western medicine alone. Compared with the single application of western medicine, Binghuang Fule Ointment alone or combined with conventional western medicine has better curative effect, low recurrence rate, and equivalent safety in the treatment of eczema. Nevertheless, owing to the low quality of the included papers, randomized controlled trials with large sample size, multiple centers, high methodological quality are needed to further verify the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema.

[Clinical comprehensive evaluation of Tianshu Capsules in treatment of migraine (syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang)].

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.

[Early detection and risk control of safety signals of Chinese medicine].

The safety of modern Chinese medicine has attracted increasing attention from society. Experts and scholars have carried out extensive in-depth research on the safety of commonly used Chinese medicines from various aspects such as safety monitoring, clinical research, and experimental analysis. The findings in the safety performance of Chinese medicines can inspire the mining and analysis of relevant signals in the drug safety alerts. A variety of methods are employed for the mining of risk signals or analysis and screening of relevant signals to accurately determine the correlation between medication and adverse reactions. The safety signal acquisition and mining techniques are the technical basis for the safety risk management of medicine products after Chinese medicines are marketed, which is critical in drug safety alerts. To accurately collect the safety signals of Chinese medicines and effectively and rapidly track, determine, and assess the sources of signals are important technical links in drug risk management. The ultimate purpose of safety signal discovery is to achieve normalized risk management through downgrading drugs from a high-risk level to a low-risk level.The five main steps in the standard drug risk management are listed below: to extensively collect predicted risk signals; to accurately identify drug risks by the techniques such as data mining; to evaluate the risks with process-based quality risk control; to employ management measures minimizing the impact of drug risks for risk management; to update and apply risk assessment to clinical evaluation after medication.

[Enlightenment of international pharmacovigilance system on establishment of pharmacovigilance system of Chinese medicine].

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.

[Pharmacovigilance of traditional Chinese medicine: an exploration based on prescription sequence analysis and prescription sequence symmetry analysis].

Multiple methods should be incorporated into the research on pharmacovigilance of traditional Chinese medicine(TCM for a comprehensive and objective evaluation. The arrival of the era of medical big data allows it to be deeply integrated into medical research. The real world study(RWS) represented by hospital information system(HIS) provides a data basis for exploring the pharmacovigilance of TCM. Prescription sequence analysis(PSA) and prescription sequence symmetry analysis(PSSA) developed based on the former serve as a methodological basis for clinical safety evaluation of Chinese patent medicines after marketing. By collating the related studies of HIS, PSA and PSSA and employing the propensity score matching( PSM) method and nested case-control study(NCCS), this paper formed a HIS-, PSA-and PSSA-based technical system for clinical safety evaluation of Chinese patent medicines in the real world, in order to provide a methodological demonstration for the future research on the pharmacovigilance of TCM.

[Cognition of traditional Chinese medicine properties and thinking of clinical rational use of drug].

This paper discusses the rational use of traditional Chinese medicine based on chemical composition, body state and biological effect. The essence and connotations of traditional Chinese medicine are explained by modern scientific theory and technical means, and the mechanism of traditional Chinese medicine in the treatment of diseases is defined in modern medicine language, which is conducive to promoting rational and safe clinical use of drugs. Based on the chemical composition of traditional Chinese medicine,the selected genuine medicinal materials were collected and processed in a standardized way, and then used in the combination with other traditional Chinese medicines, with the aim to improve the efficacy of traditional Chinese medicine in clinical indications, increase the advantages, eliminate the disadvantages, and adapt to flexible and safe clinical drug demands. Based on the body state elements, clinical diagnosis and treatment shall be patient-centered, and doctors shall distinguish the differences of pathogenesis, symptoms and diseases, and consider the drug contraindications of special groups. According to the " dose-effect-toxicity" relationship, doctors shall select the appropriate dosage form, control the drug dosage, balance the benefits and risks of drugs, and carry out appropriate medical treatment. Based on the biological effect elements and the regulatory mechanism of traditional Chinese medicine on the target and pathway of disease, traditional Chinese medicine shall strengthen the precise positioning, provide accurate treatment; evaluate the safety of traditional Chinese medicine combination, explore the adverse reaction mechanism, strengthen the clinical safety monitoring of traditional Chinese medicine, and guide the clinical rational use of drugs, in the expectation of ensuring the safe use of traditional Chinese medicine and maximize the clinical efficacy of traditional Chinese medicine.

