最新刊期
卷 34 ， 期 4 ， 2023
- 摘要：OBJECTIVETo provide reference for the construction of remote inspection mode of pharmaceutical production in China.METHODSBy combing the guidance documents of remote inspection and related pilots issued abroad， the experience of constructing remote inspection mode of pharmaceutical production was summarized. RESULTS &CONCLUSIONSTypical foreign countries and regions have carried out remote inspection pilots all over the world， and clearly defined the application situation， implementation process， inspection techniques and related points for attention of remote inspection of pharmaceutical production. In terms of application， the European Union pointed out four specific applicable situations， including travel restrictions， while the United States stipulated that remote inspection was applicable to pre-approved inspection and so on. In terms of the implementation process， the United States developed a four-step method of remote inspection， while the European Union has defined the specific implementation process of remote inspection in more detail. In comparison， Japan paid more attention to the remote inspection process of production documents. In terms of inspection techniques， the European Union used 360° cameras， Matterport 3D technology and document review software to realize the remote inspection of production sites and production documents. In terms of attention points for remote inspection， the United States required that access rights should be set for information sharing to avoid information disclosure. Both the European Union and the United States required inspectors to be trained and equipment inspected before remote inspection. It is suggested that China should formulate unified guidelines for remote inspection of pharmaceutical production， clarify the applicable situations， and formulate the implementation process of remote inspection of pharmaceutical production with reference to the opinions of drug manufacturers. In addition， intelligent remote inspection technology can be used in combination with the information construction level of drug manufacturers， and remote inspection training program can be formulated to cultivate professional remote inspection team.关键词：application situation;implementation process;inspection techniques;enlightenment
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发布时间：2023-02-24 - 摘要：OBJECTIVETo evaluate the effectiveness， safety， economy， innovation， suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein （EC）， and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis.METHODSThe effectiveness and safety of EC compared with purified protein derivative of tuberculin （TB-PPD） were analyzed by the method of systematic review. Cost minimization analysis， cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD， and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation， suitability and accessibility were determined by systematic review and improved Delphi expert consultation， and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator.RESULTSThe scores of effectiveness， safety， economy， innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent， while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight， the scores of effectiveness， safety， economy， innovation， suitability， accessibility and the comprehensive score of EC were all higher than those of TB-PPD.CONCLUSIONSCompared with TB-PPD， EC performs better in all dimensions of effectiveness， safety， economy， innovation， suitability and accessibility. However， it is worth noting that EC should further improve its availability in the dimension of accessibility.关键词：purified protein derivative of tuberculin;tuberculosis;diagnostic drugs;clinical comprehensive evaluation
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发布时间：2023-02-24 - 摘要：OBJECTIVETo provide reference for perfecting prescription circulation service and related platforms construction and improving online medical service level.METHODSA questionnaire was designed after literature review and consulting expert opinions. Patients who had received prescription circulation service in the prescription circulation platform of a Grade-A third-class hospital in Sichuan Province from November 22， 2019 to May 2022 were randomly selected， and the knowledge， attitude and practice of prescription circulation service were investigated by questionnaires， which were sent through telephone contact and short message.RESULTSA total of 285 patients were investigated， and the number of effective responses was 200. Most of the surveyed patients in prescription circulation service for 1-5 times in the past year （129 cases， 64.50%）； 77.0% of the patients had a “general understanding” or “no understanding” of prescription circulation services， and the main prescription circulation services they received were online consultation service （169 cases， 84.50%） and drug delivery service （106 cases， 53.00%）. The average waiting time and expected waiting time were 1-5 min. The services with the largest number of demand （145 cases， 72.50%） and the highest demand （3.585 points） were drug delivery services. Most of the respondents’ willingness to pay was “general willingness” （83 cases， 41.50%）， and most of the patients were willing to pay less than or equal to 5 yuan per time （92 cases， 46.00%）. Totally 73.0% of the surveyed patients were “satisfied” or “relatively satisfied” with the prescription transfer service. The results of univariate analysis showed that the main factors influencing patients’ satisfaction with prescription circulation service were service awareness， service waiting time， patients’ demand satisfaction and patients’ willingness to pay.CONCLUSIONSThe surveyed patients are generally satisfied with prescription circulation service， and the service content with high satisfaction is drug distribution service， and patients are willing to pay a lower price for prescription circulation service. It is suggested that relevant departments should strengthen the publicity of prescription circulation service， improve the content of prescription circulation service and reduce the payment price of prescription circulation service， so as to improve the operation efficiency of Chinese medical system while facilitating patients.关键词：Sichuan;knowledge， attitude and practice survey;questionnaire;satisfaction;effect
