最新刊期
卷 33 ， 期 9 ， 2022
- 摘要：There are numerous dr ugs availabl e for the treatment and prevention of cardiovascular diseases. However ，the lack of scientific and standardized clinical comprehensive evaluation system for drugs is the current situation. In order to guide and promote medical institutions to develop the clinical comprehensive evaluation of drugs related to chronic cardiovascular diseases ， with the participation of Hangzhou Pharmacy Management Quality Control Center and 15 medical institutions in Hangzhou ，by widely soliciting the suggestions of clinical and pharmaceutical experts ，Hangzhou First People ’s Hospital Affiliated to the School of Medicine of Zhejiang University has organized the formulation of Hangzhou Expert Consensus on Comprehensive Clinical Evaluation of Drugs for Chronic Cardiovascular Diseases . The pilot evaluation is carried out with antihypertensive drugs and lipid-lowering drugs as examples. The evaluation system of expert consensus adopts a quantitative evaluation system of percentile ， which is systematically evaluated from 7 dimensions including pharmaceutical properties ，safety，effectiveness，economy， innovation，accessibility，and other attributes. The evaluation dimension is more detailed ，which enhances the operability of the drug evaluation system. The purpose of this expert consensus is to provide a decision-making basis for the evaluation and selection of drugs for chronic cardiovascular diseases in medical institutions ，to promote rational drug use and to meet people ’s growing need for better medications.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To prov ide reference for improving the participation mechanism of stakeholders in the process of medical insurance negotiation for oncology drug in China. METHODS Based on the stakeholder theory ，combined with literature research，case analysis （taking the review of reimbursement of Bentuximab as an example ）and other methods ，analysis and research were conducted on the Canadian oncology drug review process and the participation mechanism and role of stakeholders. The suggestions were put forward for our country. RESULTS & CONCLUSIONS Canadian oncology drug reimbursement review process was composed of four stages ：the pre-submission planning stage ，the formal submission stage of application，the review stage，and the stage of forming reimbursement recommendations. As the role of stakeholders ，drug manufacturers ，patient representative advisory group ， clinical review expert advisory groups and provincial advisory groups participated in the reimbursement review process of oncology drug by providing suggestions and feedback to CADTH. The participation of stakeholders had improved the transparency of the review of oncology drugs in Canada and made the reimbursement results of oncology drugs more scientific ，reasonable and accurate. In China ，it is recommended to define rights ，responsibilities and interests as well as the participation mechanism of stakeholders in the medical insurance negotiation process ，attach importance to the role of patients in the medical insurance negotiation process of oncology drug ，improve information disclosure and increase the transparency of the negotiation mechanism and process so as to increase the participation of stakeholders.关键词：oncology drug;stakeholders;Medical insurance negotiation;Health technology assessment;Canada
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发布时间：2022-06-21 - 摘要：OBJECTIVE To pro vide so lutions for the appli cation of legal liability caused by the confusion of the concept of pharmaceutical care. METHODS Literature research and comparative method were adopted to clarify the legal concept of pharmaceutical care ，analyze the civil and administrative liabilities arising from different forms of pharmaceutical care ，and standardize the new responsibilities of pharmacists in pharmaceutical care. RESULTS & CONCLUSIONS The legal concept of pharmaceutical care has the function of judgement standard. Only such behaviors can belong to pharmacists ’liability under legal regulation，which are based on mutual agreements ，ensure the public medication safety and optimize patient treatment effect through the application of pharmaceutical expertise related to drug treatment. Under this definition ，the civil liability of pharmaceutical care needs to distinguish the professional degree of pharmaceutical care in different situations ，so as to establish a typed civil liability system and provide different levels of protection for patients ；regarding administrative liability ，it is necessary to improve the pharmaceutical regulatory system with the dual core of the Drug Administration Law and the Pharmacist Law from the perspective of liability integration.关键词：Pharmaceutical care;legal concept;pharmaceutical liability;legal liability
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发布时间：2022-06-21 -
Research on the institutions of dispensing and use for preparations of medical institutions of China
