最新刊期

    35 17 2024
    • ZHENG Yujie,JIANG Rong,CHEN Yixuan,LI Haiqi,YUAN Sihan,SHAO Rong
      Vol. 35, Issue 17, Pages: 2061-2067(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.01
      摘要:OBJECTIVETo analyze the practices of electronic drug instructions in the European Union (EU), the United States (US) and Japan, so as to provide references for promoting electronic drug instructions under Chinese existing regulatory systems.METHODSBy searching the official websites of FDA, European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA), as well as relevant literature, the practice and system of electronic drug instructions in different countries/regions were compared and analyzed. The problems of regulatory system, accessibility form and management system of electronic drug instructions in China were analyzed to put forward the suggestions. RESULT &CONCLUSIONSThe EU, the US and Japan had established relevant laws for the implementation of electronic drug instructions, issued guidance to specify management requirements and work processes, and set up information platforms to standardize data requirements and enrich search channels. In contrast, the practice of electronic drug instructions in China is still in its infancy, the implementation of electronic drug instructions in China still lacks legislative support, and its accessibility form and future regulatory system need to be further explored. It is suggested to take the opportunity to carry out the pilot reforms of the age-friendly and barrier-free environment for drug instructions in China, improve the regulatory system of electronic drug instructions, promote the readability of drug instructions by exploring the accessibility form of electronic drug instructions in stages, establish and improve the regulatory system of electronic drug instructions, actively build an electronic information platform for it, and promote the development and implementation of electronic drug instructions.  
      关键词:electronic instructions;readability;age-friendly   
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      发布时间:2024-09-09
    • DENG Ruimin,FU Yuqi,YANG Wei,SUN Lulu
      Vol. 35, Issue 17, Pages: 2068-2071(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.02
      摘要:OBJECTIVETo investigate the current allocation status of automated equipment in pharmacy intravenous admixture services (PIVAS) of medical institutions in China, and to provide reference for understanding the current status and future direction of PIVAS automation construction.METHODSIn the form of a questionnaire survey, a questionnaire was distributed to medical institutions in 30 provinces across the country through the “Wenjuanxing” platform to investigate the four aspects of PIVAS, such as the allocation of automated equipment, intelligent intravenous medication dispensing robots, design and development of workflow software and information integration methods for automated equipment, and conduct statistical analysis.RESULTSA total of 761 PIVAS participated in the survey, 373 PIVAS were equipped with automated equipment. Among 373 PIVAS with automated equipment, automatic finished infusion sorting machines and automatic labeling machines were the main equipment, and 93.56% of PIVAS were not equipped with intelligent intravenous medication dispensing robots; 511 PIVAS used workflow software designed and developed by third-party software companies. In the project of information integration for automated equipment, there was not much difference in the proportion of cases where there was no automated equipment, automated equipment directly interfaced with hospital information systems, and automated equipment interfaced with PIVAS software platform.CONCLUSIONSThe automated equipment allocation rate of PIVAS in China is relatively low, and there is still a lot of room for development. We should improve the relevant guidelines for automated equipment as soon as possible, promote standardized and reasonable equipment research and development, and enable PIVAS to more efficiently complete intravenous drug dispensing, in order to provide more comprehensive pharmaceutical services.  
      关键词:automated equipment;current situation investigation;dispensing robots   
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      发布时间:2024-09-09
    • CHEN Kunfu,LI Jun,GU Ling,WU Fuyu,SHI Aiping
      Vol. 35, Issue 17, Pages: 2072-2076(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.03
      摘要:OBJECTIVETo develop the evaluation system for the readability of drug instructions based on Chinese patient needs, and to provide scientific evidence for improving the readability of drug instructions in China.METHODSThe literature review and expert consultation were adopted to establish the evaluation index system for the readability of drug instructions. Then, by the analytic hierarchy process, the index weight in the evaluation system was determined, and the evaluation system for the readability of drug instructions was established. Fuzzy comprehensive evaluation was used to test the evaluation system, taking drug instruction of Dexamethasone acetate cream as an example.RESULTSThe evaluation system for the readability of drug instructions was established with 5 primary criteria such as text expression, numerical application, content design, behavioral suggestions, and layout design, as well as 17 sub-criteria such as easy-to-understand words and appropriately long sentences. The reliability and validity tests met the requirements. The result of 100 respondents evaluating the readability of the drug instructions of Dexamethasone acetate cream showed that the readability of drug instructions was scored as good as 4.24.CONCLUSIONSEstablished evaluation system for the readability of drug instructions in the study can be used to evaluate the quality and readability of drug instructions in China.  
      关键词:readability;evaluation system;analytic hierarchy process;fuzzy comprehensive evaluation method   
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      发布时间:2024-09-09
    • WANG Tao,PENG Tangyi,WANG Xu,CHEN Xiang,LIU Xueqiong
      Vol. 35, Issue 17, Pages: 2077-2081(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.04
      摘要:OBJECTIVETo develop the norms for the construction and acceptance of smart traditional Chinese medicine (TCM) pharmacy, and to provide guidance for the construction and acceptance of smart TCM pharmacy in medical institutions at all levels.METHODSIn April 2023, a drafting group was established to publicly solicit opinions through websites, meetings, and other means. Research was conducted through methods such as demand research, field visits, literature review, and expert interviews. Combined with the experience of TCM pharmacy construction in various medical institutions, the main content and requirements of smart TCM pharmacy construction, as well as the preparation of various acceptance indicators, were completed in December 2023.RESULTSThe construction and acceptance standards for smart TCM pharmacy in Anhui Province were completed. On February 11, 2024, the Anhui Provincial Administration for Market Regulation approved the release and implementation of the local standards for the Construction and Acceptance of Smart TCM Pharmacy (DB34/T4700-2024).CONCLUSIONSThe formulated standards are applicable to the construction and acceptance of smart TCM pharmacy in various medical institutions, provide a basis for medical institutions to carry out standardized construction and acceptance of smart TCM pharmacy, thus promoting the service capabilities of TCM pharmacy of medical institutions in Anhui Province.  
