最新刊期

    35 15 2024
    • MAO Kaifeng,YU Jie,WANG Linning,LU Yun,CHANG Feng
      Vol. 35, Issue 15, Pages: 1801-1806(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.01
      摘要:OBJECTIVETo provide reference for the improvement of the price system of innovative drugs in China.METHODSBased on the current situation of innovative drug healthcare management in China, innovation recognition and price management of innovative drugs in typical countries or regions were compared and analyzed, and the suggestions were put forward to improve the price system of innovative drugs in China. RESULTS &CONCLUSIONSTaiwan of China, Japan, Australia, Germany and the United Kingdom have different practices in recognition and grading of drug innovation, differentiated pricing and subsequent price management. However, the mainstream practice is to identify and grade drugs mostly based on clinical value, differentiate pricing based on the grading, and carry out risk-sharing agreement or active price adjustment to manage the price. Based on the comparative analysis, it is suggested that China should further clarify the connotation and classification of innovation in the management of innovative drugs, apply a variety of pricing methods to promote differentiated management of innovative drugs, explore the introduction of risk-sharing agreements, and further build an active drug price adjustment mechanism to improve the price system of innovative drugs in China.  
      关键词:innovation recognition;differentiated pricing;level-to-level administration;drug price management;dynamic adjustment;risk sharing   
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      发布时间:2024-08-11
    • CAO Jie,CAI Xuefeng,LYU Yongning,CHEN Jun,FU Yuqi,SUN Lulu
      Vol. 35, Issue 15, Pages: 1807-1811(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.02
      摘要:OBJECTIVETo investigate and analyze the operational costs and current charging policies of pharmacy intravenous admixture service (PIVAS) in China, and provide a reference for promoting high-quality and sustainable development of PIVAS.METHODSQuestionnaires were distributed in 30 provinces, autonomous regions, and municipalities across the country through the “Wenjuanxing” platform from May 6th to July 1st, 2022. The operational costs, charging status and suggestions of PIVAS were investigated and analyzed.RESULTSA total of 761 PIVAS participated in the survey nationwide, including 666 tertiary medical institutions, 93 secondary medical institutions, and 2 primary medical institutions. Approximately 60.58% of PIVAS had implemented a charging system that allowed charges. Among them, most PIVAS required inspection and evaluation before charging. The annual operating cost of PIVAS in China was approximately 2 098 100 yuan, with the integrated operating cost comprising 89.36% of the total, while the dispensing cost accounted for only 10.64%. Human costs emerged as the highest annual consumption (74.20%), followed by decoration and facility maintenance costs (4.77%) and equipment acquisition costs (3.44%). Regarding charges for different drugs nationwide, common drugs had an average charge standard of 4.39 yuan per bag while antibacterial drugs averaged 5.01 yuan per bag; hazardous drugs had an average charge of 23.17 yuan per bag, whereas parenteral nutrition solutions averaged 38.75 yuan per bag. However, the recommended average charges of the four drugs mentioned above were 6.71, 9.63, 38.35 and 44.03 yuan per bag, respectively.CONCLUSIONSAt present, there is no unified inspection and evaluation standard and charging standard in China. Moreover, the current charging standard is lower than the recommended standard. It is necessary to combine operational costs and develop more reasonable and fair charging standards.  
      关键词:charging status;charging standard;operational cost;dispensing cost;pharmacist service   
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      发布时间:2024-08-11
    • SHANG Yuqi,GUO Hao,WANG Huiduo
      Vol. 35, Issue 15, Pages: 1812-1817(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.03
      摘要:OBJECTIVETo evaluate the effectiveness, safety and economy of lorlatinib in the treatment of non-small cell lung cancer(NSCLC), and provide evidence-based reference for the introduction of new drugs in hospitals and clinical medication decisions.METHODSRetrieved from PubMed, Embase, Cochrane Library, Epistemonikos, CNKI, VIP, Wanfang data, SinoMed databases and The International Network of Agencies for Health Technology Assessment (INAHTA), the results of the included studies were descriptively analyzed after literature screening, data extraction and quality evaluation.RESULTSA total of 19 literature were included, involving 13 system assessment (SR)/meta-analyses and 6 pharmacoeconomic reviews. Compared with the patients who received other anaplastic lymphoma kinases (ALK)-tyrosine kinase inhibitor(TKI)(such as crizotinib, brigatinib, alectinib, ensartinib, and ceritinib), those using lorlatinib obtained best progression-free survival (PFS). However, in the Asian population, lorlatinib did not show a significant advantage in prolonging PFS, compared to ensartinib, low-dose alectinib, and brigatinib. In terms of objective remission rate, lorlatinib and low-dose alectinib showed significant advantages over other ALK-TKI. At the same time, alectinib had the best overall survival. In terms of safety, lorlatinib possessed a poor safety profile with a high incidence of grade 3 or higher adverse events. Existing economic studies showed that lorlatinib brought health benefits to first-line treatment of patients with ALK-positive advanced NSCLC at the same time as higher treatment costs.CONCLUSIONSLorlatinib has good efficacy in the treatment of NSCLC, but its safety and economy need to be studied.  
