1.Evaluation of transdermal absorption of self-assembled nanoparticles of Huangqin decoction loaded with terbinafine
Chengying SHEN ; Yican HE ; Xiao CHENG ; Chaoying DU ; Hongyan MIN ; Baode SHEN ; Lingfei TONG
China Pharmacy 2026;37(2):180-185
OBJECTIVE To investigate the effect of Huangqin decoction (HQD)-based self-assembled nanoparticles (SAN) co-loaded with terbinafine (TBF) (TBF-HQD-SAN NPs) on the transdermal absorption of TBF. METHODS High-speed centrifugation combined with dialysis was used to separate HQD-SAN, and TBF-HQD-SAN NPs were obtained by loading TBF using the ultrasound magnetic stirring method; the particle size distribution, Zeta potential and polydispersity index (PDI) of the nanoparticle were characterized, and the encapsulation efficiency (EE) and drug loading (DL) of TBF were determined; using in vitro and in vivo transdermal experiments, the differences in transdermal performance between TBF-HQD-SAN NPs and TBF raw materials, as well as TBF and HQD-SAN physical mixture (TBF-HQD-SAN PM), were compared and analyzed. RESULTS TBF- HQD-SAN NPs were spherical with a particle size of (177.60±2.57) nm, a PDI of 0.197 4±0.007 9, and a Zeta potential of (-14.63±0.85) mV. The EE and DL of TBF were (99.49±0.71)% and (3.22±0.10)% , respectively. In vitro transdermal experiments, compared with TBF raw materials, the steady-state permeation rate (Jss) and skin retention of TBF-HQD-SAN NPs increased by 3.34 times and 27.56 times, respectively (P<0.05); compared with TBF-HQD-SAN PM, its Jss and skinretention were increased by 2.04 times and 7.44 times, respectively (P<0.05). In vivo transdermal experiments 69号) showed that, the area under the drug-time curve and the maximum concentration of TBF-HQD-SAN NPs increased by 2.13 times and 2.06 times respectively compared to TBF raw materials, and increased by 1.59 times and 1.65 times respectively compared to TBF-HQD-SAN PM (P<0.05). CONCLUSIONS TBF-HQD-SAN NPs can significantly enhance the in vitro and in vivo transdermal absorption efficiency and skin retention of TBF.
2.Clinical Observation on Prevention of Recurrence of Common Bile Duct Stones After ERCP with Yuyin Lidan Granules
Xiao WANG ; Yong FANG ; Cong HE ; Jiali ZHANG ; Meng YU ; Jing KONG ; Yi JIANG ; Chuanqi CHENG ; Xiaosu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):159-166
ObjectiveTo observe the clinical efficacy and safety of Yuyin Lidan granules (YYLD) in preventing the recurrence of common bile duct stones (CBDS) in patients with liver and gallbladder dampness-heat syndrome following endoscopic retrograde cholangiopancreatography (ERCP). MethodsThis randomized, parallel, controlled trial enrolled postoperative CBDS-ERCP patients who met the inclusion and exclusion criteria. Sixty-four patients were randomly assigned to an observation group or a control group, with 32 cases in each. Both groups received conventional Western medical treatment after ERCP, while the observation group additionally received YYLD for 8 weeks. The follow-up period lasted for 1 year. The efficacy indicators included bile bilirubin levels, traditional Chinese medicine (TCM) syndrome scores, clinical efficacy rate, pancreatitis and inflammation markers, postoperative liver function, and CBDS recurrence rate at 1-year follow-up, which were used to jointly evaluate the clinical efficacy and safety of both groups. ResultsA total of 56 patients completed the study and were included in the final analysis, i.e., 29 in the observation group and 27 in the control group. Baseline characteristics were comparable between the two groups. Compared with pre-treatment and with the control group after treatment, the bile bilirubin level in the observation group significantly decreased (P<0.05). After treatment, the clinical cure and marked improvement rates were higher in the observation group than in the control group, showing a statistically significant difference in overall clinical efficacy (P<0.05). Compared with pre-treatment, the primary and secondary symptoms in the observation group, as well as the primary symptom and the secondary symptom of nausea and vomiting in the control group (weeks 4 and 8), were significantly reduced (P<0.05). Compared with the control group after treatment, the observation group showed significant reductions in the primary symptom of loose stools/constipation (day 5 and week 4) and in three secondary symptoms, i.e., bitter taste and sticky dry mouth, abdominal distension and poor appetite (throughout the treatment period), and general heaviness and fatigue (day 5 and week 4), with statistical differences (P<0.05). Compared with pre-treatment, both groups showed decreased lipase and urinary amylase levels (P<0.05). However, no significant between-group differences were observed in pancreatitis or inflammation-related indices after treatment. Compared with pre-treatment, all liver function indicators in the observation group and alanine aminotransferase ( ALT ), γ-glutamyl transferase ( γ-GT ), alkaline phosphatase (ALP), and conjugated bilirubin in the control group significantly decreased at weeks 4 and 8 (P<0.05). Compared with the control group after treatment, only serum total bilirubin and unconjugated bilirubin were significantly reduced in the observation group during the treatment period (P<0.05). ConclusionYYLD combined with conventional Western medical treatment can effectively regulate bilirubin metabolism (in bile and serum), improve TCM clinical symptoms, and prevent CBDS recurrence after ERCP in patients with liver and gallbladder dampness-heat syndrome. This regimen is safe and effective and is worthy of further clinical research and promotion.
