最新刊期
卷 33 ， 期 1 ， 2022
- 摘要：OBJECTIVE To provide referen ce for improving the application of health technology assessment （HTA） in decision-making for health insurance drugs in China. METHODS The application of HTA in decision-making for health insurance drugs in Britain ，France，Germany and Sweden were sorted out and analyzed from two aspects ：the establishment of HTA institutions and the process of HTA. The suggestions for improvement were put forward ，combined with the implementation of HTA in China. RESULTS & CONCLUSIONS Britain，France，Germany and Sweden have set up special HTA institutions ，which perform their respective duties and cooperate closely. During the implementation of HTA ，the above four countries have set different value assessment criteria to screen drugs with “high cost performance ”，all stakeholders actively participate ，make the evaluation results and decisions public ，set up objection handling links ，open a rapid evaluation channel to improve the accessibility of drugs ，and re-evaluate the drugs included in the reimbursement list to ensure the sustainability of medical insurance. It is suggested that China should combine the national conditions ，strengthen the cooperation of HTA institutions ，focus on talent training and comprehensive value assessment criteria ， promote stakeholder ’s participation ， improve the transparency of decision-making，and improve the implementation procedures of HTA in China.关键词：Health technology assessment;health insurance drug list;pricing and reimbursement
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provide reference for improving the techn ological innovation efficiency of biopharmaceutical enterprises in China. METHODS In this research ，the technological innovation process of the biopharmaceutical enterprises was divided into two stages ：the technological development and the achievement transformation. Two-stage data envelopment analysis （DEA） model was established under the premise of considering the two-stage correlation ，and the two-stage technological innovation efficiency of 23 listed biopharmaceutical enterprises in China was evaluated from 2016 to 2020 on the basis of hysteresis effect. RESULTS & CONCLUSIONS The two-stage technological innovation efficiency of listed biopharmaceutical enterprises in China was at a relatively low level ，and the average overall efficiency of the technological development stage and the achievement transformation stage were only 0.377 and 0.347. At present ，the low efficiency of technology is the main factor restricting the improvement of the two-stage technological innovation efficiency of listed biopharmaceutical enterprises in China. In the technology development stage ，redundant investment in R&D funds and insufficient patent output are the main reasons for the invalid DEA of listed biopharmaceutical enterprises ，while in the achievement transformation stage ，the redundant input of invention patents is the main reason for the invalid DEA of listed biopharmaceutical enterprises. From a regional perspective ，in the technology development stage ，the average overall efficiency and technical efficiency of listed biopharmaceutical enterprises in the eastern region are 0.378 and 0.603，which are higher than the central and western regions. In the stage of achievement transformation，the average values of comprehensive efficiency and technical efficiency of listed biopharmaceutical enterprises in the central and western regions are 0.361 and 0.548，which are higher than those in the eastern region. It is suggested that biopharmaceutical enterprises should enhance their ability to transform technological achievements ，optimize the allocation of scientific and technological resources ，attach importance to （No.2021GXJK332） regional cooperation and exchanges ， promote the overall innovation efficiency of biopharmaceutical industry in China.
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发布时间：2022-06-21 - 摘要：O BJECTIVE To investigate the e ffects of methyl ferulate （MF） on the mitochondrial function of H 9c2 cardiomyocytes after hypoxia-induced injury. METHODS H9c2 cardiomyocytes were divided into normal group （no administration，no modeling ），hypoxia model group （modeling alone ），MF high-dose ，medium-dose and low-dose groups （40， 20，10 μmol/L）and positive control drug group （cyclosporin A ，1 μmol/L）. After drug pretreatment and inducing hypoxia-induced injury，the levels of lactate dehydrogenase （LDH），malondialdehyde（MDA），creatine kinase （CK）and adenosine triphosphate （ATP）were tested. The intracellular reactive oxygen species （ROS），mitochondrial membrane potential （MMP），the opening of mitochondrial membrane permeability transition pore （mPTP） were detected with flow cytometry. RESULTS Compared with hypoxia model group ，the levels of LDH ，MDA，CK and ROS fluorescence intensity were decreased significantly in MF high-dose，medium-dose and low-dose groups ，while the level of ATP was increased significantly （P＜0.01 or P＜0.05）. The red/ green fluorescence intensity ratio of MMP and the green fluorescence intensity of mPTP were increased significantly （P＜0.01 or P＜0.05）. CONCLUSIONS MF can reverse the levels of biochemical indexes in H 9c2 cardiomyocyte after hypoxia-induced injury，keep MMP stable ，reduce the opening of mPTP ，and has an obvious protective effect on the mitochondrial function of H9c2 cardiomyocytes injured by hypoxia ，and this protective effect is dose-dependent.关键词：methyl ferulate;Myocardial ischemia;hypoxia-induced injury;Mitochondria;H9c2 cardiomyocytes
