SHEN Yueyue,LIU Pengcheng,LUO Xueyan,QI Minyou,YUAN Quan
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To evaluate th e effects of comprehensive drug cost control in China ,and to provide reference for further improving the effects of cost control. METHODS Entropy method was used to establish a comprehensive evaluation index system of the comprehensive drug cost control effect from the respective of drug price control ability ,drug cost control ability and patient affordability. The comprehensively evaluate the effects of drug cost control in 31 provinces (autonomous regions and municipalities)during 2016-2020. The k-means cluster method was used to analyze the effects of comprehensive drug cost control in various provinces. RESULTS & CONCLUSIONS During the period of 2016-2020,the total score of comprehensive drug cost control effect of 31 provinces were 14.64,16.71,17.58,17.57,17.88,respectively. The results of cluster analysis were similar to the ranking of entropy method. Medical and health system reform policy had entered a stable period after achieving phased results ; the effects of comprehensive drug cost control was characterized by regional steps in 31 provinces;the effects of comprehensive drug cost control were better in developed coastal areas and some provinces and cities of western regions ,followed by provinces and cities in central China ;however,comprehensive drug cost control in 3 provinces of northeast China showed poor effect. The effects of comprehensive drug cost control in pilot cities of comprehensive medical reform were significantly improved. It is suggested that the successful experience of pilot cities of comprehensive medical reform should be promoted nationwide ,and policies such as volume-based drug procurement ,medical insurance drug price negotiation ,and diagnosis-related groups / diagnosis-intervention packet payment method reform should be further deepened.
关键词:comprehensive drug cost control;effect e valuation;entropy method;Cluster analysis
摘要:OBJECTIVE To provide reference for improving resource carrying capacity of pharmaceutical industry and guaranteeing the healthy and sustainable development of pharmaceutical industry of China. METHODS The evaluation system of resource carrying capacity was constructed ,including 4 primary indicators and 17 secondary indicators. The data of above indicators were selected from 31 provinces(autonomous regions and municipalities )(hereinafter referred to as provinces )of China during 2013-2020. The index weight and regional relevance were calculated by entropy weight technique for order preference by similarity to ideal solution(TOPSIS)method. RESULTS & CONCLUSIONS The weights of 4 primary indicators were 0.182 0 (industrial scale ),0.349 5(industrial innovation resources ),0.211 5(economic resources )and 0.257 1(industrial development foundation). It indicated that industrial innovation resources were the main factor affecting the resource carrying capacity of pharmaceutical industry ,followed by industrial development foundation and economic resources ,and the impact of industrial scale was the least. From 2013 to 2016 and from 2018 to 2020,the average closeness of the pharmaceutical industry in China ’s provinces were 0.259 6,0.267 1,0.253 6,0.249 9,0.250 5,0.248 5 and 0.252 0,respectively. It indicated that the resource carrying capacity of China ’s pharmaceutical industry showed a stable development trend ,but the overall development was in low level. The top 5 regions in terms of closeness of carrying capacity were Jiangsu ,Guangdong,Shandong,Zhejiang and Beijing ;the regions in the bottom 5 were Gansu ,Hainan,Qinghai,Tibet and Ningxia. Overall ,the resource carrying capacity of China ’s pharmaceutical industry showed a gradual decreasing trend from the eastern coastal area to the western inland area. For the provinces with the highest resource carrying capacity of pharmaceutical industry ,further development can be carried out on the basis of maintaining the original carrying capacity ;for the provinces with the middle resource carrying cap acity of p harmaceutical industry ,enhancing the development potential and improving the industrialfoundation are the main methods to improve the resource carrying capacity of pharmaceutical industry ;for the provinces wangjl@126.com with low resource carrying capacity of pharmaceutical industry , it can be considered to start from their own unique advantages , make full use of characteri stic industrial resources ,form a characteristic industrial foundation ,actively promote interregional cooperation ,implement regional cluster development and improve the resource carrying capacity of pharmaceutical industry.
关键词:pharmaceutical industry resources;carrying capacity;entropy weight method;technique for order preference
摘要:OBJECTIVE To identify an d analyze chemical cons tituents of Pleione yunnanensis with origin of Pleione yunnanensis. METHODS UPLC-Q-Exactive-Plus-Orbitrap-MS was adopted. The determination was performed on Hyperdil GOLD column with mobile phase consisted of 0.1% formic acid solution-0.1% formic acid acetonitrile solution (gradient elution )at the flow rate of 0.3 mL/min. The column temperature was set at 40 ℃,and sample size was 2 µL. The electrospray ion source was adopted,and the scanning range was m/z 100-1 500,and the scanning mode was positive and negative ion exchange mode of full scan+ddMS2. The structure of chemical constituents were determined by using Compound Discoverer 3.1 software,comparing with mzCloud,PubChem network database and OTCML ,on the basis of reference substance and published literatures. RESULTS & CONCLUSIONS A total of 42 chemical constituents were identified (positive ion mode has 24,negative ion mode has 27), including 13 benzyl succinate glycosides (such as dactylorhin C ,coelovirin A ,militarine),4 phenol glycosides (such as adenosine , guanosine,gastrodin),3 alkaloids(choline,betaine,berberine),and one flavonoid (nobiletin),7 aromatics(such as DL-lysine , DL-arginine,DL-glutamine),one sugar (sucrose),3 benzenes(shancigusin H ,shancigusin H isomer ,batatasin Ⅲ)and 10 others (such as p-methoxybenzoic acid ,monomethyl dodecanedioate ,diphenylamine). Glucose oxybenzyl and some small mole cules are easy to be lost in the cleavage of benzyl succinate glycosides;glycosyl is easy to be lost in the cleavage of phenol glycosides;the cleavage of alkaloids mainly manifest as the cleavage and loss of small molecular substituents ;demethyla- tion reaction is occurred in most flavonoids.
