1.Cost–utility analysis of lecanemab and donanemab for early Alzheimer’s disease in China
Wei SHAO ; Fei YU ; Ying LIU ; Lixin SHU ; Dan HAN
Journal of Pharmaceutical Practice and Service 2026;44(7):376-382
Objective To evaluate the cost–utility of lecanemab and donanemab in the treatment of early Alzheimer’s disease (AD) in China. Methods A Markov model was developed from a societal perspective to compare standard of care (SOC), lecanemab plus SOC, and donanemab plus SOC in terms of costs, quality-adjusted life years (QALY), and incremental cost–utility ratios (ICUR). Deterministic and probabilistic sensitivity analyses were conducted to assess parameter uncertainty. Results Both intervention strategies increased QALY compared with SOC but were associated with substantially higher costs, and neither was cost-effective under the current willingness-to-pay threshold. Conclusion Lecanemab and donanemab may be more appropriately considered within a multi-tiered healthcare reimbursement framework in China rather than relying solely on basic medical insurance.
2.Preventive Effect and Safety Evaluation of Xiaozhen Formula (消疹方) on Skin Toxicity Induced by Epidermal Growth Factor Receptor Inhibitors in the Treatment of Non-small Cell Lung Cancer:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial
Ling LUO ; Xintian WANG ; Cheng CHENG ; Zitong HAN ; Chunru WANG ; Guoli WEI ; Jianyue LI ; Li WANG ; Jirong WANG ; Peng SHU ; Liang LI ; Fenglin LIU ; Ran SONG ; Jing BAI ; Haiyan XING
Journal of Traditional Chinese Medicine 2026;67(18):1987-1994
ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula (消疹方) in preventing skin toxicity induced by epidermal growth factor receptor inhibitors (EGFRIs) in patients with EGFR-mutant non-small cell lung cancer (NSCLC). MethodsA randomized, double-blind, placebo-controlled, multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group (60 cases) or a control group (60 cases). On the basis of EGFRI-targeted therapy, patients in the treatment group received Xiaozhen Formula granules, whereas those in the control group received Xiaozhen Formula placebo granules, both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) scores, the Hospital Anxiety and Depression Scale (HADS) scores, and disease control rate, together with safety assessments. ResultsBased on the full analysis set (FAS), the incidence of skin toxicity in the treatment group was 18.33% (11/60), significantly lower than 45.00% (27/60) in the control group (P<0.01), with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash, the resolution rate in the treatment group was 90.91% (10/11), higher than that 33.33% (9/27) in the control group. The median time to resolution was 15 days (95%CI: 8-17 days) in the treatment group and it was not reached in the control group; the distribution of time to resolution differed significantly between groups (P<0.001). After treatment, the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores, and lower symptom scale, single-item scores, as well as HADS-A, and HADS-D scores than the control group (P<0.05). In the FAS analysis, the disease control rate (DCR) was 85.0% (51/60) in the treatment group, lower than 100.0% (60/60) in the control group (P=0.003), whereas no significant between-group difference was observed in the per-protocol set (PPS) analysis (P=0.464). The incidence of adverse events did not differ significantly between the two groups (P>0.05), and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity, and improve the outcome of rash regression, the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.
