The compilation instructions for the Expert Consensus on Clinical Application of Yifei Zhike Capsules systematically expound the development background， methodological framework， and core achievements of this consensus. In view of the problems existing in the clinical application of Yifei Zhike Capsules， such as insufficient efficacy evidence and lack of standardized syndrome differentiation， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences took the lead and collaborated with 21 tertiary grade-A hospitals and research institutions across China to form a multidisciplinary expert group （comprising 30 experts in clinical medicine， pharmacy， and methodology）. The compilation work was carried out in strict accordance with the World Health Organization （WHO） guidelines， the GB/T 1.1-2020 standard， and the writing specifications for the explanatory notes of expert consensus on clinical application of Chinese patent medicines. Through systematic literature retrieval （including 32 studies， with 24 clinical studies）， Grading of Recommendations Assessment， Development and Evaluations （GRADE）-based evidence grading， and multiple rounds of discussions using the nominal group method （25 experts voted to determine 17 clinical questions）， 5 evidence-based recommendations and 11 expert consensus suggestions were formed. It is clarified that this medicine （Yifei Zhike Capsules） is applicable to the treatment of expectoration/hemoptysis in acute and chronic bronchitis and the adjuvant treatment of pulmonary tuberculosis. It is recommended that it can be used alone or in combination with anti-tuberculosis drugs. The safety evaluation shows that this medicine mainly induces the following adverse reactions： mild gastrointestinal reactions （such as nausea and abdominal pain） and rashes. The contraindicated populations include pregnant women and women during menstruation. The compilation process of the consensus underwent three rounds of expert letter reviews， two rounds of peer reviews， and quality control assessments to ensure methodological rigor and clinical applicability. In addition， through policy alignment， academic promotion， and a dynamic revision mechanism， the standardization of clinical application was promoted， providing a demonstration for the evidence-based transformation of characteristic therapies of Miao medicine.

The field of post-marketing benefit-risk assessment for traditional Chinese medicine（TCM） is still in its nascent stage， lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM， and explored the critical techniques and specific implementation steps involved in the assessment process. Initially， appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently， key technologies were outlined， including the establishment of a benefit-risk indicator system， the assignment of indicator weights， and the definition of criteria attributes. Furthermore， the implementation steps were elaborated， which involved defining decision-making issues， data collection， evaluation methodologies， variability factors， and sensitivity analysis. Finally， a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM.

As an exclusive Miao medicine of Honwing Pharma （Guizhou） Co. Ltd.， Yifei Zhike capsules are both a prescription drug and an over-the-counter （OTC） drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs， as well as relieving cough and reducing phlegm， Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis， pulmonary tuberculosis， and other diseases. However， there is insufficient understanding of their efficacy， suitable syndromes， and safety in clinical practice， with a lack of relevant expert consensus on clinical application. To standardize their clinical application， 30 experts from the fields of respiratory medicine， pharmacy， and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules （Consensus for short） through evidence-based medicine methods. The Consensus clarified the syndrome characteristics， disease stages， dosages， treatment courses， combined medication， and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis， it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients， increase the sputum smear conversion rate， and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections， Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile， recommendations for specific usage， dosages， and treatment courses were given for different diseases， and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety， the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions， and pregnant women and women during menstruation were prohibited from using it. In addition， modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However， further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules， which helps to improve clinical efficacy and reduce medication risks.

As an exclusive Miao medicine of Honwing Pharma （Guizhou） Co. Ltd.， Yifei Zhike capsules are both a prescription drug and an over-the-counter （OTC） drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs， as well as relieving cough and reducing phlegm， Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis， pulmonary tuberculosis， and other diseases. However， there is insufficient understanding of their efficacy， suitable syndromes， and safety in clinical practice， with a lack of relevant expert consensus on clinical application. To standardize their clinical application， 30 experts from the fields of respiratory medicine， pharmacy， and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules （Consensus for short） through evidence-based medicine methods. The Consensus clarified the syndrome characteristics， disease stages， dosages， treatment courses， combined medication， and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis， it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients， increase the sputum smear conversion rate， and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections， Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile， recommendations for specific usage， dosages， and treatment courses were given for different diseases， and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety， the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions， and pregnant women and women during menstruation were prohibited from using it. In addition， modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However， further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules， which helps to improve clinical efficacy and reduce medication risks.

ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.

ObjectiveTo comprehensively evaluate the clinical value of Feilike mixture and provide a basis for the allocation of medical resources， rational drug use， and hospital procurement and supply of Chinese patent medicines. MethodWith the data from available studies and provided by drug manufacturers， the methods of evidence-based medicine， pharmacoeconomics， and health technology assessment were employed to construct a multi-criteria decision-making analysis framework from the "6+1" dimensions of safety， effectiveness， economy， innovation， suitability， accessibility， and characteristics of traditional Chinese medicine （TCM）. The clinical evidence and value evaluation software of Chinese patent medicine， CSCv2.0， was used to comprehensively evaluate the clinical value of Feilike mixture. ResultBased on the existing clinical evidence， the following results were obtained. ① Safety： Multi-sources of evidence showed that Feilike mixture had little known risk and sufficient evidence， with the safety rated as grade A， which indicated good safety. ② Effectiveness： The systematic review and Meta-analysis showed that Feilike mixture combined with conventional Western medicine in the treatment of bronchitis shortened the time to disappearance of cough compared with conventional Western medicine alone， with the evidence rated as grade B by the Grading of Recommendations Assessment， Development， and Evaluations （GRADE） system， which indicated high effectiveness. ③ Economy： From the perspective of health system， Feilike mixture combined with conventional Western medicine was more economical than conventional Western medicine alone， and the quality evaluation of pharmacoeconomics rated the economy as grade B. ④ Innovation： Feilike mixture combined with conventional Western medicine improved the clinical treatment effect and had innovation advantages compared with similar drugs. From the aspects of cultivation， identification of medicinal materials， and production， the sufficient supply and safety of medicinal materials can be ensured for Feilike mixture. This medicine was rated as grade B in terms of the medicinal material quality， preparation technology， and patents， which indicated good innovation. ⑤ Suitability： According to the results of the questionnaire survey， the usage of Feilike mixture was easy to be mastered and accepted by doctors and nurses， without special administration time， complex personalized treatment， and special technical and management requirements. It is convenient for patients to use， with convenient supply and storage， and weak influences of policy， publicity， and drug information. Therefore， the suitability of Feilike mixture was rated as grade B. ⑥ Accessibility： Among the similar Chinese patent medicines， Feilike mixture had a moderate price， high production capacity， wide sales coverage， wide coverage of hospitals， sustainable supply of medicinal materials， and low costs of treatment for acute bronchitis， with the accessibility rated as grade A. ⑦ TCM characteristics： Feilike mixture is composed of Scutellariae Radix， Peucedani Radix， Stemonae Radix， Gentianae Rhodanthae Herba， Scleromitrion diffusum， Firmiana platanifolia Radix， and Aster ageratoides， with reasonable compatibility. This formula is derived from the medical experience of Miao ethnic group， with rich experience in human use and the TCM characteristics rated as grade B. According to the evaluation results in the "6+1" dimensions， Feilike mixture was evaluated as class B， with a high clinical value. ConclusionAccording to the existing clinical evidence， compared with conventional Western medicine alone， Feilike mixture combined with conventional Western medicine demonstrates a high clinical value and prominent TCM characteristics in the treatment of acute bronchitis with phlegm-heat invading lung. It is suggested that it should be translated into the basic clinical drug management policy results according to the conditions.

The repair and reconstruction of long ureteral defects is a technical challenge faced by urologists. The ileal ureter replacement is currently the main surgical method for treating long segment ureteral defects. After the ileal ureter replacement surgery, mucin 2 (MUC2) and mucin 3 (MUC3), which are the main functional components of ileal mucus, continue to be strongly expressed. In addition, the expression of MUC2 gene after surgery is not limited to goblet cells, but can even be expressed in absorption cells of the ileum, ultimately leading to a large amount of mucin synthesis and mucus secretion. Mucus can cause many complications such as obstruction and infection, seriously affecting the treatment effect. At present, the industry has tried various methods to reduce the secretion of mucus and related complications after ileal ureteral replacement surgery, such as cutting the ileum to reduce mucosal area and mucosal exfoliation to reduce mucus production, and has achieved certain results. This article provides a review of research progress on the types, molecular mechanisms, and solutions of mucus related complications after ileal ureteral replacement surgery.