WANG Ying,ZHANG Yushan,SUN Liping,CHEN Haoyuan,WANG Qing,YAN Kaili,QI Bin,LIU Li
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To analyze the changes of volatile co mponents in Olibanum and its processed products ,and to determine the contents of 4 components as octyl acetate. METHODS The volatile oil of Olibanum ,fried Olibanum and Olibanum stir-baked with vinegar were extracted. The components of volatile components were identified by GC-MS. The structure identification and data analysis of the chemical components with similarity ≥80% were performed by using Xcalibur 4.0 software and NIST 2.0 mass spectrum database. The peak area normalization method was used to calculate the relative content of each component. GC method was adopted to simultaneously determine and compare the contents of limonene ,octyl acetate ,linalool and n-octanol in volatile components of Olibanum and its processed products. RESULTS Thirteen components were identified from volatile components of Olibanum ,fried Olibanum and Olibanum stir-baked with vinegar ,mainly including alcohols ,olefins and esters;among them ,relative contents of octyl acetate in Olibanum ,fried Olibanum and Olibanum stir-baked with vinegar were higher,which were 23.86% ,37.80% and 53.86% respectively. The linear ranges of limonene ,octyl acetate ,linalool and n-octanol were 0.006 6-0.066 4,0.179 2 -1.792 0,0.003 7-0.037 0 and 0.032 8-0.328 0(r>0.999 5)respectively;RSDs of precision,repeatability and stability (24 h)tests were all less than 2%;average recoveries were 98.56%,100.02%,99.13% and 98.66%,respectively(RSD≤2.16,n=6). Average contents of 4 components in Olibanum were 0.15%,16.27%,0.36% and 2.26%,while those of fried Olibanum were 0.85%,17.58%,0.66% and 3.47%,respectively;those of Olibanum stir-baked with vinegar were 0.50%,19.75%,0.58% and 3.34%,respectively. Compared with Olibanum ,average contents of octyl acetate , linalool,n-octanol and limonene in volatile components of fried Olibanum and Olibanum stir-baked with vinegar were increased significantly(P<0.05 or P<0.01). Compared with fried Olibanum ,average contents of limonene ,linalool and n-octanol were decreased significantly ,while those of octyl acetate were increased significantly (P<0.05 or P<0.01). CONCLUSIONS After fried and stir-baked with vinegar ,the volatile components in Olibanum are similar ,but the relative contents are different ,and the contents of octyl acetate and other components are increased.
MA Rui,LI Shuang,WANG Zhen,GAO Juanjuan,XIE Aidi,HAN Haixia
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To screen the effective anti-depressant part from Coreopsis tinctoria and study its mechanism. METHODS The anti-depressant effects of 30%,50%,70% and 90% ethanol elution fractions from 75% ethanol extract of C. tinctoria(CCTE)were investigated by tail suspension test and forced swimming test. Mice head-drop test ,reserpine antagonistic test,yohimbine toxicity enhancement test and in vitro monoamine oxidase (MAO) inhibition test were used to explore the mechanism of the relationship between the effective parts and 5-hydroxytryptamine (5-HT) and norepinephrine (NE) nerves. RESULTS The 50% and 70%CCTE could significantly shorten the accumulative immobility time in tail suspension test and forced swimming test (P<0.05 or P<0.01),increase the number of head-shaking times (P<0.01),reverse the eyelid ptosis , hypothermia and immobility caused by hematopin (P<0.05 or P<0.01),and increase the number of dead mice caused by yohimbine toxicity (P<0.01). IC 50 of okanin (CCT-6),isookanin(CCT-7)and taxifolin (CCT-8)against MAO were 8.71,37.89 and 67.07 µmol/L,respectively. CONCLUSIONS The 50% and 70%CCTE are the effective anti-depressant parts of C. tinctoria . Its anti-depressant effect may be related to the reinforcement of 5-HT and the activation of NE nerves. The inhibition of CCT- 6, CCT-7 and CCT- 8 against MAO may be one of the anti-depressant mechanism of C. tinctoria .
