最新刊期

    35 23 2024
    • Chongqing Pharmaceutical Association,The Drafting Team of Expert Consensus on Pharmaceutical Active Consultation Service in Medical Institutions
      Vol. 35, Issue 23, Pages: 2837-2843(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.01
      摘要:OBJECTIVETo further standardize the implementation and management standards of pharmaceutical active consultation in medical institutions and provide a reference for providing high-quality pharmaceutical services.METHODSGuided by the Chongqing Pharmaceutical Association and led by the Third Affiliated Hospital of Chongqing Medical University, a panel of experts consisting of pharmaceutical and medical management professionals from multiple medical institutions was established to discuss the basic requirements, service processes, quality control, and evaluation improvement of pharmaceutical active consultation. The drafting team then organized, summarized, analyzed and revised the opinions, and provided feedback to ultimately form a consensus. RESULTS &CONCLUSIONSThis consensus provides a detailed exposition of the basic requirements, service processes, quality control, and evaluation improvement of pharmaceutical active consultation, offering standards for the implementation of pharmaceutical active consultation in medical institutions in China, which is of major implications for strengthening the pharmaceutical service capabilities of medical institutions.  
      关键词:pharmaceutical active consultation;Pharmacy service;Clinical pharmacy;Expert Consensus   
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      发布时间:2024-12-09
    • ZHANG Lele,ZHU Keying,WANG Duanning,HE Yuying,DING Zuoqi
      Vol. 35, Issue 23, Pages: 2844-2850(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.02
      摘要:Under the “patient-centered” drug regulation concept, the inclusion of patient dimensions in real-world evidence becomes increasingly important. Patient experience data can complement and interpret existing data, generate evidence directly from patients, and achieve patient participation in drug development. Data types include patient-reported outcomes and free-text data, which can be collected autonomously or obtained from databases. Application scenarios involve new drug registration, safety evaluation, and additional indications. In China, applying patient experience data to real-world study mainly faces the following challenges: lack of conditions, standards, and motivation to collect high-quality data, a single type of data, and the difficulty of balancing data security with freedom, etc. It is recommended to issue special guidelines, establish a measurement tool certification process, expand data collection channels, explore data source integration methods, optimize the informed consent mechanism, and establish an evidence synergy mechanism to promote the practical application of the “patient-centered” concept in real-world study of drugs.  
      关键词:real-world study;regulatory decision-making;patient-reported outcome   
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      发布时间:2024-12-09
    • HUANG Linlang,HUANG Xiaofang,LIU Yanyan,QIN Yiwei,CHEN Xin,JI Bo
      Vol. 35, Issue 23, Pages: 2851-2857(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.03
      摘要:OBJECTIVETo conduct a clinical comprehensive evaluation of potassium-competitive acid blockers (P-CAB) and provide reference for medical institutions to select new drugs, optimize drug catalogs, and use such drugs reasonably.METHODSclinical application guidelines, expert consensus, drug instructions, drug registration data (including phase Ⅲ clinical trials), meta-analysis/systematic review of databases such as PubMed and CNKI related to Vonoprazan fumarate tablets, Tegorasen tablets, and Keverprazan hydrochloride tablets already on the market in China were collected and organized. Based on the Quick Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions (Second Edition), a comprehensive evaluation of the three P-CAB drugs was conducted from five dimensions: pharmaceutical characteristics, efficacy, safety, economy, and the other property.RESULTSThe five dimensions of the three P-CAB were ranked from high to low as follows: Vonoprazan fumarate tablets (81.8 points), Tegorasen tablets (75.7 points), and Keverprazan hydrochloride tablets (75.6 points). Among them, Vonoprazan fumarate tablets scored the highest in 4 dimensions of pharmaceutical properties, efficacy, economy, and the other property; but the safety score was slightly low.CONCLUSIONSThe three types of P-CAB are comprehensively strongly recommended and demonstrated good clinical efficacy. Vonoprazan fumarate tablets have more advantages in terms of pharmaceutical properties, efficacy, and economy.  
      关键词:Vonoprazan fumarate tablets;Keverprazan hydrochloride tablets;Tegorasen tablets;clinical comprehensive evaluation   
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      发布时间:2024-12-09
    • ZHAO Linlin,LU Yuanyuan,LIU Maochang,JIN Fan,PANG Liangfang,FU Wei
      Vol. 35, Issue 23, Pages: 2858-2862(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.04
      摘要:OBJECTIVETo study pharmaceutical management provisions in the Evaluation Standards for Third-level Maternal and Child Health Care Hospitals in Hubei Province (2024 Edition) (hereinafter referred to as 2024 Edition of Hubei Maternal and Child Health Care Standards).METHODSThe formulation of pharmaceutical management clauses and management rules in the 2024 Edition of Hubei Maternal and Child Health Care Standards was elaborated and compared with the pharmaceutical management clauses in the Evaluation Standards for Third-level Maternal and Child Health Care Hospitals (2016 Edition) to find out their similarities and differences; the basis for the formulation of unique pharmaceutical management clauses was analyzed, so as to propose further improvement suggestions. RESULTS &CONCLUSIONSCompared with the Evaluation Standards for Third-level Maternal and Child Health Care Hospitals (2016 Edition), the similarities in pharmaceutical management in the 2024 Edition of Hubei Maternal and Child Health Care Standards were mainly reflected in the relevant laws, regulations, rules and personnel requirements that should be followed, the full process management of drug procurement, reserve, storage and recall, drug dispensing and formulation management, etc. The unique provisions of the 2024 Edition of Hubei Maternal and Child Care Standards were mainly reflected in the establishment of children’s medication working group, the establishment of a list of children’s specific drugs, the development of surplus drug management system, and the management of off-label drug use, etc. The formulation of unique provisions for pharmaceutical management not only conformed to the newly released policy requirements in recent years, but also combined the characteristics and actual situation of maternal and child health care hospitals. 2024 Edition of Hubei Maternal and Child Health Care Standards should be further improved in terms of strengthening detail management and enhancing the rational application management of traditional Chinese medicine.  