      关键词:non-small cell lung cancer;rapid health technology assessment;effectiveness;safety;economy   
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      发布时间:2024-08-11
    • KE Yijun,WANG Wei,HUANG Can,JIN Yong,QI Lamei
      Vol. 35, Issue 15, Pages: 1818-1824(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.04
      摘要:OBJECTIVETo evaluate the efficacy, safety and cost-effectiveness of vericiguat in the treatment of heart failure (HF) by rapid health technology evaluation method, and provide reference for the selection and decision-making of clinical treatment plans.METHODSChinese and foreign databases such as CNKI, PubMed and related health technology evaluation websites were searched by computer. Relevant researchers independently screened literature, extracted data, and comprehensively analyzed the results of the included literature based on literature quality evaluation.RESULTSA total of 17 pieces of literature were included, involving 12 systematic reviews/meta-analyses and 5 pharmacoeconomic studies. The effectiveness analysis showed: for HF patients, compared with placebo, vericiguat (10 mg/d) significantly improved the EuroQol five dimensions questionnaire (EQ-5D) index and decreased the rate of hospitalization due to HF (P<0.05). For heart failure with reduced ejection fraction (HFrEF) patients, vericiguat reduced the incidence of hospitalization due to HF compared with sodium-glucose cotransporter 2 inhibitor (SGLT2i)(P<0.05); compared with angiotensin-converting enzyme inhibitor, vericiguat significantly reduced the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF(P<0.05). For HFrEF patients with chronic kidney disease, vericiguat had a tendency to reduce the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF compared with neurohormone inhibitors. Safety analysis showed: vericiguat did not increase drug-related adverse reactions compared to placebo (P>0.05). Economic analysis showed: domestic studies indicated that vericiguat had a higher incremental cost-effectiveness ratio.CONCLUSIONSVericiguat has good safety and efficacy in the treatment of HF but does not possess an economic advantage in the Chinese population.  
      关键词:heart failure;efficacy;safety;cost-effectiveness;rapid health technology assessment   
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      发布时间:2024-08-11
    • XIE Yuxin,YANG Zhengqing,XIAO Lianlian,ZHU Yubo,ZHAO Mian,HU Yang,LIU Taoshi,CHENG Jianming
      Vol. 35, Issue 15, Pages: 1825-1830(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.05
      摘要:OBJECTIVETo study the pharmacological substance basis of Shaoyao gancao decoction for relieving acute and chronic pain.METHODSThe antispasmodic effect of Shaoyao gancao decoction, ethyl acetate extract of Shaoyao gancao decoction and its effluent part of macroporous resin and 90% ethanol elution part of macroporous resin (the concentration of 4 drugs was 13.44 g/mL according to crude drug) was observed by in vitro small intestine tension test in rats. The acetic acid writhing test was conducted in mice to evaluate the analgesic effects of macroporous resin efflux site and macroporous resin 90% ethanol elution site (the dosage of 2.4 g/kg according to crude drug). The levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), prostaglandin E2 (PGE2) and cyclooxygenase-2 (COX-2) in serum of mice were detected. The serum prototype and metabolites of mice after intragastric administration of macroporous resin 90% ethanol elution site were identified by high performance liquid chromatogre-time-of-flight mass spectrometry.RESULTSIn vitro experiment showed that 90% ethanol eluting part of macroporous resin represented the best antispasmodic effect, and the inhibitory rate of small intestine tension was significantly higher than macroporous resin efflux site of Shaoyao gancao decoction (P<0.05) without statistical significance, compared with Shaoyao gancao decoction (P>0.05). In the acetic acid writhing experiment, compared with model group, the writhing times of mice in the macroporous resin 90% ethanol elution part group were reduced significantly (P<0.05), the writhing latency was prolonged significantly (P<0.05), and the levels of COX-2, IL-1β, PGE2 and TNF-α in serum were decreased significantly (P<0.05). Ten kinds of protoproducts including paeoniflorin and glycyrrhizic acid were identified from serum of mice, and twenty-two kinds of metabolites including hydroxylated glycyrrhizin and glucosylated liquiritin were identified.CONCLUSIONSThe effective part of Shaoyao gancao decoction for relieving acute and chronic pain is 90% ethanol elution part prepared by macroporous resin from the ethyl acetate extract. Ten components, including glycyrrhetinic acid and paeoniflorin, may be the basis of its pharmacological substances.  
      关键词:acute and chronic pain relief;serum medicinal chemistry;pharmacological substances   
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      发布时间:2024-08-11
    • PANG Yan,MAO Meiling,LU Jianqi,CHEN Jiayong,TANG Meiling,HUANG Puwei
      Vol. 35, Issue 15, Pages: 1831-1836(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.06
      摘要:OBJECTIVETo investigate the effects of Qiangxin decoction on myocardial mitochondrial and energy metabolism in rats with chronic heart failure (CHF) based on mitophagy.METHODSMale SD rats were collected to establish CHF model by ligating the left anterior descending branch of coronary artery. The successful modeling rats were divided into model group, Qiangxin decoction group [12.25 g/(kg·d), calculated by crude drug], captopril group [10.38 mg/(kg·d)], and Qiangxin decoction+captopril group (the same usage and dosage as single drug group) according to a random number table method, with 8 rats in each group. Another 8 normal rats were selected and received threading in the left anterior descending branch of the coronary artery without ligation as the sham operation group. Starting from the second day after successful modeling, the rats in administration groups were given relevant drug intragastrically, twice a day, for consecutive 28 days. After the last medication, the levels of adenosine triphosphate (ATP), adenosine monophosphate (AMP) and free fatty acid (FFA) in infarcted myocardial tissues were detected, the pathological changes and mitochondrial morphology of the infarcted myocardial tissue were observed, as well as the protein expressions of B cell lymphoma-2 (Bcl-2), Bcl-2 related X protein (Bax), TANK-binding kinase 1 (TBK1), p62 were detected in each group.RESULTSCompared with the sham operation group, the infarcted myocardial tissue fibrosis was changed evidently, with a large number of mitochondrial swelling and fusion, and internal cristae rupture; the levels of AMP and FFA, the protein expressions of Bax and p62 were all increased or up-regulated significantly in infarcted myocardial tissue, while the level of ATP, and the protein expressions of Bcl-2 and TBK1 were all decreased or down-regulated significantly (P<0.05). Compared with the model group, the pathological changes of infarcted myocardial tissue and mitochondrial swelling had been improved; the levels of AMP and FFA, and the protein expressions of Bax and p62 in infarcted myocardial tissue were significantly decreased or down-regulated in administration groups, while the level of ATP, and the protein expressions of Bcl-2 and TBK1 were increased or up-regulated significantly (P<0.05). And the effect of Qiangxin decoction+captopril group was better than that of single drug group.CONCLUSIONSQiangxin decoction can alleviate myocardial fibrosis and mitochondrial swelling in CHF rats, and improve their myocardial energy metabolism, which may be related to regulating the expression of Bcl-2, Bax, TBK1 and p62 proteins and promoting myocardial mitophagy.  
