最新刊期
      卷 35 ， 期 16 ， 2024
      • SONG Zaiwei,HU Yang,YU Lingling,ZHU Jun,ZHANG Lingli,ZHANG Yu,MIAO Liyan,ZHAI Suodi,ZHAO Rongsheng
        Vol. 35, Issue 16, Pages: 1933-1945(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.01
        摘要：OBJECTIVETo provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment.METHODSThe design， planning， and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） followed the WHO Handbook for Guideline Development （2nd edition）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations.RESULTS&CONCLUSIONSEvidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.  
        关键词：clinical application;guideline;evidence-based medicine;patient willingness   
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        发布时间：2024-08-23
      • ZHOU Pengxiang,LIU Xiaoxia,LI Xiaofei,XING Xiaomin,TAN Sitao,ZHAO Rongsheng
        Vol. 35, Issue 16, Pages: 1946-1950(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.02
        摘要：OBJECTIVETo systematically summarize the working model of pharmacy consultation in medical institutions in China， and to provide reference for the normalization of process， standardization of content and homogenization of services of pharmacy consultation.METHODSA systematic search of Chinese and English literature databases was conducted to incorporate the literature on the working model of pharmacy consultation published by medical institutions in China. Two researchers screened and extracted the key information， and ultimately conducted qualitative summary and descriptive analysis.RESULTSBased on the included 11 articles， the pharmacy consultation working models were explored by clinical pharmacists in China. The contents of consultation mainly involved anti-infection， parenteral nutrition， cancer pain， etc. The general concept of pharmacy consultation should refer to the constructed flowchart， specific consultation problems could refer to the pathway， mind map， or decision tree and other framework guidance to carry out the work. Finally， consultation opinions could be written according to the consultation system or specialty consultation templates， and the adoption of a new working model （such as pharmacist active consultation） could also promote the number and acceptance rate of pharmacy consultation.CONCLUSIONSA series of working models of pharmacy consultation have been initially explored in medical institutions in China. However， it is not yet perfect and lacks a unified quality control and evaluation system for pharmacy consultation， which should be the focus of future research and practice.  
        关键词：pharmaceutical care;clinical pharmacist;working model;medical institution   
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        发布时间：2024-08-23
      • CHEN Wenting,CHEN Shiyi,LI Yanan,FENG Yi,LUO Shuping,ZHANG Yuqin
        Vol. 35, Issue 16, Pages: 1951-1956(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.03
        摘要：OBJECTIVETo investigate the effect mechanism of Gualou guizhi granule on neurological function and synaptic plasticity in rats with cerebral ischemia-reperfusion injury.METHODSThe rats were randomly divided into sham operation group， model group and Gualou guizhi granule group （3.6 g/kg）， with 6 rats in each group. The cerebral ischemia-reperfusion injury model was established by the suture occlusion method. Two hours after modeling， the model rats were given relevant medicine or normal saline intragastrically， once a day， for 7 consecutive days. After the last medication， the neurological function of rats was evaluated [calculated by modified neurological severity scores （mNSS） and corner turning percentage]； the neuronal apoptosis rate of brain histiocyte in the ischemic side of rats was detected in each group； the positive expressions of growth associated protein 43 （GAP43） and microtubule associated protein 2 （MAP2） were detected； protein expressions of neuron-specific nuclear protein （NeuN）， synaptophysin-1 （Syn-1）， postsynaptic density protein-95 （PSD-95）， peroxisome proliferators-activated receptor γ （PPARγ）， brain-derived neurotrophic factor （BDNF） and tropomyosin receptor kinase B （TrkB）， as well as mRNA expressions of NeuN， Syn-1 and PSD-95 were detected.RESULTSCompared with the model group， mNSS， corner turning percentage and neuronal apoptotic rate were decreased significantly in Gualou guizhi granule group （P＜0.01）； GAP43 represented weak immunoreactivity， and MAP2 represented moderate immunoreactivity； protein expressions of NeuN， Syn-1， PSD-95， PPARγ， BDNF， TrkB and mRNA expressions of Syn-1， NeuN， PSD-95 were all increased significantly （P＜0.05 or P＜0.01）.CONCLUSIONSGualou guizhi granule can promote synaptic plasticity by activating BDNF/TrkB signaling pathway， thus playing a protective role in cerebral ischemia-reperfusion injury in rats.  