3.Effect of Simo decoction in improving low-grade inflammation of duodenum and protecting mucosal barrier in functional dyspepsia rats
Haiyue ZHANG ; Qian LUO ; Qin LIU ; Xingxu WEI ; Longbiao CHEN ; Yunzong HAN ; Siqing CHEN ; Shu ZHOU ; Xiaoyuan LIN ; Sainan ZHOU
Chinese Journal of Immunology 2025;41(7):1737-1742,1751
Objective:To explore the effect of Simo decoction improving the low duodenal inflammation and protecting the du-odenal mucosal barrier in rats with functional dyspepsia(FD).Methods:Sixty SD rats were randomly divided into control group(10 rats)and model group(50 rats),and the modeling rats were prepared by multivariate intervention method.After successful modeling,the modeling rats were randomly divided into model group,Simo decoction high-dose,medium-dose,low-dose group and mosapride group,with 10 rats in each group.The high-dose,medium-dose,and low-dose groups of Simo decoction were ga-vage given 5.62 g/kg,2.81 g/kg,and 1.40 g/kg,respectively,and the mosapride group was gavage given 0.305 mg/kg of mosapride,and the control group and model group were gavage given the same amount of distilled water for 14 days.The body weight of rats was observed;gastric emptying rate and small bowel propulsion rate were measured;transmission electron microscopy was used to observe the morphology of duodenal epithelial cells;ELISA detected serum levels of IL-17A and IL-22;Western blot and immunohistochemis-try were used to detect the expressions of protease-activated receptor 2(PAR-2)and tight junction protein(ZO-1,claudin-1)in the duodenum.Results:Compared with the control group,the body weight,gastric emptying rate and small intestinal propulsion rate of the model group were significantly reduced(P<0.01),transmission electron microscopy showed widening of the duodenal epithelial cell space,serum IL-17A and IL-22 levels were significantly increased(P<0.01),the expression of PAR-2 in duodenal tissue was in-creased,and the expressions of ZO-1 and claudin-1 were downregulated(P<0.01).Compared with model group,the gastric emptying rate and small intestinal propulsion rate in Simo decoction high-dose,medium-dose and mosapride group were increased(P<0.05,P<0.01),the contents of IL-17A and IL-22 in serum decreased(P<0.05,P<0.01),and the expression of PAR-2 in duodenal tissues was down-regulated,the expressions of ZO-1 and claudin-1 was significantly increased(P<0.01).The low-dose group of Simo soup could improve weight loss(P<0.01),reduce IL-17A content and PAR-2 expression,and increase ZO-1 and claudin-1 expression(P<0.05,P<0.01),while the effect on other indexes was not obvious.Conclusion:Simo decoction may reduce low-grade duodenal in-flammation to repair the mucosal barrier by down-regulating the levels of IL-17A and IL-22 and the expression of PAR-2,and up-regu-lating the expression of ZO-1 and claudin-1,so as to exert the effect of FD treatment.
4.Design and implementation of disinfection and disinsection device based on centrifugal atomization principle
Jun-shu HAN ; Jian-xin CHEN ; Wei-wen YANG
Chinese Medical Equipment Journal 2025;46(4):35-39
Objective To design a centrifugal agtomization principle-based disinfection and disinsection device for plateau areas.Methods A disinfection and disinsection device was developed based on centrifugal atomization principle,which was composed of a spraying body,lifting and rotating mechanisms,an electrical control system,a spray tank and a sprayer carriage.The spraying body consisted of spraying components,a motor,an air blower,a fan and etc,and the spraying components adopted the structural form of multi-layer disc stacking to realize the atomization of liquid medicine;the lifting mechanism implemented up-and-down adjustment of the air blower through an electric actuartor,and the rotating mechanism executed left-and-right adjustment of the air blower thrgouth the worm gear motor and limit switch;the electrical control system was made up of a power source,electrical devices,a distribution system and a control system,in which a lead-acid battery pack was used for power supply and a DGUS touch screen and a DCS001 controller were involved in the control system;the spray tank was formed of a tank body,a needle valve,a water pump,float switch,etc;the sprayer carriage comprised a frame,a pusher,two sealing plates and four wheels.Some disc samples with different diameters were trial produced,and comparison experiments were carried out to investigate the relationship between disc diameter,motor speed,spray flow rate and atomization effect;a prototype was manufactured for performance testing of the device.Results The disc diameter and motor speed were inversely proportional to the droplet size;the spray flow rate was directly proportional to the droplet size,when the spray flow rate increased by 60%,the increment of the droplet size was restrained within 2%to 11%.The prototype test results indicated that the device could be used for ultra-low-volume disinfection and insecticide in plateau areas,with the D50 and D90 of the droplet size being 31 and 48 μm,respectively.Conclusion The device developed gains advantages in atomiztion,and meets the requirements for epidemic prevention,disinfection and disinsection in plateau areas.[Chinese Medical Equipment Journal,2025,46(4):35-39]