      关键词:chronic heart failure;mitophagy;mitochondrial homeostasis;energy metabolism   
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      发布时间:2024-08-11
    • WAN Xiongfei,LIANG Meifeng,LIAO Nian,ZHU Shanshan,WANG Zhijian
      Vol. 35, Issue 15, Pages: 1837-1843(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.07
      摘要:OBJECTIVETo comprehensively evaluate the quality of Yifei qinghua ointment by multi-component quantitative analysis combined with chemometrics and entropy weight-technique for order preference by similarity to ideal solution (TOPSIS) method.METHODSThe contents of lobetyolin, syringin, calycosin 7-O-β-D-glucopyranoside, ononin, astraisoflavan-7-O-β-D-glucoside, isomucronulatol 7-O-glucoside, astragaloside Ⅳ, deapi-platycoside E, platycoside E, platycodin D3, feretoside, asperulosidic acid, asperuloside, methylophiopogonanone A and methylophiopogonanone B in 14 batches of Yifei qinghua ointment (S1-S14) were determined by high-performance liquid chromatography method. Then, the quality of 14 batches of Yifei qinghua ointment was analyzed by chemometrics (principal component analysis and orthogonal partial least-squares discriminant analysis) and entropy weight TOPSIS method.RESULTSThe results of chemometrics showed that 14 batches of Yifei qinghua ointment could be clustered into three categories, S1-S6 as the first category, S7-S10 as the second category, and S11-S14 as the third category. The values of variable importance for projection of calycosin 7-O-β-D-glucopyranoside, ononin, feretoside, astragaloside Ⅳ, astraisoflavan-7-O-β-D-glucoside, lobetyolin, methylophiopogonanone A and platycoside E were higher than 1. The results of the entropy weight TOPSIS method showed that the Euclidean closeness of the optimal solution of 14 batches of Yifei qinghua ointment were between 0.152 9 and 0.736 6, and that of sample S14 was the highest (0.736 6).CONCLUSIONSAmong 14 batches of Yifei qinghua ointment, sample S14 has the best quality, and 8 components such as calycosin 7-O-β-D-glucopyranoside and ononin may be differential markers affecting the quality of Yifei qinghua ointment.  
      关键词:HPLC method;multi-component;quantitative analysis;chemometrics;entropy weight TOPSIS method;quality evaluation   
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      发布时间:2024-08-11
    • TAN Penghao,CHENG Yuxi,GUO Dongqin,ZHOU Nong
      Vol. 35, Issue 15, Pages: 1844-1848(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.08
      摘要:OBJECTIVETo compare the effects of different drying processing methods in the producing area on the quality of Peucedanum praeruptorum, and screen the optimal drying processing in the producing area.METHODSP. praeruptorum was processed by traditional drying in the sun, drying in the shade, and modern drying processing methods such as electric heating and blast drying, vacuum drying, infrared drying, and vacuum freeze drying. Technique for order preference by similarity to ideal solution (TOPSIS) method was used to perform the comprehensive quality evaluation using drying rate, water content, extract content, color chroma value, and the contents of 4 coumarins as indexes.RESULTSUnder different drying processing methods, the drying rates of 12 samples of P. praeruptorum were 31.56%-40.10%; the moisture contents were 6.96%-8.58%, and the extract contents were 27.56%-43.10%; the color chroma values red green degree, yellow blue degree and brightness were 1.80-7.50, 19.90-30.20, 46.90-59.90, respectively. The contents of umbelliferolactone, praeruptorin A, praeruptorin B and praeruptorin E were ≤0.05, 3.70-14.05, 0.72-2.37, 0.81-3.90 mg/g, respectively; and the total contents were 5.47-19.65 mg/g. The comprehensive score of P. praeruptorum was the highest under the condition of drying at 40 ℃ by electric heating and blast.CONCLUSIONSThe drying method at 40 ℃ by electric heating and blast is the first choice for P. praeruptorum in the producing area.  