        关键词：cerebral ischemia-reperfusion injury;synaptic plasticity;BDNF   
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        发布时间：2024-08-23
      • REN Shasha,HU Jianchun,ZHANG Yuanxian,CHEN Qingqing,LIU Chunhua,ZHENG Lin,GONG Zipeng,HUANG Yong,JIN Yang,LI Yueting
        Vol. 35, Issue 16, Pages: 1957-1963(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.04
        摘要：OBJECTIVETo screen the potential active components of Polygonum orientale flower against myocardial ischemia-reperfusion injury （MIRI） in rats based on physiological and pathological states.METHODSSD rats were divided into normal control group， normal administration group， MIRI control group and MIRI administration group， with 5 rats in each group. After drug intervention or modeling and drug intervention， chromatographic separation plasma samples were collected， and chromatographic separation and mass spectrometry data collection were performed by using UPLC-Q-TOF/MS. The prototype components and metabolites were analyzed by comparing the reference substance maps， the maps of each plasma sample， and the relevant literature. At the same time， the common peaks in plasma samples of rats in normal administration group and MIRI administration group were identified. Combined with principal component analysis and orthogonal partial least square-discriminant analysis， the differential transitional components were screened out according to the value of variable importance in the projection （VIP）＞1， to speculate the potential active components of P. orientale flower in rats under physiological and pathological states. The SD rats were divided into control group， MIRI group， positive control group （Compound danshen tablets 0.2 g/kg， 3 times a day）， and potentially active compound groups （10 mg/kg， twice a day）， with 5 rats in each group. The rats in administration groups were given relevant medicine intragastrically， for 3 consecutive days. The activity of superoxide dismutase （SOD）， the leakages of lactate dehydrogenase （LDH）， creatine kinase isoenzyme-MB （CK-MB） and cardiac troponin Ⅰ （cTnⅠ） in plasma were detected after the last administration.RESULTSTwenty-six main chromatographic peaks were obtained from the total ion chromatogram of the extract of P. orientale flower， and 14 of them were determined， including gallic acid， catechin， protocatechuic acid and so on. There were fifteen （including 6 absorbed prototype components and 9 metabolites） and nineteen transitional components （including 6 absorbed prototype components and 13 metabolites） in the plasma sample of normal rats and MIRI rats. Eight transitional components were detected in both normal rats and MIRI rats， and the VIP values of kaempferol glucuronidation metabolites， quercetin carbonylation metabolites and N-p-paprazine to the corresponding peak were higher than 1. Compared with MIRI group， the activities of SOD were increased significantly in the plasma of MIRI rats in each potential active compound group （P＜0.01）， and the leakages of LDH， CK-MB， and cTnⅠ in the plasma of MIRI rats were reduced significantly （P＜0.01）.CONCLUSIONSThe potential anti-MIRI active components in extract of P. orientale flower are N-p-paprazine， quercetin， kaempferol and kaempferol-3-O-β-D-glucoside.  
        关键词：myocardial ischemia-reperfusion injury;active ingredients;plasma pharmacochemistry   
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        发布时间：2024-08-23
      • XIE Youyin,WANG Rongjin,SHAO Lilin,LIU Guantong,ZHANG Leifang
        Vol. 35, Issue 16, Pages: 1964-1971(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.05
        摘要：OBJECTIVETo prepare C-phycocyanin nanoparticles （CPC-NPs） and evaluate the in vitro mechanism of CPC-NPs on acute lung injury induced by lipopolysaccharide （LPS） combined with seawater.METHODSIon crosslinking method was used to prepare CPC-NPs using CPC as the drug， carboxymethyl chitosan （CMCS） as the carrier， and CaCl2 as the crosslinking agent. The basic characterization of CPC-NPs was carried out. Mouse alveolar type Ⅱ epithelial cells MLE-12 and macrophages RAW264.7 were divided into 7 groups： normal group （Con group）， model group （Mod group）， blank NPs group， CPC-NPs 30， 60， 120 and 240 μg/mL groups. Except for the Con group， all other groups were treated with a combination of 10 μg/mL LPS and 25% seawater for 6 hours. After modeling， each treatment group was treated with corresponding drugs for 24 hours. The levels of malondialdehyde （MDA）， total antioxidant capacity （T-AOC）， superoxide dismutase （SOD）， catalase （CAT）， and glutathione peroxidase （GSH-Px） in MLE-12 cells， as well as the expression levels of B-cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）， caspase-3 protein and mRNA， CAT and glutathione S-transferase （GST） mRNA were determined. The levels of interleukin-1β （IL-1β）， tumor necrosis factor-α （TNF-α） and IL-6 in RAW264.7 cells， as well as the expression levels of NOD-like receptor thermal protein domain associated protein 3 （NLRP3）， cleaved caspase-1 protein， and mRNA expressions of IL-1β， TNF-α， IL-6 and inducible nitric oxide synthase （iNOS） were all detected.RESULTSThe prepared CPC-NPs had particle size of （675.69±64.58） nm， Zeta potential of （－20.11±0.98） mV， polydispersity coefficient of 0.455±0.010 （n＝3）； entrapment efficiency of 35.60%， and drug loading of 16.13%；CPC-NPs had regular spherical shapes， where the drug could be sustainably released for more than 30 hours. Compared with Mod group， the levels of T-AOC， SOD， CAT （excluding the 30 μg/mL group of CPC-NPs） and GSH-Px， mRNA expressions of CAT and GST， as well as the Bcl-2/Bax protein ratio and mRNA ratio were significantly increased in MLE-12 cells of different concentration groups of CPC-NPs， while MDA levels and caspase-3 protein and mRNA expression were significantly reduced （P＜0.01 or P＜0.05）. Compared with Mod group， the levels of IL-1β， TNF-α and IL-6， NLRP3 and cleaved-caspase-1 protein expressions， as well as the mRNA expressions of IL-1β， TNF-α， IL-6 and iNOS in RAW264.7 cells of different concentration groups of CPC-NPs were significantly reduced （P＜0.01 or P＜0.05）.CONCLUSIONSCPC-NPs with lung targeting and sustained release property were prepared successfully， which can alleviate acute lung injury induced by LPS combined with seawater through antioxidant stress， inhibiting cell apoptosis and inflammatory response.  
