最新刊期
卷 34 ， 期 13 ， 2023
- 摘要：To provide prevention and control strategies of occupational exposure risks to cytotoxic drug in medical institutions，improve the awareness of protection among medical staff，and reduce potential occupational exposure risks，the Guidelines for the Prevention and Control of Occupational Exposure Risk to Cytotoxic Drugs in Medical Institutions is developed. Based on the World Health Organization Guidelines Development Manual，the exposure risk issues of the cytotoxic drug collected from the time that it entered the hospital to the several stages after delivery to hospital，such as transportation，receipt，storage，unpacking，dispensing，use of finished products，and waste disposal. Delphi method is used to construct identification of clinical issues，and evidence-based research method is used to develop relevant evidence. Quality evaluation is conducted by using the recommended GRADE method. The consensus is reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls，administrative controls and personal protective equipment at different levels，a graded control approach is established. A total of 37 clinical issues are identified，resulting in 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drug prevention and control measures in medical institutions.关键词：occupational exposure;risk prevention and control;guideline;medical institutions
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发布时间：2023-08-15 - 摘要：At present， many antidepressant drug categories have been marketed in China， but still lack a scientific and standardized system for drug comprehensive clinical evaluation. To guide and promote medical institutions to standardize the comprehensive clinical evaluation of antidepressant drugs， 19 clinical， pharmacy and evidence-based medicine experts from China were organized by the China Population Welfare Foundation to evaluate 11 drugs in 5 categories， including sertraline/escitalopram/paroxetine/fluvoxamine/citalopram/fluoxetine/venlafaxine/duloxetine/vortioxetine/agomelatine/mirtazapine， through seminars and interviews， concerning clinical real-world data and evidence-based medicine， and to form the first draft of Expert Consensus on Comprehensive Clinical Evaluation of Antidepressant drugs， which is finalized after peer review by 18 clinical and pharmacy experts. The evaluation system of this expert consensus adopts the quantitative evaluation system of percentile and carries out a systematic evaluation from 6 dimensions of effectiveness， safety， economy， suitability， accessibility and innovativeness， while the evaluation dimensions are more detailed， with the operability of the drug evaluation system and the characteristics of drugs in the field of antidepressants. It aims to provide a theoretical basis for the rational use of drugs in the field of psychiatric disorders in medical institutions and help improve the quality of pharmacy services to better meet the needs of the people for medication.关键词：comprehensive clinical evaluation;expert consensus;rational drug use
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发布时间：2023-08-15 - 摘要：OBJECTIVETo provide reference for the access to medical insurance for rare diseases in China based on the existing access pathway and framework by analyzing the access policy of medical insurance for rare diseases in the United Kingdom （UK）.METHODSAfter collecting relevant guidelines and policy documents related to drug use for rare diseases in the UK， content analysis method was used to analyze the evaluation mechanism of drug use for rare diseases， reimbursement decision-making standards， stakeholder participation， coping strategies for dealing with uncertainties and risks， and policy implementation effects， and extract the key points of medical insurance access for drug use for rare diseases in the UK， to provide some suggestions for the establishment of medical insurance access system for rare diseases in China. RESULTS &CONCLUSIONSFrom the perspective of access， the UK had adopted a separate approach and clear criteria to assess and reimburse drugs for rare diseases. From the perspective of evaluation mechanism， multi-stakeholders such as doctors， patients and applicants participated in the decision-making process in the UK. The UK addressed uncertainty and risk by gathering better clinical evidence and using the patient access programme. After the implementation of the policy related to drug use for rare diseases， the UK had achieved remarkable results in terms of funding for drug use for rare diseases， the reimbursement rate of drug application， and the number of funded patients. It is suggested that in the process of establishing and improving the evaluation and reimbursement system for rare diseases drugs in China， the availability of rare diseases drugs should be improved by establishing a separate access assessment path for rare diseases drugs and involving more stakeholders.关键词：United Kingdom;medical insurance system;medical insurance access policy
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发布时间：2023-08-15 - 摘要：OBJECTIVETo provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China.METHODSWith text analysis， empirical research and other methods， the competitive generic drug incentive system in the United States was combed， its implementation effect and successful experience were analyzed， and the reference was provided for the implementation of relevant systems in China.RESULTSThe competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects： encouraging generic drug applications， accelerating the listing of generic drugs， and promoting drug price reduction， which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent，Off-Exclusivity Drugs without an Approved Generic， while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods.CONCLUSIONSChina’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore， we can refer to it， improve the system of releasing the catalog of encouraged generic drugs to be imitated， optimize the approval process for them， and authorize the exclusive period incentive to them.关键词：the United States;implementation effect;system reference