      关键词:drying processing in producing area;color chroma values;extracts;coumarins;drying rate;water content   
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      发布时间:2024-08-11
    • FEI Yuanyuan,GE Mingkun,BIAN Qingping
      Vol. 35, Issue 15, Pages: 1849-1854(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.09
      摘要:OBJECTIVETo explore the improvement effect and mechanism of vitexin on asthmatic model mice based on Notch signaling pathway.METHODSAsthma model of mice was established by intraperitoneal injection of ovalbumin and aluminum hydroxide suspension and nebulization stimulation of ovalbumin, and randomly divided into model group, vitexin group (40 mg/kg), Notch activator group (1 mg/kg Jagged1), vitexin+Notch activator group (40 mg/kg vitexin+1 mg/kg Jagged1), with 12 mice in each group. Another 12 mice were selected as the control group. Each group received intragastric/intraperitoneal injection of relevant medicine or normal saline, once a day, for consecutive 14 days. After the last medication, minute ventilation at rest (VE) and peak expiratory flow (PEF) were detected in mice; the pathological morphology of lung tissue and fibrosis degeneration were observed and determined. The proportion of T helper cell 17 (Th17) and T regulatory cell (Treg) in peripheral blood were detected, and the Th17/Treg ratio was calculated. The levels of serum inflammatory factors interleukin (IL)-18, IL-6, IL-17 and IL-10 were determined, and the expressions of Notch1, Delta-like ligand 4 (DLL4), hairy and enhancer of split 1 (Hes1) in lung tissue were detected.RESULTSCompared with the control group, serious pathological injury and inflammatory cell infiltration occurred in the lung tissue of mice in the model group, while VE, PEF, the proportion of Treg cells in peripheral blood and serum level of IL-10 were significantly reduced (P<0.05); collagen volume fraction (CVF) in lung tissue, Th17 cells proportion and Th17/Treg ratio in peripheral blood, serum levels of IL-18, IL-6 and IL-17, and the protein expressions of Notch1, DLL4 and Hes1 in lung tissue were significantly increased (P<0.05). Compared with the model group, the pathological injury of lung tissue in vitexin group was significantly improved compared with model group, and the changing trend of the above indexes was reversed (P<0.05); Notch activator Jagged1 could significantly reverse the pharmacological effects of vitexin on asthmatic mice (P<0.05).CONCLUSIONSVitexin can improve lung function, Th17/Treg immune imbalance and inflammatory response, and alleviate pathological injury and fibrosis of lung tissue in asthmatic mice by inhibiting the Notch signaling pathway.  
      关键词:Notch signaling pathway;asthma;lung fibrosis;Th17/Treg immune imbalance;inflammation   
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      发布时间:2024-08-11
    • CHEN Wenming,JIAN Minghui
      Vol. 35, Issue 15, Pages: 1855-1861(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.10
      摘要:OBJECTIVETo study the protective effect of tetrahydropalmatine (Thp) on platelet-derived growth factor-BB (PDGF-BB) induced oxidative stress injury in vascular smooth muscle cells (VSMCs) of rats, and to explore its possible mechanism based on the nuclear factor-erythroid 2-related factor 2 (Nrf2)/heme oxygenase (HO-1) signaling pathway.METHODSIn the study about Thp inhibiting PDGF-BB-induced oxidative stress injury in VSMCs, VSMCs were divided into control group, PDGF-BB group (25 ng/mL), and Thp low-concentration, medium-concentration and high-concentration groups (5, 10, 20 mg/mL). In the Thp mechanism experiment (silencing Nrf2), VSMCs were divided into PDGF-BB+negative control of siRNA (NC-siNrf2) group (25 ng/mL PDGF-BB+NC-siNrf2), PDGF-BB+Thp+NC-siNrf2 group (25 ng/mL PDGF-BB+10 mg/mL Thp+NC-siNrf2), PDGF-BB+Nrf2 small interfering RNA (siNrf2) group (25 ng/mL PDGF-BB+siNrf2) and PDGF-BB+Thp+siNrf2 group (25 ng/mL PDGF-BB+10.0 mg/mL Thp+siNrf2). The proliferative and migratory capabilities of VSMCs, the level of reactive oxygen species (ROS), the activities of superoxide dismutase (SOD) and catalase (CAT) as well as the protein expressions of Nrf2 and HO-1 in VSMCs were all detected in two experiments.RESULTSCompared with the control group, the proliferative and migratory capabilities of VSMCs in the PDGF-BB group were significantly enhanced (P<0.01), and the level of ROS significantly increased (P<0.01), while the activities of SOD and CAT, and the relative expressions of Nrf2 and HO-1 protein significantly decreased (P<0.01). Compared with the PDGF-BB group, the proliferative and migratory capabilities of VSMCs in the Thp groups at different concentrations were significantly reduced (P<0.01), the levels of ROS were significantly reduced, while the activities of SOD and CAT, and relative expressions of Nrf2 and HO-1 were significantly enhanced (P<0.01). Silencing Nrf2 significantly reversed the improvement of Thp on the oxidative stress damage of VSMCs induced by PDGF-BB (P<0.01).CONCLUSIONSThp can reduce the oxidative stress level of VSMCs by activating the Nrf2-mediated antioxidant defense pathway, thereby inhibiting the proliferation and migration of VSMCs.  