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发布时间：2023-02-24 - 摘要：OBJECTIVETo investigate the improvement effects and possible mechanism of 7-hydroxyethyl chrysin （7-HEC） on PC12 cell injury induced by hypobaric hypoxia.METHODSThe rat adrenal pheochromocytoma cell line PC12 was cultured under low-pressure hypoxia （5%CO2， 94%N2， 1%O2， 54 004 Pa） to investigate the different concentrations of 7-HEC （100， 10， 1， 0.1， 0.01 μmol/L） on the survival rate of hypoxic cells； the effects of 7-HEC（1 μmol/L） on the contents of lactate dehydrogenase （LDH） and malondialdehyde （MDA）， superoxide dismutase （SOD） activity， apoptotic rate， cell cycle， and the expressions of cleaved caspase-3， Bcl-2 and Bax were detected.RESULTSCompared with control group， the survival rate of cells in hypobaric hypoxia group was decreased significantly （P＜0.01）； 10， 1， 0.1 μmol/L 7-HEC could reverse the decrease of cell survival rate caused by hypobaric hypoxia （P＜0.05 or P＜0.01）. Compared with control group， LDH content in supernatant， MDA content in cells， apoptotic rate， the proportion of cells at G1 stage and the protein expression of cleaved caspase-3 were increased significantly in hypobaric hypoxia group， while SOD activity in cells， the proportion of cells at S stage and G2 stage and Bcl-2/Bax ratio were decreased significantly （P＜0.05 or P＜0.01）. Compared with hypobaric hypoxia group， the contents of LDH and MDA， apoptotic rate， the proportion of cells at G1 stage and the expression of cleaved caspase-3 in 7-HEC group were decreased significantly， while SOD activity， the proportion of cells at G2 stage and Bcl-2/Bax ratio were increased significantly （P＜0.01）.CONCLUSIONS7-HEC can significantly increase the survival rate of hypobaric hypoxia cells， reduce the LDH content in supernatant， improve cell cycle arrest， and reduce the rate of apoptosis. Its improvement effects on hypobaric hypoxia cell injury may be related to the inhibition of caspase-3/Bax/Bcl-2 pathway activation.关键词：PC12 cells;hypobaric hypoxia;cell apoptosis;caspase-3/Bax/Bcl-2 pathway
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发布时间：2023-02-24 - 摘要：OBJECTIVETo investigate the improvement effects and mechanism of imperatorin on cachexia model mice.METHODSFifteen male C57BL/6J mice were randomly divided into blank control group， model group and imperatorin group， with 5 mice in each group. Except for blank control group， the remaining mice were inoculated with LLC cell suspension subcutaneously on the dorsal surface， and the drug was administered by gavage daily from the 7th day of inoculation. The imperatorin group was gavaged with imperatorin suspension （0.5% sodium carboxymethylcellulose solution as solvent） at 60 mg/kg； blank control group and model group were given an equal volume of 0.5% sodium carboxymethylcellulose solution， for 13 d of continuous administration. During the administration period， food intake and body mass of mice were recorded daily and regularly， tumor long and short diameters were measured every two days， and tumor volume was calculated. The skeletal muscle mass and tumor mass of each group were weighed and the tumor-free body weight was calculated； the pathological changes of skeletal muscle were observed and the cross-sectional area of skeletal muscle fibers was calculated； the phosphorylation levels of signal transduction and activator of transcription 3 （STAT3） （measured as p-STAT3/STAT3 ratio）， muscle atrophy box F gene （MAFbx）， myostatin （Myog）， B-cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）， Caspase3 protein and mRNA expression were all detected.RESULTSCompared with blank control group， body mass and skeletal muscle mass of model group were decreased significantly （P＜0.05）， and reduced food intake， loose arrangement of skeletal muscle， large cell space were observed； the cross-sectional area of skeletal muscle fiber was significantly reduced， while p-STAT3/STAT3 ratio， protein and mRNA expressions of MAFbx， Bax and Caspase3 were increased significantly （P＜0.05）. The protein and mRNA expressions of Myog and Bcl-2 were significantly reduced （P＜0.05）. Compared with model group， body weight， tumor-free weight and skeletal muscle weight were increased significantly in imperatorin group （P＜0.05）； food intake increased， while the expressions of tumor weight and volume were decreased significantly （P＜0.05）； the expressions of above proteins and genes were improved significantly （P＜0.05）.CONCLUSIONSImperatorin can improve the tumor cachexia state， the mechanism of which may be related to the regulation of ubiquitin-proteasome pathway and anti-apoptosis.关键词：cancer cachexia;muscle atrophy;mice
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发布时间：2023-02-24 - 摘要：OBJECTIVETo study the intervention effect and metabolic mechanism of Mongolian medicine Echinops sphaerocephalus extract on D-galactose-induced osteoporosis.METHODSThirty-six 12-week-old male Wistar rats were selected and randomly divided into blank group， model group， Gushukang group， E. sphaerocephalus high-dose， medium-dose and low-dose groups， with 6 rats in each group. Except for blank group， other groups were intraperitoneally injected with D-galactose at 120 mg/kg per day. After 8 weeks of continuous injection， E. sphaerocephalus high-dose， medium-dose and low-dose groups were given drugs intragastrically at dose of 878， 439， 219.5 mg/kg， respectively. Gushukang group was given Gushukang 105.1 mg/kg intragastrically， once a day， for consecutive 8 weeks. After last administration， blood was collected from the abdominal aorta. Enzyme-linked immunosorbent assay was used to measure the contents of bone metabolism indexes [hydroxyproline （HYP）， alkaline phosphatase （ALP）] and oxidative stress indexes [total antioxidant capacity （TAOC）， superoxide dismutase （SOD）， malondialdehyde （MDA）] in serum of rats. Positron emission tomography/computedtomography （PET/CT） was used to analyze the changes of bone microstructure in right tibia bone. Meanwhile， metabolomic technology was