CAO Yaxuan,ZHENG Rongfei,WANG He,CAO Yingjie,DONG Wenjie,CUI Lin,LI Bin,CHEN Yushan,ZHU Mingjun
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To study the effects of Shenfu yixin granule on mitochondrial autophagy of cardiomyocytes in rats with heart failure after acute myocardial infarction. METHODS The model of heart failure after acute myocardial infarction was established by ligaturing the anterior descending branch of the left coronary artery in rats. The model rats were divided into model group,Shenfu yixin granule low-dose and high-dose groups (1.76,8.8 g/kg),Fosinopril sodium tablets group (positive control ,4 mg/kg),sham operation group was set up (only threading without ligation at the same position ),with 8 rats in each group. After 4 weeks of drug intervention ,the hemodynamic indexes of rats in each group were measured by physiological recorder. The pathological changes of myocardial tissue were observed in each group. The level of oxidative stress in cardiomyocytes , mitochondrial membrane potential ,protein expression of PTEN-induced putative kinase 1(PINK1),E3 ubiquitin ligase Parkin and ubiquitin binding protein P 62 in myocardial tissue of rats in each group were detected. RESULTS Compared with sham operation group ,the pathological injuries such as myocardial fiber morphology disorder and inflammatory cell infiltration were serious. The left ventricular end systolic pressure (LVESP),maximum rate of rise of left ventricular internal pressure (+dp/dtmax), maximun rate of decrease of left ventricular internal pressure (-dp/dtmax),total antioxidant capacity ,mitochondrial membrane potential,PINK1,Parkin and P 62 protein expression were significantly decreased in model group (P<0.01). The left ventricular end diastolic pressure (LVEDP),the level of reactive oxygen species and the activity of reduced nicotinamide adenine dinucleotide phosphate in left ventricular ischemic cardiomyocytes were significantly increased (P<0.01). Compared with model group ,the pathological injuries of myocardial tissue in intervention groups were alleviated ,and above indexes were improved in varying degrees(P<0.01 or P<0.05). CONCLUSIONS Shenfu y ixin granule can reduce the level of oxidative stress and alleviate heart failure after acute myocardial infarction ,which may be related to the activation of Parkin-dependent pathway to strengthen mitochondrial autophagy and reduce mitochondrial dysfunction.
摘要:OBJECTIVE To prepare hyperoside mixed nanomicelles (Hyp-F127/TPGS) and optimize its preparation technology,and to investigate its intestinal absorption characteristics. METHODS Hyp-F127/TPGS was prepared by thin film dispersion method. Based on single factor test and Plackett-Burman design ,combined with Box-Behnken response surface method , the preparation process was optimized and validated using entrapped efficiency (EE)and drug loading (DL)as evaluation indexes , F127-TPGS mass ratio ,hydration time and the amount of Hyp as factors. The appearance and microscopic morphology of Hyp-F127/TPGS obtained by the optimal technology were observed ,and the particle size ,polydispersity index (PDI)and Zeta potential were also determined. The critical micelle concentration (CMC)of blank micelle (F127/TPGS),in vitro release behavior and preliminary stability of Hyp-F 127/TPGS were investigated ,and absorption characteristics of Hyp-F 127/TPGS were investigated by in situ unidirectional intestinal perfusion model. RESULTS The optimal preparation technology of Hyp-F 127/TPGS included F127-TPGS mass ratio of 2∶1,hydration time of 2 h,and Hyp amount of 9 mg. Results of three validation tests showed that the EE of Hyp-F 127/TPGS was (87.20±0.99)%,and the DL was (5.02±1.20)%,deviations from predicted values were 0.92% and 2.39%. The micelles prepared by optimal technology were yellow ,clear and transparent solution ,with good Tyndall effect ;under transmission electron microscope ,they were spherical ,complete and evenly distributed ;the particle size was (15.02±0.16)nm, the PDI was 0.092±0.031,and the Zeta potential was (-6.67±1.47)mV. The CMC of F 127/TPGS was 21 μg/mL,Hyp-F127/ TPGS was stable after 4 weeks of storage at 4 ℃,and the cumulative release rates of Hyp-F 127/TPGS and Hyp control were (66.30±2.93)%(96 h)and(99.24±0.27)%(60 h),respectively. Hyp-F 127/TPGS and Hyp reference were absorbed in each intestinal segment ,and the main absorption sites were jejunum and duodenum respectively ;drug absorption rate constant andapparent absorption coefficient of the former were significantly higher than those of the latter (P<0.05 or P<0.01). E-mail:zhangyuhangxz@163.com CONCLUSIONS The optimized preparation technology of Hyp-F127/TPGS is stable and feasible ;prepared Hyp-F 127/ TPGS shows a sustained -release effect ,which promotes the intestinal absorption of H yp to a certain extent.
