最新刊期
卷 35 ， 期 22 ， 2024
- 摘要：OBJECTIVETo analyze the factors affecting the inclusion of Chinese patent medicines in China’s National reimbursement drug list （NRDL）， and assist these medicines in fully reflecting their actual value in the reimbursement admission process.METHODSFrom the official website of the China’s National Healthcare Security Administration， the application materials of Chinese patent medicines outside the list that passed the formal review from 2021 to 2023 were obtained， including basic information on the medicines， safety， efficacy， innovation and heritage information， and supplemented with references from the pharmacopeia and the Yaozhi Database. Economic information and enterprise information were obtained through websites such as the Yaozhi Database. Univariate analysis， multivariate Logistic regression analysis and stepwise regression analysis were conducted on the initial application information and admission outcomes of the medicines. Sensitivity analysis was also performed on medicines that applied multiple times in different years as independent samples. RESULTS &CONCLUSIONSThere were 27 Chinese patent medicines that passed the formal review from 2021 to 2023， involving 37 applications. The univariate analysis results showed that medicines with descriptions of traditional Chinese medicine （TCM） syndrome types， clear adjustment information for medication plans for specific population groups， short time to market in the indications of the package insert， registered as Class 1 to 6 following or class Ⅰ innovative TCM/class Ⅲ ancient classic prescription compound TCM registered， and those produced by enterprises listed in the “Top 100 Chinese Pharmaceutical Industry Enterprises” list for the current year were more likely to be included in the NRDL （P＜0.05）. The results of the multivariate Logistic regression analysis were not statistically significant， but the stepwise regression results indicated good consistency with the univariate analysis. The results of the sensitivity analysis were consistent with the trend of basic analysis. It is recommended that Chinese patent medicine enterprises further clarify the description of product instructions， expand innovation capabilities， inherit and develop ancient classic prescriptions， and promptly complete clinical trial evidence.关键词：national reimbursement drug list;influencing factors
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发布时间：2024-11-26 - 摘要：OBJECTIVETo investigate the effects of Buyang huanwu decoction on red blood cells in hyperlipidemia model mice.METHODSMale C57BL/6 mice were fed a high-fat diet to prepare a hyperlipidemia model. Successfully modeled mice were randomly assigned to the model group， atorvastatin calcium group （0.26 g/kg）， fenofibrate group （1.3 mg/kg）， and high-， medium-， and low- dose groups of Buyang huanwu decoction （18.6， 9.3， 4.6 g/kg）， with 10 mice in each group. Additionally， 10 mice fed with regular chow served as the normal group. Each group of mice received intragastric administration with the corresponding drug or normal saline once daily for 21 consecutive days. After the last administration， the body weight of the mice in each group was measured， and blood glucose， total cholesterol （TC）， triglyceride （TAG）， high-density lipoprotein cholesterol （HDL-C）， and low-density lipoprotein cholesterol （LDL-C） levels were measured. Red blood cell morphology changes were observed， and the expression levels of glucose transporter type 1 （GLUT1）， erythrocyte membrane protein band 4.2 （protein 4.2）， caveolin-1， and flotillin-1 in erythrocyte membrane were determined.RESULTSCompared with the model group， the body weight and levels of TC， TAG， HDL-C， LDL-C， and the expression levels of GLUT1， caveolin-1 and flotillin-1 in the Buyang huanwu decoction groups were significantly decreased， while blood glucose levels and the expression levels of protein 4.2 were significantly increased （P＜0.05）. The red blood cell morphology in the low- and medium-dose groups of Buyang huanwu decoction was significantly promoted.CONCLUSIONSBuyang huanwu decoction can reduce blood lipid levels in hyperlipidemia model mice and strengthen the morphology and function of red blood cells in a hyperlipidemic environment， which has the potential to be used for preventing hyperlipidemia complications such as atherosclerosis.关键词：hyperlipidemia;blood lipids;red blood cells;erythrocyte membrane proteins
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发布时间：2024-11-26 - 摘要：OBJECTIVETo characterize paclitaxel nanoparticles （PTX-PLGA-NPs） and evaluate their in vitro inhibitory effect on Lewis lung cancer cells.METHODSThe PTX-PLGA-NPs prepared by the emulsion-solvent evaporation method were characterized in terms of particle size， polydispersity index （PDI）， Zeta potential， microscopic morphology， encapsulation efficiency， drug loading， ultraviolet-visible absorption characteristics and stability. Using mouse Lewis lung cancer cells as the subjects and paclitaxel reference substance as the control， the cytotoxicity and in vitro killing activity of PTX-PLGA-NPs were detected using CCK-8 method and Calcein-AM/PI double staining method， respectively. The effects of PTX-PLGA-NPs on cell apoptosis and cell cycle were assessed by Annexin Ⅴ-FITC/PI staining method and PI staining method， respectively.RESULTSPTX-PLGA-NPs were spherical with an average particle size of （172.03±0.95） nm， PDI of 0.098±0.012， and Zeta potential of （－1.76±0.02） mV. The encapsulation efficiency and drug loading were （52.32±0.66）% and （7.07±0.18）%， respectively， and the ultraviolet-visible absorption characteristics were not affected by the carrier polylactic-co-glycolic acid. When stored in the dark at 4 °C for 7 days， no significant change was noted in particle size， and the average PDI （after 1， 2， 4 and 7 days of storage） was under 0.3. Compared with the paclitaxel reference substance group， the PTX-PLGA-NPs group had more cells in a state of death， the survival rate （at the PTX concentration of 11.2 μg/mL） was significantly decreased， and both the apoptosis rate and the proportion of G2 phase cells were significantly increased （P＜0.05）.CONCLUSIONSThe prepared PTX-PLGA-NPs indicate homogeneity in particle size， uniform dispersion， stable properties， and stronger in vitro killing effect on lung cancer cells than PTX.关键词：polylactic-co-glycolic acid;nanoparticles;characteristics;Lewis lung cancer cells;antitumor effects in vitro
