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  • 01 December 2021 Volume 40 Issue 12
      

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  • YIN Qinan,HAN Lizhu,BIAN Yuan,HUANG Xuefei,LEI Yang,SONG Yujie,TONG Rongsheng
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    In April 2021,the European Heart Rhythm Society (EHRA) published the "Guidelines for the Use of Non-vitamin K antagonists oral anticoagulants in patients with Atrial fibrillation".This paper provides a practical guidance on the use of non-vitamin K antagonists oral anticoagulants(NOACs) as the anticoagulant of choice for the prevention of stroke in patients with atrial fibrillation.In this paper,the updated content was interpreted in detail by comparing it with the guidance of new oral anticoagulant drugs for patients with atrial fibrillation in 2018,in order to provide a reference for clinical application.

  • LIANG Liying,CHEN Jing,ZHANG Yongqin,LAN Yanmei,LIU Huan
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    Objective To investigate the mechanism of astragaloside Ⅳ in inhibiting hypoxia-reoxygenation cardiomyocyte injury by targeting PTEN via microRNA-21 (miR-21). Methods Rat cardiomyocytes (H9c2 cells) were cultured in vitro to establish hypoxia-reoxygenation injury model.Using lentivirus expression system,H9c2 cells were overexpressed or interfered with miR-21 inhibitor.The cells were then divided into six groups:normal control group,model control group (H/R),miR-21 mimic group,miR-21 inhibitor group,and miR-21 inhibitor group.Except for the normal control group,the other groups were incubated in a three-gas incubator (1% O2,94% N2,and 5% CO2) for 12 h,and then cultured in a conventional incubator for 6 h reoxygenation treatment.The cells were treated with 200 μmol·L-1 astragaloside Ⅳ in miR-21 mimic group and miR-21 inhibitor plus astragaloside Ⅳ group for 72 h.Apoptosis was detected by flow cytometry,and the expression of miR-21 and PTEN was detected by QRT PCR.The expression of Bcl-2 protein was detected by immunofluorescence,and the expressions of Caspase-3 and Cyt-C were detected by enzyme-linked immunosorbent assay (ELISA). Results Compared with the model control group,the expression of miR-21 in normal control group and miR-21 mimic group increased,and apoptosis percentage and PTEN expression decreased significantly,and caspase-3 and Cyt-C expression decreased,and bcl-2 expression decreased.Compared with miR-21 mimic group,the expression of miR-21 in miR-21 mimic plus astragaloside group increased,and apoptosis percentage and PTEN expression decreased significantly,and bcl-2 expression,caspase-3 and Cyt-C expressions decreased.Compared with miR-21 inhibitor group,miR-21 expression increased,and apoptosis percentage and PTEN expression decreased significantly;and bcl-2 expression,caspase-3 and Cyt-C expression decreased.In inhibitor plus astragaloside group,miR-21 expression increased,and apoptosis percentage and PTEN expression decreased significantly;and caspase-3 and Cyt-C expression decreased (P<0.05 or P<0.01). Conclusion Astragaloside Ⅳ can protect cardiomyocytes from injury by up-regulating the expression of miR-21,targeting PTEN,reducing the release of Caspase-3,Bcl-2 and Cyt-C,inhibiting cardiomyocyte apoptosis and reducing myocardial cell injury.

  • ZHANG Lei,LI Ping,LIU Weihong,LIN Yan,XIE Xinran
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    Objective To investigate the intervention and mechanism of Qingxue xiaozhi formula (QXXZF) on psoriasis combined with dyslipidemia. Methods The experimental mice was divided into 4 groups: the normal control group,the model control group,the Qingxue xiaozhi prescription group,and the atorvastatin calcium group.They were given continuous oral administration once a day.After 3 weeks,all ApoE-/- mice were coated with 62.5 mg 5% imiquimod cream on the back,and C57BL/6J mice were treated as the normal control group with the same amount of petrolatum for 5 consecutive days,and the corresponding drugs were continued.The changes in the skin lesions of the mice were observed and the PASI score was calculated.The pathological changes of of skin lesions were determined by HE staining and the epidermis thickness were calculated.The expressions of PCNA,involucrin,and LOX-1 were detected by immunofluorescence staining.Serum lipid levels (TC,TG,LDL,and HDL) were detected by biochemical method.Th1/Th17 cell type of spleen was detected by flow cytometry.The cytokines (IL-17A,IL-17F,IL-12/IL-23p40,and IL-6) levels in serum were detected by CBA methods.The mRNA expressions of cytokines (IL-17A,IL-17F,IL-23,and IL-6) in skin lesions were detected by realtime PCR. Results QXXZF could improve the psoriasis-like skin lesions in imiquimod induced ApoE-/- mice.The reduction of scales and erythema,infiltration,reduction of PASI score,epidermal thickness thinning were observed.It also could inhibit the expressions of PCNA,involucrin,and LOX-1 in basal epidermal cells.QXXZF could inhibit TG and increase HDL.QXXZF significantly reduced Th1/Th17 cell counts in mice spleen and inhibited the gene expressions of inflammatory factors IL-17A,IL-23,and IL-6 in the skin lesions.It had a certain inhibition on IL-17F levels in serum. Conclusion Qingxue xiaozhi formula exhibits an interventional effect on psoriasis combined with dyslipidemia by inhibiting IL-23/Th17 axis.