摘要:OBJECTIV E To investigate the effect s and mechanism of the ethanol extract of Tiarella polyphylla (“TPE”)on learning and memory impairment in mice. METHODS Male Kunming mice were randomly divided into normal group ,model group,positive group (donepezil hydrochloride 4 mg/kg)and TPE low-dose ,medium-dose and high-dose groups (150,300,600 mg/kg),with 10 mice in each group. Drug administration groups were given relevant medicine intragastrically once a day ,and normal group and model group were given water intragastrically once a day ,for consecutive 22 d. On the 17th day ,administration groups and model group were intraperitoneally injected with scopolamine hydrobromide (3 mg/kg)to establish a model of learning and memory impairment. The learning and memory ability of the mice were evaluated by the Morris water maze. Hematoxylin-eosin (HE) staining was used for morphological observation of hippocampus cells of the mice. The levels of acetylcholinesterase (AChE),choline acetyltransferase (ChAT),superoxide dismutase (SOD),malondialdehyde(MDA),interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)in cerebral tissue as well as the relative expression of phosphorylated Tau protein (p-Tau),β-site amyloid precursor protein cleaving enzyme 1(BACE1)and amyloid precursor protein (APP)in hippocampus tissue were all detected. RESULTS The escape latency of mice in positive group ,TPE medium-dose and high-dose groups were all significantly shortened than the model group on the 4th to 5th day of training ,while the times of crossing platform and the percentage of movement distance in target quadrant were significantly increased (P<0.05). Compared with model group ,the neurons in the hippocampal CA 1 region of mice were increased to var ying degrees in administration groups ,the ne urons in solidified and atrophic state decreased ,and the arrangement of neurons tended to be close;the levels of ChAT and SOD in cerebral tissue were significantly increased in positive group and TPE medium-dose and high-dose groups ;the levels of AChE ,MDA,IL-6,the levels of TNF-α and relative expression of p-Tau ,BACE1 and APP in hippocampus tissue were decreased significantly (P< 0.05). CONCLUSIONS TPE can improve the learning and memory impairment induced by scopolamine in mice ,and the mechanism may be related to balancing the brain cholinergic system ,alleviating oxidative stress injury ,improving inflammatory response,and inhibiting the overexpression of p-Tau ,BACE1 and APP .
关键词:Tiarella polyphylla ethanol extract;learning and memory impairment;acetylcholinesterase;scopolamine;Mice
摘要:OBJECTIVE To e stablish the fingerprint of Qings hen tiaozhi xiaoke tablets (QTXT)and carry out the analysis of chemical pattern recognition ,and determine the contents of seven active components simultaneously. METHODS Using coptisine hydrochloride as reference ,the Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition)was utilized to establish the HPLC fingerprints of 13 batches of QTXT and analyze their similarity. The common peaks were confirmed by comparing with the chromatogram of the mixed control ;the attribution of the common peak was determined by comparing the chromatograms of the sample solutions of single decoction pieces and negative sample solutions ;using SPSS 22.0 and SIMCA 14.1 software,cluster analysis (CA),principal component analysis (PCA)and orthogonal partial least squares-discriminant analysis (OPLS-DA)were carried out ,and the markers affecting the quality of QTXT were screened ,using the variable importance in projection(VIP)value greater than 1 as the standard. Using coptisine hydrochloride as internal reference ,the contents of naringin , hesperidin,neohesperidin,berberine hydrochloride ,palmatine hydrochloride and lovastatin were determined by quantitative analysis of multicomponents by single marker (QAMS),and then compared wi th the result s(except for coptisine hydrochloride ) of external standard method. RESULTS There were 17 Δ 基金项目:江苏省“双创团队”项目[No.(2018)2024号] *硕士研究生。研究方向:中药新药药学。E-mail:2769544062@ common peaks in 13 batches of QTXT ,and the similarity was qq.com 0.987-0.999. Seven chromatographic peaks were identified , # 通信作者:副研究员,硕士生导师,博士。研究方向:中药药剂 namely naringin (peak 4), hesperidin (peak 5), 学。E-mail:tsliur411@sina.com neohesperidin(peak 6),coptisine hydrochloride (peak 8), ·1204· China Pharmacy 2022Vol. 33 No. 10 中国药房 2022年第33卷第10期 palmatine hydrochloride (peak 9),berberine hydrochlo ride(peak 10),lovastatin(peak 14). Peaks 7-10 were the exclusive peaks of Coptis chinensis ;peaks 3-6 and 11-13 were the exclusive peaks of bran-fried Fructus aurantii ;peak 14 was the exclusive peak of Monascus purpureus ;peak 1 was the common peak of C. chinensis and M. purpureus . Peak 2 and 15 were the common peak of bran-fried F. aurantii and M. purpureus ;peaks 16 and 17 were the common peaks of 6 traditional Chinese medicines. The results of CA showed that 13 batches of QTXT could be divided into three categories ,S2 was clustered into one category ,S1,S9,S10 were clustered into one category ,S3-S8 and S 11-S13 were clustered into one category. The results of PCA showed that accumulative variance contribution of the first three principal components was 85.120%. Compared with CA ,S1 was further distinguished from S9 and S 10 by PCA. OPLS-DA showed that 7 common peaks with VIP value greater than 1(from large to small )were peak 10 (berberine hydrochloride ),peak 9(palmatine hydrochloride ),peak 5(hesperidin),peak 11 and peak 8(coptisine hydrochloride ), peak 12 and peak 6(neohesperidin). The contents of naringin ,hesperidin,neohesperidin,berberine hydrochloride ,palmatine hydrochloride and lovastatin measured by QAMS were 40.198-77.552,6.138-13.413,71.823-125.868,11.274-49.951,3.303- 5.367,1.821-3.185 mg/g,respectively. The contents of naringin ,hesperidin,neohesperidin,berberine hydrochloride ,coptisine hydrochloride,palmatine hydrochloride and lovastatin measured by external reference method were 41.454-79.976,6.404-13.993, 74.068-129.081,11.627-51.512,5.922-12.020,3.158-5.131 and 1.901-3.325 mg/g,respectively. The deviations of the two methods (except for coptisine hydrochloride )were all less than 3.00%. CONCLUSIONS The established HPLC fingerprint and the method of QAMS are simple ,accurate and reproducible. Combined with chemical pattern recognition analysis ,it can be used for the quality evaluation of QTXT. Berberine hydrochloride ,palmatine hydrochloride and other components may be the markers affecting the quality of the drug.