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发布时间：2023-08-15 - 摘要：OBJECTIVETo prepare progesterone-2-chloro-4-nitroaniline cocrystal （CNA） so as to improve the solubility of progesterone and primarily evaluate the safety of the progesterone cocrystal in vivo.METHODSUsing progesterone as the main body and CNA as the ligand， progesterone-CNA cocrystal was prepared with solvent evaporation method. The cocrystal was characterized by X-ray single crystal diffraction， X-ray powder diffraction （XRPD）， differential scanning calorimetry （DSC） and Fourier transform infrared spectroscopy （IR）. The dissolution rate of cocrystal was compared with those of progesterone and physical mixture. Forty-eight female KM mice were randomly divided into normal group （phosphate buffer containing 0.1% dimethyl sulfoxide）， progesterone group （16 mg/kg）， CNA group （9 mg/kg）， progesterone-CNA cocrystal low-dose， medium-dose and high-dose groups （6， 12.5， 25 mg/kg）， with 8 mice in each group. They were given relevant medicine/solvent intramuscularly， once a day， for consecutive 14 d. The safety of cocrystal was evaluated primarily by determining/observing the changes in body weight， organ index， tissue morphology， blood routine indicators， and liver and kidney function indicators.RESULTSThe new crystal structure in the X-ray single crystal diffraction results， the new characteristic peak in the XRPD pattern， the change of melting point in the DSC results， and the change of the characteristic peak position in the range of 3 500- 2 750 cm－1 and 1 700-1 250 cm－1 in the infrared spectrum all indicated that progesterone-CNA cocrystal was successfully prepared， and the dissolution rate of cocrystal was more than twice that of the progesterone raw material drug. The results of in vivo safety experiments showed that the mortality rate of all groups was zero. Compared with normal group， uterine indexes of mice in progesterone group and progesterone-CNA cocrystal groups were significantly increased （P＞0.05）， and endometrium was also thickened； there was no statistical difference in the changes of body mass， liver and kidney function， liver index， kidney index， the number of leukocyte， lymphocyte and neutrophil in routine blood test among those groups （P＞0.05）， and the morphology of liver and kidney tissue has also no significant difference. However， the number of plasma red blood cells in the progesterone group decreased significantly （P＜0.05）， and there was no statistical significance in the number difference of red blood cells among progesterone-CNA cocrystal groups （P＞0.05）.CONCLUSIONSThe progesterone-CNA cocrystal is successfully prepared with good safety in vivo， which significantly improve the solubility of progesterone.关键词：cocrystal;characterization analysis;safety in vivo
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发布时间：2023-08-15 - 摘要：OBJECTIVETo optimize the preparation process of Soft-shelled turtle blood lyophilized powder （STBLP）， and to provide a reference for improving the availability and quality stability of soft-shelled turtle blood （STB）.METHODSSTBLP was prepared with vacuum freeze-drying. Taking the solubility as the index， the preparation process parameters of STBLP were optimized by single factor experiment and Box-Behnken response surface method.RESULTSThe optimal freeze-drying process for STBLP was obtained： pre-freezing time of 4 h， total drying time of 13 h （before at 0 ℃）， and resolution drying temperature of 25 ℃. The average solubility of 3 batches of STBLP prepared according to the optimal process was 95.72% （RSD＝0.68%， n＝3）， the relative error of which was －0.97% to the theoretical solubility （96.66%）.CONCLUSIONSOptimized lyophilization process in this study are stable and feasible， the solubility of the prepared sample is high.关键词：vacuum freeze-drying;solubility;process optimization
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发布时间：2023-08-15 - 摘要：OBJECTIVETo explore the material basis and potential mechanism of Kazakh classic prescription Wuzdekh （WZDK） in the treatment of enteritis.METHODSLC-MS/MS technology was used to analyze the chemical components in WZDK. Through network pharmacology and molecular docking technology， the main chemical components of WZDK were screened and the target was predicted； therapeutic effect and target of WZDK on acute enteritis were verified through in vivo experiments. The acute enteritis model of mice was induced by dextran sulfate sodium salt； the general condition of the mice was observed during administration and the disease activity index （DAI） score was calculated； pathological changes of the intestine and mRNA expression of core target were validated by HE staining and quantitative real-time PCR.RESULTSA total of 316 chemical components were obtained by LC-MS/MS. The core targets of network pharmacological analysis mainly included interleukin 1β（IL-1β）， protein kinase B1 （AKT1）， tumor protein p53 （TP53）， IL-6， tumor necrosis factor （TNF） and so on. The results of molecular docking showed that chemical components such as mairin， lappadilactone， costunolide and dehydrocostus lactone were stable in binding to the core target. The results of in vivo experiment showed that， compared with model group， high dose （5.00 g/kg） of WZDK could significantly reduce the DAI score （P＜0.05）， improve inflammatory cell infiltration and mucosal tissue damage of colon tissue， and significantly down-regulated mRNA expressions of IL-6， TNF-α， IL-1β and TP53 in colon tissue（P＜0.05 or P＜0.01）.CONCLUSIONSChemical components of WZDK such as mairin， lappadilactone， costunolide and dehydrocostus lactone may play the role of improving the imbalance of local inflammatory factors in the intestine and repairing damage of colonic mucosal tissue by down-regulating mRNA expressions of TNF-α， IL-6， IL-1β and TP53 in colon tissue.关键词：Kazakh medicine;classic prescription;network pharmacology;molecular docking;enteritis