  • ZHANG Mingshuo,YE Tianyuan,ZHU Na,HUANG Xiulan,LI Zhiyong
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    Objective The compatibility ratio of gastrodin (Gas) and diosgenin (Dio) was optimized,and its protective mechanism against hypoxia/reoxygenation injury in primary human umbilical vein endothelial cells (HUVECs) was studied. Methods The compatibility ratio of Gas and Dio was determined by a baseline proportional increase/decrease design.The principal component analysis was used to optimize the compatibility ratio using an SH-SY5Y cell model induced injury by glutamate and a hypoxia/reoxygenation HUVECs model.The best compatible combination was applied to HUVECs model by hypoxia/reoxygenation to observe its effects on cell apoptosis.And the expression levels of HIF-1α,VEGF,iNOS and eNOS in HUVECs model were detected by Western blotting. Results The seven compatibility ratios of Gas and Dio were 10:0,9:1,8:2,7:3,6:4,5:5,and 0:10.The results of principal component analysis showed that the best effective ratio of Gas and Dio was 8:2. After the best ratio was applied to HUVECs induced damages by hypoxia/reoxygenation,the expressions of VEGF,HIF-1α,and iNOS were significantly reduced,and the expression of eNOS was significantly increased. Conclusion When the compatibility ratio of Gas and Dio were 8:2 and 9:1,the effect were the best;and the compatibility ratio of 8:2 was applied to act on hypoxic HUVECs,and it was found that it could inhibit apoptosis,oxidative stress,and blood vessel nascent pathway to be involved in the protection of hypoxic HUVECs.

  • SHI Yu,BAO Xiaofeng,LU Qun,QIAO Jin,LIU Lingyan
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    Objective To analyze the antichlamydial activity and mechanism of previously synthesized five dihydrobenzofuranol compounds,so as to provide novel candidates for the development of antichlamydial drugs. Methods The antichlamydial activity of the compounds on Chlamydia trachomatis L2 (CtL2) and Chlamydia pneumonia (Cpn AR39) was evaluated by immunofluorescence staining and measuring the titers of infectious offsprings,and the IC50 values were calculated based on percentage inhibition data.Cytotoxicity was evaluated by Evans Blue cytoplasm staining,DAPI nuclear staining,and living cells counting.The host cell and Chlamydia pretreatment assays were used to analyze the effect of compounds on the infection process.Also,the effect of compounds on the proliferation period was analyzed by post drug treatment and withdrawal assays. Results All the five dihydrobenzofuranol compounds inhibited Ct L2 and Cpn AR39 in a dose-dependent manner,and the IC50 values were around 5 μmol·L-1.At 16 μmol·L-1,the highest concentration tested in our experiment,no compounds showed cytotoxic effect.All the compounds did not affect the infection period of the chlamydial life cycle.However,compounds 1,3 and 5 strongly inhibited the proliferation period of the chlamydial life cycle,while the inhibitory effect of compounds 2 and 4 was weak,which required continuous incubation throughout the process of the whole proliferation period. Conclusion All the five dihydrobenzofuranol compounds have broad-spectrum anti-chlamydia activity,and their action has the effect mainly at the proliferation period but not the infection period of the life cycle.

  • ZHOU Shuai,HAN Zhanying,CHI Xiaowei
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    Objective To investigate the effect of compound Danshen capsules on pharmacokinetics of ticagrelor in rats and the mechanism mediated. Methods Sixteen male Sprague-Dawley rats were randomly divided into the control and Danshen capsules group.Pharmacokinetic parameters of ticagrelor were determined in male rats after the administration of ticagrelor (20 mg· kg-1,i.g.) to rats in the presence and absence of the co-adminsitration of Danshen capsules (90 mg· kg-1,i.g.) for 7 days.Then their liver tissue was isolated and analyzed for mRNA expressions of CYP3A1 and CYP3A2.CYP3A2 protein expression was analyzed by Western blotting.The activity of CYP3A were detected in LC-MS/MS. Results Compound Danshen capsules (90 mg· kg-1,i.g.,7 days) significantly decreased the Cmax,AUC0-t,and AUC0-∞ of orally administered ticagrelor by 32.03%,30.65% and 38.89% folds,respectively (P<0.01) and increased the CL/F and VZ/F by 1.42 and 1.37 folds,respectively (P<0.01).Further study revealed that the expression of CYP3A2 was significantly increased in Danshen capsules treated liver with oral multiple doses.The mRNA and protein expression of CYP3A2 were increased Danshen capsules treated groups with multiple doses.And the activities of CYP3A were largely increased. Conclusion Compound Danshen capsules decreased the oral bioavailability of ticagrelor significantly in rats,which may be mainly attributable to the induction of CYP3A2 protein expression and activity.Administration of Danshen capsules plus ticagrelor may require dose adjustment and closely monitoring of ticagrelor plasma concentrations.