LI Jiawen,CAO Wenfeng,XU Hao,FENG Yuhan,LENG Yuting,JING Qiufang,REN Fuzheng
Vol. 33, Issue 10, (2022)
摘要:OBJECT IVE To prepar e and characterize danazol (DAZ)-sodium caseinate (SC)composite nanoparticles ,and to study the mechanism of preparing nanoparticles in “bottom-up”technology. METHODS SC was used as a stabilizer for regulating nanoparticles,so that DAZ-SC composite nanoparticles were prepared by anti-solvent precipitation method. The particle size , Zeta-potential,micro-morphology,stability,encapsulation efficiency ,drug loading and in vitro dissolution rate were characterized. Fluorescence spectra ,IR spectra ,FBRM and other methods were used to analyze the interaction mechanism between DAZ and SC. RESULTS The particle size of DAZ-SC composite nanoparticles was (223.7±12.5)nm,and the polydispersity index was 0.274± 0.012. Zeta-potential was -(17.81±1.63)mV(n=3). The stability of nano-suspension was good ,the solid properties of DAZ were greatly improved ,and the dissolution rate was significantly increased. SC was statically quenched under the action of DAZ and the secondary structures of SC were changed. The crystallization process of DAZ was controlled under the action of SC ,and the interaction between DAZ and SC was mainly hydrogen bond and van der Waals force. CONCLUSIONS In this study ,DAZ-SC composite nanoparticles are successfully prepared. In the “bottom-up”technology,the interaction between SC and DAZ caused by hydrogen bond and van der Waals force inhibits the growth and agglomeration of drug crystals .
摘要:OBJECTIVE To establish a met hod for the determination of amentoflavone ,bilobetin,ginkgetin,isoginkgetin and sciadopitysin in Ginkgo biloba leaves tablets. METHODS After extracted with methanol ,ultra-performance liquid chromatography (UPLC)was adopted to determine G. biloba leaves tablets. The determination was performed on Waters Acquity UPLC HSS T 3 column with acetonitrile- 0.4% phosphoric acid as mobile phase (gradient elution )at the flow rate of 0.4 mL/min. The column temperature was set at 35 ℃,and the detection wavelength was 340 nm. The sample size were 1 μL(substance control )and 10 μL (test sample ). The relative correction factors (RCFs)of bilobetin ,ginkgetin,isoginkgetin and sciadopitysin were calculated by quantitative analysis of multicomponents by single marker (QAMS)using amentoflavone as control. The chromatographic peak was located with the relative retention time method. Then the contents of the above components were calculated ,and the results were compared with those of external standard method (ESM)(except for amentoflavone ). RESULTS The linear ranges of amentoflavone,bilobetin,ginkgetin,isoginkgetin and sciadopitysin were 0.10-8.21,0.24-19.34,0.16-12.98,0.22-17.66,0.06-4.86 ng,respectively(all r>0.999). The quantitation limits were 0.10,0.24,0.16,0.22,0.06 ng,respectively. RSDs of precision , repeatability and stability tests (36 h)were all lower than 3.00%. The average recoveries were 99.77%-102.85%,and RSDs were 1.90%-4.40%(n=6). The average RCFs of bilobetin ,ginkgetin,isoginkgetin and sciadopitysin were 0.91,0.93,0.96 and 0.95, respectively. The average relative retention times were 1.08,1.18,1.19 and 1.30,respectively. The relative deviation between the calculation result of QAMS and ESM was within ±3.00%. CONCLUSIONS The established method is accurate and stable ,and can be applied to the determination of Ginkgo biflavones in G. biloba leaves tablets and control the quality.