      关键词:construction specification;acceptance specification;standard formulation;functional guidance;intelligence   
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      发布时间:2024-09-09
    • LIU Jinglin,WANG Weiping,WANG Hongtao,GAO Ning,ZHANG Chao,ZHOU Xibei,WU Chunnuan,LU Lu,ZHANG Jie,SONG Xiaokun
      Vol. 35, Issue 17, Pages: 2082-2087(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.05
      摘要:OBJECTIVETo provide reference for strengthening the standardized management of off-label drug use in cancer hospitals.METHODSThe evaluation system for off-label drug use was established to standardize the application, approval, and filing process for off-label drug use in our hospital. The changes in off-label drug application quantity, proportion, disease category and drug category in our hospital were compared before (October 1st, 2021-September 30th, 2022) and after (October 1st, 2022-September 30th, 2023) the establishment of the evaluation system; drug items supported by high-level evidence screened by pharmacy department were analyzed statistically.RESULTSThe number of off-label drug use applications in our hospital had gradually increased, from 306 pieces in the fourth quarter of 2021 to 3 828 pieces in the third quarter of 2023. In the year before the construction of the evaluation system, there were a total of 4 482 applications for off-label drug use, and in the year after the construction of the evaluation system, there were 11 840 applications for off-label drug use. After the construction of the evaluation system, the proportion of unregistered off-label drug use significantly decreased, compared to the same period last year (P<0.05). Among them, there were no unregistered applications for off-label drug use for digestive system tumors, head and neck tumors, and radioactive drugs; lymphoma, breast tumors, urogenital system tumors, cytotoxic drugs and new anti-tumor drugs all had a decrease of over 70% in unregistered off-label drug applications. Twenty-seven off-label drug use items related to 19 drugs supported by high-level evidence were screened by the pharmacy department of our hospital, among which 25 items were drug use beyond indication.CONCLUSIONSThe establishment of off-label drug use evaluation system in cancer hospital is helpful to the rational use and refined management of clinical anti-tumor drugs.  
      关键词:anti-tumor drugs;evaluation system;evidence-based reference   
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      发布时间:2024-09-09
    • HE Xudong,SONG Chengzhu,NI Haoyu,HU Yunkai,LI Min,CHEN Dajun,SU Wentao,YU Jie,YANG Xingxin
      Vol. 35, Issue 17, Pages: 2088-2095(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.06
      摘要:OBJECTIVETo explore the action mechanism of kushenol F (KSCF) in treating ulcerative colitis (UC) in mice.METHODSThe potential targets of KSCF intervening in UC were predicted with network pharmacology and molecular docking. C57BL/6J mice were randomly divided by body weight into model group, positive control group (sulfasalazine, 703 mg/kg), KSCF group (100 mg/kg), and normal group, with 6 mice per group. The UC model of mice was induced by dextran sulfate sodium solution. During the modeling period, the mice were given relevant medicine intragastrically, once a day, for 7 consecutive days. After the last administration, the disease activity index (DAI) of the mice was scored; the length of the mice’s colon was measured; pathological changes in the colon tissue of mice were observed; the levels of lipopolysaccharide (LPS) in serum, myeloperoxidase (MPO), nitric oxide (NO) and superoxide dismutase (SOD) in the colon were detected in mice; the expression levels of occludin and ZO-1 in colon tissue of mice were detected; the proportions of CD3+T, CD4+T, and CD8+T lymphocytes in the spleen and the ratio of CD4+/CD8+ were detected; changes in colonic microbiota were analyzed by 16S rDNA sequencing.RESULTSResults of network pharmacology indicated that KSCF may treat UC by regulating signaling pathways such as phosphatidylinositol-3 kinase/protein kinase B (PI3K/AKT) and nuclear factor kappa B (NF-κB). Molecular docking results showed that KSCF bound most stably with NF-κB p65 protein. Animal experiment results demonstrated that, compared with the model group, the pathological characteristics of colon tissue in mice were improved in KSCF group. DAI scores, serum levels of LPS, the levels of MPO, NF-κB p65 phosphorylation and NLRP3 protein expression in the colon, and the proportion of CD8+T lymphocytes in the spleen were reduced significantly (P<0.05). Body weight, SOD levels, expression levels of occludin and ZO-1 in the colon, proportions of CD3+T and CD4+T lymphocytes, and the CD4+/CD8+ ratio in the spleen were significantly increased (P<0.05); the abundance of Firmicutes, Actinobacteria, Akkermansia, and Lactobacillus genera were increased, while Proteobacteria decreased; the microbial community structure tended towards that of the normal group.CONCLUSIONSKSCF alleviates UC by restoring intestinal microbial imbalance, enhancing immune response, and inhibiting colonic inflammatory responses, thereby improving intestinal barrier integrity.  
