1.Cost-effectiveness analysis of cefiderocol for the treatment of confirmed or suspected carbapenem-resistant Gram-negative bacteria serious infections
Yuan GONG ; Shuo KANG ; Yibing HOU ; Xiaohui WANG ; Ying NIE ; Jing WANG ; Zhenhua PAN
China Pharmacy 2026;37(2):192-197
OBJECTIVE To evaluate the cost-effectiveness of cefiderocol versus best available therapy (BAT) or standard-of- care (SOC) for the treatment of confirmed or suspected carbapenem-resistant Gram-negative bacterial (CRGNB) serious infections from the perspective of the Chinese healthcare system, and to explore its reasonable pricing. METHODS A decision tree model was constructed based on data from two phase Ⅲ clinical trials (CREDIBLE-CR and GAME CHANGER) to simulate the cost- effectiveness of cefiderocol in two scenarios: salvage therapy for confirmed CRGNB infection (scenario 1) and empirical therapy for suspected CRGNB infection (scenario 2). The primary outcome measure was the incremental cost-effectiveness ratio (ICER). The willingness-to-pay (WTP) was set at 1 to 3 times China’s per capita GDP in 2024. To verify the robustness of the results, one- way and probabilistic sensitivity analyses were conducted, and based on these, a reasonable price range for cefiderocol in the Chinese market was explored. RESULTS The results for scenario 1 showed that the clinical cure rate in the cefiderocol group was higher than that in the BAT group (47.50% vs. 34.21%), but its ICER was 415 065.03 yuan per cured case, exceeding three times China’s GDP per capita. Scenario 2 revealed that the ICER for cefiderocol relative to SOC was as high as 1 362 446.16 yuan per cured case, far exceeding the WTP. Sensitivity analysis indicated that the treatment duration and price of cefiderocol were key factors affecting its cost-effectiveness. In the two scenarios described above, the unit price of cefiderocol must fall below 683.47 and 242.00 yuan/g, respectively, to be considered cost-effective. CONCLUSIONS Based on the current market price, cefiderocol lacks sufficient cost-effectiveness for treating confirmed or suspected CRGNB serious infections within China’s healthcare system. To improve its accessibility, price negotiations or a tiered medical insurance payment strategy are required.
2.Exploring on Quality Evaluation Methods of Clinical Case Reports in Traditional Chinese Medicine Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Feng ZHANG ; Bo ZHOU ; Haimin CHEN ; Yong ZHU ; Changcheng HOU ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Guoshuang ZHU ; Shukun GONG ; Jianwen HE ; Yang YE ; Yuqiu AN ; Chunquan SUN ; Qingjie YUAN ; Buman LI ; Xingzhong FENG ; Kegang CAO ; Hongcai SHANG ; Jihua GUO ; Xiaoxiao ZHANG ; Zhining TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):271-276
As the core vehicle for preserving and transmitting traditional Chinese medicine(TCM) academic thought and clinical experience, the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine, this study conducted a comprehensive analysis of critical challenges, including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic, encompassing three dimensions of authenticity and standardization, characteristics and advantages, application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment, while aligning with modern scientific research standards, achieving a balance between individualized TCM experience and standardized evaluation. Concurrently, this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases, contributing significantly to the inheritance of TCM knowledge, evidence-based practice, and the reform of talent evaluation mechanisms.
