最新刊期
卷 33 ， 期 12 ， 2022
- 摘要：OBJECTIVE To provide reference for scientifi c and standardized development of clinical comprehensive evaluation of drugs in China. METHODS Guided by the theory of total quality management （TQM），drawing lessons from the successful experience of the British and German conducting evaluation ，combining with plan-do-check-act cycle and other quality management methods and tools ，drug clinical comprehensive evaluation of total quality management system was constructed in accordance with the requirements for our country related policy and local practice. RESULTS & CONCLUSIONS To construct total quality management system of clinical comprehensive evaluation of drugs in China from 5 aspects of organization system ，management process，assessment system ，evaluation and supervision platform ，support and guarantee mechanism. The organization system included national ，provincial and medical institutions ；management process should focus on the key links in the 3 stages of theme selection，evaluation and implementation ，and result transformation and application ；assessment system ，evaluation and supervision platform，support and guarantee mechanism should be established together so as to further improve the scientificity ，rationality， practicality and standardization of total quality management of clinical comprehensive evaluation of drugs. The development of total quality management is an effective starting point to promote the continual improvement of the drug clinical comprehensive evaluation；relevant government departments and the implementation of evaluation of medical institutions should further set up quality management consciousness ，establish report quality feedback mechanism and the results co-constructing and sharing mechanism and strengthen professional personnel training and innovation synergy regulation mode to ensure that the authenticity and reliability of evaluation results.关键词：Clinical comprehensive evaluation of drugs;total quality management;Quality control
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发布时间：2022-11-09 - 摘要：OBJECTIVE To provide reference for improving the professional identity of clinical pharmacists and the quality of pharmaceutical care ，and promoting the effects of clinical pharmaceutical intervention. METHODS A questionnaire survey was conducted among clinical pharmacists in secondary and tertiary hospitals in 31 provinces（autonomous regions and municipalities ） in 2019 by stratified semi-random sampling. Through descriptive analysis of survey data ，their job satisfaction status was evaluated ； χ 2 test and Logistic regression analysis were used to analyze the influential factors of job satisfaction ；the robustness test of study results by propensity score matching method and replacement regression model ，and grouping Logistic regression of samples from hospital on different levels. Targeted improvement measures were put forward according to the results of survey . RESULTS There was statistical significance in the difference of job satisfaction among pharmacists of different professional titles （P＜0.05）. Results of Logistic regression showed that whether to participate in standardized training ，whether to obtain communication and support from patients ，whether the pharmaceutical management rules and regulations were sound ，whether to set up economic compensation means such as pharmaceutical service fee ，whether to work overload ，and whether to smoothly perform pharmaceutical care duties were significant influential factors for job satisfaction of clinical pharmacists （P＜0.05）. These results showed good robustness as tested by propensity score matching method and replacement regression model. Heterogeneity analysis results showed that the job satisfaction of clinical pharmacists in tertiary hospitals was more significantly affected by economic compensation ，while clinical pharmacists in secondary hospitals were more concerned about training opportunities and workload conditions （P＜0.05）. CONCLUSIONS The job satisfaction level of Chinese clinical pharmacists remains to be improved. Accordingly ，it is compulsory to continue the promotion of standardized training courses ，consummate the pharmaceutical management system ，and fair remuneration structure in order to improve the job satisfaction of clinical pharmacists and build a high-level clinical pharmacist team.关键词：Clinical pharmacist;job satisfaction;secondary hospital;tertiary hospital;Influential factors;survey