        关键词：nanospheres;acute lung injury;oxidative stress;apoptosis;inflammatory response;seawater;lipopolysaccharide   
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        发布时间：2024-08-23
      • ZHOU Zhihong,HU Qin,XIAO Mingming
        Vol. 35, Issue 16, Pages: 1972-1978(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.06
        摘要：OBJECTIVETo optimize the ultrasound-assisted extraction-deep eutectic solvents technology of total flavonoids from Hypericum japonicum， evaluate its hypoglycemic activity in vitro， and analyze its chemical compositions preliminarily.METHODSThe most suitable deep eutectic solvent for total flavonoids from H. japonicum was screened using the composition of hydrogen bond acceptor and donor， molar ratio， water content as factors， and the total flavonoid yield as the response value. Using liquid-solid ratio， ultrasonic power， ultrasonic temperature and ultrasonic time as factors， the yield of total flavonoids as response value， the extraction technology of total flavonoids from H. japonicum was optimized by single-factor experiments combined with Box-Behnken response surface method， and the optimum extraction technology was validated. Taking acarbose as the positive control， the inhibitory activities of total flavonoids from H. japonicum on α-amylase and α-glucosidase in vitro were determined. The chemical constituents of total flavonoids from H. japonicum were analyzed by UPLC combined with comparing the reference substances.RESULTSThe most suitable deep eutectic solvent was choline chloride-oxalic acid （the molar ratio of 1∶1， the water content of 30%）. The optimum extraction technology was as follows： the ratio of liquid-solid was 52∶1 （mL/g）， the ultrasonic temperature was 54 ℃， the ultrasonic power was 240 W， and the ultrasonic time was 42 min； the total extraction yield of total flavonoids from H. japonicum in 3 validation tests was （73.26±2.48） mg/g， the relative error of which with the theoretical value （73.48 mg/g） was －0.30%. The total flavonoids from H. japonicum could inhibit α-amylase and α-glucosidase with IC50 values of 0.73 and 0.44 mg/mL， respectively， which were higher than those of acarbose （0.23 and 0.15 mg/mL）. UPLC analysis showed that the total flavonoids from H. japonicum contained isoquercetin， quercitrin， quercetin-7-O-α-L-rhamnoside and quercetin.CONCLUSIONSThe optimized extraction technology of total flavonoids from H. japonicum is stable and feasible， and the extract has certain hypoglycemic activity in vitro and contains isoquercetin， quercitrin and quercetin-7-O-α-L-rhamnoside， etc.  
        关键词：ultrasound-assisted extraction;deep eutectic solvents;response surface method;hypoglycemic activity;component analysis   
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        发布时间：2024-08-23
      • ZHANG Li,XIN Xiaobing,HU Huanhuan,LI Xiaolin,DONG Hongxiao,JIANG Xiangju
        Vol. 35, Issue 16, Pages: 1979-1984(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.07
        摘要：OBJECTIVETo explore the effects of the water extract of Morinda officinalis on the expressions of sex hormones and receptors in bisphenol A （BPA）-contaminated mice.METHODSTotally 60 male Kunming mice were randomly divided into control group， model group， and low-dose， medium-dose and high-dose groups of M. officinalis water extract （20， 40， 60 mg/kg）， with 12 mice in each group. The model group and M. officinalis water extract groups were given BPA intragastrically [50 mg/（kg·d）， once a day， for 4 consecutive weeks] to establish the BPA-contamination model of mice. After modeling， each drug group was gavaged with the corresponding drug solution， once a day， for 4 consecutive weeks. After the last medication， the body weight and testicular weight of the mice in each group were weighed， the histopathological changes in the testis were observed， and the serum sex hormones [luteinizing hormone （LH）， follicle-stimulating hormone （FSH）] contents and the mRNA and protein expressions of LH receptor （LHR） and FSH receptor （FSHR） in the testicular tissues were detected.RESULTSCompared with the control group， the testicular tissues of mice in the model group had structural degeneration， loose connections between spermatogenic cells and Sertoli cells， obvious lacunae and reduced number of spermatogenic cells； the mRNA and protein expressions of LHR and FSHR in testicular tissues were significantly down-regulated （P＜0.01）， but there were no significant changes in their body weights， testicular weights， and serum contents of LH and FSH （P＞0.05）. Compared with the model group， the histopathological changes of testicular tissues of mice in each dose group of M. officinalis water extract were improved to different degrees， and the mRNA and protein expressions of LHR and FSHR in testicular tissues were up-regulated to different degrees （P＜0.05 or P＜0.01）， and some indicator levels were similar to those of the control group （P＞0.05）. However， there were no significant changes in their body weights， testicular weights， and serum contents of LH and FSH （P＞0.05）.CONCLUSIONSThe water extract of M. officinalis has a certain improvement effect on testicular injury in BPA-contaminated mice， which might be related to its increase in the mRNA and protein expressions of LHR and FSHR.  
        关键词：water extract;bisphenol A;sex hormone;sex hormone receptor;testis   
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        发布时间：2024-08-23
      • ZHANG Ran,YANG Kun,ZENG Zhenjun,LI Sujuan,LIU Jie
        Vol. 35, Issue 16, Pages: 1985-1990(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.08
        摘要：OBJECTIVETo investigate the effects of Codonopsis pilosula polysaccharide （CPP） regulating the nuclear factor-erythroid 2-related factor 2 （Nrf2）/heme oxygenase-1 （HO-1） signaling pathway on gastric mucosal injury in rats with chronic atrophic gastritis （CAG）.METHODSRats were randomly divided into control group， model group， CPP low-dose， medium-dose and high-dose groups （CPP 10， 20， 40 mg/kg）， and ML385 group （Nrf2 inhibitor ML385 30 mg/kg+CPP 40 mg/kg）， 10 rats per group. CAG rat model was established using N-methyl-N′- nitro-N-nitrosoguanidine combined with irregular diet， then they were given drugs for consecutive 6 weeks. HE staining was used to observe the pathological changes in gastric tissue morphology； the levels of serum gastrin （GAS）， motilin （MTL）， pepsin （PP）， as well as tumor necrosis factor-α （TNF-α）， interleukin-8 （IL-8） malondialdehyde （MDA） and superoxide dismutase （SOD） in gastric mucosal tissue were detected； TUNEL assay was used to observe gastric mucosal tissue cell apoptosis； immunohistochemical assay was adopted to observe the expressions of Nrf2 and recombinant Bcl2 associated X protein （Bax） in gastric mucosal tissue； Western blot was used to detect the expressions of Nrf2， HO-1， Bax and Bcl-2 proteins in gastric mucosal tissue.RESULTSCompared with the control group， the gastric mucosal tissue was damaged； the levels of GAS， MTL， PP and SOD， and the protein expressions of Nrf2， HO-1 and Bcl-2 were significantly reduced in model group （P＜0.05）， while the levels of MDA， TNF-α and IL-8， the cell apoptosis index， and the protein expression of Bax were significantly increased （P＜0.05）. Compared with model group， CPP low-dose， medium-dose and high-dose groups showed varying degrees of improvement in gastric mucosal histopathology； the levels of the quantitative indicators were significantly reversed （P＜0.05）. Nrf2 inhibitor ML385 significantly attenuated the improvement effect of high-dose CPP on the above indicators in CAG rats （P＜0.05）.CONCLUSIONSCPP can improve gastric mucosal injury in CAG rats， and inhibit oxidative stress， inflammatory response， and cell apoptosis. The mechanism of action may be related to the activation of Nrf2/HO-1 signaling pathway.  