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发布时间：2024-11-26 - 摘要：OBJECTIVETo establish the fingerprint of the Zhuang medicine preparation Fuzheng capsules and a method for the determination of multi-ingredient content for quality evaluation.METHODSHigh-performance liquid chromatography （HPLC） was used in conjunction with the Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine （2004A edition） to establish the fingerprint of 12 batches of Fuzheng capsules， evaluate their similarity and confirm the common peaks. Cluster analysis and principal component analysis were performed using SPSS 20.0 software with the peak areas of the common peaks in the fingerprint as variables. The same HPLC method was adopted to determine the content of liquiritin， specnuezhenide， 3，6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples.RESULTSA total of 22 common peaks were identified in the fingerprints of the 12 batches of Fuzheng capsules， with the similarities greater than 0.91. Four common peaks were identified as liquiritin （peak 8）， specnuezhenide （peak 10）， 3，6′-disinapoyl sucrose （peak 11）， and ammonium glycyrrhizinate （peak 21）. The 12 batches of samples could be clustered into 3 categories， with 200801， 200802 and 200803 as category Ⅰ， samples 1 to 8 as category Ⅱ， and 221101 as category Ⅲ. The sample 200802 had the highest comprehensive score （2.540）. The contents of liquiritin， specnuezhenide， 3，6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples were 0.44 to 0.73， 1.28 to 2.47， 0.08 to 0.12， and 1.31 to 1.81 mg per capsule， respectively.CONCLUSIONSThe main components of the 12 batches of Fuzheng capsules were similar， but the content varied， with the sample 200802 indicating the highest quality. The established fingerprint and multi-ingredient content determination method were highly specific and accurate， which can be used for the quality evaluation of Fuzheng capsules in combination with chemical pattern recognition analysis.关键词：fingerprint;content determination;chemical pattern recognition analysis;quality evaluation;HPLC
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发布时间：2024-11-26 - 摘要：OBJECTIVETo evaluate the quality of Lycopodium japonicum from different producing areas.METHODSSixteen batches of L. japonicum from six provinces were used as samples. The contents of α-obscurine， β-obscurine， lycopodine， lycodoline， lyclaninol， 21-episerratenediol， stigmasterol and β-sitosterol in L. japonicum were detected by quantitative analysis of multi-components by single-marker （QAMS）. The results were compared with the results of external standard method. The extract and total ash were measured according to the appendix of Chinese Pharmacopoeia. Principal component analysis， orthogonal partial least squares-discriminant analysis and weighted technique for order preference by similarity to ideal solution （TOPSIS） methods were combined to evaluate its quality.RESULTSThe contents of lyclaninol in the 16 batches of L. japonicum were 0.183-0.446 mg/g. Using lyclaninol as internal reference material， the contents of α-obscurine， β-obscurine， lycopodine， lycodoline， 21-episerratenediol， stigmasterol and β-sitosterol were 1.250-2.097， 0.690-1.184， 0.035-0.102， 0.076-0.150， 0.356-0.570， 0.085-0.229 and 0.238-0.855 mg/g， respectively， with no significant difference from the results of external standard method. The extract was 12.18%-22.78%， and the total ash was 3.16%-6.11%. Principal component analysis showed that samples S1-S6，S7-S11，S12-S16 could be clustered into 3 categories. The variable importance in projection values for α-obscurine， β-sitosterol， lyclaninol， β-obscurine and 21-episerratenediol were all greater than 1. The weighted TOPSIS evaluation results showed that sample S14 had the best quality （Jb＝0.709 2）.CONCLUSIONSL. japonicum from Suijiang county of Yunnan province had the best quality. The established QAMS combined with chemometric and weighted TOPSIS methods can be used for quality evaluation of L. japonicum from different producing areas.关键词：HPLC;chemometric methods;OPLS-DA;weighted TOPSIS method;quality evaluation;QAMS
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发布时间：2024-11-26 - 摘要：OBJECTIVETo optimize the freeze-drying process for sheep placenta slices.METHODSAn orthogonal test design was used with pre-freezing time， drying time and drying temperature as indicators to screen for the optimal freeze-drying process for sheep placenta slices. The peptide content， ethanol-soluble extract content， and freeze-drying rate of sheep placenta were used as indicators，the analytic hierarchy process-criteria importance through intercriteria correlation （AHP-CRITIC） method was employed to determine the weight of each indicator and calculate the comprehensive score， which was verified using the technique for order of preference by similarity to ideal solution （TOPSIS） model.RESULTSThe optimal preparation process was found to be the pre-freezing time of 2 hours， the drying time of 16 hours， and the drying temperature of 30 °C. The average values of peptide content， ethanol-soluble extract content， and freeze-drying rate for three batches of samples were 5.883 mg/mL， 27.1%， and 95.77%， respectively； the comprehensive scores of three batches were 96.42， 99.18 and 99.58， with RSD of 1.75%.CONCLUSIONSThis study successfully optimized the freeze-drying process for sheep placenta slices， which can provide a reference for the quality standard setting and industrial production of this type of slice.关键词：AHP;CRITIC;orthogonal design;TOPSIS;freeze-drying;process optimization