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发布时间：2022-11-09 - 摘要：OBJECTVE To study the effects of Zhilong huoxue tongyu capsules on intracerebral hemorrhage ，long non-coding RNA（LncRNA）and its target genes in mice. METHODS Twenty-four male C 57BL/6 mice were randomly divided into sham operation group 1，model group 1 and Zhilong huoxue tongyu capsule low-dose and high-dose groups （0.35，1.40 g/kg）. Collagenase was injected into the caudate nucleus to construct the model of intracerebral hemorrhage. One hour after the operation ， the mice in each treatment group were given the corresponding medicinal solution ，and the mice in the sham operation group 1 and the model group 1 were given normal saline intragastrically ，once a day ，for 3 consecutive days. The morphological changes of the brain tissue of the mice in each group were observed by hematoxylin-eosin staining and Nissl staining. The protein and mRNA expression of interleukin- 1β（IL-1β）and tumor necrosis factor-α（TNF-α）in the brain tissue were detected by immunohistoche- mistry，Western blot and real-time quantitative polymerase chain reaction （PCR）. In addition ，9 of male C 57BL/6 mice were randomly divided into sham operation group 2，model group 2 and intervention group （Zhilong huoxue tongyu capsule 1.40 g/kg）. The mice were modeled and administered according to the above method ，and then the whole brain tissue of mice in E-mail：tanruizhi627@swmu.edu.cn each group was isolated ， total RNA was extracted and sequenced，followed by analyzing the different LncRNA. Gene ontology（GO）enrichment was performed to predict effective LncRNA and target genes ，and verified by real-time quantitative PCR. RESULTS Compared with model group 1，the brain tissue pathological damages were significantly improved in Zhilong huoxue tongyu capsule low-dose a nd high-dose groups ，and the IL -1β， TNF-α protein and mRNA expression in brain tissue were significantly decreased （P＜0.05）. Two effective LncRNAs were screened out. The results of in vivo verification test （LncRNA-Dlst-211 was highly expressed in model group 2，and significantly down-regulated after the intervention of Zhilong huoxue tongyu capsules ； LncRNA-Dlst-211 target genes Rps 6kl1 and LncRNA-MSTRG.8169.4 were expressed weakly in model group 2，and strongly up-regulated after intervention ）were consistent with the sequencing results. CONCLUSIONS Zhilong huoxue tongyu capsules can improve the brain injury and inflammatory response in intracerebral hemorrhage model mice ，and its mechanism may be related to down-regulating the expression of LncRNA-Dlst-211 and up-regulating the expression of LncRNA-MSTRG. 8169.4 and Rps 6kl1.关键词：Zhilong huoxue tongyu capsules;intracerebral hemorrhage;Inflammation;long non-coding RNA;transcriptome
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发布时间：2022-11-09 - 摘要：OBJECTIVE To es tablish the fingerprints of pith-nodecayed and pith-decayed Scutellaria baicalensis ，and to investigate the difference of their anti-inflammatory activities. METHODS HPLC method was adopted to establish the fingerprints of 5 batches of pith-nodecayed S. baicalensis and 5 batches of pith-decayed S. baicalensis . SIMCA 14.1 software was adopted to screen the markers of weight difference between pith-decayed S. baicalensis and pith-nodecayed S. baicalensis ，using variable importance in projection （VIP）＞1 as standard. Using the inhibitory rates of NO ，IL-6 and IL- 1β in supernatant of lipopo- lysaccharide（LPS）-induced monocyte macrophages （RAW264.7 cells）as indexes ，the anti-inflammatory activities of pith-decayed and pith-nodecayed S. baicalensis were evaluated and median effective concentration （EC50）of NO were calculated. The gray correlation method was used for spectrum-effect relationship analysis ；SPSS 26.0 software was used for cluster analysis using the inhibitory rates of NO ，IL-6 and IL- 1β in cells at the concentration of 50 μg/mL. RESULTS There were 15 common peaks in 5 batches of pith-nodecayed S. baicalensis and 5 batches of pith-decayed S. baicalensis ，and the similarity of them was greater than 0.990. There were total of 8 peaks with VIP 1.0，they were peak 14，12，15，6，10，13，11 and 4. At jcqinge@163.com the concentration of 50 μg/mL，the inhibitory rates of pith- decayed S. baicalensis extract to NO ，IL-6，IL-1 β and the average EC 50 were 62.14％-71.13％，3.32％ -18.38％ and 93.12％-95.47％ and 25.35 μg/mL，respectively；those of pith-nodecayed S. baicalensis extract were 39.52％-50.19％， 6.21％-22.55％，94.10％-96.44％ and 58.63 μg/mL，respectively. Average NO inhibition rate of pith-decayed S. baicalensis extract was significantly higher than that of pith- nodecayed S. baicalensis extract；average EC 50 and average IL- 6 inhibitory rate of pith-decayed S. baicalensis extract were significantly lower than those of pith-nodecayed S. baicalensis extract（P＜0.05）. There was no statistical significance in average inhibitory rate of IL- 1β（P＞0.05）. The correlation degrees of peaks 2-3，5-8 and 10-11 with inhibitory rate of NO were all greater than 0.8. The correlation degrees of peaks 2，5，8-9 with inhibitory rate of IL- 1β were all greater than 0.9. The correlation degrees of 15 common peaks with inhibitory rate of IL- 6 were all less than 0.8. Ten batches of samples could be grouped into two categories ，K1-K5 were clustered into one category and T 12-T16 were clustered into one category. CONCLUSIONS At the concentration of 50 µg/mL，the inhibitory effect of pith-decayed S. baicalensis extract to NO is stronger than that of pith-nodecayed S. baicalensis extract，while the inhibitory effect on IL- 6 is weaker than that of pith-nodecayed S. baicalensis extract；they have similar inhibitory effect on IL- 1β. The corresponding components of peak 6，10-11 are preliminarily identified as main chemical components of the difference in anti-inflammatory activity between pith-decayed S. baicalensis and pith-nodecayed S. baicalensis .