[Visualization of research on Chinese medicine-induced kidney injury by CiteSpace].

This study aimed to provide researchers with a better understanding of the research status, progress and problems of Chinese medicine-induced kidney injury. The mapping knowledge domain(MKD) was chosen to visualize the research process, hotspots,and frontiers, thus providing a reference for follow-up research. The relevant articles were retrieved from China National Knowledge Infrastructure(CNKI) from its inception to November 20, 2020, and 683 were finally included for visualization, with a knowledge map covering the keywords, research institutions and authors plotted by Cite Space. Since 2006, the annual number of published articles regarding Chinese medicine-induced kidney injury has steadily declined. The top five keywords sorted by frequency of co-occurrence were tubulointerstitial nephritis(TIN), aristolochic acid(AA), Akebiae Caulis, experimental research, and descriptive research. Akebiae Caulis appeared at the highest frequency of co-occurrence among Chinese medicines and exhibited the highest burst intensity. The burst ended in 2020, when the Chinese medicine with the highest burst intensity changed to Tripterygii wilfordii and its preparations. It could be seen that Akebiae Caulis was the hotspot in the research of Chinese medicine-induced kidney injury, and T. wilfordii became the research frontier. The current research has mainly focused on " organic anion transporters" and " metabolomics". The decline in articles about Chinese medicine-induced kidney injury was attributed to the reduced clinical case reports after the in-depth study of Chinese medicine-induced kidney injury. However, more clinical studies need to be conducted based on the concept and method of pharmacovigilance to construct a pharmacovigilance system of Chinese medicine for actively and passively monitoring and collecting the clinical cases with Chinese medicine-induced kidney injury, figuring out the incidence and characteristics of adverse reactions caused by Chinese medicine, and carrying out comprehensive and multi-dimensional safety research.

[Report standards for clinical comprehensive evaluation of Chinese patent medicine].

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.

[ADR/AE early warning analysis of Shujin Jianyao Pills based on spontaneous reporting system].

To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.

[Randomized double-blind parallel controlled multicenter trial of Reyanning Mixture in treatment of acute tonsillitis].

This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1∶1∶1, a total of 144 patients were randomly divided into Reyanning Mixture group(RYN), Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil), with 48 cases in each group, in order to evaluate the efficacy and safety of RYN alone or combined with Amoxil in the treatment of acute tonsillitis, and provided high-quality evidences for treatment of infectious diseases with traditional Chinese medicine and reduced use of antibiotics. The dosage of RYN was 20 mL, 3 times a day, 100 mL/bottle, oral for 7 days, and Amoxil dosage was 0.5 g, 3 times a day, 0.5 g×12 tablets/plate, oral for 7 days. A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS). The results showed statistical differences in the recovery time of the disease, the disappearance rate of fever on the 3 rd day and the disappearance rate of tonsillar redness and swelling between RYN and Amoxil. There were statistical differences in the cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate between the RYN+Amoxil and Amoxil, but with no significant difference in the above aspects compared with RYN. The DDD of antibiotic use in RYN+Amoxil was significantly lower than that in Amoxil(P<0.01). According to the findings, when RYN was used alone in the treatment of acute tonsillitis, it was superior to Amoxil in time of recovery, short-term improvement of fever and redness and swelling of tonsil. Compared with RYN+Amoxil, there was no difference in cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil, with a better efficacy than Amoxil. The clinical effect of RYN was similar to that of combined Amoxil in the treatment of acute tonsillitis, and RYN was superior to Amoxil in the time of recovery, short-term improvement of fever and redness and swelling of tonsil, with no adverse event or adverse reaction. RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.

[Study on precise mechanism of Chinese patent medicine from perspective of activating data].