        关键词：chronic atrophic gastritis;gastric mucosal injury;Nrf2/HO-1 signaling pathway   
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        发布时间：2024-08-23
      • ZHONG Mingyan,YANG Fan,LI Haizhen,ZHAN Qi,ZHANG Wei
        Vol. 35, Issue 16, Pages: 1991-1997(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.09
        摘要：OBJECTIVETo investigate the effects of brusatol on the malignant biological behavior of ovarian cancer cells by regulating the sphingosine kinase 1 （SPHK1）/sphingosine-1-phosphate （S1P）/sphingosine-1-phosphate receptor 3 （S1PR3） signaling pathway.METHODSHuman ovarian cancer cell strain SKOV-3 were randomly divided into control group， brusatol group， SPHK1 overexpression group， brusatol+blank load group， brusatol+SPHK1 overexpression group. The cell viability， colony formation rate， the number of migration and invasion， apoptosis rate， the expressions of cell proliferation-related proteins [myelocytomatosis viral oncogene homolog （C-myc）]， apoptosis-related proteins [B-cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）]， epithelial mesenchymal transition （EMT）-related proteins （E-cadherin， N-cadherin） and SPHK1， S1P， S1PR3 proteins were all detected in each group. Transplanted tumor model of nude mice was constructed by using SKOV-3 cells and randomly separated into control group， brusatol low-dose， medium-dose and high-dose groups， SPHK1 overexpression group， high-dose brusatol+blank load group， and high-dose brusatol+SPHK1 overexpression group； the growth of transplanted tumors were detected. The nude mice model of SKOV-3 transplantation tumor was randomly divided into control group， brusatol group， SPHK1 overexpression group， brusatol+blank load group， and brusatol+SPHK1 overexpression group； the proliferation and apoptosis of transplanted tumor tissue， the expressions of EMT-related proteins and SPHK1/S1P/S1PR3 signaling pathway proteins were detected in each group.RESULTSCell experiments in vitro had shown that compared with the control group， the cell viability， clone formation rate， migration number， invasion number， protein expressions of C-myc， Bcl-2， N-cadherin， SPHK1， S1P and S1PR3 were decreased significantly in brusatol group （P＜0.05）， while the apoptosis rate， protein expressions of Bax and E-cadherin were increased significantly （P＜0.05）； overexpression of SPHK1 could weaken the effects of brusatol on the above indicators in SKOV-3 cells. Mice experiments in vivo had shown that compared with the control group， the transplanted tumor volumes of nude mice in the brusatol low-dose， medium-dose and high-dose groups were decreased significantly in a dose-dependent manner after 21 days of intervention （P＜0.05）. Brusatol of high dose could also significantly reduce the protein expressions of C-myc， Bcl-2， N-cadherin， SPHK1， S1P and S1PR3 in transplanted tumor tissue of nude mice （P＜0.05）， and significantly increase the protein expressions of Bax and E-cadherin （P＜0.05）； overexpression of SPHK1 could weaken the effects of brusatol on the above indicators in transplanted tumor tissue of nude mice.CONCLUSIONSBrusatol can inhibit the proliferation， cloning， EMT， migration and invasion of ovarian cancer cells， and induce their apoptosis by down-regulating the expression of SPHK1/S1P/S1PR3 signaling pathway. It can also inhibit the growth of ovarian cancer cells in nude mice， ultimately suppressing their malignant biological behavior and exerting significant anti-cancer effects on ovarian cancer.  
        关键词：SPHK1/S1P/S1PR3 signaling pathway;ovarian cancer;malignant biological behavior   
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        发布时间：2024-08-23
      • DAI Xiaoyan,SHEN Wei,ZHANG Yan,ZHAO Yanping
        Vol. 35, Issue 16, Pages: 1998-2001(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.10
        摘要：OBJECTIVETo evaluate the antioxidant activity compounds extracted from the pine needle of Cedrus deodara.METHODSUsing vitamin C （VC） and gallic acid as positive control， HPLC method was employed to determine the changes of the DPPH peak area after antioxidant compounds from pine needle of C. deodara were treated with 1， 1-diphenyl-2-picrylhydrazyl radical （DPPH）. Then， the antioxidant activities of 3 active parts and 8 monomer compositions from pine needle of C. deodara were evaluated by calculating the inhibition rate of DPPH free radicals and the half inhibitory concentration （IC50）. HPLC conditions were using Agilent Eclipse Plus-C18 column （250 mm × 4.6 mm， 5 μm） with acetonitrile-water （62∶38， V/V） as the mobile phase. The detection wavelength was 517 nm； the flow rate was 1.0 mL/min； the column temperature was 25 ℃； the injection volume was 20 μL.RESULTSThe order of DPPH free radical inhibition activity of active parts from pine needle of C. deodara was total flavonoids＞total polyphenols＞total lignans， with IC50 of 76.10， 100.50 and 115.40 μg/mL， respectively. Compared with positive control， except for kaempferol-3-O-β-D-glucoside， the sequence of seven monomer compounds for DPPH free radical inhibition activity was dihydromyricetin＞hypericin＞protocatechuic acid＞gallic acid＞ferulic acid＞myricetin＞kaempferol-3-O-（6″-O-E-feruloyl）-β-D-glucopyranoside＞VC＞isohamnin， with IC50 of 16.50， 19.40， 23.73， 27.24， 32.10， 32.20， 47.60， 93.20 and 297.20 μg/mL， respectively.CONCLUSIONSHPLC-DPPH method is established to evaluate the antioxidant activity of pine needle of C. deodara. The pine needle of C. deodara has strong antioxidant activity， among which the effective compounds of total flavonoids， total polyphenols， monomer dihydromyricetin and hypericin are natural antioxidants with development prospects.  
