[Economic evaluation of Annao Pills combined with antihypertensive drugs in treatment of primary hypertension: a study based on decision tree model].

The purpose of this study was to evaluate the economics of Annao Pills combined with antihypertensive drugs in the treatment of primary hypertension in the Chinese medical setting. TreeAge pro 2018 was used for cost-effect analysis and sensitivity analysis of the two treatment regimens. The intervention time of the simulation model was 2 weeks. The cost parameters were derived from Yaozhi.com, and the effect parameters were based on Meta-analysis of randomized controlled trial(RCT) involving Annao Pills. The experimental group was treated with Annao Pills combined with anti-hypertensive drugs(nifedipine controlled-release tablets + losartan potassium tablets), and the control group was treated with anti-hypertensive drugs(nifedipine controlled-release tablets + losartan potassium tablets). The basic analysis showed that the incremental cost-effect ratio(ICER) of the two groups was 2 678.67 yuan, which was less than 7.26% of the per capita disposable income in 2022. That is, compared with anti-hypertensive drugs alone, Annao Pills combined with antihypertensive drugs cost 2 678.67 yuan more for each additional patient with primary hypertension. The results of sensitivity analysis verified the robustness of the basic analysis results. The probability sensitivity results showed that when the patient's personal willingness to pay the price was higher than 2 650 yuan, the probability of the regimen in the experimental group was higher, which was consistent with the results of the basic analysis. In conclusion, when the price was higher than 2 650 yuan, Annao Pills combined with anti-hypertensive drugs was more economical than anti-hypertensive drugs alone in terms of improving the response rate of the patients with primary hypertension.

Cancer and Atrial Fibrillation Comorbidities Among 25 Million Citizens in Shanghai, China: Medical Insurance Database Study.

BACKGROUND: With population aging, the prevalence of both cancer and atrial fibrillation (AF) have increased. However, there is scarce epidemiological data concerning the comorbid state of cancer and AF in low- and middle-income countries, including China. OBJECTIVE: We aimed to evaluate the site-, sex-, and age-specific profiles of cancer and AF comorbidities in Chinese populations. METHODS: Data from the Shanghai Municipal Health Commission database between 2015 and 2020 were screened, covering all medical records of Shanghai residents with medical insurance. Site-specific cancer profiles were evaluated for the population with AF relative to the age- and sex-adjusted population of residents without AF. The sex distribution and peak age of cancer diagnosis were also assessed. RESULTS: A total of 25,964,447 adult patients were screened. Among them, 22,185 patients presented cancers comorbid with AF (median 77, IQR 67-82 years of age; men: n=13,631, 61.44%), while 839,864 presented cancers without AF (median 67, IQR 57-72 years of age; men: n=419,020, 49.89%), thus yielding a higher cancer prevalence among residents with AF (8.27%) than among those without AF (6.05%; P<.001). In the population with AF, the most prevalent cancer type was lung cancer, followed by colorectal, male genital organ, stomach, breast, liver, bladder, thyroid, leukemia, and esophageal cancers. AF was associated with an average of nearly 1.4-fold (prevalence ratio [PR] 1.37, 95% CI 1.35-1.38) increased prevalence of cancer after adjusting for age and sex. For site-specific analyses, an increased prevalence of cancer in the population with AF was observed in 20 of 21 cancer sites. This increased prevalence was most prominent for nonsolid tumors, including multiple myeloma (PR 2.56, 95% CI 2.28-2.87), leukemia (PR 1.73, 95% CI 1.57-1.90), and non-Hodgkin lymphoma (PR 1.59, 95% CI 1.43-1.77); intrathoracic malignancies, including mediastinum (PR 2.34, 95% CI 1.89-2.90), lung (PR 1.64, 95% CI 1.59-1.69), and esophageal cancers (PR 1.41, 95% CI 1.28-1.56); bone and soft tissue neoplasms (PR 1.56, 95% CI 1.37-1.77); and kidney cancer (PR 1.53, 95% CI 1.36-1.72). Cancer prevalence in the population with AF relative to that in the population without AF was higher in men than in women in 14 of 18 cancer sites, and female predominance was only observed for thyroid cancer. The peak age of index cancer diagnosis was lower in the population with AF (age group: 70-74 years) than in that without AF (age group: 75-79 years), especially for specific cancer types, including thyroid, central nervous system, mediastinum, esophageal, bladder, and biliary cancers. CONCLUSIONS: Patients with AF are associated with increased prevalence, heightened male predominance, and younger peak age of cancer. Further studies are needed to determine whether early screening of specific cancers is cost-effective and beneficial for patients with AF.