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发布时间：2022-06-21 - 摘要：OBJECTIVE To s tudy the impr ovement effects of tilianin on the atherosclerosis （AS）model mice and its potential mechanism. METHODS Eight C 57BL/6J mice were taken as the normal group. Forty ApoE－/－ mice were randomly divided into model group ，tilianin low-dose ，medium-dose and high-dose groups [ 2.1，3.5，7.0 mg/（kg·d）] and simvastatin group [positive control drug ，3.5 mg/（kg·d）]，with 8 mice in each group. Normal group was given normal diet ，and other groups were given high-lipid diet to induce AS model. At the same time ，normal group and model group were given normal saline intragastrically ， administration groups were given relevant drug intragastrically ，once a day ，for 12 consecutive weeks. The levels of TC ，TG， LDL-C，HDL-C，Ox-LDL，IL-1β，IL-6，MCP-1 and TNF-α in plasma were determined. The pathomorphological changes of the aorta in mice were observed. The positive rate of ICAM- 1，VCAM-1 and PCNA in the aorta were determined. mRNA expressions of MMP- 2，MMP-9，TGF-β1，Smad2 and Smad 3 as well as protein expressions of TGF-β1，Smad2/3 and p-Smad 2/3 were also determined in aorta of mice. RESULTS Compared with normal group ，the plasma levels of TC ，TG，LDL-C，Ox-LDL，IL-1β， IL-6，MCP-1 and TNF-α in model group were increased significantly（P＜0.01），while HDL-C level was significantly reduced （P＜0.01）. Lipid plaques were formed in the aorta ，and the plaque area was large and caused severe stenosis of the lumen. mRNA expressions of MMP- 2，MMP-9，TGF-β1，Smad2 and Smad 3 as well as positive rate of ICAM- 1，VCAM-1，PCNA and protein expression TGF-β1，Smad2/3，and p-Smad 2/3 in the aorta were significantly increased （P＜0.01）. Compared with model group ， most of above indexes of medication groups were improved significantly （P＜0.05 or P＜0.01）. CONCLUSIONS Tilianin can inhibit the activation of TGF-β1/Smads signaling pathway and then inhibit the proliferation of vascular smooth muscle cells ，reduce ， inflammation and regulate lipid metabolism to inhibit the No.81960766） formation of AS.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To improve the quality standard of T ibetan medicine of Qinjiaohua ，and to provide scientific basis for comprehensive quality evaluation. METHODS The qualitative analysis of 16 batches of Qinjiaohua with different producing areas and different origins was carried out by microscopic and TLC identification. According to the method stated in 2020 edition of Chinese Pharmacopoeia ，water content ，total ash content ，acid-insoluble ash content and alcohol-soluble extract content were determined. HPLC method was used to determine the contents of 5 components （loganic acid ，swertiamarin，gentiopicrin， swertionolin，isoorientin） in Qinjiaohua. RESULTS The medicinal powder of Qinjiaohua was light brown-yellow ，and the microscopic features of the powder were clear ，and pollen grains ，ducts，non-glandular hairs ，corolla epidermal cells and calyx epidermal cells were all found. The results of TLC indentification showed that there were fluorescent spots of the same color in the chromatogram of the tested product and the corresponding position of substance control （isoorientin）. The content ranges of water content，total ash content ，acid-insoluble ash content and alcohol-soluble extract were 5.40％-8.87％，3.76％-6.40％，0.27％-0.58％， 26.81％-42.51％，respectively. The results of content determination methodology met the requirements of pharmacopoeia ；the content ranges of loganic acid ，swertiamarin，gentiopicrin，swertionolin and isoorientin in 16 batches of Qinjiaohua were 3.13-9.36，1.26-22.39，13.80-74.60，1.24-12.22，2.58-14.96 mg/g，respectively. CONCLUSIONS On the basis of the original quality standard of Qinjiaohua ，microscopic identification ，TLC identification ，content determination and examination items of water，total ash ，acid-insoluble ash and alcohol-soluble extract are added. It is preliminarily proposed that water content ，total ash content and acid-insoluble ash content should not exceed 9.0％，6.5％ and 0.6％，while the contents of ethanol-soluble extract and gentiopicrin should not be less than 26.0％ and 13.8 mg/g，respectively.关键词：Qinjiaohua;Quality standard;microscopic identification;TLC;HPLC;Content determination
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the spectru m-toxicity relationship of in vitro hepatotoxicity of aqueous extract from Euodia rutaecarpa. METHODS The aqueous extract from 16 batches of E. rutaecarpa from different habitats were prepared. The fingerprints of aqueous extract from E. rutaecarpa were established by ultra high performance liquid chromatography （UPLC） method and Similarity Evaluation System of TCM Fingerprint （2012A edition ），and common peaks were identified and the similarity was evaluated. Using normal human hepatocytes L 02 as subject ，inhibitory effect of aqueous extract from 16 batches of E. rutaecarpa to them were investigated. The spectrum-toxicity relationship of UPLC fingerprint of aqueous extract from E. rutaecarpa with the hepatotoxicity of hepatocytes L 02 was analyzed by grey relational analysis （GRA）and partial least squares regression analysis （PLSR）. The corresponding compound of the chromatographic peak with the greatest correlation with the in vitro hepatotoxicity of E. rutaecarpa were isolated ，prepared and identified. RESULTS There were 27 common peaks in UPLC fingerprints of aqueous extract from 16 batches of E. rutaecarpa ，with similarity of 0.375-0.995. Totally 9 peaks were confirmed ，i.e. neochlorogenic acid （peak 5），chlorogenic acid （peak 9），cryptochlorogenic acid （peak 10），caffeic acid （peak 12），rutin （peak 16），hyperin（peak 17），dehydroevotarine（peak 19），evotarine（peak 24），rutecarpine（peak 25）. The aqueous extract from 16 batches of E. rutaecarpa showed significant inhibitory effect on the growth of L 02 cells（P＜0.05 or P＜0.01），and the inhibitory rate ranged from 6.68％ to 67.95％. GRA showed that there were 18 common peaks with correlation degree greater than 0.8，which were peak 8＞peak 3＞peak 23＞peak 7＞peak 4＞peak 9＞peak 12＞peak 2＞peak 19＞peak 6＞ 4928381。