  • KANG Yutong,CAI Xiaocui,WANG Xintang,HE Jinhua
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    Objective To optimize the best formulation process and establish the quality standard for Compound kasen granules. Methods Taking the formability,hygroscopicity,solubility,bulk density,and angle of repose of the particles as the comprehensive evaluation indicators,the optimal excipient and proportion,wetting agent type,and the amount of compound kasen granules were optimized.Rosa rugosa flos and Foeniculi fructus were qualitatively identified by a thin layer chromatography (TLC).The content of gallic acid in compound Kasen granules was determined by a high performance liquid chromatography (HPLC). Results The best excipient proportion of Compound kasen granules was that dry paste powder: lactose: dextrin was 2:1:1,and wetting agent was 75% ethanol.According to this formulation process,the particles have good formability,solubility,and moisture resistance.The results of TLC showed that the relevant spots were clear,well separated,and negative without interference.The TLC method was highly specific.Gallic acid concentration graph showed a good linear relationship at a range of 11.25-89.97 μg·mL-1 (r=0.999 9).The average recovery rate was 92.47%,RSD=0.79% (n=6). Conclusion The process was reliable,stable,and reproducible.The granules met the requirements for “granules” in the fourth part of Pharmacopoeia of the Peoples Republic of China (2020 Edition).The established TLC and HPLC methods in this study are highly specific and sensitive with good reproducibility,and can be effectively used for the quality control of Compound kasen granules.

  • LIU Jing,LIU Yan,ZHAO Jun,LI Yajie,GU Zhengyi
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    Objective To investigate the anti-inflammatory and analgesic effects of the effective parts from Euphorbium resinifera and euphol. Methods Eighty Kunming mice were selected and randomly divided into 8 groups,including the high,medium,and low (60,30,15 mg·kg-1) dose groups of the effective parts from Euphorbium resinifera,the high,medium,and low (30,15,7.5 mg·kg-1) dose groups of euphol,0.5% CMC-Na group,and indomethacin group (10 mg·kg-1),with ten rats in each group.Through the xylene-induced ear swelling model,capillary permeability test and cotton ball granuloma test,the anti-inflammatory effects of the effective part from Euphorbium resinifera and euphol were observed.The analgesic effect was evaluated by using hot plate method,acetic acid writhing method and formalin method. Results The effective parts from Euphorbium resinifera and euphol showed certain anti-inflammatory effects on the three inflammatory models,and also had good analgesic effects.Among them,the high-dose group of euphol had the best effect. Conclusion The effective parts from Euphorbium resinifera and euphol have significant anti-inflammatory and analgesic effects,and euphol plays a major role.

  • WANG Qiuping,SONG Duanhui,ZANG Jie,YANG Jinxiang,QI Yunyun,HAN Bo
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    Objective To prepare the suitable dosage form from Turkish galls polyphenols and to evaluate its efficacy on cervicitis in rats. Methods Turkish gallic polyphenols were isolated and identified.The gallic polyphenols were prepared into nanoparticles (NPs) by the nanoprecipitation method,and then loaded into the reverse thermosensitive gel and characterized.The effect of thermosensitive gel was then evaluated on cervicitis in rats induced by 25% phenol mucilage. Results The specific Turkish gallic polyphenols were separated by polyamide column.After preparing them into nanoparticles,the particle size was (53.20±7.60) nm,and zeta potential value was (-94.93±12.17) mV,and the entrapment efficiency was (14.94±2.52)%.For the NPs-gel,the cumulative release rate was (13.81±1.47)% at 48 h The viscosity was (1076.67±20.55) mPa·s-1.The gel temperature is (33.33±0.47) ℃ with the gel time of (118±17) s.The animal experiments showed that NPs gel could improve vaginal redness and swelling,reduce cervical secretion,and prevent the increase of cervical organ index.HE staining of cervical tissue showed that NPs-gel could reduce the infiltration of inflammatory cells and repair cervical mucosal epithelium.The results of ELISA kit showed that NPs-gel could inhibit tumor necrosis factor alpha (TNF-α) of cervicitis in rats and promote the secretion of epidermal growth factor (EGF) and epidermal growth factor receptor (EGFR). Conclusion The NPs gel can enhance the colloidal stability of the Turkish galls polyphenols and prolong the drug release.It could treat and prevent the development of cervicitis effectively.

