摘要:OBJECTIVETo know about the pharmacy intravenous admixture charge and operation balance of pharmacy intravenous admixture services (PIVAS) in national medical institutions.METHODSUsing questionnaire survey method, the national PIVAS leaders were invited to fill in the questionnaire, investigation and statistical analysis of the drug dispensing charge standard and the income and expenditure situations of PIVAS nationwide were conducted.RESULTSA total of 761 PIVAS completed the questionnaire, among which 466 PIVAS (61.2%) had already started implementing pharmacy intravenous admixture charge, mainly in tertiary hospitals. The charge standards for chemotherapy drugs and parenteral nutrition solutions were relatively high, while the standards for packaged drugs were the lowest, with differences in charge standards among provinces(P<0.05). Among the 25 provinces that reported annual drug preparation fee revenue, Hubei had the highest revenue in both 2019 and 2021. In 2019, the number of PIVAS with a balance of payments was more than that of PIVAS with an imbalance of payments, but the number of PIVAS with an imbalance of payments in 2021 exceeded the number of PIVAS with a balance of payments (P<0.05); among them, eight provinces were unbalanced in 2019 and 2021, such as Tianjin, Chongqing, Guizhou, etc.CONCLUSIONSPIVAS charge standards of the surveyed medical institutions in all provinces are not unified. It is suggested to improve the charge standard further, formulate the charge adjustment cycle, and promote a sustainable development of PIVAS.
关键词:balance of payments;charge standard;operating cost;questionnaire survey
摘要:OBJECTIVETo investigate the effects and mechanism of Glycyrrhiza inflata polysaccharides (GiP) and GiP-B1 on the maturation and anti-tumor effect of dendritic cell (DC).METHODSThe immature DC (imDC) of hepatocellular carcinoma cell H22 tumor-bearing mice cultured in vitro were divided into control group, tumor necrosis factor-α (TNF-α) group, GiP group, and GiP-B1 group. The viability, positive expressions of surface markers (CD11c, CD80, CD86, MHC-Ⅱ), the levels of interleukin-12p70 (IL-12p70) and IL-4 in mature DC (mDC) of tumor-bearing mice were detected. mDC and CD4+T lymphocytes were co-cultured to generate CD4-cytotoxic T cell (CD4-CTL); stimulation index, the levels of IL-12p70, interferon-γ (IFN-γ), IL-4 and IL-10, the killing activity of CD4-CTL to H22 cell were detected. mRNA expressions of IL-12, IL-12 receptor (IL-12R), signal transducer and activator of transcription-4 (STAT-4), as well as the protein expression of IL-12 receptor β2 (IL-12Rβ2), phosphorylation levels of nuclear factor-kappa B (NF-κB) p65 and STAT-4 proteins in mDC were detected after co-culture.RESULTSCompared with the control group, the viability of mDC, the positive expressions of MHC-Ⅱ, and the levels of IL-12p70 and IL-4 were increased significantly in GiP group and GiP-B1 group (P<0.05). The positive expressions of CD11c, CD80 and CD86 showed an increasing trend, but the differences were not statistically significant (P>0.05). After co-culturing, the stimulation index, the levels of IL-12p70 and IFN-γ were significantly increased (P<0.05), while the levels of IL-4 and IL-10 (except for the GiP group) were significantly decreased (P<0.05); the cytotoxicity against H22 cells was significantly enhanced (P<0.05). mRNA expressions of IL-12 and IL-12R (except for GiP group) and STAT-4, protein expression of IL-12Rβ2 as well as phosphorylation levels of NF-κB p65 and STAT-4 protein were increased significantly in mDC (P<0.05).CONCLUSIONSGiP and GiP-B1 have a good promoting effect on the maturation of DC in tumor-bearing mice, effectively stimulate CD4+T cell proliferation, enhance the anti-tumor activity of CD4-CTL, and its mechanism may be related to activating IL-12/NF-κB/STAT-4 signaling pathway.