摘要：OBJECTIVE To understand the future development trend of dispensing and use for preparations of medical institutions，and to provide countermeasures and suggestions for promoting the high-quality development of application and dispensing use for preparations of medical institutions . METHODS The development history of dispensing and use for preparations of medical institutions of China was reviewed as a whole ，and then the differences of domestic dispensing and use institutions for preparations of medical institutions over the years were compared from different perspectives ；and the differences between domestic institutions and Japan ’s hospital preparation dispensing and use institutions were compared. The development trend of dispensing and use for preparations of medical institutions of China was summarized to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The development process of dispensing and use for preparations of medical institutions of China could be roughly divided into the initial stage （2001-2004），the forming stage （2005-2018） and the development stage （2019-present）. Year by year ，the dispensing and use institutions of preparations of medical institutions had shown that the scope of dispensing and use had been expanded ；the approval process had been accelerated ，and the responsibilities of all parties had been clearly defined. Compared with Japan ，regulatory model for preparations of medical institutions was relatively simple in China. In the future ，the large-scale promotion and application of preparations of medical institutions will be normalized ，the time limit for dispensing approval will be shortened ，the approval process will be simplified ，the access threshold for dispensing and use will be gradually lowered ，and the supervision of dispensing and use will be strengthened during and after the event. It is recommended to strictly control the quality and safety of preparations of medical institutions ，implement classified management of use for preparations of medical institutions ，and further improve the supervision mechanism during and after the event.关键词：preparations of medical institutions;dispensing and use;institutions- 25
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发布时间：2022-06-21 - 摘要：OBJECTIVE To stud y the chemical cons tituents of n-butanol part of Qubai tablet and its pharmacodynamic effect on the model of de melanocyte. METHODS The n-butanol part of Qubai tablet was prepared. The chemical constituents were analyzed by ultra-high performance liquid chromatography-mass spectrometry （UPLC-MS）. Taking mice B 16 melanoma cells as the research object ，the de melanocyte model was established and divided into model group ，positive control different concentration groups（8-methoxypsoralen 10，50，100，150，200 μmol/L），solvent group （diluted with DMSO ）and Qubai tablet n-butanol part different concentration groups （10，50，100，150，200 μmol/L）. The number of cells were observed by inverted microscope ，and the cell proliferation rate ，the rate of melanin production and promotion rate of tyrosinase activity were also detected. RESULTS In the positive and negative ion mode ，53 compounds in the n-butanol part of Qubai tablet were preliminarily determined （29 in the positive ion mode ，33 in the negative ion mode ，overlapping 9），of which coumarins accounted for the largest proportion ， followed by flavonoids. The n-butanol part of Qubai tablet could significantly increase the number of cells ，which was positively correlated with the action time and administration concentration. It could significantly increase the proliferation rate of cells ，the rate of melanin production and promotion rate of tyrosinase activity （P＜0.01）. CONCLUSIONS Coumarins and flavonoids may be the material basis for the anti-vitiligo effect of n-butanol part from Qubai tablet ；anti-vitiligo effect of n-butanol part of Qubai tablet may be realized by promoting tyrosinase activity.关键词：Qubai tablet;n-butanol part;vitiligo;UPLC- MS;melanin;tyrosinase
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To prepare and characterize evodiamine phospholipid complex self-microemulsifying drug delivery system（EVO-PC-SMEDDS），and to investigate its gastric mucosal permeability. METHODS EVO-PC-SMEDDS was prepared ， and particle size ，polydispersity（PDI）and Zeta potential were tested ，and microscopic observation was carried out. The stability of EVO-PC-SMEDDS in simulated gastric liquid with different pH （1.2，2.0，4.0，7.0）was investigated. The entrapment efficiency and drug-loading amount of the preparation were determined ，and the in vitro release was investigated. The gastric mucosal permeability of EVO-PC-SMEDDS was studied by combining rat gastric mucosal tissue and Ussing Chamber technology. RESULTS The particle size of EVO-PC-SMEDDS was （53.63±1.51）nm，PDI and Zeta potential were 0.217±0.017 and （－12.20±0.15）mV，entrapment efficiency was （95.25±0.97）％ and drug-loading amount was （19.30±1.21）mg/g. EVO-PC- SMEDDS exhibited a uniformly dispersed round spherical shape under transmission electron microscope. Stability experiments showed that EVO-PC-SMEDDS exhibited no significant change in particle size ，PDI and Zeta potential under the simulated gastric fluid with different pH and showed excellent stability. Results of in vitro release test showed that compared with evodiamine （EVO），in vitro accumulative release of EVO-PC-SMEDDS were enhanced 6.83-fold，which was in line with the first-order kinetic release model. Results of gastric mucosal permeability showed that gastric mucosal permeation transport ，permeation rate ， permeation flux and area under curve of cumulative permeability of EVO-PC-SMEDDS were higher than those of EVO ， respectively. CONCLUSIONS EVO-PC-SMEDDS is prepared N successfully and shows good stability. It could significantly improve the release behavior and gastric mucosal permeability of EVO.