摘要:OBJECTIVE To review economic studies of diabetes drugs in Chinese population systematically ,and to provide reference for promoting the development of pharmacoeconomics research in the field of diabetes and improving the research quality. METHODS Retrieving from PubMed ,Embase,SinoMed,CNKI,Wanfang data ,VIP and other databases ,the literatures on economic evaluation of diabetes drugs in Chinese population were collected ;analysis was carried out on the publication ,research content,study design of the literatures. The Consolidated Health Economic Evaluation Reporting Standards 2013(CHEERS 2013) checklist was used for quality evaluation. RESULTS A total of 380 literatures were included ,involving 348 Chinese literatures and 32 English literatures. The first paper of diabetes drugs in Chinese population was published in 2001. The most evaluated drug was metformin. Most of the studies (79.2%)were conducted by medical institutions ,73.9% of the studies were short-term economic evaluation,and the methods were mainly cost-effectiveness analysis (61.8%),and most of the studies did not reported clear research perspectives (82.6%). Evaluated by CHEERS 2013,the average score of included literatures was only 10.57,and 85.8% of the literatures was of unqualified quality. The average score of Chinese literatures was 10.05,that of English literatures was 16.23,and the reporting quality of English literatures was significantly better than that of Chinese literature s(P<0.001). CONCLUSIONS The existing literatures on the economic evaluation of diabetes drugs in Chinese population is of low quality. There are problems such as lack of research perspectives ,single research institution/method ,and non-standard reporting. It is recommended that medical institutions ,universities/research institutions ,enterprises,government and other institutions should strengthen cooperation ,improve their research level ,pay attention to more and newer clinically effective treatment regimens ,and promote the transformation of research results into decision-making evidence.
CAO Yingdan,SHI Fenghao,MENG Rui,CHEN Pingyu,FEI Zhengyang,ZHANG Xueke,MA Aixia
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To ev aluate the economical efficiency of nivolumab versus everolimus in the second-line treatment of metastatic clear cell renal cell carcinoma. METHODS From the perspective of China ’s health system ,cost-effectiveness analysis of the two therapies was carried out by developing a three-state partitioned survival model. The clinical parameters were from the updated CheckMate 025 study,and the cost and health utility were from relevant websites and published literatures. The model adopted a 2-week cycle and a lifetime research time. The robustness of the results was verified by sensitivity analysis. The economical efficiency of two therapy schemes were evaluated in the scenario of model simulation time of 80 months and charitable drug donation scheme. RESULTS The results of basic analysis showed that compared with everolimus ,the incremental cost-effectiveness ratio (ICER)of nivolumab was 586 982.60 yuan/quality-adjusted life year (QALY),which was far higher than 3 times of China ’s per capita gross domestic product (GDP)in 2020. The results of single-factor sensitivity analysis showed that the 3 parameters that had the greatest impact on the economic evaluation results were the cost of nivolumab ,the utility value of nivolumab group and everolimus group in progressive disease state. The results of probability sensitivity analysis verified the robustness of the basic analysis results. Results of scenario analysis showed that in the first scenario analysis ,in which model simulation time lasted for 80 months,ICER of nivolumab was 417 204.52 yuan/QALY;in the second scenario analysis ,in which nivolumab charitable drug donation program for low-income people was considered ,ICER of nivolumab was 124 988.58 yuan/QALY. CONCLUSIONS Under the threshold of 1-3 times of China ’s per capita GDP in 2020,compared with everolimus ,it is not economical to use nivolumab as the second-line treatment for metastatic clear cell renal cell carcinoma ; nivolumab is economical when considering its charitable drug donation program for low-income people.
LIU Lu,ZHEN Lulu,REN Meijuan,LI Rui,LIU Chang,YAN Meixing
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To eva luate the clinical comprehensive value of desloratadine in the treatment of urticaria. METHODS The clinical comprehensive evaluation index system based on six dimensions such as safety ,effectiveness,economy,suitability, innovation and accessibility were preliminarily determined by using the methods of literature investigation and expert investigation ; the core contents of the evaluation index system were evaluated and screened by Delphi method and analytic hierarchy process ;the importance of the index was assigned by Likert 5-level scoring method ;the evidence from various sources were collected and qualitative and quantitative integration analysis were conducted according to the clinical comprehensive evaluation index system with the help of system evaluation ,drug instructions ,expert guidelines/consensus ,adverse drug reaction monitoring report ,etc; the experts scored its clinical comprehensive value according to the clinical comprehensive evaluation evidence of each dimension of desloratadine ,combined with the weight of the clinical comprehensive evaluation index system ,the clinical comprehensive evaluation score of the tertiary indexes of desloratadine were calculated. The total clinical comprehensive evaluation score was obtained by accumulating the scores of each index ,and compared with loratadine. RESULTS This study successfully constructed the clinical comprehensive evaluation index system of desloratadine in the treatment of urticaria ,including 6 primary indexes ,13 secondary indexes and 30 tertiary indexes. The total clinical comprehensive evaluation score of desloratadine was 93.63 and that of loratadine was 70.91. CONCLUSIONS The clinical comprehensive value of desloratadine is higher than that of loratadine ,which can provide a reference basis for clinical rational drug use in medical institutions ,selection of drug use catalogue and improvement of national drug policy.