关键词:dendritic cell;IL-12/NF-κB/STAT-4 signaling pathway;cytotoxic T lymphocytes;anti-tumor
摘要:OBJECTIVETo study the effects of Zigui yichong formula on premature ovarian insufficiency (POI) in mice through glycolysis metabolic pathway.METHODSEighty SPF C57BL/6N female mice were divided into normal group, model group, Zigui yichong formula group (14.175 g/kg), Zigui yichong formula+2-deoxy-D-arabino-hexose (2-DG) group (Zigui yichong formula 14.175 g/kg + glycolysis inhibitor 2-DG 100 mg/kg), with 20 mice in each group. Except for the normal group, POI model mice were induced by intraperitoneal administration of cyclophosphamide in the other groups. After the model was successfully established, each group was given corresponding drugs. HE staining was employed to observe the pathomorphological changes in ovarian tissue and to count follicles at all developmental stages; radioimmunoassay was conducted to measure the serum levels of estradiol (E2), anti-Müllerian hormone (AMH), and follicle-stimulating hormone (FSH); TUNEL assay was employed to detect apoptosis in ovarian granulosa cells of mice; the activities of hexokinase (HK), pyruvate kinase (PK) and lactate dehydrogenase (LDH) were detected by colorimetry; Western blot and real-time fluorescence quantitative PCR were employed to analyze the protein and mRNA expressions of B-cell lymphoma-2 (Bcl-2), Bcl-2 associated X protein (Bax), caspase-3, HK2, pyruvate kinase M2 (PKM2), and lactate dehydrogenase A (LDHA).RESULTSCompared with model group, the number of primordial follicles, growing follicles, antral follicles and granulosa cells were increased significantly (P<0.05), and granulosa cells arranged neatly, but the number of atretic follicles and granulosa cells apoptosis were decreased significantly in Zigui yichong formula group (P<0.05); the serum levels of E2 and AMH, the activities of HK, PK and LDH, protein and mRNA expressions of Bcl-2, HK2, PKM2 and LDHA were increased significantly (P<0.05); the serum levels of FSH, the protein and mRNA expressions of Bax and caspase-3, Bax/Bcl-2 ratio were decreased significantly (P<0.05). 2-DG could reverse the improvement effects of Zigui yichong formula on the above indexes of POI model mice.CONCLUSIONSZigui yichong formula may inhibit the apoptosis of ovarian granulosa cells, reduce follicle atresia and improve ovarian reserve function by promoting glycolysis levels in POI model mice.
摘要:OBJECTIVETo explore the improvement effect and mechanism of acacetin on juvenile asthma rats based on the silence information regulator 1 (SIRT1)/AMP-activated protein kinase (AMPK) signaling pathway.METHODSJuvenile SD rats were randomly divided into control group, asthma group, acacetin group (13.33 mg/kg, gavage), SIRT inhibitor EX-527 group (1 mg/kg, intraperitoneal injection) and acacetin+EX-527 group (13.33 mg/kg acacetin, gavage+1 mg/kg EX-527, intraperitoneal injection), with 12 rats in each group (half male and half female). Except for the control group, the other groups were sensitized by intraperitoneal injection of ovalbumin and nebulized inhalation of ovalbumin to induce the asthma model. After modeling, rats in each drug group were orally administered or (and) intraperitoneally injected with the corresponding medication once a day for 2 weeks. After the last administration, the total number of cells, the proportion of eosinophils, and the levels of interleukin-5 (IL-5), IL-4 and tumor necrosis factor-α (TNF-α) in the bronchoalveolar lavage fluid (BALF) were measured. The pathological changes and abnormal proliferation of goblet cells in lung tissue were observed, the levels of malondialdehyde (MDA) and superoxide dismutase (SOD) in lung tissue and the protein expressions of SIRT1, AMPK and peroxisome proliferator activated receptor-gamma co-activator factor-1α(PGC-1α) were detected.RESULTSCompared with control group, there was a large number of inflammatory cell infiltration and obvious goblet cell dysplasia in the lung tissue of rats in asthma group; the total number of cells in BALF, the proportion of eosinophils, the levels of IL-5, IL-4 and TNF-α in BALF, PAS score and MDA level in the lung tissue were significantly increased (P<0.05); the SOD level, protein expressions of SIRT1 and PGC-1α and protein phosphorylation level of AMPK in lung tissue were significantly decreased in asthma group (P<0.05). Compared with the asthma group, the pathological changes of lung tissue and goblet cell dysplasia of rats were reduced, and all quantitative indexes were significantly improved in acacetin group (P<0.05), while the pathological changes of lung tissue and goblet cell dysplasia of rats were increased, and all quantitative indexes were significantly worsened in EX-527 group (P<0.05). The combination of EX-527 could significantly reverse the effects of acacetin on oxidative stress and airway inflammation in juvenile asthma rats.CONCLUSIONSAcacetin can inhibit oxidative stress and airway inflammation in juvenile asthma rats, which may be related to the activation of the SIRT1/AMPK signaling pathway.
摘要:OBJECTIVETo study the fingerprint of Denghong buyang huanwu granules (DBHG), screen the quality markers, and establish the method for content determination of active ingredients.METHODSHPLC method was adopted. The fingerprints of 10 batches of DBHG (S1-S10) were established by using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012 edition), and similarity evaluation was also performed. Traditional Chinese medicine pieces attribution analysis, cluster analysis (CA), principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were conducted for common peaks, and quality biomarkers were screened based on variable importance projection (VIP) values>1. The contents of 10 batches of samples were determined by the same HPLC method, such as salidroside, tyrosol, calycosin-7-O-beta-D-glucoside, scutellarin and calycosin.RESULTSA total of 25 common peaks were obtained in the fingerprints for 10 batches of samples and 6 common peaks were identified, i.e. salidroside, tyrosol, paeoniflorin, calycosin-7-O-beta-D-glucoside, scutellarin, calycosin. Their similarities were greater than 0.9, and 10 common peaks of them were unique components of Erigeron breviscapus. DBHG could be clustered into 2 categories by using CA and PCA; S4-S5, and S7 could be clustered into one category and other samples could be clustered into one category. The corresponding components of peaks 16 (scutellarin), 12, 15 (calycosin-7-O-beta-D-glucoside), 13 (paeoniflorin), and 14 were quality markers. The average contents of salidroside, tyrosol, calycosin-7-O-beta-D-glucoside, scutellarin and calycosin were 1.64, 0.45, 0.31, 0.73, 0.15 mg/g in 10 batches of samples.CONCLUSIONSHPLC fingerprint for DBHG and a method for determining the contents of five active ingredients including salidroside are successfully established. Five quality markers have been screened. It can be used for the quality control of the preparation.