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the impr ovement effects of Dianxianqing granule on blood-brain barrier （BBB）injury in Alzheimer’s disease （AD）model mice by regulating NLR family pyrin domain containing 3（NLRP3）inflammasome signaling pathway. METHODS Totally 125 mice were randomly divided into sham operation group （n＝25）and modeling group （n＝100） by body weight. AD model was induced by intracerebroventricular injection of β-amyloid 25-35 in model group. Sham operation group was given normal saline with same method. The 100 model mice were randomly divided into model group ，Donepezil hydrochloride tablets group （positive control 1，1.3 mg/kg，i.g.），MCC950 group [positive control 2（selective NLRP 3 inhibitor），10 mg/kg，i.p.] and Dianxianqing granule group （12.48 g/kg by crude drug ，i.g.）by body weight ，with 25 mice in each group. Second day after modeling ，administration groups were given relevant medicine ，once a day ，for consecutive 21 d. Sham operation group and model group were given intragastric administration of water and intraperitoneal injection of normal saline. At last administration，the learning and memory ability was determined by Y maze test ，and blood-brain barrier permeability was measured by Evans blue leakage assay. The expressions of NLRP 3，anti-ionized calcium-binding adapter molecule 1（IBA-1），nuclear factor kappa B （NF-κB）p65，p53 upregulated modulator of apoptosis （PUMA），occludin（ocln），zonula occluden- 1（ZO-1）and claudin-5 （cldn5） in cerebral tissue were determined. RESULTS Compared with model group ， spontaneous alternate response rate ，protein expressions of ocln ，cldn5 lnzyxyqy2003@163.com and ZO- 1 in cerebral tissue were increased significantly in administration groups （P＜0.05 or P＜0.01）；Evans blue E-mail：jiadg2003@126.com content and protein expressions of NLRP 3，IBA-1，PUMA and NF-κB p65 in cerebral tissue were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS Dianxianqing granule can improve BBB injury of AD model m ice by inhibiting NLRP 3 inflammasome signaling pathway.关键词：Dianxianqing granule;Alzheimer’s disese;blood-brain barrier;NLRP3 inflammasome;tight junction proteins
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发布时间：2022-06-21 - 摘要：OB JECTIVE To study the protective effects of saponins from Gleditsia sinensis on ischemic stroke with phlegm and blood stasis （ISPBS）model rats ，and to explore its mechanism. METHODS Totally 119 rats were randomly divided into normal group （normal saline ），sham operation group （normal saline ），model group （normal saline ），nimodipine group （positive control group ，5 mg/kg），G. sinensis saponin low-dose ，medium-dose and high-dose groups （3.21，6.42 and 12.84 mg/kg），with 17 rats in each group. Except for normal group ，other groups were all given high-fat diet+suture-occluded method to induce ISPBS model. The neurological function score ，water content of brain tissue ，pathological morphology of brain tissue ，the changes of hemorheology indexes （whole blood viscosity ， erythrocyte aggregation index ， Casson-viscosity）， four items of blood lipid [triacylglycerol （TG），total cholesterol （TC），low-density lipoprotein cholesterol （LDL-C），high-density lipoprotein cholesterol（HDL-C）] and inflammatory factors in serum and oxidative stress indexes [malondialdehyde （MDA），nitric oxide （NO），superoxide dismutase （SOD）] in brain tissue were determined or observed in rats. The protein expressions of B lymphocytoma 2（Bcl-2），Bcl-2 associated X protein （Bax）and caspase- 3 in cerebral tissue were also detected. RESULTS Compared with normal group ，the score of nerve function ，5 kinds of serum indexes （TC，TG，LDL-C，TNF-α，IL-1β）， hemorheology indexes ，the contents of MDA and NO and protein expressions of Bax and caspase- 3 in cerebral tissue were all increased significantly in model group （P＜0.01）. The levels of HDL-C and IL- 10 in serum ，SOD activity and protein expression of Bcl- 2 in cerebral tissue were decreased significantly （P＜0.01），and obvious lesions such as nuclear pyknosis and cell membrane fragmentation occurred in brain tissue. Compared with model group ，above indexes of administration groups were improved to different extents ，among which there was statistical significance in above indexes of G. sinensis saponin high-dose group （P＜ 0.01）. CONCLUSIONS Saponin from G. sinensis has a good protective effect on ISPBS model rats. Its mechanism may beassociated with reducing oxidative damage ， reducing the production of pro-inflammatory mediators and resisting neuronal apoptosis.