used to study the regulation effect of E. sphaerocephalus on osteoporosis model rats.RESULTSCompared with blank group， HYP， ALP， MDA， ratio of bone surface to bone volume （BS/BV）， and trabecular separation （Tb·Sp） in model group were significantly increased （P＜0.05）， while TAOC， SOD， bone mineral density （BMD）， bone volume fraction （BVF）， trabecular thickness （Tb·Th） and trabecular number （Tb·N） were significantly decreased （P＜0.05）. Compared with model group， above indexes of administration groups were all reversed to different extents. The results of metabonomics study showed that after intervened with the extract of E. sphaerocephalus， 18 metabolites such as arachidonic acid， phenylalanine， tyrosine， tryptophan， isoleucine and uric acid in the serum of rats changed significantly， involving 15 metabolic pathways such as arachidonic acid， phenylalanine and tyrosine， of which arachidonic acid metabolism， phenylalanine metabolism and tyrosine metabolism were the main influencing pathways.CONCLUSIONSE. sphaerocephalus extract can effectively improve D-galactose-induced oxidative stress and the deterioration of bone microstructure， which interferes with metabolic pathways such as arachidonic acid metabolism and amino acid metabolism.关键词：D-galactose;metabolomics;osteoporosis;metabolic regulation
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发布时间：2023-02-24 - 摘要：OBJECTIVETo evaluate the quality of total flavonoids of Lamiophlomis rotata from different producing areas.METHODSTotal flavonoids of S1-S15 batches of L. rotata from different producing areas were extracted by percolation and purified by polyamide column. The content of total flavonoids was determined by UV spectrophotometry， and its purity was calculated. HPLC fingerprint chromatograms and control fingerprint of total flavonoids from 15 batches of L. rotata were established with Similarity Evaluation System of Chromatographic Fingerprint of TCM （2012 version）. Their similarities were analyzed. Cluster analysis， principal component analysis and orthogonal partial least squares-discriminant analysis were used to evaluate the quality of total flavonoids from 15 batches of L. rotata， and the main components which affected the quality of total flavonoids were analyzed.RESULTSThe purities of total flavonoids from 15 batches of L. rotata were 55.82%-94.12%， with an average value of 77.72%； a total of five common peaks were identified in the fingerprint， and No. 3 peak was luteolin； the similarities between the fingerprint of each batch of samples and the control fingerprint were 0.925-1.000. By cluster analysis， S1 and S3-S9 were clustered into the first class， which were samples from Qinghai Province and Tibet Autonomous Region. S14 and S15 were clustered into the second class， which were samples from Yunnan Province. S10-S13 were clustered into the third class， which were all samples from Sichuan Province. S2 was clustered into the fourth class. The principal component analysis showed that the qualities of samples from the first and fourth classes were better； peaks 2， 3 and 5 were identified as the main components that caused the differences among different batches of samples by orthogonal partial least squares-discriminant analysis.CONCLUSIONSThe qualities of total flavonoids of L. rotata from Qinghai Province and Tibet Autonomous Region are better.关键词：total flavonoids;fingerprint;HPLC;chemometrics;quality evaluation
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发布时间：2023-02-24 - 摘要：OBJECTIVETo study main way and target of Euphorbia kansui after stir-frying with vinegar.METHODSTwenty-four SPF grade SD rats were randomly divided into blank group， E. kansui group （850 mg/kg） and vinegar stir-fried E. kansui group （850 mg/kg）， with 8 rats in each group. Blank group was given 0.5% sodium carboxymethyl cellulose solution intragastrically， and E. kansui group and vinegar stir-fried E. kansui group were given relevant test sample for consecutive 20 d. The rats’ urine of 12 hours was collected on the 20th day. The urine samples of rats in each group were determined by UPLC-Q-Exactive-MS. The data was pre-processed by Compound Discoverer 3.0 software， and the metabolite structure was identified by BioCyc， HMDB and other databases. Whether different groups presented their own clustering phenomenon was observed by principal component analysis （PCA） and orthogonal partial least squares-discriminant analysis （OPLS-DA）， etc. Based on the pathway analysis of MetaboAnalyst， the potential targets of detoxification mechanism of E. kansui after stir-frying with vinegar were predicted.RESULTSTwenty significantly differential endogenous metabolites were identified， of which 10 target metabolites， such as N-acetyl-L-aspartate and 3-phosphonooxypyruvic acid， were targets of detoxification mechanism of E. kansui after stir-frying with vinegar. The main metabolic pathways included arginine biosynthesis， alanine， aspartic acid and glutamic acid metabolism， cysteine and methionine metabolism， and arginine and D-ornithine metabolism. The biological significance of all related metabolites in the pathways was analyzed and speculated； after stir-frying with vinegar， E. kansui may alleviate neurotoxicity by reducing the level of N-acetyl-L-aspartic acid； E. kansui had a protective effect on cardio-cerebrovascular system by increasing the level of L-high arginine.CONCLUSIONSAfter stir-frying with vinegar， E. kansui can significantly improve the adverse factors in terms of nervous system， cardio-cerebrovascular system， immune system and energy metabolism. The most concentrated metabolic pathway related to its detoxification mechanism is arginine biosynthesis.关键词：processing and detoxification;metabonomics;target biomarkers;metabolic pathway
