最新刊期
卷 33 ， 期 8 ， 2022
- 摘要：In order to further s tandardize the clinical application of proton pump inhibitors and provide reference for prescription suitability review ，under the guidance of Guiding Principles for Clinical Use of Proton Pump Inhibitor which was promulgated by the General Office of National Health Commission of the People ’s Republic of China ，Pharmaceutical Admini- stration Committee of Chongqing Hospital Association initiates “the formulation Project on Prescription Review Rules for Proton Pump Inhibitors ”. The First Affiliated Hospital of the Army Medical University takes the lead and cooperates with clinical experts ， pharmaceutical experts and evidence-based experts from many domestic medical institutions to discuss the indications ，usage and dosage，medication for special groups and drug interactions of proton pump inhibitors ，and finally forms this consensus. The main contents of the consensus include the basic prescription review rules of omeprazole ，esmeprazole，pantoprazole，rabeprazole， lansoprazole and iprazole （including injection and oral preparations ，calculated by common name ），and 12 prescription review recommendations for some clinical applications not covered on the basic prescription review rules ，in order to provide reference for medical institutions at all levels.关键词：proton pump inhibitor;prescription suitability;prescription review rules;Clinical application;Expert Consensus
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发布时间：2022-06-21 - 摘要：OBJECT IVE To analyze the situation of comprehensive drug evaluation research in China. METHODS Using the method of bibliometrics ，CiteSpace 5.8.R3 analysis tool was used to summarize the research situation and hotspots from 6 dimensions，such as safety ，effectiveness，economy，innovation，suitability and accessibility. RESULTS & CONCLUSIONS At present，there were many types of researches on safety and effectiveness. The economic evaluation was increasing. There were still not much researches on the comprehensive evaluation of drugs from 6 dimensions. Researchers were concentrated ，and there was less collaboration between researchers or research institutions. In terms of methods ，systematic review ，meta-analysis，clinical observational research and retrospective research were more common. The topic selection of antibacterial drugs ，anti-tumor drugs ， and cardiovascular drugs were more popular. It is recommended to establish a unified method and standard for clinical comprehensive evaluation of drugs ，clarify the coordination medianism of the comprehensive drug evaluation ，make full use of real-world data to enrich the contents of 6 dimensions，implement quality control for all segments of the evaluation ，and form a comprehensive evaluation report with sufficient evidence and definite results ，so as to promote the clinical application of the results.关键词：comprehensive drug evaluation;CiteSpace;research situation;Research hotspot;Safety;Effectiveness;Economy
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To provide reference for the adjustment and optimization of the policies related to traditional Chinese medicine（TCM）injection in China. METHODS The policies related to TCM injections issued at the national level were collected from Jan. 1，1990 to May 31，2021. Based on the perspective of policy tool ，the content analysis and quantitative analysis were used to classify ，code and analyze the policy terms according to “policy serial number-chapter number-specific terms ”. RESULTS & CONCLUSIONS Totally 30 policy documents related to TCM injection were included ， with a total of 389 codes. Environment-based policy tools were the most widely used （79.95％），followed by supply-oriented policy tools ，accounting for 15.42％. Demand-based policy tools accounted for the least proportion （4.63％）. Among environment-based policy tools ，the regulatory and control policy tools （38.05％） received more attention，and the policy publicity （2.06％） received fewer applications. Among supply-oriented policy tools ，there were more applications of science and technology support （10.80％）， and fewer applications of capital investment （0.26％）. Among demand- based policy tools ，organizational coordination was the most widely used （3.34％），followed by experience demonstration （1.29％），which had not yet involved the relevant policies of international exchange. In order to promote the development of TCM injection ，it is necessary to appropriately reduce the application of environment-based policy tools ，increase the application of policies such as policy publicity ，and improve the external environment for TCM injection ；optimize the internal combination of supply-oriented policy tools ，increase the use of capital investment tools ，and effectively play the role of policy boosting；emphasize the application of demand-based policy XJY21013） tools to form an effective policy pulling force for the healthy development of TCM injection.