E-mail：799247687@qq.com peak 15＞peak 5＞peak 1＞peak 17＞peak 21＞peak 26＞ peak 20＞peak 14 in descending order of correlation degree. PLSR showed that there were 14 peaks with regression coefficient＞0 and variable importance projection value ＞1，and the order of regression coefficient was peak 8＞peak 3＞peak 23＞ peak 2＞peak 7＞peak 4＞peak 12＞peak 9＞peak 19＞peak 5＞peak 17＞peak 26＞peak 10＞peak 15. Peak 8 had the greatest correlation with in vitro hepatotoxicity，and the corresponding compound of this peak was identified as 6-O-trans caffeoyl gluconic acid. CONCLUSIONS The in vitro hepatotoxicity of aqueous extract from E. rutaecarpa is the result of multiple component interaction，among which 6-O-trans caffeoyl gluconic acid shows closest relation with in vitro hepatotoxicity.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the absorbed components of Xiebai powder in blood. METHODS UPLC-Q-TOF-MS/MS method was adopted. SD rats were randomly divided into blank group and administration group ，with 10 rats in each group. Blank group was given water intragastrically ，and administration groups were given 2 g/mL（by the amount of crude drug ）Xiebai powder solution intragastrically. Administration volume was 11.3 mL/kg，twice a day for 3 days. One point five hours after last administration，blood was taken from the abdominal aorta of each rat ，the serum was processed to obtain the supernatant for analysis；the relevant data in positive and negative ion mode were collected ，and the absorbed components of Xiebai powder in blood were analyzed and identified by using self-built secondary mass spectrometry database and consulting the relevant literature. RESULTS Totally 17 components from Xiebai powder were identified ，among which 6 components came from sovereign Moru salba，7 from minister Cortex Lycii ，12 from assistant Glycyrrhiza uralensis ，i.e. kukoamine A ，chlorogenic acid ，tachiogroside B，astringin，neoglycyrrhizin，glycyrrhizin，azelaic acid ，isoglycyrrhizin，glycyroside，anthocyanin，sebacic acid ，parthenolide， anthocyanin，18β-glycyrrhetinic acid ，6-gingerol，palmitoamide，erucamide. These compounds were mainly flavonoids ，alkaloids and organic acids. CONCLUSIONS In this study ，17 absorbed components of Xiebai powder in blood are preliminarily determined，which are consistent with the effect of Xiebai powder. They may be the pharmacodynamic substances of Xiebai powder.关键词：Xiebai powder;UPLC-Q-TOF-MS/MS;absorbed component;Rat
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the effects of Tibetan medi cine Shanhu qishiwei pill in lowering blood lipid of hyperlipidemia（HLP）model rats ，and to explore its mechanism primarily. METHODS According to their body weigh ，60 SD rats were randomly divide into normal group ，model group ，simvastatin group （positive control ，20 mg/kg）and Shanhu qishiwei pill low-dose，medium-dose and high-dose groups （50，100，200 mg/kg），with 10 rats in each group. Normal group was given conventional diet ，and other groups were given high-lipid diet to induce HLP model ，for consecutive 4 weeks. Administration groups were given relevant medicine intragastrically at the same time of modeling ；normal group and model group were given equal volume of normal saline intragastrically ，once a day ，for consecutive 4 weeks. After last administration ，the serum levels of TC ，TG， LDL-C and HDL-C were determined ；pathological changes of liver tissue were observed ；the protein expressions of AMPK ， p-AMPK，LKB1，and HMGCR in liver tissue were detected in each group. RESULTS Low-dose，medium-dose and high-dose of Shanhu qishiwei pill could significantly reduce the serum levels of TC ，TG and LDL-C and protein expression of HMGCR in liver tissue（P＜0.05），while significantly increased serum level of HDL-C ，phosphorylation level of AMPK ，protein expression of LKB 1 in liver tissue in HLP model rats （P＜0.05）；the pathological changes of liver tissue in HLP model rats were improved to different extents. CONCLUSIONS Shanhu qishiwei pill can reduce the blood lipid level of HLP model rats ，and its mechanism may be related to inhibiting the transmission of LKB 1/AMPK signal pathway and regulating lipid metabolism.关键词：Shanhu qishiwei pill;Hyperlipidemia;LKB1;AMPK1;HMGCR