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发布时间：2023-02-24 - 摘要：OBJECTIVETo compare anti-ischemic stroke （IS） effect of different extraction parts from Gastrodia elata， and to provide reference for screening the anti-IS effective parts of G. elata.METHODSG. elata was extracted and separated by ethanol reflux extraction and ethyl acetate extraction. The rat model of diffuse cerebral thrombosis was induced by internal carotid artery injection of arachidonic acid （AA）； the anti-IS effect of G. elata powder， ethanol extract of G. elata， residue of ethanol extract of G. elata， ethyl acetate extract of G. elata， residue of ethyl acetate extract of G. elata， gastrodin and aspirin （positive control drug） were investigated with the content of Evans blue （EB） in the ischemic brain tissue as index.RESULTSCompared with model group， aspirin， ethanol extract of G. elata and ethyl acetate extract of G. elata could significantly decrease the content of EB in the ischemic brain tissue of model rats （P＜0.05）. G. elata powder had the tendency to reduce the content of EB in the ischemic brain tissue of model rats， without statistical significance （P＞0.05）. The residue of ethanol extract of G. elata， residue of ethyl acetate extract of G. elata and gastrodin had little effect on the content of EB in the ischemic brain tissue of model rats.CONCLUSIONSBoth ethanol extract of G. elata and ethyl acetate extract of G. elata have anti-IS effects， which are stronger than that of G. elata powder.关键词：ischemic stroke;extraction part;pharmacodynamics;effective part
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发布时间：2023-02-24 - 摘要：OBJECTIVETo compare the components of volatile oil from Gardenia jasminoides and their liver protective effect before and after stir-frying with wine.METHODSSteam distillation was used to exact the volatile oil from G. jasminoides and wine stir-fried G. jasminoides. The components of volatile oil were identified by GC-MS method， and the relative mass fraction of each component was calculated by peak area normalization method. The rats were randomly divided into normal group， model group， positive control group （bifendate suspension 35 mg/kg）， G. jasminoides low-dose and high-dose groups [1， 2 g/kg （calculated by crude drug）] and wine stir-fried G. jasminoides low-dose and high-dose groups [1， 2 g/kg （calculated by crude drug）] with 10 rats in each group. Liver injury model was established by intraperitoneal injection of 40% carbon tetrachloride in rats of each group after continuous intragastric administration of corresponding drug solution for 7 days. The status， serum biochemical indexes， liver biochemical indexes and liver pathological sections of rats in each group were compared.RESULTSTwenty-three volatile oil components from G. jasminoides and 25 volatile oil components from wine stir-fried G. jasminoides were identified； there were 18 common volatile oil components， of which the contents of 17 common components were decreased， while the content of one common component was increased due to stir-frying with wine. Compared with model group， the symptoms of depression and liver cell damage of rats in each administration group were improved to varying degrees； the serum levels of adenosine deaminase， alanine transaminase， aspartate transaminase， direct bilirubin， lactate dehydrogenase， prealbumin， total bile acid and total bilirubin were significantly decreased， while the total protein level was significantly increased； the level of malondialdehyde in liver tissue was significantly decreased， there were statistical significance （P＜0.05 or P＜0.01）.CONCLUSIONSDuring stir-frying with wine， the contents of 17 volatile oil components are decreased， while the content of one volatile oil component is increased. Wine stir-fried G. jasminoides shows liver protective effect. .关键词：volatile oil;component;content;liver protective effect
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发布时间：2023-02-24 - 摘要：OBJECTIVETo investigate the inhibitory effect and the possible mechanism of hydrogen sulfide （H2S） on the proliferation of cardiac fibroblasts.METHODSThe heart of neonatal SD rats was collected， and cardiac fibroblasts were separated with differential centrifugation. Using sodium hydrosulfide as the donor of H2S， the effects of H2S on the proliferation of cardiac fibroblasts induced by angiotensin Ⅱ （Ang Ⅱ）， hydroxyproline content and the expression of sirtuin 3 （SIRT3） protein were detected. After SIRT3 knockdown with siRNA technology， the effects of H2S on the proliferation of cardiac fibroblasts induced by Ang Ⅱ， hydroxyproline content， the expressions of collagen Ⅰ （Col Ⅰ）， collagen Ⅲ （Col Ⅲ ） and optic atrophy protein 1 （OPA1） were detected.RESULTSH2S could inhibit the proliferation of Ang Ⅱ-induced cardiac fibroblasts， reduce the content of hydroxyproline and increase the expression of SIRT3 （P＜0.05）. After down-regulating the expression of SIRT3 with siRNA technology， the inhibition of H2S on the proliferation of Ang Ⅱ-induced cardiac fibroblasts and the reduction of hydroxyproline content were both inhibited， and the effect of H2S on reducing the expression of Col Ⅰ and Col Ⅲ and enhancing the expression of OPA1 was also significantly weakened.CONCLUSIONSH2S inhibits the proliferation of Ang Ⅱ-induced cardiac fibroblasts through increasing the expression of SIRT3.关键词：cardiac fibroblasts;angiotensin Ⅱ;sirtuin 3
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发布时间：2023-02-24 - 摘要：OBJECTIVETo investigate the effects of total glucosides of paeony （TGP） on enhancing efficacy and reducing toxicity of Tripterygium wilfordii polyglycoside （TWP） in the treatment of eczema.METHODSTotally 50 SD male rats were collected to establish eczema model by sensitizing with 2，4-dinitrofluorobenzene-acetone olive oil solution （volume ratio was 4∶1） on the abdominal area and provoking on the back and ear. Model rats were randomly divided into model group， loratadine group （0.9 mg/kg）， TWP group （9.45 mg/kg）， TGP group （162 mg/kg） and compatibility group （TWP 9.45 mg/kg+TGP 162 mg/kg）， with 10 rats in each group. Other 10 rats were collected to set as normal group. Three days after the first sensitization， administration groups were given relevant medicine intragastrically， and normal group and model group were given constant volume of 0.1% CMC-Na solution intragastrically， once a day， for consecutive 21 d. Twenty-four hours later after the final administration， the general condition of rats in each group was observed， and the eczema area and severity index （EASI） were scored； ear swelling degree of rats was measured， and the