        关键词：antioxidant activity;effective fraction;chemical constituent;HPLC-DPPH   
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        发布时间：2024-08-23
      • LI Mengyuan,GUAN Xin,JI Xinyue,WANG Yufei,TIAN Lei
        Vol. 35, Issue 16, Pages: 2002-2008(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.11
        摘要：OBJECTIVETo analyze the cost-effectiveness of abemaciclib， palbociclib and ribociclib combined with aromatase inhibitors （AI） in first-line treatment of hormone receptor-positive （HR+） advanced breast cancer from the perspective of Chinese medical system.METHODSThe 20-year disease course of the patients was simulated by the partitioned survival model， and the simulation period was determined to be 4 weeks， the model output was the total cost and quality-adjusted life year （QALY）， the cost and effect were discounted at a discount rate of 5%. A network meta-analysis was constructed by systematically searching relevant clinical trials to obtain the efficacy parameters of abemaciclib， palbociclib and ribociclib combined with AI. Survival fitting and extrapolation were performed based on the survival curve of the placebo group in MONALEESA-2 trial. Cost-effectiveness was assessed by incremental cost-effectiveness ratio （ICER） and incremental net monetary benefit （INMB）， with a willingness-to-pay threshold of 3 times China’s per capita gross domestic product （GDP） in 2023； one-way sensitivity analysis and probability sensitivity analysis were used to detect the influence of parameters on the results and the robustness of the incremental analysis results.RESULTSIn the 20-year simulation， compared with palbociclib+AI scheme， the ICER of ribociclib+AI scheme was 58 558.38 yuan/QALY and the INMB was 62 988.20 yuan. Compared with ribociclib+AI scheme， the ICER of abemaciclib+AI scheme was 264 928.34 yuan/QALY and the INMB was 344.84 yuan. One-way sensitivity analysis showed that the incremental analysis results of abemaciclib+AI scheme compared to ribociclib+AI scheme were not robust. Probabilistic sensitivity analysis confirmed that the probability of ribociclib+AI scheme becoming the most economical was the highest when the threshold was 1-3 times China’s per capita GDP in 2023.CONCLUSIONSRibociclib+AI scheme is more likely to be the most economical first-line treatment than abemaciclib+AI scheme and palbociclib+AI scheme in Chinese patients with HR+ advanced breast cancer when threshold is 1-3 times China’s per capita GDP in 2023.  
        关键词：hormone receptor-positive;abemaciclib;palbociclib;ribociclib;partitioned survival model;cost-utility analysis;incremental net monetary benefit   
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        发布时间：2024-08-23
      • ZHANG Yingying,ZHANG Yile,SHI Hao,BU Zhiqin,YANG Li,MENG Yanlei,GUO Yihong
        Vol. 35, Issue 16, Pages: 2009-2012(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.12
        摘要：OBJECTIVETo observe the efficacy of cetrorelix combined with aspirin in preventing early-onset ovarian hyperstimulation syndrome （OHSS）.METHODSA retrospective analysis was conducted on clinical data from 38 early-onset OHSS patients， who received treatment in our hospital from January 1st to July 1st， 2022. These patients were divided into intervention group （19 cases） and control group （19 cases） according to the therapy regimen. On the first day after oocyte retrieval surgery， the control group was given aspirin enteric-coated tablets 100 mg orally until menstruation began. The intervention group was given cetrorelix for injection 0.25 mg subcutaneously， for consecutive 3 days+aspirin enteric-coated tablets （same usage and dosage as the control group）. The first luteal phase， the degree of OHSS， and the ovarian volume， ascites volume， serum estradiol （E2）， white blood cell count （WBC）， hematocrit （HCT）， neutrophil ratio （NEUT%）， D-dimer （DD）， prothrombin time （PT）， fibrinogen （Fib） after oocyte retrieval surgery were observed and measured in 2 groups.RESULTSThe first luteal phase was significantly shorter， and the proportions of median and severe OHSS cases were significantly lower in the intervention group compared to the control group （P＜0.05 or P＜0.01）. After oocyte retrieval surgery， the intervention group showed significantly lower ovarian volume， ascites volume， serum E2， WBC， NEUT%， HCT， DD and Fib compared to the control group， but PT of intervention group was signiticantly higher than that of control group （P＜0.05）.CONCLUSIONSCetrorelix combined with aspirin is more effective in preventing early-onset OHSS than aspirin alone.  