      关键词:hospital evaluation standards;pharmaceutical management;special group   
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      发布时间:2024-12-09
    • WANG Ning,YANG Ya,XIONG Lirong,SUN Fengjun,TIAN Yanping,XIA Peiyuan
      Vol. 35, Issue 23, Pages: 2863-2869(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.05
      摘要:OBJECTIVETo investigate the metabolic changes in MEG-01 megakaryocytes after treatment with linezolid (LZD) from metabolomic perspective and its impact on the the proliferation of cells and generation of platelet precursors.METHODSMEG-01 cells were seeded in proliferation medium and divided into blank control group (untreated), solvent control group (4‰DMSO), and 100, 200, 400, 800 μg/mL LZD groups. The proliferation status of cells in each group was observed under the microscope; cell proliferation and viability were assessed. Cells were also seeded in differentiation medium and divided into blank control group (untreated), solvent control group (4‰DMSO), and 400 μg/mL LZD group; after 14 days of culture, platelet precursor generation was observed under the microscope; immunofluorescence staining was performed to count the proportion of cells producing pseudopodia, the relative length of pseudopodia was measured, and the expression levels of CD41 and CD42b mRNA were assessed. Cells from the solvent control group and the 400 μg/mL LZD group, cultured in differentiation medium for 14 days, were extracted and subjected to non-targeted metabolomics and targeted energy metabolomics analysis using liquid chromatography-tandem mass spectrometry. The relative content of pyruvate in cells, after being cultured for 14 days with the addition of pyruvate (10 mmol/L) or LZD (400 μg/mL)+pyruvate (10 mmol/L), was measured and observed, as well as its effects on cell proliferation and platelet precursor generation.RESULTS400 μg/mL LZD could significantly inhibit the proliferation of MEG-01 cells and the generation of platelet precursors (P<0.01). Non-targeted metabolomic analysis of MEG-01 cells after 400 μg/mL LZD treatment revealed significant changes in energy metabolism-related pathways such as mTOR signaling pathway, alanine, aspartate and glutamate metabolism, and central carbon metabolism in cancer. Targeted energy metabolomic analysis further showed that the relative contents of adenosine triphosphate, guanosine triphosphate, and pyruvate in MEG-01 cells were significantly reduced (P<0.01), while the relative contents of lactate were significantly increased (P<0.01). Compared with the LZD group, the relative content of pyruvate, cell count, the proportion of cells producing pseudopodia and the relative length of pseudopodia were significantly increased in the LZD+pyruvate group (P<0.01).CONCLUSIONSLZD may reduce pyruvate production by inhibiting mitochondrial energy metabolism, thereby suppressing megakaryocyte proliferation and platelet precursor production, ultimately leading to the occurrence of thrombocytopenia.  
      关键词:thrombocytopenia;platelet precursor;energy metabolism;pyruvate   
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      发布时间:2024-12-09
    • ZHONG Pei,XUE Jianglin,ZHAO Quan,LIU Chanming,YAN Xiaojing,SU Dan,SONG Yonggui,LU Tulin,HUANG Wei
      Vol. 35, Issue 23, Pages: 2870-2876(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.06
      摘要:OBJECTIVETo screen and quantitatively analyze differential quality markers (Q-Marker) in Zingiber officinale mixed and triturated with Schisandra chinensis (ZMTS) before and after processing.METHODSHPLC fingerprints of before processing [Z. officinale complicated with S. chinensis (ZWS)] and after processing (ZMTS) (10 batches each) were established. The differences of Q-Markers before and after processing were screened by the chemical pattern recognition method and Q-Marker “five principles”, and the contents were determined.RESULTSA total of 14 common peaks were identified in the fingerprints of ZWS, 22 common peaks were identified in the fingerprints of ZMTS, and 8 components were identified. Differential Q-Marker were screened by chemical pattern recognition and Q-Marker “five principles”, i.e. 6-gingerol, schisandrol A, schisandrol B, 8-gingerol,10-gingerol, schisandrin A, schisandrin B, schizandrin C. The average contents of the 8 differential Q-Markers in ZMTS were 229.46, 244.48, 39.96, 44.12, 61.17, 47.82, 100.11 and 9.70 μg/g, respectively. The average contents of the 4 differential Q-Markers (6-gingerol, schisandrol A, schisandrol B, 8-gingerol) in ZWS were 112.58, 19.01, 26.74 and 5.98 μg/g, respectively.CONCLUSIONSIn this study, the differential Q-Markers before and after ZMTS processing are screened. The contents of the Q-Markers in ZMTS after processing are higher than those before processing.  