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发布时间：2022-11-09 - 摘要：OBJECTIVE To investigate the effect of arctiin （ARC）relieving lipopolysaccharide （LPS）induced inflammatory injury of human nasopharyngeal epithelial cells NP- 69. METHODS The effects of 24 h treatment of 0.000 1，0.001，0.01，0.1， 1.0，10 μmol/L ARC on the proliferation of NP-69 were determined by MTS method. After 0.01，0.1，and 1.0 μmol/L ARC was applied to NP- 69 for 24 h and NP- 69 was pre-treated with 0.01，0.1 and 1.0 μmol/L ARC for 24 h，and then stimulated with 1.0 μg/mL LPS for 24 h，scratch tests were used to detect cell migration in both experiments. LPS stimulated NP- 69 to establish an inflammation injury model. The levels of nitric oxide （NO），tumor necrosis factor α（TNF-α）interleukin-6（IL-6），and IL- 1β in cell supernatants were detected ，and mRNA and protein expression of zonula oecludens protein 1（ZO-1），β-defensin 3（BD3）， Janus kinase 1 （JAK1），signal transducer and activator of transcription 3 （STAT3） in cell supernatant were also detected. RESULTS Compared with normal group ，0.000 1，0.001，0.01，0.1，1.0，10 μmol/L ARC had no effect on the proliferation of NP-69 after 24 h treatment （P＞0.05）. ARC （0.1，1.0 μmol/L）could significantly promote the rate of cell migration （P＜0.05）. For the inflammatory injure of NP- 69 cells stimulated by LPS ，ARC（1.0 μmol/L）could significantly reduce the release of NO ， TNF-α and IL-6（P＜0.05），significantly increased mRNA and protein expression of ZO- 1 and BD 3 but decreased mRNA and protein expression of STAT 3（P＜0.01 or P＜0.05）. CONCLUSIONS ARC has the effect of reducing the inflammatory injury of NP-69 cells induced by LPS ，promoting the physical and immune defense ability of the nasal mucosa epithelial barrierunder inflammatory environment. The mechanism of action may be related to inhibiting IL- 6/JAK1/STAT3 signaling pathway.关键词：arctiin;lipopolysaccharide;NP-69;inflammation;nasopharyngeal epithelial barrier
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发布时间：2022-11-09 - 摘要：OBJECTIVE To determ ine the contents of main active constituents in Gynura divaricata leaf with different drying methods and at different harvesting time ，so as to confirm the best drying method and harvesting time. METHODS G. divaricata leaf with different drying methods [drying in the shade ，drying in the sun ，oven drying （60℃，70℃，80℃），microwave drying and freeze drying] and different harvesting time （March to October ）were prepared. The content of water-soluble extract was determined by hot dip method. The contents of total flavonoids and polysaccharides were determined by ultraviolet-visible spectrophotometry. The content of astragalin was determined by HPLC. Analytic hierarchy process was used for comprehensive analysis. RESULTS The time of drying in the shade ，drying in the sun ，drying at 60 ℃，drying at 70 ℃，drying at 80 ℃， microwave drying and freeze drying were 7 d，5 d，8 h，5 h，3.5 h，6 min and 1 d respectively. The average contents of water-soluble extract in G. divaricata leaf were 55.98％，60.78％，52.33％，49.54％，46.87％，59.70％ and 58.24％；those of total flavonoids were 3.27％，3.22％，1.99％，1.70％，1.31％，3.92％ and 2.28％；those of polysaccharides were 4.70％，6.09％， 6.48％，5.45％，5.74％，5.76％ and 7.15％；those of astragalin were 0.48％，0.46％，0.24％，0.23％，0.20％，0.48％，0.29％. The comprehensive score of microwave drying was the highest ，being 0.996 3. The average contents of water-soluble extract from March to October were 41.50％，40.57％，39.16％，40.65％，40.68％，43.30％，45.19％ and 40.12％；those of total flavonoids were 2.24％，2.81％，3.87％，3.92％，3.82％，3.93％，3.66％ and 3.25％；those of polysaccharides were 4.41％，4.61％， 4.98％，5.26％，5.75％，5.94％，5.32％ and 4.47％；those of astragalin were 0.20％，0.21％，0.25％，0.26％，0.25％，0.24％， 0.25％ and 0.21％，respectively. The comprehensive scores of samples collected from May to September exceeded 0.92，and the comprehensive score in August was the highest （0.988 6）. CONCLUSIONS Microwave-dried Gynura divaricata leaf has the best quality ，and the best harvesting time is from May to September.