最新刊期
卷 34 ， 期 6 ， 2023
- 摘要：OBJECTIVETo provide reference for the hierarchical management of polypharmacy in elderly patients in China.METHODSThe formulation and development process of drug hierarchical management system FORTA （fit for the aged） for elderly patients was introduced. The treatment drugs for common cardiovascular system diseases and neuropsychiatric diseases in elderly patients were taken as examples， the disease types， drug types and drug hierarchy in Germany-FORTA， the U.S.-FORTA and Japan-FORTA were compared. RESULTS &CONCLUSIONSFORTA system was the first drug hierarchical system that combined positive and negative labels， formed through two rounds of Delphi method and covered a variety of diseases and drug items. The cardiovascular system diseases covered by the FORTA list mainly included acute coronary syndrome， chronic therapy following myocardial infarction， heart failure， atrial fibrillation， hypertension， stroke， etc. For acute coronary syndrome， chronic therapy following myocardial infarction and stroke， the related drugs were mostly class A， and the differences between those FORTA lists were minimal. The hierarchy of drugs used to treat other diseases was various. The neuropsychiatric diseases covered by the FORTA list included dementia， epilepsy， Parkinson’s disease， insomnia/sleep disorder， depression and bipolar disorder， etc.， and the drug’s hierarchy was mostly labelled with negative， mostly class C and class D， and only levodopa to treat Parkinson’s disease was class A. The hierarchy of antiepileptic drugs and drugs for the treatment of bipolar disorder （except lithium） was relatively uniform in three FORTA lists， while the hierarchy of other drugs was different. Compared with the FORTA system in the U.S. and Japan， the Germany-FORTA system updated the drug types and clinical evidence， optimized the hierarchy of diseases and drugs， and may be stricter in some drug hierarchies. The drugs with uniform hierarchy in those FORTA lists may have a wide application range， and our country can combine the above content with clinical practice to formulate a drug hierarchical management system for elderly patients to optimize the drug selection of elderly patients and improve their clinical outcomes.关键词：elderly patients;polyphar-macy;hierarchical management;Germany;the U.S.;Japan
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发布时间：2023-03-24 - 摘要：OBJECTIVETo promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects.METHODSThe ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital.RESULTSOf the 316 clinical trials of registered anti-tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）.CONCLUSIONSThere is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.关键词：informed consent form;ethical review;clinical trial;anti-tumor drugs
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发布时间：2023-03-24 - 摘要：OBJECTIVETo clarify the core content of traditional Chinese medicine （TCM） policy in the provinces of China， so as to provide reference for optimizing the structure of the policy system of traditional Chinese medicine in China and assisting the inheritance and innovation of TCM industry in various regions.METHODSThe websites of directly affiliated organs in 31 provinces， excluding Hong Kong， Macao and Taiwan， were retrieved to collect the TCM policies released from 2000 to 2021. The importance of keywords in the TCM policies of each province was measured based on term frequency-inverse documentation frequency （TF-IDF） keyword extraction method， and the similarities and differences were analyzed among TCM policies. RESULTS &CONCLUSIONSA total of 99 documents related to TCM policies of various provinces were obtained in this study， most of which were released after 2016. The theme of national TCM policy covered four aspects： building TCM talent team， perfecting TCM service system， strengthening TCM resource management and promoting TCM industry innovation. The TF-IDF values of “medical institutions”“traditional Chinese medicine”“medical treatment” were higher than other keywords in each province， indicating that the provinces paid more attention to the construction of TCM service system and the management of TCM resources than other aspects. Anhui and Jiangsu， Beijing and Henan， Hubei and Jilin， Hubei and Tianjin， and Hubei and Yunnan had the more degree of similarity in TCM policies， which all contained 16 of the same keywords. Therefore， the above regions should be encouraged to strengthen exchanges and cooperation and realize mutual promotion and joint development. Among all the keywords whose importance ratio was greater than 0.2， “Tibetan medicine” was unique to Qinghai and Tibet， “disease type” was unique to Guangdong， and the TF-IDF value of “supervision and management” in Beijing was higher， indicating that the emphasis of TCM policy formulation in different provinces was various. Meanwhile， the top 10 keywords of TF-IDF value in all provinces did not have words related to financial input， and the TF-IDF values of “informatization” in most provinces did not rank at the top. It is suggested to increase financial input or encourage social financing， and add “Internet+new business” in the field of TCM.关键词：policy text analysis;term frequency-inverse documentation frequency;regional comparison;quantitative research