[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.

The feasibility and satisfaction study of 5G-based robotic teleultrasound diagnostic system in health check-ups.

Objective: Regular check-up with ultrasound in underserved rural and/or remote areas is hampered due to the limited availability of sonologists and ultrasound devices. This study aimed to assess the feasibility and satisfaction of health check-ups with a 5G-based robotic teleultrasound diagnostic system. Methods: In this prospective study, sonologists from two hospitals manipulated the telerobotic ultrasound system to perform teleultrasound check-ups of the liver, gallbladder, pancreas, spleen, kidneys, bladder, prostate (male), uterus and ovaries (female) for the subjects. The feasibility and satisfaction of health check-ups with a 5G-based robotic teleultrasound diagnostic system were evaluated in terms of examination results, examination duration, and satisfaction questionnaire survey. Results: A total of 546 subjects were included with the most frequently diagnosed being abdominal disorders (n = 343) and male reproductive illnesses (n = 97), of which fatty liver (n = 204) and prostatic calcification (n = 54) were the most. The median teleultrasound examination duration (interquartile range) for men and women was 9 (9-11) min and 9 (7-11) min (p = 0.236), respectively. All the subjects were satisfied with this new type of telerobotic ultrasound check-ups and 96% reported no fear of the robotic arm during the examination. Conclusion: The 5G-based teleultrasound robotic diagnostic system in health check-ups is feasible and satisfactory, indicating that this teleultrasound robot system may have significant application value in underserved rural and/or remote areas to mitigate disparity in achieving health equity.

[Pharmacoeconomic evaluation of Xiangju Capsules in treatment of chronic rhinosinusitis].

Chronic rhinosinusitis refers to the non-specific inflammation that occurs in the nasal mucosa and sinuses, with clinical manifestations of mucopurulent nasal discharge, nasal congestion, hyposmia or anosmia, and head and face swelling pain.This disease has a long course and is prone to recurrence, which seriously affects the physical and mental health and quality of life of patients.Xiangju Capsules, prepared from infructescence of Platycarya strobilacea(without seeds), Prunellae Spica, Magnoliae Flos, Chuan-xiong Rhizoma, Angelicae Dahuricae Radix, Chrysanthemi Indici Flos, Astragali Radix, etc., are effective in dispelling wind by pungency and dispersing, clearing heat, and relieving orifices, and has good efficacy and safety in the clinical treatment of acute and chronic rhinosinusitis and rhinitis.From the perspective of the health system, an economic evaluation model was constructed based on the Meta-analysis of the effectiveness of Xiangju Capsules in the treatment of chronic rhinosinusitis to discuss the economic efficiency of Xiangju Capsules in combination with conventional treatment or conventional treatment alone in patients with chronic rhinosinusitis.The model simulation results showed that 53 days(average course of treatment) after treatment, Xiangju Capsules combined with conventional treatment had higher cost and higher output, with an incremental cost-effectiveness ratio of CNY 263.71, about 0.82% of per capita disposable income.As revealed by sensitivity analysis results, the research results were robust.As indicated by the findings of this study, Xiangju Capsules combined with conventional treatment for chronic rhinosinusitis patients were more economical than conventional treatment alone based on the assumption that the per capita disposable income of Chinese people in 2020 was the threshold of patients' willingness to pay.

[Cost-effectiveness analysis of Qilong Capsules in treatment of ischemic stroke based on prospective real-world cohort study].