Traditional Chinese medicine(TCM) syndrome differentiation and treatment has a characteristic and advantageous efficacy in the prevention and treatment of major diseases(no matter for new or sudden infectious diseases or major chronic diseases). At present, the clinical application by Western medicine disease's name, stage, classification and other indications limits the role of TCM syndrome differentiation and treatment, and makes TCM difficult to play its advantages. Therefore, the therapeutic value and social value attribute of Chinese patent medicine after being launched in the market cannot be effectively demonstrated, or even generalized as adjuvants. Under the circumstances, it is difficult to put forward precise positioning different from chemical drugs, with fewer high-level and high-quality evidence-based evidences for precise positioning. The research on the pathological links and therapeutic mechanism of its effect on diseases is also less systematic. The development of biotechnology, such as genomics, has brought medicine into the era of precision, providing ideas and technical support for the exploration of syndrome biomarkers and the analysis of therapeutic mechanism with them as parameters. Digital China Think Tank Forum once mentioned that the development of sequencing technology provides 100% of human genetic code, while only 3% can understand it. Block data 4.0: activation data in the era of artificial intelligence puts forward the concept of activation data, which can be regarded as a theoretical hypothesis for big data, provides a new cognitive thinking and solution for increasingly prominent data paradox between bioinformation explosion and clinical big data, and is a bridge between cross-border data association and fusion. After deeply mining the dominant and recessive value of clinical data and histological data, we can make the pathogenesis of syndrome differentiation and treatment from dark knowledge to clear knowledge. Therefore, with Chinese patent medicine as the guide, the research on the efficacy and mechanism of precise positioning of traditional Chinese medicine after marketing is carried out, and the precise system of "syndrome, disease, function, pathological link and biological connotation" is constructed, which provides a powerful basis and support for increasing the scientific and technological content of varieties.

[Suggestions on design of evidence-based traditional Chinese medicine clinical study for new public health emergencies].

2019 novel coronavirus(2019-nCoV) has occurred for 2 months, and seriously affected the people's health in the world. Therefore, scientific prevention and control strategies and effective intervention measures are the only ways to solve the world problem. In the determination of intervention measures, not only the effectiveness evaluation, but also accessibility, treatment cost, inventory and production capacity and other relevant sociological issues shall be considered, especially in low and middle-income countries and regions. With the introduction of clinical epidemiological experiment design and evidence-based medicine evidence evaluation into the evaluation of curative effect of traditional Chinese medicine(TCM), TCM has officially entered the studies of syndrome regularity of new public health emergencies(such as SARS and influenza) clearly diagnosed by modern medicine for many years, as well as the development of relevant guidelines, consensus and paths. The results of curative effect show that TCM could significantly alleviate symptoms, control disease and tendency, reduce the occurrence of critical illness, and improve the clinical efficacy and the prognosis and quality of life of patients, which fully reflects the consciousness and self-confidence of traditional Chinese medicine workers. For the evidence-based evaluation of TCM intervention in new public health emergencies, the basic principles and general methods of clinical epidemiology and evidence-based medicine shall be followed to obtain high-quality evidence; besides, we shall also fully realize that clinical scientific study is carried out with the epidemic treatment as the primary task. The scientific hypothesis comes from the clinical problems unsolved. The scientific study conclusions aim to give feedbacks to clinical diagnosis and treatment regimens. The core elements of clinical trials are population(P), intervention(I), control(C), outcome(O), which are abbreviated as "PICO". The evaluation of intervention measures for new public health emergencies with traditional Chinese medicine shall have clear study objectives and a high quality, with a correct analysis method as the guarantee of real and reliable results. Then, the selection of patients, the de-finition of intervention measures and control measures, the development of end-point indicators, the clinical quality control under special epidemics, the data verification, and the data analysis methods to be adopted are all characteristics and key points that need special consideration. It is suggested that scientific experimental design, rigorous collection and scientific data analysis shall be conducted to reflect the therapeutic value of traditional Chinese medicine, so that the study results could be adopted and shared, and become the scientific evidence for China and even the global to republish the diagnosis and treatment regimens.

[Analysis of adverse reactions risk signal of Xinyuan Capsules based on national ADR monitoring spontaneous reporting system].