摘要:OBJECTIVETo investigate the effects of celastrol (CSL) on drug resistance of liver cancer cells.METHODSHuman liver cancer lenvatinib (Len)-resistant cells Huh7/Len were constructed and divided into control group, CSL low-, medium- and high-concentration groups (1, 2.5, 5 μmol/L), and CSL high-concentration+Zn27 [focal adhesion kinase (FAK) inhibitor] group (5 μmol/L CSL+2 nmol/L Zn27), with 6 holes in each group. The proliferation (by absorbance) and cloning ability, apoptotic rate, the number of invasion cells and migration cells, the level of reactive oxygen species(ROS) as well as the protein expressions of phosphorylated FAK (p-FAK), phosphorylated mitogen-activated protein kinase kinase (p-MEK), phosphorylated extracellular signal-regulated kinase (p-ERK), B-cell lymphoma-2 (Bcl-2), Bcl-2 associated X protein (Bax) and caspase-3 were detected.RESULTSCompared with control group, cell absorbance, clone count, invasion count and migration count , and the protein expressions of p-FAK, p-MEK, p-ERK and Bcl-2 were significantly reduced in the CSL low-, medium-, high-concentration groups; the apoptosis rate, ROS level, and protein expressions of Bax and caspase-3 were significantly increased, in a concentration-dependent manner (P<0.05). Compared with CSL high-concentration group, the changes of above indexes were all reversed significantly in CSL high-concentration+Zn27 group (P<0.05).CONCLUSIONSCSL can enhance oxidative stress, promote cell apoptosis, inhibit malignant progression and chemotherapy resistance of liver cancer cells, and its mechanism may be related to the inhibition of the FAK/MEK/ERK signaling pathway.
摘要:OBJECTIVETo establish the fingerprints of Tianma jiannao granules (TJG) and the method for content determination to evaluate the quality of TJG comprehensively combined with chemometric analysis.METHODSHigh-performance liquid chromatography (HPLC) was used to establish the fingerprints of 13 batches (S1-S3) of TJG and determine the contents of inosine, gastrodin, parishin B and parishin E. Cluster analysis, principal component analysis, and orthogonal partial least squares-discriminant analysis were performed using SPSS 20.0 and SIMCA 18 software; using variable importance projection (VIP) value greater than 1 as a criterion, marker components that affected quality were screened.RESULTSA total of 28 common peaks were identified in the 13 batches of TJG with similarities greater than 0.9, and 7 common peaks were identified, which were gastrodin, p-hydroxybenzyl alcohol, parishin B, parishin E, rhynchophylline, inosine and salidroside. The 13 batches of TJG were clustered into 3 categories, S1-S2, S8-S10 and S12 were clustered into one category; S3 and S7 were clustered into one category; S4-S6, S11 and S13 were clustered into one category. VIP of inosine was greater than 1. The contents of inosine, gastrodin, parishin B and parishin E were 62.637-176.677, 17.821-37.642, 5.748-16.077 and 5.660-13.510 μg/g.CONCLUSIONSThe established HPLC fingerprints and content determination method are stable, reliable and highly reproducible, which can be used to evaluate the quality of TJG in combination with chemometric analysis. Inosine may be a marker component that affects the quality of TJG. There are differences in the quality of 13 batches of TJG.
关键词:fingerprint;content determination;cluster analysis;principal component analysis;orthogonal partial least squares-discriminant analysis
摘要:OBJECTIVETo investigate the effect mechanism of andrographolide (Andro) on neuropathic pain (NP) in rats.METHODSRats were randomly separated into sham operation group, model group, Andro low-dose (1 mg/kg), Andro medium-dose (5 mg/kg) and Andro high-dose (10 mg/kg) groups, and sodium ferulic acid (150 mg/kg) group, with 12 rats in each group. Except for sham operation group, other groups used the chronic sciatic nerve compression injury method to induce NP model. After modeling, each group was given relevant dose of Andro intrathecally or sodium ferulate intragastrically. The sham operation group and model group were given a constant volume of normal saline once a day for 14 consecutive days. The mechanical withdrawal threshold (MWT) and thermal withdrawal latency (TWL) of rats were detected in each group after 7 and 14 days of administration. After the last medication, the serum levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), prostaglandin E2 (PGE2), and substance P (SP) in rats were detected in each group, and the pathological morphology of spinal cord tissue was observed. mRNA and protein expressions of ionized calcium binding adaptor molecule-1 (Iba-1), growth arrest specific protein 6 (Gas6), and Axl in spinal cord tissue were determined.RESULTSCompared with model group, MWT and TWL after 7 and 14 days of the administration, the mRNA and protein expressions of Gas6 and Axl after the last medication were all increased significantly in administration groups (P<0.05), while the levels of IL-6, TNF-α, PGE2 and SP, mRNA and protein expressions of Iba-1 were all decreased significantly (P<0.05); pathological injuries such as the disordered arrangement of spinal cord neurons and dilation and congestion of capillaries had been alleviated to varying degrees. Compared with sodium ferulic acid group, there was no statistically significant difference in the above indicators in the Andro high-dose group (P>0.05).CONCLUSIONSAndro may inhibit inflammatory response by activating the Gas6/Axl signaling axis, thereby alleviating NP.