In this study, TreeAge Pro was used to build a decision tree model for Qilong Capsules in the treatment of ischemic stroke. We compared the economy between Qilong Capsules + conventional therapy vs conventional therapy in the treatment of ischemic stroke to guide the rational allocation of health resources in clinical practice. The cost parameters in the study were obtained from Menet and the relevant literature published recently. Meanwhile, the efficacy parameter [mean reduction in National Institute of Health stroke scale(NIHSS) score after treatment] was employed to evaluate the short-term economic performance of the two therapies based on a prospective real-world cohort study. The time span of simulation was 24 weeks, and the robustness of this study was verified by sensitivity analysis. Qilong Capsules + conventional therapy and conventional therapy had the direct medical costs of CNY 22 546.50, 21 160.50 and the effectiveness of 2.08, 1.59 points, respectively. The incremental cost-effectiveness ratio(ICER) of the two groups was CNY 2 811.36. That is, compared with conventional therapy, Qilong Capsules + conventional therapy in the treatment of ischemic stroke costed CNY 2 811.36 for each additional point reduction in NIHSS score. If the patient is willing to pay more than CNY 2 811.36, Qilong Capsules + conventional therapy is more economical. The result of sensitivity analysis verified that the ICER was robust. Thus, on the basis of the assumption that per capita disposable income in 2020 is the threshold of patients' willingness to pay, Qilong Capsules + conventional therapy is more economical than conventional therapy alone in the treatment of ischemic stroke.

Epidemiology, management, and outcomes of atrial fibrillation among 30 million citizens in Shanghai, China from 2015 to 2020: A medical insurance database study.

Background: Atrial fibrillation(AF) has become a significant public health concern in China, with population aging and urbanization. Methods: Data screening was performed for 30,244,930 subjects with medical insurance in the Shanghai Municipal Health Commission database between 2015 and 2020. Patients diagnosed with AF were identified and further assessed for treatment information and clinical outcomes, as well as sex differences and impact of COVID-19 pandemic on AF managment. Findings: AF prevalence was 0.88% in Shanghai, which increased with age and reached 6.70% at subjects 80 years and over. AF was more prevalent in women compared with men (0.89% vs. 0.88%, p<0.0001), which could be attributed to higher AF burden in women over 80 years. Driven by increased prescription of non-vitamin K antagonist oral anticoagulants, anticoagulant use increased from 19.46% in 2015 to 56.57% in 2020. The number of left atrial appendage closure increased from 0.16% in 2015 to 1.23% in 2020. Rhythm control strategy was increasingly adopted, as the use of antiarrhythmic drugs doubled and ablation increased by 21% in 2020 compared to 2015. Compared with men, women were less prone to receive rhythm control treatments, including antiarrhythmics, ablation and cardioversion, but more likely to adopt rate control drugs. During the 5.5 years follow-up, the incidences of stroke, transient ischemic attack, systemic embolism, bleeding, myocardial infarction, and in-hospital death were 6.09%, 5.74%, 1.44%, 5.11%, 8.41%, and 12.84% in patients with index diagnosis of AF in 2015, respectively. Interpretation: The burdens of AF and AF-related outcomes in Shanghai are high. Management of AF is markedly improved in recent years, and was not or only slightly impeded by the COVID-19 pandemic. There are sex differences in the prevalence, management, and outcomes of AF. Funding: Shanghai Hospital Development Center, National Natural Science Foundation of China and Shanghai Municipal Science and Technology Commission.

[Clinical comprehensive evaluation of Qilong Capsules in treatment of ischemic stroke with Qi deficiency and blood stasis syndrome].

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments. Based on the evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, and pharmacoeconomics, the qualitative and quantitative evaluation of "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility, as well as characteristics of traditional Chinese medicine(TCM) was performed with multi-criteria decision analysis(MCDA) mo-del using the information, such as public data, literature data, pharmaceutical research, and questionnaire survey, and CSC v2.0 was used to calculate the clinical value of Qilong Capsules. The evaluation results were grade A, B, C, or D. Spontaneous reporting system(SRS) monitoring data, literature reports, clinical trials, and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth, nausea, and rash, and no severe adverse reactions was found. The evidence was sufficient with small and controllable known risks, and the safety was grade A. Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits, clinical total response rate, patients' activities of daily living, and hemorheological indexes. The level of evidence was high with manifest clinical significance, and the effectiveness was grade A. The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone, but the incremental effect was not significant. The quality evaluation results of the economic report were comparatively clear, and the economy was grade B. Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM, Qilong Capsules focused on the inheritance of classics and scientific and technological innovation, and innovation was grade B. The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients, and the suitability was grade B. The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income. The drug accessibility was good with a wide range of drug sales, sufficient production capacity, and sustainable medicinal materials resources, and was grade B. This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application, which could regulate Qi and blood circulation, and the section of TCM characteristics was grade B. Based on the evidence evaluation results of "6+1" dimensions of Qilong Capsules, the comprehensive evaluation of clinical value was class A. It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.