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the fingerprints of dried Houttuynia cordata and its decoction pieces ，conduct chemometrics analysis and determine the contents of 5 flavonoids such as neochlorogenic acid. METHODS High performance liquid chromatography （HPLC）method was adopted. Using quercitrin as reference ，HPLC fingerprints of 10 batches of dried H. cordata and its decoction pieces were drawn. The similarity evaluation was conducted by Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition），the common peaks were also confirmed. SIMCA-P 14.1 software was applied for principal component analysis （PCA）and partial least square-discriminant analysis （PLS-DA），and the variable importance in projection（VIP）value more than 1 was considered as a standard to screen the differential components affecting the quality of these two products ；meanwhile，the contents of 5 components such as neochlorogenic acid in both products were determined by the same HPLC method. RESULTS There were 20 common peaks in 10 batches of dried H. cordata and 10 batches of its decoction pieces with the similarity values more than 0.960. A total of 5 common peaks were identified ，which were neochlorogenic acid （peak 1）， chlorogenic acid （peak 3），cryptochlorogenic acid （peak 4），rutin（peak 7）and quercitrin （peak 11）. The results of PCA and PLS-DA showed that dried H. cordata could be distinguished from its decoction pieces obviously ；the common peaks with VIP value greater than 1 were as follows ：peak 7（rutin），peak 20，peak 5，peak 13，peak 2，peak 18，peak 3（chlorogenic acid ）， peak 14，peak 17 and peak 19. The linear range of neochlorogenic acid ，chlorogenic acid ，cryptochlorogenic acid ，rutin and quercitrin were 3.77-60.29 μg/mL（r＝0.999 7），1.40-22.42 μg/mL（r＝0.999 5），3.76-60.22 μg/mL（r＝0.999 9），2.19-35.06 μg/mL （r＝0.999 9）and 25.49-407.88 μg/mL（r＝0.999 7），respectively. RSDs of precision ，stability（24 h）and reproducibility E-mail：20190394@njucm.edu.cn tests were all lower than 3％. The average recoveries of the above components in these two products were 98.72％-101.12％ and 98.86％ -100.63％ with RSDs less than 3％（n＝9）. In dried H. cordata ，the average contents of 5 components were 0.87，0.33，0.59，0.61 and 6.17 mg/g，while the average contents were 0.42，0.11，0.26，0.23 and 3.16 mg/g in its decoction pieces ，respectively. CONCLUSIONS HPLC fingerprint and the method of content determination are stable and feasible ，which could be used for the quality control of dried H. cordata and its decoction pieces. Besides ，rutin and other components may be the differential components which could affect the quality of these two products ；the average contents of the 5 flavonoids such as neochlorogenic acid in dried H. cordata all decrease after processing.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To prepare quercetin-human serum albumin-nanoparticles （Que-HSA-NPs），and to evaluate the in vivo and in vitro inhibitory effects of Que-HSA-NPs on hepatic fibrosis of non-alcoholic steatohepatitis （NASH）. METHODS Que-HSA-NPs were prepared by desolvation-chemical cross-linking method ，their appearance characteristics were observed ，and their particle size ，polydispersity index （PDI），Zeta potential and drug loading were detected. Quercetin （Que）and Que-HSA-NPs were applied to murine HSC-T 6 cells. The effects of them on survival rate of HSC-T 6，mRNA expression of transforming growth factor β（TGF-β），Type Ⅰ collagen α1（COL1A1）and α-smooth muscle actin （α-SMA）were compared. Que and Que-HSA-NPs were applied to mice fed with low methionine and choline deficient high-fat diet. The serum levels of liver injury indexes ，liver pathological characteristics ，mRNA expressions of TGF-β，COL1A1 and α-SMA，protein expression of α-SMA in liver tissue were determined to evaluate the improvement effects of them on hepatic fibrosis of NASH in mice. RESULTS The prepared Que-HSA-NPs was spherical ，the particle size was （172.9±2.2）nm，the PDI was 0.233，the Zeta potential was －29.2 mV，and the drug loading was 2.99％. Que and Que-HSA-NPs were nontoxic to HSC-T 6 at concentrations of 0-250 μg/mL. Both of them could significantly decrease mRNA expressions of TGF-β，COL1A1 and α-SMA，especially Que-HSA-NPs （P＜0.05）. They also could significantly decrease the serum levels of liver inju ry index ，relieve liver injury and down-regulate mRNA expressions of TGF-β，COL1A1 and α-SMA and protein expression of α-SMA， especially Que-HSA-NPs （P＜0.05）. CONCLUSIONS Que- HSA-NPs is successfully prepared ，and confirm that its anti- NASH hepatic fibrosis effect is better than that of Que .