      关键词:Schisandra chinensis;differential Q-Marker;HPLC;fingerprint   
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      发布时间:2024-12-09
    • LUO Shixi,MA Xiuping,LIU Jing,XIONG Wuqing,SUN Qingwen,DING Ning
      Vol. 35, Issue 23, Pages: 2877-2882(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.07
      摘要:OBJECTIVETo explore the material basis of the anti-inflammatory effect of the petroleum ether extract from Melastoma dodecandrum by establishing its fingerprint and combining it with cellular pharmacodynamics experiments.METHODSHPLC method was adopted; the fingerprints of 20 batches of petroleum ether extract from M. dodecandrum were drawn using The Similarity Evaluation System of TCM Chromatographic Fingerprint (2012 edition); similarity evaluation and common peak identification were carried out. The lipopolysaccharide-induced inflammation model of mice mononuclear macrophages (RAW264.7) was established; the inhibitory rates of nitric oxide (NO) and tumor necrosis factor α (TNF-α) were used as indexes to investigate the anti-inflammatory activity of the petroleum ether extract from M. dodecandrum; grey correlation degree method and partial least square regression analysis were adopted to study the spectrum-effect relationship. Molecular docking was used to validate the binding activity of the anti-inflammatory active ingredients with TNF-α and iNOS protein receptor.RESULTSThere were 19 common peaks in the fingerprint of the petroleum ether extract from M. dodecandrum, the similarity of 20 batches of samples ranged from 0.603-0.990, and five components were identified, such as vitexin (peak 5), isovitexin (peak 6), ellagic acid (peak 7), quercetin (peak 9) and luteolin (peak 10). The grey correlation degree between 19 common peaks of the petroleum ether extract from M. dodecandrum and the inhibition rates of NO and TNF-α were all greater than 0.7; peaks 19, 13, 9 (quercetin), 12, 5 (vitexin), 6 (isovitexin), 8, 7 (ellagic acid), 18, 1 were positively correlated with NO inhibition rate, and peaks 8, 10 (luteolin), 13, 15, 3, 19, 17, 7 (ellagic acid), 18, 1 were positively correlated with inhibition rate of TNF-α. The binding energies of vitexin, isovitexin and quercetin with iNOS protein receptor were less than -5.0 kcal/mol.CONCLUSIONSVitexin, isovitexin and quercetin may be the basis of the anti-inflammatory effect of the petroleum ether extract from M. dodecandrum.  
      关键词:petroleum ether extract;fingerprint;anti-inflammatory;spectrum-effect relationship   
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      发布时间:2024-12-09
    • ZHU Yaping,LIU Yuxin,SHAO Mengqi,WU Lei
      Vol. 35, Issue 23, Pages: 2883-2888(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.08
      摘要:OBJECTIVETo investigate the effects of different drying aids on the hygroscopic property of extract powder of modified Liujunzi decoction (MLJZD), and screen the best drying aid.METHODSMLJZD extract was mixed with β-cyclodextrin, microcrystalline cellulose, lactose, arabic gum, maltodextrin, corn starch, mannitol, dextrin, soluble starch and pre-gelatinized starch at the mass ratio of 1∶0.3 and 1∶0.5, respectively. The extract powder was prepared after vacuum drying. Physical fingerprints were established with 8 physical indexes, including moisture content, bulk density, vibrating-solid density, gap rate, Carr index, Hausner ratio, angle of rest and hygroscopicity, and then similarity evaluation was performed. The matrix hotspot map was drawn to analyze the influence of physical indexes on hygroscopicity. The moisture absorption rate of MLJZD extract powder was measured at room temperature for 2, 4, 8, 10 h and 1, 2, 3, 7 d. The moisture absorption rate-time curve was drawn, and the best auxiliary materials were selected by comparison.RESULTSThe similarity evaluation results of physical fingerprint showed that the prepared MLJZD extract powder were stable and the similarities were above 0.90. The matrix hotspot analysis showed that there was significant correlation between bulk density and vibratory density and the moisture absorption rate of the MLJZD extract powder (P<0.05). The moisture absorption rate-time curve analysis showed that the moisture absorption rate of MLJZD extract powder prepared with the mass ratio of 1∶0.5 was lower than prepared with the mass ratio of 1∶0.3. Under both ratios, lactose showed the best drying aid effect, followed by soluble starch and mannitol.CONCLUSIONSLactose, as the drying aid (under the mass ratio of 1∶0.5), can obviously improve the hygroabsorbance effect of the extract powder of MLJZD, which provides a reference for the selection of auxiliary materials for MLJZD solid preparations.  