[Clinical comprehensive evaluation of Reyanning Mixture in treatment of acute upper respiratory tract infection (heat-toxin attacking lung syndrome)].

This study systematically sorted out the evidence data of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) with the qualitative and quantitative evaluation methods adopted. Based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, and health technology evalua-tion(HTA), the clinical value of Reyanning Mixture was evaluated using multi-criteria decision analysis(MCDA) model, Chinese patent medicine clinical evidence, and value evaluation software(CSC v2.0). The SRS monitoring data, Meta-analysis, and other safety evidence showed that the main adverse reactions of Reyanning Mixture were nausea, diarrhea, and rash, and no serious adverse reactions were found. The pharmacovigilance system was sound, and the system was perfect. There was no recall, notification, or interview for unqualified products. Based on the existing research, the evidence was sufficient, and the risk was controllable. Hence, its safety was grade A. Meta-analysis showed that in the treatment of acute upper respiratory tract infection, Reyanning Mixture combined with Amoxicillin Capsules was better than Amoxicillin Capsules alone in shortening the complete fever relief time and improving the cure rate. Besides, it was superior to Shuanghuanglian Granules in shortening the complete fever relief time, cough relief time, nasal congestion relief time, and pharyngeal congestion relief time. The Meta-analysis was conducted based on AMSTAR standard, and its ove-rall quality was proved good. The evidence quality in GRADE system evaluation was medium and low. The quality of evidence was medium, and the clinical value was obvious. Hence, its effectiveness was grade A. The results of pharmacoeconomic research showed that compared with Amoxicillin Capsules, Reyanning Mixture alone or in combination with Amoxicillin Capsules had cost-effectiveness advantages in the treatment of acute upper respiratory tract infection, and the results were stable in sensitivity analysis. According to the CASP economic evaluation checklist, the research problems were clear and the results were reliable. As revealed by the comprehensive evaluation, the evidence quality was sufficient and the result was clear. Its economy was grade B. Reyanning Mixture had multiple therapeutic targets like anti-virus, anti-bacteria, antipyresis, and anti-cough, with good clinical innovation. There were many innovative initiatives in ensuring drug supply, especially at the grass roots, drug safety, and effectiveness, and also multiple innovative contributions to production technology, quality control, scientific and technological research and development, and enterprise management and marketing. Therefore, its innovation was grade B. The dosage form of Reyanning was mixture, which made it convenient for storage and transportation. The usage was easy to be mastered and accepted by doctors and nurses, exhibiting good suitability for clinicians, nurses, pharmacists, and patients who received this drug and basically meeting the needs of clinical medication. The suitability was grade B. The average daily cost of this drug was 8.082 yuan, and the price was low. The treatment cost accounted for a small proportion of the annual disposable income of urban and rural residents, indicating that it was affordable. Reyanning Mixture was available in 31 provinces, cities and autonomous regions, covering 6 910 hospitals. The allocation of hospitals at all levels was more than 50%. There was no shortage or supply restriction of medicinal material resources. The annual production capacity was sufficient to meet the supply demand, so its accessibility was grade A. Reyanning Mixture, sourced from "pneumonia Ⅲ", has been subjected to a real-world study of its clinical application, with 4 367 cases involved, and the characteristic of TCM was grade B. The comprehensive evaluation results demonstrated that the clinical value score of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) was 0.80, making it rated class A. According to the Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), it is recommended to convert it into the relevant policy results of basic clinical medication management according to the procedures.

[Clinical comprehensive evaluation of Ginkgolide Injection in treatment of cerebral infarction].