关键词:desloratadine;loratadine;urticaria;clinical comprehensive evaluation;Delphi method;Analytic hierarchy process
YANG Tian,ZHAN Mei,LI Dan,SONG Turun,WU Bin,XU Ting
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To com pare the long-term efficacy and safety betwe en domestic Mycophenolate mofetil dispersible tablets(dt-MMF)and imported Mycophenolate mofetil capsules (c-MMF)in kidney transplant recipients. METHODS In retrospective cohort study ,the data of patients who had undergone the living donor kidney transplantat during the period of 2012 to 2014 in West China Hospital of Sichuan University were screened and included ,and then divided into dt-MMF group and c-MMF group according to the drug use of kidney transplant recipients. Initial oral dose of dt-MMF and c-MMF were both 1 000 mg each time , twice a day ;at the same time ,both groups were additionally given Tacrolimus capsules 1.5 mg,twice a day+Prednisone acetate tablets 5-10 mg,orally after breakfast every day. The clinical data of the two groups were collected before and after kidney transplant for 5 years;the efficacy and safety indexes of two drugs were compared ,and the robustness of results were analyzed by 1∶1 propensity score matching (PSM). RESULTS A total of 666 kidney transplant recipients were included ,involving 316 patients in dt-MMF group and 350 patients in c-MMF group. The 5-year patient survival rates of dt-MMF group and c-MMF group were 99.68% and 99.43%,the 5-year graft survival rates were 96.20% and 94.29%,the acute rejection rates were 3.80% and 6.57%,the 5-year chronic rejection rates were 2.22% and 2.86%,and the incidences of delayed recovery of transplanted renal function were 0.63% and 0.29%,respectively;there was no statistical significance (P>0.05). There were no significant differences in the incidence of major adverse events between 2 groups,including infection ,adverse events of the blood system and diges tive system (P>0.05). PSM analysis indicated the efficacy and safety results were robust (except for acute rejection ). CONCLUSIONS There is no significant difference in clinical efficacy and safety between dt-MMF and c-MMF for immunosuppression after kidney transplant.
摘要:OBJECTIVE To study the characteristics of clinical distribution and drug resistance in patients with vancomycin-resistant Enterococci(VRE),and to provide reference for clinical prevention and control of infection. METHODS From May 1,2017 to May 1,2020,a total of 290 patients with Enterococci cultured from the samples submitted by inpatient department of our hospital were included. They were divided into VRE group (24 cases)and vancomycin-sensitive Enterococci (VSE)group(266 cases)according to the results of sensitivity tests. The basic information of patients (gender,age,submitting department,etc.), basic diseases (hypertension,diabetes,chronic obstructive pulmonary disease ,etc.), clinical events (catheterization,endotracheal intubation ,deep venous catheterization ,etc.),use of antibiotics (utilization and utilization time of antibiotics before and after detection ),clinical manifestations (abnormal inflammatory indicators ,clinical symptoms ,etc.), clinical outcomes (length of stay ,improvement,etc.),drug sensitivity spectrum were all collected. Clinical distribution and drug resistance were compared and analyzed between 2 groups. RESULTS There were significant differences in the type of Enterococci, mixed infection strains and clinical manifestations between 2 groups(P<0.05). In VRE group ,two natural drug-resistant bacteria were detected in 66.7% and 20.8% of the patients ,i.e. Enterococcus gallinarum and E. casseliflavus . E. faecium was only sensitive to linezolid ,teicoplanin and tegacyclin (the drug resistance rate was 0),and was resistant to other antibiotics (the drug resistance rate was 100%);E. faecalis was not detected. E. faecium and E. faecalis were detected in 51.9% and 44.7% of patients in VSE group. The resistance rates of E. faecium to other antibiotics were more than 55% except linezolid ,teicoplanin and tegacyclin (resistance rate ≤0.72%);the resistance rates of E. faecalis to clindamycin and erythromycin were all more than 60%,and the sensitivity to other antibiotics was more than 60%. CONCLUSIONS The VRE infection strains in our hospital are mainly natural drug-resistant bacteria such as E. gallinarum and E. casseliflavus ,and vancomycin-resistant E. faecium is found. The resistance rates of different strains to antibiotics are quite different.
摘要:OBJ ECTIVE To systematically evaluate the effectiveness and s afety of parecoxib sodium for gynecological surgery postoperative analgesia ,and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed , Embase,the Cochrane Library ,CNKI,VIP,Wanfang data and SinoMed during the inception to Feb. 16th,2021,randomized controlled trials (RCT) about parecoxib sodium (trial group ) versus 0.9% sodium chloride injection (control group ) for gynecological surgery and postoperative analgesia were collected. After screening literatures ,extracting data and evaluating the quality of literatures with modified Jadad scale ,Meta-analysis,sensitivity analysis and publication bias analysis were performed by using RevMan 5.3 software. RESULTS A total of 14 RCT were included ,involving 1 120 patients. The results of Meta-analysis showed that visual analogue scale (VAS)score at 4 h after operation [MD =-1.65,95%CI(-2.48,-0.82),P=0.000 1],VAS score at 6 h after operation [MD =-1.03,95%CI(-1.60,-0.45),P=0.000 5],VAS score at 12 h after operation [MD =-0.98, 95%CI(-1.38, -0.59),P<0.000 01],the proportion of postoperative analgesia requirements [OR =0.14,95%CI(0.04, 0.50),P=0.003] and the dosage of morphine [MD = -17.75, com 95%CI(-20.93,-14.56),P<0.000 01] in trial group were significantly lower than control group. There was no statistical significance in the incidence of nausea between 2 groups [OR= 0.68,95%CI(0.43,1.08),P=0.10]. The results of sensitivity analysis showed that the above results were basically stable. The results of publication bias analysis showed that there was little possibility of publication bias in this study. CONCLUSIONS Parecoxib sodium is effective and safe for gynecological surgery and posto perative analgesia.