  • NULIBIYA Abudukeyoumu,QIN Dongmei,HU Liping,HOU Jinqiu,LU Xiaobo
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    Objective To investigate the inhibitory effect of matricin (chemical name: 8-deacetyl matrichol-8-O-sulfate,No.192) was isolated from chicory on HSC-T6 cell proliferation and TGF-β1/Smad signaling transduction pathway in vitro. Methods MTT colorimetric assay was used to detect cell viability.RT-PCR was used to detect the effect of compound 192 on the mRNA expression of Smad2,Smad3,Smad7,and TGF-β1 in HSC-T6 cells and the protein expression levels of TGF-β1,Smad3 and Smad7 were detected by Western blotting. Results The results of cell proliferation measured by MTT method showed that compound 192 could significantly inhibit the proliferation of HSC-T6.The RT-PCR results showed that when TGF-β1 stimulated HSC-T6 cells for 24 h/48 h,compound 192 could effectively inhibit Smad2,Smad3 and TGF-β1 mRNA expression levels as well as up-regulate Smad7 mRNA expression,and the effect was better at 24 h.Western blotting showed that compound 192 could effectively inhibit the expression of TGF-β1,Smad3 protein and up-regulate the expression of Smad7 protein. Conclusion Compound 192 exerts an anti-fibrotic effect by blocking the TGF-β/Smad signaling pathway,thereby inhibiting the activation of HSC-T6.Therefore,compound 192 may be a potential anti- liver fibrosis therapeutic agent.

  • MAO Ya,DING Mei,LIANG Huiling,DONG Xiang,LIU Guanghui
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    Objective To analyze effects of omalizumab on asthma and sensitization in the treatment of allergic asthma. Methods This study retrospectively collected the clinical data of 21 patients with allergic asthma who received omalizumab in the Department of Allergy,Zhongnan Hospital of Wuhan University from May 2018 to August 2020.Their clinical data,including asthma control test (ACT) score,exhaled nitric oxide (FeNO),forced expiratory volume in 1 second(FEV1),forced vital capacity(FVC),FEV1/FVC,and Skin Prick Test (SPT),were collected and analyzed at the beginning of treatment,4 months after treatment,and 12 months after treatment.Pearson correlation analysis was conducted between ΔSPT and ΔFeNO,ΔFEV1/FVC,etc. Results After 4 months of treatment,the patient's ACT score increased from (17.43±2.71) to (22.43±1.80) (P<0.000 1),and FeNO decreased from (46.95±44.40)×10-9 to (26.26±28.24)×10-9 (P<0.01).FEV1 increased from (2.37±1.11) L to (2.76±0.95) L (P<0.01),and FVC increased from (3.30±1.50) L to (3.62±1.35) L (P<0.01),with the FEV1/FVC increased from (72.37±13.23) % to (81.02±10.17) % (P<0.05).The SPT of Dermatophagoides farina (Df) decreased from (8.50±5.21) mm to (4.50±2.94) mm (P<0.01),and the SPT of Dermatophagoides pteronyssinus (Dp) decreased from (10.33±4.94) mm to (4.42±2.87) mm (P<0.000 1).The ΔSPT of Dp was positively correlated with ΔFeNO (r=0.66,P=0.027),and the increased FEV1/FVC was positively correlated with the decreased SPT of Dp (r=0.56,P=0.073). Conclusion Omalizumab can effectively improve the clinical symptoms,airway eosinophilic inflammation,lung function,and sensitization in patients with allergic asthma.Moreover,the improvement of sensitization status was correlated with the improvement of airway eosinophil inflammation and lung ventilation function.Meanwhile,SPT,like FeNO and FEV1/FVC,plays an important role in assessing the condition control of asthma.

  • JIANG Jizong,LIU Yi,HUANG Lulu
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    Objective To observe the efficacy and safety of fosaprepitant on the prevention of chemotherapy induced nausea and vomiting in preoperative patients with osteosarcoma. Methods Seventy-six patients with osteosarcoma were selected and randomly divided into two groups.All patients received preoperative chemotherapy with doxorubicin and cisplatin.In the fosapitan group,patients were treated with a triple antiemetic regimen (fosapitan + tropisetron + dexamethasone),and patients in the control group were treated with two combined antiemetic regimen (tropisetron + dexamethasone) treatment.The results of the observation between groups were presented by complete response rates in the overall phase,acute phase,delay phase,and the incidences of related adverse events. Results The complete response rate in delay phase was statistically lower in fosaprepitant group than in standard group.There were no significant differences of the complete response rate in overall phase and acute phase between 2 groups.The most common adverse events were fatigue,constipation,abdominal distension,and diarrhea.The incidences of these adverse events were not significant different between 2 groups. Conclusion Fosaprepitant is efficient and safe in the reduction of chemotherapy induced nausea and vomiting in preoperative patients with osteosarcoma.