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发布时间：2023-08-15 - 摘要：OBJECTIVETo explore the intervention effect and related mechanism of Tongxinluo capsule on renal fibrosis in rats with diabetic nephropathy （DN）.METHODSEight rats were selected as control group （ordinary feed）， the remaining rats were given high-glucose and high-fat diet combined with ip injection of streptozotocin （35 mg/kg） to induce DN model. Model rats were randomly divided into model group （purified water）， irbesartan group （positive control， 14.12 mg/kg） and Tongxinluo capsule group （0.3 g/kg）， including 12 rats in the model group and 11 rats for each of the other two groups. All groups were given relevant medicine or water intragastrically， once a day， for 16 consecutive weeks. After the last medication， fasting blood glucose and 24 h urinary total protein （24 h UTP） were detected. Pathological changes in renal cortex of rats in each group were observed. Serum levels of tissue-type plasminogen activator （PA） and plasminogen activator inhibitor 1 （PAI-1） were measured. mRNA expressions of transforming growth factor-β1（TGF-β1）， type Ⅳ collagen（COL-Ⅳ）， Wnt4 and β-catenin in renal cortex of rats were detected. The protein depositions or expressions of TGF-β1， COL-Ⅳ， focal adhesion kinase （FAK）， integrin-linked kinase （ILK）， E-cadherin， PA， PAI-1， Wnt4 and β-catenin in renal cortex of rats were observed or determined.RESULTSCompared with model group， 24 h UTP of rats in Tongxinluo capsule group were all significantly reduced （P＜0.05）； pathological damage and fibrosis of renal cortex were relieved； the expression of PA in serum and renal cortex was significantly increased， while PAI-1 level was significantly reduced （P＜0.05）； the depositions of COL-Ⅳ and TGF-β1 in renal cortex were all reduced， and corresponding mRNA expression was decreased significantly （P＜0.05）； the depositions of ILK and FAK were decreased， while the deposition of E-cadherin was increased； protein and mRNA expressions of Wnt4 and β-catenin were significantly reduced （P＜0.05）.CONCLUSIONSTongxinluo capsule can relieve pathological damage to renal tissue and renal fibrosis of DN model rats， and reduce extracellular matrix deposition. The mechanism may be related to regulation of fibrinolytic system activity， the decrease of ILK and FAK expression， and inhibition of Wnt/β-catenin signaling pathway.关键词：Tongxinluo capsule;fibrinolytic system;renal fibrosis;Wnt/β-catenin signaling pathway
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发布时间：2023-08-15 - 摘要：OBJECTIVETo explore the mechanism of Cirsium japonicum extract in improving hypercholesterolemia based on metabolomics technology.METHODSThe extract of C. japonicum was prepared by macroporous resin adsorption， and its main components were identified by liquid chromatography-tandem mass spectrometry. The experimental mice were randomly divided into control group （n＝6） and modeling group （n＝16）. The hypercholesterolemia model was induced by diet in modeling group； after modeling， the rats of modeling group were divided into model group （n＝8） and C. japonicum extract group （n＝8）. C. japonicum extract group was given C. japonicum extract 400 mg/（kg·d） by gavage （calculated by extract）， and other 2 groups were given constant volume of 0.3% sodium carboxymethyl cellulose solution， for 6 weeks. After medication， the intervention effect of C. japonicum extract was evaluated by the levels of serum total cholesterol （TC）， triglyceride （TG） and the histopathological changes of liver. The mechanism of C. japonicum extract in improving hypercholesterolemia model mice was investigated by metabolomics.RESULTSIt was identified that C. japonicum extract contained 12 components， such as chlorogenic acid， linarin and pectolinarin. After 6 weeks of intervention， compared with control group， serum level of TC was increased significantly while the level of TG was decreased significantly in model group （P＜0.05）， while a large number of lipid droplets， disorderly arrangement of liver cells and the damaged structure of liver cord were observed in liver tissue. Compared with model group， the serum level of TC was decreased significantly in C. japonicum extract group（P＜0.05）； the lipid droplets in liver tissue were significantly reduced， with liver cells arranged radially and tightly centered around the central vein， and liver cords arranged neatly. The metabolomics study showed that after the intervention of C. japonicum extract， the levels of metabolites were significantly adjusted back， such as ethanolamine， fumaric acid and cholesterol； finally， three metabolism pathways， such as alanine-aspartate-glutamic acid metabolism， arginine biosynthesis， citric acid cycle， were obtained.CONCLUSIONSThe main components of C. japonicum extract are phenolic acids and flavonoids， such as chlorogenic acid， linarin， pectolinarin. C. japonicum extract can improve hypercholesterolemia by regulating the contents and distribution of differential metabolites， adjusting alanine-aspartate-glutamic acid metabolism， arginine biosynthesis and citric acid cycle， participating in oxidation-reduction reaction， improving liver lipid accumulation， and playing anti-inflammatory role.关键词：metabolomics;hypercholesterolemia;metabolism pathway