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发布时间：2023-03-24 - 摘要：OBJECTIVETo study the protective effects of ligustrazine-scutellarein twin drug ST-11 on rat adrenal medullary pheochromocytoma PC12 cell injury induced by oxygen-glucose deprivation/reperfusion （OGD/R） and its mechanism.METHODSPC12 cells were divided into blank group， model group， nimodipine group （positive control， 5 μmol/L） and different concentration groups of ST-11 （5， 10， 20 μmol/L）. After 24 hours of pre-administration intervention， all the other groups except the blank group were cultured in glucose-free DMEM culture medium containing 10 mmol/L Na2S2O4 for 4 hours with glucose deficiency and hypoxia. After 4 hours of glucose and oxygen re-introduction， the survival rate of cells in each group， the contents of lactate dehydrogenase （LDH）， catalase （CAT）， glutathione （GSH）， malondialdehyde （MDA） and superoxide dismutase （SOD） in cell supernatant， apoptosis rate， the levels of reactive oxygen species （ROS） and mitochondrial membrane potential （MMP）， the protein expressions of B-cell lymphoma 2 related X protein （Bax）， B-cell lymphoma 2 （Bcl-2） and caspase-3 were all detected in each group.RESULTSCompared with blank group， the cell survival rate， the contents of CAT， GSH and SOD in cell supernatant， MMP level， relative expression of Bcl-2 and Bcl-2/Bax ratio in model group decreased significantly （P＜0.05）， while the contents of LDH and MDA， ROS level， apoptosis rate， relative expressions of Bax and caspase-3 were significantly increased （P＜0.05）. Compared with model group， above indexes of ST-11 groups （except for the protein expression of caspase-3 in 5 μmol/L ST-11 group） were reversed signifi-cantly （P＜0.05）.CONCLUSIONSST-11 has a certain protec-tive effect on OGD/R-injured PC12 cells， and its effects may be related to reduction of oxidative stress and inhibition of cell apoptosis.关键词：ligustrazine;scutellarein;twin drug;oxygen-glucose deprivation/reperfusion;oxidative stress;cell apoptosis;PC12 cells
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发布时间：2023-03-24 - 摘要：OBJECTIVETo analyze chemical components of Shenqi tiaoshen formula （SQTS）.METHODSUPLC-QE-MS method was adopted. The determination was performed on ACQUITY UPLC BEH C18 column with mobile phase consisted of 0.1% formic acid solution-0.1% formic acid acetonitrile solution （gradient elution） at the flow rate of 0.4 mL/min. The column temperature was set at 40 ℃， and the sample size was 5 μL. The electrospray ionization source was used to scan positive and negative ions， and the scanning range was m/z 100-1 500. Combined with TCMSP， PubChem and other databases， SQTS active component database was established and the components were identified in combination with relevant literature. RESULTS &CONCLUSIONSTotally 131 chemical components were identified from SQTS， including 23 terpenoids， 22 flavonoids， 21 phenylpropanoids， 12 alkaloids， 11 phenols， 9 amino acid derivatives， 4 fatty acyls， 3 organic acids and others， such as rutin， citrinin， synephrine， cinnamic acid and ginsenoside Rg1，etc. The cracking process of the main components involved the breaking of glycosidic bonds， dehydration， etc.关键词：chemical components;UPLC-QE-MS;structure identification
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发布时间：2023-03-24 - 摘要：OBJECTIVETo investigate the effects of Wenyang jieyu decoction on phosphoinositide 3-kinase （PI3K）/protein kinase B （Akt） signaling pathway and neurotransmitters in rats with kidney-yang deficiency depression.METHODSThe SD rats were divided into blank group， model group， fluoxetine group （positive control of western medicine， 4.17 mg/kg）， Xiaoyao powder group （positive control of TCM， 1.88 g/kg） and Wenyang jieyu decoction low-dose， medium-dose and high-dose groups （1.25， 2.50， 5.00 g/kg）， with 15 rats in each group. Except for blank group， the other groups were treated with corticosterone 20 mg/kg subcutaneously to induce kidney-yang deficiency depressed model， meanwhile the mice were given relevant medicine intragastrically， once a day， for 28 consecutive days. The general conditions of rats were observed. The sucrose preference rate and the static time of forced swimming were detected， and organ indexes of rats were calculated. The levels/contents of neurotransmitters in serum were detected， the expressions of PI3K/Akt pathway-related proteins in hippocampus were detected， and the number of dendritic spines was determined.RESULTSCompared with blank group， model group suffered from the symptoms such as hair loss， fear of cold， curling up； sucrose preference rate， indexes of adrenal gland， thymus gland and spleen， serum levels of cyclic adenosine phosphate （cAMP）， brain-derived neurotrophic factor and gamma-aminobutyric acid， the ratio of cAMP to cyclic guanosine monophosphate， the contents of norepinephrine， dopamine and 5-hydroxy-tryptamine， the expressions of PI3K， Akt， mammalian target of rapamycin， and the number of dendritic spines in the hippocampus were significantly decreased （P＜0.01）. The time of immobility， level of glutamic acid and protein expression of glycogen synthetase kinase-3β were prolonged and increased （P＜0.01）. Compared with model group， depression symptoms of rats in each administration group were improved， and the above indexes were mostly reversed （P＜0.05 or P＜0.01）.CONCLUSIONSWenyang jieyu decoction can improve depression-like behavior and the deficiency of kidney-yang， regulate the secretion of neurotransmitters， and activate PI3K/Akt signaling pathway， thus playing a role in protecting hippocampal neurons.关键词：depression;kidney-yang deficiency;PI3K/Akt signaling pathway;neurotransmitter;rat
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发布时间：2023-03-24 - 摘要：OBJECTIVETo investigate the effects of omeprazole on pharmacokinetic parameters of imatinib in rats.METHODSAccording to body weight， the rats were divided into imatinib+low-dose， medium-dose， and high-dose omeprazole groups， imatinib group， with 6 rats in each group. They were given omeprazole suspension at the doses of 1.8， 3.6 and 7.2 g/kg， or 0.5% sodium carboxymethyl cellulose solution intragastrically respectively； one hour later， imatinib suspension was administered by oral gavage at a the dose of 10 mg/kg. Blood sample （100 μL） was taken from the orbit before and 0.5， 1， 2， 2.5， 3， 4， 5， 6， 8， 12， 24 and 36 hours after intragastric administration of imatinib. Using imatinib-d3 as internal standard， the plasma concentrations of imatinib and its metabolite N-desmethyl imatinib in rat were determined by high performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters were calculated by DAS 2.0 software and compared.RESULTSCompared with imatinib group， AUC0－∞ and AUMC0－∞ of imatinib in rat plasma of imatinib+medium-dose omeprazole group， cmax， t1/2， AUC0－∞ and AUMC0－∞ of imatinib in rat plasma of imatinib+high-dose omeprazole group were all increased or prolonged significantly （P＜0.05）. Compared with imatinib group， AUC0－∞ and AUMC0－∞ of N-desmethyl imatinib in rat plasma of imatinib+medium-dose omeprazole group， and cmax and AUC0→∞ of N-desmethyl imatinib in rat plasma of imatinib+high-dose omeprazole group were decreased significantly （P＜0.05）.CONCLUSIONSOmeprazole may increase the plasma concentration of imatinib in rats and reduce the plasma concentration of N-desmethyl imatinib in rats， which may be associated with inhibiting the metabolism of imatinib.关键词：imatinib;N-desmethyl imatinib;pharmacokinetics;rats