      关键词:extract powder;drying aid;hygroscopicity;physical fingerprint   
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      发布时间:2024-12-09
    • LI Rui,LU Liyan,XU Chu,HAO Rui,TIAN Xianghan,RUAN Wenhui,WANG Yingli
      Vol. 35, Issue 23, Pages: 2889-2895(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.09
      摘要:OBJECTIVETo study the pharmacokinetics and tissue distribution of cannabidiol(CBD)-cholesterol succinate monoester-g-carboxymethyl chitosan (CCMC) nano-micelles in rats, and to evaluate its anti-inflammatory effect.METHODSCBD-CCMC nano-micelles were prepared by dialysis method and the properties were characterized. SD rats were divided into CBD group and CBD-CCMC nano-micelles group with 6 rats in each group. The rats were given 100 mg/kg CBD and CBD-CCMC nano-micelle by intragastric administration, respectively (based on the CBD load). Blood was collected from the posterior ophthalmic venous plexus at 0.5, 1, 1.33, 1.5, 1.75, 2, 4, 8, 24, 48 h after administration. The heart, liver, spleen, lung, kidney and muscle tissues of rats were separated at 0.25, 1.5, 10 and 24 h after administration of CBD and CBD-CCMC nano-micelle with the same dose. The drug content in plasma and tissues was determined, the pharmacokinetic parameters were calculated, and the tissue distribution was analyzed. The inflammatory model of Caco-2 cells was induced by lipopolysaccharide, after 24 h of treatment with 5, 10, and 15 µg/mL CBD and CBD-CCMC nanomicelles (based on loaded CBD), its anti-inflammatory activity was investigated by measuring cell viability, transepithelial electrical resistance (TEER) and inflammatory cytokines IL-1β, IL-8 and TNF-α.RESULTSThe prepared CBD-CCMC nano-micelles had a particle size of (230.6±1.8) nm, a polydispersity index of 0.170±0.053, a Zeta potential of (-13.5±1.2) mV, an encapsulation rate of (86.35±0.56)% and a drug loading of (9.18±0.32)%, respectively; the solubility was 68.240 μg/mL. The pharmacokinetic results showed that the AUC0-48 h, AUC0-∞, half-life time and peak concentration of CBD-CCMC nano-micelle group were significantly increased/extended compared with CBD group (P<0.05 or P<0.01). The results of the tissue distribution study showed that at the same time point, the drug distribution concentration of CBD-CCMC nanomicelles in the rat tissue was higher than that in the CBD group. Research on anti-inflammatory effects shows that compared with CBD of the same mass concentration, CBD-CCMC nano-micelles can significantly increase cell viability (P<0.05 or P<0.01), enhance TEER, and reduce the levels of IL-8, IL-1β and TNF-α in cells (P<0.01), and the secretion levels of inflammatory cytokines IL-8, IL-1β and TNF-α were significantly decreased (P<0.01).CONCLUSIONSCBD-CCMC nano-micelles can increase the plasma concentration and tissue distribution concentration of CBD, and improve anti-inflammatory activity of CBD.  
      关键词:nano-micelles;cholesterol succinate monoester;carboxymethyl chitosan;pharmacokinetics   
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      发布时间:2024-12-09
    • CHEN Qiuping,SUN Quan,SHEN Zhengnan,TANG Congying,LIU Jibin,LI Baixue
      Vol. 35, Issue 23, Pages: 2896-2902(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.10
      摘要:OBJECTIVETo evaluate the cost-effectiveness of the first-line treatment using the combination therapy of sugemalimab and chemotherapy (hereinafter referred to as the “combination therapy”) for advanced esophageal squamous cell carcinoma (ESCC) with high programmed death-ligand 1 (PD-L1) expression from the perspective of the Chinese healthcare system.METHODSA partitioned survival model was constructed based on data from the GEMSTONE-304 study. The model cycle was set at 3 weeks, with a study duration of 10 years and a discount rate of 5%. The primary output parameters of the model included total costs, quality-adjusted life year (QALY), incremental costs, and incremental cost-effectiveness ratio (ICER). Cost-utility analysis was employed to assess the economic feasibility of the combination therapy compared to chemotherapy alone. The robustness of the base case analysis results was evaluated through univariate sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis.RESULTSThe ICER of the combination therapy compared to chemotherapy alone was 288 430.35 yuan/QALY, significantly exceeding the willingness-to-pay (WTP) threshold of 173 354.52 yuan/QALY which was set at 1.94 times the per capita gross domestic product (GDP) in 2023. The price of sugemalimab was the primary factor influencing the ICER. When the WTP threshold was set at 1.94 times the per capita GDP (173 354.52 yuan/QALY), the probability of the combination therapy being cost-effective compared to chemotherapy alone was 0. The combination therapy only became cost-effective compared to chemotherapy alone when the price of the drug dropped to 6 107.41 yuan per box (600 mg).CONCLUSIONSFrom the perspective of the Chinese healthcare system, the combination therapy for first-line treatment of advanced ESCC with high PD-L1 expression is not cost-effective; the combination therapy is cost-effective when the price of sugemalimab decreas by 50.65%.  