This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the "6+1" dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0. After entering the market, Ginkgolide Injection has been subjected to phase Ⅳ clinical trial, spontaneous reporting system(SRS)-based data monitoring, systematic review and Meta-analysis, acute toxicity and long-term toxicity assays, active monitoring, and RCTs, and the evidence of safety was sufficient. The results of active monitoring showed that the incidence of adverse reactions was 0.09%(rare), mainly manifested as flushing, dizziness, rash, nausea, and vomiting. According to the nested case-control study, the adverse reactions of this drug had nothing to do with the product batch, implying that the drug quality was controllable. The adverse reactions mainly resulted from the pharmacodynamic reactions. Because the drug was effective in resisting platelet aggregation, the resulting adverse reactions such as flushing, dizziness, headache, and phlebitis were caused by vasodilation. Skin rash and gastrointestinal symptoms were mainly attributed to the patients' sensitivity to drugs and their own allergic constitution. According to the sufficiency of evidence and the incidence of adverse reactions in the safety research, the safety of Ginkgolide Injection was grade A. The results of Meta-analysis showed that Ginkgolide Injection combined with conventional western medicine was superior to conventional western medicine in improving the clinical effective rate, neurological function score, and activity of daily living score of patients with cerebral infarction. The validity evidence was evaluated according to the PICO principle to be high. According to the GREAD evaluation principle, the quality of such evidence as clinical effective rate, National Institute of Health stroke scale(NIHSS), and Barthel Index(BI) was evaluated, and the results demonstrated that the evidence quality of clinical effective rate and activity of daily living score was medium. The effectiveness of Ginkgolide Injection was grade A. According to the economic report of Ginkgolide Injection, it had short-term and long-term pharmacoeconomic advantages in the treatment of ischemic stroke, and the economic evidence value was good. According to the CASP economic evaluation checklist, the overall quality evaluation results of the economic report are basically clear. To be specific, the economic evidence quality was high. Based on the comprehensive economic evidence quality and economic value, the economy of this drug was grade A. The innovation of this product was evaluated from three aspects: clinical innovation, enterprise service system innovation, and industrial innovation. Ginkgolide Injection could be used 24 h after intravenous thrombolysis for improving patients' neurological function without increasing bleeding, indicating its important clinical innovation. There were many innovations in ensuring drug supply, especially at the grass roots, drug safety, effectiveness, and reasonable price, which has provided reference for establishing enterprise philosophy, managing drug resources, developing process and technology, and determining enterprise management and marketing. Therefore, its innovation was grade A. The drug had no special medication plan in use, exhibiting good suitability for doctors, nurses, and patients. The suitability was grade B. Compared with similar drugs, its price was at a medium level, meaning good affordability, sufficient production capacity, and easy accessibility. Its accessibility was therefore grade B. This drug belonged to Chinese medicinal injection. The large-sample real-world research revealed rich human use experience, so it was grade C for the traditional Chinese medicine characteristic. According to the comprehensive evaluation, the clinical value of Ginkgolide Injection in the treatment of cerebral infarction fell into class A. It is suggested that it can be transformed into the relevant policy results of basic clinical medication management according to the procedure.

[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.

[Multiphase Spatial Distribution Characteristics of Cd Morphology in Typical Intertidal Zones in the Guangdong-Hong Kong-Macao Greater Bay Area and Its Influencing Factors].

Simultaneous sampling and observation were conducted at 14 stations in typical intertidal zones of the Guangdong-Hong Kong-Macao greater bay area. The spatial distribution characteristics of Cd morphology in surface water, pore water, suspended matters, and sediments at each sampling site were analyzed, and the influencing factors of Cd morphology changes in each medium were discussed using statistical analyses based on environmental factors. The results showed that the total contents of Cd in surface water, pore water, suspended matters, and sediments in each intertidal zone ranged from 0.41-15.03 µg·L-1, 0.41-27.54 µg·L-1, 0.41-4.88 mg·kg-1, and 0.20-5.30 mg·kg-1, respectively. The contents of Cd in Shajiao Bay were significantly higher than those in other sampling sites, which should be related to the developed electronics and manufacturing industries in Dongguan. The concentration of Cd in surface water was slightly lower than that in pore water, whereas the content of Cd in suspended matter was comparable to that in sediment at the same sampling site. The results of morphological analysis showed that the ionic-state Cd was dominant in both surface water and pore water, accounting for 67.23%-97.56% and 33.33%-97.16%, respectively. In suspended matter and sediment, Cd was mainly in the residual state, accounting for 45.45%-96.36% and 45.80%-97.27%, respectively. Pearson correlation analysis showed that the complex-state Cd in the aqueous phase was negatively correlated with oxidation reduction potential (ORP) and pH and positively correlated with total organic carbon. The bioavailable Cd in solid sediment was significantly positively correlated with the proportion of clay, ORP, and solid organic carbon and significantly negatively correlated with pH. The single factor linear regression analysis showed that ORP had the greatest effect on the complex-state Cd in the aqueous phase, with regression coefficients of 0.864 and 0.824, respectively. The bioavailable Cd in solid sediment at different depths was significantly affected by the proportion of clay, and the regression coefficients were 0.968, 0.980, 0.977, and 0.877, respectively. The above results indicate that the distribution of total Cd content in the typical intertidal environment of the Greater Bay Area was affected by the characteristics of urban economic development, whereas the allocation of Cd morphology was closely related to environmental factors.