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发布时间：2023-08-15 - 摘要：OBJECTIVETo prepare Xiongzhi shigao decoction soluble microneedles， characterize it and investigate its transdermal properties in vitro.METHODSTwo-step centrifugal method was used to prepare Xiongzhi shigao decoction soluble microneedles. The formability and mechanical property of the microneedles were evaluated from aspects of stroma fluidity， microneedle formability， needle hardness， etc. The appearance， mechanical strength， dissolution performance， skin barrier recovery performance and drug loading of the prepared microneedles were characterized by using active components of the soluble microneedle （chlorogenic acid， ferulic acid， notopterol， imperatorin， ligustilide， isoimperatorin） as indicators. The in vitro transdermal performance was investigated by Franz diffusion cell.RESULTSThe soluble microneedle tips of Xiongzhi shigao decoction prepared in this study were conical， evenly distributed and of the same thickness， with good mechanical properties； the tip of the needle could be almost completely dissolved after being penetrated into the skin of rats for 2 hours， and the skin barrier recovery performance was good； the drug loading of chlorogenic acid， ferulic acid， notopterol， imperatorin， ligustilide and isoimperatorin were （87.04±1.12）， （67.69±1.23）， （20.65±0.17）， （35.00±0.11）， （153.83±0.21） and （23.52±0.50） μg per patch respectively. The results of in vitro transdermal study showed that cumulative release rates of 6 active components in this microneedle after 72 hours were 36.94%， 56.72%， 19.36%， 57.98%， 11.06% and 35.19%， respectively.CONCLUSIONSXiongzhi shigao decoction soluble microneedles are prepared successfully in this study and have good formability， mechanical properties and pliable backing， which can significantly promote the transdermal drug delivery.关键词：soluble microneedles;characterization;in vitro transdermal properties
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发布时间：2023-08-15 - 摘要：OBJECTIVETo study the intervention effect and mechanism of Zhongfeng yure decoction on ischemic stroke model rats.METHODSTotally 85 rats were randomly divided into sham operation group （normal saline， n＝15）， model control group （normal saline， n＝18）， Nimodipine tablet group （positive control， 10.8 mg/kg， n＝18）， high-dose group of Zhongfeng yure decoction （20.52 g/kg， n＝17） and low-dose group of Zhongfeng yure decoction （5.13 g/kg， n＝17）， respectively. After 7 days of preventive continuous administration （once a day）， except for the sham operation group， the rats’ middle cerebral artery occlusion （MCAO） model was established by the modified suture method in other groups. After modeling， the rats in each group continued to be administered for 3 days. During experiment， general condition of the rats was observed， and the neurological function score was performed. After the last administration， the organ index was calculated， the cerebral infarction area and pathological changes of brain tissue were observed. The levels of tumor necrosis factor-α （TNF-α） and interleukin 6 （IL-6） in brain tissue and serum， and the average optical density value of caspase-3 and phosphorylated protein kinase B（p-AKT） protein in brain tissue were detected.RESULTSThree days after modeling， compared with sham operation group， the neurological function score， in brain tissue index， spleen tissue index， proportion of cerebral infarction area， the levels of TNF-α and IL-6 in brain tissue and serum， and the average optical density value of caspase-3 protein in brain tissue were significantly increased in the model control group （P＜0.05 or P＜0.01）； karyopyknosis， diffuse edema and other lesions appeared in brain tissue. Compared with the model control group， the above indexes in each administration group were improved to varying degrees. Among them， there were significant regression in brain tissue index， spleen tissue index， proportion of cerebral infarction area， TNF-α level in brain tissue and serum， and the average optical density values of caspase-3 protein and p-AKT protein in brain tissue of rats in high-dose group of Zhongfeng yure decoction （P＜0.05 or P＜0.01）.CONCLUSIONSZhongfeng yure decoction has a certain intervention and therapeutic effect on MCAO model rats. The mechanism may be to reduce the secretion of inflammatory factors TNF-α and IL-6， down-regulate the expression of caspase-3 protein in ischemic brain tissue， up-regulate the expression of p-AKT protein， so as to protect the neurons.关键词：ischemic stroke;middle cerebral artery occlusion model;caspase-3;phosphorylated protein kinase B;rats
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发布时间：2023-08-15 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of sugemalimab in patients with stage Ⅲ non-small cell lung cancer （NSCLC） whose disease had not progressed after concurrent or sequential chemoradiotherapy from the perspective of the Chinese healthcare system.METHODSBased on the GEMSTONE-301 clinical trial，a three-health state partitioned survival model （PartSA） was developed to simulate the progression of disease，with model cycle of 3 weeks and a lifetime time range； the main output indicators of the model were total cost，quality-adjusted life year （QALY），and incremental cost-effectiveness ratio （ICER）； the cost and health output were discounted using 5% discount rate. Using 1-3 times China’s per capita gross domestic product （GDP） in 2022 as the willingness-to-pay （WTP） threshold，the cost-utility analysis method was used for analysis，and sensitivity analysis and scenario analysis were conducted to assess model robustness.RESULTSCompared with placebo，ICER for