      关键词:esophageal squamous cell carcinoma;high PD-L1 expression;cost-utility analysis;partitioned survival model;pharmacoeconomics   
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      发布时间:2024-12-09
    • YANG Shuhan,ZHOU Shu,REN Yanfeng,GUO Jingjing,WANG Zengxia,WANG Zhifang
      Vol. 35, Issue 23, Pages: 2903-2907(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.11
      摘要:OBJECTIVETo explore the effects of esmolol on cardiac function, inflammatory factors and serum microRNA (miR)-29a and miR-129-5p in patients with acute anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention (PCI).METHODSA total of 120 patients with acute anterior ST-segment elevation myocardial infarction undergoing PCI in our hospital from April 2021 to June 2023 were selected and divided into control group (60 cases) and study group (60 cases) according to the random number table method. The control group was given conventional treatment, and the study group was additionally given Esmolol hydrochloride injection based on the control group for one week. The levels of cardiac function indexes (left ventricular ejection fraction, left ventricular end-systolic volume index, left ventricular end-diastolic diameter, peak ejection fraction, cardiac output), inflammatory factors (C-reactive protein, myeloperoxidase, interleukin-6, brain natriuretic peptide, homocysteine) myocardial enzyme indexes (creatine kinase isoenzyme, β2-microglobulin, cardiac troponin Ⅰ), and serum expression of miR-29a and miR-129-5p were observed in two groups, and the occurrence of ADR was recorded.RESULTSAfter one week of treatment, left ventricular ejection fraction, peak ejection fraction, cardiac output, and the expression of miR-129-5p in two groups was significantly higher than before treatment (P<0.05), while left ventricular end-systolic volume index, left ventricular end-diastolic diameter, inflammatory factors and myocardial enzyme index levels, and the expression of miR-29a were significantly lower than before treatment (P<0.05). The study group was significantly better than the control group (except for the creatine kinase-MB) (P<0.05). There was no statistically significant difference in the incidence of symptomatic hypotension, symptomatic bradycardia, cardiogenic shock, and arrhythmia between two groups (P>0.05).CONCLUSIONSEsmolol can improve cardiac function, reduce inflammatory factors, lessen myocardial injury, and regulate serum expressions of miR-29a and miR-129-5p in patients with acute anterior ST-segment elevation myocardial infarction after PCI, with good safety.  
      关键词:acute anterior ST-segment elevation myocardial infarction;percutaneous coronary intervention;safety;inflammatory factors;miR-29a   
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      发布时间:2024-12-09
    • WANG Yan,JIN Fangxin,LI Minne,LI Rujiang,ZHANG Xueli
      Vol. 35, Issue 23, Pages: 2908-2914(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.12
      摘要:OBJECTIVETo systematically evaluate the regulatory effect of liraglutide on hypoglycemia in patients with type 1 diabetes mellitus (T1DM) and provide evidence for the prevention and control of hypoglycemia in the clinical treatment of T1DM.METHODSElectronic databases including The Cochrane Library, PubMed, Embase, Web of Science, China Biology Medicine Disc (CBM), CNKI, Wanfang database, and VIP database were searched from the inception of the databases to June 30, 2023. The clinical randomized controlled trials (RCTs) of liraglutide on hypoglycemia in T1DM patients were screened according to inclusion and exclusion criteria. Data extraction, grouping, and subgroup meta-analysis were conducted for the included studies.RESULTSA total of 11 RCTs involving 1 685 patients were ultimately included. Meta-analysis results showed that treatment with 1.2 mg liraglutide could reduce the frequency of hypoglycemia in patients with T1DM [OR=0.81, 95%CI (0.74, 0.88), P<0.01], while treatment with 1.8 mg liraglutide could increase the frequency of hypoglycemia [OR=1.33, 95%CI (1.23, 1.44), P<0.01]. The effect of liraglutide on hypoglycemia in patients with T1DM was not correlated with the duration of hypoglycemia [MD= -0.29, 95%CI (-1.21, 0.63), P=0.53], and did not increase the incidence of severe hypoglycemia in these patients [OR=0.87, 95%CI (0.57, 1.33), P=0.53]. Liraglutide could reduce the levels of glycated hemoglobin [MD=-1.39, 95%CI (-2.65, -0.13), P=0.03], weight [MD=-4.28, 95%CI (-5.01, -3.55), P<0.01], and body mass index [MD=-1.20, 95%CI (-1.80, -0.60), P<0.01] in them.CONCLUSIONSLiraglutide has a bidirectional regulatory effect on hypoglycemia in patients with T1DM, which is correlated with the dose of liraglutide. An appropriate dose of liraglutide (1.2 mg) can inhibit hypoglycemia in these patients, while an increased dose of liraglutide (1.8 mg) can promote hypoglycemia in them.  
      关键词:type 1 diabetes mellitus;hypoglycemia;bidirectional regulation   
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      发布时间:2024-12-09
    • ZHAN Yakun,ZENG Jin,HU Ziwei,CHEN Juliang
      Vol. 35, Issue 23, Pages: 2915-2922(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.13
      摘要:OBJECTIVETo systematically evaluate the efficacy and safety of compound danshen preparations combined with conventional chemical drug treatment for peptic ulcer (PU), providing evidence-based guidance for clinical treatment of PU.METHODSRelated clinical randomized controlled trials were collected from CNKI, VIP, Wangfang data, CBM, PubMed, Embase and Web of Science from their establishment date to September 30, 2023. The qualities of included literature were evaluated by Cochrane Systematically Evaluator Manual 5.1.0. Meta-analysis, sensitivity analysis and publication bias analysis were conducted with RevMan 5.3 software.RESULTSTotally 26 pieces of literature were included with total of 2 451 cases, including 1 243 cases in trial group (compound danshen preparations+conventional chemical drug treatment) and 1 208 cases in the control group (conventional chemical drug treatment). In terms of effectiveness, trial group had significant advantages in ulcer healing rate [OR=4.66, 95%CI (3.53, 6.15), P<0.000 01], HP eradication rate [OR=1.90, 95%CI (1.12, 3.22), P=0.02],and pain relief rate [OR=3.91, 95%CI (2.31, 6.61), P<0.000 01] than control group, while ulcer recurrence rate [OR=0.22, 95%CI (0.15, 0.32), P<0.000 01] and serum levels of pepsinogen (PG)Ⅰ [SMD=-1.92, 95%CI (-2.25, -1.58), P<0.000 01], PGⅡ [SMD=-3.88, 95%CI (-4.35, -3.41), P<0.000 01] and G-17 [SMD=-3.44, 95%CI (-3.87, -3.00), P<0.000 01] were significantly lower than control group. In terms of safety, the main adverse reactions were abdominal discomfort, headache, dizziness, dry mouth, facial flushing, etc. There was no significant difference in the incidence of adverse reactions between the two groups [OR=1.08, 95%CI (0.75, 1.54), P=0.69]. Subgroup analysis of ulcer healing rate and HP eradication rate based on dosage form showed that HP eradication rate in the compound danshen pellet group was not significantly improved compared to the control group, with consistent results for the remaining outcomes. The sensitivity analysis showed that above results were stable. There was less possibility of publication bias in this study.CONCLUSIONSCompared with conventional chemical drug treatment alone, the combination of compound danshen preparations can effectively improve the clinical symptoms of PU patients with similar safety.  