3.Rapid health technology assessment of serplulimab in the first-line treatment of small-cell lung cancer
Yibing HOU ; Shuo KANG ; Yuan GONG ; Xiaohui WANG ; Ying NIE ; Huanlong LIU
China Pharmacy 2025;36(11):1405-1410
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of serplulimab as a first-line treatment of small- cell lung cancer (SCLC), and provide an evidence-based basis for drug selection in hospitals. METHODS Rapid health technology assessment was adopted; PubMed, Cochrane Library, Embase, CNKI, Wanfang, VIP and official websites of domestic and international health technology assessment agencies were systematically searched from the inception to Oct. 2024. Two reviewers independently screened the literature, assessed the quality of included studies and carried out the qualitative analysis according to the inclusion and exclusion criteria. RESULTS A total of 13 systematic reviews/meta-analyses and 9 economic studies were included, and the literature quality was generally good. In terms of effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy significantly improved progression-free survival, overall survival, and objective response rate in patients with SCLC. In terms of safety, serplulimab combined with chemotherapy showed no significant difference in the incidence of ≥3 grade adverse events compared with chemotherapy alone in the treatment of SCLC, indicating a good safety profile; compared with combination therapies involving other immunosuppressive agents, the incidence rate of adverse events was also lower. In terms of cost-effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy is not cost- effective, which may be related to the high price of serplulimab. CONCLUSIONS Serplulimab is effective and safe in the treatment of SCLC, but has no obvious advantage in terms of cost-effectiveness.
5.Influencing factors for the diagnostic accuracy of endoscopic ultrasonography for colorectal submucosal tumors
Xiaobing CUI ; Kui YUAN ; Lin LING ; Chunling XU ; Pei GUO ; Genhua YANG ; Chongju BAO ; Wei HU ; Wei GONG
Chinese Journal of Digestive Endoscopy 2025;42(10):780-788
Objective:To identify the factors influencing the diagnostic accuracy of endoscopic ultrasonography (EUS) for colorectal submucosal tumors (SMT).Methods:A retrospective analysis was conducted on 330 colorectal SMT lesions (from 323 patients) diagnosed by EUS at Shenzhen Hospital of Southern Medical University from December 2015 to October 2023. Pathological diagnosis were confirmed through endoscopic resection, EUS-guided fine needle aspiration (EUS-FNA) or surgical resection. Diagnostic accuracy was calculated for each type of colorectal SMT. Univariate and multivariate logistic regression analysis were performed to identify factors affecting EUS diagnostic accuracy.Results:The overall diagnostic accuracy of EUS for colorectal SMT was 73.6% (243/330). Among 19 SMT subtypes enrolled, neuroendocrine neoplasms (51.2%, 169/330) and lipomas (15.5%, 51/330) were most prevalent, while 17 rare subtypes each accounted for <6%. Seven rare SMT (mucosal chronic inflammation, colorectal schwannoma, xanthogranulomatous inflammation, capillary hemangioma, colonic xanthoma, lymphadenoid complex, and angiomyolipoma) showed 0% diagnostic accuracy. Seven other subtypes (granular cell tumor, leiomyoma, rectal tonsil, intestinal schistosomiasis, fibrous tissue hyperplasia, gastrointestinal stromal tumor, and lymphangioma) showed accuracy <30%, whereas five subtypes (cyst, bowel endometriosis, neuroendocrine neoplasm, lipoma, and pneumatosis cystoides intestinalis) achieved >60% accuracy. Multivariate logistic regression analysis confirmed that the lesion location (left colon VS rectum: OR=0.06, 95% CI: 0.02-0.17, P<0.001; right colon VS rectum: OR=0.04, 95% CI: 0.01-0.13, P<0.001; ileocecal valve VS rectum: OR=0.09, 95% CI: 0.02-0.42, P=0.002); echogenicity (anechoic VS hypoechoic: OR=6.26, 95% CI: 1.31-29.97, P=0.022; hyperechoic VS hypoechoic: OR=13.39, 95% CI: 4.16-43.09, P<0.001) and ultrasonic layer (layer 4 VS layer 3: OR=0.22, 95% CI: 0.06-0.81, P=0.023) were independent influencing factors of EUS diagnostic accuracy for colorectal SMT. Conclusion:Neuroendocrine neoplasms and lipomas represent the most common colorectal SMT, whereas rare and uncommon SMT exhibit low EUS diagnostic accuracy. Lesion location, echogenicity, and ultrasonic layer significantly influence EUS diagnostic accuracy for colorectal SMT.