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发布时间：2024-11-26 - 摘要：OBJECTIVETo explore the impact and mechanism of curcumin on endometriosis （EMS） model rats based on Notch1 signaling pathway.METHODSFemale SD rats with synchronized estrous cycles were implanted with autologous endometrium on the abdominal wall to construct EMS model. EMS rats were randomly divided into model group， low-， medium- and high-dose groups of curcumin （60， 120， 240 mg/kg）， and Notch 1 inhibitor DAPT group （7 mg/kg）. The sham surgery group was also established， with 10 rats in each group. Rats in each group received intragastric administration or injection via caudal veins with the corresponding drugs for 4 weeks. Endometriotic lesions were observed and measured using ultrasound and visual inspection， and their volumes were calculated. Histopathological morphology of the lesion tissues was observed. The levels of interleukin-1β （IL-1β）， IL-6， and tumor necrosis factor-α （TNF-α） in the abdominal cavity fluid， as well as the mRNA and protein expression levels of Notch1， matrix metalloproteinase-9 （MMP-9）， and vascular endothelial growth factor （VEGF） in the endometriotic lesions were measured.RESULTSCompared with the model group， the volume of endometriotic lesions in the low-， medium- and high-dose groups of curcumin and the DAPT group was significantly decreased （P＜0.05）； atrophy or disappearance of columnar epithelium， cyst disappearance； the levels of IL-1β， IL-6， and TNF-α （except for the low-dose curcumin group） in the abdominal cavity fluid， as well as the mRNA （except for MMP-9 and VEGF in the low-dose curcumin group） and protein （except for MMP-9 in the low-dose curcumin group） expression levels of Notch1， MMP-9， and VEGF in the endometriotic lesions were significantly decreased （P＜0.05）. The curcumin high-dose group and DAPT group showed superior results in most indicators compared to the curcumin low- and medium-dose groups.CONCLUSIONSCurcumin has an improving effect on EMS， and its mechanism may be related to inhibiting Notch1 signaling pathway， reducting local inflammatory responses， and inhibiting ectopic endometrial invasion and angiogenesis.关键词：curcumin;Notch1 signaling pathway
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发布时间：2024-11-26 - 摘要：OBJECTIVETo explore the effect of Shilinqing granules on calcium oxalate nephrolithiasis in rats and its potential mechanisms through the silence information regulator 1 （SIRT1）/nuclear factor-κB （NF-κB）/nucleotide-binding domain leucine-rich repeat and pyrin domain-containing receptor 3 （NLRP3） signaling pathway.METHODSSixty male SD rats were randomly assigned to control group， model group， and low-， medium-， high-dose groups of Shilinqing granules （6.5， 13， 26 g/kg， calculated based on crude drug）， and high-dose of Shilinqing granules+inhibitor group （Shilinqing granules 26 g/kg+SIRT1 inhibitor nicotinamide 5 mg/kg）， with 10 rats in each group. Except for the control group， the remaining groups of rats were given 1% ethylene glycol solution to drink freely and were intubated with 2% ammonium chloride solution 2 mL （once a day， for 4 weeks） to construct a calcium oxalate nephrolithiasis model. At the same time of modeling， the administration groups were intubated or （and） intraperitoneally injected with the corresponding drug solutions， while the control and the model groups were intubated with physiological saline and intraperitoneally injected with dimethyl sulfoxide. The body weight， kidney index， urine/blood biochemical indicators [24-hour urine volume， urine pH， urinary calcium ion （Ca2+） and urinary oxalic acid （Ox） content， as well as blood creatinine （Scr）， blood urea nitrogen （BUN）， blood Ca2+ content]， serum inflammatory indicators [levels of interleukin-1β （IL-1β）， IL-18]， pathological changes in renal tissue， calcium oxalate crystallization， and crystal scoring were observed. The protein expressions of SIRT1， NLRP3， and NF-κB in renal tissue were detected.RESULTSCompared with the control group， the model group had severe renal tissue damage and a large number of calcium oxalate crystals， with significant decrease or downregulation in body weight， 24-hour urine volume， urine pH， and protein expression of SIRT1 in renal tissue （P＜0.05）； crystal score， kidney index， urinary contents of Ca2+ and Ox， serum contents of Scr， BUN and Ca2+， and serum levels of IL-1β and IL-18， as well as the protein expressions of NF-κB， NLRP3 in renal tissue were significantly increased or upregulated （P＜0.05）. The pathological changes in the rats of each dose group of Shilinqing granules were improved， the calcium oxalate crystals were reduced， and all quantitative indicators were significantly improved as compared with the model group （P＜0.05）； while the SIRT1 inhibitor could significantly reverse the improving effects of high-dose of Shilinqing granules on the above indicators （P＜0.05）.CONCLUSIONSShilinqing granules can inhibit the formation of calcium oxalate nephrolithiasis in rats， reduce the levels of inflammatory indicators and its mechanism may be related to upregulating protein expression of SIRT1， and downregulating protein expressions of NF-κB and NLRP3.关键词：calcium oxalate nephrolithiasis;inflammatory response;SIRT1/NF-κB/NLRP3 signaling pathway