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发布时间：2023-03-24 - 摘要：OBJECTIVETo establish the quality standard of Clinopodium gracile.METHODSTen batches of C. gracile were collected to perform appearance and property identification， microscopic identification and thin layer chromatography （TLC） identification. Moisture， total ash， acid-insoluble ash and dilute ethanol extract were detected， and the content of rosmarinic acid was determined by HPLC.RESULTSThe stem of C. gracile was slender， square columnar， covered by white fluff， the surface was grayish green or greenish brown； epidermal cells， non-glandular hairs， cortical cells and so on were seen in the cross section of the stem. Non-glandular hairs， ducts， wood fibers， mesophyll cells and so on could be seen in the powder. Results of TLC identification showed that there were spots of the same color in the chromatographic position corresponding to the chromatographic position of buddlejasaponin Ⅳb control. The contents of water， total ash， acid-insoluble ash， dilute ethanol extract and rosmarinic acid in 10 batches of samples were 8.69%-12.33%， 5.96%-13.33%， 0.14%-3.29%， 18.57%-32.61%， 0.35%-0.82%， respectively. The average values were 10.10%， 9.73%， 1.06%， 23.54% and 0.56%， respectively.CONCLUSIONSThe established method can be used for quality control of C. gracile. It is preliminarily proposed that the ash content in the herb should not exceed 12.0%， the total ash content should not exceed 12.0%， the acid-insoluble ash content should not exceed 1.5%， the dilute ethanol extract should not be less than 18.0%， and the rosmarinic acid content should not be less than 0.45%.关键词：quality standard;buddlejasaponin Ⅳb;rosmarinic acid;content determination
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发布时间：2023-03-24 - 摘要：OBJECTIVETo establish the fingerprint of Huangqin decoction （HQD）， to separate the phase states and screen the active phase states of antidermatophytic activity so as to study the spectrum-effect relationship.METHODSHPLC method was adopted using baicalin as reference， the fingerprints of 10 batches of HQD were drawn and the similarity evaluation was carried out using the Similarity Evaluation System of Chromatographic Fingerprint of TCM （2012 edition） to determine the common peak； the phase states of HQD were separated and characterized by high-speed centrifugation and membrane dialysis. The minimum inhibitory concentrations （MIC） of HQD and its different phase states against Trichophyton mentagrophytes were determined simultaneously. Using the peak area of 37 common peaks as independent variable， MIC as dependent variable， Pearson correlation analysis was performed by using SPSS 21.0 software.RESULTSA total of 37 common peaks were obtained in HPLC fingerprints of 10 batches of HQD， with the similarity higher than 0.99. Ten components were identified， such as albiflorin， paeoniflorin， liquiritin apioside， baicalin， melaleuca glycoside A， wogonoside， baicalein， glycyrrhizic acid， wogonin and oroxylin A. HQD was split into 3 phase states， such as precipitation phase （HQD-P）， solution phase （HQD-S） and nano phase （HQD-N）. The morphology of HQD-P was irregular granular， and the average particle size was 4.670-91.522 μm. The morphology of HQD-S was uniform flakes， and no particle size was detected. HQD-N was spherical in shape and the particle size was （129.0±12.9） nm. MIC values of each phase state of HQD against T. mentagrophytes in different phase states were HQD-N （4.64 mg/mL） ＜HQD （5.85 mg/mL） ＜HQD-P （7.37 mg/mL） ＜HQD-S （12.89 mg/mL） at the same dosage. Pearson correlation analysis showed that the peak area of 25 of the 37 common peaks （including 10 identified components） was significantly negatively correlated with MIC （absolute values of correlation coefficient＞0.95 and P＜0.05）.CONCLUSIONSThe chemical composition of 10 batches of HQD is consistent； HQD-N is the active phase state of HQD. Ten components such as paeoniflorin， liquiritin apioside and baicalin may be the main active components of HQD. The antidermatophytic effect of HQD is closely related to its component content and physical phase state.关键词：fingerprint;phase state;antidermatophytic activity;spectrum-effect relationship
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发布时间：2023-03-24 - 摘要：OBJECTIVETo study the improvement effects of Cannabis sativa oil on the symptoms in dextran sodium sulfate （DSS）-induced ulcerative colitis （UC） model rats， and to investigate its effects on intestinal flora of rats.METHODSForty SD rats were randomly divided into control group， model group， C. sativa oil group （1 g/kg） and sulfasalazine group （positive control， 300 mg/kg）， with 10 rats in each group. The rats in control group and model group were given 0.5% polysorbate 80 by gavage， and the rats in C. sativa oil group and sulfasalazine group were given corresponding drug solution by gavage once a day for 10 days. From the 4th day， rats in model group， C. sativa oil group and sulfasalazine group were given 4% DSS solution for 7 consecutive days to establish UC model. The body weight， disease activity index （DAI） score， colon length， colon weight， weight per unit length of colon， the pathological changes of colon tissue， and the contents of tumour necrosis factor-α （TNF-α）， interleukin-6 （IL-6） and IL-10 in serum of rats were determined. The changes of intestinal flora in rats were detected by high-throughput sequencing.RESULTSCompared with control group， the body weight and the length of colon were decreased significantly in model group， while DAI score， the