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To prepare Gambogic acid （GA） nanocapsules （GA-LNCs） and Neogambogic acid （NGA） nanocapsules（NGA-LNCs），and to evaluate their antidiabetic activities. METHODS Using water as the aqueous phase ，medium- chain triglyceride as the oil phase and polyethylene glycol monostearate as the surfactant ，GA-LNCs and NGA-LNCs were prepared by phase inversion method. Using entrapment efficiency and drug-loading amount as index ，the formulation technologies of above 2 nanocapsules were optimized by simplex lattice design. Its physical and chemical properties were investigated. The diabetic mice model was established. GA-LNCs and NGA-LNCs （1.92 and 2.42 mg/kg respectively ）were given intragastrically ，once a day ，for consecutive 6 weeks. The fasting blood glucose of mice ，the activities of superoxide dismutase （SOD）and glutathione peroxidase （GSH-Px），the contents of malondialdehyde （MDA），total cholesterol （TC），triglyceride （TG），high-density lipoprotein cholesterol（HDL-C）and low-density lipoprotein cholesterol （LDL-C）were all detected. RESULTS The optimal formulation of 2 kinds of nanocapsules included 60％ water，10％ medium-chain triglyceride ，30％ polyethylene glycol monostearate （total amount of the three was 2 g）and 35 mg GA or NGA . The encapsulation efficiencies of GA-LNCs and NGA-LNC obtained by the optimal formulation were （92.01±0.68）％ and（93.12±2.11）％；the drug-loading amount were （0.99±0.21）％ and（1.21±0.22）％， respectively. GA-LNCs and NGA-LNCs were yellow ，homogeneous and transparent liquid without precipitation. They were spherical in microscopic shape ， and had obvious shell- Δ 基金项目：吉林省科技发展计划项目（No.20200404090YY）；吉 membrane structure. The particle sizes were （28.11 ± 9.76） 林省教育厅科学技术研究项目（No.JJKH20210372KJ） ＊硕士研究生 。研究方向 ：植物药 。E-mail：zhanhe0108@163. and（22.06±6.84）nm；Zeta potential were （－4.09±1.00） com and（－17.40±1.32）mV，and polydispersity were 0.93±0.06 # 通信作者：讲师，博士。研究方向：中药有效成分治疗疾病的作 and 0.74±0.12. The results of animal experiments showed that 用机制。E-mail：chenweijia_jlau@163.com both GA-LNCs and NGA-LNCs could sig nificantly increase 中国药房 2022年第33卷第9期 China Pharmacy 2022Vol. 33 No. 9 ·1075· the activities of SOD and GSH-Px and the seru m content of HDL-C （P＜0.05 or P＜0.01）in model mice ，and significantly decreased the fasting blood glucose and the serum contents of MDA ， TC， TG and LDL-C （P＜0.05 or P＜0.01）. CONCLUSIONS GA-LNCs，NGA-LNCs prepared in this study are good in physical and chemical properties and have good anti-diabetes activity.关键词：gambogic acid;neogambogic acid;nanocapsules;Diabetes;Preparation
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the regulator y mech anism of glaucocalyxin A （GLA） on autophagy and apoptosis of HCCLM3 hepatocellular carcinoma cells. METHODS HCCLM3 cells were taken ，and control group ，GLA 2.5 μg/mL group，GLA 5 μg/mL group and GLA 10 μg/mL group were mainly set according to different experimental purposes. In control group，only complete medium was added ；in each administration group ，complete medium containing the corresponding final concentration of GLA was added. Cell cycle distribution and apoptosis were detected by flow cytometry ；mitochondrial morphology and autophagy were observed by transmission electron microscope （only control group ，GLA 5 μg/mL group）；JC-1 staining and fluorescence inverted microscope were used to observe and detect the mitochondrial membrane potential of the cells ；Western blot assay was used to detect the protein expression of Bcl- 2， Bax， Beclin1 and cleaved caspase- 3 proteins in the cells ； the co-immunoprecipitation method was used to detect the binding and dissociation of Bcl- 2 and Beclin 1（only GLA 5 μg/mL group， GLA 10 μg/mL group）. RESULTS Compared with control group ，GLA 5 μg/mL and GLA 10 μg/mL could induce a significant arrest of the cell cycle in the G 2-M phase for HCCLM 3，a significant decrease in mitochondrial membrane potential ，an increase in apoptosis as well as significant promotion of the protein expression of Bax ，cleaved caspase- 3 and Beclin 1，and significant inhibition of the protein expression of Bcl- 2（P＜0.01）. GLA 5 μg/mL also significantly changed mitochondrial morphology and increased autophagosomes. The results of co-immunoprecipitation showed that compared with GLA 5 μg/mL，GLA 10 μg/mL could enhance the binding of Bcl- 2 and Beclin 1. CONCLUSIONS GLA can regulate the autophagy and apoptosis of HCCLM 3 cells by Bcl-2/Beclin1 target. The effect is closely related to the dose of GLA.关键词：glaucocalyxin A;target;Mechanism;Autophagy;Apoptosis;Bcl-2;Beclin1
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the effects of the compatibility of Schisandra chinensis on Psoralea corylifolia -induced oxidative damage and endoplasmic reticulum stress in L 02 hepatocytes，and to provide reference for clinical use of the compatibility attenuation of P. corylifolia -S. chinensis . METHODS L02 cells were divided into blank control group ，P. corylifolia model group （1 200 μg/mL P. corylifolia ，calculated by crude drug ），P. corylifolia -S. chinensis low-dose，medium-dose and high-dose groups （1 200 μg/mL P. corylifolia combined with 600，1 200，2 400 μg/mL S. chinensis ，respectively，calculated by crude drug ）. After the cells in each group were cultured in culture medium or drug solution for 48 hours，the levels of aspartate aminotransferase（AST）and alanine aminotransferase （ALT）were detected ；the levels of glutathione （GSH），superoxide dismutase （SOD）and malondialdehyde （MDA）in cell culture medium were detected ；reactive oxygen species （ROS）level and mitochondrial membrane potential in cells were detected ；mRNA and protein expressions of glucose-regulated protein 78（GRP-78）and protein kinase R-like endoplasmic reticulum kinase （PERK）were detected. RESULTS Compared with blank control group ，the levels of AST，ALT，MDA and ROS ，mRNA and protein expressions of GRP- 78 and PERK were increased significantly in P. corylifolia model group （P＜0.05 or P＜0.01）；while GSH and SOD levels ，mitochondrial membrane potential were decreased significantly （P＜0.05 or P＜0.01）. Compared with P. corylifolia model group ，above indexes of P. corylifolia -S. chinensis low-dose， medium-dose and high-dose groups were all improved significantly （P＜0.05 or P＜0.01）. CONCLUSIONS The compatibility of P. corylifolia -S. chinensis can alleviate P. corylifolia -induced oxidative damage and endoplasmic reticulum stress of L 02 cells.关键词：Schisandra chinensis;Psoralea corylifolia;Compatibility attenuation;Liver injury;oxidative damage;endoplasmic