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the grade s tandard for Panax quinquefoli um and to evaluate the quality of different grades of medicinal materials. METHODS Totally 24 batches of P. quinquefolium were used as test samples. Pearson correlation analysis method was used to analyze the correlation between qualitative analysis indicators （taproot length ，taproot diameter and weight of single root ）and internal component indicators （ethanol-soluble extract ，and the contents of ginsenoside Rg 1，ginsenoside Re ， ginsenoside Rb 1，ginsenoside Rc ，ginsenoside Rb 2，ginsenoside Rd ，pseudo-ginsenoside F 11）. Combined with chemometrics methods，the reference indexes for the classification of P. quinquefolium were selected ，and the classification standards were formulated. HPLC-ELSD fingerprints of 24 batches of P. quinquefolium were established and their similarity evaluation was also performed. The chromatographic peaks were identified by comparison with the reference substance ，and then the quality of different grades of P. quinquefolium was evaluated by cluster analysis. RESULTS After screening ，taproot diameter ，the weight of single root and the content of ginsenoside Rd were taken as the reference indexes for the classification of P. quinquefolium . According to above 3 indexes，P. quinquefolium were divided into 3 grades：special grade ，first grade and second grade. According to the center value of K-means clustering ，the total score of special-grade medicinal materials was more than 135.40，that of first-grade medicinal materials was 61.82-135.40，and that of second-grade medicinal materials was less than 61.82. In the HPLC-ELSD fingerprints of 24 batches of P. quinquefolium ，25 common peaks were confirmed ，and 7 characteristic peaks were identified. The similarity of the chromatograms of P. quinquefolium of special grade ，first grade and second grade with fingerprints ranged 0.980-0.989，0.962-0.968，0.940-0.949，respectively. The results of cluster analysis showed that different grades of P. quinquefolium could be identified significantly. CONCLUSIONS The grade standard and HPLC-ELSD fingerprints of P. quinquefolium are established，which can be applied for exclusive identification of P. quinquefolium ，and provide reference for its quality control and grade classification.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To prepare apigenin silk fibroin（API@SF）nanoparticles and to evaluate their safety and anti-tumor activity. METHODS API@SF nanoparticles were prepared by nanoprecipitation method ，and their morphology ，particle size ，Zeta potential，drug loading amount and in vitro release were characterized. The safety of nanoparticles was evaluated by hemolysis test and HE staining. MTT assay was adopted to evaluate inhibitory effects of API@SF nanoparticles on breast cancer 4T1 cells in mice. RESULTS The prepared API@SF nanoparticles were spherical with uniform distribution. The average particle size was 406.61 nm， the polydispersity index was 0.154，the Zeta potential was －18.4 mV，and the average drug-loading amount was 5.20％. The in vitro release results showed that the release rate of the nanoparticles was relatively fast in the release medium of pH 5.0 and relatively slow in the release medium of pH 7.4. Results of hemolysis test and HE staining showed that the nanoparticles had good biocompatibility. Results of MTT assay showed that the inhibitory effect of API@SF nanoparticles on 4T1 cells was significantly higher than that of API raw materials （P＜0.05），and its mechanism may be related to increasing the level of reactive oxygen species in cells. CONCLUSIONS API@SF nanoparticles are prepared successfully ，which possess good safety and anti-tumor activity.关键词：Apigenin;silk fibroin;Nanoparticles;Preparation;Safety;anti-tumor activity
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the mitigation effect and its possible mechanism of Astragalus membranaceus polysaccharide on the pulmonary hypertension induced by monocrotaline in rats. METHODS One hundred SD male rats were randomly divided into normal control group ，monocrotaline group ，A. membranaceus polysaccharide low-dose and high-dose groups. In addition to the normal control group, rats in other groups were injected with monocrotaline by single intraperitoneal injection of 60 mg/kg. On days 2 to 28 after administration ，rats in the A. membranaceus polysaccharide low-dose and high-dose groups were intraperitoneally injected with A. membranaceus polysaccharide of 200 mg/kg and 400 mg/kg，respectively，once a day. There were 25 rats in each group，and 15 rats were taken for index detection. The mean pulmonary artery pressure （mPAP）and right heart hypertrophy index （RVHI）were detected ，and morphology changes of pulmonary artery and cardiomyocytes were monitored . mRNA and protein expression of IL- 17 in their lung tissues were detected. RESULTS Compared with normal control group ，mPAP and RVHI of monocrotaline group and A. membranaceus polysaccharide groups were increased significantly （P＜0.01）；mRNA and protein expression of IL- 17 in lung tissues were significantly increased （P＜0.01），and there were obvious pathological changes in pulmonary artery and cardiomyocytes. Compared with monocrotaline group ，mPAP and RVHI were significantly decreased in A. membranaceus polysaccharide groups （P＜0.01），while mRNA and protein expression of IL- 17 in lung tissue were decreased significantly （P＜0.01）；pathological changes in pulmonary artery and cardiomyocytes were improved. Compared with A. membranaceus polysaccharide low-dose group ，above indexes and pathological changes were improved significantly in high-dose group. CONCLUSIONS A. membranaceus polysaccharide can reduce monocrotaline-induced pulmonary hypertension ，improve pulmonary artery structure and myocardial remodeling in rats ， the mechanism of which is presumably related to the down-regulation of IL- 17 expression in lung tissue of rats.