      关键词:ulcerative colitis;immune response;gut microbiota;inflammation;oxidative stress;16S rDNA sequencing   
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      发布时间:2024-09-09
    • WANG Xin,LU Hua,KONG Lujiao,GUO Xiaoyang,MA Tingting,LU Yue
      Vol. 35, Issue 17, Pages: 2096-2101(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.07
      摘要:OBJECTIVETo investigate the protective effect and mechanism of cryptotanshinone (CTS) on heart and kidney function in rats with cardiorenal syndrome (CRS) by regulating phosphoinositide kinase-3 (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway.METHODSCRS model of rats was induced by left anterior descending coronary artery ligation combined with acute renal ischemia-reperfusion injury. Model rats were randomly divided into CRS model group (CRS group), low-dose CTS group (CTS-L), high-dose CTS group (CTS-H group), high-dose CTS+PI3K activator 740Y-P group (CTS-H+740Y-P group), with 12 rats in each group. Another 12 rats were selected as the normal control group (Normal group) and were carried out surgery without modeling. CTS-L group and CTS-H group were respectively given CTS 30 and 60 mg/kg intragastrically, once a day, for consecutive 14 d. Besides the intervention of CTS 60 mg/kg intragastrically, CTS-H+740Y-P group was given 10 mg/kg 740Y-P intraperitoneally, once a day, for 14 consecutive days. After the last medication, the levels of cardiac function [left ventricular ejection fraction (LVEF), left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), left ventricular fraction shortening (LVFS)] and renal function [24 h urinary protein, blood urea nitrogen (BUN), serum creatinine (Scr), brain natriuretic peptide (BNP)] were detected in rats. The pathological changes and fibrosis of the heart and kidney in rats were observed; the expressions of PI3K/Akt/mTOR signaling pathway in heart and renal tissue were all detected.RESULTSCompared with Normal group, the levels of LVEF and LVFS in rats were all decreased significantly in CRS group (P<0.05); the levels of LVESD, LVEDD, 24 h urinary protein, serum levels of BUN, Scr and BNP, collagen area and the phosphorylation of PI3K, Akt and mTOR protein in heart and renal tissue were all increased significantly (P<0.05). The morphology of myocardial cells was enlarged and disordered; the structure of renal tubules was disordered, epithelial cells were wrinkled, and there was infiltration of inflammatory cells. Compared with CRS group, the above indexes of rats were reversed significantly in CTS-L group and CTS-H group (P<0.05); heart and kidney function had been restored, and pathological damage and fibrosis had been reduced. PI3K activator 740Y-P weakened the protective effect of CTS on cardiac and renal function in CRS rats.CONCLUSIONSCTS can protect heart and kidney function in CRS rats, the mechanism of which may be associated with inhibiting the PI3K/Akt/mTOR signaling pathway.  
      关键词:PI3K/Akt/mTOR signaling pathway;cardiorenal syndrome;heart and kidney function   
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      发布时间:2024-09-09
    • LIANG Jin,XU Dan,DU Jinjun
      Vol. 35, Issue 17, Pages: 2102-2107(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.08
      摘要:OBJECTIVETo investigate the effect and mechanism of asperuloside on liver fibrosis in non-alcoholic fatty liver disease (NAFLD) rats by regulating the sphingosine kinase 1 (SphK1)/sphingosine-1-phosphate (S1P) signaling pathway.METHODSSD rats were fed with a high-fat diet to establish a NAFLD model. They were randomly separated into model group, asperuloside low-dose group (14 mg/kg, i.g., similarly hereinafter), asperuloside high-dose group (28 mg/kg), high dose of asperuloside (28 mg/kg)+pc-NC (empty plasmid, 50 µg, via tail vein, similarly hereinafter) group, and high dose of asperuloside (28 mg/kg)+pc-SphK1 (SphK1 overexpression plasmid, 50 µg) group, with 12 rats in each group. Another 12 rats were fed with a normal diet as control group. Each group was given relevant medicine or plasmid intragastrically once a day or via tail vein twice a week, for 3 consecutive weeks. After the last medication, the levels of blood lipid indexes [total cholesterol (TC), triglyceride (TG), and free fatty acid (FFA)] and liver function indexes [aspartate transaminase (AST) and alanine transaminase (ALT)] were detected in each group. The pathological changes of liver tissue and liver fibrosis in rats were also observed in each group. The levels of serum fibrosis-related factors [procollagen type Ⅲ (PCⅢ), collagen type Ⅳ (Ⅳ-Col), laminin (LN)], pro-fibrotic factor [transforming growth factor-β1 (TGF-β1)], and pro-inflammatory factors [interleukin-1β (IL-1β), inducible nitric oxide synthase (iNOS), IL-6] of rats were determined in each group. The expressions of collagen formation-related proteins (Ⅰ-Col, Ⅳ-Col) and SphK1/S1P pathway-related proteins in the liver tissues of rats were detected in each group.RESULTSCompared with control group, the liver tissue of rats in model group showed significant pathological damage; the NAFLD activity score, liver tissue collagen volume fraction, serum levels of TC, TG, FFA, AST, ALT, PCⅢ, Ⅳ-Col, LN, TGF-β1, IL-1β, iNOS and IL-6, and protein expressions of Ⅰ-Col, Ⅳ-Col, SphK1 and S1P in liver tissue were greatly increased (P<0.05). Compared with the model group, the liver tissue pathological damage symptoms of rats in asperuloside low-dose and high-dose groups were improved, and the above indexes were all reduced significantly (P<0.05); moreover, the high-dose group had a better effect (P<0.05). Compared to asperuloside high-dose group, high dose of asperuloside+pc-NC group, the pathological damage of liver tissue symptoms in rats were aggravated in high dose of asperuloside+pc-SphK1 group, and the above indexes were all increased significantly (P<0.05).CONCLUSIONSAsperuloside can reduce the expressions of pro-fibrotic factor, pro-inflammatory factors and collagen formation-related proteins by inhibiting the activity of SphK1/S1P signaling pathway, thus alleviating liver fibrosis in NAFLD rats.  
