1.Consideration of Health Economics Evidence in Clinical Practice Guidelines: Methods and Steps
Dongrui PENG ; Qi ZHOU ; Xufei LUO ; Zijun WANG ; Hui LIU ; Junxian ZHAO ; Jinghong HUANG ; Hongyu HU ; Xin XING ; Jing WU ; Shitong XIE ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(3):862-870
Health economics evidence plays an important role in linking clinical value evidence with health resource allocation decisions in the development of clinical practice guidelines. It can not only effectively balance clinical effectiveness and economic feasibility but also avoid forming "idealized" recommendations that are detached from the affordability of the healthcare system or the burden-bearing capacity of patients. To promote guideline developers to use health economics evidence more standardizedly and fully, this paper conducts an in-depth analysis of the current application status, existing challenges, access channels, and application processes of health economics evidence in current guidelines, and on this basis, puts forward considerations and suggestions for strengthening and standardizing the application of health economics evidence in China's clinical practice guidelines.
2.Associations of systemic immune-inflammation index and systemic inflammation response index with maternal gestational diabetes mellitus: Evidence from a prospective birth cohort study.
Shuanghua XIE ; Enjie ZHANG ; Shen GAO ; Shaofei SU ; Jianhui LIU ; Yue ZHANG ; Yingyi LUAN ; Kaikun HUANG ; Minhui HU ; Xueran WANG ; Hao XING ; Ruixia LIU ; Wentao YUE ; Chenghong YIN
Chinese Medical Journal 2025;138(6):729-737
BACKGROUND:
The role of inflammation in the development of gestational diabetes mellitus (GDM) has recently become a focus of research. The systemic immune-inflammation index (SII) and systemic inflammation response index (SIRI), novel indices, reflect the body's chronic immune-inflammatory state. This study aimed to investigate the associations between the SII or SIRI and GDM.
METHODS:
A prospective birth cohort study was conducted at Beijing Obstetrics and Gynecology Hospital from February 2018 to December 2020, recruiting participants in their first trimester of pregnancy. Baseline SII and SIRI values were derived from routine clinical blood results, calculated as follows: SII = neutrophil (Neut) count × platelet (PLT) count/lymphocyte (Lymph) count, SIRI = Neut count × monocyte (Mono) count/Lymph count, with participants being grouped by quartiles of their SII or SIRI values. Participants were followed up for GDM with a 75-g, 2-h oral glucose tolerance test (OGTT) at 24-28 weeks of gestation using the glucose thresholds of the International Association of Diabetes and Pregnancy Study Groups (IADPSG). Logistic regression was used to analyze the odds ratios (ORs) (95% confidence intervals [CIs]) for the the associations between SII, SIRI, and the risk of GDM.
RESULTS:
Among the 28,124 women included in the study, the average age was 31.8 ± 3.8 years, and 15.76% (4432/28,124) developed GDM. Higher SII and SIRI quartiles were correlated with increased GDM rates, with rates ranging from 12.26% (862/7031) in the lowest quartile to 20.10% (1413/7031) in the highest quartile for the SII ( Ptrend <0.001) and 11.92-19.31% for the SIRI ( Ptrend <0.001). The ORs (95% CIs) of the second, third, and fourth SII quartiles were 1.09 (0.98-1.21), 1.21 (1.09-1.34), and 1.39 (1.26-1.54), respectively. The SIRI findings paralleled the SII outcomes. For the second through fourth quartiles, the ORs (95% CIs) were 1.24 (1.12-1.38), 1.41 (1.27-1.57), and 1.64 (1.48-1.82), respectively. These associations were maintained in subgroup and sensitivity analyses.
CONCLUSION
The SII and SIRI are potential independent risk factors contributing to the onset of GDM.
Humans
;
Female
;
Pregnancy
;
Diabetes, Gestational/immunology*
;
Prospective Studies
;
Adult
;
Inflammation/immunology*
;
Glucose Tolerance Test
;
Birth Cohort
3.Strategies for overcoming enrollment challenges of patients in control group in randomized controlled trials of traditional Chinese medicine.