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the effect of Longsheng zhi capsule on lear ning and memory ability of vascular dementia model rats and explore its mechanism based on metabonomics. METHODS Totally 90 SD rats were randomly divided into sham operation group ，model group ，Dihydroergotoxin mesylate tablet group （positive control ，0.54 mg/kg），Longshengzhi capsule high-dose，medium-dose and low-dose groups （2.16，1.08 and 0.54 g/kg），with 15 rats in each group. In addition to sham operation group （only threading without ligation ），the vascular dementia model was prepared by permanent ligation of bilateral common carotid arteries in each group ，which was administered by gavage for 28 d. Morris water maze test was used to determine the learning and memory ability of rats ；hematoxylin eosin （HE）staining was used to observe the histopathological changes of hippocampus；the serum levels of superoxide dismutase （SOD），malondialdehyde（MDA）and glutathione peroxidase （GSH-Px） were detected ；the serum metabolic map was analyzed by ultra high performance liquid chromatography quadrupole time of flight tandem mass spectrometry （UPLC-Q-TOF/MS），the specific metabolites were screened by multivariate statistical analysis ，and the metabolic pathway was enriched and analyzed. RESULTS Morris water maze test showed that compared with model group ，the escape latency of rats in each administration group was significantly shortened ，the number of crossing the platform was significantly increased ，and the residence time in the target quadrant was significantly prolonged （P＜0.01 or P＜ 0.05）. The results of serum biochemical indexes showed that compared with model group ， the s erum level of SOD increased significantly in Dihydroergotoxine mesylate tablet group and Longshengzhi capsule high-dose group ，the serum level of GSH-Px increased significantly while the MDA level decreased significantly in each administration group （P＜0.05 or P＜0.01）. HE staining showed that Longshengzhi capsule could improve the histopathological damage of hippocampus in vascular dementia model rats. A total of 14 differential metabolites were screened and identified by UPLC-Q/TOF-MS and orthogonal partial least squares discriminant analysis model （VIP＞1 and P＜0.05）. The results of metabolic pathway enrichment analysis showed that the metabolic pathways involved in vascular dementia in rats mainly included vitamin B 6 metabolism，fatty acid metabolism and steroid hormone biosynthesis. CONCLUSIONS Longshengzhi capsule can improve the learning and memory ability of rats caused by vascular dementia. Its effect may be related to improving the oxidative stress injury caused by lipid accumulation in the process of vascular dementia. The metabolic pathways involved mainly include vitamin B 6 metabolism，fatty acid metabolism and steroid hormone biosynthesis.关键词：Longshengzhi capsule;Vascular dementia;learning ability;memory abilit y;metabonomics;Rat
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发布时间：2022-06-21 - 摘要：OBJECTIVE To eva luate the economy of loratinib versus crizo tinib in the first-line treatment of anaplastic lymphoma kinase （ALK）-positive advanced non-small cell lung cancer （NSCLC）from the perspective of China ’s health system ， and to provide reference for the product pricing and related medical decisions of the drug in other regions of China except for Hong Kong. METHODS Markov model and partition survival model both constructed based on the CROWN data （the simulation time limit was 10 years and the cycle period was 4 weeks）；the quality adjusted life year （QALY）was used as the outcome index to calculate the incremental cost-effectiveness ratio （ICER）. One-way sensitivity analysis ，probability sensitivity analysis and scenario analysis were used to verify the robustness of the results. RESULTS The basic analysis results based on Markov model showed that compared with crizotinib group ，the per capita cost of loratinib group increased by 17 867 588.63 yuan，the per capita utility increased by 1.76 QALYs，and the ICER was 10 152 038.99 yuan/QALY. The basic analysis results based on the partition survival model showed that compared with the crizotinib group ，the Δ 基金项目：江苏省博士后科研资助计划项目（No.2021K496C）； per capita cost of loratinib group increased by 18 009 592.54 2020年度高校哲学社会科学研究一般项目（No.2020SJA0070） yuan，the per capita utility increased by 1.74 QALYs，and the ＊硕士研究生 。研究方向 ：药物经济学 、卫生经济与政策 。 E-mail：sunlei_cpu@163.com ICER was 10 350 340.54 yuan/QALY. The results of one-way # 通信作者：教授，博士生导师。研究方向：药物经济学、卫生经 sensitivity analysis of the two models both showed that 济与政策。E-mail：ma86128@sina.com progression-free survival （PFS）state utility v alue，progression- ·1102· China Pharmacy 2022Vol. 33 No. 9 中国药房 2022年第33卷第9期 disease（PD）state utility value and loratinib cost had great influence on the results. The results of probability sensitivity analysis showed that when 1-3 times of China ’s per capita GDP in 2020 was taken as the willingness to pay threshold ，the probability of loratinib being economical was 0. The recommended unit price of loratinib per 100 mg was 657.10-815.60 yuan. CONCLUSIONS For patients with ALK-positive advanced NSCLC ，loratinib is more effective than crizotinib in the first-line treatment ，but it is not economical under the current price ；reasonably lowering the price of loratinib can increase the probability of its economy.关键词：loratinib;crizotinib;anaplastic lymphoma kinase;non-small cell lung cancer;Pharmacoeconomic evaluation