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发布时间：2024-11-26 - 摘要：OBJECTIVETo explore the effects and potential mechanism of asperuloside （ASP） on colonic pathological injury and inflammatory response in rats with ulcerative colitis （UC） based on the stimulator of interferon genes （STING）/TANK binding kinase 1 （TBK1）/interferon regulatory factor 3 （IRF3） signaling pathway.METHODSA UC rat model was established by intrarectal injection of trinitrobenzenesulfonic acid and ethanol. The successfully modeled rats were allocated to model group， low-dose ASP group （17.5 mg/kg）， high-dose ASP group （35 mg/kg）， and high-dose ASP+STING activator ADU-S100 group （35 mg/kg ASP+20 mg/kg ADU-S100）， with 16 rats in each group. Another 16 healthy rats were selected as control group， by intrarectally injecting with normal saline. The rats in each group were given the corresponding drug solutions or normal saline by gavage or/and intraperitoneal injection once a day for 14 consecutive days. Twenty-four hours after the last administration， the disease activity index （DAI） and colonic mucosal damage index （CMDI） were employed to assess the severity of UC and colonic mucosal damage in each group. Colonic tissue pathological changes were observed， and histopathological scores were recorded. Apoptosis in colonic tissue， levels of inflammatory cytokines [tumor necrosis factor-α （TNF-α）， interferon-β （IFN-β）， interleukin-4 （IL-4）， IL-10]， and expressions of pathway-related proteins [STING， TBK1， IRF3， nuclear factor-κB p65 （NF-κB p65）] were detected.RESULTSCompared with the control group， the model group showed severe destruction of colonic mucosa and glandular structure， mucosal epithelial erosion， crypt loss， marked inflammatory cell infiltration； it also demonstrated significant increase in DAI score， CMDI score， colonic histopathological score， apoptosis rate， the levels of TNF-α and IFN-β， and protein expression of STING and phosphorylation levels of TBK1， IRF3 and NF-κB p65， while the levels of IL-4 and IL-10 were significantly decreased （P＜0.05）. Compared with the model group， the low- and high-dose ASP groups showed relatively intact colonic mucosal structure， orderly glandular arrangement， reduced congestion and edema， and markedly reduced inflammatory cell infiltration and ulcers； all quantitative indicators were significantly improved， with the high-dose group showing more pronounced improvements than the low-dose group （P＜0.05）. Compared with the high-dose ASP group， the above indicators of rats in the high-dose ASP+STING activator group were significantly reversed （P＜0.05）.CONCLUSIONSASP may alleviate colonic pathological injury and inflammatory response in UC rats by inhibiting the STING/TBK1/IRF3 signaling pathway.关键词：ulcerative colitis;colonic pathological injury;inflammatory response;STING/TBK1/IRF3 signaling pathway
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发布时间：2024-11-26 - 摘要：OBJECTIVETo explore the improving effect of luteolin （Lut） on placental dysfunction in rats with gestational diabetes mellitus （GDM） and its potential mechanism based on hedgehog （Hh） signaling pathway.METHODSTwenty female rats were randomly selected as a control group and fed a normal diet. The remaining female rats were fed a high-fat and high-sugar diet for 8 weeks and then caged with male rats. Pregnant rats were administered 35 mg/kg streptozotocin intraperitoneally to establish GDM models. Successfully modeled female rats were randomly allocated to model group， SAG group （Hh signaling pathway activator SAG 50 mg/kg）， Lut low-dose group （Lut 40 mg/kg）， Lut high-dose group （Lut 80 mg/kg）， and Lut high+ITR group （Lut 80 mg/kg+Hh signaling pathway antagonist itraconazole 50 mg/kg）， with 20 rats in each group. Female rats in each drug group were intubated with the corresponding drug solution once a day for 19 days. After the final administration， the serum glucose-fat metabolic parameters （levels of fasting blood glucose and fasting insulin， insulin resistance index）， placental quality， placental permeability [Evan’s blue （EB） content]， and pathological changes in placental tissue were observed. The activities of superoxide dismutase （SOD）， the contents of malondialdehyde （MDA） and reduced glutathione （GSH）， and the protein expressions of Sonic Hh （Shh）， Patched-1 （Ptch1）， Smoothened （Smo） and Gli family zinc finger-1 （Gli1） in placental tissue were detected.RESULTSCompared with the control group， rats in the model group showed narrow capillary lumens， perivascular fibrosis in placental tissue， and a significant increase in serum glucose-fat metabolic parameters， placental quality， contents of EB and MDA， while there was a significant decrease in SOD activity， GSH content， and protein expressions of Shh， Ptch1， Smo and Gli1 （P＜0.05）. Compared with the model group， rats in the SAG group， Lut low-dose and high-dose groups had widened capillary lumens， a significant decrease in perivascular fibrosis in placental tissue， serum glucose-fat metabolic parameters， placental qualities， EB and MDA contents， while there was a significant increase in SOD activities， GSH contents， and protein expressions of Shh， Ptch1， Smo and Gli1 （P＜0.05）， with the high-dose group showing no significant difference compared to the SAG group （P＞0.05）. The Hh signaling pathway antagonist itraconazole could significantly reverse the improving effects of Lut on the above indicators （P＜0.05）.CONCLUSIONSLut can improve glucose metabolism parameters of GDM rats， reduce placental permeability， alleviate pathological damage to placental tissue， and reduce oxidative stress. These effects may be related to the activation of the Hh signaling pathway.关键词：gestational diabetes mellitus;placental dysfunction;hedgehog signaling pathway