[Pharmacoeconomic evaluation of Qidong Yixin Oral Liquid in treatment of viral myocarditis (Qi-Yin deficiency syndrome) with TreeAge Pro].

To evaluate the pharmacoeconomic value of Qidong Yixin Oral Liquid in the treatment of viral myocarditis(Qi-Yin deficiency syndrome) by supplementing Qi, nourishing the heart, calming the mind, and relieving palpitation, the present study performed the Meta-analysis based on the published papers on Qidong Yixin Oral Liquid by AMSTAR and carried out pharmacoeconomic evaluation using TreeAge Pro by the cost-effectiveness analysis. The results showed that the quality of the included papers was good. After four weeks of treatment, Qidong Yixin Oral Liquid combined with the conventional treatment regimen was superior to the conventional treatment in improving creatine kinase isoenzyme, and the difference was statistically significant. Furthermore, the treatment cost was also higher than that of conventional treatment, with an incremental cost-effectiveness ratio of CNY 95.89, accounting for 0.30% of per capita disposable income. The results of sensitivity analysis showed that the research results were robust. Therefore, based on the assumption that the per capita disposable income in 2020 was the threshold of patients' willingness to pay, it is more economical for patients with viral myocarditis to use Qidong Yixin Oral Liquid combined with conventional secondary prevention regimen than conventio-nal secondary prevention regimen alone. The economic evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis will help physicians and patients choose optimal treatment options, improve rational clinical medication, and provide references for the efficient allocation and utilization of medical resources in China.

Radiomics model based on shear-wave elastography in the assessment of axillary lymph node status in early-stage breast cancer.

OBJECTIVES: To develop and validate an ultrasound elastography radiomics nomogram for preoperative evaluation of the axillary lymph node (ALN) burden in early-stage breast cancer. METHODS: Data of 303 patients from hospital #1 (training cohort) and 130 cases from hospital #2 (external validation cohort) between Jun 2016 and May 2019 were enrolled. Radiomics features were extracted from shear-wave elastography (SWE) and corresponding B-mode ultrasound (BMUS) images. The minimum redundancy maximum relevance and least absolute shrinkage and selection operator algorithms were used to select ALN status-related features. Proportional odds ordinal logistic regression was performed using the radiomics signature together with clinical data, and an ordinal nomogram was subsequently developed. We evaluated its performance using C-index and calibration. RESULTS: SWE signature, US-reported LN status, and molecular subtype were independent risk factors associated with ALN status. The nomogram based on these variables showed good discrimination in the training (overall C-index: 0.842; 95%CI, 0.773-0.879) and the validation set (overall C-index: 0.822; 95%CI, 0.765-0.838). For discriminating between disease-free axilla (N0) and any axillary metastasis (N + (≥ 1)), it achieved a C-index of 0.845 (95%CI, 0.777-0.914) for the training cohort and 0.817 (95%CI, 0.769-0.865) for the validation cohort. The tool could also discriminate between low (N + (1-2)) and heavy metastatic ALN burden (N + (≥ 3)), with a C-index of 0.827 (95%CI, 0.742-0.913) in the training cohort and 0.810 (95%CI, 0.755-0.864) in the validation cohort. CONCLUSION: The radiomics model shows favourable predictive ability for ALN staging in patients with early-stage breast cancer, which could provide incremental information for decision-making. KEY POINTS: • Radiomics analysis helps radiologists to evaluate the axillary lymph node status of breast cancer with accuracy. • This multicentre retrospective study showed that radiomics nomogram based on shear-wave elastography provides incremental information for risk stratification. • Treatment can be given with more precision based on the model.

[Clinical comprehensive evaluation of Danhong Injection in treatment of stroke with blood stasis syndrome].