skin histomorphology observation and pathological score were performed； protein expressions of p38 mitogen-activated protein kinase （p38 MAPK）， phosphorylated p38 MAPK （p-p38 MAPK） and phosphorylation level of p38 MAPK in rat skin tissue were detected； the levels of inflammatory indexes （interleukin-4， interferon-γ）， liver and kidney function indexes [glutamic-pyruvic transaminase （GPT）， glutamic-oxaloacetic transaminase （GOT）， serum creatinine （SCr） and blood urea nitrogen （BUN）] and oxidant stress indexes [total superoxide dismutase （T-SOD） and malondialdehyde （MDA）] were measured.RESULTSCompared with normal group， EASI score， ear swelling degree， pathological score， protein expressions of p38 MAPK and p-p38 MAPK， phosphorylation level of p38 MAPK， the levels of inflammatory indexes and BUN were all increased significantly in model group （P＜0.05）. Compared with model group， EASI scores， ear swelling degree， pathological scores， protein expressions of p38 MAPK and p-p38 MAPK， phosphorylation levels of p38 MAPK and levels of inflammatory indexes were all improved significantly in administration groups （P＜0.05）. The levels of GPT， GOT， SCr and BUN were increased significantly in TWP group， while the serum levels of GOT and SCr in TGP group and serum level of SCr in loratadine group were all decreased significantly （P＜0.05）. The levels of T-SOD in liver and kidney tissue were all decreased significantly in TWP group and compatibility group， while the levels of MDA were increased significantly （P＜0.05）. The compatibility group showed more obvious effect in improving the ear swelling degree， pathological score， p38 MAPK expression and its phosphorylation level and levels of inflammatory indexes， and could reverse the abnormality of liver and kidney indexes caused by TWP （P＜0.05）.CONCLUSIONSThe combination of TGP and TWP has the effects of anti-inflammatory， synergistic and hepatorenal detoxification in eczema model rats. Its mechanism may be associated with down-regulating the expression of serum proinflammatory indexes and inhibiting the activation of p38 MAPK pathway.关键词：Tripterygium wilfordii polyglycoside;eczema;enhancing efficacy and reducing toxicity;p38 MAPK pathway;rat
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发布时间：2023-02-24 - 摘要：Cancer is one of the major fatal diseases that seriously threaten human health， and its burden needs to be solved urgently. Health technology assessment （HTA） can provide scientific evidence-based basis for cancer diagnosis， treatment， prevention and related policy formulation. Cost-utility analysis is the gold standard for economic evaluation in HTA， and the accurate measurement of its health utility is one of the key elements to determine the accuracy of its results. This article focuses on systematic introduction of direct measures， multi-attribute health utility scales， and mapping methods in the field of cancer measurement and reviews their applications in cancer patients. Among them， direct measures are complex， costly， and require a high level of subject knowledge； multi-attribute health utility measures are currently the preferred method for measuring health utility in cancer patients； with the continuous development and refinement of disease-specific utility measures in multi-attribute health utility instruments， the mapping method may gradually decrease in future applications. This paper can provide a reference for the selection of health utility measurement tools for HTA in the field of cancer， and provide evidence-based basis for optimizing resource allocation and policy formulation in the field of cancer.关键词：health utility;measurement method;health technology assessment;cost-utility analysis
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发布时间：2023-02-24 - 摘要：OBJECTIVETo compare the effects of individualized parenteral nutrition versus pre-mixed parenteral nutrition on liver function of patients with acute kidney injury （AKI）.METHODSTotally 97 AKI patients in the intensive care unit of our hospital from January 2021 to March 2022 were collected and randomly divided into pre-mixed multi-chamber bag （MCB） group （48 cases） and compounded parenteral nutrition （COM） group （49 cases）. The patients in both groups were given routine treatment to correct the reversible cause in time， and parenteral nutrition support treatment was started within 48 hours after the fluid resuscitation was successful or the hemodynamics of low-dose vasoactive drugs were stable. MCB group was given one bag of Fat emulsion amino acid （17） glucose （11%） injection， intravenous infusion， once a day； COM group was given Medium/long chain Fat emulsion injection （C8-24Ve） 0.5-0.8 g/kg+Compound amino acid 18AA-Ⅶ 1.0-1.2 g/kg+Glucose injection 1.5-2.5 g/kg+one Water soluble vitamin injection+Fat-soluble vitamin injection （Ⅱ） 10 mL+Multiple trace element injection （Ⅱ） 10 mL+individualized supplement of sodium chloride and potassium chloride， with a ratio of glucose to lipid of 5∶5 and a ratio of heat to nitrogen of 100∶1. The treatment course of both groups lasted for 7 days. The percentage of abnormal liver function， the levels of liver function indexes [alanine aminotransferase （ALT）， total bilirubin （TBIL）， aspartate transaminase （AST）]， albumin （ALB）， interleukin-6 （IL-6） and C-reactive protein （CRP） were observed in 2 groups before and after treatment.RESULTSAfter treatment， the ratio of liver dysfunction， the levels of ALT， AST and CRP in MCB group were significantly higher than before treatment； the ratio of liver dysfunction， the levels of ALT and CRP in MCB group were significantly higher than COM group （P＜0.05）. There were no statistical significance in the ratio of liver dysfunction， the levels of ALT， AST， TBIL and CRP in COM group before and after treatment （P＞0.05）.CONCLUSIONSIndividualized parenteral nutrition support treatment can reduce the occurrence of liver injury and improve the nutritional status of AKI patients.关键词：liver injury;individualized parenteral nutrition;liver function