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发布时间：2022-06-21 - 摘要：OBJECTIVE To evaluate the econo mical efficiency of Recombinant human thrombopoietin injection （called “rhTPO”for short ）versus Etrapopa ethanolamine tablets （called“Etrapopa”for short ）in the second-line treatment of primary immune thrombocytopenia （ITP）in the Chinese adult patients. METHODS Based on the decision tree-embedded Markov model with a 4-week cycle ，the cost and utility related to bleeding events and adverse events after the use of the two drugs were measured and compared from the perspective of Chinese health system. The horizon was 12 weeks，and the cost and health outcome were not discounted. RESULTS Compared with Etrapopa ，rhTPO improved the quality adjusted life year by 0.002 5 and reduced the cost by 1 824.36 yuan，which was the absolute advantage scheme. Univariate sensitivity analysis showed that the base results were greatly affected by the dosage of rhTPO and Etrapopa during maintainance period. In most cases ，rhTPO was economical. Probability sensitivity analysis showed that when willingness-to-pay threshold varied between 0 yuan and 250 000 yuan，the probability about that rhTPO was economical ranges from 99.90％ to 100％. CONCLUSIONS Based on the available evidence ，rhTPO is more economical in the short term than Etrapopa in the second-line treatment of ITP.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To investigate the effects of esketamine combined with dexmedetomidine used for drug-induced sleep endoscopy in patients with obstructive sleep apnea syndrome. METHODS Totally 60 patients with obstructive sleep apnea syndrome were randomly divided into control group and observation group ，with 30 cases in each group. Anesthesia induction scheme of control group included loading dose of dexmedetomidine 1 μg/kg，pumped for 10 min，maintained at 1 μg（/ kg·h），and intravenous administration of propofol at a constant rate of 3 mg（/ kg·h）until the patient snored. That of observation group included same administration route and dose of dexmedetomidine as control group ，intravenous administration of esketamine 1 mg/kg at a constant rate of 0.5 mg/（kg·h）until the patient snored. Sleep endoscopy was performed when the bispectral index （BIS）was lower than 75 and the alert /sedation（OAA/S）score was higher than 1. The vital signs ，BIS and OAA/S scores of patients in awake state （T0），10 min load dose of dexmedetomidine infusion （T1），at the time of examination （T2）and at the end of examination （T3） were recorded ，as well as the patient ’s medication （including the one-time success rate of examination ，the number of additional drugs due to physical movement during examination ），and the occurrence of adverse events after medication. RESULTS In the comparison between groups ，the pulse oxygen saturation （SpO2）and BIS of patients in the observation group were significantly higher than those in the control group at T1，T2 and T3；the heart rates and mean arterial pressures （MAP）at T2 and T3 were significantly lower than those in the control group ；and the OAA/S score at T1 and T2 were significantly higher than those in the control group （P＜0.05）. Comparison within the group ，the heart rates at T1，T2 and T3 in the observation group were significantly lower than those at T0，and the MAP at T2 and T3 were significantly lower than that at T1（P＜0.05）；in control group ，compared with T0，SpO2 decreased significantly at T1，T2 and T3，heart rate decreased significantly at T1，and MAP increased significantly at T2（P＜0.05）. Sixty patients successfully completed drug-induced sleep endoscopy after medication. The one-time success rate of examination in the observation group was significantly higher （No.191460443） than control group （P＜0.05），and the number of additional drugs due to physical movement during examination was significantly less than control group （P＜0.05）. There was no significant difference in the incidence of adverse events between 2 groups（P＞0.05）. CONCLUSIONS Esketamine combined with dexmedetomidine has less respiratory inhibition and less effect on hypoxia hemodynamics in patients with obstructive sleep apnea syndrome. It has less intervention times in the process of sleep endoscopy ，and has more advantages than propofol.关键词：esketamine;obstructive sleep apnea syndrome;drug-induced sleep endoscopy