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To in vestigate inhibitory effect s of gallic acid （GA）on human esophageal cancer TE- 1 cells in vitro and its potential mechanism. METHODS The effects of GA on the proliferation of TE- 1 cells were determined by MTT assay after treated with GA for 24 h and 48 h. Cell fluorescence counting （CCK-F）method and inverted fluorescence microscope were used to observe the changes in the number and morphology of TE- 1 cells after treated with GA. The change of cell migration ability was detected by scratch test. The effects of GA on the colony-forming ability of TE- 1 cells were tested by plate colony formation experiment. Cell apoptosis was detected by flow cytometry. Fluorescence probe （DCFH-DA）method was used to observe reactive oxygen species （ROS）production. Western blot assay was used to detect the expression of caspase- 3，caspase-9，Bcl-2，Bcl-2 associated X protein （Bax），cyclin D 1 and cyclin D 3. RESULTS GA significantly reduced the proliferation ability of TE- 1 cells in time and concentration dependent manner. the IC 50 of GA to TE- 1 cells were （281.22±26.81）μmol/L（24 h）and（220.90±31.15） μ mol/L（48 h），respectively. Compared with control group ，the cells in the administration group showed shrinkage ，sparse arrangement and nuclear pyknosis ，and the number of cells decreased significantly. Compared with control group ，the cell migration ability and colony formation ability were decreased significantly in administration groups （P＜0.01 or P＜0.05）. The apoptosis rates of TE- 1 cells were （6.21±0.32）％，（12.59±0.58）％ and（15.41±0.41）％ after treated with 100，300 and 500 μmol/L GA for 24 h，all of which were significantly higher than （5.29±0.28）％ of control group （P＜0.01 or P＜0.05）. Except for GA 100 μmol/L group，the level of ROS in other administration groups were significantly increased （P＜0.01 or P＜0.05）. Compared with control group，the expressions of Bcl- 2（only GA 200 μmol/L group），Bax（except for GA 100 μmol/L），caspase-3 and caspase- 9（except for GA 100 μmol/L）were increased significantly （P＜0.01 or P＜0.05），while the protein expressions of Bcl- 2（except GA 100， 200 μmol/L group），cyclin D 1 and cyclin D 3 were significantly decreased （P＜0.01 or P＜0.05）. CONCLUSIONS GA can inhibit the proliferation of esophageal cancer TE- 1 cells， E-mail：1209364115@qq.com restrict their migration ability and colony-forming ability ，and promote apoptosis. The mechanism may be related to the increase of ROS level ，up-regulation of the expressions of pro-apoptotic proteins caspase- 3，caspase-9 and Bax ，and down-regulation of the expressions of anti-apoptotic protein Bcl- 2，cyclin D1 and cyclin D 3.关键词：Gallic acid;esophageal cancer;Apoptosis;reactive oxygen;TE-1 cells
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发布时间：2022-11-09 - 摘要：OBJECTIVE To establish the met hod for the purific ation of test sample of Banxialu granules ，and to determine the contents of 4 ephedrine components such as ephedrine ，pseudoephedrine，norpseudoephedrine and methylephedrine. METHODS Three batches of Banxialu granules were extracted with methanol（containing 1％formic acid ）and pretreated with QuEChERS method of N-propyl ethylenediamine adsorbent （PSA）and octadecyl bonded silica gel adsorbent （C18）. Ultra high performance liquid chromatography tandem triple quadrupole mass spectrometry （UHPLC-MS/MS）was adopted. The separation was performed on an Agilent XDB-C 18 column with 5 mmol/L ammonium acetate solution （containing 0.1％ formic acid ）-acetonitrile as mobile phase（gradient elution ）at the flow rate of 0.40 mL/min. The column temperature was set at 30 ℃，and sample size was 2 μL. The electrospray ionization source was adopted ，and positive ion scanning was performed in multiple reaction monitoring mode. The ion pairs used for quantitative analysis were m/z 166.2→148.1（ephedrine，pseudoephedrine），m/z 152.2→134.1（norpseudoephedrine）， m/z 180.2→162.2（methylephedrine）. RESULTS The solution obtained by QuEChERS purification method was clear and nearly colorless. The linear ranges of ephedrine ， pseudoephedrine， norpseudoephedrine and methylephedrine were 1.38-206.82， 1.41-212.13，1.29-19.34，1.99-59.83 ng/mL（r＞0.99）. The limits of detection were 0.41，0.42，0.39 and 0.60 ng/mL. The limits of quantitation were 1.38 ，1.41 ，1.29 and 1.99 ng/mL，respectively. RSDs of precision ，stability（48 h）and repeatability tests were all lower than 2％. The average recoveries were 95.75％-100.87％（RSD＜2％，n＝9）. The contents of above 4 ephedrine components were 20.62-26.02，20.96-24.90，2.26-2.63，5.36-6.32 μg/g， respectively. CONCLUSIONS Established method is simple ，rapid，sensitive and suitable for simultaneous determination of 4 ephedrine components in Banxialu granules.