sugemalimab consolidation therapy was 59 872.57 yuan/QALY，which was less than one time China’s per capita GDP in 2022 （85 698 yuan） as the WTP threshold. The scenario analysis results further confirmed the robustness of the model. The results of single factor sensitivity analysis indicated that the cost of drugs （pembrolizumab，sugemalimab，docetaxel） and the utility value of disease progression status had a significant impact on ICER； the results of the probabilistic sensitivity analysis showed that sugemalimab had 67.2% probability of being cost-effective at one time China’s GDP per capita in 2022 as the WTP threshold； when 20 000 yuan （less than 3 times GDP per capita in China of 257 094 yuan） was used as the WTP threshold，the probability of sugemalimab consolidation therapy being cost-effective was greater than 98%.CONCLUSIONSThe consolidation therapy with sugemalimab is cost-effective for stage Ⅲ NSCLC whose disease had not progressed after concurrent or sequential chemoradiotherapy.关键词：stage Ⅲ non-small cell lung cancer;cost-utility analysis;partitioned survival model;pharmacoeconomics
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发布时间：2023-08-15 - 摘要：OBJECTIVETo investigate the effects of individualized dosing regimen on blood trough concentration of vancomycin and renal function in critically ill patients.METHODSAccording to relevant guidelines and the results of Vancomycin Calculator， clinical pharmacists formulated an individualized dosing regimen of vancomycin including loading dose and maintenance dose for critically ill patients based on the two independent variables of body weight and creatinine clearance rate. Using the method of retrospective study， patients who were admitted to the department of intensive care unit （ICU） of the Second Affiliated Hospital of Guangzhou Medical University and used the regimen from July 2018 to December 2021 were selected as the trial group， and patients who were treated with vancomycin and received blood drug concentration monitoring in ICU from January 2015 to June 2018 were recruited in the control group. The difference in trough concentration distribution and the incidence of acute kidney injury （AKI） after medication were compared between the two groups， the change of serum creatinine before and after medication in the trial group was analyzed.RESULTSTotally 197 patients were included in the trial group and 144 patients were in the control group. There was no significant difference between the two groups in the clinical information （gender， age， body weight， acute physiology and chronic health evaluation Ⅱ score， the proportion of patients with renal insufficiency， etc.） （P＞0.05）. The proportions of major infection sites （including lung， urinary， abdominal， blood and central nervous system） and treatment type （target or empirical treatment） also had no significant difference between the two groups （P＞0.05）. There was no significant difference in the attainment rate of ideal trough concentration （15-20 μg/mL） and the proportion of patients with trough concentration ＞20 μg/mL between the two groups （P＞0.05）， while the attainment rate of target trough concentration （10-20 μg/mL） and the proportion of patients with trough concentration ＜10 μg/mL were significantly different between the two groups （P＜0.05）. The attainment rate of target trough concentration in patients with chronic renal insufficiency in trial group was significantly higher than that in control group （P＜0.05）. There was no significant difference in the incidence of AKI and vancomycin-associated AKI between the two groups （P＞0.05）. In the trial group with medication duration ≥7 days ， the level of serum creatinine on the 7th day of treatment was increased significantly， compared with that on the 3rd day of treatment （P＜0.05）.CONCLUSIONSThis individualized dosing regimen can improve the attainment rate of target trough concentration of vancomycin in critically ill patients， especially those with chronic renal insufficiency， during the first standardized monitoring， and not increase the risk of renal injury compared with previous empirical medication.关键词：critically ill patients;individualized dosing regimen;therapeutic drug monitoring;blood trough concentration;renal function
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发布时间：2023-08-15 - 摘要：OBJECTIVETo explore the efficacy of alfacalcidol combined with conventional antihypertensive and lipid-lowering drugs on liver and kidney function， serum inflammatory cytokines and renin-angiotensin system（RAS） in hypertensive patients with renal impairment.METHODSA total of 200 hypertensive patients with renal impairment who were treated in the department of nephrology in our hospital from December 2017 to December 2020 were selected and randomly divided into control group and observation group， with 100 cases in each group. Both groups of patients were treated with conventional antihypertensive and lipid-lowering drugs for a total of 14 weeks， patients in the observation group were additionally treated with oral alfacalcidol after 2 weeks of treatment （0.25 μg each time， once a day， for a total of 12 weeks）. The levels of liver function indexes [aspartate aminotransferase （AST）， alanine aminotransferase （ALT）]， renal function indexes [blood calcium， blood phosphorus， blood urea nitrogen （BUN）， cystatin C （Cys-C）， serum creatinine （Scr）， urine microalbumin （mAlb）， β2-microglobulin （β2-MG）， urinary N-acetyl β-D-glucosaminidase （NAG）， 24 h urinary protein]， inflammatory factors [serum interleukin 6 （IL-6）， tumor necrosis factor α （TNF-α）， hypersensitive C-reactive protein （hs-CRP）] and RAS activity indexes [renin， angiotensin Ⅰ（Ang Ⅰ）， Ang Ⅱ and aldosterone] were observed in 2 groups before and after