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发布时间：2022-06-21 - 摘要：OBJECTIVE To syste matically evaluate the prevention effects of nicorandil on contrast-induced nephropathy in patients underwent coronary angiography （CAG）or stent implantation （CSI），and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed ，Embase，Cochrane library ，Wanfang database ，CBM and CNKI ，randomized controlled trial （RCT）about nicorandil （trial group ）versus normal saline or placebo （control group ）prevented contrast-induced nephropathy in patients underwent CAG or CSI were collected during the inception to Nov. 2021. After extracting literature that met the inclusion criteria ，the bias risk assessment tool of RCT in Cochrane manual was used for quality evaluation ，and meta-analysis was performed by using RevMan 5.3 software. RESULTS A total of 17 RCTs were included ，involving 3 279 patients. Among them，there were 1 587 patients in trial group ，and 1 692 patients in control group. Results of meta-analysis showed that the incidence of contrast-induced nephropathy in trial group was significantly lo wer than control group [RR ＝0.40，95％CI（0.31，0.51）， P＜0.000 1] . Results of subgroup analysis showed that the incidence of contrast-induced nephropathy in trial group was significantly lower than control group ，whether intravenous administration [RR ＝0.47，95％CI（0.29，0.74），P＝0.001] or oral administration [RR ＝0.37，95％CI（0.28，0.50），P＜0.000 01]，whether patients with normal renal function [RR ＝0.42，95％CI（0.30， 0.59），P＜0.000 01] or with renal insufficiency [RR ＝0.38， 95％ CI（0.26，0.54），P＜0.000 01]. Scr of 24 h[SMD＝ －1.38，95％CI（－2.32，－0.44），P＝0.004]，48 h[SMD＝ －0.81，95％CI（－1.19，－0.43），P＜0.000 1] and 72 h[SMD＝ －0.24，95％CI（－0.43，－0.05），P＝0.01] after surgery in trialgroup were significantly lower than control group ；the 163.com decrease of creatinine clearance rate of 48 h[SMD＝1.27， 95％CI（0.48，2.07），P＝0.001] and 72 h[SMD＝0.37，95％CI（0.07，0.67），P＝0.02] after surgery in trial group were significantly lower than control group ；cystatin C of 24 h[SMD＝－0.93，95％CI（－1.72，－0.14），P＝0.02]，48 h[SMD＝－1.72，95％CI （－2.33，－1.10），P＜0.000 01] and 72 h[SMD＝－0.36，95％CI（－0.62，－0.10），P＝0.006] after surgery in trial group were significantly lower than control group. CONCLUSIONS Pretreatment of nicorandil can reduce the incidence of contrast-induced nephropathy in patients underwent CAG or CSI ，and reduce the damage of renal function after application of contrast.关键词：nicorandil;coronary angiography;coronary stent implantation;contrast-induced nephropathy;Prevention
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provide reference for standardizing the labeling of medication information for pregnant women and lactating women in the instructions of antiarrhythmic drugs. METHODS The instructions of antiarrhythmic drugs were collected from the terms of “medication reference ”on official website of Yimaitong Technology Co. ，Ltd. The labeling of medication information of pregnant women and lactating women were sorted out ，counted and analyzed with reference to the Detailed Rules for Specifications of Instructions of Chemical Drugs and Therapeutic Biological Products issued by the State Food and Drug Administration. RESULTS A total of 111 instructions of antiarrhythmic drugs were collected in this study ，of which 102 instructions were marked with “medication for pregnant women ”（91.89％），of which the proportion of those with medication guidance and without medication guidance were 75.68％ and 16.22％ respectively. Eighty-eight drug instructions were marked with the item “medication for lactating women ”（79.28％），of which the proportion of those with medication guidance and without medication guidance were 70.27％ and 9.01％ respectively. Among different categories of antiarrhythmic drugs ，the best labeling of “medication for pregnant women ”was class Ⅰ antiarrhythmic drugs （100％），while class Ⅲ drugs（25.00％）were most missing ； class Ⅳ antiarrhythmic drugs （94.44％）were the best labeled for “medication for lactating women ”，while class Ⅰ（26.47％）were the most missing . There were differences in the labeling contents of “medication for pregnant women ”and“medication for lactating women ”in some drug instructions of the same variety from different manufacturers. Among the 99 drug instructions of domestic pharmaceutical enterprises ， 92 listed the items of “medication for pregnant women”and“medication for lactating women ”，and the proportions of them with medication guidance were 74.75％ and 69.70％ respectively；among the 12 drug instructions of foreign pharmaceutical enterprises ，10（83.33％）listed the items of “medication for pregnant women ”and“medication for lactating women ”，and the proportion with medication guidance was 83.33％ and 75.00％ respectively. CONCLUSIONS There are some problems in the labeling content of domestic antiarrhythmic drug instructions，such as the lack of information related to “medication for pregnant women ”and“medication for lactating women ”， the confusion of guidance expression ， the inconsistent content of drug instructions of the same variety from different manufacturers，the lag of modification and update ，and the poor standardization of drug instructions. Drug supervision and administration departments and drug manufacturers should pay attention to them and constantly strengthen the management and standardization of instructions.关键词：pregnant women;lactating women;antiarrhythmic drugs;Drug instructions;medication for special population