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发布时间：2022-06-21 - 摘要：OB JECTIVE To establish the quality standard of Kuipingning gastric floating tablets. METHODS Kuipingning gastric floating tablets were prepared and investigated in terms of property ，weight difference and friability. Crydalis yanhusuo was identified qualitatively by thin layer chromatography （TLC）method. High performance liquid chromatography method was used to determine the content of total anthraquinones in Rheum palmatum ，and set the content limit of total anthraquinones. The floating performance and release degree of the preparation were investigated ，and the release kinetic process was fitted. RESULTS Kuipingning gastric floating tablets prepared in this study were gray white to gray tablets with slight smell and bitter taste ；the weight difference and friability were all in line with relevant regulations ；the established TLC method possessed strong specificity and could accurately identify C. yanhusuo . The average content of total anthraquinones in R. palmatum was 17.95 mg/tablet，and its content limit would not be less than 14.36 mg/tablet. The initial floating time of the preparation was no more than 10 s，and the holding time was more than 8 h. The release kinetics process accorded with the Retger-Peppas release model. CONCLUSIONS The method established in this study shows good reliability ，stability and feasibility ，and can effectively control the quality of Kuipingning gastric floating tablets.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the clinical characteristics of leflunomide-induced int erstitial pneumonia （Lef-IP），and to provide reference for its clinical diagnosis ，treatment and prevention. METHODS Lef-IP cases published in domestic and foreign journals from January 2004 to June 2021 were collected. Relevant information of patients were extracted and analyzed retrospectively， including basic characteristics ，clinical manifestations ，imaging manifestations ，laboratory examinations ， histopathological examinations ，treatment and outcome. RESULTS A total of 54 Lef-IP patients from case reports of 24 publications were included ，with a median age of 61 years（9-83 years）. Pulmonary symptoms appeared from 3.3 weeks to 132.9 weeks（median time of 14.5 weeks）. Patients with a loading dose of leflunomide have a shorter median time to pulmonary symptoms appearing （7.5 weeks）. The main clinical manifestations were dyspnea （85.2％），cough（57.4％），fever（53.7％）. CT imaging examination showed 19 cases with ground-glass shadow in both lungs ，and 29 cases showed interstitial infiltration in both lungs on chest radiograph；blood gas analysis showed hypoxemia and hypocapnia ；the levels of C-reactive protein and Krebs von Den lungen- 6 （KL-6）increased；histopathological examination mainly showed interstitial pneumonia （8 cases），including 3 cases of diffuse alveolar injury ，4 cases of lymphocytes in bronchoalveolar lavage fluid ，and 1 case of noncaseating granuloma. After discontinued leflunomide and symptomatic treatment （antibiotics，hormones，colecenamine，plasma exchange ），35 patients（64.8％）recovered or improved their lung symptoms. Twelve patients （22.2％）died，and patients with fever may had a higher mortality rate （34.5％， P＝0.02）. CONCLUSIONS The main clinical manifestations of Lef-IP are dyspnea ，cough and fever. Loading doses of leflunomide should be avoided at the beginning of treatment. When lef-IP occurs ，leflunomide is discontinued and corresponding treatment is given，and most of the patients ’pulmonary symptoms can return to normal or be improved.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To eval uate the effectiveness ，safety and economy of deferasir ox for the treatment of iron overload in thalassemia with rapid health technology assessment ，and to provide evidence-based basis for rational clinical use. METHODS Retrieved from Chinese and English database/website as PubMed ，Embase，Cochrane Library ，NHS EED ，CADTH，CNKI and Wanfang database ，health technology assessment （HTA），systematic evaluation/meta-analysis and pharmacological studies about deferasirox versus deferoxamine/deferiprone for the treatment of iron overload in thalassemia were collected from the inception to June 2021. Based on literature screening and data extraction ，the quality of literature about HTA reports ，systematic evaluation/ Meta-analysis and pharmacoeconomic research were evaluated with HTA checklist ，A Measurement Tool to As sess Systematic Reviews，standard scale of economic evaluation report. The effectiveness and safety results were described quantitatively ，and the economic evaluation results were described qualitatively. RESULTS One HTA report ，five systematic evaluation/meta-analysis and five pharmacoeconomic studies were selected from 1 569 literature. Included HTA reports ， systematic evaluation/meta-analysis，pharmacoeconomic studies were high in quality. Most studies reported that 30 mg/（kg·d） deferasirox was E-mail：aydgs@126.com better than deferoxamine in reducing the levels of s erum ferritin and liver iron overload ；ADR induced by deferasirox were mainly gastrointestinal irritation symptoms ，skin itching ，joint pain，transaminase elevation ，etc.，which generally did not affect subsequent treatment. There was no statistical significance in severe ADR between deferoxamine group and deferasirox group [RR ＝0.96，95％CI（0.85，1.08），P＝0.52]. Compared with deferoxamine，deferasirox had higher cost-effectiveness ；but deferasirox was less likely to be cost-effective than deferiprone. CONCLUSIONS Deferasirox has good effectiveness and safety for iron overload in thalassemia ，and has good economic advantages in Britain and Iran ，compared with deferoxamine.关键词：deferasirox;iron overload in thalassemia;Rapid health technology assessment