      关键词:non-alcoholic fatty liver disease;liver fibrosis;SphK1/S1P signaling pathway   
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      发布时间:2024-09-09
    • LU Yuxuan,JIANG Zhiwei,XIE Yijun,WANG Yizhu,HA Jingwen,SHU Yachun
      Vol. 35, Issue 17, Pages: 2108-2113(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.09
      摘要:OBJECTIVETo study the improvement effect and mechanism of Shuhou tongqi formula on intestinal injury in mice with postoperative ileus (POI).METHODSMice were randomly divided into sham operation group, model group, positive control group (Mosapride citrate tablets, 1.95 mg/kg), and Shuhou tongqi formula group (1.88 g/kg), with 6 mice in each group. Except for the sham operation group, POI model was induced in other groups by typical small intestinal interference. Each group was given relevant drug liquid/water, once a day, for consecutive 2 days. After the last medication, the percentage of carbon powder propulsion in small intestine was detected, and pathomorphological changes in ileum tissue of mice were observed. The serum levels of interleukin-6 (IL-6), IL-10, tumor necrosis factor-α (TNF-α), motilin (MTL) and somatostatin (SS) were all detected; the expression levels of Toll-like receptor 4 (TLR4), nuclear factor κB (NF-κB p65) and p38 mitogen-activated protein kinase (p38 MAPK) were determined in ileal tissue of mice; the gut microbiota of colon contents was analyzed in each group of mice.RESULTSAfter the intervention of Shuhou tongqi formula, pathological damage such as intestinal wall atrophy and mucosal capillary congestion in ileum tissue were improved significantly; the percentage of carbon powder propulsion and the serum level of IL-10 and MTL were increased significantly (P<0.05); however, serum levels of TNF-α, IL-6 and SS, the expressions of TLR4, NF-κB p65 and p38 MAPK were decreased significantly (P<0.05). The analysis of gut microbiota showed that Shuhou tongqi formula could significantly increase ACE, Chao1, Shannon and PD indexes, and relative abundance of Akkermansia (P<0.05), but decreased relative abundance of Proteobacteria, Ligilactobacillus and Escherichia-Shigella significantly (P<0.05).CONCLUSIONSShuhou tongqi formula can improve intestinal injury and inflammatory reaction of POI mice, the mechanism of which may be associated with inhibiting the activity of TLR4/NF-κB/MAPK signaling pathway, regulating the levels of gastrointestinal hormones and improving the disturbance of intestinal flora in mice.  
      关键词:postoperative ileus;intestinal injury;inflammatory factor;intestinal flora   
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      发布时间:2024-09-09
    • GUO Ya,WEN Haitang,XIE Youjia,XIE Fei,WANG Bing,CHEN Yongbang,YANG Ning,YANG Chen,WAN Ning
      Vol. 35, Issue 17, Pages: 2114-2119(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.10
      摘要:OBJECTIVETo predict the possible impact of pembrolizumab(PEM) as a first-line drug after being included in the national medical insurance system in the treatment of advanced or metastatic non-small cell lung cancer based on real-world data from the perspective of the national medical insurance payer, to provide a basis for the decision-making of the medical insurance department.METHODSA budget impact analysis model was constructed to compare the impact of pembrolizumab not included in medical insurance and included in medical insurance on medical insurance fund expenditure in the next five years (2024-2028) with 2023 as the baseline year. The target population was the patients with EGFR gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative locally advanced or metastatic non-small cell lung cancer; estimated cost mainly included the cost of drugs, the cost of adverse reaction treatment, the cost of examination, the cost of admission and monitoring, etc; equipment ratio of PEM in 183 hospitals of Guangdong province from 2020 to 2022 was used as the market share. Univariate sensitivity analysis was used to test the robustness of the basic analysis results.RESULTSWhen PEM was not included in the medical insurance, the medical insurance reimbursement amount of the target population from 2024 to 2028 was 4 933 623.5 thousand yuan-5 151 198.3 thousand yuan, respectively. If PEM was included in the medical insurance, the above data were 11 871 972.2 thousand yuan-14 540 571.0 thousand yuan, respectively; the increase in medical insurance reimbursement under the two scenarios was 6 720 773.9 thousand yuan-9 606 947.5 thousand yuan, respectively. The proportion of medical insurance reimbursement to the medical insurance expenditure of the year after PEM was included in medical insurance was 0.298 0%, 0.262 1%, 0.228 8%, 0.208 2%, and 0.185 7%, respectively. The increase in medical insurance reimbursement accounted for 1.084 0%, 0.995 7%, 0.888 6%, 0.886 3%, and 0.861 6% of the increase in the expenditure of the medical insurance fund in the current year, all of which showed a decreasing trend year by year.CONCLUSIONSIf PEM is included in medical insurance, due to its high unit price, the medical expenditure will increase accordingly, which will have a great impact on the medical insurance fund expenditure. However, when the drug is used in patients with EGFR mutation-negative and ALK-negative locally advanced or metastatic non-small cell lung cancer, the proportion of the medical insurance reimbursement amount in the current year’s medical insurance fund expenditure and the proportion of the increase in medical insurance reimbursement in the current year’s increase in medical insurance fund expenditure are decreasing year by year.  