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发布时间：2023-02-24 - 摘要：OBJECTIVETo analyze the efficacy and safety of polymyxin B in the treatment of carbapenem-resistant Klebsiella pneumoniae （CRKP）-bloodstream infection （BSI） in patients with hematologic malignancies.METHODSThe medical records of patients with hematologic malignancies with CRKP-BSI who received polymyxin B for at least 3 days in our hospital from September 2019 to June 2021 were retrospectively analyzed. All patients were initially treated with a triple therapy namely polymyxin B+tigecycline+carbapenems for anti-infection therapy.RESULTSA total of 10 patients were enrolled as the study subjects. Eleven strains of CRKP were cultured in blood， including 10 strains of CRKP produced Klebsiella pneumoniae carbapenemase（KPC） and 1 strain of CRKP produced both KPC and metal-beta-lactamase； 9 strains were sensitive to colistin， 7 strains were sensitive to tigecycline， 5 strains were sensitive to amikacin and 2 strains were sensitive to compound sulfamethoxazole. All patients were accompanied by neutropenia， with an average duration of （14.1±6.4） days. They were all characterized by fever， chills and fatigue. After treatment， 6 patients were cured and discharged， 4 patients died of ineffective treatment of septic shock. No serious adverse events related to polymyxin B occurred in all patients.CONCLUSIONSPolymyxin B can be used as a therapeutic drug for CRKP-BSI in patients with hematological malignancies. No serious adverse event related to polymyxin B occurs during the treatment.关键词：carbapenem-resistant Klebsiella pneumoniae;hematologic malignancy;bloodstream infection;therapeutic efficacy;safety
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发布时间：2023-02-24 - 摘要：OBJECTIVETo analyze the influencing factors for the metabolism of voriconazole in adult patients， and to provide reference for the rational use of voriconazole in clinic.METHODSThe clinical data of adult patients admitted in our hospital receiving voriconazole and therapeutic drug monitoring from April 2021 to March 2022 were collected. The trough concentration of voriconazole （c0） and plasma concentration of voriconazole-N-oxide concentration （cN） were determined， and voriconazole-to-voriconazole N-oxide concentration ratio （c0/cN） was calculated. Pearson’s correlation analysis was used to analyze the influencing factors for c0 and c0/cN of voriconazole. Multiple linear regression models were used to analyze the independent influencing factors for c0 and c0/cN of voriconazole.RESULTSThe underlying diseases of the patients were mainly pneumonia， kidney disease and leukemia. The detected fungi were mainly Aspergillus， Candida and yeast-like fungi. Voriconazole was mainly administered by intravenous drip， especially in patients who used proton pump inhibitor in combination. The levels of C-reactive protein （CRP）， total bilirubin （TBIL）， direct bilirubin （DBIL） and indirect bilirubin （IBIL） were positively correlated with c0 of voriconazole， while platelet count and albumin levels were negatively correlated with voriconazole c0. The levels of CRP， TBIL and DBIL were positively correlated with c0/cN， while albumin levels were negatively correlated with c0/cN. Multiple linear regression analysis showed that the independent influencing factors of voriconazole c0 included the levels of CRP and IBIL， route of administration and dose of voriconazole， and the independent influencing factors of voriconazole c0/cN were the levels of CRP and DBIL and age.CONCLUSIONSThe levels of CRP and IBIL， route of administration and dose of voriconazole are independent influencing factors of voriconazole c0； the levels of CRP and DBIL and age are independent influencing factors of voriconazole c0/cN. The influence of above indexes on the metabolism of voriconazole should be considered when using voriconazole clinically； and the route of administration and dose of voriconazole should be adjusted reasonably.关键词：voriconazole-N-oxide;therapeutic drug monitoring;trough concentration;influencing factor;correlation
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发布时间：2023-02-24 - 摘要：OBJECTIVETo investigate the efficacy of Methotrexate （MTX） injection combined with Mifepristone tablets in the treatment of ectopic pregnancy.METHODSA retrospective cohort study method was used to collect data on patients with ectopic pregnancy who visited the Affiliated Hospital of Chengdu University from January 1， 2013 to December 31， 2021. Control group was given MTX injection alone， and exposure group was given MTX injection combined with Mifepristone tablets. Baseline variables were balanced between the two groups using a propensity score matching （PSM）， and the outcomes of the matched cohorts were compared.RESULTSA total of 125 patients were included， involving 68 in the control group and 57 in the exposure group. After PSM， 46 cases in each group were successfully matched. There was no significant difference in the treatment response rate and the incidence of adverse drug reaction （ADR） between the exposure group and the control group， which were 73.91% and 63.04%， 21.74% and 13.04% （P＞0.05）. Compared with before treatment， serum levels of β-HCG were all significantly decreased in 2 groups after treatment （P＜0.05）； there was no significant difference in the serum level of β-HCG after treatment， the time to return to normal， the interval time of second pregnancy， second ectopic pregnancy and second intrauterine pregnancy between 2 groups （P＞0.05）. The mean diameter difference of B-ultrasound pregnancy mass before and after treatment， duration of clinical symptom remission and length of hospital stay in the exposure group were significantly higher than those in the control group （P＜0.05）， but drug costs during hospitalization and total hospitalization costs were not significantly increased （P＞0.05）. There were no significant difference between single-dose group and multi-dose group of MTX in the treatment response rate and the incidence of ADR （P＞0.05）. The hospitalization time， drug cost and total cost of the single dose group were significantly less than those of the multi-dose group （P＜0.05）.CONCLUSIONSMTX injection combined with or without Mifepristone tablet can both effectively treat ectopic pregnancy， with comparable efficacy and safety. MTX single-dose regimen is similar to the multi-dose regimen in efficacy， but the multi-dose regimen increases the hospital stay and hospitalization costs.关键词：mifepristone;propensity score matching;ectopic pregnancy;second pregnancy;efficacy;economy