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发布时间：2022-06-21 - 摘要：OBJECTIVE To conduct the pharmacoeconomic evaluation of empagliflozin in the treatment of heart failure with reduced ejection fraction （HFrEF），and to provide evidence-based reference for rational drug use and medical and healthy decision-making. METHODS A Markov model was used to perform a cost-effectiveness analysis of the regimen of empagliflozin in the treatment of HFrEF ，and to evaluate the cost and effectiveness of standard treatment plan plus empagliflozin （empagliflozin group）vs. standard treatment plan （standard treatment group ）. Clinical parameters were obtained from the EMPEROR-Reduced study；cost and utility data came from the published literatures. The cycle of the model was 1 month and the simulation time was 20 years. Single-factor sensitivity analysis and probability sensitivity analysis were performed to validate the results of cost-effectiveness analysis. RESULTS Compared with the standard treatment group ，each additional quality-adjusted life year in the empagliflozin group cost 37 995.94 yuan more ，which was less than China ’s 1 time GDP per capita in 2020（72 447 yuan）. The results of single factor sensitivity analysis showed that steady-state hospitalization rate of 2 groups was the most important factor affecting the incremental cost-effectiveness ratio . The results of probability sensitivity analysis showed that when the willingness-to-pay threshold （WTP）was 1 time GDP per capita in 2020（72 447 yuan），the probability of empagliflozin group with cost-effectiveness advantage was 58.8％；when the WTP was 3 times GDP per capita in 2020（217 341 yuan），the probability of empagliflozin group with cost-effectiveness advantage was 63.8％. CONCLUSIONS Compared with standard treatment plan alone，standard treatment plan plus empagliflozin is more cost-effective in the treatment of HFrEF. However ，the economic probability is not high.关键词：empagliflozin;heart failure with reduced ejection fraction;Cost-effectiveness analysis;Pharmacoeconomics
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发布时间：2022-06-21 - 摘要：OBJECTIVE To observe the effects of Xuesaitong soft capsule on the complement-inflammatory receptor system in patients with type 2 diabetic nephropathy. METHODS A total of 92 patients with type 2 diabetic nephropathy were divided into control group and observation group by random number table method ，with 46 cases in each group. Patients in the control group were given basic treatment programs （including low-salt and low-protein diet ，quitting smoking and alcohol ，appropriate exercise ， lowering blood pressure ，blood sugar and lipid ，etc.）. The patients in the observation group took Xuesaitong soft capsules orally on the basis of the treatment of the control group ，0.55 g each time ，3 times a day. The treatment course of both groups was 4 weeks. Compare the renal function of the two groups of patients [24 h urine protein quantification ，serum creatinine （Scr），blood urea nitrogen，glomerular filtration rate （GFR）]，fasting blood glucose ，glycosylated hemoglobin ，complement factors [C3，C5， complement factor H （CFH），C5b-9]，inflammatory factors [interleukin 1（IL-1），tumor necrosis factor α（TNF-α），IL-6，monocyte chemoattractant protein- 1（MCP-1）]，renal tubular injury markers [β2-microglobulin（β2-MG），retinol binding protein 4（RBP4）， neutrophil gelatinase associated lipocalin] levels；correlation between renal tubular damage and complement-inflammatory receptor system was analyzed in the observation group before and after treatment. RESULTS Compared with before treatment ，24 h urine protein quantity ，Scr，C3，IL-1，TNF-α，MCP-1，β2-MG and RBP 4 of 2 groups were reduced significantly after treatment ，while GFR and CFH were significantly increased ；except for C 3，the observation group was significantly better than the control group （P＜ 0.05）. C 5 of the observation group was significantly decreased after treatment and was significantly lower than the control group （P＜0.05）. There were no statistically significant 60979837。E-mail：shanght126@126.com differences in other indicators of the two groups before and after treatment and between groups （P＞0.05）. C 3，MCP-1 and TNF-α were significantly correlated with renal tubular com damage （P＜0.05），and esp ecially C 3. CONCLUSIONS Xuesaitong soft capsule can reduce renal tubular damage in patients with type 2 diabetic nephropathy and improve renal function by acting on the complement system and reducing inflammation.关键词：Xuesaitong soft capsule;diabetic nephropathy;complement-inflammatory receptor system;Type 2 diabetes