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发布时间：2022-06-21 - 摘要：OBJECTIVE To conduc t qualitative and quantitative analysis for the chemical compounds in 3 species of wild Veratrum（V. nigrum ，V. maackii ，V. dahuricum ）from Inner Mongolia. METHODS HPLC-Q-Exactive-MS/MS technology was used to identify the chemical components of V. nigrum ，V. maackii and V. dahuricum by consulting SciFinder ，ChemSpider database and related literatures and comparing with the reference substance. The contents of polydatin ，oxyresveratrol and resveratrol in 3 species of wild Veratrum were determined by HPLC. RESULTS A total of 31 compounds were identified ，including 13 stilbenes， 11 flavonoids，4 organic acids ，2 glycosides，1 brasilin. Most of the compounds were shared by 2 or 3 species of wild Veratrum， only 2 flavonoids kaempferol and luteolin were owned by V. dahuricum . The total contents of polydatin ，oxyresveratrol and resveratrol in 3 species of wild Veratrum were in the range of 6.618-11.292 mg/g，and the total contents of them in V. nigrum were the highest ，followed by V. maackii and V. dahuricum . The contents of polydatin and resveratrol in V. maackii were the highest ，and the content of oxyresveratrol in V. nigrum was highest. CONCLUSIONS Most of the components of 3 species of wild Veratrum are similar，only kaempferol and luteolin are unique to V. dahuricum . The contents of polydatin ，oxyresveratrol and resveratrol are significantly different among 3 species of wild Veratrum.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To optimize the pr eparation technology of the baicalin lipid nano foam aerosol （BC-LN-FA）. METHODS Baicalin lipid nanoparticle （BC-LN）and BC-LN-FA were prepared by the thin film dispersion method and homogeneous emulsification method ，respectively，using baicalin （BC） as the model drug. The preparation technology was optimized by Box-Behnken design-response surface methodology using particle size and encapsulation efficiency （EE）as indexes ，with dosage ， emulsifier dosage ，co-emulsifier dosage and homogenization time as factors. The morphology ，particle size ，polymerdispersity index（PDI），EE，the viscosity ，the foam dissolution rate and in vitro transdermal release of BC-LN-FA were characterized. RESULTS The optimal technology included 25 mg BC ，40 mg emulsifier （mass ratio of stearic acid-soybean lecithin-glycerol was 1∶1∶1），30 mg co-emulsifier （mass ratio of octadecanol-lactic acid was 1∶1），homogenization time of 20 min. Results of 3 times of validation tests showed that particle size of prepared BC-LN-FA was （151.70±2.40）nm，EE was （68.62±1.16）％；the deviation of them from the predicted value （particle size of 150.80 nm，EE of 67.02％）were 0.60％ and 2.39％ respectively. The BC-LN-FA prepared by the optimal process was light yellow opalescence ，uniform in particle size and round-like in shape. The viscosity，the foam dissolution rate ，the content of BC and PDI were （122.92±5.09）mPa·s，（65.32±3.22）％，（7.01±0.12）％ and（0.199±0.006），respectively. At 48 h，the cumulative release rates of BC-LN-FA in phosphate buffer saline （PBS）at pH 7.4， 6.8，5.0 were（54.12±2.69）％，（57.85±4.25）％ and（59.47±1.83）％，respectively；those of free BC in PBS at pH 7.4 was only （15.04±1.43）％. CONCLUSIONS The optimized technology is stable and feasible. Prepared BC-LN-FA has a uniform particle size，high digestion rate and certain viscosity.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To opti mize the supercritical CO 2 extraction technology of volatile oil from Blumea balsamifera ，and compare the components of the volatile oil from B. balsamifera obtained by supercritical CO 2 extraction and steam distillation. METHODS The volatile oil of B. balsamifera was extracted by supercritical CO 2 extraction. Using extraction rate of volatile oil as index，extraction temperature ，extraction pressure and extraction time as factors ，based on single-factor experiment ，orthogonal experiment was used to optimize the supercritical CO 2 extraction technology. Gas chromatography-mass spectrometry was used to identify the components of volatile oil from B. balsamifera . Peak area normalization was used to calculate the relative contents of each component. Taking the volatile oil obtained by steam distillation as a reference ，the extraction rates ，components and contents of volatile oil by the two methods were compared. RESULTS The optimal supercritical CO 2 extraction technology of volatile oil from B. balsamifera included extraction pressure of 30 MPa，extraction temperature of 50 ℃ and extracting for 50 min. After 3 times of validation tests ，average extraction rate of volatile oil was 4.64％（RSD＝0.54％，n＝3）. Thirty-nine components such as tritriacontane，stigmasterol，squalene were identified