5.Diagnostic value of fecal calprotectin for assessing endoscopic activity in ulcerative colitis: comparison with conventional inflammatory markers
Qianqian XIA ; Ye GUO ; Wei HAN ; Yuzhe ZHOU ; Xiaoyan TANG ; Hong LYU ; Huijun SHU ; Gechong RUAN ; Hong YANG ; Jiaming QIAN
Chinese Journal of Inflammatory Bowel Diseases 2025;09(6):448-455
Objective:To evaluate the diagnostic performance of fecal calprotectin (FC) in predicting endoscopic activity of ulcerative colitis (UC), and to compare it with high-sensitivity C reactive protein (hsCRP) and erythrocyte sedimentation rate (ESR) .Methods:A cross-sectional stydy was conducted. UC patients diagnosed at Peking Union Medical College Hospital between May 2023 and July 2025 were retrospective enrolled. Patients were divided into the endoscopically active group and endoscopic remission group according to endoscopic activity. FC levels were measured using latex-enhanced turbidimetric immunoassay (LETIA). Receiver operating characteristic (ROC) curves and logistic regression models were used to assess diagnostic efficacy. Subgroup analyses were conducted according to disease extent.Results:A total of 166 UC patients were enrolled, including 92 males and 74 females with the age of 40.00 (32.00, 52.00) years old and disease course 5.00 (2.00, 10.75) years. Forty-six patients were assigned to the active group, while the remaining 120 were assigned to the remission group. FC levels were significantly higher in the active group than in the remission group (620.72 μg/g vs. 29.00 μg/g, P < 0.001), with an AUC of 0.894 at a cutoff value of 122.54 μg/g. hsCRP and ESR had lower AUC (0.712 and 0.736, respectively). The combination of FC, hsCRP, and ESR slightly improved specificity (AUC 0.898). FC was strongly correlated with the endoscopic activity ( r =0.669, P < 0.001) but not with disease extent. Conclusions:FC measured by latex-enhanced turbidimetric immunoassay had comparable diagnostic accuracy to ELISA-based methods commonly used abroad, and provided a reference cutoff value of 122.54 μg/g. FC outperforms hsCRP and ESR in assessing intestinal inflammation in UC and it is less affected by disease extent, making it a reliable non-invasive biomarker for UC monitoring.
6.Cross-sectional study of fecal calprotectin in predicting endoscopic activity in patients with Crohn's disease
Yuzhe ZHOU ; Qianqian XIA ; Ye GUO ; Wei HAN ; Xiaoyan TANG ; Hong LYU ; Huijun SHU ; Gechong RUAN ; Hong YANG ; Jiaming QIAN
Chinese Journal of Inflammatory Bowel Diseases 2025;09(6):462-468
Objective:To evaluate the predictive efficacy of fecal calprotectin (FC) for endoscopic activity in patients with Crohn's disease (CD) .Methods:A cross-sectional study was conducted and patients diagnosed as CD at Peking Union Medical College Hospital from June 2023 to September 2025 were enrolled consecutively. Data was collected including general information, laboratory tests [hemoglobin (HGB), platelet (PLT), FC, high-sensitivity C-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR) and so on], and endoscopic results. FC levels were measured by latex-enhanced turbidimetric immunoassay (LETIA). Endoscopic activity was defined as the simplified endoscopic score for Crohn's disease (SES-CD) > 2. Patients were divided into the endoscopically active group and endoscopic remission group according to endoscopic activity, and the differences in clinical data between the two groups were compared. Spearman correlation analysis was used to assess the correlation between FC and endoscopic activity, and receiver operating characteristic (ROC) curve was used to evaluate the predictive efficacy of FC, hsCRP and ESR for endoscopic activity, and the differences were compared.Results:A total of 90 CD patients were enrolled, including 65 males and 25 females with the age of 30 (22, 41) years old and disease course 4.0 (0.5, 8.0) years. Seventy-one patients (78.9%) had ileocolonic disease involvement (L3), and 55 patients (61.1%) were using biologics. Sixty-nine patients in endoscopic active phase were assigned to the endoscopically active group, while the remaining 21 were assigned to the endoscopic remission group. There were no statistically significant differences in general characteristics such as age and gender between the two groups (all P > 0.05). Compared with endoscopic remission group, HGB was significantly lower in the endoscopically active group, while PLT, hsCRP, ESR, and FC were moderataly higher (all P < 0.05). Among the 90 CD patients, FC levels were moderatly correlated with endoscopic activity (ρ = 0.494). ROC curve analysis indicated that the area under the curve for FC in predicting endoscopic activity was 0.836 (95% CI: 0.737-0.935), with a sensitivity of 0.725, specificity of 0.952, and accuracy of 0.778 at the optimal FC cutoff value of 153.8 μg/g. FC outperformed hsCRP and ESR. Conclusion:FC measured by LETIA demonstrates certain efficacy in predicting endoscopic activity in CD and will assist in efficient clinical monitoring of CD patients.