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发布时间：2022-11-09 - 摘要：OBJECT IVE To study the effects and potential mechanism of saltwater stir-baked Eucommia ulmoides on kidney-yang deficiency in rats. METHODS Ninety SD rats were randomly divided into normal control group （15 rats） and modeling group （75 rats）. Modeling group was given adenine intragastrically to establish kidney-yang deficiency model. After modeling，modeling group were randomly divided into model group ，positive control group （Guifu dihuang tablet 2.5 g/kg）， low-dose，medium-dose and high-dose groups of saltwater stir-baked E. ulmoides （1.5，3，6 g/kg），with 15 rats in each group. Administration groups were given relevant medicine intragastrically ，normal control group and model group were given normal saline intragastrically ，once a day ，for consecutive 8 weeks. The body weight of rats was measured before modeling and after medication. The score of kidney-yang deficiency syndrome was performed after medication. The levels of blood urea nitrogen （BUN），serum creatinine （SCR），testosterone（T）and cortisol （COR）in serum and superoxide dismutase （SOD）activity， malondialdehyde（MDA）level in renal tissue were detected. The pathological changes of renal tissue were observed after HE staining. Relative expressions of hypoxia-inducible factor- 1 α（HIF-1 α）and signal transducer and activator of transcription 5 （STAT5） mRNA in renal tissue were detected by RT-PCR. The relative expressions of HIF- 1α，STAT5 and phosphorylated STAT 5 （p-STAT5）protein and the ratio of gray values of p-STAT 5 and STAT 5（p-STAT5/STAT5）in renal tissue were detected by Western blot. RESULTS Before modeling ，there was no statistical significance in body weight of rats in each group （P＞0.05）. After medication， compared with model group ， pathological changes of renal tissue were all recovered in saltwater stir-baked E. ulmoides groups and positive control group ， while body weight ，the level of T in serum and SOD activity qq.com in renal tissue were all increase d significantly （P＜0.05）. The scores of kidney-yang deficiency syndrome ，levels of BUN ， SCR and COR in serum ，MDA level in renal tissue ，the relative expressions of HIF- 1α and STAT5 mRNA，the relative expressions of HIF- 1α，STAT5 and p-STAT 5 protein as well as p-STAT5/STAT5 were all significantly decre ased （P＜0.05）. The above effects of saltwater stir-baked E. ulmoides were in dose-dependent manner （P＜0.05）. CONCLUSIONS Saltwater stir-baked E. ulmoides can significantly relieve renal tissue damage in rats with kidney-yang deficiency ，decrease the levels of BUN ，SCR and COR in serum ，increase the level of T in serum ，the mechanism of which may be associated with anti-oxidative stress and inhibition of the expression of HIF- 1α and STAT5 protein.关键词：saltwater stir-baked Eucommia ulmoides;Kidney-yang deficiency;Rat;hypoxia-inducible factor- 1 α;signal
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发布时间：2022-11-09 - 摘要：OBJECTIVE To evaluate the cost-utility of pembrolizumab combined with chemotherapy versus chemotherapy alone in the first-line treatment of advanced or metastatic esophageal carcinoma. METHODS Cost-utility analysis of pembrolizumab combined with chemotherapy versus chemotherapy alone for advanced or metastatic esophageal carcinoma was conducted by using a three-state partitioned survival model from the perspective of health system in China. The model use d a lifetime simulation time frame with 3 weeks as a cycle. The survival data were extrapolated using KEYNOTE- 590 data；cost data were obtained from the median of 2022 public winning bid on Yaozhi network ，among which the price of pembrolizumab was obtained after discounting by a patient assistance program ；utility data were obtained from the literatures ，and a 5％ discount rate was used for both cost and utility. One-way sensitivity analysis and probabilistic sensitivity analysis were also conducted to examine model robustness. RESULTS Analysis of the base case results showed that compared to chemotherapy alone ，the incremental cost-effectiveness ratio （ICER）of pembrolizumab combined with chemotherapy regimens were 950 528.42 yuan/QALY，107 845.39 yuan/QALY and 315 754.56 yuan/QALY for esophageal squamous cell carcinoma （ESCC），programmed deathligand- 1 combined positive score （PD-L1 CPS）≥10 and intention-to-treat population （ITT），respectively. The results of sensitivity analysis verified the robustness of the basic analysis results. CONCLUSIONS Under our healthcare system ，using a threshold of willingness-to-pay of 1-3 times our GDP per capita in 2021，pembrolizumab combined with chemotherapy regimen isn ’t cost-utility compared with chemotherapy alone in the ESCC and ITT subgroups of patients ，while it is cost-utility in the PD-L 1 CPS≥10 subgroup of patients.
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发布时间：2022-11-09 - 摘要：OBJECT IVE To investigate the influential factors of direct economic burden of acute exacerbation of chronic obstructive pulmonary disease （AECOPD）patients in hospital ，and to provide related suggestions to reduce the direct economic burden of hospitalization. METHODS During Dec. 1st，2019-Oct. 31st，2020，the data of 1 923 AECOPD patients admitted into the First Affiliated Hospital of Guangzhou Medical University were collected. The information of demographic sociological characteristics，clinical characteristics and cost characteristics were collected ；descriptive analysis ，single factor regression analysis and multiple linear stepwise regression analysis were adopted to investigate the influential factors of direct economic burden of hospitalization. On the basis of literature review ，relevant suggestions were put forward to reduce the direct economic burden of AECOPD patients in hospital. RESULTS & CONCLUSIONS The median of hospitalization cost of AECOPD patients was 15 621.00 yuan. The multiple linear stepwise analysis regression analysis revealed that the influential factors of direct economic burden of AECOPD patients in descending order （by partial regression coefficient ）were the length of stay （logarithmic conversion value ）， admission to ICU ，surgical treatment ，discharge outcome ，whether to salvage ，the use of respirator ，common complications and smoking history （model F＝572.200，R2＝0.750，P＜0.001）. It is suggested to strengthen comprehensive hospital management and promote multidisciplinary cooperation to reduce hospitalization days ；strictly follow the diagnosis and treatment guidelines and clinical pathways to avoid deterioration of the condition and transfer to ICU treatment ；control indications for surgery to avoid“ask for great treatment with only miner illness ”；do a good job in the publicity and education of disease and smoking cessation ，and improve the self-management ability of patients.