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发布时间：2024-11-26 - 摘要：OBJECTIVETo establish an ion chromatography method for the simultaneous determination of chloride， sulfate and bicarbonate ions in Polyethylene glycol electrolyte powder （Ⅲ）.METHODSThe chromatographic column was a Dionex IonpacTM AS11-HC anion analysis column， with a Dionex IonPacTM AG11-HC guard column. The mobile phase was 10 mmol/L potassium hydroxide at an isocratic elution flow rate of 1.2 mL/min. The detector was a conductivity detector， and the suppressor was a Dionex AERS with a suppressor current of 30 mA. The column temperature was maintained at 30 °C， and the injection volume was 10 μL. Chloride and sulfate contents were calculated by external standard method， while bicarbonate content was determined by double logarithmic fitting standard curve method.RESULTSUnder these chromatographic conditions， chloride， sulfate and bicarbonate ions were effectively separated with linear ranges of 0.055 to 0.219 mg/mL （r＝0.999 9）， 0.155 to 0.618 mg/mL （r＝1.000 0）， and 0.065 to 0.121 mg/mL （r＝0.999 9）， respectively. The recoveries were 98.06% to 101.34%， 97.37% to 101.25%， and 97.16% to 99.81%， respectively， with RSDs of 1.1%， 1.3% and 1.0% （n＝9）. The RSDs for the evaluation of precision， accuracy， stability and ruggedness were all less than 2%.CONCLUSIONSThe established ion chromatography is simple， rapid， accurate， precise and durable， can simultaneously determine the contents of chloride， sulfate and bicarbonate ions in Polyethylene glycol electrolyte powder （Ⅲ）， which is suitable for its quality control.关键词：Polyethylene glycol electrolyte powder （Ⅲ）;chloride ion;sulfate ion;bicarbonate ion
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发布时间：2024-11-26 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of using Bacillus Calmette-Guérin （BCG） versus epirubicin for intravesical perfusion after transurethral resection of bladder tumor （TUR-BT） in patients with intermediate- to high-risk non-muscle-invasive bladder cancer （NMIBC）.METHODSFrom the perspective of China’s health system， a Markov cohort model was constructed based on the ChiCTR-IIR-16008357 study. Quality-adjusted life years （QALYs） were used as the health outcome measure， with the willingness-to-pay（WTP） threshold set at one time the per capita gross domestic product of China in 2023 （89 358 yuan/QALY）. A cost-utility analysis was used to compare the incremental cost-effectiveness ratio （ICER） of the BCG regimen relative to the epirubicin regimen for intravesical perfusion after TUR-BT in patients with intermediate- to high-risk NMIBC in China. In addition， sensitivity analysis was performed.RESULTSThe incremental cost of the BCG regimen compared to the epirubicin regimen was 34 309.51 yuan， with an incremental utility of 0.800 QALYs， resulting in an ICER of 42 871.33 yuan/QALY， which is below the WTP threshold. When the WTP threshold was 89 358 yuan/QALY， the probability that the BCG regimen would be acceptable was 77.70% in the probabilistic sensitivity analysis， higher than that of the epirubicin regimen， and the acceptability of the BCG regimen increased with increasing in the WTP threshold.CONCLUSIONSWhen the WTP threshold was set at one time the per capita gross domestic product of China in 2023， compared to epirubicin， BCG used for intravesical perfusion after TUR-BT in patients with intermediate- to high-risk NMIBC demonstrated better cost-effectiveness.关键词：non-muscle-invasive bladder cancer;transurethral resection of bladder tumor;bladder perfusion;epirubicin;pharmacoeconomics
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发布时间：2024-11-26 - 摘要：OBJECTIVETo study the influencing factors for proteinuria in patients with malignant tumors treated with apatinib， then establish and evaluate a risk prediction model based on it.METHODSA total of 120 patients with malignant tumors treated with apatinib in our hospital from January 2020 to December 2022 were selected as the training set， and the clinical data was collected. Univariate analysis and multivariate Logistic regression analysis were used to identify independent risk factors for proteinuria associated with apatinib and then construct a risk prediction model. The predictive value of the model was evaluated by using the receiver operator characteristic （ROC） curve. A total of 34 patients with malignant tumors treated with apatinib from January to December 2023 in our hospital were selected as the validation set， and their clinical data were obtained to cross-validate the accuracy of the prediction model.RESULTSThe incidence of proteinuria in the training set of 120 patients was 26.67%. The proportions of patients with smoking history， combined hypertension， apatinib daily dose of ≥500 mg， and alanine aminotransferase level were significantly higher in proteinuria group than those in non-proteinuria group. At the same time， the neutrophilic granulocyte count was significantly lower than that in non-proteinuria group （P＜0.05）. Patients with smoking history and combined hypertension were the independent risk factors for apatinib-induced proteinuria （odds ratios were 5.005 and 5.342， respectively； with 95% confidence intervals of 1.806-13.872 and 1.227-9.602， respectively； P＜0.05）. The binary Logistic regression model equation for the probability （P） of apatinib-induced proteinuria is expressed as LogitP＝1.610XMH+1.233XSH－1.483 （MH for combined hypertension， SH for the smoking history）， with a model accuracy of 80.0%. ROC curve analysis demonstrated the area under the ROC curve of 0.771， the maximum Youden’s index of 0.474， and the optimal cut-off value for LogitP was 0.159 9， with a sensitivity of 90.6% and specificity of 56.8%. Cross-validation results indicated an overall prediction accuracy of 88.24% for the 34 patients.CONCLUSIONSCombined hypertension and smoking history are independent risk factors for apatinib-induced proteinuria. The constructed risk prediction model has moderate predictive value and can be used to predict the risk of proteinuria in patients with malignant tumors induced by apatinib.关键词：malignant tumors;proteinuria;risk factors;risk prediction model;Logistic regression;ROC curve