      关键词:non-small cell lung cancer;budget impact analysis;real-world data;EGFR gene mutation-negative;anaplastic lymphoma kinase-negative;health insurance   
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      发布时间:2024-09-09
    • YANG Xiaojuan,ZHANG Qingwen,DU Xiaosa,DONG Jinpeng,HU Yiming,WANG Shudi,FENG Yubin
      Vol. 35, Issue 17, Pages: 2120-2125(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.11
      摘要:OBJECTIVETo screen potential adverse drug event (ADE) signals for the treatment of multiple sclerosis (MS) with ofatumumab, and to provide reference for the safe use of drugs in clinical practice.METHODSUsing “ofatumumab” and the trade name “Kesimpta” as the search keywords, adverse event (AE) reports related to ofatumumab included in FDA Adverse Event Reporting System database from January 2009 to December 2023 were screened, and their reason contained the “multiple sclerosis”; ADE signal mining and analysis were conducted by reporting odds ratio method and proportional reporting ratio method.RESULTSA total of 21 759 eligible AE reports were selected, involving 62 449 AE cases; 27 system organ classes included general diseases and various reactions at the site of administration (15 021 cases), neurological diseases (9 668 cases), infectious and invasive diseases (5 967 cases), injury, poisoning and surgical complications (4 952 cases), musculoskeletal and connective tissue disorders (4 647 cases). A total of 21 759 AE reports correspond to 606 ADE signals, including 234 ADE positive signals. A total of 107 ADE positive signals were not included in drug instruction of ofatumumab, including flu-like diseases, nasopharyngitis, cough, urinary tract infection, sore throat, insomnia, runny nose, anemia, hair loss, atrial fibrillation, and thrombocytopenia, etc.CONCLUSIONSIn the process of using ofatumumab for MS, sufficient attention should be paid to ADE included in drug instructions. The ADE with strong signal strength screened in this study should also be paid special attention to, such as flu-like diseases, hemocytopenia, temperature intolerance, optic neuritis, and moyamoya disease. The increased risk of infection, cardiovascular disease, and potential damage to the respiratory and spiritual systems caused by ofatumumab can not be ignored.  
      关键词:multiple sclerosis;FAERS data;reporting odds ratio method;proportional reporting ratio method;adverse drug event;nasopharyngitis;atrial fibrillation   
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      发布时间:2024-09-09
    • ZHANG Liyi,JIANG Fengxi,GUI Dingqing
      Vol. 35, Issue 17, Pages: 2126-2130(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.12
      摘要:OBJECTIVETo explore the short-term and long-term efficacy of bevacizumab combined with paclitaxel (PTX) and carboplatin (CBP) chemotherapy in the treatment of persistent or recurrent cervical cancer, as well as its impact on patient quality of life, tumor markers and safety.METHODSTotally 80 patients with persistent or recurrent cervical cancer admitted to our hospital from January 2020 to October 2022 were randomly divided into control group (40 cases) and observation group (40 cases) using a random number table method. Both groups received PTX+CBP chemotherapy, while the observation group was treated with bevacizumab in combination. Both groups were treated continuously for 6 cycles. The recent efficacy, the incidence of toxic side effects as well as European Organization for Research and Treatment of Cancer Life Questionnaire Core 30 (EORTC QLQ-C30) scores, and the serum tumor markers [carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125), and squamous cell carcinoma antigen (SCCA)] levels before and at the end of the entire course of treatment were compared between two groups. The survival curves of the two groups were drawn by using Kaplan-Meier method, and progression-free survival (PFS) and overall survival (OS) were compared between the two groups by Log-rank test.RESULTSThe objective response rate of the observation group was significantly higher than that of the control group (62.50% vs. 35.00%, P<0.05), and the median PFS (9.30 months vs. 6.30 months) and median OS (14.90 months vs. 10.60 months) were also significantly longer than the control group (P<0.05). EORTC QLQ-C30 score of the observation group after treatment was significantly higher than that of the control group (P<0.05). Compared to before treatment, the serum levels of CEA, CA125 and SCCA in both groups were significantly reduced after treatment (P<0.05), while the observation group had a larger decrease (P<0.05). There was no significant difference in the grading of various types of toxic side effects between the two groups during treatment (P>0.05). Most patients experienced automatic disappearance of toxic side effects 1-2 months after discontinuation of medication, or symptoms disappearance after symptomatic treatment.CONCLUSIONSThe combination of bevacizumab and PTX+CBP chemotherapy regimen can effectively improve the objective efficacy rate of persistent or recurrent cervical cancer, reduce serum tumor marker levels, improve patient quality of life, prolong survival, and have good safety.  
      关键词:recurrent cervical cancer;bevacizumab;paclitaxel;carboplatin;therapeutic efficacy;quality of life;tumor markers;safety   
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      发布时间:2024-09-09
    • LIAO Dan,LI Guihua,HUANG Guangchi
      Vol. 35, Issue 17, Pages: 2131-2135(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.13
      摘要:OBJECTIVETo evaluate the clinical efficacy of Baogong zhixue granule combined with medroxyprogesterone acetate (MPA) in the treatment of perimenopausal abnormal uterine bleeding (AUB) (yin deficiency and blood heat syndrome).METHODSA total of 146 patients with perimenopausal AUB (yin deficiency and blood heat syndrome) admitted to Hainan Modern Women and Children’s Hospital from March 2022 to February 2023 were prospectively enrolled and divided into control group (73 cases) and combined group (73 cases) by random number table method. The control group took MPA orally, 10 mg each time, twice a day; the combined group took Baogong zhixue granule on the basis of the control group, 15 g each time, 3 times a day. Both groups started taking the medicine from the 5th day of menstruation, and took the medicine for 22 days as a treatment cycle. Both groups were treated for 2 consecutive cycles and followed up for 12 months. The bleeding control time, complete hemostasis time, endometrial thickness, total effective rate, recurrence rate, traditional Chinese medicine syndrome score, sex hormone and inflammatory factor levels, and adverse reactions were compared between the two groups.RESULTSThe bleeding control time and complete hemostasis time of the combined group after treatment were significantly shorter than those of the control group (P<0.05), and the scores of light-color menstrual blood or clots, lower abdominal pain, sallow complexion, and fatigue and shortness of breath were significantly lower than those of the control group (P<0.05). The total effective rates of the combined group at 1, 3, 6 and 12 months after treatment were significantly higher than those of the control group (P<0.05), and the overall recurrence rate within 12 months was significantly lower than that of the control group (P<0.05). Compared with before treatment, the endometrial thickness, the serum sex hormones (follicle stimulating hormone, estradiol, and luteinizing hormone), and the inflammatory factors (interleukin-6, tumor necrosis factor-α) levels of the two groups after treatment were significantly reduced or decreased (P<0.05), and the reduction or decrease in the combined group was greater than the control group (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05).CONCLUSIONSBaogong zhixue granules combined with MPA are effective in treating perimenopausal AUB (yin deficiency and blood heat syndrome). They can quickly stop bleeding, inhibit endometrial hyperplasia, and regulate the levels of serum sex hormones and inflammatory factors. They also have a low recurrence rate and high safety.  