FU Fangfang,ZHOU Guobo,LIN Congru,GAO Wenjuan,ZHOU Pengfei,LIAO Chaofeng
Vol. 33, Issue 10, (2022)
摘要:OBJECTIVE To analyze the medication reconciliation for the inpatients in cardiovascular medicine department ,to provide reference for the establishment of working mode of clinical pharmacists in the department of cardiovascular medicine and to provide a basis for clinical pharmacists and community pharmacists developing pharmaceutical care for patients after transfering to community health center. METHODS From October 2020 to September 2021,newly admitted or newly transferred inpatients with chronic disease were selected from Shiyan People ’s Hospital of Shenzhen Bao ’an District. Medication reconciliation was conducted by clinical pharmacists after pharmaceutical consultation. According to the Pharmaceutical Care Network Europe (PCNE) classification system V 9.1,the existing drug-related problems (DRPs)were classified and summarized. The effectiveness and safety evaluation,medication education and other measures were provided ,and the acceptance of intervention was analyzed at the same time. RESULTS A total of 100 patients were included ,including 54 males and 46 females. The average age was (60.21±9.69) years,the average number of chronic diseases was (2.84±0.83),and the median number of drugs was 5.00. Among them ,110 treatment drug deviations were found in 74 patients,involving 10 categories and 61 drugs. Top three drugs in the list of accumulative drug deviation were cardiovascular system drugs (35 deviations),digestive medicine drugs (16 deviations)and endocrine system drugs (15 deviations). The above treatment drug deviation may cause 122 DRPs, mainly “treatment effectiveness”problems(74 DRPs),and the causes were “inappropriate medication time ormedication interval ”(32 DRPs), followed by “inappropriate drug combination ”(10 DRPs). Interventions to DRPs mainly concentrated on patient level ,drug level (58)and doctor level (58),155 of which (84.70%)were fully accepted and implemented. CONCLUSIONS Some patients have a weak awareness of medications according to doctor ’s advice;drug reconciliation led by clinical pharma- cists at admission can fully understand the potential drug problems of patients ,and help doctors improve the drug compliance of patients and ensure their medication safety .
关键词:medication reconciliation;clinical pharma cist;cardiovascular medicine department;Rational drug use;chronic
SONG Weiwei,HUANG Yuehua,WANG Lan,TANG Jing,MAO Qiantai,WANG Jianxin,AI Chao
Vol. 33, Issue 10, (2022)
摘要:OBJEC TIVE To expl ore the clinical significance of folic acid metabolic gene detection in methotrexate (MTX) treatment of acute myeloid leukemia (AML). METHODS Therapeutic drug monitoring (TDM)pharmacists participated in the treatment process of an AML patient who had neurotoxic side effects such as dizziness ,headache,and vomiting after intrathecal injection of MTX. According to the results of the test of the folic acid metabolic gene MTHFR C677T(rs1801133)(mutant homozygous)and the results of MTX blood concentration monitoring (<0.05 μmol/L),combined with clinical manifestations ,it was recommended to stop MTX ,give intravenous drip of calcium folinate for rescue ,and consider using azacytidine for follow-up treatment. RESULTS The doctor took the advice of TDM pharmacist ,and the above symptoms were significantly relieved after the patient rescued for 2 times and successfully discharged from the hospital. CONCLUSIONS For AML patients who meet the indications and receive intrathecal injection of MTX ,drug metabolism genetics testing and MTX drug concentration monitoring can be performed before medication ,which helps doctors and pharmacists evaluate the feasibility of drug treatment options and reduce medical risks.
FAN Dongsheng,LI Ling,WANG Keke,HU Yujie,HUANG Jian,ZHOU Chanyuan,RUAN Jinghua,ZHANG Wenlong
Vol. 33, Issue 10, (2022)
摘要:Blumea balsamifera belonging to Blumea of Compositae family is a perennial herb or subshrub ,which is the only source of Traditional Chinese medicine Aipian and ethnic medicine essential oil of B. balsamifera . B. balsamifera contains volatile oil,flavonoids,sesquiterpenoids,phenylpropanoids,etc.,and shows antibacterial ,anti-inflammatory,analgesic,treating burns and scalds,neuroprotective and antioxidant effects ,etc. In this paper ,the chemical constituents and pharmacological activities are summarized by reviewing the domestic and foreign research literatures ,and it is expected to provide a reference for the in-depth research and development and utilization of B. balsamifera .