in the volatile oil of B. balsamifera obtained by supercritical CO 2 extraction； and 51 components such as triacontane ，ledol，humulene epoxide Ⅰ were identified by steam distillation. The extraction rate of volatile oil from B. balsamifera obtained by 2 methods were 4.64％ and 0.99％. A total of 26 common components were obtained ， such as xanthoxylin ，L-borneol，β-caryophyllene. Except for xanthoxyline （34.829％ by supercritical CO 2 extraction，30.676％ by steam distillation method ）and phytol （2.401％ by supercritical CO 2 extraction，1.273％ by steam distillation ），the relative contents of the components of volatile oil obtained by supercritical CO 2 extraction were lower than those of steam distillation. CONCLUSIONS The optimal supercritical CO 2 extraction technology is stable and feasible ；the components and contents of volatile oil obtained by two methods varies greatly ，and main compounds are aldehydes and ketones ，alkenes，alcohols and other components.关键词：Blumea balsamifera;Volatile oil;supercritical CO 2 extraction;orthogonal experiments;steam distillation;gas
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish a method for simultaneous determination of zeaxanthin ，β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate in Lycium barbarum . METHODS L. barbarum was extracted with n-hexane-anhydrous ethanol-acetone-toluene（10∶6∶7∶7，V/V/V/V）by ultrasonic method. High performance liquid chromatography （HPLC）method was adopted. The determination was performed on YMC C 30 column with mobile phase A consisted of methanol-acetonitrile-water （81∶ 14 ∶ 5，V/V/V）and mobile phase B consisted of dichloromethane （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was set at 20 ℃. The detection wavelength was set at 450 nm，and sample size was 20 μL. Using zeaxanthin as control，the relative correction factors （RCFs）of β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate were calculated ， and then the content of each component was calculated according to RCFs and compared with the results of external standard method（ESM）. RESULTS The linear range of zeaxanthin ，β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate were 0.119 4-2.983 8，0.121 7-1.521 6，0.285 9-5.718 8，8.460 5-211.513 3 μg/mL（all R2＞0.999）. RSDs of precision ，repeatability and stability（16 h）tests were all less than 4％. The average recoveries were 103.34％，107.37％，105.64％，96.16％（RSD＜5％，n＝ 9）. The average RCFs of β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate were 1.109，1.390，1.158. The relative errors of the content determination results by quantitative analysis of multi-components by singer marker （QAMS）and ESM were within ±1％. CONCLUSIONS The established HPLC-QAMS method is accurate and stable ，which can be used for the content determination and quality control of 4 carotenoids in L. barbarum .关键词：Lycium barbarum;HPLC;QAMS;zeaxanthin;β-carotene;β-cryptoxanthin palmitate;zeaxanthin dipalmitate
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish a quality standard for rice-fired Glehnia littoralis . METHODS Appearance observation ， powder microscopic identification and thin-layer chromatography （TLC）identification were performed for the samples of rice-fired G. littoralis decoction piece. According to the relevant methods stated in 2020 edition of Chinese Pharmacopoeia （part Ⅳ），the contents of moisture ，total ash ，acid-insoluble ash ，water-soluble extract and acid-soluble extract were determined. The contents of psoralen，zanthoxylin，bergapten，imperatorin and isoimperatorin were determined by high performance liquid chromatography （HPLC）. RESULTS The rice-fired G. littoralis decoction pieces were round-like small segments ，slightly rough ，yellow（peeled） or dark yellowish brown （with peel ），special gas and slightly sweet taste. The powder was yellowish white. Under the microscope ， secretions and secretory cells ，ducts，gelatinized starch granules ，ray cells ，parenchyma cells ，etc. could be seen. TLC showed the spots developed clearly. In the chromatogram of the test sample ，there was the same blue fluorescent spot at the corresponding position of the chromatogram of isoimperatorin control sample. The moisture ，total ash ，acid-insoluble ash ，water-soluble extract and ethanol-soluble extract from 9 batches of samples were 5.82％-6.27％，3.19％-3.59％，0.21％-0.27％，24.91％-30.30％ and 20.66％ -25.83％ ，respectively. The linear range of psoralen ，zanthotoxin，bergapten，imperatorin and isoimperatorin were 0.240-2.400，0.320-3.200，0.224-2.240，0.292-2.920，0.208-2.080 µg/mL（all r＞0.999 0）. Limits of quantitation were 0.032 0， 0.030 0，0325 0，0.032 0，0.045 0 µg，respectively. Limits of detection were 0.100 8，0.089 6，0.071 5，0.090 0，0.132 0 µg， respectively. RSDs of prescision ，stability（24 h）and