      关键词:Baogong zhixue granules;medroxyprogesterone acetate;yin deficiency and blood heat syndrome;perimenopausal period;therapeutic effect;endometrial thickness;sex hormones;inflammatory factors   
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      发布时间:2024-09-09
    • CAO Wenjing,ZHANG Peng,XIAO Can,LIU Xiang
      Vol. 35, Issue 17, Pages: 2136-2141(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.14
      摘要:OBJECTIVETo optimize drug treatment plans for patients in cardiovascular FM35 disease group using full-process pharmaceutical services, and achieve the goals of ensuring patient medication safety and controlling drug costs.METHODSOverall 213 patients in the cardiovascular FM35 disease group who were discharged from July to August 2023 were selected as control group; all medical orders were screened and complex network analysis and drug evaluation standards of our hospital were used to establish an optimized treatment drug library; 83 FM35 patients who newly admitted to the cardiovascular department in September 2023 were selected as intervention group; a model of policy promotion-treatment plan intervention was established and applied to provide full process pharmaceutical services to patients. The treatment cost, length of stay and outcome were analyzed and compared between 2 groups.RESULTSThrough the full process pharmaceutical services provided by clinical pharmacists, compared with the control group, the total hospitalization cost, drug cost, drug proportion, and case proportion of medical insurance settlement amount in the intervention group significantly decreased (P<0.05). The median length of hospital stay in the intervention group was shortened by 1 d, and the discharge improvement outcome rates of both groups of patients were ≥99%.CONCLUSIONSClinical pharmacists can effectively improve the efficiency of medical services and save the medical costs through full-process pharmaceutical services, meanwhile ensuring medical quality and safety. This can effectively assist in the smooth implementation of DRGs.  
      关键词:DRG;clinical pharmacist;drug cost control;complex network analysis method;residency pharmaceutical service   
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      发布时间:2024-09-09
    • SUN Min,XIN Benru,LI Ying,QI Xiaoyan,LIU Jianfang,XU Li
      Vol. 35, Issue 17, Pages: 2142-2146(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.15
      摘要:OBJECTIVETo explore the new idea of creating pharmaceutical science popularization oriented by internet medication consultation questions, and provide references for pharmacists to create high-quality pharmaceutical science popularization articles.METHODSBy taking the internet medication consultation questions from September 1st, 2021 to February 28th, 2022 in a hospital as samples, pharmaceutical science popularization were created by using the Pareto chart for summarizing and analyzing the demands of the public pharmaceutical knowledge. The readers and creating cycle of pharmaceutical science popularization before and after the implementation of this method were compared by statistical analysis.RESULTSAccording to the Pareto principle, the types of consultation questions were mainly concentrated on usage and dosage, adverse reactions, and precautions; the types of drug consultation were mainly concentrated on respiratory system medications, anti-infective drugs, rheumatic immune system medications, and orthopedic medications, etc. Fifteen topics of science popularization were identified. Among them, 5 were published before 2022 and did not adopt the Pareto chart method, serving as the pre-method and consistent with the target theme group (A group); 10 were published in 2022 after adopting the Pareto chart method, serving as the post-method group (B group); 5 articles published before 2022 were selected randomly, without adopting the Pareto chart method and inconsistent with the target theme, serving as the pre-method and inconsistencies with the target theme group (C group). Compared with the A group and the C group, the creating cycle of pharmaceutical science popularization in the B group was significantly reduced. Compared with the C group, the readers were significantly increased in the A group and the B group.CONCLUSIONSPareto chart could help pharmacists utilize medication consultation questions to identify the pharmaceutical science popularization needed by the public, which could improve the efficiency and quality of creating pharmaceutical science popularization by pharmacists.  
      关键词:Pareto chart;internet medication consultation;problem-oriented   
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      发布时间:2024-09-09
    • WANG Jinping,ZHAO Jie,YANG Chunyan,LAI Xiaomin,ZHU Yunteng,WU Zhi’ang
      Vol. 35, Issue 17, Pages: 2147-2151(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.16
      摘要:OBJECTIVETo explore the practicality of the pharmaceutical pathway for prophylactic use of antibiotics during the perioperative period of class Ⅰ neurosurgery incisions.METHODSThe previously established pharmaceutical pathway for the prophylactic use of antibiotics in the perioperative period of class Ⅰ neurosurgery incisions was used to retrospectively evaluate the prophylactic use of antibiotics in 127 cases. The “antibiotics prophylactic use scoring system” in the pharmaceutical pathway was used to conduct preoperative scoring, and the patient’s actual antibiotics use was compared and analyzed in combination with existing Guiding Principles for Clinical Application of Antibiotics (2015 Edition) (hereinafter referred to as the Guiding Principles). The pharmaceutical pathway also innovatively proposes key points for improvement in terms of the frequency of adding antibiotics during surgery and the duration of prophylactic use of antibiotics after surgery. By comparing with the actual medication situation of patients, the direction for updating the Guiding Principles was explored.RESULTSAccording to the retrospective analysis results, for neurosurgery class Ⅰ incision surgery, in addition to the preoperative prophylactic use of antibacterial drugs for skull mass resection and carotid endarterectomy recommended in the guidelines, endoscopic trigeminal microvascular decompression, arthroscopy and other specific joint examinations, spinal nerve Radical decompression, endoscopic lumbar nucleectomy, dural repair, and spinal canal decompression can also be further explored about the situation of not using antibacterial prophylaxis before surgery; at the same time, for the patients undergoing class Ⅰ neurosurgery incisions, the use of antibiotics during and after surgery may be considered for a second addition of antibiotics, taking into account the surgical time. If cerebrospinal fluid leakage occurred after surgery, it is recommended to extend the duration of prophylactic use of antibiotics appropriately.CONCLUSIONSThe application of pharmaceutical pathways can provide more targeted analysis of key points in the prevention of antibiotic use, which promotes the transformation of perioperative antibiotics management for class Ⅰ incisions from “qualitative, empirical” management to “quantitative, scientific” management.  