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发布时间：2023-02-24 - 摘要：OBJECTIVETo compare the efficacy and safety of parecoxib and ketorolac tromethamine for perioperative analgesia， and to provide evidence-based reference for clinical drug use.METHODSRetrieved from PubMed， Embase， the Cochrane Library， CNKI， VIP， Wanfang Data， Baidu and Google， randomized controlled trials （RCT） about parecoxib （trial group） versus ketorolac tromethamine （control group） for perioperative analgesia were collected from the inception to Jun. 17th， 2022. After screening the literature and extracting the data， the quality of the included literature was evaluated using the bias risk assessment tool recommended by Cochrane system evaluator manual 5.1.0. Meta-analysis， sensitivity analysis and publication bias analysis were performed with RevMan 5.4 software.RESULTSA total of 12 RCTs were included， with 1 118 patients. Meta-analysis results showed that at the time of administration before anesthesia induction， there was no statistically significant difference between the 2 groups in visual analogue scale （VAS） [MD＝－0.16， 95%CI （－0.41， 0.09）， P＝0.20]， numerical rating scale （NRS） [MD＝0.01， 95%CI （－0.36， 0.38）， P＝0.97]， postoperative bleeding [MD＝0.15， 95%CI （－0.63， 0.93）， P＝0.71]， and consumption of opioid analgesics [MD＝0.12， 95%CI （－0.77， 1.01）， P＝0.79]. At the time of postoperative administration， VAS and bleeding volume at 48 h after operation of trial group were significantly lower than control group （P＜0.05）. The results of subgroup analysis by different assessment time points showed that the VAS of patients in trial group at 0 h after operation were significantly lower than control group at the time of administration before anesthesia induction； at the time of postoperative administration， VAS of patients in the trial group at 12 h and 48 h after operation were significantly lower than control group （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups [RR＝0.93，95%CI（0.78，1.11），P＝0.43]. The results of subgroup analysis according to different types of adverse reactions showed that the incidence of nausea and vomiting of trial group was significantly lower than control group， and the incidence of other adverse reactions was significantly higher than control group （P＜0.05）. Results of sensitivity analysis showed that study results were stable and reliable. Results of publication bias analysis showed that there was great possibility of publication bias in this study.CONCLUSIONSThe efficacy of parecoxib is equivalent to that of ketorolac tromethamine for perioperative analgesia before operation； at the time of administration after operation， parecoxib has better analgesic effect and less postoperative bleeding； the incidence of nausea and vomiting caused by parecoxib is lower at any time of administration.关键词：ketorolac tromethamine;perioperative period;analgesia;efficacy;safety
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发布时间：2023-02-24 - 摘要：OBJECTIVETo systematically evaluate the efficacy and safety of immune checkpoint inhibitors （ICIs） in the treatment of metastatic colorectal cancer （mCRC）， so as to provide evidence-based reference for clinical practice.METHODSPubMed， the Cochrane Library， Web of Science， Embase， CNKI， Wanfang and VIP databases were searched to collect randomized controlled trials （RCT） of ICIs （trial group） versus traditional chemotherapy or optimal supportive treatment （control group） in the treatment of mCRC from the establishment of the database to June 1， 2022. After literature screening and data extraction， Cochrane Systematic Review Manual 5.1.0 was used to evaluate the quality of the included literature， and RevMan 5.4 software was used for meta-analysis and sensitivity analysis.RESULTSA total of 4 RCTs were included， involving 833 patients. Meta-analysis showed that the overall survival （OS） [HR＝0.77， 95%CI （0.64， 0.94）， P＝0.01] and progression-free survival （PFS） [HR＝0.67， 95%CI （0.57， 0.79）， P＜0.000 01] were significantly higher in trial group than control group； the difference was not statistically significant when comparing the incidence of grade 3 and above adverse events in the two groups [RR＝1.22， 95%CI （0.77， 1.94）， P＝0.39]. Subgroup analysis by mutation pattern showed that patients with mismatch repair proficiency and low levels of microsatellite instability （pMMR-MSS） mCRC patients in trial group had significantly higher PFS than control group （P＜0.05）. The results of sensitivity analysis showed that the results were robust.CONCLUSIONSCompared with traditional chemotherapy or optimal supportive treatment， ICIs can prolong the OS and PFS of mCRC patients， and maybe has more advantages in pMMR-MSS mCRC patients； the safety of ICIs is equivalent to that of traditional chemotherapy or optimal supportive treatment.关键词：metastatic colorectal cancer;meta-analysis;efficacy;safety
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发布时间：2023-02-24 - 摘要：OBJECTIVETo make up the research gap of the concept of collaboration between clinical pharmacists and physicians in China， and to provide a theoretical basis for further improving the collaboration.METHODSLiterature analysis was used to sort out the existing concepts of collaboration. Combined with the current practice and development trend of the collaboration between clinical pharmacists and physicians in China， the basic elements of the concept were deconstructed and the connotation of each component of the concept was explained in detail. RESULTS &CONCLUSIONSBased on the above theoretical research and practical analysis， the concept of collaboration between clinical pharmacists and physicians in the context of China was defined， that is， clinical pharmacists and physicians adhere to the patient-centered and rational drug use as the core in clinical drug therapy， and make joint decisions on drug management and drug therapy on the basis of communication， respect， trust and sharing， so as to ensure the effectiveness， safety and economy of clinical pharmaceutical care， and improve the coordination and cooperation process of comprehensive disease treatment system.关键词：collaboration between clinical pharmacists and physicians;multi-disciplinary collaboration;concept definition