6.Sugemalimab as first-line treatment for non-small cell lung cancer:a rapid health technology assessment
Yibing HOU ; Shuo KANG ; Yuan GONG ; Xiaohui WANG ; Ying NIE ; Huanlong LIU
Chinese Journal of Pharmacoepidemiology 2025;34(7):806-814
Objective To evaluate the efficacy,safety and economy of sugemalimab in the first-line treatment of non-small cell lung cancer(NSCLC)by rapid health technology assessment.Methods PubMed,Cochrane Library,Embase,CNKI,WanFang Data,VIP and official websites of health technology assessment(HTA)institutions were systematically searched to collect HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic studies of sugemalimab in first-line treatment of NSCLC from inception to October 31,2024.Two reviewers independently screened the literature,extracted information and performed quality assessment of the included studies,and then performed descriptive analysis on the results.Results A total of 15 articles were selected,including 4 systematic reviews/Meta-analysis and 11 pharmacoeconomic studies.In terms of effectiveness,compared with chemotherapy alone,sugemalimab combined with chemotherapy significantly improved progression-free survival(PFS),overall survival(OS),and objective response rate(ORR)in patients with NSCLC.In terms of safety,compared with chemotherapy alone,sugemalimab combined chemotherapy had higher incidence of overall adverse events,but it had a better safety profile compared to other immune combination therapies.In terms of economy,most studies suggested that compared with chemotherapy alone,sugemalimab combined with chemotherapy was not cost-effective,which may be related to the high price of sugemalimab.However,a few studies indicated that sugemalimab combined with chemotherapy could be cost-effective in specific scenarios.Conclusion Sugemalimab has good efficacy in the first-line treatment of NSCLC,but its safety and economy need to be further studied.
7.Correlation of TRPV1 and inflammatory cytokines in peripheral blood in patients with schizophrenia
Rui XU ; Yuan LI ; Xiaofen LI ; Shijing WANG ; Xiaowei WANG ; Huan HUANG ; Hao LIU ; Xuan GONG ; Huiling WANG
Chinese Journal of Psychiatry 2025;58(10):742-749
Objectives:This study aims to investigate the expression changes of transient receptor potential vanilloid type 1 (TRPV1) channel and inflammatory factors in the peripheral blood of patients with schizophrenia, and to evaluate their potential value for diagnostic prediction.Methods:This cross-sectional study was conducted at Renmin Hospital of Wuhan University from September 2023 to June 2024. A total of 35 patients with schizophrenia (patient group) from the outpatient/inpatient departments and 35 age-and sex-matched healthy individuals (control group) were recruited. Psychiatric symptoms and cognitive function were evaluated using the Positive and Negative Syndrome Scale (PANSS) and the Brief Assessment of Cognition in Schizophrenia (BACS), respectively. The between-group comparisons of the total scores of these two instruments were calculated using independent samples t-tests. Fasting peripheral blood samples were collected from all participants. Plasma and peripheral blood mononuclear cells (PBMCs) were isolated for subsequent analysis. TRPV1 protein expression was quantified by Western blotting, while inflammatory cytokines, including tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-10 (IL-10), were measured using enzyme-linked immunosorbent assay (ELISA). The between-group differences in TRPV1 and inflammatory cytokines were analyzed using the analysis of covariance (ANCOVA), controlling for age and sex. Pearson correlation analysis was employed to examine relationships between continuous variables, controlling for years of education, age, and sex. The diagnostic performance of TRPV1 and inflammatory cytokines for schizophrenia was assessed using receiver operating characteristic (ROC) curve analysis. Results:Significant between-group differences were observed in BACS total and subscale scores ( t=2.57-9.72, all P<0.01). Compared with the control group, the patient group exhibits significantly decreased expression of TRPV1, IL-4, and