      关键词:neurosurgery;class Ⅰ incisions;antibiotics;prophylactic use of drugs   
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      发布时间:2024-09-09
    • YANG Fang,LIU Xingchen,LIU Xingyu,LIU Xiaoyong,XIANG Cheng,YANG Caijun
      Vol. 35, Issue 17, Pages: 2152-2157(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.17
      摘要:OBJECTIVETo investigate and analyze the use of acetaminophen in primary medical institutions of Shaanxi province, and to provide evidence for promoting the standardized and rational use of acetaminophen.METHODSAccording to the method of cluster stratified random sampling, all prescriptions of acetaminophen issued by primary medical institutions in one district and one county (or two districts) were randomly selected from 10 provincial cities of Shaanxi province from 2020 to 2023; the existing clinical diagnoses were classified by using the International Classification of Diseases (ICD) code, and the drug information of collected prescriptions was analyzed descriptively. SPSS 25.0 software was used for single-factor analysis and Logistic regression analysis to find out the key factors affecting the duration of medication >10 d.RESULTSA total of 7 375 valid prescriptions for acetaminophen were collected in this study. The patients who used acetaminophen were mainly female (52.11%) and aged 19-64 (66.73%). Based on the ICD code, the disease categories most involved in the use of acetaminophen were musculoskeletal system, connective tissue diseases or symptoms and signs (43.48%); the top 3 clinical diagnoses were joint disease (25.59%), fracture (9.95%), and toothache (8.58%). Among the 7 175 prescriptions with clear drug usage and dosage, 3 366 were in line with the recommendation of acetaminophen instruction, and 5.63% of the prescriptions exceeded the maximum dose limit of acetaminophen 2.0 g/d. There were 4 051 prescriptions exceeding the conventional limit of treatment duration (7 d), and 1 336 prescriptions exceeding the limit of treatment duration (10 d). The main factors affecting the duration of drug treatment >10 d were the region and type of medical institutions, the gender and age of patients, and the phenomenon of the duration of drug treatment >10 d was common in the primary medical institutions from southern Shaanxi, township health centers, the elderly and female patients.CONCLUSIONSThere are some unreasonable clinical applications of acetaminophen in primary medical institutions of Shaanxi province, which are mainly manifested in inappropriate usage and dosage, unsuitable clinical diagnosis and drug duration. The region, type of medical institution, age and gender of patients will affect the duration of this drug prescription.  
      关键词:primary medical institutions;analgesics;rational drug use;Shaanxi province   
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      发布时间:2024-09-09
    • LI Mengyin,SONG Guihua,WANG Tingting,REN Mingyue
      Vol. 35, Issue 17, Pages: 2158-2164(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.18
      摘要:Bronchial asthma (referred to as “asthma”) is a heterogeneous airway disease characterized by chronic airway inflammation and airway remodeling. Its pathogenesis is complex, the incidence is high and the disease is easy to repeat. Autophagy plays an important regulatory role in improving asthma symptoms. By regulating autophagy-related proteins and signaling pathways,the active components of traditional Chinese medicine (such as flavonoids, anthraquinones, terpenoids) and traditional Chinese medicine compounds (such as Wuhu decoction, Pingchuan granule, Sanzi yangqin decoction) can inhibit airway inflammatory response,reduce airway hyperresponsiveness,and alleviate airway remodeling,thus playing a role in the treatment of asthma. However, most of the current studies are basic studies,and the quality of evidence is not high.In the future,high-quality clinical and basic studies should be further carried out to fully demonstrate the scientific nature of traditional Chinese medicine in the treatment of asthma by regulating autophagy.  
      关键词:autophagy;active components of traditional Chinese medicine;traditional Chinese medicine compound;research progress   
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      发布时间:2024-09-09
    • YUAN Xinwen,ZHAO Zhenyu
      Vol. 35, Issue 17, Pages: 2165-2170(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.19
      摘要:Anticoagulants are the cornerstone of the prevention and treatment of thromboembolic diseases. Existing parenteral and oral anticoagulants achieve effective control of thrombosis by interfering with key aspects of the coagulation cascade reaction, but this is accompanied by an increased risk of bleeding. FⅪ inhibitors, anticoagulants targeting coagulation factor Ⅺ (FⅪ), can block the amplification phase of the thrombin generation process by inhibiting FⅪ, reducing thrombogenesis with less impact on normal hemostatic effects, and have become one of the most promising new anticoagulants. There are currently no marketed FⅪ inhibitor drugs, while FⅪ inhibitors in phase Ⅱ or phase Ⅲ clinical trials include 3 classes:antisense oligonucleotide, monoclonal antibody and small molecule inhibitors. In addition, most of the natural inhibitors and nucleic acid aptamers targeting FⅪ are under preclinical development. As new target drugs for anticoagulation therapy, FⅪ inhibitors are expected to become a safer and more effective therapeutic option, compensating for the limitations of current anticoagulants and providing patients with more effective thromboprophylaxis and therapeutic options while reducing the risk of bleeding.  