      关键词:platelet-derived growth factor-BB;vascular smooth muscle cells;Nrf2/HO-1 signaling pathway;oxidative stress   
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      发布时间:2024-08-11
    • LAN Chunyan,YANG Xiaolan,HE Xuefeng,ZHAO Dan,YANG Haiyan
      Vol. 35, Issue 15, Pages: 1862-1867(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.11
      摘要:OBJECTIVETo study the regulation effects and mechanism of liquiritin (LIQ) on immune function in gastric cancer-bearing mice based on the Janus kinase 2 (JAK2)/signal transducer and activator of transcription 3 (STAT3) pathway.METHODSGastric cancer cells MFC were injected subcutaneously to establish gastric cancer-bearing model of mice. The model mice were divided into model group, LIQ low-dose group (LIQ-L group, 20 mg/kg), LIQ high-dose group (LIQ-H group, 40 mg/kg), and high-dose LIQ+JAK2 activator coumermycin A1 group (LIQ-H+coumermycin A1 group, 40 mg/kg LIQ+1 mg/kg coumermycin A1), with 12 mice in each group. Another 12 mice without modeling were set as normal group. Mice in each group were given the corresponding drug or normal saline by intragastric administration/intraperitoneal injection, once a day, for consecutive 14 days. After the last administration, the volume and mass of gastric cancer tumor and organ index were measured. The percentages of CD4+ and CD8+T lymphocytes were detected in peripheral blood. The histopathological morphology of gastric cancer tumor tissues was observed, and the expression levels of JAK2/STAT3 signaling pathway-related proteins and interleukin-6 (IL-6) protein in gastric cancer tumor tissues were detected.RESULTSCompared with the normal group, the thymus index, spleen index, and the percentage of CD8+T lymphocyte in the peripheral blood of mice were obviously increased in model group (P<0.05), while the percentage of CD4+T lymphocyte in the peripheral blood were decreased (P<0.05). Compared with model group, the above indexes in LIQ-L group and LIQ-H group were significantly reversed (P<0.05), while the volume and mass of gastric cancer tumor, the phosphorylation levels of JAK2 and STAT3 protein and the expression level of IL-6 protein were significantly decreased in tumor tissue (P<0.05), and the effect of LIQ was in a dose-dependent manner (P<0.05); the tumor cells showed varying degrees of loose arrangement, vacuolization, and uneven distribution. JAK2 activator coumermycin A1 weakened the improvement effect of LIQ on the immune function of gastric cancer-bearing mice and its inhibitory effect on gastric cancer tumors (P<0.05).CONCLUSIONSLIQ can improve the immune function of gastric cancer-bearing mice by inhibiting the activation of JAK2/STAT3 signaling pathway, thus playing an anti-tumor role.  
      关键词:JAK2/STAT3 signaling pathway;gastric cancer;immune function   
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      发布时间:2024-08-11
    • ZHU Xiaohong,LIU Shixian,LI Shunping,DOU Lei,WANG Ruixue,SONG Zehua,CHEN Hao
      Vol. 35, Issue 15, Pages: 1868-1875(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.12
      摘要:OBJECTIVETo review the current research progress on pharmacoeconomics evaluation related to spinal muscular atrophy (SMA), in order to provide valuable insights for clinical treatment, screening and medical insurance payment decision-making.METHODSA computerized search was conducted across multiple databases including PubMed, Web of Science, Embase, Scopus, Cochrane Library, EBSCOhost, CNKI, VIP, CBM and Wanfang database as well as other important health technology assessment (HTA) websites, such as National Institute for Health and Care Research,International Society of Technology Assessment in Health Care, Agency for Healthcare Research and Quality, etc. The pharmacoeconomics evaluation studies related to SMA were collected from the inception to December 31st, 2023. The literature/reports were rigorously screened based on predefined inclusion and exclusion criteria by two researchers, and the essential information from the included literature/reports was extracted using Excel 2019. The quality of the included literature/reports was evaluated by Consolidated Health Economic Evaluation Reporting Standards 2022.RESULTSFinally, 9 articles and 15 HTA reports were included, with overall good quality of literature, but poor quality of HTA reports. There were a total of 24 studies on the pharmacoeconomics evaluation of SMA, including treatment options such as nusinersen sodium, sovaprevir, risperidone, and best supportive therapy. The review results showed that nusinersen sodium was not cost-effective in the treatment of SMA; there was no consensus on the economic viability of treatment options such as risperidone and sovaprevir; newborn/prenatal screening combined with medication therapy was cost-effective.CONCLUSIONSnewborn/prenatal screening combined with SMA medication therapy demonstrates economic advantages. It is suggested to further investigate the cost-effectiveness of new SMA drugs and SMA screening in China, taking localization parameters and medical insurance prices into account, and gradually incorporate SMA screening into the scope of neonatal genetic disease detection, in order to alleviate the financial burden of patients’ families and healthcare systems.  
      关键词:pharmacoeconomics;systematic review;nusinersen sodium;sovaprevir;risperidone;newborn screening   
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      发布时间:2024-08-11
    • ZHANG Rongrong,FU Yu,ZHAO Ruixia,FANG Yuxuan,WANG Jingwen,SHAO Mingyi
      Vol. 35, Issue 15, Pages: 1876-1881(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.13
      摘要:OBJECTIVETo evaluate the comprehensive value of four first-line combination immunotherapy for unresectable hepatocellular carcinoma, and provide a reference for determining the optimal clinical treatment decision for unresectable hepatocellular carcinoma.METHODSR4.2 software was used for network meta-analysis to obtain the effect values of the efficacy and safety indicators of four combination therapies [atezolizumab combined with bevacizumab (AB), sintilimab combined with bevacizumab biosimilars (SB), camrelizumab combined with apatinib (CA), durvalumab combined with tremelimumab (DT)]. Combined with the efficacy, safety and economic indicators, the categorical based evaluation technique (M-MACBETH) was used to establish the value tree. At the same time, the comprehensive value scores of four therapies were calculated, and sensitivity analysis was performed to evaluate the robustness.RESULTSIn terms of prolonging median overall survival, the advantage order of the four therapies was ranked as SB, CA, AB and DT. In terms of extending median progression-free survival, the advantage order of the four therapies was CA, SB, AB and DT. In terms of safety, the order of advantages was DT, AB, SB and CA. In terms of economy, the order of advantages was CA, SB, AB and DT. The comprehensive scores of SB, CA, AB and DT were 67.11, 57.77, 52.53 and 42.59 points, respectively. The results of the sensitivity analysis showed that the ranking results of comprehensive value for four regimens were robust.CONCLUSIONSAmong the four first-line immune combination therapies for unresectable hepatocellular carcinoma, SB is the optimal treatment regimen, followed by CA, AB and DT.  
