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ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome, and to provide guidance for national medical decision-making, clinical drug promotion, and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (Trial Version, 2021) using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software, this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions, including safety pre- and post-market launch, effectiveness in treating migraine, economy (cost-effectiveness), and innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics in both its technology and clinical applications. ResultSafety: Duliang soft capsules were found to have good safety based on evidence from known adverse reactions (spontaneous reporting system (SRS) data, literature data, etc.), pre-marketing toxicological research, and post-marketing drug monitoring. Effectiveness: A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy: Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation: Duliang soft capsules, with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components, hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction (CO2 supercritical extraction technology) and formulation (soft capsule) processes. The product's innovation was rated as "Better". Suitability: A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility: Duliang soft capsules are moderately priced, making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics: The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio (Shi Zhai Bai Yi Xuan Fang) from the Song Dynasty, and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue (Jing Yue Quan Shu) as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch, and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness, suitability, and accessibility, and outstanding TCM characteristics. The product's safety, economy, and innovation received good ratings. In summary, Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics, the evidence was sufficient, and the result was confirmed, providing crucial references for clinical decision-making and pharmaceutical management.
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Objective To isolate endophytic fungi from Angelica sinensis and evaluate the bioactivity of their secondary metabolites.Methods Angelica sinensis and rhizosphere soil were utilized as materials.The tissue homogenization method was employed with six diverse culture media to isolate endophytic fungi.The antibacterial activity of secondary metabolites was gauged using a 96-well plate assay,while UV spectrophotometry was used to evaluate the inhibitory activity of four enzymes.Results A total of 153 fungal strains were isolated and purified from Angelica sinensis roots,stems,leaves,and soil.The samples exhibited specific inhibitory activities against adenosine deaminase(ADA),β-lactamase,xanthine oxidase(XO),and tyrosinase(TYR),with rates of 45.83%,52.78%,51.39%and 55.56%,respectively.Furthermore,1.39%of the samples displayed wide-ranging inhibitory effects against four indicator bacteria.Strain 6B also showcased the lowest inhibitory concentration values of 62.5 and 7.81 μg/mL against Escherichia coli ATCC25922 and ATCC35218,respectively,signifying its potential research significance.Conclusion Angelica sinensis has abundant endophytic fungal resources and is a good source for discovering active compounds,demonstrating certain research value.
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ObjectiveTo explore the comprehensive clinical value of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat stasis syndrome, and to provide evidence for the decision-making of clinical basic drug management. MethodBased on the "Guidelines for Comprehensive Clinical Evaluation of Drugs (Trial Version 2021)", this study systematically reviewed the existing research on the treatment of chronic prostatitis with damp-heat stasis syndrome by Qianlieping capsules. Based on evidence-based medicine, clinical epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, health statistics, health technology assessment, and other disciplines, the multi-criteria decision analysis model (MCDA) and CSC 2.0 software were used. The six dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility of drugs, as well as traditional Chinese medicine(TCM) characteristics, were comprehensively evaluated qualitatively and quantitatively. ResultIn terms of safety, based on the spontaneous reporting system (SRS) of the National Center for ADR Monitoring, safety literature analysis, pharmacological and toxicological experiment report, and other evidence, the safety grade of Qianlieping capsules was evaluated as grade A, with good safety. In terms of effectiveness, based on the results of pharmacological and pharmacodynamic studies and Meta-analysis, and combined with the value and quality of the evidence for efficacy, the final efficacy grade of Qianlieping capsules was rated as B. In terms of economy, Qianlieping capsules was a class B drug of national medical insurance. Compared with those of similar Chinese patent medicines, the average daily cost of Qianlieping capsules was moderate, and there was no related cost increase during the administration process. Economic research showed that Qianlieping capsules combined with α-receptor blockers were more economical than α-receptor blockers alone. Based on the quality evaluation of economic evidence and the value evaluation of economic evidence, the economic grade of Qianlieping capsules was rated as B. In terms of innovation, Qianlieping capsules were a combination of cold and warm drugs, focusing on clearing heat, detoxifying, removing blood stasis, and relieving pain, with non-toxic medicinal materials. They obtained a number of invention patents. The enterprise service system was perfect, and the quality standard was higher than the international and Chinese standards. The innovation grade of Qianlieping capsules was rated as B. In terms of suitability, the results of the questionnaire survey showed that it had relatively good suitability for clinicians, nurses, pharmacists, and patients who used Qianlieping capsules. The information on Chinese patent medicines was complete and met the requirements of national standards. The suitability grade of Qianlieping capsules was rated as A. In terms of accessibility, Qianlieping capsules were moderately priced and affordable, with sufficient resources of medicinal materials, no shortage of medicinal materials, and good availability. The accessibility grade of Qianlieping capsules was rated as B. In terms of TCM medicine characteristics, the prescription of Qianlieping capsules was derived from Danshen Huoxue Decoction. The original prescription was used for the treatment of chronic prostatitis with blood stasis syndrome. The whole formula was recorded in The Complete Compendium of Fine Formulas (《良方大全》) published by Beijing Publishing Group Co., Ltd. in 1991 and has been used for more than 30 years. The formula was a combination of warm and cold drugs, attacking pathogens without hurting healthy Qi. The grade of TCM characteristics of Qianlieping capsules was rated as B. ConclusionBased on the above "6+1" dimensions, the comprehensive evaluation result of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat and blood stasis syndrome is grade B, and it is recommended to convert it into the relevant policy results of basic clinical drug management according to the conditions.