  • WANG Jinhua,DENG Chaohua,HUA Zhen,XU Qiongfang,LIU Huijun,HU Weikun
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    Objective To investigate the microbial detection rate and microbial spectrum of infantile dacryocystitis,and to provide references for rational use of antibiotics in clinic. Methods A total of 198 infants (32 of whom were binocular) with dacryocystitis were included in this study from October 2018 to December 2019 in Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology.There were 115 males and 83 females with a male-to-female ratio of 1.39:1.All the patients were treated with nasolacrimal duct probing,and samples of lacrimal sac flushing fluid were collected for bacterial culture and drug sensitivity test.According to the results,the drug sensitivity and resistance of pathogenic bacteria were analyzed. Results The average detection rate of pathogenic bacteria in infantile dacryocystitis was 69.2% (137/198).There was no significant difference in the detection rate of pathogenic bacteria in all ages.There were 15 cases of children with two or more kinds of pathogenic bacteria detected at the same time.There were various kinds of pathogenic bacteria in infantile dacryocystitis,and Gram-positive coccus constituted the main pathogenic bacteria in infantile dacryocystitis,including Streptococcus pneumoniae (43 eyes,28.9%),Staphylococcus aureus (15 eyes,10.1%),Streptococcus mitis (13 eyes,8.7%),etc.The Gram-negative pathogens mainly included: Moraxella catarrhalis (12 eyes,8.1%),Haemophilus influenzae (7 eyes,4.7%),stenotrophomonas maltophilia (7 eyes,4.7%),etc.It also contains rare pathogenic bacteria,among which fungi include: Candida albicans (9 eyes,6.0%) and Aspergillus flavus (1 eyes,0.7%).The results of drug sensitivity test showed that most pathogenic bacteria were sensitive to levofloxacin,ceftriaxone,and vancomycin. Conclusion Gram-positive cocci are still the main pathogenic bacteria of infantile dacryocystitis.Levofloxacin eye drops can be the first choice for the anti-infective use in the patients with infantile dacryocystitis,which can effectively control the most of the pathogenic bacteria infection.

  • YI Xiaoqing,CUI Xiaojiao,CHEN Zhujun,YIN Qinan,GOU Mengqiu,BIAN Yuan
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    Protein kinase C (PKC) is a group of serine / threonine kinases,which are important signal transduction molecules in cells.The PKCε,PKCα,PKCγ,and PKCδ subtypes of PKC kinases can regulate ion channels and receptors,which participate in the occurrence of pain.The PKC kinase has been studied in various types of pain,including chronic pain in sickle cell disease,disc degeneration,chronic migraine,inflammatory pain,cancerous bone pain,neuropathic pain,and so on.The commonly used analgesic drugs include non-steroidal anti-inflammatory drugs,opioids,anticonvulsant drugs,etc.Studies have shown that the PKC is associated with morphine,remifentanil,acetaminophen,parecoxib,gabapentin,pregabalin and other analgesics.At present,there are many studies on the application of the PKC kinase in pain.This article reports the relationship between PKC kinase and pain and analgesic drugs.It is expected to provide novel ideas for the treatment of pain and become drug targets for the study of the pathophysiological mechanism.

  • ZHOU Yongqiang,ZHOU Wei,YUE Lanxin,DENG Huifang,QIU Lizhen,NI Yuhao,GAO Yue
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    Celastrol,extracted from the root of Tripterygium wilfordii,has been recognized as the most potential anti-obesity drug for its unique effects on the regulation of body mass and lipid metabolism.Based on the latest developments in domestic and foreign research on celastrol,this paper systematically reviews the role of celastrol in the regulation of lipid metabolism and provides a summary of the molecular biological mechanisms involved,such as increasing the sensitivity to leptin receptors sensitivity,inhibiting insulin resistance,increasing energy consumption,suppressing the differentiation of adipocytes,improving intestinal microecology,and anti-inflammatory control,aiming to promote the research and development of metabolic drugs based on celastrol.

  • XIE Jingjing,YANG Yongshou,HAO Fangfang,XIAO Peiyun
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    Objective To optimize the formulation process of Periplaneta Americana anti-hepatic fibrosis granules. Methods Taking the total evaluation normalization values of pellet forming rate and hygroscopic rate as the controlling indexes,and the mass ratio of drug to excipient,excipient ratio,and the volume fraction of ethanol as the factors to be investigated,the formulation process of Periplaneta americana anti liver fibrosis granules was optimized and verified by the single-factor experiment and central composite design-response surface methodology. Results The optimal formulation process of Periplaneta Americana anti-hepatic fibrosis granules were as follows, the ratio of main drug to excipients was 1:2.84;the ratio of cellulose to starch was 1.37:1,and the volume fraction of ethanol was 77.4%.In the validation test,the total evaluation normalization value of pellets formability and hygroscopicity was 0.6835,and the predicted value was 0.6766,and the relative error was 1.02%.The physical properties of particles were in accordance with the regulation requirements. Conclusion The optimized formulation process was stable and reliable,and the method was simple.The granules have good formability and anti-hygroscopicity,which could be used for the preparation of Periplaneta americana anti-hepatic fibrosis granules.