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发布时间：2024-11-26 - 摘要：OBJECTIVETo explore the clinical characteristics and influencing factors of immune-related adverse events （irAEs） in patients with extensive-stage small cell lung cancer （SCLC） treated with immune checkpoint inhibitors （ICIs）.METHODSThe data from 130 patients with extensive-stage SCLC treated with ICIs at our hospital from January 1， 2023， to May 31， 2023 was collected retrospectively using the Chinese Hospital Pharmacovigilance System. The occurrence of irAEs and the use of corticosteroids during treatment for all patients were recorded. A multifactorial Logistic regression model was used to analyze the influencing factors for the occurrence of irAEs.RESULTSAmong the 130 patients included， 32 patients experienced 38 episodes of irAEs， with an incidence rate of 24.6% and severity of degree 1-3. Skin symptoms were the most common （8.4%） and predominantly occurred in the first cycle of treatment. Five patients developed irAEs involving multiple organ systems. The irrational use rate of corticosteroids in patients with irAEs was 23.1% （excluding patients with thyroid dysfunction）. Neuron specific enolase （NSE） was a independent factor influencing the occurrence of irAEs （P＜0.05）.CONCLUSIONSThe incidence of irAEs caused by ICIs remains relatively high and can involve various organ systems throughout the body， with skin symptoms occurring earliest. NSE is an independent influencing factor for the occurrence of irAEs， and could predict the risk of irAEs to a certain extent.关键词：immune-related adverse events;extensive-stage small cell lung cancer;neuron specific enolase;influence factor
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发布时间：2024-11-26 - 摘要：OBJECTIVETo evaluate the therapeutic efficacy and safety of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori （Hp） infection.METHODSFrom March 2022 to August 2023， 198 treatment-naive patients with Hp infection treated at the outpatient service of department of gastroenterology in our hospital were assigned to the vonoprazan-based triple therapy group （VAC group， n＝98） and the bismuth-based quadruple therapy group （BQT group， n＝100） using the random number table method. Patients in VAC group were given Vonoprazan fumarate tablets （20 mg） + Amoxicillin capsules （1 g） + Clarithromycin tablets （0.5 g）， all twice daily. Patients in BQT group were given Esomeprazole magnesium enteric-coated tablets （20 mg， twice daily） + Metronidazole tablets （0.4 g， four times daily） + Tetracycline tablets （0.5 g， three times daily） + Bismuth potassium citrate capsules （0.6 g， twice daily）. The treatment course for both groups was 14 days. The Hp eradication rates were compared between the two groups in intention-to-treat （ITT）， modified intention-to-treat （MITT）， and per-protocol （PP） analysis sets， while adverse reaction occurrence and medication compliance of two groups were recorded.RESULTSIn the ITT， MITT and PP analyses sets， the Hp eradication rates in VAC group were non-inferior to those in BQT group. The incidences of grades 1-2 nausea， vomiting， and loss of appetite in VAC group were significantly lower than in BQT group， and the proportion of patients with good compliance was significantly higher in VAC group （P＜0.05）. Regardless of whether the body mass index （BMI） ≤25 kg/m2 or ＞25 kg/m2， no statistically significant difference was observed in the Hp eradication rates between the two groups （P＞0.05）.CONCLUSIONSVonoprazan-based triple therapy is non-inferior to bismuth-based quadruple therapy in the treatment of treatment-naive patients with Hp infection， with higher safety and good patient medication compliance. BMI has no significant impact on the Hp eradication rate.关键词：vonoprazan;bismuth-based quadruple therapy;treatment-naive;therapeutic efficacy;safety
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发布时间：2024-11-26 - 摘要：OBJECTIVETo investigate the relationship between metformin and sarcopenia-related traits.METHODSBased on the data from publicly genome-wide association study-related databases， using single nucleotide polymorphisms strongly associated with metformin as instrumental variables， the two-sample Mendelian randomization （MR） analysis methods [inverse variance weighting （IVW） method， MR-Egger regression method and weighted median estimator method] were employed to investigate the relationship between metformin and three sarcopenia-related traits （low grip strength， muscle mass and walking speed）. Cochran’s Q test was used to assess heterogeneity， MR-Egger intercept test was used to detect horizontal pleiotropy， and leave-one-out analysis was performed for sensitivity analysis.RESULTSThe results of IVW method showed that metformin use was significantly associated with an increased risk of low grip strength （β＝1.550， 95%CI was 0.389-2.711， P＝0.009） and reduced limb muscle mass （right leg lean body mass： β＝－0.665， 95%CI was －1.018-－0.312， P＜0.001； left leg lean body mass： β＝－0.710， 95%CI was －1.049-－0.371，P＜0.001； right arm lean body mass： β＝－0.471， 95%CI was －0.890-－0.053， P＝0.027； left arm lean body mass： β＝－0.463， 95%CI was －0.865-－0.061， P＝0.024），but was not associated with walking speed. The results or causal effects of the other two methods are consistent with it. The Cochran’s Q test indicated some degree of heterogeneity in the result of this study. No horizontal pleiotropy was detected by the MR-Egger intercept test. The sensitivity analysis suggested that the results of this study were stable.CONCLUSIONSMetformin may increase the risk of sarcopenia.关键词：metformin;sarcopenia;low grip strength;muscle mass;relationship analysis