weight of colon， weight per unit length of colon， serum contents of TNF-α and IL-6 were increased significantly， and the content of IL-10 was decreased significantly （P＜0.05）； epithelial layer of colon tissue fell off， inflammatory cells infiltrated and invaded the submucosa， and intestinal glands were disordered. Compared with model group， above indexes of C. sativa oil group and sulfasalazine group were reversed significantly （P＜0.05）， and related symptoms were improved significantly. The result of flora sequencing showed that ACE index and Chao1 index of model group were decreased significantly， compared with control group （P＜0.05）； while Chao1 index of C. sativa oil group was increased significantly， compared with model group （P＜0.05）. Compared with control group， 41 genera of bacteria in the model group changed； compared with model group， C. sativa oil could return 3 of the 41 genera to normal state， including Dubosilla， Porphyrobacter and Allobaculum.CONCLUSIONSC. sativa oil can improve the symptoms of UC model rats by regulating the diversity of intestinal flora， increasing beneficial bacteria and decreasing pathogenic bacteria.关键词：ulcerative colitis;intestinal flora;high-throughput sequencing;rats
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发布时间：2023-03-24 - 摘要：OBJECTIVETo systematically analyze the status of health economic evaluation studies of influenza vaccination in Guangdong-Hong Kong-Macao Greater Bay Area （GBA） of China， and to provide a methodological reference for future scholars to carry out economic evaluations of influenza vaccine in GBA.METHODSSeven English databases such as PubMed and Embase and three Chinese databases such as CNKI and Wanfang database were searched. The economic evaluation studies of influenza vaccines with the study area of GBA were collected. The search time frame was from the inception to June 30， 2022. After screening the literature and extracting key information， descriptive analysis was conducted on the study design， evaluation methods， model settings， results and conclusions of these collected papers， and the quality of the papers was evaluated using Quality of Health Economic Studies.RESULTSA total of 12 papers were included， of which 7 had a study region of Hong Kong in China， 6 had an older target group， 5 had a society-wide perspective， and the study time frame ranged from 6 months to 9 years. Besides， 8 papers used cost-utility analysis， only 2 used an epidemic model； 8 papers conducted sensitivity analyses， and most of them conducted both one-way sensitivity analysis and probabilistic sensitivity analysis. Moreover， the results of the economic evaluation of 10 papers showed that （combined） vaccination or increased vaccination rates were more economical. In addition， 4 of the 12 papers had a quality score＞75， which were considered high-quality studies.CONCLUSIONSAlthough most of the included studies showed that vaccination was economical， the quality of the existing paper needed to be improved. It is recommended that subsequent studies on the economic evaluation of influenza vaccines in GBA may consider adding economic evaluations for Macau and other cities in Guangdong of China， prioritizing dynamic models and recent data from local residents， and referring to relevant tools and guidelines to improve the standardization and scientificity of the study design.关键词：influenza vaccine;economic evaluation;systematic review
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发布时间：2023-03-24 - 摘要：OBJECTIVETo establish a method for the determination of polymyxin B concentration in plasma and apply it to clinical practice.METHODSAfter precipitated with 5% trichloroacetic acid solution， using polymyxin E2 as internal standard， the concentrations of polymyxin B1 and B2 in plasma sample were determined by UPLC-MS/MS. The determination was performed on BEH C18 chromatographic column with water （0.1% formic acid）-acetonitrile （0.1% formic acid） as mobile phase （gradient elution） at the flow rate of 0.5 mL/min. The sample size was 10 µL. The detection was accomplished with electrospray ionization operated in positive ion scanning by multi-reaction monitoring mode. The ion pairs for quantitative analysis were m/z 603.2→101.2 （polymyxin B1）， m/z 595.7→101.1 （polymyxin B2） and m/z 578.5→101.1 （internal standard）. The plasma concentration of polymyxin B in 79 critically ill patients was measured by the above method， the occurrence of acute renal injury （AKI） was recorded and the relationship of polymyxin B concentration in plasma with AKI was analyzed.RESULTSThe linear ranges of polymyxin B1 and polymyxin B2 were 200-20 000， 50-5 000 ng/mL （r＞0.995）， and the lower limits of quantification were 200 and 50 ng/mL， respectively. RSDs of intra‐day and inter‐day precision tests were not higher than 12.06%， the average extraction recovery was 103.04%-117.44%， and RSDs of matrix effect test and stability test were all not higher than 7.42%. Steady state trough and peak plasma concentration were （2.54±2.52） and （8.17±5.20） mg/L for 79 clinical patients using polymyxin B. Eighteen patients out of 27 included patients developed AKI， with an incidence of 66.67%. The peak concentration of polymyxin B of patients without AKI was significantly lower than that of patients with AKI （P＜0.05）， but there was no significant difference in the trough concentration between two groups （P＞0.05）.CONCLUSIONSThe established UPLC-MS/MS has the advantages of simple operation and high sensitivity， and can be used to monitor the plasma concentration of polymyxin B in patients. The occurrence of AKI is correlated with the peak concentration of polymyxin B.关键词：UPLC-MS/MS;plasma concentration;acute renal injury