reprodu- cibility tests were less than 3％. Average recoveries were 100.56％ （RSD＝1.36％ ，n＝6），100.73％（RSD＝2.25％ ，n＝6）， 100.36％（RSD＝0.98％，n＝6），98.24％（RSD＝0.40％，n＝6） E-mail：853063968@qq.com and 99.40％（RSD＝0.35％，n＝6），respectively. The contents of above five components were 5.85-13.31，8.63-33.38，6.23- E-mail：shixiaofeng2005@sina.com 15.25，6.12-12.98，5.52-10.77 µg/g，respectively. The total contents were 34.20-83.47 µg/g. CONCLUSIONS It is preliminarily proposed that the moisture ，total ash and acid-insoluble ash should not exceed 7.30％，4.10％，0.30％. The water-soluble extract and ethanol-soluble extract are no less than 21.00％ and 18.00％，respectively. The total content of coumarin should not be less than 52.03 µg/g（with peel ）and 26.34 μg/g（peeled）. Established quality standard can be used for the quality control of rice-fired G. littoralis .关键词：rice-fired Glehnia littoralis;Quality standard;microscopic identification;TLC;HPLC;Content determination
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发布时间：2022-06-21 - 摘要：OBJECTI VE To explore the effects of total flavonoids of Bidens polisa L.（TFB）on insulin resistance （IR）of HepG2 cells. METHODS B. polisa L. was refluxed and extracted with 80％ ethanol to obtain TFB. Palmitic acid was used to induce IR mode of HepG 2 cells in vitro . The effects of low-concentration ，medium-concentration and high-concentration （20，40， 80 mg/L） of TFB on the consumption of glucose were investigated. Using metformin as positive control ，the effects of low-concentration，medium-concentration and high-concentration （20，40，80 mg/L）of TFB on the protein expression of insulin receptor substrate- 1（IRS-1），c-Jun N-terminal kinase （JNK）and protein kinase C （PKC）were investigated. Molecular docking technology was used to explore the interaction between eight main active components of TFB such as quercetin ，quercitrin and IRS-1，JNK and PKC proteins. RESULTS The glucose consumption of TFB low-concentration ，medium-concentration and high-concentration groups were increased significantly （P＜0.05 or P＜0.01）. Compared with normal group ，the expression of IRS-1 and JNK protein in the model group decreased significantly ，and the expression of PKC protein increased significantly （P＜ 0.01）. Compared with model group ，the protein expression of IRS- 1 and JNK could up-regulated while the protein expression of PKC down-regulated in TFB low-concentration ，medium-concentration and high-concentration groups and metformin positive control group （P＜0.05 or P＜0.01）. The score of molecular docking energy between maritimetin in TFB and IRS- 1 protein was －7.9 kcal/mol（1 kcal＝4.816 kJ）. The scores of molecular docking energy of maritimetin ，rutin and JNK protein were －9.3 kcal/mol. The score of molecular docking energy between quercitrin and PKC protein was －4.9 kcal/mol. Interactions between components and proteins included forming hydrogen bonds ，hydrophobic bonds and so on. CONCLUSIONS TFB can significantly improve IR of HepG 2 cells，the mechanism of which may be related to the regulation of protein expression of IRS ，JNK and PKC. Maritimetin，rutin and quercitrin may be potential active ingredients for improving IR.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To explore the merging methods and influencing factors of health state disutility values estimation. METHODS Retrieved from 6 Chinese and English databases such as CNKI and PubMed ，the literatures about disutility values of diarrhea caused by antitumor drugs were collected from the inception to July 2021. After 2 researchers independently screened the literature，extracted the data ，assessed the quality ，the Meta-analysis and regression analysis were conducted using Stata 16.0 software. RESULTS Fifteen literatures were included. The results of Meta-analysis showed that diarrhea caused by antitumor drugs had a significant impact on health utility [ MD＝－0.26，95％CI（－0.30，－0.22），P＜0.05]. The results of subgroup analysis showed that the disutility values of the 3 types of negative value ，non-negative value changed into negative value ，and non-negative value combined with basic state changed into to negative value were MD ＝－0.14，95％CI（－0.19，－0.09）；MD＝－0.46，95％CI （－0.56，－0.36）；MD＝－0.12，95％CI（－0.20，－0.05），respectively. Meta regression results showed that the year of publication ， survey country/region ，severity of adverse events ，basic state settings ，utility estimation tools ，utility report types ，and utility statistical methods significantly affected the value of diarrhea disutility （P＜0.05）. CONCLUSIONS Disutility values for treatment-related symptoms or complications should be fully considered when inputting the parameters to the economic evaluation model. In the study or application of disutility values ，the types of utility reports should be distiguished ，and the core influencing factors such as the investigation country or region ，the severity of symptoms or complications ，and whether the basic state is set should be focus on.