3.An excerpt of ACG clinical guideline: Perioperative risk assessment and management in patients with cirrhosis (2025 edition)
Qizhen HE ; Junqi XIA ; Cheng ZHANG ; Xingshun QI
Journal of Clinical Hepatology 2026;42(2):293-295
Recently, the American College of Gastroenterology (ACG) released the clinical guidelines on perioperative risk assessment and management of patients with cirrhosis, proposing a comprehensive approach for perioperative risk assessment and management in these patients. The guidelines mainly focus on the severity of liver diseases, extrahepatic comorbidities, and surgery-specific factors, with an emphasis on individualized risk stratification using validated risk assessment tools (such as the VOCAL-Penn score) for patients with cirrhosis. This article gives an excerpt of the key statements in the guidelines.
4.Clinical Efficacy and Economic Evaluation of 1293 Non-Severe Adult Patients with Community-Acquired Pneumonia Treated by the Jiangsu Traditional Chinese Medicine Diagnosis and Treatment Protocol for Dominant Diseases:A Multicenter,Retrospective Real-World Cohort Study
Ye MA ; Yeqing JI ; Zhichao WANG ; Fanchao FENG ; Mingzhi PU ; Hong LYU ; Xiaodong HU ; Gaohua FENG ; Xiaoqian FANG ; Guicai ZHANG ; Yanfen TANG ; Yeqing ZHANG ; Yao ZHUFU ; Wenpan PENG ; Hao WANG ; Cheng GU ; Zhichao ZHANG ; Shuang YANG ; Xinyu SUN ; Qi ZHAO ; Aojie GUO ; Xin TONG ; Zhuoyue WU ; Xiaoxiao WANG ; Jia LIU ; Hailang HE ; Xianmei ZHOU
Journal of Traditional Chinese Medicine 2026;67(9):966-974
ObjectiveTo evaluate the clinical efficacy and economic value of the Jiangsu Traditional Chinese Medicine (TCM) Diagnosis and Treatment Protocol for Dominant Diseases (abbreviated as the Diagnosis and Treatment Protocol) in adult patients with non-severe community-acquired pneumonia (CAP) based on real-world clinical data. MethodsA retrospective real-world cohort study was conducted using electronic medical records of adult patients hospitalized for non-severe CAP from September 1st, 2023 to December 31st, 2024 across 10 TCM hospitals in Jiangsu province. Patients were classified into an exposure group and a non-exposure group based on whether they received Chinese herbal medicine (CHM) according to the Diagnosis and Treatment Protocol. The non-exposure group received only conventional western medicine, while the exposure group additionally received differentiated CHM for at least five consecutive days. Outcomes were compared between two patient groups, including cough resolution rate, sputum resolution rate (assessed by volume, color, and consistency), incidence of abnormal C-reactive protein (CRP), incidence of abnormal white blood cell (WBC) count, and radiographic resolution rate of pulmonary infiltrates on chest imaging. Multivariable logistic regression was performed to identify factors influencing clinical efficacy. Subgroup analyses were conducted according to age, gender, smoking status, history of hypertension, and pneumonia severity score (CURB-65), and the efficacy of treatment for cough and sputum was analyzed within each subgroup. Cost-effectiveness analysis was conducted using cough resolution rate as the outcome measure, evaluating the pharmacoeconomics of the two groups. ResultsA total of 1688 patients were included with 1293 in the exposure group and 395 in the non-exposure group. Compared to the non-exposure group, the exposure group demonstrated significantly higher resolution rates of cough, sputum volume, color, and consistency, as well as a significantly lower incidence of abnormal CRP (P<0.05). No statistically significant difference was observed between the groups in terms of abnormal WBC count and radiographic resolution rate of pulmonary infiltrates (P>0.05). Logistic regression analysis showed that the cough resolution rate in the exposure group was 1.83 times that of the non-exposure group, while the probabilities of resolution in sputum volume, color, and consistency were 1.37, 2.09, and 1.56 times those of the non-exposure group, respectively (P<0.05). Subgroup analyses showed that the exposure group achieved significantly higher cough resolution rates across most subgroups except for populations with a CURB-65 score ≥2 or those with a history of hypertension (P<0.05). Specifically, among females, patients aged ≥18 and <65 years, non-smokers, those without hypertension, and those with a CURB-65 score of 0, the exposure group showed a higher cough resolution rate than the non-exposure group (P<0.05). From an economic perspective, total hospitalization cost, length of stay, antibiotic cost, and CHM cost all differed significantly between groups (P<0.05). The cost-effectiveness ratio (CER) was 10,788.80 CNY/case in the exposure group, while 22,513.80 CNY/case in the non-exposure group. This implies that, compared with the exposure group, the non-exposure group incurred an additional 17,302.27 CNY to achieve one case of cough resolution. When the willingness-to-pay threshold ranged from 0 to 50,000 CNY, the probability of economic advantage was consistently higher in the exposure group than in the non-exposure group. ConclusionOn the basis of conventional western medicine, the addition of CHM in accordance with the Diagnosis and Treatment Protocol can effectively improve clinical symptoms, reduce inflammatory markers, promote clinical recovery, and is more cost-effective in treating adults with non-severe CAP.
5.Efficacy and Economic Evaluation of Weishi Qingjin Formula (苇石清金方)in the Treatment of Adult Community-Acquired Pneumonia with Phlegm-Heat Obstructing the Lung Syndrome:A Multicenter Retrospective Real-World Cohort Study
Yeqing JI ; Ye MA ; Zhichao WANG ; Fanchao FENG ; Mingzhi PU ; Hong LYU ; Xiaodong HU ; Gaohua FENG ; Xiaoqian FANG ; Guicai ZHANG ; Yanfen TANG ; Yeqing ZHANG ; Yao ZHUFU ; Wenpan PENG ; Hao WANG ; Cheng GU ; Zhichao ZHANG ; Shuang YANG ; Xinyu SUN ; Qi ZHAO ; Aojie GUO ; Xin TONG ; Zhuoyue WU ; Xiaoxiao WANG ; Jia LIU ; Hailang HE ; Xianmei ZHOU
Journal of Traditional Chinese Medicine 2026;67(9):975-984
ObjectiveTo observe the real‑world effectiveness and economic outcomes of Weishi Qingjin Formula (苇石清金方, WQF) in the treatment of adult community‑acquired pneumonia (CAP) with phlegm‑heat obstructing the lung syndrome. MethodsBased on a multicenter, real-world retrospective cohort study, clinical data were collected from hospitalized adult patients diagnosed with non‑severe CAP and phlegm‑heat obstructing the lung syndrome in 10 traditional Chinese medicine (TCM) hospitals in Jiangsu province. Patients were divided into an exposure group (those who received oral WQF) and a non‑exposure group (those who did not). The following outcomes were compared between the two groups before and after treatment, which were remission rates of clinical symptoms including cough, expectoration (sputum volume, color, consistency), and chest pain, levels of inflammatory markers including C‑reactive protein (CRP) and white blood cell count (WBC), and the rate of pulmonary inflammatory absorption on chest CT. Subgroup analyses were performed based on age, gender, smoking status, presence of hypertension, and the severity of community-acquired pneumonia (CURB‑65) score, comparing the two groups in terms of cough remission rate, chest pain remission rate, and chest CT absorption rate. For health economic evaluation, cost‑effectiveness analysis was used to calculate the cost‑effectiveness ratio (CER) and incremental cost‑effectiveness ratio (ICER). Univariate sensitivity analysis and probabilistic sensitivity analysis were performed to test the robustness of the results. ResultsA total of 647 patients in the exposure group and 1491 patients in the non-exposure group were included in the final statistical analysis. There was no statistically significant difference in length of hospital stay, gender, marital status, smoking history, bronchoscopy history, and comorbidities between the groups (P>0.05), but age, CURB-65 score, and antibiotic use. The exposure group had significantly higher remission rates of cough and sputum consistency than the non-exposure group (P<0.05). After adjusting for confounders using propensity score matching and logistic regression, the cough remission rate in the exposure group was 1.49 times that of the non-exposure group (P<0.01). No significant difference was observed between groups in the reduction rates of CRP and WBC, and in the rate of pulmonary inflammatory absorption on chest CT (P>0.05). Subgroup analyses revealed