Tian-Tian ZHOU ; Jia-Xin ZUO ; Hong WANG ; Xing LIAO ; Jing HU
China Journal of Chinese Materia Medica 2025;50(7):1980-1986
Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
Humans
;
Medicine, Chinese Traditional/methods*
;
Randomized Controlled Trials as Topic/methods*
;
Research Design
;
Patient Selection
;
Drugs, Chinese Herbal/therapeutic use*
;
Control Groups
4.Identification and biomimetic synthesis of iphionanes and cyperanes from Artemisia hedinii and their anti-hepatic fibrosis activity.
Xiaofei LIU ; Xing WANG ; Chunping TANG ; Changqiang KE ; Bintao HU ; Sheng YAO ; Yang YE
Chinese Journal of Natural Medicines (English Ed.) 2025;23(7):871-880
Two novel skeleton sesquiterpenoids (1 and 6), along with four new iphionane-type sesquiterpenes (2-5) and six new cyperane-type sesquiterpenes (7-11), were isolated from the whole plant of Artemisia hedinii (A. hedinii). The two novel skeleton compounds (1 and 6) were derived from the decarbonization of iphionane and cyperane-type sesquiterpenes, respectively. Their structures were elucidated through a comprehensive analysis of spectroscopic data, including high-resolution electrospray ionization mass spectrometry (HR-ESI-MS) and 1D and 2D nuclear magnetic resonance (NMR) spectra. The absolute configurations were determined using electronic circular dichroism (ECD) spectra, single-crystal X-ray crystallographic analyses, time-dependent density functional theory (TDDFT) ECD calculation, density functional theory (DFT) NMR calculations, and biomimetic syntheses. The biomimetic syntheses of the two novel skeletons (1 and 6) were inspired by potential biogenetic pathways, utilizing a predominant eudesmane-type sesquiterpene (A) in A. hedinii as the substrate. All compounds were evaluated in LX-2 cells for their anti-hepatic fibrosis activity. Compounds 2, 8, and 10 exhibited significant activity in downregulating the expression of α-smooth muscle actin (α-SMA), a protein involved in hepatic fibrosis.
Artemisia/chemistry*
;
Sesquiterpenes/chemical synthesis*
;
Molecular Structure
;
Humans
;
Liver Cirrhosis/genetics*
;
Biomimetics
;
Plant Extracts/pharmacology*
5.Spatio-Temporal Pattern and Socio-economic Influencing Factors of Tuberculosis Incidence in Guangdong Province: A Bayesian Spatiotemporal Analysis.
Hui Zhong WU ; Xing LI ; Jia Wen WANG ; Rong Hua JIAN ; Jian Xiong HU ; Yi Jun HU ; Yi Ting XU ; Jianpeng XIAO ; Ai Qiong JIN ; Liang CHEN
Biomedical and Environmental Sciences 2025;38(7):819-828
OBJECTIVE:
To investigate the spatiotemporal patterns and socioeconomic factors influencing the incidence of tuberculosis (TB) in the Guangdong Province between 2010 and 2019.
METHOD:
Spatial and temporal variations in TB incidence were mapped using heat maps and hierarchical clustering. Socioenvironmental influencing factors were evaluated using a Bayesian spatiotemporal conditional autoregressive (ST-CAR) model.
RESULTS:
Annual incidence of TB in Guangdong decreased from 91.85/100,000 in 2010 to 53.06/100,000 in 2019. Spatial hotspots were found in northeastern Guangdong, particularly in Heyuan, Shanwei, and Shantou, while Shenzhen, Dongguan, and Foshan had the lowest rates in the Pearl River Delta. The ST-CAR model showed that the TB risk was lower with higher per capita Gross Domestic Product (GDP) [Relative Risk ( RR), 0.91; 95% Confidence Interval ( CI): 0.86-0.98], more the ratio of licensed physicians and physician ( RR, 0.94; 95% CI: 0.90-0.98), and higher per capita public expenditure ( RR, 0.94; 95% CI: 0.90-0.97), with a marginal effect of population density ( RR, 0.86; 95% CI: 0.86-1.00).