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To ex plore the economic value of medication therapeutical management （MTM）service for patients with stable coronary disease. METHODS Totally 140 patients with stable coronary disease were divided into a control group and a intervention group ，70 cases in each group. Patients in control group were received routine medical services ，and patients in intervention group additionally received standardized MTM services on this basis. Medication complication ，satisfaction degree ， safety indexes and efficacy indexes were compared between 2 groups. From the perspective of the whole society ，the economic value of MTM service for patients with stable coronary disease were evaluated by pharmacists using cost minimization analysis. RESULTS A total of 15 patients did not complete the study ，including 5 cases in intervention group and 10 cases in control group ； there was no death endpoint during the follow-up period. MMAS- 8 score，satisfaction score of drug communication dimension and score of overall satisfactionin of intervention group were obviously higher than control group （P＜0.01）. There was no significant difference in blood pressure standard rate ，blood lipid standard rate ，the incidence of adverse drug reaction ，and the incidence of acute coronary events between 2 groups（P＞0.05）. The total cost of intervention group was lower than that of control group （P＜ 0.01）；the results of sensitivity analysis were consistent with those of cost minimization analysis. CONCLUSIONS Pharmacists implement MTM service for patients with stable coronary disease can reduce total cost ，save medical resources and has economic advantages.关键词：medication thera peutical management;stable coronary disease;economic evaluation;Pharmaceutical care
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发布时间：2022-06-21 - 摘要：OBJECT IVE To e stablish the method for simultaneous determination of levetiracetam and carbamazepine concentrations in human plasma. METHODS After plasma samples were precipitated with methanol ，using carbamazepine-D 10 as the internal standard ，the concentrations of levetiracetam and carbamazepine were determined by high performance liquid chromatography-tandem mass spectrometry （HPLC-MS/MS）. The determination was performed on XBridge BEH C 18 column with methanol-0.1％ formic acid as mobile phase （gradient elution ）at the flow rate of 0.35 mL/min. The column temperature was set at 40℃，and sample size was 2 μL. With electrospray ion source，a multiple reaction monitoring mode was used for positive ion scanning；the detected ion pairs for quantitative analysis were m/z 171.3→126.3（levetiracetam），m/z 237.1→194.1（carbamazepine）， 247.1→204.1（internal standard ）. RESULTS The linear range of the concentrations of levetiracetam and carbamazepine were 0.5-50 and 0.2-20 μg/mL（r＝0.997 3 and 0.998 5），respectively；the lower quantitative limits were 0.5 and 0.2 μg/mL，respectively. RSDs of intra-day and inter-day were all no more than 10.00％. RE of intra-day and inter-day were within ±4.00％；the average extraction recoveries rate were 95.60％-105.00％；the average internal standard correction matrix factors were 98.40％-110.00％； RSDs of stability tests were all not higher than 5.60％. The concentrations of levetiracetam and carbamazepine in the plasma of 22 patients measured by this method were 3.36-40.90 and 3.64-9.93 μg/mL，respectively. CONCLUSIONS The established method for determining the concentration of levetiracetam and carbamazepine in human plasma is f ast，sensitive，accurate and stable ，and can be used for the monitoring of plasma concentration and pharmacokinetic study in epilepsy patients.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To analyze the influential factors of cardioto xicity in patients with positive breast cancer of human epidermal growth factor receptor 2（HER-2）treated by trastuzumab combined with chemotherapy. METHODS From April 2017 to January 2021，200 HER-2 positive breast cancer patients receiving pirarubicin + cyclophosphamide combined with sequential paclitaxel+trastuzumab were collected from our hospital. According to the presence or absence of cardiotoxicity ，the patients were divided into cardiotoxicity group and non-cardiotoxicity group. The clinical data and echocardiographic results of the patients were collected，and the influential factors of cardiotoxicity were analyzed. RESULTS Among 200 patients，43 patients suffered from cardiotoxicity with the incidence of 21.5％. The