that the cough remission rate in the exposure group was significantly better than that in the non-exposure group except for patients aged ≥65 years, smokers, hypertensive patients, those using other type antibiotics or not using antibiotics, and those with a CURB-65 score ≥1 (P<0.05). Among smokers, the chest pain remission rate in the exposure group was 4.38 times that of the non-exposure group (P<0.01). No significant difference in chest CT absorption rate was found between groups across subgroups of gender, age, hypertension status, or antibiotic type (P>0.05). In terms of economic evaluation, CER was 10,877.60 CNY/case in the exposure group and 16,773.10 CNY/case in the non-exposure group. Compared to the exposure group, the non-exposure group incurred an additional 15,034.26 CNY to achieve one case of cough resolution, indicating a more favorable cost-effectiveness profile. Probabilistic sensitivity analysis yielded results consistent with the cost-effectiveness analysis, confirming the robustness of the findings. ConclusionWQF demonstrates significant efficacy in improving cough symptoms in the treatment of adult CAP with phlegm-heat obstructing the lung syndrome, and also exhibits favorable economic benefits.
6.Clinical Efficacy and Economic Evaluation of 1293 Non-Severe Adult Patients with Community-Acquired Pneumonia Treated by the Jiangsu Traditional Chinese Medicine Diagnosis and Treatment Protocol for Dominant Diseases:A Multicenter,Retrospective Real-World Cohort Study
Ye MA ; Yeqing JI ; Zhichao WANG ; Fanchao FENG ; Mingzhi PU ; Hong LYU ; Xiaodong HU ; Gaohua FENG ; Xiaoqian FANG ; Guicai ZHANG ; Yanfen TANG ; Yeqing ZHANG ; Yao ZHUFU ; Wenpan PENG ; Hao WANG ; Cheng GU ; Zhichao ZHANG ; Shuang YANG ; Xinyu SUN ; Qi ZHAO ; Aojie GUO ; Xin TONG ; Zhuoyue WU ; Xiaoxiao WANG ; Jia LIU ; Hailang HE ; Xianmei ZHOU
Journal of Traditional Chinese Medicine 2026;67(9):966-974
ObjectiveTo evaluate the clinical efficacy and economic value of the Jiangsu Traditional Chinese Medicine (TCM) Diagnosis and Treatment Protocol for Dominant Diseases (abbreviated as the Diagnosis and Treatment Protocol) in adult patients with non-severe community-acquired pneumonia (CAP) based on real-world clinical data. MethodsA retrospective real-world cohort study was conducted using electronic medical records of adult patients hospitalized for non-severe CAP from September 1st, 2023 to December 31st, 2024 across 10 TCM hospitals in Jiangsu province. Patients were classified into an exposure group and a non-exposure group based on whether they received Chinese herbal medicine (CHM) according to the Diagnosis and Treatment Protocol. The non-exposure group received only conventional western medicine, while the exposure group additionally received differentiated CHM for at least five consecutive days. Outcomes were compared between two patient groups, including cough resolution rate, sputum resolution rate (assessed by volume, color, and consistency), incidence of abnormal C-reactive protein (CRP), incidence of abnormal white blood cell (WBC) count, and radiographic resolution rate of pulmonary infiltrates on chest imaging. Multivariable logistic regression was performed to identify factors influencing clinical efficacy. Subgroup analyses were conducted according to age, gender, smoking status, history of hypertension, and pneumonia severity score (CURB-65), and the efficacy of treatment for cough and sputum was analyzed within each subgroup. Cost-effectiveness analysis was conducted using cough resolution rate as the outcome measure, evaluating the pharmacoeconomics of the two groups. ResultsA total of 1688 patients were included with 1293 in the exposure group and 395 in the non-exposure group. Compared to the non-exposure group, the exposure group demonstrated significantly higher resolution rates of cough, sputum volume, color, and consistency, as well as a significantly lower incidence of abnormal CRP (P<0.05). No statistically significant difference was observed between the groups in terms of abnormal WBC count and radiographic resolution rate of pulmonary infiltrates (P>0.05). Logistic regression analysis showed that the cough resolution rate in the exposure group was 1.83 times that of the non-exposure