        关键词：cetrorelix;aspirin;long-lasting follicular phase protocol;ovulation induction   
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        发布时间：2024-08-23
      • TAN Fengyan,TANG Yiding,MENG Long,SONG Jie,QIU Feng,LONG Rui
        Vol. 35, Issue 16, Pages: 2013-2017(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.13
        摘要：OBJECTIVETo observe the efficacy and safety of camrelizumab combined with pemetrexed and nedaplatin in the treatment of epidermal growth factor receptor （EGFR） and anaplastic lymphoma kinase （ALK） wild-type advanced non-squamous non-small cell lung cancer （NSCLC）.METHODSThe data of 92 patients with EGFR/ALK wild-type advanced non-squamous NSCLC patients who visited the First Affiliated Hospital of Chongqing Medical University from August 2021 to May 2023 were collected and divided into nedaplatin group （46 cases） and carboplatin group （46 cases） based on different treatment regimens. Nedaplatin group was given camrelizumab for injection+nedaplatin for injection+pemetrexed disodium for injection； carboplatin group was given camrelizumab for injection+carboplatin injection+pemetrexed disodium for injection. Both groups received treatment with 21 days as one cycle， and all patients would be treated at least two cycles. The recent efficacy and the incidence of adverse drug reactions were observed in two groups， and the factors affecting progression-free survival （PFS） of patients were analyzed.RESULTSThere was no statistically significant difference in the objective response rate， disease control rate， median PFS， and the incidence of grade 3-5 treatment-related adverse event （TRAE） between the two groups （P＞0.05）. While the incidence of grade 1-2 renal and urinary system TREA， palpitations and pericardial effusion in nedaplatin group were significantly lower than carboplatin group， the incidence of nausea， vomiting and decreased appetite were significantly higher than carboplatin group （P＜0.05）. The patient’s gender， age， smoking history， Eastern United States Cancer Collaboration score， and TNM staging were not significant factors affecting patient’s PFS （P＞0.05）.CONCLUSIONSCamrelizumab combined with pemetrexed and nedaplatin has significant efficacy in the treatment of EGFR/ALK wild-type advanced non-squamous NSCLC， with good safety.  
        关键词：nedaplatin;non-squamous non-small cell lung cancer;EGFR/ALK wild-type;efficacy;safety   
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        发布时间：2024-08-23
      • ZHANG Lu,LU Yanqiu,LIU Dan,HU Jing
        Vol. 35, Issue 16, Pages: 2018-2022(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.14
        摘要：OBJECTIVETo observe the efficacy and safety of amphotericin B combined with posaconazole in the treatment of patients with AIDS combined with cryptococcal meningitis （CM）.METHODSThe data of 44 patients with AIDS combined with CM admitted to Chongqing Public Health Medical Center and the First Affiliated Hospital of Army Military Medical University from January 2021 to June 2023 were collected retrospectively. They were divided into amphotericin B combined with flucytosine （AmB+FC） group and amphotericin B combined with posaconazole （AmB+POS） group according to treatment regimen， with 22 cases in each group. AmB+FC group was given Amphotericin B for injection+Flucytosine injection； AmB+POS group was given Amphotericin B for injection+posaconazole injection. After 12 weeks of treatment， clinical efficacies of two groups， clinical symptoms and the negative coversion rate of cerebrospinal fluid， and laboratory test results before and after treatment were observed in 2 groups， and the occurrence of adverse drug reactions was recorded in 2 groups.RESULTSAfter 12 weeks of treatment， the total effective rate， the incidences of fever， blurred vision， leukopenia， anemia， renal function abnormalities， hypokalemia， liver function abnormalities， rash， and peripheral neuropathy were compared between the two groups， and the differences were not statistically significant （P＞0.05）. The negative coversion rate of cerebrospinal fluid in AmB+POS group was significantly higher than AmB+FC group； the incidences of headache， nausea and vomiting symptoms， and the incidence of any adverse events were significantly lower than AmB+FC group （P＜0.05）. The cerebrospinal fluid pressure and cerebrospinal fluid protein content of the two groups were significantly lower than those before treatment， and the cerebrospinal fluid glucose content and cerebrospinal fluid chloride content were significantly higher than those before treatment （P＜0.05）； however， the differences were not statistically significant between 2 groups （P＞0.05）.CONCLUSIONSAmphotericin B combined with posaconazole improves the negative coversion rate of cerebrospinal fluid and relieves clinical symptoms in patients with AIDS combined with CM with good safety.  
        关键词：human immunodeficiency virus;amphotericin B;posaconazole;flucytosine;efficacy;safety   
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        发布时间：2024-08-23
      • CHEN Yongyan,SUN Didi,HAN Wenchao,WANG Qian,ZHANG Hanjuan
        Vol. 35, Issue 16, Pages: 2023-2026(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.15
        摘要：OBJECTIVETo establish two-dimensional liquid chromatography method for the determination of imipenem blood concentration and apply it in clinical practice.METHODSThe method for the determination of imipenem blood concentration was established based on automatic two-dimensional liquid chromatography. The targets were extracted by 1-dimensional column Aston SNCB （50 mm ×4.6 mm， 5 μm） and further separated and determined by 2-dimensional column Aston SCB （250 mm×4.6 mm， 5 μm）. The 1-dimensional mobile phase was imipenem-1D mobile phase [acetonitrile-methanol-water （15∶10∶75， V/V/V）] with a flow rate of 1.0 mL/min； 2-dimensional mobile phase was 72%OPI-1 organic mobile phase （chromatographic grade methanol）-20% BPI-1 alkaline mobile phase [water （containing 20.0 mmol/L ammonium phosphate， pH adjusted to 7.2 with triethylamine）]-8%API-1 acidic mobile phase [water （containing 20.0 mmol/L ammonium phosphate， pH adjusted to 3.0 with phosphoric acid）] with a flow rate of 1.0 mL/min； the column temperature was 40 ℃， UV detection wavelength was 310 nm and injection volume was 100 μL. Elution procedure： 1-dimensional column consisted of imipenem-1D mobile phase with eluting for 0-3.40 min； 2-dimensional column consisted of 72% OPI-1 organic mobile phase-20%BPI-1 alkaline mobile phase-8%API-1 acidic mobile phase with eluting for 3.40-11.00 min.RESULTSThe linear range of imipenem was 0.171-18.570 μg/mL （R 2＝0.999 9） with the lower limit of quantification for 0.171 μg/mL； the recovery rate ranged from 93.47% to 106.16% （n＝5） and the RSDs of both intra-day and inter-day precision were below 15% （n＝5）. The minimum concentration of imipenem in 51 patients ranged from 0 to 19.57 μg/mL.CONCLUSIONSThe established method is simple and fast with the large scale of sample， and can be used for the imipenem blood concentration monitoring in patients with severe infection.  