proportion of patients with cardiotoxicity during pirarubicin+cyclophosphamide therapy accounted for 5.5％（11/200），and the proportion of patients with cardiotoxicity during sequential paclitaxel+trastuzumab therapy accounted for 20.5％（41/200）；the latter was significantly higher than the former （P＜0.01）. At the same time ，the decrease of left ventricular ejection fraction during sequential therapy of paclitaxel and trastuzumab was significantly higher than that during pirarubicin+cyclophosphamide therapy [ 14％（12％，17％）vs. 7％（3％，10％），P＜0.001]. Compared with patients without cardiotoxicity ，the proportion of patients with cardiotoxicity with a history of hyperlipidemia was significantly higher （P＜ 0.01），while the proportion of patients receiving dexrazoxane was significantly lower （P＜0.01）. Results of binary Logistic regression analysis showed that the history of hyperlipidemia [OR ＝3.672，95％ CI（1.499，8.992），P＝0.004] and the use of dextrazoxane [OR ＝0.154，95％ CI（0.072，0.330）， P＜0.001] were associated with the occurrence of cardiotoxicity. CONCLUSIONS Hyperlipidemia is an independent risk factor for cardiotoxicity induced by pirarubicin + cyclophosphamide combined with sequential paclitaxel+trastuzumab in HER 2 positive breast cancer patients ，while the use of dextrazoxane is a protective factor.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To analyze the si tuation and hot spots of gabapentinoid drugs in the treatment of pain. METHODS Related researches about gabapentinoid drugs in the treatment of pain were retrieved from Web of Science core collection database during Jan. 1st，2011-Dec. 31st，2020. VOSviewer 1.6.17，CiteSpace 5.8.R1 and Excel 2018 software were used to statistically analyze the key characteristics of relevant literature ，such as the annual publications ，countries/regions，institutions，authors， journals and research hot spots. RESULTS & CONCLUSIONS A total of 3 519 literatures were retrieved ，and the annual publication outputs showed an upward trend generally. Totally 86 countries/regions had conducted relevant studies ，of which the United States ranked first （up to 1 219），and had close cooperation with the United Kingdom ，Canada，China，Germany，Japan， etc；a total of 3 996 institutions had published relevant literatures ，and the Pfizer Inc. issued the most publications ；the most studies were devoted by Professor Parsons from the University of California San Diego ，and the highest co-citations author was Professor Gilron from the Queen ’s University. Among 1 185 journals，Pain ranked first not only in the high-productive journal ，but also in the co-cited journal. The main hot topics include abuse and misuse of gabapentinoid ，off-label use of gabapentinoid ，clinical application of gabapentinoid as a component of multimodal analgesia ，and the update of guidelines for pain based on systematic evaluation and meta-analysis.关键词：gabapentinoid drugs;pain treatm ent;Bibliometrics;visualization;VOSviewer;CiteSpace
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发布时间：2022-06-21 - 摘要：OBJECTIVE To compare the efficacy ，safety and immunogenicity of bevacizumab biosimilars and original drugs for non-small cell lung cancer （NSCLC），and to provide evidence-based reference for clinical use. METHODS PubMed，Embase， Web of Science ，Cochrane Library ，CBM，CNKI，VIP，Wanfang database ，ClinicalTrials.gov，and Clinical Trial Center of China were searched from the establishment of the database to September 25，2021，randomized controlled trials （RCTs）about bevacizumab biosimilars（trial group ）versus bevacizumab original drugs （control group ）for NSCLC were collected. After literature screening ， data extraction and quality evaluation of included RCTs with bias risk assessment tool recommended by Cochrane Handbook 5.1.0， meta-analysis，sensitivity analysis and publication bias analysis were performed by using RevMan 5.3 software. RESULTS A total of 11 RCTs were included ，involving 6 596 patients in total. Meta-analysis showed that there was no statistical significance in the difference of overall response rate [RR＝0.97，95％CI（0.92，1.02），P＝0.22]，the total incidence of adverse reaction [RR＝1.00， 95％CI（0.99，1.01），P＝0.79]，the incidence of severe adverse reaction [RR＝1.04，95％CI（0.96，1.13），P＝0.38]，positive rate of anti-drug antibody [RR ＝1.10，95％CI（0.88，1.36，P＝0.41] and the incidence of common adverse reactions （except for vomiting）among 2 groups（P＞0.05）. The sensitivity analysis results showed that the obtained results were robust. The results of publication bias analysis showed that there was little possibility of publication bias. CONCLUSIONS The efficacy ，safety and immunogenicity of bevacizumab biosimilars used for NSCLC are equivalent to those of bevacizumab original drugs.