  • GUO Aixin,GONG Xiaofang,HE Jialin,GUO Yiming,NING Lifeng,CHEN Xiaofeng,XU Juan,GUO Yingzhi,WANG Huiping
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    Objective To study the polymorphic phenomenon of steroid estrogenic estradiol and to find out the dominant medicinal crystal which is effective in clinic.The eutectic compounds of estradiol were screened out and the pharmacodynamic evaluation of crystal type was made. Methods After a structural design,the complex which can form cocrystal with estradiol in crystal engineering was selected.The co-crystals were prepared by evaporation crystallization,cooling crystallization,grinding or mixing liquid.Single crystal diffraction (SXRD),powder X-ray diffraction analysis (PXRD),thermogravimetric differential scanning calorimetry (TG-DSC),infrared spectroscopy (IR) were used to identify co-crystal properties.The stability of the crystal sample was studied by means of different factors.The solubility of cocrystal samples was studied by in vitro solubility evaluation,and the eutectic morphology was identified. Results Estradiol-urea co-crystal (co-crystal I) and estradiol-acetamide co-crystal (co-crystal II) were obtained by evaporation crystallization method and were prepared into single crystals.PXRD,NMR,TG-DSC,and melting point methods can characterize co-crystals and API as well as the difference between the two co-crystals.Single crystal X-ray diffraction shows that the molecular ratio of the two co-crystal is 1:1 and 4:4,respectively.Compared with estradiol,the two co-crystal samples were stable under high temperature,high humidity,and pressure.The dissolution behavior of the two eutectics in six dissolution media was consistent.In pH=1.2 hydrochloric acid buffer solution,the cumulative dissolution of cocrystal II was nearly 2 times higher than API,and 1.2 times higher than the cocrystal I.The dissolution rate of Cocrystal II was higher than that of cocrystal I. Conclusion In this paper,two kinds of estradiol cocrystal samples were obtained by eutectic screening with estradiol as drug active component (API).And cocrystal II was the new eutectic of estradiol for the first time.The newly obtained eutectic sample was also stable compared with the crystal form of estradiol API,but the dissolution rate increased.Co-crystal II was the dominant crystal form.

  • FU Yuanyuan,CHEN Pingyu,FANG Wentong,ZHOU Ying,ZHANG Ji,ZOU Ying
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    Objective To evaluate the efficacy,safety,and cost-effectiveness of ceftazidime-avibactam for the treatment of Gram-negative bacterial infections in a rapid health technology assessment,so as to provide the latest evidence-based basis for health providers and decision makers. Methods Pubmed,the Cochrane Library,CNKI,WanFang,VIP database and University of York Centre for Reviews and Dissemination (CRD) Web,International Network of Agencies for Health Technology Assessment (INAHTA) Web,Canadian Agency for Drugs and Technologies in Health (CADTH) Web,Health Technology Assessment international (HTAi) Web,National Institute for Health and Care Excellence (NICE) Web were searched.The retrieval time limit was from the establishment of the database to May 20,2021.Only the systematic review,meta-analysis,health technology assessment and pharmacoeconomic research of ceftazidime avibactam in the treatment of gram-negative bacterial infections were included.Two reviewers independently screened the literature and extracted the data results,and comprehensively analyzed the results. Results A total of 15 literatures were included,including 10 systematic reviews/meta-analyses,4 pharmacoeconomic studies,and 1 systematic review/meta-analysis combined with pharmacoeconomic studies.This study shows that Ceftazidime-avibactam is a good option for the treatment of mild to moderate complicated urinary tract and intra-abdominal infections caused by ESBL-producing Enterobacteriaceae,infections caused by KPC-producing carbapenem-resistant Enterobacteriaceae,bacteremia and complicated urinary tract infections caused by multi-resistant P.aeruginosa,but the curative effect on hospital acquired pneumonia was not better than other antibiotics.The safety studies show that there is no significant difference in mortality between ceftazidime-avibactam and other therapeutic drugs,but the incidence of AEs was higher,especially in patients with abdominal infection,the incidence of gastrointestinal reaction,elevated creatinine and withdrawal due to adverse events were significantly higher than those in the control group.Foreign pharmacoeconomic studies show that Ceftazidime-avibactam is a cost-effective treatment for Gram-negative bacterial infections compared with other antibiotic treatment options in Europe and the United States,while there is no relevant research on Chinese population. Conclusion Ceftazidime-avibactam is effective,safe and cost-effective for the treatment of Gram-negative bacterial infections.Pharmacoeconomic studies focusing on Chinese populations are needed to provide more evidence for local healthcare decision makers.