Objective:To investigate whether murine peroxidase reductase-5(mPRDX5)has anti-tumor activity in mice,so as to further confirm the anti-tumor activity and mechanism of recombinant peroxidase reductase-5.Methods:High purity mPRDX5 was obtained by heterologous expression and purification in vitro.Pancreatic cancer Pan02 cells were inoculated subcutaneously on the left axillary back of mice to establish a tumor bearing mouse model.Mice were randomly divided into PBS(solvent control)group,GEM(gemcitabine)50.0 mg/kg group and mPRDX5 10.0 mg/kg group,with 10 mice in each group,and the tumor related indexes were detected in mice.Results:Compared with PBS group,weight of tumor-bearing mice in GEM group was decreased obviously,while weight of mPRDX5 group was increased to a certain extent.Tumor growth was good in PBS group,according to tumor volume,com-pared with PBS group,tumor growth inhibition rates in D7 were 87.07%in GEM group and 52.82%in mPRDX5 10.0 mg/kg group,re-spectively;according to tumor weight,compared with PBS group,GEM group and mPRDX5 10.0 mg/kg group had tumor growth inhibi-tion rates of 95.39%and 48.33%in D7,respectively.Polarization state of macrophages in tumor tissues of mice in PBS group and mPRDX5 group was analyzed,and it was found that compared with PBS group,M1 macrophages expressing CD86 in tumor tissues of mice in mPRDX5 group were significantly increased,while M2 macrophages expressing CD206 were significantly decreased.Conclu-sion:mPRDX5 has significant anti-pancreatic cancer activity in mice,and the activity is exerted by promoting M1-type polarization of macrophages in the tumor microenvironment.

ObjectiveTo comprehensively evaluate the clinical value of Jintiange Capsules （JCs） in the treatment of osteoporosis （OP） and clarify the intrinsic advantages and clinical treatment characteristics of JCs， providing references for relevant departments of national health and medicine decision-making and the basis and clues for clinical and basic in-depth research. MethodBased on evidence-based medical evidence， this study integrated quantitative and qualitative methods and combined with questionnaires， official website data， human experience， pharmacoeconomic evaluation， and other research methods. From the effectiveness， safety， economy， innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics of the '6+1' dimension， the clinical evidence and value of JCs in the treatment of OP were comprehensively evaluated， forming the 'clinical evidence and value evaluation index'. The comprehensive evaluation of clinical value was based on the multi-criteria decision analysis framework. The expert meeting method was used to empower each dimension and value index. The clinical evidence and value evaluation software of Chinese patent medicine （CSC v2.0） was used to calculate the total value score， and the clinical advantages of JCs were comprehensively evaluated. ResultBased on randomized controlled clinical studies and systematic review， data analysis of spontaneous reporting system （SRS）， case reports， non-clinical safety studies， etc.， serious adverse drug reactions （ADRs） were reported after the launch of this product monitored by SRS， mainly involving abnormal liver function and adverse reactions of cardiovascular system. Therefore， the safety evidence adequacy of this product should be further improved， and the safety evaluation was Grade B. Meta-analysis showed that JCs were superior to the control group in improving the total clinical effective rate， improving bone mineral density， reducing visual analogue scale （VAS） score， and shortening fracture healing time. Combined with Grading of Recommendations Assessment， Development and Evaluation （GRADE） evidence evaluation， the comprehensive evaluation of effectiveness was Grade A. Pharmacoeconomic evaluation showed that JCs combined with calcium carbonate D₃ tablets were more cost-effective than calcium carbonate D₃ tablets alone in patients with OP. Compared with Gushukang capsules， JCs had more cost-effectiveness advantages， but the sample size included in the study was small， and the results needed to be verified by further studies. Combined with the results of the Comparative Assessment of Structure Prediction （CASP） evaluation list， the comprehensive economic evaluation was Grade B. JCs were the only bionic medicine of tiger bone in China with all intellectual property rights， with 3 national invention patents. Its process preparation and fingerprint detection had obvious technical advantages. It had innovative advantages in the supply base equipment， medicine resource management， production technology， and other aspects. Thus， its innovative comprehensive evaluation was Grade A. JCs were in capsule dosage form， which was relatively convenient for storage and transportation. The dosage form was suitable for indications， and the usage was easy for patients to grasp and accept. The statutory information and non-statutory information met the national standards. The comprehensive evaluation of suitability was Grade A. JCs did not contain toxic ingredients， had no restrictions on origin and prescription， and had abundant resources of original medicinal materials. The affordability of JCs in the treatment of OP was good in urban areas （14.97%） but not in rural areas （39.76%）. The price was higher than that of similar Chinese patent medicines， and the comprehensive evaluation of availability was Grade B. JCs had a reasonable proportion of natural animal bones， and their composition was basically the same as that of natural tiger bones. After marketing， more than 2 000 cases of real-world clinical research evidence was accumulated， and the comprehensive evaluation of TCM characteristics was Grade B. CSC v2.0 software was used for quantitative synthesis of the '6+1' dimension， and the comprehensive clinical value of JCs in the treatment of OP was Grade A. ConclusionJCs have good clinical value in the treatment of OP， and the TCM characteristics are prominent. It is suggested that JCs can be directly transformed into the related policy results of basic clinical drug management according to procedures.