In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.

[Systemic evaluation and Meta-analysis of efficacy and safety of Kangfu Xiaoyan Suppository in treatment of pelvic inflammatory disease].

To evaluate the efficacy and safety of Kangfu Xiaoyan Suppository in the treatment of pelvic inflammatory disease. Four Chinese databases,namely CNKI,VIP,WanFang and SinoMed,and three English databases Cochrane Library,namely Medline,and ClinicalTrail.gov were systematically and comprehensively retrieved from the establishment of each database to June 2018. The quality of the included studies was evaluated by using the risk assessment tools developed by the Cochrane Collaboration,and RevMan 5. 3 software was used for Meta-analysis. A total of 675 articles were retrieved,and finally 56 studies were included. The total sample size was 6 228,the test group included 3 267 cases,and the control group included 2 961 cases. The overall quality of the included studies was generally low. According to the intervention measures and outcome indicators,the included studies were divided into different subgroups for analysis. The main results of Meta-analysis showed that the recurrence rate of Kangfu Xiaoyan Suppository combined with antibiotics was lower than that of antibiotics alone. Kangfu Xiaoyan Suppository combined with antibiotics was superior to antibiotics alone in terms of abdominal pain,leucorrhea abnormality relief time,mass absorption time and pain relief time. In terms of safety,Kangfu Xiaoyan Suppository combined with antibiotics had a lower incidence of adverse reactions than antibiotics alone. Based on the results of this study,it is indicated that Kangfu Xiaoyan Suppository had a certain effect on the treatment of pelvic inflammatory disease,especially with a lower recurrence rate. The long-term effect is remarkable. No serious adverse reaction was observed. Restricted by the quality of the studies included,the above conclusion need to be further verified in high-quality,largesize,multi-center clinical researches.

[Expert consensus statement on Kangfu Xiaoyan Suppository in treatment of pelvic inflammatory in clinical practice].

Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases. Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics. As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration. It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017. To further enhance clinicians' understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus. This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method. The expert consensus is mainly formed in the consideration of six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format. However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.

Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial.

BACKGROUND: Acute uncomplicated lower urinary tract infection (UTI) is one of the most common bacterial infections. Patients usually present with dysuria, urinary urgency, urinary frequency, and suprapubic pain or tenderness. Approximately 150 million people are diagnosed with UTI each year worldwide. The high recurrence rate of lower UTI is a common problem of clinical treatment. The misuse of antibiotics has led to the emergence of a number of resistant bacterial strains. Thus, traditional Chinese medicine is considered as an alternative option for treating acute uncomplicated lower UTI. Thus, this study aims to evaluate the efficacy and safety of Sanjin tablets (SJT) for the treatment of acute uncomplicated lower UTI, explore whether SJT can reduce or substitute the use of antibiotics, and reduce the recurrence rate in the treatment of acute uncomplicated lower UTI. METHODS/DESIGN: In this study, a randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical study will be established. A total of 252 patients with acute uncomplicated lower UTI (syndrome of dampness-heat in the lower jiao) will be randomly allocated in the ratio of 1:1:1 to three groups: experimental group; control group 1; and control group 2. The experimental group receives Sanjin tablets plus levofloxacin tablets (LT) placebo; the control group 1 receives LT plus SJT placebo; and the control group 2 receives SJT plus LT on the first five days, SJT plus LT placebo on the last two days. Each group will be treated for seven days and followed-up 1-2 times. The primary outcome measures of effective rate and recurrence rate are symptoms. Secondary outcome measures of effective rate and recurrence rate are the urine leukocytes, bacteriology examination, and safety assessment. Outcomes will be assessed at baseline and after treatment. DISCUSSION: This study protocol will provide the research data of efficacy and safety of SJT for the treatment of acute uncomplicated lower UTI. The first aim is to determine whether Sanjin tablets can reduce the use of antibiotics; the second aim is to determine whether Sanjin tablets can substitute the use of antibiotics. The recurrence rate will be assessed after cured to determine whether SJT can reduce the recurrence rate. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.