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发布时间：2023-03-24 - 摘要：OBJECTIVETo mine the safety signals of FOLFOX scheme and FOLFIRI scheme-induced hepatotoxicity， and to provide reference for the selection of clinical rational treatment plan and the prevention and treatment of drug adverse reaction （ADR）.METHODSReporting odds ratio method and proportion report ratio method were used to analyze adverse drug event （ADE） reports of FOLFOX scheme and FOLFIRI scheme in FDA adverse event reporting system during January 1， 2004-June 30， 2022. The potential safety signals of FOLFOX scheme and FOLFIRI scheme-induced hepatotoxicity were mined.RESULTSThe amounts of ADE reports related to FOLFOX scheme and FOLFIRI scheme were respectively 3 454 and 1 359； the proportions of male and female patients involved were 1.50∶1 and 1.67∶1 in these two schemes， respectively. The top five countries with the largest number of reports were the United States， Japan， France， Italy and the United Kingdom， respectively accounting for 58.48% and 53.79% of the total reported cases. More than 90% of patients took no more than 5 drugs in combination， the proportion of patients receiving FOLFOX scheme and FOLFIRI scheme combined with anti-angiogenic drugs or epidermal growth factor receptor inhibitors was 45.45% and 86.82%， respectively. Totally 443 ADE reports of FOLFOX scheme-induced hepatotoxicity were collected， and 22 ADR signals were generated， including hepatic sinusoidal obstruction syndrome， nodular regenerative hyperplasia， drug-induced liver injury， blood bilirubin increased， etc. Totally 128 ADE reports of FOLFIRI scheme-induced hepatotoxicity were reported， and 9 ADR signals were generated， including blood bilirubin increased， hepatotoxicity， steatohepatitis， hepatic steatosis， etc.CONCLUSIONSFOLFOX scheme and FOLFIRI scheme can cause different types of hepatotoxicity. Clinical drug monitoring should be strengthened to guarantee drug safety.关键词：FOLFIRI scheme;FAERS database;hepatotoxicity;safety signal;proportional imbalance method
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发布时间：2023-03-24 - 摘要：OBJECTIVETo explore the effects of ADRB2 gene regulatory region polymorphism on the efficacy of short-acting beta 2 receptor agonists （SABA） in the treatment of acute asthma attack in children.METHODSA total of 127 children with acute mild to moderate bronchial asthma who received SABA treatment for 7 days in the General Hospital of Northern Theater Command from October 2016 to October 2020 were selected to detect their genotype distribution and compare the improvement of pulmonary functional indicators and curative effect among different genotypes. The effect of the high-order interaction of gene polymorphism on therapeutic effect was investigated.RESULTSAmong 127 children， there were 80， 44 and 3 cases of TT， TA and AA types at locus rs2895795， 93， 32 and 2 cases of CC， CG and GG types at locus rs11168070， and 41， 64 and 22 cases of GG， GA and AA types at locus rs12654778， respectively， in accordance with Hardy-Weinberg equilibrium （P＞0.05）. After treatment， the improvement rate of the peak expiratory flow in percent predicted value （PEF%pred） and the improvement rate of the forced expiratory flow at 75% vital capacity in percent predicted value （FEF75%pred） in children with TA type were significantly lower than that of TT type at locus rs2895795 （P＜0.05）； the improvement rates of PEF%pred and FEF75%pred in children with CG type were significantly lower than that of CC type at locus rs11168070 （P＜0.05）； the improvement rates of PEF%pred in children with GA and AA type were significantly lower than that of GG type at locus rs12654778 （P＜0.05）. The differences in fractional exhaled nitric oxide before and after treatment were not statistically significant among different genotypes at each locus （P＞0.05）. The proportion of remarkable improvement of children with TT type at locus rs2895795 was 2.358 times that of children with TA+AA type （P＜0.05）， and there was no significant effect of higher-order interaction of ADRB2 polymorphism on the efficacy in children with asthma （P＞0.05）.CONCLUSIONSPolymorphisms in the regulatory region of the ADRB2 gene in children with bronchial asthma are associated with the efficacy of SABA in the treatment of acute asthma attack in children. At locus rs2895795， rs11168070 and rs12654778， the improvement of lung function of children with wild-type is more obvious， and the efficacy of SABA treatment on children with TT type is better at locus rs2895795.关键词：ADRB2;gene regulatory region polymorphism;short-acting beta 2 receptor agonists;efficacy;children
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发布时间：2023-03-24 - 摘要：OBJECTIVETo observe the effects of low-dose esketamine on analgesia and inflammatory factors after thoracoscopic surgery.METHODSTotally 120 patients who underwent thoracoscopic lobectomy in our hospital from October 2021 to March 2022 were selected and randomly divided into low-dose group （group A）， conventional-dose group （group B）， normal saline group （group C） by using the random number table method， with 40 patients in each group. All the patients were anesthetized with traditional general intravenous anesthesia， group A and B were anesthetized with low dose or normal dose （0.2 or 0.5 mg/kg） of Esketamine hydrochloride injection， and group C was given normal saline intravenously. The visual analog scale （VAS） score 0， 6， 24， 48 h after operation and the consumption of sufentanil 24 h after operation were compared among 3 groups. The levels of white blood cell count （WBC）， neutrophil percentage， C-reactive protein （CRP）， tumor necrosis factor-α （TNF-α）， interleukin-1 （IL-1） and IL-6 were compared 30 min before and 24 h after surgery. The Pittsburgh sleep quality index （PSQI） score and the Beck depression inventory （BDI） score were compared before operation and 0， 1， 2 d after operation， and the occurrence of adverse reaction was also recorded.RESULTSAt 0， 6 and 24 h after operation， VAS scores and the consumption of sufentanil within 24 h after operation in group A and B were significantly lower than group C； VAS score 6 h after operation in group A was significantly lower than that in group B （P＜0.05）. The levels of WBC， neutrophil percentage， CRP， TNF-α， IL-1 and IL-6 in the 3 groups 24 h after surgery were significantly increased， compared with 30 min before surgery； the levels of above indexes in group A and B were significantly lower than those in group C （P＜0.05）. PSQI score and BDI score 0， 1 and 2 days after operation in group A and B were significantly lower than those in group C， while BDI score 0 day after operation in group A was significantly lower than that in group B （P＜0.05）. The total incidence of adverse reaction in group A， B and C were 5.0%， 10.0% and 17.5%， without statistical significance （P＞0.05）.CONCLUSIONSThe low-dose esketamine has significant analgesic effect after thoracoscopic surgery， can reduce the levels of inflammatory factors after surgery and improve sleep quality and depression， with good safety.关键词：low-dose;thoracoscopic surgery;postoperative analgesia;inflammatory factors