  • LIU Siyuan,GUO Daihong,KONG Xianghao,YU Chengxuan,ZHU Yu
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    Objective To understand characteristics and risk factors of oxaliplatin-related allergic reactions in hospitalized patients,and to provide references for clinical medication. Methods Using active surveillance and assessment system of adverse drug events (ADE-ASAS-Ⅱ),we retrospectively monitored the electronic medical record information of 12 073 patients (41 495 cases) who used oxaliplatin in our hospital from January 1,2012 to December 31,2019.After receiving the system intelligent alarm and one by one screening manually,we determine the positive cases and conduct in-depth analysis. Results A total of 94 positive patients (105 cases) were obtained.The main chemotherapy regimens were XELOX (38 patients,40.43%) and FOLFOX (15 patients,15.96%).Allergic reactions usually occurred in the median time of the sixth cycle of oxaliplatin-containing therapy,and the median cumulative dose of oxaliplatin was 900 mg.Most of the allergic reactions occurred in cycle 8 (17 patients,18.09%),cycle 1 (15 patients,15.96%),and cycle 2 (12 patients,12.77%).Sixteen allergic reactions occurred in the second cycle after an oxaliplatin-free interval.Fifty percent of positive patients were interrupted because of the reactions.Allergic reactions occurred in 27.50% of the 40 rechallenging patients,and there was no significant difference between the prophylactic and non-prophylactic groups (P=0.153).The proportion of females in the anaphylaxis group (56.60%) was higher than that in the general group (29.27%),P=0.008.Univariate comparisons between the positive and control groups revealed that younger age,tumor metastasis,having an oxaliplatin-free interval,and combined use of monoclonal antibodies were risk factors.Multivariate regression results showed that tumor metastasis was an independent risk factor (OR: 1.864,95%CI: 1.100~3.159). Conclusion Oxaliplatin-related allergic reactions could occur in all cycles of administration,but mainly in cycles 1,2 and 7,8.The second cycle after an oxaliplatin-free interval was also of concern.The severity of allergic reactions was higher in females.Tumor metastasis was an independent risk factor.Thus,clinical attention should be paid to the high-risk population.

  • CHEN Pei,HE Chaoneng,XU Gaoqi,WANG Zeng,ZHANG Huangjie,FANG Luo
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    Objective To provide references for rational drug use,the adverse reactions (ADR) reported from 2016 to 2019 in Cancer Hospital of The University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) were summarized and analyzed. Methods A total of 1455 ADR reports were retrospectively collected and analyzed in terms of original diseases,gender,age,drug type,route of administration,system/organ involved in ADR,manifestation,reporter occupations,ADR type,relevance evaluation,outcome,and so on. Results Among 1455 ADR reports,the most common disease was lung malignant tumors,and 77.46% of the correlations were rated as very likely.The elderly patients aged from 61-70 years were accounted for the highest composition ratio (36.36%).The drugs that caused ADR were antitumor drugs,analgesic,intracenteral and parenteral nutrition preparations,antimicrobial agents.The intravenous administration was the main route of administration causing ADR;and blood system and digestive system were involved frequently.Adverse drug reactions were mainly reported by pharmacists;and most of the adverse reactions were improved after treatment,and there were no deaths. Conclusion The occurrence of adverse drug reactions was related to factors such as the patients’ original diseases,age,route of administration,system/organ involved in ADR,reporter occupations.Strengthening the monitoring of adverse drug reactions,improving the awareness and reporting of adverse drug reactions in medical staff may reduce the occurrence of adverse drug reactions and provide safe,economical and effective treatment for patients.

  • LI Wei,LIU Yu,GUO Min,JinLIU Yu,LIU Xiulan,ZENG Lu,LIU Dong,LI Juan
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    Objective The false positive problems of repeated drug use were analyzed to improve the review mechanism of repeated drug uses,so as to provide a reference for improving the quality of prescription review. Methods Based on the review mechanism of "PASS Prescription Audit System" and the basic audit knowledge database of Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,the concept of repeated drug use was clarified,and the review mechanism of repeated drug use was improved and the review rules were further refined. Results The improved review mechanism of repeated drug prescription can adapt to the complexity of clinical drug use,which can not only identify the problem of reuse,but also ensure rational clinical combination of drug use. Conclusion The refined drug prescription review mechanism can identify false positive problems of repeated drug use,reduce the obstacles caused by false positive problems of repeated drug use to clinical diagnosis and treatment,and improve the quality and efficiency of prescription drug review.