      关键词:coagulation factor Ⅺ;thrombosis;FⅪ inhibitors;thromboembolic disease   
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      发布时间:2024-09-09
    • JIN Panpan,LIU Yang,QIU Bo,WU Huizhen
      Vol. 35, Issue 17, Pages: 2171-2175(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.20
      摘要:Tafamidis is a selective stabilizer for transthyretin (TTR), used for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and transthyretin amyloidosis with polyneuropathy (ATTR-PN). This article provides a review of the basic information and clinical studies on the efficacy and safety of tafamidis. It is found that tafamidis slows down or prevents the progression of TTR amyloidosis by inhibiting the dissociation of TTR tetramers. Multiple clinical studies have shown that tafamidis has good efficacy and safety, significantly reducing all-cause mortality and cardiovascular-related hospitalization rates in patients with amyloidosis, and delaying disease progression. Although tafamidis treatment may have certain limitations, it is still a key drug for the treatment of TTR amyloidosis, and the first drug approved for the treatment of ATTR-CM.  
      关键词:transthyretin;amyloid transthyretin;clinical research   
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      发布时间:2024-09-09
    • HE Chunbo,WANG Dan,YANG Shujia,ZHOU Kaiwen,DENG Yiping,DONG Shouliang
      Vol. 35, Issue 17, Pages: 2176-2180(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.21
      摘要:Opioid analgesics are currently known as the best analgesics. However, toxicity and side effects such as constipation, tolerance and addiction severely limit their clinical application. With the in-depth understanding of the signal transduction mechanism of opioid receptors and the continuous advancement of drug design technology, researchers have managed to develop many promising new methods to get low-toxic and more efficient opioid analgesics, which are different from the traditional morphine skeleton structure modifications. This article focuses on three new research strategies of G-protein biased activation, “one drug-multiple targets” and peripheral activation. The basic principles of relative separation of analgesic activity and adverse drug reaction by each strategy are introduced, and the latest research progress of representative drugs is briefly reviewed. Among them, the recently approved novel opioid analgesics oliceridine and tegileridine are G-protein biased μ-opioid receptor agonists, Cebranopadol is a typical “one drug-multiple targets” analgesic, and NFEPP is a representative drug of peripheral opioid receptor agonists. The above several strategies complement each other and provide reference for the development of new opioid analgesic drugs.  
      关键词:biased agonist;one drug-multiple targets;peripheral agonist;new drug development   
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      发布时间:2024-09-09
    • ZHANG Yi,CHEN Ping,WU Yueliang,XUE Miaomiao,SUN Jianhua
      Vol. 35, Issue 17, Pages: 2181-2187(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.22
      摘要:Polycystic ovary syndrome (PCOS) is a common endocrine disorder among women of childbearing age. Persistent chronic inflammation can promote the progression of PCOS, thereby causing serious impacts on women’s endocrine metabolism, reproductive function, and psychological status. Nuclear factors-κB (NF-κB) signaling pathway is one of the most classic inflammatory response transduction pathways and is closely related to the pathological process of PCOS. This article summarizes the mechanism of traditional Chinese medicine intervention in PCOS based on the NF-κB signaling pathway, and finds that various monomers of traditional Chinese medicine [flavonoids (naringenin, soy isoflavone, rhamnocitrin, etc.), alkaloids (berberine, ligustrazine) and terpenoids (artesunate, cryptotanshinone), glycosides (salidroside, glycyrrhizic acid)] and traditional Chinese medicine compounds [formula for tonifying kidney (Bushen huayu formula, Bushen huatan formula, etc.), formula for eliminating damp and dissolving phlegm (Cangfu daotan decoction, Xiehe yin, Erchen decoction), formula for regulating blood circulation and removing stasis (Gexia zhuyu decoction, Huatan tongmai yin)] can alleviate inflammatory response, improve abnormal glucose and lipid metabolism, and enhance ovarian function by inhibiting NF-κB signaling pathway, thus improving PCOS.  
      关键词:NF-κB signaling pathway;traditional Chinese medicine;inflammation   
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      发布时间:2024-09-09
    • LU Dongyuan,JIN Jianfeng,LUO Weiwei,QIAN Qilei,WEN Xiaoya
      Vol. 35, Issue 17, Pages: 2188-2192(2024) DOI: 10.6039/j.issn.1001-0408.2024.17.23
      摘要:pontaneous abortion is one of the most common complications of pregnancy, and two or more spontaneous abortions in a row are defined as recurrent spontaneous abortion (RSA), of which about half of patients have unknown etiology. However, the pathogenesis of unexplained RSA (URSA) has not been elucidated, and the lack of effective treatment has made it one of the key and difficult points in the field of obstetrics and gynecology. This article conducts a literature review of recent research on URSA and finds that the pathogenesis of URSA is related to the imbalance of immune tolerance at the maternal-fetal interface, apoptosis of trophoblast cells, inhibition of angiogenesis, and activation of immune responses. Immunotherapy (including cell therapy, cytokine therapy, and immunosuppressive intervention), hormone drugs, anticoagulant regimens, and traditional Chinese medicine therapies are commonly used in clinical practice to intervene in URSA, but the safety and effectiveness of some therapies are still controversial.  
      关键词:pathogenesis;therapies;immune   
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      发布时间:2024-09-09
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