group, while the probabilities of resolution in sputum volume, color, and consistency were 1.37, 2.09, and 1.56 times those of the non-exposure group, respectively (P<0.05). Subgroup analyses showed that the exposure group achieved significantly higher cough resolution rates across most subgroups except for populations with a CURB-65 score ≥2 or those with a history of hypertension (P<0.05). Specifically, among females, patients aged ≥18 and <65 years, non-smokers, those without hypertension, and those with a CURB-65 score of 0, the exposure group showed a higher cough resolution rate than the non-exposure group (P<0.05). From an economic perspective, total hospitalization cost, length of stay, antibiotic cost, and CHM cost all differed significantly between groups (P<0.05). The cost-effectiveness ratio (CER) was 10,788.80 CNY/case in the exposure group, while 22,513.80 CNY/case in the non-exposure group. This implies that, compared with the exposure group, the non-exposure group incurred an additional 17,302.27 CNY to achieve one case of cough resolution. When the willingness-to-pay threshold ranged from 0 to 50,000 CNY, the probability of economic advantage was consistently higher in the exposure group than in the non-exposure group. ConclusionOn the basis of conventional western medicine, the addition of CHM in accordance with the Diagnosis and Treatment Protocol can effectively improve clinical symptoms, reduce inflammatory markers, promote clinical recovery, and is more cost-effective in treating adults with non-severe CAP.
7.Efficacy and Economic Evaluation of Weishi Qingjin Formula (苇石清金方)in the Treatment of Adult Community-Acquired Pneumonia with Phlegm-Heat Obstructing the Lung Syndrome:A Multicenter Retrospective Real-World Cohort Study
Yeqing JI ; Ye MA ; Zhichao WANG ; Fanchao FENG ; Mingzhi PU ; Hong LYU ; Xiaodong HU ; Gaohua FENG ; Xiaoqian FANG ; Guicai ZHANG ; Yanfen TANG ; Yeqing ZHANG ; Yao ZHUFU ; Wenpan PENG ; Hao WANG ; Cheng GU ; Zhichao ZHANG ; Shuang YANG ; Xinyu SUN ; Qi ZHAO ; Aojie GUO ; Xin TONG ; Zhuoyue WU ; Xiaoxiao WANG ; Jia LIU ; Hailang HE ; Xianmei ZHOU
Journal of Traditional Chinese Medicine 2026;67(9):975-984
ObjectiveTo observe the real‑world effectiveness and economic outcomes of Weishi Qingjin Formula (苇石清金方, WQF) in the treatment of adult community‑acquired pneumonia (CAP) with phlegm‑heat obstructing the lung syndrome. MethodsBased on a multicenter, real-world retrospective cohort study, clinical data were collected from hospitalized adult patients diagnosed with non‑severe CAP and phlegm‑heat obstructing the lung syndrome in 10 traditional Chinese medicine (TCM) hospitals in Jiangsu province. Patients were divided into an exposure group (those who received oral WQF) and a non‑exposure group (those who did not). The following outcomes were compared between the two groups before and after treatment, which were remission rates of clinical symptoms including cough, expectoration (sputum volume, color, consistency), and chest pain, levels of inflammatory markers including C‑reactive protein (CRP) and white blood cell count (WBC), and the rate of pulmonary inflammatory absorption on chest CT. Subgroup analyses were performed based on age, gender, smoking status, presence of hypertension, and the severity of community-acquired pneumonia (CURB‑65) score, comparing the two groups in terms of cough remission rate, chest pain remission rate, and chest CT absorption rate. For health economic evaluation, cost‑effectiveness analysis was used to calculate the cost‑effectiveness ratio (CER) and incremental cost‑effectiveness ratio (ICER). Univariate sensitivity analysis and probabilistic sensitivity analysis were performed to test the robustness of the results. ResultsA total of 647 patients in the exposure group and 1491 patients in the non-exposure group were included in the final statistical analysis. There was no statistically significant difference in length of hospital stay, gender, marital status, smoking history, bronchoscopy history, and comorbidities between the groups (P>0.05), but age, CURB-65 score, and antibiotic use. The exposure group had significantly higher remission rates of cough and sputum consistency than the non-exposure group (P<0.05). After adjusting for confounders using propensity score matching and logistic regression, the cough remission rate in the exposure group was 1.49 times that of the non-exposure group (P<0.01). No significant difference was observed between groups in the reduction rates of CRP and WBC, and in the rate of pulmonary inflammatory absorption on chest CT (P>0.05). Subgroup analyses revealed that the cough remission rate in the exposure group was significantly better than that in the non-exposure group except for patients aged ≥65 years, smokers, hypertensive patients, those using other type antibiotics or not using antibiotics, and those with a CURB-65 score ≥1 (P<0.05). Among smokers, the chest pain remission rate in the exposure group was 4.38 times that of the non-exposure group (P<0.01). No significant difference in chest CT absorption rate was found between groups across subgroups of gender, age, hypertension status, or antibiotic type (P>0.05). In terms of economic evaluation, CER was 10,877.60 CNY/case in the exposure group and 16,773.10 CNY/case in the non-exposure group. Compared to the exposure group, the non-exposure group incurred an additional 15,034.26 CNY to achieve one case of cough resolution, indicating a more favorable cost-effectiveness profile. Probabilistic sensitivity analysis yielded results consistent with the cost-effectiveness analysis, confirming the robustness of the findings. ConclusionWQF demonstrates significant efficacy in improving cough symptoms in the treatment of adult CAP with phlegm-heat obstructing the lung syndrome, and also exhibits favorable economic benefits.
8.Signal mining for bleeding risk associated with the concomitant use of direct oral anticoagulants and triazole antifungals
Ziyang WU ; Ying ZHU ; Menghua ZHANG ; Na HE ; Qiong QIN ; Cheng XIE
China Pharmacy 2026;37(9):1185-1189
OBJECTIVE To assess the bleeding risk signals associated with the concomitant use of direct oral anticoagulants (DOACs) and triazole antifungals, and to provide pharmacovigilance evidence for the safety evaluation and monitoring of combined clinical use. METHODS Adverse event reports involving the concomitant use of DOACs and triazole antifungals were extracted from the US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2025. Nine bleeding-related preferred terms (PTs) were selected. The Ω shrinkage measure, additive model, multiplicative model, and combined risk ratio method were employed to detect drug-drug interaction signals. The strength of positive signals was further analyzed based on the Ω shrinkage measure. RESULTS A total of 790 adverse event reports involving the concomitant use of DOACs and triazole antifungals were included, among which 229 reports involved nine bleeding-related PTs. A total of 13 signals were consistently identified as posit ive by all four methods. These signals involved six drug combinations: apixaban-fluconazole, apixaban-posaconazole, rivaroxaban-itraconazole, dabigatran etexilate-fluconazole, apixaban-voriconazole, and dabigatran etexilate-itraconazole. The Ω shrinkage measure showed that the apixaban-posaconazole combination exhibited stronger signals for bleeding ( Ω =2.73, Ω 025 =2.05) and hemoptysis ( Ω =2.17, Ω 025 =0.83); the apixaban-fluconazole combination exhibited stronger signals for hematoma ( Ω =2.30, Ω 025 =1.47) and hematuria ( Ω =1.71, Ω 025 =0.74); the rivaroxaban-itraconazole combination exhibited stronger signals for epistaxis ( Ω =2.01, Ω 025 =0.90) and hematoma ( Ω =1.93, Ω 025 =0.42); no positive Ω signals were observed for intracranial hemorrhage or upper gastrointestinal hemorrhage. CONCLUSION S This study suggests that the concomitant use of DOACs and triazole antifungals may increase the risk of bleeding-related events, with differences in signal strength and signal distribution across various drug combinations. In clinical practice, particular attention should be paid to the concomitant use of apixaban or rivaroxaban with strong cytochrome P450 3A4 or P-glycoprotein inhibitors such as posaconazole and itraconazole. For other DOAC-triazole antifungal combinations, close monitoring for bleeding-related manifestations and timely adjustment of anticoagulation or antifungal regimens are also warranted.