This study systematically reviewed the existing research on Danhong Injection in the treatment of stroke with blood stasis syndrome. The methods of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, drug economics, mathematical statistics, and health technology assessment(HTA) were employed to qualitatively and quantitatively evaluate the "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) of Danhong Injection through questionnaire survey, public information, real world data, and secondary evaluation of literature. With the weights given by experts, the multi-criteria decision analysis(MCDA) model was employed to measure each dimension and highlight the clinical value of Danhong Injection. Multi-source safety evidence showed that Danhong Injection had been fully monitored and studied. The severity of adverse reactions was mostly moderate or mild, and the prognosis was good. So it was rated as grade A for safety. Compared with Ligustrazine Injection, Fufang Danshen Injection and conventional treatment of western medicine, Danhong Injection had obvious advantages in clinical response rate and NIHSS score improvement in the treatment of stroke with blood stasis syndrome. So it was rated as grade A for effectiveness. Compared with Ligustrazine Injection and Yinxing Damo Injection, Danhong Injection had a cost-effectiveness advantage in the treatment of stroke with blood stasis syndrome, and the economic results were good. According to the existing evidence, the Danhong Injection was rated as grade B for economy. Danhong Injection had won a number of national patents, which was rated as grade A for its good innovation in guaranteeing supply measures, scalability of production capacity, and production process. It had good suitability for clinicians, nurses, pharmacists, and patients using the drug, and met the needs of clinical medication, so it was rated as grade B for suitability. Danhong Injection is rich in medicinal materials, stable in price, and sustainable. However, its availability needed to be further improved due to the limitation of prescription use, so it was rated as grade B for accessibility. Danhong Injection can promote blood circulation, resolve blood stasis, warm vessels, and smooth collaterals. It had accumulated more than 30 000 pieces of empirical evidence for human use in the real world. It had prominent characteristics of traditional Chinese medicine and was rated as grade B. CSC v2.0 was used for calculation, and the clinical value of Danhong Injection was comprehensively evaluated as class A, which could be directly translated into relevant policy results of basic clinical medication management according to the Guidelines for the Management Clinical Comprehensive Evaluation of Drugs(trial version 2021).

[Clinical comprehensive evaluation of Diemailing~® Kudiezi Injection in treatment of cerebral infarction].

Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.

Ultrasound-based deep learning radiomics in the assessment of pathological complete response to neoadjuvant chemotherapy in locally advanced breast cancer.

PURPOSE: The aim of the study was to develop and validate a deep learning radiomic nomogram (DLRN) for preoperatively assessing breast cancer pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) based on the pre- and post-treatment ultrasound. METHODS: Patients with locally advanced breast cancer (LABC) proved by biopsy who proceeded to undergo preoperative NAC were enrolled from hospital #1 (training cohort, 356 cases) and hospital #2 (independent external validation cohort, 236 cases). Deep learning and handcrafted radiomic features reflecting the phenotypes of the pre-treatment (radiomic signature [RS] 1) and post-treatment tumour (RS2) were extracted. The minimum redundancy maximum relevance algorithm and the least absolute shrinkage and selection operator regression were used for feature selection and RS construction. A DLRN was then developed based on the RSs and independent clinicopathological risk factors. The performance of the model was assessed with regard to calibration, discrimination and clinical usefulness. RESULTS: The DLRN predicted the pCR status with accuracy, yielded an area under the receiver operator characteristic curve of 0.94 (95% confidence interval, 0.91-0.97) in the validation cohort, with good calibration. The DLRN outperformed the clinical model and single RS within both cohorts (P < 0.05, as per the DeLong test) and performed better than two experts' prediction of pCR (both P < 0.01 for comparison of total accuracy). Besides, prediction within the hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative, HER2+ and triple-negative subgroups also achieved good discrimination performance, with an AUC of 0.90, 0.95 and 0.93, respectively, in the external validation cohort. Decision curve analysis confirmed that the model was clinically useful. CONCLUSION: A deep learning-based radiomic nomogram had good predictive value for pCR in LABC, which could provide valuable information for individual treatment.

Deep learning with convolutional neural network in the assessment of breast cancer molecular subtypes based on US images: a multicenter retrospective study.