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发布时间：2023-03-24 - 摘要：OBJECTIVETo evaluate the clinical effectiveness and safety of domestic generic and imported original clopidogrel for antiplatelet therapy in patients with acute coronary syndrome （ACS）.METHODSThe clinical data of ACS patients in Nanjing Drum Tower Hospital of China Pharmaceutical University from January 2020 to June 2021 were retrospectively collected by using electronic medical record system， and the patients were divided into original drug group （321 cases） and generic drug group （328 cases） according to the drug use. Both groups were given dual antiplatelet therapy with clopidogrel and aspirin. The effectiveness and safety outcomes of the two groups were followed up for 12 months and compared， the related influential factors were analyzed.RESULTSMajor adverse cardiovascular events （MACE） occurred in 16 and 22 patients in original drug group and generic drug group respectively， including nonfatal myocardial infarction （4 and 5 cases）， stroke （2 and 4 cases）， revascularization （8 and 3 cases）， cardiovascular related death （2 and 4 cases）， and all-cause death （4 and 6 cases）. There were 12 and 7 patients with major bleeding events， 38 and 29 patients with minor bleeding events， and 33 and 21 patients with non-bleeding adverse events. There was no statistically significant difference in the cumulative incidence of related events （P values of Log-Rank tests were all greater than 0.05）. Cox regression analysis showed that the use of generic clopidogrel did not increase the risk of MACE and major bleeding events in ACS patients [hazard ratio of 1.305 and 0.416， 95% confidence interval of （0.678， 2.512） and （0.155， 1.117）， respectively， P＞0.05]， and the combination of proton pump inhibitors （PPI） could reduce the risk of major bleeding events [hazard ratio of 0.196， 95% confidence interval of （0.063， 0.611）， P＜0.05].CONCLUSIONSCompared with imported original drug， domestic generic clopidogrel has similar clinical effectiveness and good safety. Combined use of PPI may be a beneficial factor to reduce the occurrence of major bleeding events in patients.关键词：acute coronary syndrome;dual antiplatelet therapy;domestic generic drug;imported original drug
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发布时间：2023-03-24 - 摘要：OBJECTIVETo evaluate the rationality of clinical application of polymyxin B in the inpatients of a third grade class A hospital，so as to provide evidence for the optimization of clinical scheme of the drug.METHODSA retrospective method was conducted on the electronic medical records of inpatients treated with Polymyxin B sulfate for injection from January 2020 to March 2022 to collect the basic information of patients， inpatient departments and time， infection diagnosis， results of pathogenic bacteria test， laboratory test indicators， usage and dosage， and combined medication，etc. Based on the drug instructions， according to relevant guidelines and consensus， the rationality， efficacy and safety of polymyxin B in inpatient were evaluated. RESULTS & CONCLUSIONSA total of 101 inpatients were included， respiratory system infection was the main cause （62.4%）. All patients had received the etiological examination， and the pathogen with the highest detection rate was carbapenem‑resistant Acinetobacter baumannii （40.6%）. One hundred patients were treated by intravenous drip， and 4 patients were treated by combination of aerosol inhalation or intrathecal injection； 99 patients were given the dose of 500 thousand units by continuous intravenous infusion， q12 h. Totally 51.5% of patients were treated for 7-14 days； and 77 patients were treated with other anti-Gram-negative drugs. There were unreasonable phenomena including too short time of medication （29.7%）， no combination of medication （23.8%）， and no indication of medication （17.8%）. The clinical effective rate of 101 patients treated with polymyxin B was 49.5%， and 16 patients （15.8%） had acute kidney injury during the treatment. Clinical pharmacists should actively participate in the clinical treatment of polymyxin B， formulate individualized treatment plans according to the guidelines/consensus and in combination with the patient’s condition and infection status to improve the rationality of clinical medication.关键词：rationality;safety;efficacy;guideline;consensus
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发布时间：2023-03-24 - 摘要：OBJECTIVETo systematically evaluate the efficacy and safety of vonoprazan in the treatment of gastroesophageal reflux disease， and to provide evidence-based reference for clinical drug use.METHODSRandomized controlled trials （RCTs） about vonoprazan （trial group） versus placebo or proton pump inhibitor （control group） were searched in PubMed， the Cochrane Library， Web of Science， CNKI， Wanfang， VIP and CBM databases from the inception to June， 2022. After literature screening and data extraction， the qualities of included literature were evaluated with bias assessment tool recommended by Cochrane system evaluator manual 5.1.0. Meta-analysis， sensitivity analysis and publication bias analysis were conducted by using RevMan 5.4 software.RESULTSA total of 9 RCTs were included， involving 1 882 patients. The results of meta-analysis showed that： total response rate [OR＝1.94，95%CI（1.45，2.58），P＜0.000 01]， cure rate [OR＝2.27，95%CI（1.33，3.86），P＝0.003] and remission rate [OR＝1.81，95%CI（1.28， 2.55）， P＝0.000 7] of trial group were significantly higher than control group； there was no significant