      关键词:combination immunotherapy;multi-criteria decision analysis;comprehensive evaluation   
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      发布时间:2024-08-11
    • ZHANG Xiaoxiao,ZHANG Zhiwei,DONG Xiaoqian,XIE Manli,DENG Wanli,ZHANG Ming
      Vol. 35, Issue 15, Pages: 1882-1887(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.14
      摘要:OBJECTIVETo observe the clinical efficacy of Kanglaite injection assisted with camrelizumab combined with chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC).METHODSA total of 192 patients with advanced NSCLC and hospitalized in the TCM oncology department of our hospital from January 1st, 2018 to December 1st, 2022 were retrospectively selected as the study objects, and were divided into observation group (additional use, n=104) and control group (without additional use, n=88) according to whether the patients additionally received Kanglaite injection based on camrelizumab combined with chemotherapy (carboplatin+pemetrexed). The short-term therapeutic effects of 2,4 and 6 cycles were compared between the two groups. The levels of peripheral blood immune function indexes and serum tumor markers were compared before treatment, after 3 cycles of treatment and after treatment. The long-term therapeutic effects as well as the occurrence of adverse drug reaction(ADR) during hospitalization were compared between the two groups.RESULTSAfter 3 treatment cycles and at the end of treatment, the CD4+ T lymphocyte ratio and CD4+/CD8+ in the observation group were notably greater than the control group (P<0.05); the levels of serum carcinoembryonic antigen and cytokeratin 19 fragment antigen 21-1 were significantly lower than those in the control group (P<0.05). The overall survival of the observation group was significantly longer than that of the control group (P<0.05), and the median overall survival was (185.27±38.21) d and (132.11±34.23) d, respectively. There were no significant differences in the whole ADR and grade ≥3 ADR between the two groups during hospitalization(P>0.05).CONCLUSIONSBased on camrelizumab combined with chemotherapy, the addition of Kanglaite injection can enhance immunological response and prolong overall survival in advanced NSCLC patients.  
      关键词:camrelizumab;combination chemotherapy;non-small cell lung cancer;clinical efficacy;overall survival   
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      发布时间:2024-08-11
    • LIU Yang,HAN Minzhen,XIA Jie,HU Hanshuai,YAO Lei,LAN Xue,LIU Qian,WANG Jinxingyi
      Vol. 35, Issue 15, Pages: 1888-1892(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.15
      摘要:OBJECTIVETo mine the adverse drug events (ADE) signals for gilteritinib, and provide a reference for safe drug use in clinic.METHODSADE reports with gilteritinib as the primary suspected drug were extracted from the FDA Adverse Event Reporting System (FAERS) database from February 1st, 2018 to December 31st, 2023. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were applied to detect the risk signals from the data in the FAERS database. The classification and statistics of collected signal data were conducted by using the preferred term (PT) and systemic organ class (SOC) in ADE terminology set of the Medical Dictionary for Regulatory Activities (24.1 edition).RESULTSTotally, 2 755 gilteritinib-related ADE reports were collected from the database, involving 676 ADE signals (95 positive signals), 313 PTs and 25 SOCs. Among them, nine signals were not recorded in the package insert. The top 5 PTs consisted of abnormal liver function, decreased platelet count, febrile neutropenia, pneumonia and myelosuppression. The top 6 SOCs for positive signal counts were examinations, general disorders and administration site conditions, respiratory, thoracic and mediastinal disorders, infections and infestations, heart organ disorders, and nervous system disorders. ADEs not recorded in the drug package insert included pneumonia, myelosuppression, decreased blood cell count, sepsis, hemorrhage, infection (not specifically referred to), septic shock, respiratory failure, and aspergillosis.CONCLUSIONSIn addition to paying attention to common ADEs such as liver dysfunction and thrombocytopenia, it is necessary to monitor ADEs with strong signals that are not mentioned in the drug instructions when using gefitinib, such as pneumonia, bone marrow suppression, cytopenia, sepsis, bleeding, infection (not specifically referred to), septic shock, respiratory failure, Aspergillus infection, elevated serum creatinine and interstitial lung disease.  