关键词:neuropathic pain;Gas6/Axl signal axis;analgesia
摘要:OBJECTIVETo estimate the cost-utility of sacituzumab govitecan (SG) versus single-agent chemotherapy in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced metastatic breast cancer.METHODSFrom the perspective of the Chinese medical system, a three-state partitioned survival model was constructed to examine the cost-utility of SG versus single-agent chemotherapy based on TROPiCS-02 trial. The cycle length was set to 1 month, and the time horizon was 10 years. The annual discount was 5%. The model output included total costs and quality adjusted life month (QALM), and incremental cost-effectiveness ratio (ICER) was calculated for cost-utility analysis, by setting willingness-to-pay (WTP) threshold at 3 times gross domestic product (GDP) per capita of China in 2023 (22 340 yuan/QALM). Univariate sensitivity analyses, probability sensitivity analyses, and scenario analyses were performed to evaluate the robustness of the results and calculate the price threshold when SG had economic advantages.RESULTSSG group gained incremental 4.25 QALM and 561 570 yuan compared with single-agent chemotherapy, which resulted in an ICER of 132 102/QALM that was higher than WTP. The results of the univariate sensitivity analysis showed that the monthly average cost of SG had the greatest impact on the results; the results of probability sensitivity analysis showed that the probability of SG scheme being cost-effective at the WTP threshold was 0. The results of scenario analysis showed that the conclusions of this study were robust under different time horizons (5, 10, 15 years). The price threshold for SG being cost-effective was 1 344 yuan per 180 mg.CONCLUSIONSBased on the perspective of Chinese medical system, SG appears to be not cost-effective compared with single-agent chemotherapy for HR+/HER2- advanced metastatic breast cancer at the price of 8 400 yuan per 180 mg. A substantial price cut should be taken to be cost-effective.
关键词:cost-utility analysis;HR+/HER2- advanced metastatic breast cancer;partitioned survival model;pharmacoeconomics
摘要:OBJECTIVETo analyze the influential factors on trough concentration (cmin) and area under the drug concentration time curve (AUC) of voriconazole (VRZ) in pediatric patients with thalassemia undergoing hematopoietic stem cell transplantation (HSCT).METHODSA total of 60 pediatric patients with thalassemia undergoing HSCT who used VRZ for prevention or treatment of invasive fungal infection were collected in our hospital from January 2021 to January 2024. The plasma concentration of VRZ was measured by high-performance liquid chromatography and the AUC was calculated. The factors affecting cmin and AUC of VRZ were analyzed using multiple linear regression.RESULTSA total of 120 cases of VRZ cmin in 60 pediatric patients was obtained and 27 cases of VRZ AUC in 26 pediatric patients were obtained. The median concentration of VRZ cmin was 0.31 mg/L; 46 cases had a cmin in 0.5-5 mg/L(38.33%), 2 cases had a cmin>5 mg/L(1.67%), and 72 cases had a cmin<0.5 mg/L. The median AUC of VRZ was 11.68 mg·h/L. The patient’s body weight, HSCT postoperative days, lymphocyte count, and combined use of phenytoin sodium, tacrolimus or cyclosporine had significant effects on VRZ cmin (P<0.05). Lymphocyte count and combined use of phenytoin sodium had significant effects on VRZ AUC (P<0.05).CONCLUSIONSThe body weight, HSCT postoperative days, lymphocyte count, and combined use of phenytoin sodium, tacrolimus or cyclosporine are independent factors affecting VRZ cmin. Lymphocyte count and combined use of phenytoin sodium are independent factors affecting VRZ AUC.