CONCLUSION
The incidence of TB in Guangdong varies spatially and temporally. Areas with poor economic conditions and insufficient healthcare resources are at an increased risk of TB infection. Strategies focusing on equitable health resource distribution and economic development are the key to TB control.
Humans
;
China/epidemiology*
;
Incidence
;
Bayes Theorem
;
Spatio-Temporal Analysis
;
Tuberculosis/epidemiology*
;
Socioeconomic Factors
6.Association between Serum Chloride Levels and Prognosis in Patients with Hepatic Coma in the Intensive Care Unit.
Shu Xing WEI ; Xi Ya WANG ; Yuan DU ; Ying CHEN ; Jin Long WANG ; Yue HU ; Wen Qing JI ; Xing Yan ZHU ; Xue MEI ; Da ZHANG
Biomedical and Environmental Sciences 2025;38(10):1255-1269
OBJECTIVE:
To explore the relationship between serum chloride levels and prognosis in patients with hepatic coma in the intensive care unit (ICU).
METHODS:
We analyzed 545 patients with hepatic coma in the ICU from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. Associations between serum chloride levels and 28-day and 1-year mortality rates were assessed using restricted cubic splines (RCSs), Kaplan-Meier (KM) curves, and Cox regression. Subgroup analyses, external validation, and mechanistic studies were also performed.
RESULTS:
A total of 545 patients were included in the study. RCS analysis revealed a U-shaped association between serum chloride levels and mortality in patients with hepatic coma. The KM curves indicated lower survival rates among patients with low chloride levels (< 103 mmol/L). Low chloride levels were independently linked to increased 28-day and 1-year all-cause mortality rates. In the multivariate models, the hazard ratio ( HR) for 28-day mortality in the low-chloride group was 1.424 (95% confidence interval [ CI]: 1.041-1.949), while the adjusted hazard ratio for 1-year mortality was 1.313 (95% CI: 1.026-1.679). Subgroup analyses and external validation supported these findings. Cytological experiments suggested that low chloride levels may activate the phosphorylation of the NF-κB signaling pathway, promote the expression of pro-inflammatory cytokines, and reduce neuronal cell viability.
CONCLUSION
Low serum chloride levels are independently associated with increased mortality in patients with hepatic coma.
Humans
;
Male
;
Female
;
Middle Aged
;
Intensive Care Units
;
Prognosis
;
Chlorides/blood*
;
Aged
;
Coma/blood*
;
Adult
7.Effect of Modified Zhigancao Granules (炙甘草汤加味颗粒) on Early Recurrence Following Radiofrequency Ablation in Patients with Atrial Fibrillation of Qi-Yin Deficiency Syndrome:A Randomized,Double-Blind,Placebo-Controlled Trial
Yucai HU ; Boyong QIU ; Jingjing WEI ; Bin LI ; Zuoying XING ; Huixia PENG ; Mingjun ZHU ; Yongxia WANG
Journal of Traditional Chinese Medicine 2025;66(23):2460-2466
ObjectiveTo evaluate the clinical effectiveness and safety of Modified Zhigancao Granules (炙甘草汤加味颗粒) for preventing the early recurrence following radiofrequency ablation in patients with atrial fibrillation (AF) of qi-yin deficiency syndrome. MethodsA multi-center, randomized, double-blind, placebo-controlled trial was designed. A total of 116 patients with atrial fibrillation of qi-yin deficiency syndrome who underwent radiofrequency ablation for the first time were enrolled from 3 centers, and they were randomly divided into a treatment group (59 cases) and a control group (57 cases). Both groups received basic western medicine treatment after surgery. In addition, the treatment group was given oral Modified Zhigancao Granules, while the control group was given oral placebo granules. The dosage for both groups was 20 g each time, twice a day, with continuous treatment for 12 weeks. The recurrence of atrial fibrillation in both groups was recorded at 24 hours, 4 weeks, 8 weeks, and 12 weeks after surgery. The serum levels of B-type natriuretic peptide (BNP), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), and tumor necrosis factor-α (TNF-α) were detected before treatment and 12 weeks after treatment in both groups. The scores of Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (including scores of the daily life dimension, symptom dimension, treatment worry dimension, treatment satisfaction dimension, and total score) and traditional Chinese medicine (TCM) syndrome scores were compared before treatment and at 4 weeks, 8 weeks, and 12 weeks between groups. Safety indicators such as blood routine, urine routine, liver function, and renal function were monitored before and after treatment. ResultsNine of the treatment group and seven of the control group dropped out. Finally, 50 patients in each group were included in the statistical analysis. At 24 hours, 4 weeks, 8 weeks, and 12 weeks after surgery, the recurrence rates of AF in the treatment group were 2.0% (1/50), 2.0% (1/50), 4.0% (2/50), and 10.0% (5/50), respectively; while those in the control group were 2.0% (1/50), 26.0% (13/50), 28.0% (14/50), and 34.0% (17/50), respectively. Compared with the control group at the same time points, the early recurrence rates of AF in the treatment group were significantly lower at 4 weeks, 8 weeks, and 12 weeks after surgery (P<0.01). Compared with the baseline within group, BNP, hs-CRP, IL-6, and TNF-α in the treatment group all decreased after 12 weeks of treatment (P<0.05); the difference in hs-CRP levels (before vs. after treatment) in the treatment group was higher than that in the control group (P<0.01). Compared with the baseline within group, both groups showed decreases in the total score of AFEQT Questionnaire, scores of the daily life dimension, treatment worry dimension, symptom dimension, and TCM syndrome scores at 4 weeks, 8 weeks, and 12 weeks after treatment. Meanwhile, the score of the treatment satisfaction dimension of AFEQT increased in both groups (P<0.01), and the improvements in all the above scores in the treatment group were superior to those in the control group at all time points (P<0.05 or P<0.01). All safety indicators of patients in both groups were within the normal range before treatment and at 12 weeks after treatment, and no adverse reactions or adverse events occurred in either group. ConclusionModified Zhigancao Granules can reduce the early recurrence rate following radiofrequency ablation in AF patients with qi-yin deficiency syndrome, improve clinical symptoms and quality of life, suppress inflammatory response, and show good safety.
8.The construction and application of a trauma limb salvage map in Shaanxi province.
Meng WANG ; Jian-Min LIU ; Xing-Bo DANG ; Long-Yang MA ; Gong-Liang DU ; Wei HU
Chinese Journal of Traumatology 2025;28(4):235-240
Trauma is an important cause of death in young- and middle-aged people. Trauma is comprehensive and includes many surgical specialties, and the surgical techniques of these specialties have long been mature. To reduce the mortality and disability rate of trauma patients, it is necessary to improve trauma management. Trauma has attracted attention in China and trauma treatment and care developed rapidly in recent years. To decrease traumatic mortality and disability rates, our team is committed to building an efficient trauma system in Shaanxi province and has successfully developed a trauma limb salvage map to address the high rates of amputation and disability in patients with limb injuries. This article elaborates on the construction experience of a trauma limb salvage map and its application details in Shaanxi province of China.
Humans
;
China
;
Limb Salvage/methods*
;
Wounds and Injuries/surgery*
;
Male
;
Extremities/injuries*
;
Adult
;
Amputation, Surgical
;
Middle Aged
;
Female
9.Prediction of testicular histology in azoospermia patients through deep learning-enabled two-dimensional grayscale ultrasound.