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发布时间：2023-02-24 - 摘要：OBJECTIVETo establish the path-based management mode of 5-hydroxytryptamine-3 receptor antagonist （5-HT3RA） in chemotherapy patients， and to improve the rationality of medication in chemotherapy patients.METHODS5-HT3RA standardized drug use control rules were formulated， with the help of medical intelligence and decision support （MINDS） system， path-based management was carried out for chemotherapy patients using 5-HT3RA in the form of whole-process information capture and prescription pre-review， and whole-process intervention was implemented on medication indications， usage and dosage， course of treatment， etc. The intervention effect was analyzed by comparing the changes in the use of 5-HT3RA without indication， unreasonable usage and dosage， repeated medication， unreasonable course of treatment， and per capita drug cost before and after the implementation of path-based management.RESULTSA total of 9 181 patients were included. After the implementation of path-based management， the proportion of unindicated drugs decreased by 0.48%， and the rate of unreasonable single dosage， unreasonable frequency， repeated medication， unreasonable treatment course （5-HT3RA still used 3 days after chemotherapy） decreased by 10.48%， 0.65%， 1.33% and 0.34%； per capita cost of 5-HT3RA decreased by 13.72 yuan； there were statistical significance （P＜0.05）.CONCLUSIONS5-HT3RA path-based management mode effectively improves the rationality of medication and provides a new idea for rational clinical drug use.关键词：chemotherapy patients;path-based management;informatization
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发布时间：2023-02-24 - 摘要：Acute ischemic stroke is a cerebrovascular disease with high incidence， high mortality and disability， and high recurrence rate， which seriously endangers patients’ health. Thrombolytic drugs play a key role in the treatment of acute ischemic stroke by activating plasminogen， rapidly dissolving thrombi， reducing platelet aggregation， and achieving successful recanalization. In this study， we reviewed the principle of action of thrombolytic drugs， their classification and use on the basis of current research progress at home and abroad. The results show that the safety and efficacy of thrombolytic drugs have improved significantly from the first generation of thrombolytic drugs， streptokinase， which is not fibrin-specific， to the third generation of thrombolytic drugs， tenecteplase， which not only retain the characteristics of directly activating plasminogen， but also enhance the specificity of fibrin and prolong the half-life. With the development of research， small-molecular compounds with the inhibition of plasminogen activator， or the modification of thrombolytic drugs with strong anti-plasminogen activator inhibition activity in vivo， or the search for new small-molecular substances with thrombolytic effect from microorganisms and natural plants， have become the focus of research on new thrombolytic drugs. The new thrombolytic drugs are likely to replace the current thrombolytic drugs because of greater thrombolytic efficacy and fewer side effects.关键词：acute ischemic stroke;thrombolytic drug;plasminogen activator
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发布时间：2023-02-24 - 摘要：The traditional model Franz diffusion cell method has always been the “gold standard” for evaluating the permeability of transdermal drug delivery system （TDDS） drug. However， in the high throughput screening of a large number of drug molecules， it has the disadvantages of low efficiency， high cost， difficulty to obtain isolated skin，poor reliability and large workload. The emergence of parallel artificial membrane permeation assay （PAMPA） model provides reliable pre-prediction data for the evaluation of permeability of TDDS drug. PAMPA model has been widely used in the permeability screening research of TDDS drugs and their preparations such as analgesics， local anesthetics， antioxidants， antipyretics， analgesics and anti-inflammatory drugs， vitamins， cholinesterase inhibitors， active ingredients of natural products， and has the characteristics of high reliability， good selectivity， high efficiency， low cost and data stability. PAMPA model has greatly improved the high throughput screening efficiency of TDDS drug permeability. With the extensive application and gradual maturity of this model， it will become a new and effective evaluation method in addition to the traditional evaluation model.关键词：parallel artificial membrane permeation assay;drug penetration screening
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发布时间：2023-02-24 - 摘要：With the advantage of high efficiency， low toxicity and targeting， liposomes have become the research hotspot of new drug preparations at home and abroad. In this paper， the research progress in recent years is reviewed from the aspects of preparation methods， classification and clinical application of liposomes. The results showed that in order to obtain more stable and controllable liposomes， scholars improved and optimized the traditional preparation methods and established novel preparation methods such as supercritical fluid methods， freeze-drying method and double-asymmetric centrifugation method. In order to enhance the efficacy and reduce toxicity， the conventional liposomes were optimized to get novel ones such as environmentally sensitive liposomes， long-circulating liposomes and multifunctional liposomes， which had greatly promoted the clinical application of liposomes. For now， liposomes have been used in many fields， such as anti-cancer agents， antimicrobial and vaccines， but most of the new liposomes are still in the early stage of development.关键词：drug delivery system;anti-cancer;antimicrobial;vaccine
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发布时间：2023-02-24
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