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ObjectiveTo analyze factors related to the suspected allergic reaction of elememe emulsion injection based on hospital information system. MethodData on cases that used elememe emulsion injection were collected from the information systems of 60 first-class hospitals nationwide. The nested case-control design method was adopted. Finally, 30 cases were included in the suspected allergy group and 120 cases in the control group. SAS 9.3 was employed for descriptive analysis of the gender, age, occupation, admission route, conditions of patients at the admission, and the diagnosis with frequency and percentage. The factors affecting the occurrence of suspected allergic reaction were analyzed by conventional logistic regression and propensity score weighted logistic regression. In the case that the number of independent variables was larger than the sample number, MCP (minimax concave penalty) was used to screen the key variables and the conditions of patients at admission, conditions of patients during hospitalization, hospital stay, diagnostic information, and medication information were compared between two groups. ResultThe male-to-female ratio was about 2∶1 in both groups and most of the patients were 46-65 years old. Patients in the control group were mainly "professional and technical personnel", and the majority in the suspected allergy group were "business and service personnel" and "clerks and related personnel". They were mainly admitted at the outpatient and conditions of patients were average at the admission. Compared with the control group, suspected allergy group showed severe conditions during the hospitalization, short average hospital stay, large proportion with intravenous infusion, and low cure rate and effective rate. The results of logistic regression analysis showed no statistical difference in conditions of patients at admission, hospital stay, combined diseases, medicine dosage, and treatment course. ConclusionThe suspected allergic reaction of elememe emulsion injection mainly occurs in the first administration with rapid onset even with the dose lower than the commonly used one. The occurrence is related to the intravenous infusion and the severe conditions of patients during hospitalization and has nothing to do with the conditions of patients at admission, hospital stay, treatment course, use of other medicines, and diagnostic information. In summary, it is mainly related to the constitution and immune status of patients.
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Advent of Internet hospitals has optimized resource allocation and reduced cost of medical services, yet it also brought along challenges to physicians scheduling. The challenges are found mostly in two aspects.First, diversified service channels of physicians and fragmentation of their service time, result in the difficulty of physicians scheduling, and secondly, massive information as faced by patients causes confusion for them in selection of appropriate physicians. Based on analysis of the present physician management in Internet hospitals and theories of healthcare operations, this paper proposed an improvement path from the perspectives of data-driven, service channel coordination, short-term service capability design and intelligent matching of physician-patient information.
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PURPOSE: Several studies have compared the effects of coronary stenting and coronary-artery bypass grafting (CABG) on left main coronary artery (LMCA) disease. However, there are limited data on the long-term outcomes of these two interventions in diabetic patients. MATERIALS AND METHODS: We evaluated 56 patients with LMCA stenosis who underwent drug-eluting stent (DES) implantation and 116 patients who underwent CABG in a single hospital in China between January 2004 and December 2006. We compared long-term major adverse cardiac events (death; a "serious outcome" composite of death, myocardial infarction, or stroke; and target-vessel revascularization). RESULTS: In-hospital (30-day) mortality was 0% for the DES group and 3.4% for the CABG group (p=0.31). There was no difference between the two groups in terms of risk of death [hazard ratio for stenting group, 0.49; 95% confidence interval (CI), 0.13-1.63; p=0.55] or risk of serious outcome (hazard ratio for DES group, 1.11; 95% CI, 0.39-1.45; p=0.47). The target-vessel revascularization rate was higher in the DES group than in the CABG group (hazard ratio, 3.67; 95% CI, 1.24-11.06; p=0.018). CONCLUSION: In this cohort of diabetic patients with LMCA stenosis, there was no difference in composite endpoints between patients receiving DESs and those undergoing CABG. However, stenting was associated with higher rates of target-vessel revascularization than CABG. DES implantation in diabetic patients with LMCA disease was found to be at least as safe as CABG.