关键词:thalassemia;hematopoietic stem cell transplantation;plasma concentration;trough concentration;area under the drug concentration-time curve;influential factors
摘要:OBJECTIVETo evaluate the effectiveness of Polyene phosphatidylcholine capsules (PPC) as adjuvant therapy for chronic hepatitis B (CHB).METHODSRetrospective data were collected from the patients diagnosed with CHB, treated with hepatoprotective drugs combined with antiviral drugs or antiviral drugs alone, and underwent long-term follow-up in the outpatient department of Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital from January 1, 2017 to December 31, 2022. After balancing confounding factors through propensity score matching, the effectiveness of PPC combined with antiviral therapy versus antiviral therapy alone (PPC+antiviral group versus antiviral group) and PPC+Diammonium glycyrrhizinate enteric-coated capsules (DGC) combined with antiviral therapy versus DGC combined with antiviral therapy (PPC+DGC+antiviral group versus DGC+antiviral group) as therapy for CHB were compared under real medical conditions.RESULTSTotally 382 patients with CHB who received hepatoprotective agents based on antiviral therapy (221, 63 and 98 patients who received DGC, PPC and combination therapy, respectively) and 400 patients who received antiviral therapy alone were ultimately included. After propensity score matching, there were 47 patients each in the PPC+antiviral group and the antiviral group, respectively; after treatment, the alanine transaminase (ALT) levels in the PPC+antiviral group were significantly reduced compared to before treatment and the antiviral group at the same time (P<0.05), while there was no statistically significant difference in the ALT normalization rate between the two groups (P>0.05). There were 74 patients each in the PPC+DGC+antiviral group and the DGC+antiviral group, respectively; after treatment, the ALT levels of patients in both groups were significantly reduced compared to before treatment, the ALT levels of PPC+DGC+antiviral group were significantly lower than those in the DGC+antiviral group at the same time, and the ALT normalization rate was significantly higher in the PPC+DGC+antiviral group than that in the DGC+antiviral group (P<0.05).CONCLUSIONSBased on using antiviral drugs to treat CHB, adjuvant therapy combined with PPC has a significant advantage in reducing liver enzymes; in addition, compared with the DGC combined antiviral regimen, the dual hepatoprotective drug of DGC and PPC combined with an antiviral regimen has better effects on liver protection and reduction of liver enzymes.
关键词:hepatoprotective drug;chronic hepatitis B;alanine transaminase;propensity score matching;real-world study
摘要:OBJECTIVETo explore the effect and safety of dapagliflozin on cardiac function and renal function, blood glucose, and quality of life in patients with heart failure (HF) combined with chronic kidney disease (CKD).METHODSA total of 156 patients with HF combined with CKD admitted to Shangqiu First People’s Hospital from January 1, 2021 to January 1, 2023 were included. According to the random number table, the patients were randomly divided into conventional treatment group (n=80) and dapagliflozin group (n=76). Conventional treatment group was given conventional treatment; dapagliflozin group was additionally given Dapagliflozin tablets 10 mg orally, once a day, based on conventional treatment group. Both groups were treated for 6 months. Cardiac function [left ventricular ejection fraction (LVEF), left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), N-terminal pro-brain natriuretic peptide (NT-proBNP)], renal function [blood creatinine, urea nitrogen, urinary albumin excretion rate (UAER), glomerular filtration rate (GFR), creatinine clearance rate (CCR)], glycosylated hemoglobin, and the quality of life were observed in 2 groups before and after treatment. The occurrence of ADR was recorded.RESULTSAfter treatment, LVESD, LVEDD, NT-proBNP, blood creatinine, urea nitrogen, UAER in 2 groups as well as the level of glycosylated hemoglobin in dapagliflozin group were significantly lower than before treatment; the dapagliflozin group was significantly lower than the conventional treatment group. LVEF, GFR, CCR and Kansas City Cardiomyopathy Questionnaire score were significantly higher than before treatment, and the dapagliflozin group was significantly higher than the conventional treatment group (P<0.05). There was no statistical significance in glycosylated hemoglobin of conventional treatment group before and after treatment (P>0.05). There was no statistically significant difference in the incidence of dizziness, rash, liver dysfunction, urinary system infection, new dialysis and hypotension between the two groups (P>0.05).CONCLUSIONSDapagliflozin can improve the cardiac function and renal function of patients with HF complicated with CKD, improve patients’ quality of life and lower blood sugar levels without increasing the risk of adverse events.