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发布时间：2022-06-21 - 摘要：OBJECTIVE To re-eval uate the systematic review and meta-an alysis of umeclidinium bromide and vilanterol trifenatate（UMEC/VIL）in the treatment of chronic obstructive pulmonary disease （COPD），so as to provide evidence-based basis for the treatment of COPD. METHODS Retrieved from PubMed （Medline），the Cochrane library ，Embase，CNKI，CBM，VIP and Wanfang database ，etc.，the systematic review and meta-analysis of UMEC/VIL in the treatment of COPD were collected from the inception to Apr. 2021. Two reviewers independently screened the literatures and extracted the data. AMSTAR 2 scale，PRISMA statement，and GRADE evaluation system were used to evaluate the methodological quality of the included studies ，the quality of reports and the grade of outcome indexes. The efficacy and safety of UMEC/VIL in the treatment of COPD were reported. RESULTS Six systematic reviews were finally included. The results of AMSTAR 2 scale showed that 1 study was of high quality ， 2 were of medium quality and 3 were of low quality. The score of PRISMA statement was between 21.5 and 27，and the quality of the report was relatively perfect. The results of GRADE evaluation showed that more than 60％ of the 134 outcome indicators were of medium to high quality of evidence. Comparison of effectiveness and safety showed that UMEC/VIL was superior to placebo ， unilateral bronchodilator and salmeterol fluticasone in improving forced expiratory volume in one second （FEV1）trough，FEV1 peak and forced vital capacity （FVC）. In the improvement of transition dyspnea index （TDI），SGRQ and SOBDA scores ，UMEC/ VIL was better than placebo ，unilateral bronchodilator and fluticasone propionate/salme terol. The adverse reaction rate ，acute exacerbation rate ，mortality rate ，withdrawal rate ，pneumonia rate and other negative indicators of UMEC/VIL were not inferior to placebo，unilateral bronchodilator and fluticasone propionate/salme terol. CONCLUSIONS Compared with placebo and unilateral bronchodilator，UMEC/VIL can significantly improve lung function ，symptoms and quality of life ，and has non-inferior effect for negative indicators. Compared with β2 adrenoceptor agonists combined with glucocorticoid ，UMEC/VIL can improve lung function of COPD patients ，but they are similar in other aspects.
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发布时间：2022-06-21 - 摘要：OBJECT IVE To deeply unders tand the utilization of monoclonal antibody drugs in different levels of medical institutions in China ，so as to provide an empirical basis for further promoting tiered healthcare delivery system. METHODS The basic informations of listed monoclonal antibody drugs in China as of May 2021 were collected through the official websites of government agencies such as National Medical Products Administration and National Healthcare Security Administration ，so as to understand the overall development status of monoclonal antibody drugs in China. The clinical utilization data of monoclonal antibody drugs in all categories of antitumor drugs and immune modulators were collected through “chemical drug terminal of Chinese public medical institutions ”database of Metnet ；the clinical application of monoclonal antibody drugs in medical institutions at different levels was analyzed. RESULTS As of May 2021，there were 53 monoclonal antibody drugs had been approved for listing in China ，including 31 imported monoclonal antibody drugs and 22 domestic monoclonal antibody drugs. From 2015 to 2019，the amount and quantity of monoclonal antibody drugs used in urban medical institutions were the highest among the three levels of medical institutions （both accounted for more than 95％ for five consecutive years ），but the growth rate of drug use in county-level medical institutions was the fastest. In 2019，the cumulative proportion of DDDs and drug amount of the top 10 monoclonal antibody drugs ranked in DDDs were the highest among county-level medical institutions ，being 97.09％ and 94.16％ respectively. From the change trend of DDDc of monoclonal antibody drugs from 2015 to 2019，DDDc of cetuximab decreased the most （70.32％），followed by trastuzumab （67.29％） and bevacizumab（62.89％）. From 2015 to 2019，the number of monoclonal antibody drugs with B/A value of no less than 1 ranked the top 10 of the annual cost were 6，6，6，7 and 5， respectively. CONCLUSIONS In China ，the overall approval and listing speed of monoclonal antibody drugs has accelerated，their quantity has increased rapidly ，and the accessibility is also improved. Among them ，the quantity of monoclonal antibody drugs has increased the fastest in county-level medical institutions ，and they are mainly medical insurance drugs ，and the effect of tiered healthcare delivery system has gradually appeared.关键词：monoclonal antibody drugs;drug utilization;tiered healthcare delivery;Medical institution
