Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.

OBJECTIVE To assess the cost-effectiveness of durvalumab combined with chemotherapy as a first-line treatment for advanced biliary tract cancer from the perspective of the Chinese healthcare system. METHODS Using data from the TOPAZ-1 clinical trial， a three-state Markov model comprising progression-free survival （PFS）， progressive disease （PD） and death was developed， with a cycle length of 21 days and a 10-year time horizon. Patients in the observation group received durvalumab in combination with gemcitabine and cisplatin， whereas those in the control group received placebo plus the same chemotherapy regimen. The evaluation indexes were quality-adjusted life year （QALY） and the incremental cost-effectiveness ratio （ICER）. The willingness-to-pay （WTP） threshold was set at three times the 2024 Chinese per capita gross domestic product （GDP） （287 247 yuan/QALY）. The sensitivity analyses， along with scenario analyses， were performed. RESULTS In the base-case analysis， the ICER of observation group compared to control group was 1 166 344.46 yuan/QALY， far exceeding the WTP threshold， indicating that the regimen was not cost-effective. One-way sensitivity analysis identified the PD state utility， discount rate， cost of durvalumab， and PFS state utility as the main drivers of ICER variation. Probabilistic sensitivity analysis showed that， at the above WTP threshold， the probability of the acceeptance of this regimen was 0， further supporting the robustness of the base-case findings. In the scenario analysis， inclusion of a patient assistance program reduced the ICER to 235 885.16 yuan/ QALY， below the above WTP threshold， suggesting cost-effectiveness under this assistance program. However， when applying a regional WTP threshold set at three times the per capita GDP （158 475 yuan/QALY） of Gansu Province （the province with the lowest GDP in China in 2024）， the ICER remained above the threshold， indicating that the regimen was not cost-effective at the regional level. CONCLUSIONS At current pricing， durvalumab plus chemotherapy as a first-line treatment for advanced biliary tract cancer is not cost-effective in China. Although the introduction of a patient assistance program can substantially reduce the ICER and achieve cost-effectiveness at a WTP threshold set at three times the 2024 per capita GDP of China， due to limited affordability in low-income areas， the program remains not cost-effective.

Objective To compare the efficacy and safety of different cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer. Methods Randomized controlled trials (RCTs) on CDK4/6i for the treatment of HR+/HER2− metastatic or advanced breast cancer were retrieved from databases including PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, Wanfang, VIP, and SinoMed, with the search period ranging from database inception to August 2023. Bayesian network meta-analysis was conducted using R 4.2.0 software. Results A total of 18 RCTs from 25 articles, involving 8 031 patients and 11 treatment regimens, were included. There was no significant difference in progression-free survival (PFS) or overall survival (OS) among different CDK4/6i+ET combinations. The highest cumulative probability for PFS was observed with dalpiciclib (DAL)+fulvestrant (FUL), while ribociclib (RIB)+FUL ranked first for OS. In terms of efficacy, abemaciclib (ABE)+aromatase inhibitors (AI) and ABE+FUL ranked first in objective response rate and clinical benefit rate, respectively. Regarding safety, statistically significant difference in grade 3-4 adverse events was observed among certain types of CDK4/6i (P<0.05). Conclusion Current evidence suggests that CDK4/6i+ET is superior to ET alone for the treatment of HR+/HER2− advanced/metastatic breast cancer. Different CDK4/6i+ET combinations demonstrate comparable or similar efficacy; however, the incidence of adverse reactions is higher with combination therapy. Treatment regimens should be selected based on individual conditions.

The paper introduces the experience of Professor LI Rui in treatment of diseases with bloodletting therapy. Regarding acupoint selection, the main acupoints are selected from the meridians containing excessive blood based on the identification of pathogenesis, and the back-shu points of the foot-taiyang bladder meridian are predominant. The acupoints (e.g. Geshu [BL17], Xuehai [SP10] and Weizhong [BL40]) acting on blood regulations are frequently selected, and the acupoints from the governor vessel (e.g. Dazhui [GV14], Zhiyang [GV9] and Yaoyangguan [GV3]) are specially used for regulating yang qi. Besides, the five-shu points and local points are combined in the prescriptions. This paper expounds the connotation of bloodletting therapy, explores the basis of acupoint selection and clinical application characteristics, and analyzes the clinical cases, so as to provide the approaches to acupoint selection for the clinical application of bloodletting therapy.
Humans ; Acupuncture Points ; Acupuncture Therapy ; Bloodletting ; Meridians