摘要:OBJECTIVETo explore the effects of levosimendan on cardiac function, hemodynamics and prognosis of patients with septic shock complicated with myocardial depression, and evaluate the safety of levosimendan.METHODSPatients with septic shock complicated with myocardial depression who were admitted to the Department of Critical Care Medicine of Chongqing University Three Gorges Hospital from April 2021 to August 2023, underwent adequate fluid resuscitation, had a mean arterial pressure (MAP) ≥65 mmHg, and received pulse indicator continuous cardiac output (PiCCO) monitoring were enrolled. The patients were randomly divided into dobutamine group and levosimendan group according to a random number table, with 20 patients in each group. Both groups received intravenous infusion of Norepinephrine bitartrate injection at a dose of 0.1-2.0 μg/(kg·min). On this basis, the dobutamine group additionally received intravenous infusion of Dobutamine hydrochloride injection at a dose of 5-10 μg/(kg·min) for 3 to 7 days, while the levosimendan group additionally received intravenous infusion of Levosimendan injection at a dose of 0.1-0.2 μg/(kg·min) for 24 hours. Heart rate (HR) and hemodynamic parameters [systolic blood pressure, diastolic blood pressure, MAP, central venous pressure (CVP)], PiCCO monitoring parameters [cardiac function index (CFI), cardiac index (CI), stroke volume index (SVI), extravascular lung water index, global end-diastolic volume index, pulmonary vascular permeability index (PVPI), global ejection fraction (GEF), systemic vascular resistance index, left ventricular contractility index], and prognosis indicators [death within 3 days after administration, mechanical ventilation time, intensive care unit (ICU) stay time, 28-day mortality rate] were compared between the two groups before treatment and at 24 and 72 hours after treatment. Adverse reactions were recorded for both groups.RESULTSCompared with before treatment in the same group, CFI, CI and GEF at 24 hours after treatment, CI and GEF at 72 hours after treatment in the dobutamine group, as well as SVI at 24 hours after treatment and SVI and GEF at 72 hours after treatment in the levosimendan group were significantly increased; PVPI at 72 hours after treatment in the dobutamine group was significantly decreased (P<0.05). Compared with the dobutamine group during the same period, patients in the levosimendan group had significantly lower HR and significantly higher CVP at 24 hours after treatment (P<0.05). Within 3 days after administration, there were no deaths in either group; there were no statistically significant differences in mechanical ventilation time, ICU stay time, 28-day mortality rate, or the incidence of adverse reactions between the two groups (P>0.05).CONCLUSIONSFor patients with septic shock complicated with myocardial depression who have undergone adequate fluid resuscitation and have a MAP of ≥65 mmHg, levosimendan is comparable to dobutamine in improving cardiac function and hemodynamic parameters, without affecting patients’ prognosis or increasing the risk of adverse reactions such as hypotension.
摘要:OBJECTIVETo compare the efficacy and safety between the drug winning the bidding for centralized procurement and the original drug of ticagrelor in acute coronary syndrome (ACS) patients one year after percutaneous coronary intervention (PCI).METHODSOverall 420 ACS patients treated with PCI in our hospital from July 2021 to June 2023 were divided into centralized procurement group (156 cases) and original drug group (264 cases) according to the different varieties of ticagrelor. All patients were given Aspirin enteric-coated tablets 100 mg regularly, once a day; on this basis, patients in the centralized procurement group were given Ticagrelor tablets winning the bidding, while patients in the original drug group were given the original drug of Ticagrelor tablets. The dosage of Ticagrelor tablets taken by both groups of patients was 90 mg, twice a day, and the course of treatment was 12 months. The blood routine indicators were compared before treatment and one week after treatment, while the incidence of net adverse clinical events (NACE), major adverse cardiovascular and cerebrovascular events (MACCE) and bleeding events, and the survival rate without MACCE and bleeding events during a one-year follow-up after PCI were also compared between two groups.RESULTSThere were no statistically significant differences in blood routine indicators before treatment and one week after treatment, as well as the incidence of NACE, MACCE and bleeding events, survival rate without MACCE and bleeding events during a one-year follow-up after PCI between the two groups (P>0.05).CONCLUSIONSDuring a one-year follow-up after PCI, the efficacy and safety of the drug winning the bidding for centralized procurement of ticagrelor are comparable to the original drug.
摘要:OBJECTIVETo mine the adverse drug event (ADE) signals of sacituzumab govitecan and provide a reference for its clinical safety application.METHODSThe data of sacituzumab govitecan-related ADE reports were collected from the FDA Adverse Event Reporting System (FAERS) database from April 1, 2020 to April 30, 2024. The reporting odds ratio(ROR) method, the United Kingdom Medicines and Healthcare Products Regulatory Agency comprehensive standard method (MHRA) and Bayesian confidence propagation neural network (BCPNN) method were used for data mining. Systematic organ classification (SOC) and preferred term (PT) in the ADE terminology set of version 27.0 of the Medical Dictionary for Regulatory Activities (MedDRA) were used for data classification and statistics.RESULTSA total of 753 ADE reports were obtained for sacituzumab govitecan, including 46 ADE signals, involving 12 SOCs, and 13 new suspicious ADE signals not recorded in the instructions. Top 5 PTs in terms of occurrence frequency were disease progression, death, diarrhea, off label use and inappropriate schedule of product administration. Top 5 PTs in terms of signal strength were febrile bone marrow aplasia, neutropenic colitis, disease progression, pulmonary sepsis, general physical condition abnormal. New ADE not recorded in the drug instructions included neutropenic sepsis, hepatic cytolysis, meningitis, aplasia, etc.CONCLUSIONSWhen using sacituzumab govitecan in clinical practice, special attention should be paid to ADE with highly reported cases and strong signal intensity, such as febrile neutropenia, febrile bone marrow aplasia, weight fluctuations, colitis. We should also be alert to new suspected ADE such as neutropenic sepsis, hepatic cytolysis, meningitis, and aplasia to ensure patient medication safety.