7.Construction and identification of synovial tissue conditional Grk2 knockout mice
Shu-jun ZUO ; Wei-kang WANG ; Jin-tao GU ; Fu-yuan GUO ; Hao-zhou GUO ; Chen-chen HAN ; Wei WEI
Chinese Pharmacological Bulletin 2025;41(6):1194-1199
Aim To construct and analyze the genotype of G protein-coupled receptor kinase 2(GRK2)conditional knockout mice in synoviocytes,and to provide an animal model for stud-ying the function of GRK2 in synoviocytes.Methods Grk2flox/+mice were bred to generate Grk2flox/flox mice,Grk2flox/flox mice were bred to Col1a1-iCre+mice,Grk2flox/+Col1a1-iCre+mice were bred to Grk2flox/flox mice.Grk2flox/flox Col1a1-iCre+mice were ob-tained as target mice.DNA was extracted and amplified by PCR to identify the genotype.Western blot was used to verify the effect of Grk2 knockout in synovium,liver and kidney tissues.HE staining was used to detect the effects of Grk2 conditional knockout in synovial cells on ankle synovium,liver and kidney tissues.Multiple immunofluorescence was used to detect GRK2 expression in synovial cells.Results The results of gene iden-tification showed that Grk2flox/flox Col1a1-iCre+mice had both Flox and Col1a1-iCre genotypes.Western blot results showed that GRK2 expression decreased in synovial tissues of Grk2flox/flox Col1a1-iCre+mice,but there was no significant change in the expression of GRK2 in liver and kidney tissues.HE staining showed that Grk2flox/flox Col1a1-iCre+mice had no significant pathological changes in the ankle synovium,liver and kidney.The results of multiple immunofluorescence showed that GRK2 expression in synovial cells of Grk2flox/flox Col1a1-iCre+mice de-creased.Conclusion Grk2 conditional knockout mice in syno-viocytes are successfully constructed and identified,which pro-vides an animal model for further study of the role of GRK2 in synovial-related diseases.
8.Current status and influencing factors of intrinsic capacity in elderly patients with Parkinson's disease based on health ecology model
Yan ZHANG ; Fan JI ; Mengya HAN ; Xinyu ZHAO ; Ludan XU ; Huanhuan FENG ; Ping ZHUANG ; Wei SHU ; Binru HAN
Chinese Journal of Modern Nursing 2025;31(22):2962-2972
Objective:To explore the current status and influencing factors of intrinsic capacity in elderly patients with Parkinson's disease.Methods:Convenience sampling was used to select 306 elderly patients with Parkinson's disease who attended Xuanwu Hospital of Capital Medical University from March to September 2024 for the study. Influencing factors were screened based on the health ecology model. Elderly patients with Parkinson's disease were surveyed using the General Information Questionnaire, Connor-Davidson Resilience Scale, Family APGAR Scale, Social Support Rating Scale, and Intrinsic Capacity Assessment Tool. Multiple linear regression was used to analyze the factors influencing the total score and the scores of each dimension of intrinsic capacity in elderly patients with Parkinson's disease.Results:A total of 306 questionnaires were distributed and 301 valid questionnaires were recovered, with a valid recovery rate of 98.37% (301/306). The total intrinsic capacity score of 301 elderly patients with Parkinson's disease was (67.21±11.47), of which 297 elderly patients with Parkinson's disease had impaired intrinsic capacity, and the rate of impaired intrinsic capacity was 98.7% (297/301). The dimensions in descending order of impairment were motor [89.7% (270/301) ], mental [76.1% (229/301) ], sensory [70.4% (212/301) ], vitality [38.2% (115/301) ], and cognitive [25.6% (77/301) ]. Multiple linear regression analysis showed that age, Hoehn-Yahr staging, levodopa equivalent dosage, activity of daily living, history of falls, regular exercise, psychological resilience, social support, and monthly income were the factors influencing the total intrinsic capacity score of elderly patients with Parkinson's disease ( P<0.05) and heterogeneity of influencing factors in each dimension. Conclusions:Elderly patients with Parkinson's disease have a high rate of impaired intrinsic capacity, with the motor dimension being the most severely impaired. Healthcare professionals should pay attention to the assessment of the intrinsic capacity of elderly patients with Parkinson's disease, and customize interventions according to the influencing factors to promote the functioning of elderly patients so as to reduce the burden of care on families and society.