BACKGROUND: Without timely and effective rehabilitation, hearing loss may profoundly affect human life quality. China has a large population of hearing-impaired individuals, which imposes a heavy health burden on society. Moreover, this population is projected to increase rapidly owing to China's aging society. METHODS: We used data from a population-representative epidemiological investigation of hearing loss and ear diseases in four Chinese provinces. We estimated the national prevalence using multiple linear regression of the age-group proportions and prevalence in 31 provinces with clustering analysis. We used years lived with disability (YLDs) to analyze the disease burden and forecasted the prevalence of hearing loss by 2060 in China. RESULTS: An estimated 115 million people had moderate-to-complete hearing loss in 2015 across the 31 provinces of China (8.4% of 1.37 billion people). Of these, 85.7% were older than age 50 years (99 million people) and 2.4% were younger than 20 years old (2.8 million people). Of all YLDs attributable to hearing loss, 68.9% were attributable to moderate-to-complete cases. By 2060, a projected 242 million people in China will have moderate-to-complete hearing loss, a 110.0% increase from 2015. CONCLUSIONS The hearing loss prevalence in China is high. Population aging and socioeconomic factors substantially affect the prevalence and severity of hearing loss and the disease burden. The prevalence and severity of hearing loss are unevenly distributed across different provinces. Future public health policies should take these trends and regional variations into account.
Humans ; China/epidemiology* ; Hearing Loss/epidemiology* ; Prevalence ; Middle Aged ; Male ; Female ; Adult ; Aged ; Adolescent ; Young Adult ; Child ; Child, Preschool ; Infant ; Aged, 80 and over ; Cost of Illness

Chronic heart failure （CHF） represents the terminal stage of cardiovascular diseases， and its prevalence remains high in China. In this study， existing animal models of CHF were retrieved and categorized. In combination with the characteristics of CHF from traditional Chinese medicine （TCM） and Western medicine perspectives， the models were weighted， and their clinical consistency was evaluated. The advantages and disadvantages of the models were assessed. Among them， models with higher TCM clinical consistency included the doxorubicin-induced model， the isoproterenol-induced model， and the left anterior descending coronary artery ligation model， each with a TCM consistency rate of 90%. The animal model established by the left anterior descending coronary artery ligation showed a high degree of clinical consistency with Western medicine， with a consistency rate of 82%. Each model exhibited its own advantages and disadvantages， with a general lack of modeling methods combining diseases and syndromes of TCM and Western medicine. At present， the inducement factors used for animal models are relatively singular， mainly reflecting the etiology and pathogenesis of Western medicine， with insufficient correlation to the pathogenesis of TCM. The characteristics of TCM syndromes are not fully represented， and the consistency between TCM and Western medicine is generally not high. TCM has the advantage of a multi-dimensional syndrome differentiation and treatment approach. It is necessary to integrate the characteristics of diseases and syndromes of TCM and Western medicine， adopt multi-factor modeling methods to reflect the pathological process of CHF， improve existing models， and establish animal models of CHF that better align with the characteristics of clinical diseases and syndromes of TCM and Western medicine， so as to provide a reliable reference for clinical prevention and treatment.