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发布时间：2022-06-21 - 摘要：OBJECTIVE To compare five com monly used judgment criteria for potentially inappropriate medication （PIM）in the elderly ，and to provide reference for clinical selection of appropriate PIM evaluation tools for the elderly. METHODS From the aspects of applicable age ，content and scale characteristics ，five commonly used PIM judgment criteria for the elderly at home and abroad were analyzed and compared ，namely Beer ’s criteria ，STOPP/START v 2 criteria，ACOVE 3 criteria，PIM-Check criteria and“Judgment Criteria for Potentially Inappropriate Medication for Chinese Elderly ”（Chinese criteria ）. RESULTS The five standards both overlapped and focused in terms of scale characteristics. In each study ，the incidence of PIM was different according to different standards. Proton pump inhibitors ，diuretics，non-steroidal anti-inflammatory drugs and anticoagulants were the most frequently occurring PIM drugs for the elderly. CONCLUSIONS Combining with the specific conditions of patients and fully considering the benefits and risks of treatment ，rational selection and combination of five PIM judgment criteria ，and necessary supplements to my country ’s PIM judgment criteria ，will help clinicians and pharmacists to improve the efficacy and safety of the medication in the elderly patients.关键词：potentially inappropriate medication;the elderly;judgment criteria;Efficacy;Safety
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发布时间：2022-06-21 - 摘要：OBJECTIVE To sum marize the pro cedure and informatization construction of centralized volume-based procurement（VBP）in our hospital ，in order to give references for normal development of centralized VBP. METHODS The standardized workflow system was established ，including using flow chart method to establish standardized workflow ，carrying out procedure training and inspection of procedure implementation ， and continuously conducting procedure optimization. The information system was developed for the task links that needed a lot of calculation to improve the automation level of information processing. RESULTS & CONCLUSIONS Eight specific work procedures were established in our hospital ，including the work procedures of submitting the demand data of centralized VBP and the implementation of centralized VBP ，and has taken measures such as procedure training ，establishing supervision and inspection system and using auxiliary means to promote the implementation of the procedure ，so as to optimize the procedure and work form. An informatization platform for the clinical task allocation of the agreed purchase quantity of centralized VBP and a supervision platform for the daily use of VBP were also established in our hospital，then the two tasks with a large amount of calculation could be finished. Standardized workflow system and informatization platform construction has improved the operation and supervision efficiency of centralized VBP in our hospital ，ensured the completion of centralized purchase tasks and saved human resources ，which has a certain promotion value.关键词：volume-based procurement;standardized workflow system;informatization platform;procedure optimization
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发布时间：2022-06-21 -
Research advance of population pharmacokinetics of imipenem-cilastatin in special status populations
摘要：Imipenem-cilastatin is a broad-spectrum carbapenem antibiotic drug that has been widely used in clinical practice ， but there is a lack of guidelines and expert consensus on the development of individualized regimens for special status populations [e.g. continuous renal replacement therapy （CRRT）patients，extracorporeal membrane oxygenation （ECMO）patients， critically ill burn patients ，neonates and children]. In this paper ，by searching population pharmacokinetics research of imipenem- cilastatin in special status populations ，it is recommended that imipenem-cilastatin is given 1 to 3 g/d for CRRT patients ；500 mg to 1 g，q6 h for burn patients ；750 mg to 1 g，q6 h for ECMO patients ；20 mg/kg or 25 mg/kg，q8 h for neonates ；and 25 mg/kg，q6 h for children.- 48
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发布时间：2022-06-21 - 摘要：Nucleic acid drugs ha ve received increasing attention and are considered to be potential for the therapy of many diseases such as tumor therapy. This is due to their selective regulation of specific protein expression ，simple sequence design ，easy synthesis and modification ，and clear mechanism of action. However ，nucleic acid drugs have to be delivered by carriers to produce therapeutic effects ，because nucleotides must rely on effective carriers to overcome their limitations and various transmembrane barriers. Currently ，most non-viral nucleic acid delivery carriers have the disadvantage of poor transfection efficiency. The researchers design a series of smart responsive nanocarriers that respond to the pathological environments in vivo or physical stimulations in vitro . By responding to internal special changes such as pH values and redox conditions or to external stimuli such as temperature ，ultrasound，magnetic field and light ，the smart responsive nanocarriers can achieve precise regulation of drug release ，enhance the transfection efficiency of nucleotides in target cells and reduce the toxic side effects on normal tissues and cells. This review summarizes the progress of smart responsive nanocarriers in the field of nucleic acid drugs delivery and introduces the functional design and features of smart responsive nanocarriers. The intent is to provide a reference for the development of nucleic acid drugs and their delivery systems.关键词：nucleic acid drugs;nanocarriers;delivery system;smart responsive;endogenous stimulus;physical stimulus
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发布时间：2022-06-21
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