      关键词:peptic ulcer;efficacy;safety   
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      发布时间:2024-12-09
    • LUO Hongmei,ZOU Jiafeng,ZHAO Jiufeng,SUN Chengxin,YANG Jianwen
      Vol. 35, Issue 23, Pages: 2923-2928(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.14
      摘要:OBJECTIVETo evaluate the efficacy and safety of programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors combined with bevacizumab in the treatment of advanced non-small cell lung cancer (NSCLC) based on platinum-containing dual therapy.METHODSRetrieved from CNKI, Wanfang, VIP, Web of Science, PubMed and other Chinese and English databases, cohort studies or randomized controlled trial studies on the treatment of advanced NSCLC with platinum-containing double agents in combination with PD-1/PD-L1 inhibitors and bevacizumab (trial group) versus platinum-containing double agents with or without PD-1/PD-L1 inhibitor or bevacizumab (control group) were collected from the inception to April 25, 2024. After screening literature, extracting data and evaluating quality, meta-analysis and sensitivity analysis were performed by using RevMan 5.4.1 software.RESULTSA total of 15 pieces of literature were included, involving 13 clinical studies with a total of 3 282 patients. Compared with the control group, partial response rate [RR=0.75,95%CI(0.68,0.82),P<0.000 01], complete response rate [RR=0.47,95%CI(0.29,0.76),P=0.002], progressive disease rate [RR=1.23,95%CI(1.11,1.37),P<0.000 1], objective response rate (ORR) [RR=0.72,95%CI(0.67,0.79),P<0.000 01] and disease control rate (DCR) [RR=0.85, 95%CI (0.77,0.95),P=0.003] were higher in the trial group. There was no statistically significant difference in the stable disease rate [RR=1.25, 95%CI (0.86, 1.83), P=0.25] or overall adverse drug reaction incidence rate [RR=0.95, 95%CI (0.90, 1.00), P=0.07] between the two groups of patients. Sensitivity analyses showed robust and reliable results for all outcome indicators.CONCLUSIONSPD-1/PD-L1 inhibitors combined with bevacizumab based on platinum-containing dual therapy in the treatment of advanced NSCLC can improve patients’ clinical benefits, such as ORR and DCR, without increasing the risk of adverse drug reaction.  
      关键词:PD-1/PD-L1 inhibitors;bevacizumab;efficacy;safety   
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      发布时间:2024-12-09
    • ZHAO Yufang,LEI Wenpu,LIU Zhien,YANG Shengnan,ZHANG Yanan,ZHAO Ke,GUO Hao
      Vol. 35, Issue 23, Pages: 2929-2935(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.15
      摘要:OBJECTIVETo analyze the use of children’s drugs in public medical institutions in the Inner Mongolia Autonomous Region, and provide some reference for the rational use of children’s drugs and the improvement of children’s drug list in the whole region.METHODSThe generic names, specifications, and dosage forms of children’s drugs were collected from all levels of public medical institutions in the Inner Mongolia Autonomous Region in 2023. The method of defined daily dose (DDD) and ranking ratio (B/A) were used to explore the frequency of drug use, daily average cost and cost-effectiveness of children’s drugs in this region, and the dosage forms, category, and drug use convergence of children’s drugs in medical institutions in the whole region.RESULTSIn 2023, 1 751 public medical and health institutions in Inner Mongolia Autonomous Region were equipped with 267 kinds of children’s drugs, including 12 drug categories. The main dosage forms were granules, oral solutions, and syrups. The drugs that were frequently used in medical institutions at all levels were mainly antipyretic, analgesic, anti-inflammatory drugs (mostly Chinese patent medicines), and respiratory drugs. The daily average cost of children’s drugs with the highest DDDs in tertiary, secondary, and primary public medical institutions was low, and the B/A value of most drugs with higher DDDs was around 1. However, the B/A value of some drugs was high, which may lead to overuse. The drug use convergence between primary public medical institutions and secondary/tertiary public medical institutions was less than 50%.CONCLUSIONSThe types of drugs involved in children’s drugs in Inner Mongolia Autonomous Region are comprehensive and the social and economic benefits are in good synchronization, but the dosage form is single and there are few special rules and dosage forms for children. The proportions of Chinese patent medicines in primary and secondary public medical institutions are high, and the risk of drug use should be paid attention. The cohesion between children’s drugs in primary public medical institutions and higher public medical institutions is slightly poor.  