treatment， and the occurrence of adverse drug reactions was recorded during treatment.RESULTSThere was no statistical significance in the levels of detection indexes between 2 groups before treatment （P＞0.05）. After treatment， the level of blood calcium in the observation group was significantly higher than before treatment （P＜0.05）， but remained at clinically normal level. Compared with before treatment， the levels of Cys-C， Scr， BUN， urine mAlb， β2-MG， NAG and 24 h urinary protein， hs-CRP， IL-6， TNF-α， renin， Ang Ⅰ， Ang Ⅱ and aldosterone were significantly decreased in the observation group after treatment （P＜0.05）. After treatment， the level of blood calcium in observation group was significantly higher than control group （P＜0.05）. Additionally， the levels of Cys-C， Scr， BUN， urine mAlb， β2-MG， NAG， 24 h urinary protein， hs-CRP， IL-6， TNF-α， renin， Ang Ⅰ， Ang Ⅱ and aldosterone were significantly lower than control group （P＜0.05）. There was no statistical significance in the incidence of adverse drug reactions between 2 groups during treatment （P＞0.05）.CONCLUSIONSAlfacalcidol combined with routine therapy of antihypertensive and lipid-lowering drugs could effectively improve liver and renal functions， inhibit inflammation and RAS activity in hypertensive patients with renal impairment， with a favorable safety.关键词：hypertensive renal impairment;renin-angiotensin system;inflammatory cytokines
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发布时间：2023-08-15 - 摘要：OBJECTIVETo provide reference for clinically safe application of avapritinib.METHODSThe adverse drug event （ADE） reports of avapritinib from January 9th，2020，to September 30th，2022 were collected from FDA Adverse Event Reporting System （FAERS） database. For data mining and analysis，reporting odds ratio （ROR） method and proportional reporting ratio （PRR） method in the proportional imbalance method were utilized.RESULTSA total of 10 895 ADE reports with avapritinib as the main suspect drug were gathered，and 201 ADE signals involving 19 systematic organ classifications were found after eliminating invalid signals. The instruction of the drugs did not mention any of the ADE，including tinnitus，dementia，chilly limbs，the reduction of blood iron，the reduction of blood sugar，fever，the reduction of vitamin D and vitamin B12，as well as all ADE in the 2 SOCs of musculoskeletal and connective tissue illnesses，diseases of the reproductive system，and diseases of the breast. The majority of the ADE reports 670 cases with complete drug information were for the nervous system （230 cases，accounting for 34.33%） and ocular organ （277 cases，accounting for 41.34%）. Compared with other systems，daily dose and treatment course showed significant effects on ADE of neurological system and ocular organ （P＜0.05），and the patient’s age had a significant impact on the ADE of the nervous system （P＜0.05）.CONCLUSIONSA greater incidence of ADE after using avapritinib is present in patients older than 65 with a daily dose of 300 mg/d and a treatment period lasting between 31 and 90 days； patients receiving a daily dose of 300 mg/d and a treatment regimen lasting 31 to 90 days are more likely to experience ADE of the ocular organ. Attention should be given to the aberrant symptoms of the patient’s eyes and nervous system throughout clinical use of avapritinib，and prompt intervention should be given.关键词：adverse drug event;proportional imbalance method;signal mining;adverse drug reaction
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发布时间：2023-08-15 - 摘要：OBJECTIVETo compare the safety of polysaccharide iron complex and ferrous sulfate in the treatment of anemia during pregnancy.METHODSRetrieved from Cochrane Library， PubMed， Embase， SinoMed， CNKI， VIP and Wanfang database， randomized controlled trials （RCTs） about polysaccharide iron complex （trial group） versus ferrous sulfate （control group） in the treatment of anemia during pregnancy were collected from the inception to May 20th， 2022. After literature screening， data extraction and quality evaluation， meta-analysis， sensitivity analysis and publication bias analysis were conducted with RevMan 5.3 software.RESULTSA total of 13 RCTs were included， with a total of 1 318 patients. Results of meta-analysis showed that the total incidence of adverse drug reactions （ADR） [RR＝0.11， 95%CI （0.06， 0.18）， P＜0 000 01]， gastrointestinal adverse reactions [RR＝0.08， 95%CI （0.05， 0.12）， P＜0.000 01]， anorexia and nausea [RR＝0.21， 95%CI （0.09， 0.54）， P＝0.001]， abdominal pain [RR＝0.18， 95%CI （0.04， 0.78）， P＝0.02]， diarrhea [RR＝0.18， 95%CI （0.04， 0.79）， P＝0.02]， vomiting [RR＝0.24， 95%CI （0.06， 0.89）， P＝0.03] and gingival melanosis [RR＝0.09， 95%CI （0.03， 0.28）， P＜0.000 1] in the trial group were all significantly lower than the control group. The results of sensitivity analysis showed that the conclusions obtained in this study were relatively robust. The results of publication bias analysis indicated that there was a high possibility of publication bias in this study.CONCLUSIONSThe polysaccharide iron complex is safer than ferrous sulfate for treatment of anemia during pregnancy.关键词：polysaccharide iron complex;ferrous sulfate;safety;meta-analysis