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To provide reference for improving rational drug use in medical institutions and strengthening individualized rational drug use monitoring. METHODS The hospital information system （HIS）was used to retrieve the patient ’s medical information and the doctor ’s medical information ；on the basis of pre-examination of prescriptions ，the chronic disease medication monitoring and visiting frequency monitoring modules were added to construct individualized rational drug use monitoring platform. Taking hypoglycemic drugs as an example ，the number of patients who were prescribed the drug ≥3 times a month in Karamay Central Hospital （hereinafter referred to as “our hospital ”）was compared before and after the operation of the individualized rational drug use monitoring platform （Jan. to Apr. 2018 regarded as before operation ，Jan. to Apr. 2019 and 2021 regarded as after operation ）. At the same time ，the number of risk prescriptions （repeatedly prescribing the same drug ≥3 times a day）and unreasonable prescriptions after the operation of the individualized rational drug use monitoring platform （Jan. to Apr. 2019 and Jan. to Apr. 2021）in our hospital were compared. RESULTS The proport ion of patients who were over prescribed Diformin tablets from Jan. to Apr. in 2021 was lower than the same period in 2018 significantly（16.65％ vs. 27.17％，P＜0.05）. From Jan. to Apr. 2019，35.3％ of the risk prescriptions in our hospital were unqualified prescriptions ；in the same period of 2021， the proportion of unqualified prescriptions in risk prescriptions in our hospital decreased to 12.82％ ，which was statistically significant compared with 2019（P＜0.05）. CONCLUSIONS Based on the actual situation of patients ，our hospital establishes the individualized rational drug use monitoring platform by using HIS to meet the actual needs of clinical drug use. The use of the platform has significantly reduced the number of patients visiting doctors many times and unreasonable prescriptions ，and promotes rational drug use. At the same time ，the platform also further strengthens the prescription review system of our hospital and improves the level of pharmaceutical care.
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发布时间：2022-06-21 - 摘要：Post-stroke cognitive impairment （PSCI） refers to a series of syndromes from mild cognitive impairment to dementia caused by stroke. The mitogen-activated protein kinases （MAPK）signaling pathway is a key pathway for transmitting cellular signals in mammals ，and p 38 is a classic branch of it. p 38 MAPK signaling pathway is involved in various pathophysiological processes such as cell growth ，differentiation，apoptosis and inflammatory response in central nervous system diseases. At present ，great progress has been made in clinical and basic experimental studies on prevention and treatment of PSCI by traditional Chinese medicine （TCM），but there is a lack of relevant systematic summary. Therefore ，this article summarizes the role of p 38 MAPK signaling pathway in PSCI and the pharmacological research progress of TCM in prevention and treatment of PSCI through p 38 MAPK signaling pathway.
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发布时间：2022-06-21 - 摘要：Chloral hydrate is a safe and effective sedative hypnotic medicine. Patients can usually calm down or fall asleep quickly after taking it. It has great clinical value and practical needs in children ’s sedation. However ，the nature of chloral hydrate itself and various factors such as ambient temperature and light affect its stability of the preparation ，most of chloral hydrate preparations are still used in clinic in the form of hospital preparations. Therefore ，developing chloral hydrate preparation with single dose ，long validity period and automatic mass production is the prospect and goal of its subsequent development. Based on it，this study collects and reviews the relevant literatures on various preparations of chloral hydrate and their clinical application by searching the Chinese and English databases.关键词：Chloral hydrate;preparation;Clinical application
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发布时间：2022-06-21
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