9.Diagnostic value of fecal calprotectin for assessing endoscopic activity in ulcerative colitis: comparison with conventional inflammatory markers
Qianqian XIA ; Ye GUO ; Wei HAN ; Yuzhe ZHOU ; Xiaoyan TANG ; Hong LYU ; Huijun SHU ; Gechong RUAN ; Hong YANG ; Jiaming QIAN
Chinese Journal of Inflammatory Bowel Diseases 2025;09(6):448-455
Objective:To evaluate the diagnostic performance of fecal calprotectin (FC) in predicting endoscopic activity of ulcerative colitis (UC), and to compare it with high-sensitivity C reactive protein (hsCRP) and erythrocyte sedimentation rate (ESR) .Methods:A cross-sectional stydy was conducted. UC patients diagnosed at Peking Union Medical College Hospital between May 2023 and July 2025 were retrospective enrolled. Patients were divided into the endoscopically active group and endoscopic remission group according to endoscopic activity. FC levels were measured using latex-enhanced turbidimetric immunoassay (LETIA). Receiver operating characteristic (ROC) curves and logistic regression models were used to assess diagnostic efficacy. Subgroup analyses were conducted according to disease extent.Results:A total of 166 UC patients were enrolled, including 92 males and 74 females with the age of 40.00 (32.00, 52.00) years old and disease course 5.00 (2.00, 10.75) years. Forty-six patients were assigned to the active group, while the remaining 120 were assigned to the remission group. FC levels were significantly higher in the active group than in the remission group (620.72 μg/g vs. 29.00 μg/g, P < 0.001), with an AUC of 0.894 at a cutoff value of 122.54 μg/g. hsCRP and ESR had lower AUC (0.712 and 0.736, respectively). The combination of FC, hsCRP, and ESR slightly improved specificity (AUC 0.898). FC was strongly correlated with the endoscopic activity ( r =0.669, P < 0.001) but not with disease extent. Conclusions:FC measured by latex-enhanced turbidimetric immunoassay had comparable diagnostic accuracy to ELISA-based methods commonly used abroad, and provided a reference cutoff value of 122.54 μg/g. FC outperforms hsCRP and ESR in assessing intestinal inflammation in UC and it is less affected by disease extent, making it a reliable non-invasive biomarker for UC monitoring.
10.Cross-sectional study of fecal calprotectin in predicting endoscopic activity in patients with Crohn's disease
Yuzhe ZHOU ; Qianqian XIA ; Ye GUO ; Wei HAN ; Xiaoyan TANG ; Hong LYU ; Huijun SHU ; Gechong RUAN ; Hong YANG ; Jiaming QIAN
Chinese Journal of Inflammatory Bowel Diseases 2025;09(6):462-468
Objective:To evaluate the predictive efficacy of fecal calprotectin (FC) for endoscopic activity in patients with Crohn's disease (CD) .Methods:A cross-sectional study was conducted and patients diagnosed as CD at Peking Union Medical College Hospital from June 2023 to September 2025 were enrolled consecutively. Data was collected including general information, laboratory tests [hemoglobin (HGB), platelet (PLT), FC, high-sensitivity C-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR) and so on], and endoscopic results. FC levels were measured by latex-enhanced turbidimetric immunoassay (LETIA). Endoscopic activity was defined as the simplified endoscopic score for Crohn's disease (SES-CD) > 2. Patients were divided into the endoscopically active group and endoscopic remission group according to endoscopic activity, and the differences in clinical data between the two groups were compared. Spearman correlation analysis was used to assess the correlation between FC and endoscopic activity, and receiver operating characteristic (ROC) curve was used to evaluate the predictive efficacy of FC, hsCRP and ESR for endoscopic activity, and the differences were compared.Results:A total of 90 CD patients were enrolled, including 65 males and 25 females with the age of 30 (22, 41) years old and disease course 4.0 (0.5, 8.0) years. Seventy-one patients (78.9%) had ileocolonic disease involvement (L3), and 55 patients (61.1%) were using biologics. Sixty-nine patients in endoscopic active phase were assigned to the endoscopically active group, while the remaining 21 were assigned to the endoscopic remission group. There were no statistically significant differences in general characteristics such as age and gender between the two groups (all P > 0.05). Compared with endoscopic remission group, HGB was significantly lower in the endoscopically active group, while PLT, hsCRP, ESR, and FC were moderataly higher (all P < 0.05). Among the 90 CD patients, FC levels were moderatly correlated with endoscopic activity (ρ = 0.494). ROC curve analysis indicated that the area under the curve for FC in predicting endoscopic activity was 0.836 (95% CI: 0.737-0.935), with a sensitivity of 0.725, specificity of 0.952, and accuracy of 0.778 at the optimal FC cutoff value of 153.8 μg/g. FC outperformed hsCRP and ESR. Conclusion:FC measured by LETIA demonstrates certain efficacy in predicting endoscopic activity in CD and will assist in efficient clinical monitoring of CD patients.

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