IL-10 ( t=6.78, 2.75, 2.53, all P<0.01), increased expression of TNF-α, IL-2, and IL-6 ( t=4.08, 2.64, 2.63, all P<0.01), and an increased IL-6/IL-10 ratio ( t=3.18, P<0.01). Correlation analyses revealed that in the patient group, the TRPV1 expression level was negatively correlated with levels of TNF-α and IL-6, and positively correlated with levels of IL-4 and IL-10 ( r=-0.589, -0.234, 0.341, 0.293, all P<0.05). In the patient group, the TRPV1 expression level was negatively correlated with the negative symptom score of PANSS ( r=-0.299, P<0.05), and the IL-6 level was positively correlated with the negative symptom score, the general pathology score, and the total score of PANSS ( r=0.387, 0.356, 0.321, all P<0.05). The TRPV1 level was positively correlated with the total score of BACS in both the control group and the patient group ( r=0.144, 0.828, all P<0.01). The IL-6/IL-10 ratio was positively correlated with the total score of PANSS and negatively correlated with the total score of BACS in the patient group ( r=0.623, -0.333, all P<0.05). The area under the ROC curve for the combination of TRPV1 level and IL-6/IL-10 ratio was 0.98 (95% confidence interval=0.96 to 1.00). Conclusions:Patients with schizophrenia exhibit reduced expression levels of TRPV1 along with an imbalanced inflammatory response. The combined assessment of TRPV1 level and IL-6/IL-10 ratio has demonstrated a high predictive and diagnostic value for schizophrenia.
8.Characteristic analysis of isometric muscle strength of knee joint in patients after unicompartmental knee arthroplasty
Yuan DING ; Jianbao GONG ; Jie ZHANG ; Yuan QIAO ; Wenlong XU
Chinese Journal of Tissue Engineering Research 2025;29(27):5833-5838
BACKGROUND:The knee osteoarthritis,a major cause of disability in the elderly,is currently treated with surgical procedures including unicompartmental knee arthroplasty in end-stage patients,but the recovery of muscle strength in patients after unicompartmental knee arthroplasty is not well understood.OBJECTIVE:To analyze the short-term and medium-term knee isometric muscle strength characteristics of patients with unilateral knee osteoarthritis after unicompartmental knee arthroplasty,to compare with those of the unaffected side,and to analyze the recovery of muscle strength in the affected limb.METHODS:Patients undergoing unicompartmental knee arthroplasty in the Qingdao Municipal Hospital from June to December 2023 were recruited to undergo standardized functional rehabilitation exercises.The A8-2M multi-joint isokinetic training and testing system was used to detect the peak torque and the maximum one-repetition work of the extensor muscle of the unaffected side and the affected side of the knee joint at the angular velocity of 60(°)/s and the range of joint motion of 0°-90° before,1 and 3 months after surgery.RESULTS AND CONCLUSION:(1)At an angular velocity of 60(°)/s,the peak moment and maximum one-repetition work of the flexor and extensor muscles of the affected side were lower than those of the unaffected side preoperatively(P<0.05).(2)The peak moment and maximum one-repetition work of the flexor and extensor muscles were significantly lower than those of the unaffected side 1 month postoperatively(P<0.05).Meanwhile,the peak moment of the flexor and extensor muscles and the maximum one-repetition work of the flexor and extensor muscles on the affected side at 1 month postoperatively were significantly lower than those on the affected side preoperatively(P<0.05).(3)The peak moment of the flexor and extensor muscles and the maximum one-repetition work of the flexor and extensor muscles on the affected side at 3 months postoperatively had no significant difference from those on the unaffected side.The peak flexor-extensor moment of the flexor-extensor muscles on the affected side was higher than that preoperatively(P<0.05).(4)It is indicated that after unicompartmental knee arthroplasty,the muscle strength on the affected side is poor after 1 month after standard functional rehabilitation.However,after 3 months,there was no significant difference between the affected side and the unaffected side.