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To evaluate the econo mical efficiency of ensatinib i n the first-line treatment of anaplastic lymphoma kinase（ALK）positive-advanced non-small cell lung cancer （NSCLC），so as to provide reference for China ’s medical insurance decision-making and rational drug use in clinic. METHODS A three-state partitioned survival model was constructed from the perspective of China ’s health system ，based on the data of the international multi-center phase Ⅲ clinical trial （eXalt3 trail），with simulation time limit of 10 years，cycle period of 30 days. The economical efficiency of ensatinib was compared with that of crizotinib（standard treatment ）in the first-line treatment of ALK positive-advanced NSCLC. The incremental cost-effectiveness ratio （ICER） was calculated with quality-adjusted life years （QALYs） as utility index. The stability of basic analysis results was validated through uncertainty analysis. RESULTS The basic analysis results showed that compared with crizotinib group ， incremental cost per capita of ensatinib group was －343 370.36 yuan，incremental utility per capita was 0.76 QALYs，ICER was －454 292.25 yuan/QALY，which was far lower than the willingness-to-pay （WTP）threshold of 1 time of China ’s per capita gross domestic product （GDP，80 976 yuan）in 2021. The results of univariate sensitivity analysis showed that progression-free survival （PFS）status utility ，progression of disease （PD）status utility and subsequent treatment cost of crizotinib had a greater impact on ICER，but these parameters could not cause the reversal of basic analysis results. Probabilistic sensitivity analysis showed that with 1 time of China ’s per capita GDP in 2021 as the WTP threshold ，the probability of ensatinib group ’s treatment possessed economical efficiency was 100％. In the situational analysis ，ICER obtained by changing the ensatinib group ’s follow-up treatment regimen was －217 671.43 yuan/QALY，which was far below WTP threshold. CONCLUSIONS For Chinese patients with ALK positive-advanced NSCLC ，compared with commonly used the first-line treatment （crizotinib），ensartinib is economical and absolutely dominant.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To mine and analyze the risk signal of glucagon- like peptide -1 receptor agonists （GLP-1RA）related adverse drug reaction （ADR）. METHODS ADR data related to GLP- 1RA from April 1，2005 to October 16，2021 in the openFDA database were collected ，and the Bayesian confidence propagation neoral network （BCPNN）method was used for data mining. ADR were classified and described by using systematic organ classification （SOC）of drug ADR terminology set in 24.0 edition of MedDRA. RESULTS & CONCLUSIONS A total of 175 719 ADR reports related to GLP- 1RA were retrieved ，with 140 ADR positive signals ，involving five drugs such as exenatide （77 027 cases of ADR and 31 ADR positive signals ），dulaglutide （45 329 cases of ADR and 26 ADR positive signals ），liraglutide （42 748 cases of ADR and 32 ADR positive signals ）， semaglutide（8 844 cases of ADR and 27 ADR positive signals ）and lixisenatide （1 771 cases of ADR and 24 ADR positive signals）. According to SOC classification ，GLP-1RA-induced ADR involved gastrointestinal system ，hepatobiliary system ，nervous system，urinary and renal system ，endocrine system ，immune system and administration site. In the gastrointestinal system ，the risk of （acute）pancreatitis was higher ，and the order of risk was liraglutide ＞exenatide＞semaglutide＞dulaglutide＞lixisenatide； ADR signal of hepatobiliary system was stronger for cholelithiasis ，and the order of risk was liraglutide ＞semaglutide＞exenatide＞ lixisenatide＞dulaglutide. In the nervous system ，the risk of taste disorder was higher ；compared with dulaglutide and lixisenatide ， liraglutide，exenatide and semaglutide were more likely to cause headache and dizziness. In urinary and renal system ， compared with exena tide，dulaglutide and lixisenatide ，liraglutide and semaglutide were more likely to cause acute renal injury. In the endocrine system ，the risk of hypoglycemia was higher ，and the order of risk was exenatide ＞liraglutide＞lixisenatide＞ semaglutide＞dulaglutide. In the immune system ，lixisenatide was more likely to develop urticaria than other drugs ，dulaglutide and liraglutide did not caused ADR signal. Among the administration sites ，the risk of ADR caused by exenatide and dulaglutide was higher，while the risk of related ADR caused by semaglutide was lower. When using GLP- 1RA clinically ，we should closely monitor the renal function and blood glucose of patients ，and pay attention to patients with sudden upper abdominal pain ；in case of relevant ADR ，timely intervention measures should be taken to ensure the safety and effectiveness of medication.关键词：glucagon-like peptide- 1 receptor agonists;openFDA;adverse drug reaction;BCPNN;Signal mining
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发布时间：2022-11-09 - 摘要：OBJECTIVE To systema tically evaluate the efficacy and safety of blinatumomab for acute lymphoblastic leukemia （ALL）in order to provide evidence-based reference for clinical use. METHODS Retrieved from PubMed ，Embase，Web of Science，the Cochrane Library ，CNKI，Wanfang database and CBM during the inception to February 3，2022，randomized controlled trials （RCTs）and cohort studies of blinatumomab （experimental group ） versus conventional chemotherapy （control group ）in the treatment of ALL were collected. After literature screening and data extraction ，the quality of RCTs was evaluated by the risk bias evaluation tool recommended by Cochrane handbook 5.1.0，and the quality of cohort studies was evaluated by the Newcastle-Ottawa scale （NOS）. Meta-analysis was performed by RevMan 5.4 software. GRADE grading system was used to evaluate the evidence quality of outcomes. The publication bias was analyzed by inverted funnel plot. RESULTS A total of 8 studies were included ，involving 3 RCTs and 5 cohort studies ，with a total of 2 841 patients. Results of Meta-analysis showed that the overall survival rate more than one year [RR ＝1.30，95％CI（1.14，1.48），P＜0.000 1]，relapse-free survival rate [RR ＝1.78，95％CI（1.50，2.12），P＜0.000 01]，complete remission rate [RR ＝1.42，95％CI（1.11，1.82），P＝0.006]，the incidence of tremor [RR ＝16.98，95％CI（2.17，133.12），P＝0.007]，and