关键词:adverse drug event;antibody-drug conjugate;data mining
摘要:OBJECTIVETo systematically evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with anti-angiogenic drugs for the treatment of unresectable primary liver cancer (PLC).METHODSRetrieved from Chinese and English databases such as CNKI, the Cochrane Library, Google, and Baidu Academic, randomized controlled trial (RCT) about TACE combined with anti-angiogenic drugs for the treatment of unresectable PLC were collected from the inception to May 27, 2024. After screening the literature, extracting data, and evaluating the quality of the literature, network meta-analysis was performed using R 4.2.2 and Stata 17.0.RESULTSA total of 44 RCT were included, involving 5 607 patients and 8 interventions. The network meta-analysis results showed that for prolonging median overall survival (mOS) and median progression-free survival (mPFS), TACE+apatinib had the best efficacy, with TACE+apatinib and TACE+sorafenib ranking as the top two. For improving objective response rate (ORR) and disease control rate (DCR), TACE+donafenib had the best efficacy, with TACE+donafenib and TACE+ lenvatinib ranking as the top two. In terms of safety, TACE+donafenib was the best, with TACE+donafenib and TACE+apatinib ranking as the top two.CONCLUSIONSTACE+apatinib and TACE+donafenib have good efficacy for patients with unresectable PLC, and TACE+donafenib has the best safety profile.
摘要:OBJECTIVETo assess the efficacy, safety and cost-effectiveness of tenecteplase in the treatment of acute ischemic stroke, and to provide a basis for clinical rational drug use and related decision-making.METHODSThe related literature in the PubMed, the Cochrane Library, CNKI, Wanfang data and health technology assessment (HTA) databases were searched from the establishment of the database to June 30th, 2024. Systematic reviews/meta-analyses, pharmacoeconomic studies and HTA reports on tenecteplase in the treatment of acute ischemic stroke were collected. After data extraction and quality assessment, descriptive analysis of the included studies was carried out.RESULTSA total of 31 articles were included, involving 28 systematic reviews/meta-analysis and 3 pharmacoeconomic studies. In terms of effectiveness, compared with alteplase, tenecteplase (0.25 mg/kg) could significantly increase the early neurological improvement; the 90 d excellent neurological recovery rate, 90 d good neurological recovery rate, and recanalization were not inferior to alteplase. For safety, compared with alteplase, tenecteplase did not increase the incidence of hemorrhage, symptomatic intracranial hemorrhage, 3-month mortality, or intracranial hemorrhage. In terms of cost-effectiveness, foreign research results showed that tenecteplase had economic advantages over alteplase.CONCLUSIONSCompared with alteplase, tenecteplase is effective and safe in the treatment of acute ischemic stroke, and it is cost-effective.
关键词:acute ischemic stroke;rapid health technology assessment;effectiveness;safety;cost-effectiveness
摘要:OBJECTIVETo provide a reference for the formulation of the antithrombotic treatment regimen of children with lower extremity deep venous thrombosis (DVT).METHODSThe clinical pharmacist participated in the antithrombotic treatment of a child with purpura nephritis complicated with lower extremity DVT and formulated an individualized dosing plan for the child. Considering that the child was readmitted to the hospital when DVT of the lower extremities did not relieve after anticoagulation therapy, it was recommended that thrombolytic therapy (Enoxaparin sodium injection 30 mg, q2 h, i.d.) be initiated after joint consultation by clinical pharmacists and physicians; catheter thrombolysis and thrombolytic drug therapy were simultaneously performed (intravenous infusion of 200 000 units of Urokinase for injection, per day); great attention should be paid to the occurrence of adverse drug reactions in children, and the changes in coagulation indexes of the children should be monitored. For long-term anticoagulation therapy after discharge, clinical pharmacists recommended oral Rivaroxaban tablets 10 mg, qd, and adjusted the dose according to the weight change of the child.RESULTSThe clinician adopted the pharmacist’s recommendations. After drug thrombolytic therapy, the child’s coagulation indicators returned to normal, the symptoms of lower extremity DVT improved significantly, and there were no adverse events of bleeding or other thrombotic events after discharge.CONCLUSIONSClinical pharmacists can assist clinicians in formulating individualized treatment plans for children based on their expertise in pharmacy to ensure the rationality of medication use in children, which helps ensure the effectiveness and safety of medication for children.