OBJECTIVES: To evaluate the prediction performance of deep convolutional neural network (DCNN) based on ultrasound (US) images for the assessment of breast cancer molecular subtypes. METHODS: A dataset of 4828 US images from 1275 patients with primary breast cancer were used as the training samples. DCNN models were constructed primarily to predict the four St. Gallen molecular subtypes and secondarily to identify luminal disease from non-luminal disease based on the ground truth from immunohistochemical of whole tumor surgical specimen. US images from two other institutions were retained as independent test sets to validate the system. The models' performance was analyzed using per-class accuracy, positive predictive value (PPV), and Matthews correlation coefficient (MCC). RESULTS: The model achieved good performance in identifying the four breast cancer molecular subtypes in the two test sets, with accuracy ranging from 80.07% (95% CI, 76.49-83.23%) to 97.02% (95% CI, 95.22-98.16%) and 87.94% (95% CI, 85.08-90.31%) to 98.83% (95% CI, 97.60-99.43) for the two test cohorts for each sub-category, respectively. In terms of 4-class weighted average MCC, the model achieved 0.59 for test cohort A and 0.79 for test cohort B. Specifically, the DCNN also yielded good diagnostic performance in discriminating luminal disease from non-luminal disease, with a PPV of 93.29% (95% CI, 90.63-95.23%) and 88.21% (95% CI, 85.12-90.73%) for the two test cohorts, respectively. CONCLUSION: Using pretreatment US images of the breast cancer, deep learning model enables the assessment of molecular subtypes with high diagnostic accuracy. TRIAL REGISTRATION: Clinical trial number: ChiCTR1900027676 KEY POINTS: • Deep convolutional neural network (DCNN) helps clinicians assess tumor features with accuracy. • Multicenter retrospective study shows that DCNN derived from pretreatment ultrasound imagine improves the prediction of breast cancer molecular subtypes. • Management of patients becomes more precise based on the DCNN model.

Economic burden of readmission due to postoperative cerebrospinal fluid leak in Chinese patients.

Aim: This real-world data study investigated the economic burden and associated factors of readmissions for cerebrospinal fluid leakage (CSFL) post-cranial, transsphenoidal, or spinal index surgeries. Methods: Costs of CSFL readmissions and index hospitalizations during 2014-2018 were collected. Readmission cost was measured as absolute cost and as percentage of index hospitalization cost. Factors associated with readmission cost were explored using generalized linear models. Results: Readmission cost averaged US$2407-6106, 35-94% of index hospitalization cost. Pharmacy costs were the leading contributor. Generalized linear models showed transsphenoidal index surgery and surgical treatment for CSFL were associated with higher readmission costs. Conclusion: CSFL readmissions are a significant economic burden in China. Factors associated with higher readmission cost should be monitored.

Assessment and Management of Urinary Dysfunction in 187 Patients with Parkinson's Disease.

BACKGROUND: Urinary dysfunction is common in Parkinson's disease (PD) patients and management options are limited. OBJECTIVE: This study aimed to explore the management of urinary dysfunction by researching the special needs of PD patients. METHODS: PD patients with urinary dysfunction who underwent urodynamic testing were recruited from a single center from October 2013 to February 2019. The urinary symptoms, International Prostate Symptom Score and Hoehn-Yahr scale were evaluated. Management was made at the urologists' discretion with follow-up after three weeks. Urinary symptoms, urodynamics and the management of urinary dysfunction were analyzed. RESULTS: A total of 187 patients with a median age of 66.2 and Hoehn-Yahr scale soccer of 2 were enrolled. Irritative symptoms were more common than obstructive symptoms, while obstructive symptoms were more common in male than female patients, except for incomplete voiding. There were 51% cases of detrusor overactivity, followed by 33% with bladder outlet obstruction, 13% had normal function, 12% had detrusor underactivity, 9% had stress incontinence, 7% had increased bladder sensation and 4% had an acontractile bladder. Tolterodine and tamsulosin were the most common therapeutic agents, respectively prescribed to 38.5% and 27.3% of the patients. Other treatments included catheterization, botulinum toxin A bladder wall injection, transurethral resection of the prostate and urethral dilatation. Urinary symptoms were improved significantly in 74.5% of the patients (p < 0.001), including 27 patients treated with tamsulosin only and 54 patients with tolterodine only. CONCLUSIONS: Urinary symptoms and urodynamics were highly variable in PD patients, indicating that most patients may benefit from personalized management.