9.Study on the influencing factors of venetoclax trough concentration and its association with efficacy in patients with acute myeloid leukemia
Weiwei HE ; Zhirui LIU ; Shiwei QIN ; Qiang GONG ; Lin CHENG
China Pharmacy 2026;37(9):1200-1205
OBJECTIVE To investigate the effect of plasma trough concentration of venetoclax and its influencing factors in patients with acute myeloid leukemia (AML). METHODS After 5 days of venetoclax administration, venous blood samples were collected from AML patients before the next dose. Plasma trough concentrations of venetoclax were determined using high-performance liquid chromatography-tandem mass spectrometry. Spearman correlation was used to assess the correlations between venetoclax plasma trough concentration and various parameters (including patients’ general information, venetoclax-related indicators, liver function indicators, kidney function indicators, and blood routine indicators). Multiple linear regression analysis was performed to identify independent factors influencing plasma trough concentration of venetoclax. Using efficacy as dependent variable [complete remission (CR)+partial remission (PR) vs. no remission (NR)], univariate and multivariate binary Logistic regression analyses were conducted to identify factors affecting efficacy. The receiver operating characteristic (ROC) curve was used to evaluate the predictive value of venetoclax plasma trough concentration for clinical efficacy (assessed as CR). RESULTS A total of 172 venetoclax plasma trough concentration measurements from 101 patients were included in this study. The median plasma trough concentration of venetoclax was 2.38 (1.18, 3.85) μg/mL; the median sampling time for plasma trough concentration of venetoclax was 10 (7, 15) d; the duration of venetoclax use was (34±12) d. Multiple linear regression analysis showed that alkaline phosphatase ( B =14.65, 95%CI: 5.35-23.95, P =0.002), total bilirubin ( B =-101.71, 95%CI: -197.16 to -6.25, P =0.037), and white blood cell count ( B =-106.84, 95%CI: -187.61 to -26.07, P =0.010) were independent factors influencing plasma trough concentration of venetoclax. Due to patient attrition during treatment, 114 venetoclax plasma trough concentration measurements from 69 patients were included for efficacy evaluation. The results showed that 46 patients (66.7%) achieved CR, 11 patients (15.9%) achieved PR, and 12 patients (17.4%) were NR. Multivariate binary Logistic regression analysis showed that age, hemoglobin, venetoclax plasma trough concentration, hematocrit, and mean corpuscular hemoglobin were independent factors affecting patient efficacy ( P <0.05). ROC curve analysis showed that the cut-off value of plasma trough concentration of venetoclax for predicting patient efficacy (assessed as CR) was 1.68 μg/mL (AUC=0.66, 95%CI: 0.54-0.78, P =0.014). CONCLUSIONS There is considerable inter-individual variability in plasma trough concentration of venetoclax among AML patients. Plasma trough concentration of venetoclax is significantly correlated with alkaline phosphatase, total bilirubin, and white blood cell count. Plasma trough concentration of venetoclax is an independent factor affecting patient’s efficacy, and when the cut-off value for predicting CR is above 1.68 μg/mL, better effects may be achieved.
10.Research progress of biomaterial-mediated brain-computer interfaces in neural rehabilitation
Xiangxiang YU ; Jie SHI ; Yucheng CHEN ; Lifeng CHENG ; Liangcan HE ; Kai LI
Chinese Journal of Clinical Medicine 2026;33(2):213-220
Neurological disorders such as post-stroke hemiplegia, spinal cord injury, and Parkinson disease represent a major global health burden. Brain-computer interface (BCI), which creates direct communication pathways between the nervous system and external devices, offers a promising strategy for functional restoration. The long-term efficacy of such BCI fundamentally depends on the performance of biomaterials at the neural interface. Ideal materials must concurrently satisfy biocompatibility, electrical conductivity, enduring chemical stability, and mechanical compatibility with brain tissue. This review systematically outlines the application of conductive polymers, inorganic nanomaterials, natural biomaterials, and composites in BCI, with a focus on how advanced designs, such as bionic and encapsulated electrodes, improve signal fidelity and surgical feasibility through structural innovation. It further summarizes key material-modification techniques and analyzes the complex foreign-body response orchestrated by microglia, astrocytes, and peripheral immune cells. Finally, it provides insights into future research directions and clinical translation of BCI-based neurorehabilitation, while highlighting critical challenges including long-term biosafety and the establishment of standardized evaluation frameworks, aiming to bridge the gap between laboratory innovation and effective clinical deployment.

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