        关键词：blood concentration monitoring;severe infection;2D-LC/UV   
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        发布时间：2024-08-23
      • SU Xue,CHENG Li,PU Xiaofang,WANG Yuanming
        Vol. 35, Issue 16, Pages: 2027-2032(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.16
        摘要：OBJECTIVETo construct a double helix model for evaluating the job competency of licensed pharmacists in retail pharmacies， and to provide a reference for building a talented team of licensed pharmacists and promoting the high-quality development of pharmaceutical care.METHODSBased on the competency iceberg model and double helix structure theory， literature analysis and the Delphi method were adopted to explore the model indicators； questionnaires were designed to survey licensed pharmacists in retail pharmacies from Shandong Province. The exploratory factor analysis was used to correct the model indicators and establish a double helix model for evaluating the job competency of licensed pharmacists in retail pharmacies， which was examined by validation factor analysis.RESULTSThe recovery rate of the questionnaires in the two rounds of expert consultation was greater than 90%， the expert authority coefficients were both more than 0.86， and the overall Kendall’s W values were 0.288 and 0.510， respectively； after the correction of the exploratory factor analysis， the double helix model for evaluating the job competency of licensed pharmacists in retail pharmacies was established， which contained 4 first-level indexes such as occupational literacy， occupational knowledge， occupational competency and internal motivation， and 23 second-level indexes. The model contained occupational knowledge and occupational competency in the explicit competency chain， occupational literacy and internal motivation in the implicit competency chain， and policy support， incentive mechanism， education and training as the hydrogen bonds connecting the two main chains. The validation factor analysis showed that the model’s goodness of fit index， comparative fit index， and normed fit index all exceeded 0.9； the reliability of the combination of the four first-level indexes ranged from 0.89 to 0.95； the average variance extracted ranged from 0.58 to 0.75， and Cronbach’s α coefficients for both the overall model and the first-level indicators were all greater than 0.84.CONCLUSIONSThe constructed double helix model for evaluating the job competency of licensed pharmacists in retail pharmacies is scientific， reasonable and practical.  
        关键词：licensed pharmacist;job competency;iceberg model;double helix structure theory;Delphi method   
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        发布时间：2024-08-23
      • HAN Dan,NIE Li,WANG Meihua,WU Jinli,YAN Simin,LI Fuchao,QIAN Yun,XI Youli
        Vol. 35, Issue 16, Pages: 2033-2037(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.17
        摘要：OBJECTIVETo explore the effects of multi-disciplinary comprehensive management team of tertiary hospital collaborated with the pharmacists from community health service center （hereinafter referred to as “community pharmacists”） on elderly patients with hypertension in the community.METHODSElderly patients with hypertension from May 2020 to May 2021 in Yuhua Community Health Service Center of Nanjing were divided into control group （76 cases） and observation group （76 cases） according to the management style. The control group was treated with regular community medical services and the observation group received regular community medical services plus pharmaceutical care provided by the comprehensive management team collaborated with community pharmacists. The compliance， blood pressure control status and hypertension-related complications were compared between 2 groups before management and after 24 months of management.RESULTSAfter 24 months of management， the compliance and blood pressure compliance rates in both groups were higher than before management； meanwhile， the observation group was significantly higher than control group at the corresponding period （P＜0.05 or P＜0.01）. The blood pressure levels of both groups were significantly lower than before management， and the systolic blood pressure as well as the incidences of the whole complications and cerebrovascular injury in the observation group were significantly lower than control group at the corresponding period （P＜0.05）. There was statistical significance in the effects of the rate of reaching the standard of blood pressure on the complications （P＜0.01）.CONCLUSIONSThe hypertension management mode of comprehensive management team collaborated with community pharmacists can significantly improve the compliance and blood pressure compliance rate of elderly patients with hypertension， and reduce the incidence of hypertension-related complications.  
        关键词：multi-disciplinary comprehensive management;community pharmacist;compliance   
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        发布时间：2024-08-23
      • DENG Tiying,LIN Min,HU Zhimin,ZOU Liang,WU Zhihong,LIU Jianmin,HUANG Lei
        Vol. 35, Issue 16, Pages: 2038-2043(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.18
        摘要：OBJECTIVETo provide a reference for the adjustment of antibacterial drug regimens， identification of adverse reactions， and personalized pharmaceutical care for patients with bullous pemphigoid and pulmonary aspergillosis combined with disseminated Nocardia farcinica infection.METHODSClinical pharmacists participated in the entire treatment process of a patient with bullous pemphigoid and pulmonary aspergillosis combined with disseminated N. farcinica infection. Evidence-based medicine was used to assist in the selection of an initial combined drug regimen against nocardiosis， and timely communication with the microbiology laboratory to provide early antimicrobial susceptibility data. When the patient exhibited epilepsy， the suspected drugs were identified， and it was reminded that imipenem-cilastatin sodium could affect the efficacy of valproic acid. It was suggested to replace valproic acid with levetiracetam for anti-epileptic treatment and to discontinue imipenem-cilastatin sodium. During treatment， it was recommended to monitor the blood concentrations of voriconazole and linezolid， and assist in adjusting the dosage promptly based on the monitoring results.RESULTSThe physicians accepted the recommendations of the clinical pharmacists. The patient’s condition improved， and they were discharged with medication.CONCLUSIONSBased on evidence-based medical evidence， antimicrobial susceptibility test results， and blood concentration monitoring data， clinical pharmacists assist clinicians in selecting a sensitive anti-infective regimen for the patient， identifying adverse reactions， adjusting the treatment regimen and providing full-course medication monitoring to ensure the safety and efficacy of clinical drug therapy.  