difference in the incidence of adverse drug events， diarrhea， nasopharyngitis， upper respiratory tract infection and alkaline phosphatase elevation between two groups （P＞0.05）. The results of subgroup analysis showed that cure rate of trial group was significantly higher than control group at 2 weeks of treatment （P＜0.05）； at 4 and 8 weeks of treatment， there was no significant difference in the cure rate between two groups （P＞0.05）. There was no statistically significant difference in the cure rate between two groups at 2， 4 and 8 weeks of treatment among the patients with Los Angeles grade A/B （P＞0.05）； among the patients with Los Angeles grade C/D， the cure rate of patients in the trial group was significantly higher than control group at 2， 4 and 8 weeks of treatment （P＜0.05）. The results of sensitivity analysis and publication bias analysis showed that the results of this study were robust and the possibility of publication bias was small.CONCLUSIONSVonoprazan has a considerable effectiveness and safety in the treatment of gastroesophageal reflux disease.关键词：gastroesophageal reflux disease;effectiveness;safety;meta-analysis
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发布时间：2023-03-24 - 摘要：OBJECTIVETo analyze the influential factors for potentially inappropriate medication （PIM） in elderly cancer patients.METHODSThe data of elderly cancer patients hospitalized in a hospital from January to December 2021 were collected. According to the Beers standard of the American Geriatrics Society in 2019 （hereinafter referred to as the “2019 version of Beers standard”） and Criteria for Potentially Inappropriate Drug Use in Chinese Elderly （2017 version） （hereinafter referred to as the “Chinese PIM standard”）， the PIM status of elderly cancer patients was retrospectively analyzed. Multivariate Logistic regression analysis was used to identify influential factors for PIM.RESULTSA total of 293 patients were included in the study. According to the 2019 version of Beers standard， 211 patients （72.01%） had PIM， of which 204 （69.62%） had PIM related to drugs， 6 （2.05%） had PIM related to diseases or symptoms， 46 （15.70%） had PIM that should be used with caution， 32 （10.92%） had PIM with drug-drug interaction that should be avoided， and 11 （3.75%） had PIM based on renal function； the top 5 drugs in the list of incidence were proton pump inhibitors， metoclopramide， the first-generation antihistamines as promethazine， analgesics as ibuprofen and megestrol. According to the Chinese PIM standard， there were 132 patients （45.05%） with PIM， of which 119 （40.61%） had PIM related to drugs， involving 25 drugs （included 7 high-risk drugs and 18 low-risk drugs）， and 24 （8.19%） with PIM in disease status； top 4 drugs in the list of incidence were promethazine， megestrol， ibuprofen and cimetidine. Multivariate Logistic regression analysis showed that compared with patients with hospital stay≤10 days， patients with hospital stay between 11 and 30 days had a higher risk of PIM [odds ratio （OR）＝8.836 8， 95% confidence interval （CI） （3.217 8， 31.940 9）， P＝0.000 1]； compared with the patients with the number of clinical disease diagnosed≤5， patients with the number of clinical disease diagnosed≥11 had a higher risk of PIM [OR＝10.930 1， 95%CI （3.000 9， 70.922 9）， P＝0.001 8]； compared with surgical treatment， patients receiving antineoplastic drugs had a higher risk of PIM [OR＝2.209 5， 95%CI （1.180 2， 4.176 9）， P＝0.013 6].CONCLUSIONSElderly cancer patients have multiple diseases， complicated medication， and a high incidence of PIM. The length of hospital stay （11-30 d）， the number of clinical disease diagnosed （≥11） and anti-tumor drugs are main influential factors for PIM in patients.关键词：potentially inappropriate medication;influential factors;safety of drug use
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发布时间：2023-03-24 - 摘要：OBJECTIVETo help to realize high-quality development of clinical pharmacy education in China by exploring new reform paths of high-level talents training in clinical pharmacy.METHODSThe concept definition and key links of high-level talents training in clinical pharmacy were consulted by expert consultation， and the literature analysis and empirical methods were used to prepare a questionnaire to conduct online research on clinical pharmacy professionals in universities and hospitals.RESULTSA total of 637 effective electronic questionnaires were received. Totally 95.13% of the respondents believed that the cultivation of high-level talents in clinical pharmacy was very or relatively important； 51.96% expressed different degrees of dissatisfaction with the current situation of training； 88.85% regarded “rational clinical use of drugs” and 88.70% regarded “clinical research of drugs” as one of the main training objectives and service orientation； precision pharmacy， evidence-based pharmacy， medication therapy management， therapeutic drug monitoring and evaluation， clinical discovery and evaluation of new drugs were considered as important core specialty knowledge and competences， which were different from those high-level talents in clinical medicine；62.01% agreed that “academic degree+professional degree” dual degree training was the main degree type for high-level talents training in clinical pharmacy； 79.28% thought it was very necessary or relatively necessary to adopt the “long schooling” education mode； 98.58% thought that the core courses of clinical pharmacy such as clinical pharmacotherapy were very important or relatively important；59.81% believed that college or department of clinical pharmacy was the most important educational management organization that played the most important role； 87.13% agreed with the dual tutor structure of “college teachers+pharmacists” and “pharmacists+physicians”.CONCLUSIONSStarting with the target orientation， core knowledge and competence， academic degree system， curriculum system and faculties， it is necessary to speed up the exploration of new reform paths of talent training and build a high-level talent training system of clinical pharmacy with Chinese characteristics and world level.关键词：high-level talents training;doctor-degree education;reform paths