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发布时间：2024-11-26 - 摘要：OBJECTIVETo sort out drug prophylaxis regimens for venous thromboembolism （VTE） in adult patients after artificial joint replacement， and provide a basis for clinic.METHODSDatabases and related official websites were searched according to the “6S” model， including the National Institute for Health and Clinical Excellence （NICE）， the Scottish Intercollegiate Guidelines Network （SIGN）， the Guidelines International Network （GIN）， the National Guidelines Clearinghouse （NGC）， PubMed， Embase， CNKI， Wanfang database and SinoMed， to search for guidelines， expert consensuses， systematic evaluations， randomized controlled trials， and cohort studies about preventing VTE in adult patients after artificial joint replacement from the inception until December 2023. Literature that met the inclusion criteria were selected， and the quality evaluation of the literature was completed by 2 researchers independently； the evidence rating was performed by using the Joanna Briggs Institute （JBI） evidence pre-classification and evidence rank system （2014 edition）.RESULTSA total of 36 articles were included in the study， which were categorized into 9 areas of risk assessment， post-assessment prophylaxis， medication selection， medication method， duration of medication prophylaxis， medication prophylaxis observation points， contraindications to drug prophylaxis， response to bleeding， and health education， which were summarized to form 37 pieces of evidence on the pharmacological prophylaxis for postoperative VTE in patients who underwent artificial joint replacement.CONCLUSIONSThe evidence of drug prophylaxis for postoperative VTE in patients who underwent artificial joint replacement summarized in this study is comprehensive， with certain scientific reference and practicality， which can provide clinical pharmacists with a scientific evidence-based basis for perioperative VTE prophylaxis management.关键词：artificial joint replacement;drug prophylaxis;evidence-based pharmacy
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发布时间：2024-11-26 - 摘要：OBJECTIVETo assess the efficacy and safety of different treatment modalities for moderate to severe Henoch-Schönlein purpura nephritis （HSPN）.METHODSLiterature searches were conducted in the CNKI， VIP， Wanfang Data， SinoMed， PubMed， OVID， Web of Science， Embase， and the Cochrane Library to collect randomized controlled trials （RCTs） and cohort studies on the treatment of moderate to severe HSPN with 12 intervention measures： monotherapy with glucocorticoid （GC）， as well as cyclophosphamide， mycophenolate mofetil （MMF）， Tripterygium wilfordii multiglucoside （TWM）， leflunomide， mizoribine， tacrolimus， cyclosporin A， hemoperfusion， tonsillectomy combined with GC， and double filtration plasmapheresis （DFPP） combined with GC and cyclophosphamide or mycophenolate mofetil. The search period was from the inception of the databases to March 2024. After literature screening， data extraction， and quality assessment， a network meta-analysis was performed using Stata 16.0 software.RESULTSA total of 28 articles were included， with 14 RCTs and 14 cohort studies， involving 1 746 patients. The network meta-analysis results showed the combination of tacrolimus and GC had the highest probability of being the best in overall remission rate， followed by the combination of TWM and GC， and DFPP combined with GC and MMF. The combination of leflunomide and GC had the highest probability of being the best in complete remission rate， followed by the combination of mizoribine and GC， and DFPP combined with GC and cyclophosphamide. The combination of mizoribine and GC had the highest probability of being the best in terms of reducing 24-hour urinary protein quantification， followed by DFPP combined with GC and MMF， and the combination of leflunomide and GC. Moreover， the combination of tacrolimus and GC had the highest probability of being the best in safety， followed by the combination of cyclosporin A and GC， and the combination of leflunomide and GC.CONCLUSIONSCompared to other treatment methods， the combination therapy of tacrolimus and GC shows better efficacy and safety in the treatment of moderate to severe HSPN.关键词：glucocorticoid;immunosuppressant;network meta-analysis;efficacy;safety