        关键词：bullous pemphi-goid;pulmonary aspergillosis;epilepsy;clinical pharmacist;pharmaceutical care   
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        发布时间：2024-08-23
      • WANG Dong,ZHANG Yan,JI Chuang
        Vol. 35, Issue 16, Pages: 2044-2047(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.19
        摘要：OBJECTIVETo investigate the effect of the medical intelligent dispensing machine in the dispensing of pharmacy intravenous admixture services（PIVAS） parenteral nutrition drugs.METHODSFrom December 1st to 31st， 2023， 14 PIVAS staff members in Shandong Provincial Hospital Affiliated to Shandong First Medical University were selected to participate in manual dispensing and dispensing with the medical intelligent dispensing machine in the form of rotation. Ten prescribed formulas are prepared daily by each of the two groups. The dispensing efficiency and quality of specified parenteral nutrition drugs were compared between 2 groups， and the effects of the introduction of medical intelligent dispensing machine on the cleanliness class were also compared.RESULTSThe medical intelligent dispensing machine group prepared a total of 310 bags of parenteral nutrition solution， while the manual dispensing group prepared a total of 306 bags； the time for drug dispensing per bag， the residual amount of drug liquid， the number of dispensing punctures， the leakage rate of finished infusion inlet and desquamation rate of vial glue plug in the medical intelligent dispensing machine group were less or lower than manual dispensing group （P＜0.05）. Before and after the introduction of the medical intelligent dispensing machine， the qualified rate of sedimentation bacteria detection in mixing operation room and horizontal laminar flow clean workbench in both groups was 100%.CONCLUSIONSThe application of medical intelligent dispensing machine in the dispensing of PIVAS parenteral nutrition drugs can improve the efficiency of drug dispensing and improve the quality of finished infusion without affecting the cleanliness level of operation room and horizontal laminar flow clean workbench.  
        关键词：pharmacy intravenous admixture services;parenteral nutrition drugs;sedimentation bacteria;dispensing efficiency   
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        发布时间：2024-08-23
      • SUN Xin,LIANG Xiao,LI Yalan,XIAO Zhan,WEN Wulong,ZHANG Weiye,YANG Jing,WANG Rui
        Vol. 35, Issue 16, Pages: 2048-2054(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.20
        摘要：Autophagy is mediated by multiple molecules and pathways. In cardiovascular diseases， autophagy can play a role through key signaling pathways such as phosphoinositide 3-kinase （PI3K）/protein kinase B （Akt）/mammalian target of rapamycin （mTOR）， adenosine monophosphate-activated protein kinase （AMPK）/mTOR， mitogen-activated protein kinases （MAPK）， p53， Wnt/β-catenin， etc. Traditional Chinese medicine （TCM） monomers for promoting blood circulation and removing blood stasis such as hydroxysafflor yellow A， ginsenoside Rb1， salidroside， ligustrin， curcumin， etc.， and TCM prescription and preparations such as Huangqi baoxin decoction， Taohong siwu decoction， Tongxinluo capsule， Shuangshen ningxin capsule， Suxiao jiuxin pills， etc. can regulate autophagy through the above-mentioned key signaling pathways， thereby alleviating the progression of cardiovascular diseases.  
        关键词：traditional Chinese medicine;promoting blood circulation and removing blood stasis;cardiovascular disease   
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        发布时间：2024-08-23
      • LI Guangcan,ZHANG Ping,ZHENG Jiaoni,HUANG Xingyan,SHAN Xuefeng
        Vol. 35, Issue 16, Pages: 2055-2060(2024) DOI: 10.6039/j.issn.1001-0408.2024.16.21
        摘要：Ceftazidime-avibactam （CAZ/AVI）is a novel β-lactam antibiotic with broad-spectrum antibacterial activity and good tolerability. However， the physiological and pathological differences in special populations [e.g. augmented renal clearance （ARC） patients， undergoing continuous renal replacement therapy （CRRT） patients， neonates and children， obese patients， undergoing extracorporeal membrane oxygenation （ECMO） patients， elderly patients and liver dysfunction patients] may affect the pharmacokinetic （PK） properties of CAZ/AVI， leading to treatment failure. At present， there is currently a lack of corresponding guidelines or consensus on dose adjustment of CAZ/AVI in special populations. This article summarizes the research on PK/pharmacodynamic （PD） characteristics and dose adjustment of CAZ/AVI in special populations and recommends the following dosing regimens： for ARC patients， the recommended dose is 2.5 g， q8 h； for undergoing CRRT patients with infections caused by sensitive strains （i.e. MIC＜4 mg/L） and infections at sites where hydrophilic antibiotics distribute well， a dose of 1.25 g， q8 h may be used； for undergoing CRRT patients with less sensitive strains or sites with poorer drug distribution， a dose of 2.5 g， q8 h or continuous infusion may be considered； for children aged 6 months to ＜18 years with normal or mildly impaired renal function， a dose of 62.5 mg/kg， q8 h is infused for 2 h （maximum dose not exceeding 2.5 g per dose）； for infants aged 3～6 months with normal or mildly impaired renal function， a dose of 50 mg/kg， q8 h is infused for 2 h； for obese patients， the recommended dose is 2.5 g， q8 h， with therapeutic drug monitoring recommended； undergoing ECMO patients， elderly patients， and those with impaired liver function may also use the recommended dose of 2.5 g， q8 h.  
        关键词：pharmacokinetic;phar-macodynamic;special populations;renal dysfunction   
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        发布时间：2024-08-23
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