      关键词:Inner Mongolia Autonomous Region;dosage form;DDD;DDC;B/A value;essential medicine   
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      发布时间:2024-12-09
    • TAN Rui,ZOU Tingting,SUN Wei,PENG Libo,GOU Jinghui
      Vol. 35, Issue 23, Pages: 2936-2940(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.16
      摘要:OBJECTIVETo explore the application effects of the multi-disciplinary treatment (MDT)-based continuous pharmaceutical care system in patients undergoing anti-infection treatment.METHODSThis research team innovatively developed an MDT continuous pharmaceutical care system, which was applied to cases of anti-infection treatment following MDT due to infection, aiming to innovate the continuous medication supervision model. A retrospective analysis method was used to collect data from 150 patients in the intensive care unit who underwent conventional anti-infection MDT consultations from January to October 2021 in Banan Hospital Affiliated to Chongqing Medical University, serving as the control group, and 130 patients in the intensive care unit who were under the MDT continuous pharmaceutical care system from January to October 2022 were selected as the intervention group. The general information of the patients, the information continuous tracking management, the outcomes of anti-infection treatment, adverse drug reactions, antibacterial drug management indicators, and the degree of satisfaction of relevant medical staff with the clinical pharmacists’ pharmaceutical services were compared between the two groups.RESULTSComparison of general information between the two groups showed no statistically significant differences (P>0.05). The proportion of continuous tracking management in the intervention group was significantly higher than in the control group (P<0.01), and the differences in the initiators and reasons for continuous tracking management between the two groups were statistically significant (P<0.05). The intervention group had better outcomes in anti-infection treatment compared to the control group (P<0.05). The antibacterial drug management indicators (total length of hospital stay, duration of antibacterial drug use, total drug costs, and amount of antibacterial drugs used) in the intervention group were significantly lower than in the control group, while overall degree of satisfaction among medical staff was significantly higher in the intervention group than in the control group (P<0.05). No statistically significant differences were found in adverse reaction occurrence and antibacterial drug costs between the two groups (P>0.05).CONCLUSIONSThe application of this system in patients who underwent anti-infection treatment after MDT can achieve continuous multi-disciplinary tracking management with clinical pharmacists at the core, which is beneficial for promoting the follow-up efficiency of the MDT team, raising the quality of clinical pharmacists’ pharmaceutical services, strengthening treatment outcomes, and promoting the rational use of antibacterial drugs in clinical practice.  
      关键词:continuous pharmaceutical care system;pharmaceutical service;antibacterial drug;tracking management;degree of satisfaction   
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      发布时间:2024-12-09
    • QIU Changlu,BI Hongpeng,DAI Xuefei
      Vol. 35, Issue 23, Pages: 2941-2947(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.17
      摘要:OBJECTIVETo promote rational use of antibiotics taking diagnosis related group (DRG) of respiratory system infection/inflammation as a starting point.METHODSThe rules for evaluating the rationality of clinical use of antibiotics in patients with respiratory system infection/inflammation were established(including 12 evaluation indicators such as drug selection, centrally procured varieties, usage and dosage), and the attribute hierarchy model was applied to assign scoring weights to each indicator. A total of 102 cases from January to September 2021 (before multi-department collaboration and control, as control group) and 103 cases from January to September 2022 (after multi-department collaboration and control, as interention group) were comprehensively evaluated by weighted pros and cons method. The relative proximity (Ci) between each evaluation index and the optimal scheme was calculated, and the rationality of the use of antibacterial, antibacterial drug related index, health economic evaluation index and diagnosis and treatment outcome index were compared before and after multi-department collaboration control.RESULTSIn the use of antibiotics, the irrational rate of antibiotics use, the average cumulative defined daily dose (DDD) and the utilization rate of combined drugs in the intervention group were significantly lower than control group (P<0.05). In the indicators of health economic evaluation, the average cost of antibiotics per time and average cost of hospitalization per time in the intervention group were significantly lower than control group (P<0.05). In the relevant indicators of diagnosis and treatment outcome, the average hospitalization days of patients in the intervention group were significantly lower than control group (P<0.05), but the clinical efficacy was not significantly different (P>0.05). Further comparison between groups showed that the average cumulative DDD of ES31, ES33 and ES35 patients in the intervention group was significantly lower than control group (P<0.05). The utilization rate of combined drugs in ES31 and ES35 patients was significantly lower in the intervention group than control group. In the ES35 disease group (P<0.05), the average cost of antibiotics per time in the intervention group was significantly lower than control group (P<0.05), and the cost of antibiotics per time of ES35 and ES33 disease groups in the intervention group were significantly lower than ES31 disease group (P<0.05).CONCLUSIONSThe rational evaluation rules for the clinical application of antibiotics in patients with respiratory system infection/inflammation based on DRG are successfully established, which can be used for comprehensive evaluation of the use of antibiotics; multi-department collaboration control can improve the rational rate of antibiotic use and reduce the medical cost.  