Jia-Ying HU ; Zhen-Zhe LIN ; Li DING ; Zhi-Xing ZHANG ; Wan-Ling HUANG ; Sha-Sha HUANG ; Bin LI ; Xiao-Yan XIE ; Ming-De LU ; Chun-Hua DENG ; Hao-Tian LIN ; Yong GAO ; Zhu WANG
Asian Journal of Andrology 2025;27(2):254-260
Testicular histology based on testicular biopsy is an important factor for determining appropriate testicular sperm extraction surgery and predicting sperm retrieval outcomes in patients with azoospermia. Therefore, we developed a deep learning (DL) model to establish the associations between testicular grayscale ultrasound images and testicular histology. We retrospectively included two-dimensional testicular grayscale ultrasound from patients with azoospermia (353 men with 4357 images between July 2017 and December 2021 in The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China) to develop a DL model. We obtained testicular histology during conventional testicular sperm extraction. Our DL model was trained based on ultrasound images or fusion data (ultrasound images fused with the corresponding testicular volume) to distinguish spermatozoa presence in pathology (SPP) and spermatozoa absence in pathology (SAP) and to classify maturation arrest (MA) and Sertoli cell-only syndrome (SCOS) in patients with SAP. Areas under the receiver operating characteristic curve (AUCs), accuracy, sensitivity, and specificity were used to analyze model performance. DL based on images achieved an AUC of 0.922 (95% confidence interval [CI]: 0.908-0.935), a sensitivity of 80.9%, a specificity of 84.6%, and an accuracy of 83.5% in predicting SPP (including normal spermatogenesis and hypospermatogenesis) and SAP (including MA and SCOS). In the identification of SCOS and MA, DL on fusion data yielded better diagnostic performance with an AUC of 0.979 (95% CI: 0.969-0.989), a sensitivity of 89.7%, a specificity of 97.1%, and an accuracy of 92.1%. Our study provides a noninvasive method to predict testicular histology for patients with azoospermia, which would avoid unnecessary testicular biopsy.
Humans
;
Male
;
Azoospermia/diagnostic imaging*
;
Deep Learning
;
Testis/pathology*
;
Retrospective Studies
;
Adult
;
Ultrasonography/methods*
;
Sperm Retrieval
;
Sertoli Cell-Only Syndrome/diagnostic imaging*
10.Genetic and clinical characteristics of children with RAS-mutated juvenile myelomonocytic leukemia.
Yun-Long CHEN ; Xing-Chen WANG ; Chen-Meng LIU ; Tian-Yuan HU ; Jing-Liao ZHANG ; Fang LIU ; Li ZHANG ; Xiao-Juan CHEN ; Ye GUO ; Yao ZOU ; Yu-Mei CHEN ; Ying-Chi ZHANG ; Xiao-Fan ZHU ; Wen-Yu YANG
Chinese Journal of Contemporary Pediatrics 2025;27(5):548-554
OBJECTIVES:
To investigate the genomic characteristics and prognostic factors of juvenile myelomonocytic leukemia (JMML) with RAS mutations.
METHODS:
A retrospective analysis was conducted on the clinical data of JMML children with RAS mutations treated at the Hematology Hospital of Chinese Academy of Medical Sciences, from January 2008 to November 2022.
RESULTS:
A total of 34 children were included, with 17 cases (50%) having isolated NRAS mutations, 9 cases (27%) having isolated KRAS mutations, and 8 cases (24%) having compound mutations. Compared to children with isolated NRAS mutations, those with NRAS compound mutations showed statistically significant differences in age at onset, platelet count, and fetal hemoglobin proportion (P<0.05). Cox proportional hazards regression model analysis revealed that hematopoietic stem cell transplantation (HSCT) and hepatomegaly (≥2 cm below the costal margin) were factors affecting the survival rate of JMML children with RAS mutations (P<0.05); hepatomegaly was a factor affecting survival in the non-HSCT group (P<0.05).
CONCLUSIONS
Children with NRAS compound mutations have a later onset age compared to those with isolated NRAS mutations. At initial diagnosis, children with NRAS compound mutations have poorer peripheral platelet and fetal hemoglobin levels than those with isolated NRAS mutations. Liver size at initial diagnosis is related to the prognosis of JMML children with RAS mutations. HSCT can improve the prognosis of JMML children with RAS mutations.
Humans
;
Leukemia, Myelomonocytic, Juvenile/therapy*
;
Mutation
;
Male
;
Female
;
Child, Preschool
;
Retrospective Studies
;
Child
;
Infant
;
GTP Phosphohydrolases/genetics*
;
Membrane Proteins/genetics*
;
Adolescent
;
Hematopoietic Stem Cell Transplantation
;
Proportional Hazards Models
;
Proto-Oncogene Proteins p21(ras)/genetics*
;
Prognosis

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