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发布时间：2023-08-15 - 摘要：OBJECTIVETo evaluate the effect of PDCA cycle on prophylactic use of antibiotics in laparoscopic cholecystectomy during perioperative period and to conduct pharmacoeconomic analysis.METHODSUsing retrospective analysis method， 80 discharged patients of each group underwent laparoscopic cholecystectomy were randomly selected from Hefei Second People’s Hospital before PDCA cycle （from May to June 2019）， after the first round of PDCA cycle （from May to June 2020）， after the second round of PDCA cycle （from May to June 2021） according to real or basic reasons for irrational drug use. The rationality of prophylactic use of antibiotics for patients was evaluated. The general situation， antibiotic use， clinical efficacy and treatment cost of patients were compared before cycle and after the first and second rounds of PDCA cycle. Cost-effectiveness analysis method and sensitivity analysis method were adopted to evaluate pharmacoeconomic significance of PDCA cycle.RESULTSAfter two rounds of PDCA cycle， the irrational rate of antibiotics， cost ratio of antibiotics， the number of days of antibiotics use， DDDs， drug utilization index， the frequency of antibiotics use per capita， the total amount of antibiotics， the cost of antibiotics， the total amount of drugs， and the total cost of hospitalization all decreased significantly （P＜0.05）. The results of cost-effectiveness analysis indicated that the pharmacoeconomic effect was the best after two rounds of PDCA cycle； the results of sensitivity analysis were consistent with it， which confirmed the reliability of the research results.CONCLUSIONSPDCA cycle promotes the rational use of antibiotics of laparoscopic cholecystectomy during perioperative period， reduces the cost of antibiotics and relieves the economic burden of patients.关键词：laparoscopic cholecystectomy;perioperative period;antibiotics;cost-effectiveness analysis;sensitivity analysis
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发布时间：2023-08-15 - 摘要：OBJECTIVETo analyze the grouping effect and composition of hospitalization costs for cases of patients with malignant proliferative disease under the diagnosis-related group （DRG） payment system， as well as any changes， in order to provide a basis for medical institutions to improve DRG payment-related measures， control drug costs， and for relevant departments to make decisions.METHODSThe data of patients with malignant proliferative disease cases were collected from a “Third Grade Class A” hospital in 2021 and 2022， and the variation coefficient （CV） was used to evaluate the grouping of DRG. The structural variation degree and the new grey correlation analysis were used to study the structural variation of hospitalization cost and the correlation degree between the hospitalization cost and the cost of other items.RESULTSThe overall reduction in variance （RIV） for the DRG group of patients with malignant proliferative disease was 79.36%； the CV of other groups were all lower than one except that the RW21 group was 1.09. Compared with 2021， the hospitalization cost for patients with malignant proliferative disease in 2022 decreased by 17.80%， and the decreases in management fees and drug costs were 32.15% and 21.30%， respectively， while the per capita medical expenses increased by 17.26%. The new grey correlation degree of drug cost decreased， but that of medical expenses increased.CONCLUSIONSUnder the DRG payment system， hospitalization costs for patients with malignant proliferative disease in the sample hospital decrease， but the grouping efficiency of RW21 and other disease groups needs improvement， and the cost structure needs optimization.关键词：patients with malignant proliferative disease;grouping effect;hospitalization costs
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发布时间：2023-08-15 - 摘要：OBJECTIVETo investigate the present equipment and management situation of narcotic drugs in primary healthcare institutions from Qiandongnan prefecture of Guizhou province.METHODSThe questionnaire survey was conducted among pharmacy department heads and medical staff from primary healthcare institutions in Qiandongnan prefecture of Guizhou province. Descriptive statistical analysis was conducted on the survey results.RESULTSOf 251 healthcare institutions in this survey， 29 healthcare institutions were equipped with narcotic drugs， accounting for 11.55%. The reasons for the narcotic drugs unequipped were mainly as follows: insufficient attention， no storage conditions for narcotic drugs， complex program of narcotic drug management， small amount usage and so on. Among the 29 primary healthcare institutions equipped with narcotic drugs， all of them did not monitor patient usage， accounting for 100%； 29 healthcare institutions did not implement a return visit or follow-up every 3 months， accounting for 100%.CONCLUSIONSThe health administration departments should strengthen the administration of narcotic drugs in primary healthcare institutions. At the same time， training on standardized management and clinical rational application of narcotic drugs for medical staff in primary healthcare institutions should be enhanced by the health administrative department.关键词：narcotic drugs;questionnaire survey
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发布时间：2023-08-15 - 摘要：OBJECTIVETo further improve the rational drug use control mechanism based on performance appraisal， explore new paths of pharmaceutical care and promote the rational clinical drug use management to deepen development.METHODSThe reform of pharmaceutical management system in our hospital was performed through implementing the “ten-point system of prescription behavior management”， supplemented by the two carriages of “strengthening prescription review” and “standardizing clinical medication”. By implementing a number of auxiliary measures such as man-machine integration pre-prescription review， improving pharmacists’ prescription review ability， optimizing prescription review mechanism in real time， regulating physicians’ off-label drug use behavior， and improving drug evaluation mechanism， pre-control and in-process intervention were completed. The evaluation results were incorporated into performance assessment by referring to the “ten-point system