      关键词:multi-department cooperation control;weighted TOPSIS method;respiratory system infection/inflammation;antibiotics;rationality evaluation   
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      发布时间:2024-12-09
    • LIANG Xiabing,FAN Baohua,WEN Zhiping,WANG Xiaoyi
      Vol. 35, Issue 23, Pages: 2948-2953(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.18
      摘要:OBJECTIVETo establish anticoagulation pharmaceutical service model based on the integrated theory of health behavior change (ITHBC), and analyze its effects.METHODSReferring to relevant literature and soliciting opinions from 8 experts from departments such as pharmacy, respiratory medicine, and vascular surgery, a anticoagulation pharmaceutical service model based on ITHBC was ultimately formed. VTE inpatients were selected from The First Affiliated Hospital of Shihezi University from December 2023 to June 2024 as the research subjects. They were randomly assigned into intervention group (58 cases) and control group (60 cases) using a random number table method. The intervention group implemented pharmacist-led anticoagulant pharmaceutical service model based on ITHBC, while the control group adopted a conventional anticoagulant pharmaceutical service model. The anticoagulation-related outcomes of two groups were compared after 3 months: anticoagulation compliance rate, the incidence of adverse drug reactions, the score of medication adherence and compliance rate of anticoagulant prescription; economic evaluation was conducted.RESULTSAfter implementing ITHBC-based anticoagulant pharmaceutical services for 3 months, the intervention group had higher anticoagulation compliance rate, score of medication adherence, and compliance rate of anticoagulant prescription than the control group (P<0.05). There was no statistically significant difference in the total incidence of adverse drug reactions between the two groups (P>0.05). For every 1% point increase in anticoagulant compliance rate, the hospital needed to invest 4.35 yuan additionally in anticoagulant pharmaceutical service fees. Compared with China’s per capita gross domestic product (GDP, 89 358 yuan) in 2023, the incremental cost-effectiveness ratio value that increased the anticoagulation compliance rate by 50% is far less than one time of per capita GDP.CONCLUSIONSThe pharmacist-led anticoagulant pharmaceutical service model based on ITHBC can effectively improve the outcomes of anticoagulant therapy for VTE patients, enhance medication compliance, improve patients’ awareness and recognition of adverse drug reactions to anticoagulants, and has certain economic and social benefits.  
      关键词:venous thromboembolism;anticoagulant therapy;pharmaceutical care;medication compliance   
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      发布时间:2024-12-09
    • CHENG Fangrui,SUN Shuang,ZHANG Huan,LI Yongji,LYU Shaowa
      Vol. 35, Issue 23, Pages: 2954-2958(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.19
      摘要:Pulmonary administration can directly deliver drugs to the lungs, making it the preferred mode of administration for pulmonary disease. Active ingredients of traditional Chinese medicine (TCM), such as quercetin and paclitaxel have demonstrated promising therapeutic effects on lung diseases. However, they face challenges such as poor water solubility and high lung clearance rates. Loading the active ingredients of TCM onto nano-drug delivery systems can enhance their water solubility, stability, permeability and retention in the lungs. Based on this, this study reviewed the research progress on inhalation nano-drug delivery systems for the active ingredients of TCM in the treatment of lung diseases. It was found that there are nano-drug delivery systems for TCM active ingredients based on chitosan, lipids (including liposomes, solid lipid nanoparticles, and nanostructured lipid carriers), and targeting ligands (including targeting folate receptor, targeting transferrin receptor, and exosomes). These inhalation nano-drug delivery systems comprehensively consider key factors such as particle size, surface charge, and hydrophobicity, which can prevent the drugs from being cleared by mucus, cilium and macrophages, thus exhibiting great potential for application.  
      关键词:active ingredients of traditional Chinese medicine;pulmonary diseases   
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    • SUN Shumeng,LIN Lin,ZHANG Daizhou,LI Xin,GUAN Yongxia,CHEN Kai
      Vol. 35, Issue 23, Pages: 2959-2964(2024) DOI: 10.6039/j.issn.1001-0408.2024.23.20
      摘要:There are three types of bioanalytical methods for nucleic acid drugs, including ligand binding assay, quantitative polymerase chain reaction and liquid chromatography-based bioanalytical technologies. Although the first two assays have high sensitivity, they have poor selectivity and can not differentiate between intact and truncated metabolites. Liquid chromatography-based bioanalytical technologies which are less sensitive, offer high selectivity for the identification of intact and truncated metabolites. They have broad application prospects in both preclinical and clinical investigations of therapeutic nucleic acid drugs. This paper provides a critical review on the characteristics of these technologies and their application to analyze nucleic acid drugs, including high performance liquid chromatography-ultraviolet detection (HPLC-UV), high performance liquid chromatography-fluorescence (HPLC-FL), liquid chromatography-tandem mass spectrometry (LC-MS/MS), liquid chromatography-high resolution-mass spectrometry, microflow liquid chromatography-tandem mass spectrometry (microflow LC-MS/MS) and hybridization liquid chromatography-tandem mass spectrometry. Although these technologies have high sensitivity except for HPLC-UV, they still have some shortcomings, such as suitable probes need to be designed for HPLC-FL, standard substance for LC-MS/MS, and high cost for microflow LC-MS/MS. In addition, the development of some related strategies or technologies (e.g. non-specific adsorption strategy, sample pretreatment) which can improve the sensitivity, has hastened the development of liquid chromatography-based bioanalytical technologies for nucleic acid drugs.  
      关键词:oligonucleotide;bioanalysis;liquid chromatography;separation technology   
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      发布时间:2024-12-09
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