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发布时间：2024-11-26 - 摘要：OBJECTIVETo systematically evaluate the effectiveness of different treatment regimens as first-line treatment for metastatic urothelial carcinoma （UC） using a network meta-analysis （NMA） approach.METHODSElectronic databases including PubMed， the Cochrane Library， Embase， Wanfang Data， CNKI， and VIP were searched for randomized controlled clinical trials （RCTs） on first-line treatment for metastatic UC from January 1， 2010 to January 31， 2024. After literature screening and data extraction， a risk of bias assessment of included studies was conducted. R software （version 4.3.2） was used to perform the NMA.RESULTSA total of 11 RCTs involving 14 treatment interventions were included. No significant differences were noted in objective response rate among groups， with the combination of pembrolizumab， gemcitabine and cisplatin having the highest probability of ranking first. Regarding progression-free survival （PFS） and overall survival （OS）， no significant differences were observed among groups， while enfortumab vedotin combined with pembrolizumab showed a trend towards better PFS extension compared to gemcitabine combined with cisplatin [HR＝0.45， 95%CI（0.20，1.06）， P＝0.049]， and it had the highest probability of ranking first in both PFS and OS.CONCLUSIONSThe combination of enfortumab vedotin and pembrolizumab may have an advantage in prolonging survival in the first-line treatments for metastatic UC.关键词：network meta-analysis;pembrolizumab;enfortumab vedotin;gemcitabine;cisplatin
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发布时间：2024-11-26 - 摘要：OBJECTIVETo analyze the pharmaceutical service process in a fracture patient complicated by fat embolism syndrome （FES） following postoperative fracture， aiming to provide a reference for clinical treatment and pharmaceutical service for similar patients.METHODSClinical pharmacist participated in the entire treatment process of a patient with FES following postoperative fracture. Based on the patient’s clinical manifestations and test results， literature was reviewed to assist clinical physicians in formulating the therapeutic regimen of glucocorticoids. For the drug-related adverse reactions of renal function impairment and reduced platelet count that occurred during the treatment， suspicious drugs were analyzed and disposed of accordingly.RESULTSThe clinical pharmacist recommended Hydrocortisone sodium succinate for injection （100 mg， q8 h， ivgtt， for about one week followed by a gradual dose reduction） for treating FES. The Vancomycin hydrochloride for injection used in this case was assessed as “very probably” associated with the adverse drug reactions of renal function impairment and thrombocytopenia. The clinical physician adopted the pharmacist’s medication recommendations， and the patient’s condition stabilized after treatment， with improvement in adverse reactions， and was discharged from the hospital.CONCLUSIONSThe use of glucocorticoids in treating FES has a definite therapeutic efficacy. Clinical pharmacists should individualize the medication plan based on the patient’s pathological state and distinguish it from postoperative sepsis. Meanwhile， drug-induced adverse reactions in the kidney and blood system should be closely monitored.关键词：pharmaceutical service;postoperative fracture;glucocorticoids;renal function impairment;thrombocytopenia
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发布时间：2024-11-26 - 摘要：OBJECTIVETo provide a reference for accurately identifying and treating adverse reactions of osteonecrosis induced by bevacizumab.METHODSClinical pharmacists participated in the treatment process of an adult patient with glioma who developed femoral head necrosis after the use of bevacizumab. By searching the FDA Adverse Event Reporting System （FAERS） and consulting relevant literature and drug instructions， the association between femoral head necrosis and bevacizumab was assessed. Medication recommendations were provided to the physician， and medication educations were provided to the patient.RESULTSThe association between the patient’s femoral head necrosis and bevacizumab was assessed as “possibly related”. The physicians accepted the clinical pharmacists’ advice to discontinue bevacizumab and switched to anlotinib to continue antitumor treatment. The patient also followed the clinical pharmacists’ advice to avoid prolonged standing. Upon re-examination， the patient’s pain symptoms were under control， and the femoral head necrosis had not progressed.CONCLUSIONSPatients who receive long-term bevacizumab should attach great importance to bone pain and osteonecrosis， undergo regular imaging examinations， and detect and treat symptoms early to prevent the occurrence of severe osteonecrosis.关键词：bevacizumab;FAERS;adverse reactions
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发布时间：2024-11-26 - 摘要：Pleural mesothelioma （PM） is a rare malignant tumor originating from the pleura. Most patients are already in the advanced stage at the time of diagnosis， resulting in a low overall survival rate. MicroRNA （miRNA）， as key regulators of tumor epigenetic modification， have an intertwined interactive network with PM drug resistance. The mechanisms of drug resistance in PM to chemotherapeutic drugs include increasing drug efflux， reducing drug intake， enhancing DNA repair， and altering drug targets. The mechanisms of resistance to targeted therapy drugs include activating alternative signaling pathways， establishing a favorable tumor microenvironment， and triggering epithelial-mesenchymal transition. MiRNA plays a key part in the aforementioned resistance mechanisms， with some miRNAs promoting the drug sensitivity of cancer cells， while others contribute to increased drug resistance. In light of these key regulatory functions， targeting the dysregulated expression of endogenous miRNAs in the process of resistance formation using miRNA antagonists or miRNA mimics may be an effective therapeutic strategy to reverse drug resistance in PM.关键词：pleural mesothelioma;targeted therapy;drug resistance
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发布时间：2024-11-26
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