  • YE Lijun,CAI Shufan,LIN Nengming,WANG Fei
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    Objective To analyze the protocol deviations in oncology registration clinical trials in National drug clinical trial institution of Hangzhou First People's hospital,and to provide a reference for improving the quality of clinical trials. Methods Protocol deviations from 18 projects were retrospectively studied during 2017-2019. Results A total of 18 anti-tumor drug clinical trials were implemented in our hospital,and 137 subjects including 75 cases were screened,from which 120 deviations were reported.The types of the deviations that occurred were mainly 42.50% (51/120) of research procedures/assessment non-conformance processes,16.67% (20/120) of study drug use or improper management,15.00% (18/120) of untimely SAE reports,and 14.17% (17/120) of subjects’ visit/inspection overdue,respectively.The protocol deviations that significantly affect the rights and safety of subjects accounted for 3.33% (4/120),and the protocol deviations that significantly affected the integrity/accuracy of key data accounted for 0.83% (1/120).The deviations which were attributable to the clinical research team accounted for 56.67% (68/1200),to subject accounted for 29.17% (35/120) to sponsor accounted for 1.67% (2/120),and to both clinical research team and sponsor accounted for 12.50% (15/120). Conclusion This study analyzes the common deviations of the protocols in the clinical trials of anti-cancer drugs,and proposes effective measures to reduce deviations from the protocols,thus providing a reference for improving the quality of clinical trials of anti-cancer drugs

  • SHEN Qing,HU Yuan,BIAN Yuan,ZHOU Yimeng,HAN Yong
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    Prescription and medical order reviewing is a vigorous way to facilitate rational use of medicines and ensure medication safety for patients.In this article,different forms,clinical application,and characteristics of prescription reviewing in medical institutions in China were briefly introduced.Advantages and existing problems were discussed,followed by improvement recommendations.The aim is to provide perspective and references for the implementation of reviewing work in Chinese medical institutions,thus to assist medical institutions in choosing appropriate reviewing way according to their own characteristics.

  • YANG Jinwen,FU Wei,LI Dongyan,DONG Bin,LI Juan,DU Guang,LIU Dong
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    Objective To investigate pharmaceutical care in designated hospitals for corna virus disease 2019 (COVID-19) in Hubei Province during the epidemic,so as to provide a reference for the continuous improvement of hospital pharmacy work in the post-epidemic era. Methods The pharmaceutical care of designated hospitals for COVID-19 in Hubei Province were investigated,analyzed,and evaluated based on questionnaires issued. Results A total of 183 effective questionnaires from medical institutions have been received,including 81 tertiary public hospitals,94 secondary public hospitals,3 primary medical institutions,and 5 private hospitals.There are big differences in the situation of pharmacy personnel,pharmaceutical care,scientific research and popularization of science among different levels and nature of medical institutions. Conclusion In the prevention and control of the epidemic,hospital pharmacists took the initiative and actively participated in the front line of epidemic prevention and control,and made positive contributions to protect life and health of people.At the same time,hospital pharmacy also exposed some shortcomings in the event of public health emergencies.It suggests that the construction of pharmacists should be reinforced and the capability of clinical pharmacy practice should also be strengthened.The Hubei Clinical Pharmaceutical Quality Control Center should take the lead to gradually improve the quality and standards of pharmaceutical care and scientific research ability of medical institutions at all levels.More attention should be paid to the popularization and scientific research of pharmacy and how pharmacists developed their expertise in the use of the “Internet + pharmacy”.Emergency pharmacy mechanisms should be established and improved to respond to repeated COVID-19 epidemics and public health emergencies in the future.

  • WANG Huizhen
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    Objective To explore and analyze the impact of WeChat public platform on patients' compliance with rabies vaccination. Methods Two hundred and forty patients who received rabies vaccine in our hospital's emergency department from August 2019 to January 2020 were selected.Patients who received rabies vaccine from August 2019 to October 2019 (before using the WeChat Official Account) were selected as the control group,and there were 130 patients in the group.Those patients who received rabies vaccine from November 2019 to January 2020 (after using the WeChat public platform) were selected as the experimental group,and there were 110 patients in the group.According to routine procedures,both the control group and the experimental group were given wound treatment,vaccination,and health education.After the doctor prescribed the vaccination,the experimental group was asked to scan the QR code to follow the Wechat public platform.And in the rabies vaccine vaccination function,the patients filled in personal information,and opened the reminder function.The last four shots of the experimental group were reminded 3 days in advance by WeChat through the mobile phone before each vaccine,and were reminded once a day in the morning till the day of the vaccination.The proportion of patients who received first,second,third,fourth,and fifth injections was compared in two groups.The proportion of patients who completed the entire vaccination process and those who did not complete the entire vaccination process were counted,and adverse reactions during the vaccination period were observed.Patient compliance and satisfaction were compared in two groups. Results There was no significant difference in the proportion of the first and second injections between the experimental group and the control group (P>0.05).The proportion of injections of the third,fourth,and fifth injections rate in the experimental group was higher than in the control group,and the difference was statistically significant (P<0.05).During the injection period,there was no significant difference in the incidence of adverse reactions between the two groups (P>0.05).The proportion of patients who completed the whole course of vaccination and patient satisfaction was higher in the experimental group than those in the control group,and the difference was statistically significant (P<0.05). Conclusion The application of the WeChat public platform has significantly increased the vaccination rate of rabies vaccination of patients throughout the course,and patients have better compliance and higher satisfaction.