the incidence of cytokine release syndrome [RR ＝14.11， 95％CI（3.43，58.01），P＝0.000 2] in trial group were all significantly higher than control group ，but there was no statistical significance in the incidence of headache between two groups [RR ＝1.31，95％CI（0.66，2.59），P＝0.44]. The incidence of adverse events with grade more than or equal to 3，infection，stomatitis，thrombocytopenia，febrile neutropenia ，anorexia， constipation，diarrhea，abdominal pain ，hypokalemia in trial group were significantly lower than control group （P＜0.05）. The incidence of cough ，rash and hypogamma globulinemia and fever in the trial group were significantly higher than control group （P＜0.05）. There was no statistical significance in the total incidence of adverse events ，sepsis，anemia，leucopenia，neutropenia， lymphopenia，nausea，vomiting，hyperglycemia，hypotension，hypertension，elevated transaminase or epistaxis between two groups（P＞0.05）. Results of subgroup analysis by study type showed that the overall survival rate ，relapse-free survival rate and complete response rate （except for cohort studies ）of patients in trial group were significantly higher than control group in both RCTs and cohort studies （P＜0.05）. The results of GRADE evaluation showed that the overall quality of index evidence included in this study was low. There was little possibility of publication bias in this study based on the publication bias analysis. CONCLUSIONS Blinatumomab is effective in the treatment of ALL ，with low incidence of infection and adverse events of digestive system ，but high incidence of tremor ，cough，rash，fever，hypoproglobulinemia and cytokine release syndrome. The evidence quality of the indicators included in this study is generally low .关键词：blinatumomab;acute lymphoblastic leukemia;Meta-analysis;Efficacy;Safety
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发布时间：2022-11-09 - 摘要：OBJECTIVE To provide reference for safe use of bevacizumab in tumor patient. METHODS Retrospective analysis was performed for a case of tracheomediastinal fistula caused by bevacizumab after radiotherapy in which clinical pharmacist participated. Retrieved from PubMed ，Elsevier Science Direct ，Springer Link ，Wiley Oline Library ，CNKI and Wanfang database ，the cases of respiratory fistula caused by bevacizumab were collected ，and the causes of respiratory fistula were analyzed. RESULTS & CONCLUSIONS Referring to relevant literatures ，combined with the formation position of fistula and considering its correlation with the use time of bevacizumab ，considering that it may be bevacizumab related tracheomediastinal fistula，clinical pharmacists recommended that patients stopped bevacizumab and underwent stent implantation. The patient refused to implant stent for personal reasons ，but the tracheomediastinal fistula improved 3 months after drug withdrawal. Combined with the data of 16 patients with respiratory fistula caused by bevacizumab ，it could be inferred that the use of bevacizumab on the basis of radiotherapy may be the cause of tracheomediastinal fistula ；the mechanism may be related to bevacizumab inhibiting angiogenesis and affecting wound healing. This suggests that for patients who have received radiotherapy ，clinical pharmacists should strengthen medication monitoring and medication education when using bevacizumab ；clinical pharmacists should not only pay attention to the common adverse reactions such as hypertension and bleeding caused by the drug ，but also pay attention to rare but life-threatening adverse reactions such as respiratory fistula ，so as to ensure the safety of drug use.关键词：bevacizumab;radiation;tracheomediastinal fistula;respiratory fistula;Clinical pharmacists
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发布时间：2022-11-09 - 摘要：OBJECTIVE To improve the a pplicability of the prescription pre-review system to traditional Chinese medicine （TCM），and improve the quality of prescription review and rational drug use. METHODS The inappropriate pre-review rules of TCM prescription in prescription automatic screening system of our hospital were summarizd ，review rules were revised and the review process was standardized purposefully. The data of prescription review of Chinese patent medicine and TCM decoction pieces were collected from outpatient and emergency department of our hospital in the second quarter of 2020 （before the optimization of review rules ）and the fourth quarter of 2021（after the optimization of review rules ）. The reasonable rate of prescription and effective rate of intervention before and after the optimization of review rules were compared，and unreasonable problems were counted. RESULTS In our hospital ，the pre-review system had poor applicability in reviewing TCM prescriptions. There were some problems ，such as inconsistent or nonstandard names of TCM decoction pieces ，unreasonable dosage range settings，mechanical review of repeated drug use ，excessively strict review of “eighteen incompatible medicaments ”and“nineteen medicaments of mutual restraint ”and lack of safety warnings for special populations. In view of the above problems ，our hospital standardized the name of TCM decoction pieces ，and optimized the review rules such as dose range of TCM decoction pieces ， usage and dosage of Chinese patent medicine ，repeated medication ，drug interaction ，drug taboos for special people ，etc. After the revision of the rules ，the qualification rate of Chinese patent medicine prescriptions increased from 97.38％ to 98.17％（P＞0.05）， and the rate of effective intervention increased from 42.86％ to 79.71％（P＜0.05）；the qualification rate of TCM decoction pieces prescriptions increased from 47.98％ to 79.29％（P＜0.05），and the rate of effective intervention increased from 11.17％ to 29.13％（P＜0.05）. The number of unreasonable problems such as excessive daily dosage of TCM ，excessive dosage range ，drug interaction and drug contraindications for special groups decreased significantly in our hospital （P＜0.05）. There was no statistical significance in the number of unreasonable problems of repeated medication between 2 groups （P＞0.05），but there was a downward trend. T he total number of unreasonable problems had also decreased significantly （P＜0.05）. CONCLUSIONS The optimization measures of review rules in our hospital canimprove the applicability of the review system for TCM prescriptions，and improve the quality of prescription review and the level of rational drug use. However ，review rules of indications and the effectiveness of prescription intervention still needs to be further improved.