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发布时间：2022-06-21 - 摘要：OBJECTIVE To explore the role of the establishment of the trans-regional review system on rational drug use in second-grade general hospital ，and to promote the rational drug use. METHODS With the administrative support of Jiuquan Health Commission，5 second-grade general hospitals in Jiuquan Medical Association jointly established Jiuquan Rational Drug Use Review Training Center . A trans-regional review system was established to carry out cross-review of prescriptions and medical orders among 5 second-grade general hospitals. Totally 1 500 prescriptions and 900 medical records were collected from 5 second-grade general hospitals before （April to June ，2020）and after （July to September ，2020）the implementation of the project. The changes of rational drug use indicators ，the results of prescriptions and medical order review were investigated before and after the implementation of the project. RESULTS After the implementation of the project ，except for one hospital ，the proportion of drugs in other hospitals decreased to varying degrees with the highest decline rate of 22.56％ . Compared with before the implementation of the project ，reasonable rate of outpatient and emergency prescription review increased by 5.72％ averagely and the reasonable rate of medical order review increased by 10.10％（P＜0.05）. The average utilization rate of antibiotics in outpatients decreased by 14.45％，the average utilization rate of antibiotics in inpatients decreased by 7.98％，and the average use intensity of antibiotics decreased by 25.19％. CONCLUSIONS Through the establishment of trans-regional review system ，medical institutions can be forced to pay more attention to prescription review ，effectively improve the prescription review of pharmacists in medical institutions，and promote the rational use of drugs in medical institutions in the region. However ，there are still some problems ， such as incomplete system coverage ，insufficient work experience ，lagging of informatization ，uneven pharmacist level ，and insufficient assessment and supervision of administrative functional departments.关键词：Prescription review;trans-regional review;second-grade general hospital;Rational drug use;intervention
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发布时间：2022-06-21 -
Bibliometric analysis of status quo and hot spots of domestic and foreign pharmacovigilance research
摘要：OBJECTIVE To investigate th e status quo and hot spots of domestic and foreign pharmacovigilance research ，so as to provide reference for scientific evaluation of drug safety. METHODS Relevant literature were searched from Web of Science and CNKI during the inception to Mar. 31st，2021. Excel 2019 software and CiteSpace 5.7R2 software were used to visualize and analyze the co-occurrence ，clustering and burst of annual document volume ，researchers，countries/regions，institutions and keywords. RESULTS & CONCLUSIONS A total of 5 422 foreign literature and 966 domestic literature were included ，with an increasing trend year by year. The cooperation between foreign researchers was relatively close ，while the cooperation between domestic researchers was less. A close network of cooperation was set up ，mainly in Europe and the United States. China although the late start ，but since 2018，there was a relatively rapid development trend and has continued so far. In domestic literature ，the organizations with a large number of published literature were mainly national medicine regulatory authorities ，research institute ， colleges and universities ，the cooperation of them was relatively weak. ADR ，drug safety and relevant risk factors are the research hotspots of pharmacovigilance abroad ；the frontier mainly focuses on pharmacovigilance research for vaccines ，drugs and therapeutic methods. The current research hotspot in China is ADR ，and special attention is paid to the safety of traditional Chinese medicine. The establishment of pharmacovigilance system of “Drug Marketing Authorization Holders ”is the research frontier. In the process of drug safety evaluation ，attention should be paid not only to the monitoring and reporting of ADR ，but also to the evaluation and application of multi-link and multi-dimensional research evidence of pharmacovigilance ，so as to effectively promote safe and rational drug use.关键词：Pharmacovigilance;Safety;ADR;Bibliometrics;CiteSpace- 128
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发布时间：2022-06-21 - 摘要：Alzheimer’s disease （AD）is a common latent neurodegenerative disease ，which is characterized by cognitive impairment，loss of learning and memory function ，abnormal behavior and dementia. At present ，there is no specific drug to effectively prevent or reverse AD. Gardenia jasminoides is the dried and mature fruit of G. jasminoides J. Ellis ，a gardenia plant in Rubiaceae. Its chemical components mainly include iridoids ，triterpenoids，organic acids and volatile oils ，among which iridoids are the main active components of G. jasminoides . This paper summarizes the researches on the mechanism of iridoids from G. jasminoides against AD at home and abroad in recent years ，in order to provide reference for the development of new drugs against AD.关键词：Alzheimer’s disease;Gardenia jasminoides;iridoids;geniposide;Mechanism
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发布时间：2022-06-21
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