9.Spring and summer-autumn pollen grading and forecasting model based on daily visits of allergic rhinitis patients
Yuhui OUYANG ; Zhaoyin YIN ; Yun YAN ; Jingguo CHEN ; Wenxuan FEI ; Lili GONG ; Weiwei LIU ; Xiaojia LIU ; Daoliang SONG ; Zhendong XU ; Ying ZHANG ; Yuan ZHANG ; Luo ZHANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):313-320
Objective:To establish graded forecast models of pollen concentration in spring and summer-autumn in northern China, based on long-term data of pollen and allergic rhinitis (AR) medical visits in 8 cities of northern China.Methods:Pollen concentration and the characteristics of AR patients from 8 cities of northern China, including Beijing, Baotou, Hohhot, Xi′an, Xining, Cangzhou, Liaocheng and Zibo, were analyzed. Spearman′s correlation was used to examine the relationship between pollen concentration and daily AR patient visits. A pollen concentration grading was establish, and a pollen forecast model was created using the eXtreme gradient boosting (XGBoost) algorithm. The model incorporated meteorological factors and the 3-day moving average of pollen concentrations.Results:The spring pollen period started early and lasted long in Beijing and Xi ′an, while the summer-autumn pollen period started earlier and persisted longer in Xining, Baotou and Hohhot. During summer-autumn pollen period, and the spring period in most cities (except Baotou and Cangzhou), average daily patient visits were significantly higher than those in non-pollen periods. A strong correlation was observed between daily AR patient visits and the 3-day moving average of pollen concentrations in both the spring and summer-autumn periods across all cities. Based on the correlation, a pollen concentration grading standard of northern China was established. The accuracy evaluation of pollen concentration prediction model showed that the percentage of forecasts with either completely accurate or within one level difference exceeded 91% in spring and 95% in summer-autumn. The most important predictive variable in the model was the pollen level from previous day, followed by the temperature and humidity.Conclusion:The grading prediction model for pollen concentration provides guidance for AR patients in term of travel, early defense and treatment, as well as the determining medication schedules for clinical drug research and specific immunotherapy.
10.Plasma proteomics study to predict cardiovascular and renal outcomes in individuals with metabolic syndrome
Yansong ZHAO ; Weiming GONG ; Lujia SHEN ; Shukang WANG ; Zhongshang YUAN
Chinese Journal of Endocrinology and Metabolism 2025;41(5):394-400
Objective:To identify circulating proteins associated with cardiovascular, renal, and cardiorenal comorbidity events in individuals with metabolic syndrome, to construct a predictive model incorporating these proteins to improve prediction accuracy and to investigate their mediating effects on the interplay between cardiovascular and renal diseases.Methods:Data from the UK Biobank cohort were utilized. Cox proportional hazards models were applied to identify circulating proteins associated with various outcomes, followed by time-truncated sensitivity analyses. A predictive model incorporating protein scores was then developed using the LightGBM algorithm and compared with other models. Gene Ontology(GO) functional enrichment analysis was performed to explore the biological pathways of the identified proteins. Finally, mediation effect analysis was conducted to assess the role of circulating proteins in cardiorenal interactions. Results:The Cox analysis identified 180, 275, and 322 circulating proteins associated with cardiovascular events, renal events, and cardiorenal comorbidity events, respectively. Incorporating protein scores significantly improved model performance; the areas under the curve(AUC) for cardiovascular, renal, and cardiorenal events were 0.833, 0.907, and 0.890, respectively. GO functional enrichment analysis demonstrated significant enrichment in pathways such as cytokine activity(GO: 0005125), glycosaminoglycan binding(GO: 0005539), and humoral immune response(GO: 0006959) among all outcome-related proteins. Notably, EDA2R, GDF15, and WFDC2 exhibited significant mediating effects, each with mediation proportions exceeding 10%. Conclusions:A predictive model incorporating circulating protein scores can substantially improve prediction accuracy for cardiovascular and renal outcomes in individuls with metabolic syndrome.

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