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发布时间：2022-11-09 - 摘要：Metformin is the most common first-line oral hypoglycemic drug ，but there are large individual differences in pharmacokinetic parameters and pharmacodynamics during clinical use. The dosage of some patients should be adjusted to achieve satisfactory therapeutic effect. Pharmacokinetic parameters of metformin are affected by many factors ，including respects of transporter gene polymorphism ，drug interaction ，intestinal flora ，plateau hypoxia and physiological function and so on. In order to guide the clinical individualized use of metformin ，this study reviews the research progress on the influencing factors of metformin pharmacokinetics.关键词：Metformin;Pharmacokinetics;Gene polymorphism;drug interactions;Intestinal flora;plateau hypoxia
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发布时间：2022-11-09 - 摘要：Linezolid is a n anti-infective drug commonly used in clinic. Considering the large difference of individual condition ， severe basic disease ，poor organ function and large variety and quantity of drugs ，standard dose of linezolid may not be suitable for all critically ill patients. This paper reviews the relevant researches on the application of linezolid in adult critically ill patients in recent years ，analyzes the pharmacokinetic characteristics of critically ill patients ，and summarizes the influence of common physiological and pathological changes in critically ill patients on drugs. When using linezolid ，the clinical comprehensive evaluation of this special group should be strengthened. In addition to appropriately reducing the drug dosage of patients with liver/ kidney function injury ，it is also necessary to consider appropriately increasing the drug dosage in other cases. After medication ，in order to avoid excessive or insufficient drug exposure ，clinical medication monitoring should be strengthened ，especially the important mean as therapeutic drug monitoring should be used well.关键词：Linezolid;adult critically ill patients;Pharmacokinetics;Therapeutic drug monitoring
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发布时间：2022-11-09 - 摘要：Flavonoid glycosides are the main active constituents of Epimedii Folium and its related plants. They can be divided into polyglycosides and low glycosides according to the number of glycosyl group. The polyglycosides of Epimedii Folium can be transformed into low glycosides after biotransformation ；pharmacological activities of low glycosides in anti-tumor ，tonifying kidney yang and anti-osteoporosis are stronger than those of polyglycosides. In this paper ， the research progress about biotransformation technology of flavonoid glycosides of Epimedii Folium was reviewed. It was found that the main biotransformation pathway of flavonoid glycosides of Epimedii Folium was to obtain low glycosides by removing glycosyl group ； related methods were mainly enzymatic hydrolysis and microbial transformation ，and also included plant cell transformation ，acid hydrolysis method and synthesis method.关键词：Epimedii Folium;flavonoid glycosides;low glycoside;biotransformation
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发布时间：2022-11-09 - 摘要：Poly（ADP-ribose）polymerase（PARP）is a kind of DNA damage repair enzyme. PARP inhibitors include Olaparib （AZD2281），Niraparib（MK-4827），Rucaparib，Veliparib（ABT-888），Fluzoparib and Talazoparib （BMN-673），etc. This article reviews the preclinical research on the combined application of PARP inhibitors against tumor by searching the relevant literatures. Through the synthetic lethal mode ，PARP inhibitors have a strong killing effect on tumor cells with homologous recombination repair defects. However ，for tumor cells with intact DNA damage repair function ，PARP inhibitors often need to be combined with radiotherapy or other drugs to play a role. Combined application drugs include antiangiogenic drugs ，heat shock protein 90 inhibitors，cyclin-dependent kinase 12 inhibitors，immune checkpoint inhibitors ，histone deacetylase inhibitors ，etc. The combined application of PARP inhibitors is expected to enhance the efficacy of anti-tumor drugs and achieve the goals of sensitization ， synergism and reversal of drug resistance ，which is worthy of further in-depth research and exploration of new combined treatment schemes.关键词：poly（ADP-ribose）polymerase inhibitors;drug combination;Anti-tumor;preclinical study
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发布时间：2022-11-09
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