      关键词:adverse drug events;pharmacovigilance;data mining   
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      发布时间:2024-08-11
    • TU Caixia,REN Danyang,SHEN Jianling,LI Yunwei,YANG Yanming,YAN Aihua,LI Lin,LI Huiying
      Vol. 35, Issue 15, Pages: 1893-1898(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.16
      摘要:OBJECTIVETo investigate the efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children, and provide reference for clinically safe and rational drug use.METHODSThe literatures about additional clobazam treatment for refractory epilepsy in children were searched from PubMed, The Cochrane Library, Embase, CNKI, VIP and Wanfang database during the inception to November 2023. After literature screening and data extraction, the quality of included literature was evaluated according to quality evaluation tool for methodological evaluation indicators of non-randomized controlled trial, and then meta-analysis of single-group rate and sensitivity analysis were performed by using RevMan 5.3 software.RESULTSFinally, 18 one-arm studies were included, with a total of 1 424 children. The results showed that compared with before additional treatment, the proportion of patients with seizures-free (proportion of patients with seizure reduction of 100%) was 24%[95%CI(0.18,0.32), P<0.000 01] after conversion; the proportion of patients with seizure reduction ≥75% was 32%[95%CI(0.25,0.40),P<0.000 1] after conversion; the proportion of patients with seizure reduction ≥50% was 53%[95%CI(0.44,0.61),P<0.000 01]; the proportion of patients with seizure reduction <50% or no change was 35%[95%CI(0.24,0.49),P=0.04] after conversion; the proportion of patients with seizure increase was 9%[95%CI(0.05,0.18),P<0.000 01] after conversion. The proportion of patients with adverse reactions was 31%[95%CI(0.23,0.40),P<0.000 1] after conversion; the proportion of patients with discontinuation due to adverse reactions was 10%[95%CI(0.07, 0.15), P<0.000 01] after conversion. The common adverse drug reactions were drowsiness, fatigue and behavior change, etc. The results of the sensitivity analysis showed that the study was robust.CONCLUSIONSClobazam is an effective additional therapy for refractory epilepsy in children, but its adverse effects should be vigilant.  
      关键词:refractory epilepsy;children;additional treatment;meta-analysis   
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      发布时间:2024-08-11
    • CHEN Yang,DAN Chonghui,HE Yao,RUAN Yi,CHEN Xiao,ZHENG Xiaoyuan
      Vol. 35, Issue 15, Pages: 1899-1904(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.17
      摘要:OBJECTIVETo create a highly effective algorithm for automatically generating easily confused drug catalogs (ECDC), as well as to develop a management system for ECDC based on this algorithm, in order to improve the management efficiency of ECDC.METHODSThis study, based on Levenshtein distance algorithm, delved deeply into the automatic identification mechanism of easily confused drugs and the screening method for determining similarity thresholds, ultimately leading to the development of an algorithm for automatically generating ECDC. Besides a management system was designed and developed, using SQL Server 2008 R2 Express as the data storage platform and Visual Basic.NET as the programming language.RESULTSThe similarity threshold δ played a crucial role in the algorithm for automatically generating ECDC. As the value of δ gradually increased, the total count of easily confused drugs decreased gradually, while the count of drug groups exhibited a pattern of initially increasing and then decreasing. Practically, ECDC could be created using either the generic or varietal names of drugs, with corresponding similarity thresholds of 0.75 and 0.83. Furthermore, ECDC management system had significantly reduced the time required to establish a catalog from about one week to less than one hour, resulting in a substantial enhancement in work efficiency.CONCLUSIONSThe algorithm used to automatically generate ECDC is highly efficient and rapid, offering robust technical assistance for the management of easily confused drugs. Implementing the ECDC system can greatly reduce the time cost related to building and maintaining the catalogs, thus significantly improving the efficiency of managing ECDC.  
      关键词:Levenshtein distance;drug catalogs;similarity threshold   
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      发布时间:2024-08-11
    • CHEN Fei,WANG Qian,WANG Haizheng,LIN Xiaolan,ZHUANG Wei
      Vol. 35, Issue 15, Pages: 1905-1909(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.18
      摘要:OBJECTIVETo provide a reference for medical institutions in selecting and establishing a traditional Chinese medicine (TCM) clinical pharmaceutical care mode that suits their clinical characteristics.METHODSCombining clinical cases, this paper introduces the workflow and service content of the joint consultation mode between TCM physicians and TCM clinical pharmacists in our hospital and analyzes its effectiveness.RESULTSThe workflow of the pharmaceutical care mode in our hospital involves six stages:assessing the patient’s medication status, consultation rounds and formulating medication regimen, bedside education, pharmaceutical monitoring, pharmacist rounds, and extended pharmaceutical care. The care content primarily includes thoroughly collecting clinical information and evaluating the patient’s medication regimen before the consultation. During the consultation, TCM clinical pharmacists and TCM physicians jointly developed a dosage regimen tailored to the patient’s individual conditions. After the consultation, bedside medication education was conducted to ensure the correct use of medications and a pharmaceutical monitoring plan was developed and implemented, during which the patient’s post-consultation condition changes were monitored and timely feedback to the TCM physicians for medication plan adjustments was provided, offering extended pharmaceutical care post-consultation, including medication consultation, pharmaceutical outpatient services, and joint clinics. Since its implementation, nearly 1 000 inpatients have been served annually, with a 100% medical order review rate for patients taking TCM decoction pieces. Individualized medication education reached 78.80%, and patient’s degree of satisfaction was 100%. The prescription compliance rate of TCM decoction pieces in the wards increased from 89.33% before the implementation of the joint consultation to 97.08% afterward. Additionally, the mode provided TCM-related consultations to over 1 000 patients annually and compiled and provided nearly a hundred pharmaceutical documents to healthcare personnel.CONCLUSIONSBy establishing the joint consultation mode between TCM physicians and TCM clinical pharmacists and conducting TCM clinical pharmaceutical care, the level of rational use of TCM decoction pieces has been promoted, demonstrating the value of TCM clinical pharmacists.  