Chronic heart failure （CHF） represents the terminal stage of cardiovascular diseases， and its prevalence remains high in China. In this study， existing animal models of CHF were retrieved and categorized. In combination with the characteristics of CHF from traditional Chinese medicine （TCM） and Western medicine perspectives， the models were weighted， and their clinical consistency was evaluated. The advantages and disadvantages of the models were assessed. Among them， models with higher TCM clinical consistency included the doxorubicin-induced model， the isoproterenol-induced model， and the left anterior descending coronary artery ligation model， each with a TCM consistency rate of 90%. The animal model established by the left anterior descending coronary artery ligation showed a high degree of clinical consistency with Western medicine， with a consistency rate of 82%. Each model exhibited its own advantages and disadvantages， with a general lack of modeling methods combining diseases and syndromes of TCM and Western medicine. At present， the inducement factors used for animal models are relatively singular， mainly reflecting the etiology and pathogenesis of Western medicine， with insufficient correlation to the pathogenesis of TCM. The characteristics of TCM syndromes are not fully represented， and the consistency between TCM and Western medicine is generally not high. TCM has the advantage of a multi-dimensional syndrome differentiation and treatment approach. It is necessary to integrate the characteristics of diseases and syndromes of TCM and Western medicine， adopt multi-factor modeling methods to reflect the pathological process of CHF， improve existing models， and establish animal models of CHF that better align with the characteristics of clinical diseases and syndromes of TCM and Western medicine， so as to provide a reliable reference for clinical prevention and treatment.

Objective To explore the impact of urban and rural resident basic medical insurance(URRBMI)integration policy on the health and health inequality of middle-aged and elderly people,and to provide an evidence-based basis for further improving the URRBMI system.Methods Based on data from the China health and retirement longitudinal study(CHARLS)from 2013 to 2018,the impact of the URRBMI integration policy on the self-rated health,disability,and depression of middle-aged and elderly people was investigated using the staggered differences-in-differences method.The health inequality status of middle-aged and elderly people and its change trend were analyzed by the concentration index,and the index was decomposed according to different years and different integration modes to explore the impact of URRBMI on health inequality of middle-aged and elderly people.Results A study was conducted on 7589 middle-aged and elderly individuals,which found that the URRBMI integration policy had a significant positive impact on the self-rated health of this population(OR=1.309,P<0.001).Additionally,the policy had a significant negative impact on the occurrence of depression(OR=0.696,P<0.001).However,it was found to increase the disability score of middle-aged and elderly individuals(β=0.354,P<0.001)and did not improve their disability status.In addition,health disparity exists among middle-aged and elderly people in China,and middle-aged and elderly people with health problems are mainly concentrated in groups with lower socioeconomic status,and health disparity has been increasing over time.Health insurance for urban and rural residents has a certain effect on alleviating health inequality,the contribution rate of disability inequality and depression inequality decreased from 1.21%and 1.20%in 2013 to-0.58%and 0.31%in 2018,respectively,and compared with the one-tier model,the split-tier system has a greater negative impact on the health status of low-income groups.Conclusion The URRBMI integration policy improved the self-rated health and depression status of middle-aged and elderly people,but had a limited effect on improving the disability status.The policy can reduce the health inequality of middle-aged and elderly people to some extent,but the health inequality varies widely within the population.It is recommended to strengthen the top-level design of URRBMI,to shift from a strategy that emphasizes medicine over prevention to one that emphasizes prevention and combines prevention and treatment,and to shift from formal equity based on the elimination of household boundaries to substantive equity based on the elimination of reimbursement policies and other barriers.

Objective To systematically evaluate and synthesize the experience and coping process of bowel symptoms in patients after sphincter-preserving surgery for rectal cancer,and to provide the evidence for the subsequent development of bowel symptom management strategies.Methods A comprehensive search was conducted across the Pubmed,Cochrane Library,CINAHL,Embase,Web of Science,CNKI,Wanfang Database,VIP Database and CBM Database for qualitative studies on the experience of bowel symptoms in post-sphincter-preserving surgery patients with rectal cancer.The search period was from database inception to October 2024.The quality of the included literature was assessed according to the Australian Joanna Briggs Institute Center for Evidence-Based Health Care Quality Assessment Criteria for Qualitative Research,and the results were synthesized through the aggregative integration method.Results 14 studies were included,yielding 52 research findings,which were grouped into 10 subcategories and further synthesized into 4 results:the physical and psychological experiences of patients with bowel symptoms;the impact of bowel symptoms on patients'daily lives;coping styles for bowel symptoms in patients;facilitators of patients bowel symptom coping.Conclusion Bowel symptoms have significant negative impacts on the lives of patients following sphincter-preserving surgery for rectal cancer,and healthcare professionals should address these patients'needs by developing effective symptom management strategies and supporting patients in enhancing self-management abilities to improve quality of life.