of prescription behavior management”， so as to realize multi-dimensional and fully closed-loop rational drug use management. The effects of management were evaluated by comparing the statistical results of related indexes before and after the management.RESULTSCompared with before management， irrational rate of prescriptions and medical orders in our hospital in 2022 decreased significantly， compared to the same period in 2020； the irrational rate of inpatient medical orders decreased from 5.00% in 2020 to 2.69% in 2022， and that of outpatient prescriptions decreased from 4.59% to 2.48%； the frequency of communication between clinical pharmacists and physicians increased； the times of clinical consultations increased from 16 to 58， and doctors’ acceptance of intervention for irrational drug use had improved from 52％ to 87％； physicians had a deeper understanding and recognition of clinical pharmaceutical care， the awareness of clinical rational drug use had been significantly improved.CONCLUSIONSThe rational drug use control mechanism guided by performance appraisal further standardizes the issuance of prescriptions and medical orders， and makes physician-pharmacist cooperation more prominent， so as to realize the closed-loop pharmaceutical management of “pre-review， in-process supervision and post-evaluation”， and promote rational drug use in clinical practice.关键词：performance appraisal;control mechanism
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发布时间：2023-08-15 - 摘要：Menthol is the main component of mint volatile oil and a monoterpenoid organic compound. This article systematically summarizes the pharmacological effects， present development and application status of menthol. It is found that menthol can protect the central nervous system through acting on the transient receptor potential （TRP） channel subfamily M member 8， 5-hydroxytryptamine system， γ-aminobutyric acid system， etc. Menthol can regulate body temperature through temperature adjustment， relieving heat stress， and other means. It can play an anti-inflammatory role by regulating the production and release of inflammatory mediators such as prostaglandin E2 and leukotriene B4， and exert anti-inflammatory effects through cellular immune effect mediated by TRP channel. It can play analgesic role by activating classic pain perception targets and enhancing inhibitory synaptic transmission. It can promote transdermal absorption by destroying the stratum corneum. It can exert anti-tumor effects by regulating tumor cell proliferation， apoptosis， and adhesion pathways. Menthol can be used as a medicinal excipient for correcting the taste of drugs； it can also serve as an active ingredient and play an important pharmacological role in the treatment of disease， with potential development value.关键词：pharmacological effects;development and application
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发布时间：2023-08-15 - 摘要：Diabetic nephropathy （DN） has become one of the main causes of end-stage renal disease，and its pathogenesis is still unclear. Currently，it is believed to be closely related to kidney injury mediated by various factors such as autophagy disorder under the condition of high glucose，oxidative stress and inflammation. Mammalian target of rapamycin （mTOR） signaling pathway is crucial for protein synthesis and autophagy regulation，which plays an important role in the occurrence and development of DN. In recent years，the research on the prevention and treatment of DN with traditional Chinese medicine （TCM） has made important progress. Plenty of evidence has shown that the active ingredients of TCM can enhance autophagy，improve oxidative stress and inflammation，inhibit cell apoptosis and abnormal proliferation by regulating mTOR signaling pathway，so as to relieve pathological changes in the kidney such as podocyte injury，glomerular basement membrane thickening，mesangial tissue abnormalities and renal tubule dysfunction，thereby reducing proteinuria and improving renal function. All of the above are of great significance for delaying the progression of DN. This article systematically summarizes the research progress of saponins，flavonoids，polyphenols，alkaloids，terpenoids and other active ingredients of TCM intervening in DN through mTOR signaling pathway，in order to provide some reference for further basic research and the development of new drugs.关键词：active ingredients of traditional Chinese medicine;mammalian target of rapamycin;signaling pathway
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发布时间：2023-08-15 - 摘要：Meropenem is the first choice for the treatment of multi-drug-resistant bacterial infections， which has been widely used in clinical practice. However， the physiological and pathological characteristics of special populations have a significant impact on the pharmacokinetics/pharmacodynamics （PK/PD） parameters of meropenem， so it is necessary to develop individualized drug administration plan according to the characteristics of patients in clinical application. Therefore， this paper summarizes PK/PD characteristics and application of meropenem in special population， and recommends the dosage of meropenem as follows： 10-40 mg/kg， q8 h for children； 1 g， q8-12 h for elderly patients； 0.75 g， q8 h for the patients with renal insufficiency who received continuous veno-venous hemofiltration and continuous veno-venous hemodialysis； 1 g， q8 h prolonged infusion until 3 hours or 2 g， q8 h for patients with hyperrenal function； 1 g， q8 h after 2 g loading dose for patients with cirrhosis.关键词：pharmacodynamics;Pharmacokinetics;drug interaction;therapeutic drug monitoring
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发布时间：2023-08-15
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