关键词:lower extremity deep venous thrombosis;antithrombotic therapy;clinical pharmacist;pharmaceutical care
摘要:OBJECTIVETo introduce a case of interstitial pneumonia induced by vedolizumab (VDZ), summarize and analyze the characteristics of the occurrence of VDZ-associated lung toxicity, and provide a reference for the clinically safe use of drugs.METHODSFrom the perspective of clinical pharmacists, the diagnosis and treatment of a case of VDZ-induced interstitial pneumonia were retrospectively analyzed, and the association of adverse drug reactions (ADR) was analyzed. Retrieving from Chinese and English databases such as CNKI, VIP, PubMed and Web of Science, case reports of VDZ-associated lung toxicity were summarized and analyzed.RESULTSThe patient developed interstitial pneumonia during the use of VDZ and empirical anti-infective therapy with antibiotics was ineffective. After withdrawal of VDZ and treatment with methylprednisolone, symptoms and imaging examinations improved, but interstitial pneumonia still existed. According to Naranjo’s ADR evaluation scale and based on China Adverse Drug Reaction Reporting and Monitoring Manual, the association between VDZ and interstitial pneumonia was “very likely”. Results of the literature analysis showed that among 29 involved patients (including the patient reported in this article), there were 19 males and 10 females, with an average age of (49.24±17.06) years. Lung toxicity mainly included VDZ-associated pneumonia, eosinophilic pneumonia, pulmonary granulomas or necrobiotic nodules, interstitial lung injury, etc., which mostly occurred ≤24 weeks after medication (58.62%). The main clinical manifestations included cough, dyspnea and fever. The vast majority of patients improved or recovered after drug withdrawal and/or glucocorticoid treatment, but one patient died of respiratory failure.CONCLUSIONSLung toxicity is a rare ADR of VDZ with insidious onset and nonspecific symptoms. Once patients experience symptoms such as cough and dyspnea, early diagnosis,timely drug withdrawal,and symptomatic treatment measures such as glucocorticoid should be taken to ensure medication safety.
关键词:lung toxicity;interstitial pneumonia;adverse drug reaction;literature analysis
摘要:OBJECTIVETo summarize and analyze the profile of the implementation of pharmaceutical service by community pharmacists for patients with chronic diseases in China.METHODSLiterature was searched from CNKI, Wanfang database, PubMed (Medline), Embase, and Scopus to collect studies about community pharmacists providing pharmaceutical services for patients with chronic diseases. The ways and contents of the implementation of pharmaceutical services for chronic diseases by community pharmacists were summarized descriptively.RESULTSA total of 75 studies were included, involving 49 trial studies and 26 cross-sectional studies. The study sites were mainly located in the developed regions of China, and the types of disease involved in the studies were mainly diabetes mellitus (n=30) and hypertension (n=28); most studies used the following indexes to evaluate pharmaceutical services, such as changes in disease symptoms and related indicators(n=35), improvement of patient compliance(n=34), and the occurrence of adverse drug reactions (irrational drug use) (n=25). The pharmaceutical service provided by community pharmacists included medication education (84.0%), monitoring and follow-up (64.0%), and identifying and solving medication-related problems (58.7%). Thirty-eight studies mentioned that pharmaceutical services were achieved through teamwork, 16 of which mentioned healthcare alliances. A few studies investigated stratified healthcare systems (n=15) and internet-based pharmaceutical services (n=10).CONCLUSIONSIn China, pharmaceutical services provided by community pharmacies for patients with chronic diseases are still mainly confined to economically developed areas, and the scope of services is limited to a few diseases and basic pharmaceutical practices. In the future, the implementation of precise pharmaceutical services for different diseases and patients’ disease status, the establishment of medical alliances, and the development of internet-based pharmaceutical services should become the focus of pharmaceutical services.
关键词:community pharmacy;chronic disease;pharmaceutical service
摘要:Invasive fungal disease (IFD) is a deep infectious disease with an overall increasing incidence in patients with hematologic malignancies. Triazoles, polyenes, echinocandins echinocandin antifungal drugs, 5-fluorocytosine and Compound sulfamethoxazole are the main drugs used in the clinical treatment of IFD. Therapeutic drug monitoring for IFD prevention and treatment is helpful to optimize treatment outcomes and reduce adverse effects. In this paper, the effective plasma concentration ranges of the above 5 types of drugs are systematically summarized, and the correlation between the plasma concentration of antifungal drugs and the efficacy and adverse reactions is reviewed. Solid phase extraction combined with ultra-performance chromatography-tandem mass spectrometry is a promising detection method in this research field.
关键词:hematologic malignancies;invasive fungal disease;therapeutic drug monitoring;analytical methods
摘要:Due to the increasingly severe situation of pathogen resistance, the efficacy of classical antibiotics has declined, and the difficulty of treating community-acquired pneumonia (CAP) has gradually increased. Omadacycline was approved for marketing in China in December 2021 and has been approved for treating community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection in adults. Based on introducing the pathogen resistance of CAP, this article systematically reviews the antibacterial activity and resistance, pharmacokinetic characteristics, and clinical efficacy of omadacycline. It is found that its antibacterial spectrum is wide, its bioavailability is high, and its safety is good. Its pharmacokinetic parameters are not affected by the patients’ age, gender, liver and kidney function, or drug interactions, and it is effective against multiple drug-resistant bacteria, Gram-negative bacteria producing extended-spectrum β-lactases, atypical pathogens, etc. It can be used as one of the treatment options for CAP. However, due to limited clinical research data and the short clinical application time of the drug, more clinical studies are still needed to verify its efficacy as a monotherapy or in combination with other antibiotics for severe pneumonia patients.