      关键词:TCM physicians;joint consultation;pharmaceutical care   
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      发布时间:2024-08-11
    • DUAN Junya,ZHANG Yan,SONG Guihua,CHEN Xiaosong,GUO Yanrong,ZHOU Xuan,CHEN Xinying
      Vol. 35, Issue 15, Pages: 1910-1914(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.19
      摘要:β2-adrenergic receptor (β2-AR) agonists are widely used as first-line drugs in the treatment of bronchial asthma (hereinafter referred to as “asthma”), but long-term use can lead to β2-AR desensitization and reduce its clinical efficacy, resulting in poor symptom control of some asthma patients. The mechanism of β2-AR desensitization induced by β2-AR agonists mainly includes slow hyposensitization (related to the decrease of β2-AR density in airway mucosa) and rapid hyposensitization (related to the mechanism of stimulatory G protein decoupling). Cyclic adenosine monophosphate(cAMP)-protein kinase A and cAMP-exchange protein activated by cAMP signaling pathways are closely related to β2-AR desensitization. Glucocorticoids, peroxisome proliferator-activated receptor-gamma agonists, ASM-024, Chinese medicine monotherapies and formulations, when combined with β2-AR agonists, can improve the sensitivity of β2-AR, so as to better control asthma symptoms.  
      关键词:β2-adrenergic receptor agonists;desensitization;mechanism of occurrence;prevention effect   
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    • DUAN Xueyu,LIAO Binbin,LI Lei,ZHANG Dingcai,CHEN Ruixiang,LIU Xiaobo
      Vol. 35, Issue 15, Pages: 1915-1922(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.20
      摘要:In recent years, the potential anti-tumor effects of metformin have attracted widespread attention in the field of cancer treatment. This article summarizes the research progress of metformin in the treatment of malignant tumors,finding its potential application in the treatment of malignant tumors in the digestive system (biliary tract cancer,gastric cancer,esophagus cancer,colorectal cancer,pancreatic cancer,liver cancer) and reproductive system (prostate cancer,ovarian cancer,breast cancer,cervical cancer),non-small cell lung cancer,renal cell carcinoma,and melanoma. Metformin can inhibit the proliferation of tumor cells and extend the overall survival of patients. Its mechanisms of action include,but are not limited to,inhibiting the activity of mitochondrial complex Ⅰ,activating adenosine monophosphate-activated protein kinase/p53 signaling pathway,and blocking the cell cycle. Additionally,the combined use of metformin with chemotherapy drugs has shown potential for reducing toxicity and enhancing efficacy. It can enhance the sensitivity of biliary tract cancer,ovarian cancer,and melanoma cells to chemotherapy drugs,improve the drug resistance of gastric and colorectal cancer cells to chemotherapy,and reduce the toxic reactions of breast cancer patients during chemotherapy. Metformin is also used as an immunomodulator,applied in the immunotherapy of patients with esophagus cancer,colorectal cancer,cervical cancer,non-small cell lung cancer,and melanoma.  
      关键词:malignant tumors;mechanism of action;clinical application   
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      发布时间:2024-08-11
    • DENG Siming,LIU Lijian,LI Liqun,YANG Chengning,WEI Jinxiu,LI Jianfeng,HUANG Mingzhu,XIE Lili
      Vol. 35, Issue 15, Pages: 1923-1927(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.21
      摘要:Hepatic fibrosis is a pathological process of chronic liver injury. Without timely intervention and treatment, liver fibrosis may eventually lead to liver cirrhosis and cancer. Janus kinase (JAK)/signal transducer and activator of transcription (STAT) signaling pathway is closely associated with the occurrence and development of liver fibrosis. Based on this, this paper summarized and analyzed the mechanism and effects of active ingredients and compounds of traditional Chinese medicine improving liver fibrosis based on JAK/STAT signaling pathway. It is found that the active ingredients and compounds of traditional Chinese medicine that promote blood circulation and remove blood stasis (ingredients such as ethanol extract of Euonymus alatus and paclitaxel, as well as compounds such as Ershiwuwei songshi pill and Ganfukang), clear away heat and toxic material (ingredients such as betulinic acid, total flavonoids from Persicaria perfoliata, as well as compounds such as Pianzaihuang and Kehuang capsules), and sooth the liver and promote qi circulation (ingredients such as fraxetin and cucurbitacin B, as well as compounds such as Chaihu shugan powder and Xiaochaihu decoction) can all relieve liver fibrosis by inhibiting the activity of the JAK/STAT signaling pathway, reducing inflammatory reactions, and inhibiting the proliferation of hepatic stellate cells.  
      关键词:JAK/STAT signaling pathway;traditional Chinese medicine;active ingredients;compounds   
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      发布时间:2024-08-11
    • WU Tao,LIU Li,SONG Hongping
      Vol. 35, Issue 15, Pages: 1928-1932(2024) DOI: 10.6039/j.issn.1001-0408.2024.15.22
      摘要:Metabolic syndrome (MS) is a complex group of clinical syndromes with obesity, abnormal glucose and lipid metabolism and hypertension as the main clinical features. Swertia mussotii is a commonly used medicine among the Tibetan people in China. Its efficacy is consistent with the pathogenesis of MS, which has the potential for symptomatic treatment of MS. It is found that effective ingredients such as gentiopicroside, sweroside, swertiamarin, mangiferin, and oleanolic acid can improve MS by regulating glucose and lipid metabolism, improving obesity, regulating the cardiovascular system, inhibiting chronic inflammation, oxidative stress, endoplasmic reticulum and autophagy, and improving intestinal microflora disorder.  
      关键词:active ingredients;metabolic syndrome;obesity;glucose and lipid metabolism;mechanism of action   
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