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发布时间：2023-03-24 - 摘要：OBJECTIVETo analyze the compatible stability of commonly used intravenous drugs in the intensive care units （ICU）， and to provide a reference for improving medication safety in clinic.METHODSThe commonly used intravenous drugs in the ICU of Hebei General Hospital were investigated and confirmed in April 1-30， 2022， and used as keywords to retrieve the relevant literature about compatible stability from PubMed， CNKI， Wanfang Data and other databases， and manually filtered with Micromedex database at the same time. Then， the compatible stability results of the included literature were analyzed descriptively.RESULTSTotally 32 commonly used intravenous drugs and 39 mixed infusion combinations were collected from ICU of this hospital. A total of 40 studies were included， only 2 studies followed all quality requirements； 18 studies validated their methods to guarantee correct reproducibility； 33 studies evaluated physical stability， including precipitate formation and pH changes； 32 studies evaluated chemical compatibility， mainly content/concentration changes. A total of 666 possible two-drug combinations were obtained from the included literature， of which 254 combinations of stability data were available， including 176 were stable， 68 were unstable， and 10 were contradictory. Totally 412 combinations had no stability results. Among two-drug combinations in ICU of this hospital， 42 combinations were stable， 14 combinations were unstable， and 2 combinations were contradictory.CONCLUSIONSThe pH， solvent， excipients and preparation concentration are the factors that affect the stability. There are drug combinations with unstable compatibility of commonly used intravenous drugs in ICU of this hospital. The stability study methods are limited， and the stability data cannot meet the actual clinical needs.关键词：intravenous drugs;mixed infusion;compatible stability;literature analysis
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发布时间：2023-03-24 - 摘要：Artemisia argyi is the leaves of compositae plants of A. argyi Lévl. et Vant.， which is a traditional Chinese medicine commonly used in China. The analysis was carried out by consulting traditional medical classics， modern standard norms and literature， and using Cytoscape software to sort out and visualize the evolution of the processing and the efficacy of processed products. The processing of A. argyi was first made in the Han dynasty and was popular in the Song and Ming dynasties. There were many processing methods in ancient times， including net processing， cutting， frying， processing with auxiliary material （vinegar， wine， salt， charcoal， rice water， sulfur， medicinal juice， jujube mud processing） and other processing methods （baking， winching， making herbs into wool）. Modern common processing methods included purification， vinegar processing， charcoal processing and making herbs into wool， which are relatively simple compared with ancient processing methods. There were obvious differences in the efficacy and application of raw and processed products of A. argyi. Although the processing effects of A. argyi in ancient and modern times were mainly to reduce toxic side effects and enhance the effects of warming meridians and hemostasis， only the purified A. argyi， vinegar-processed A. argyi and vinegar-processed A. argyi charcoal could be seen in the present studies， other processed products had not been inherited and studied， and the processing mechanism was still unclear. It is suggested that in the later exploration and research， researchers can establish a multi-dimensional standard research system based on the characteristics of the medicinal plant A. argyi and the processing characteristics of A. argyi decoction pieces in order to systematically explore the transformation rules before and after processing， and clearly explain the scientific connotation.关键词：processing;historical evolution;modern research;visual analysis
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发布时间：2023-03-24 - 摘要：Rheumatoid arthritis （RA） is a refractory autoimmune disease that can cause symmetrical polyarticular disease. The key mechanism of its occurrence and development is the dysequilibrium of helper T cell 17 （Th17）/regulatory T cell （Treg） balance. Therefore， reconstructing Th17/Treg balance may be a new strategy for the treatment of RA. Traditional Chinese medicine has significant advantages in the treatment of RA such as integrity， multi-target， multi-link and multi-path. This paper summarizes the basic and clinical studies on the regulation of Th17/Treg balance in the treatment of RA by traditional Chinese medicine in the past five years， and finds that the active components/sites of traditional Chinese medicine such as flavonoids， alkaloids and terpenes have unique advantages in the regulation of Th17/Treg balance. The traditional Chinese medicine compound formula interferes with Th17/Treg balance by exerting the effects of dispelling wind， dehumidifying， removing blood stasis， unblocking collaterals， relieving pain， dispersing cold and strengthening health. The effect of external treatment of traditional Chinese medicine is obvious and can be used as a clinical adjuvant therapy for RA； related mechanisms of action include regulating the production of inflammatory factors， regulating the expression of transcription factors and interfering with the activation of signaling pathways. However， the existing research has the shortcomings of insufficient mechanism research， few clinical research， limited external treatment research of traditional Chinese medicine， and lack of combination therapy research， which need to be improved by follow-up research.关键词：helper T cell 17;regulatory T cell;active components/sites of traditional Chinese medicine;traditional Chinese medicine compound formula;external treatment of traditional Chinese medicine
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发布时间：2023-03-24
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