ObjectiveTo perform a clinical comprehensive evaluation of Xianyu capsules in the treatment of epilepsy with wind-phlegm obstruction syndrome to provide methodological references for clinical rational medication and post-marketing research on Chinese medicine. MethodBased on evidence-based medicine，clinical epidemiology，clinical medicine，evidence-based pharmacy， and pharmacoeconomics，the clinical comprehensive evaluation was carried out from the "6 + 1" dimensions of safety，effectiveness，economy，innovation，suitability，and accessibility， as well as characteristics of traditional Chinese medicine （TCM） using public data，literature data，pharmaceutical research，questionnaire survey， and other information by qualitative and quantitative evaluation methods in combination. Multi-criteria decision analysis （MCDA） model and CSC software V2.0 were adopted to evaluate the clinical value of Xianyu capsules. The evaluation results of each dimension were divided into four grades， i.e.， A，B，C， and D. ResultMultiple sources of safety evidence such as spontaneous reporting system （SRS） monitoring data，literature reports， and clinical studies showed that the main adverse reactions of Xianyu capsules were dizziness，drowsiness， and nausea，and there were no serious adverse reactions. Due to the sufficient evidence and the controllable risk， they were graded B for the safety. Meta-analysis showed that Xianyu capsules combined with conventional western medicine in the treatment of epilepsy were better than conventional western medicine alone in reducing the frequency of seizures （times/month） and improving the total clinical effective rate，and they were graded B for the effectiveness. The results of pharmacoeconomic research showed that Xianyu capsules combined with conventional western medicine （magnesium valproate sustained-release tablets） had cost-effectiveness advantages over magnesium valproate sustained-release tablets alone in the treatment of epilepsy，but the level of incremental effect was not significant. Therefore， they were graded B for economy. Xianyu capsules are the only Chinese patent medicine that can treat epilepsy under the list of phlegm-eliminating and orifices-opening agents with aromatics in the current national medical insurance catalogue. They are designed for the syndrome of wind-phlegm obstruction with clear syndrome type. The company has insisted on inheritance and innovation based on the classic famous prescriptions by virtue of modern science and technology，and obtained a number of patents for invention. Hence， they were graded A for the innovation. The questionnaire results showed that the use of drugs could meet the medication needs of clinical doctors and patients，and the publicity materials such as instructions and labels were accurate and complete without exaggeration and misleading. The information service of drug instructions，labels， and packaging was normative. According to the comprehensive questionnaire and the information service results of Chinese patent medicine，they were graded A for the suitability. Compared with the price of similar drugs，the price of Xianyu capsules is moderate. The cost of treatment accounts for a high proportion of per capita disposable income and is generally affordable. Because of a wide sales scope， sustainable medicinal material resources， and good availability，they were graded B for the accessibility. Xianyu capsules are derived from the combination of the classic prescriptions Qianzhengsan and Tianma Goutengyin， which are designed for the syndrome of wind-phlegm obstruction with rich experience in human use. Hence， they were rated as grade B for TCM characteristics. Based on the evidence evaluation results of "6 + 1" dimensions of Xianyu capsules，the comprehensive evaluation of clinical value was B. ConclusionThe clinical value of Xianyu capsules in the treatment of epilepsy with wind-phlegm obstruction syndrome is high，and the TCM characteristics are prominent. It is suggested to convert into the relevant policy results of basic clinical medication management according to the procedure.