Objective:To review the Minimal Clinically Important Difference(MCID)of EQ-5D-3L calculated by anchor-based method,evaluate the reliability of existing MCID,and provide reference thresholds for the interpretation of clinical research results.Methods:CNKI,PubMed,Embase and others were searched from inception to June 30,2023.The nonparametric tests were used to analyze the impact of statistical methods and sample size on MCID.Results:A total of 51 studies were eventually included.Studies were primarily prospective in design,32 studies focused on musculoskeletal disorders,37 studies used a single anchor,45 studies adopted patient-perspective anchor,and the Receiver Operating Characteristic(ROC)curve was the main statistical analysis method.A total of 160 MCID were obtained from 51 studies,ranging from 0.003 to 0.540,and only 3 MCID from 2 studies were rated as"high reliability"across all core items of the evaluation instrument.It is found that statistical analysis methods,sample size,and measurement time interval all significantly affect MCID.Conclusion:The disease type in EQ-5D-3L MCID studies were not abundant and unbalanced,and the heterogeneity of MCID measured in the included studies was high.The reliability evaluation results showed that the existing MCID has poor reliability in all items except the first and second items of the evaluation instrument.

Objective:To explore differences in the clinical and pathological features and postoperative survival after radical resection of biliary tract cancer in different locations such as intrahepatic cholangiocarcinoma,perihilar cholangiocarcinoma,distal cholangiocarcinoma,and gallbladder cancer.Methods:This is a retrospective case series study. The clinical and pathological data of 4 852 patients with biliary tract cancer admitted to the Department of Hepatobiliary Surgery,the First Affiliated Hospital of Xi ′an Jiaotong University from January 2013 to December 2022 were retrospectively analyzed. Among them, 2 110(43.49%%) patients were male and 2 742(56.51%) patients were female,aged from 26 to 88 years with age of (61.3±10.8) years. Observation indicators: (1) The distribution,diagnosis and treatment of patients with biliary tract cancer; (2) Comparison of clinical and pathological features of patients with biliary tract cancer after curative-intent resection; (3) Survival analysis of patients with biliary tract cancer after curative-intent resection; (4) Analysis of effect on adjuvant therapy for patients with biliary tract cancer after curative-intent resection. One-way analysis of variance,Kruskal-Wallis H test and χ 2 test were used for among-group comparisons,respectively. Survival univariate analysis was performed using the Kaplan-Meier method and Log-rank test. Results:Among the 4 852 patients with biliary tract cancer,there were 2 303 cases (47.46%) of gallbladder cancer,952 cases (19.62%) of intrahepatic cholangiocarcinoma,892 cases (18.38%) of perihilar cholangiocarcinoma,and 705 cases(14.53%) of distal cholangiocarcinoma. From the perspective of the year of diagnosis and treatment,the overall number of patients diagnosed and treated for biliary tract cancer has shown an upward trend. From the perspective of diagnosis and treatment,the curative-intent resection rate was 33.37%(1 619/4 852),and the curative-intent resection rate of distal cholangiocarcinoma was higher than that of other biliary tract cancer ( χ2=23.897, P<0.01). Univariate analysis showed that there were statistical differences in gender,age,bile duct stones,total bilirubin at admission,carcinoembryonic antigen,CA19-9,CA125,the degree of pathological differentiation,vascular invasion,microvascular invasion,perineural invasion,surgical margins,pT staging,and pN staging among patients for biliary tract cancer in different locations (all P<0.05). Survival comparison analysis showed that recurrence-free survival and overall survival of patients with gallbladder cancer after curative-intent resection were significantly better than those of intrahepatic cholangiocarcinoma,perihilar cholangiocarcinoma,and distal cholangiocarcinoma ( χ 2=87.780,83.717,both P<0.01). Comparing the postoperative prognosis of patients with biliary tract cancer between the two periods of 2013 to 2017 and 2018 to 2022, the results showed that recurrence-free survival and overall survival of patients with biliary tract cancer from 2018 to 2022 were significantly better than those from 2013 to 2017 ( χ 2=31.202,25.615, both P<0.01),and the proportion of early recurrence and short-term death after curative-intent resection was significantly reduced ( χ 2=21.588,9.623, both P<0.01),with gallbladder cancer being the most significant ( P<0.01). Postoperative adjuvant therapy for patients with biliary tract cancer can effectively prolong recurrence-free survival and overall survival ( χ 2=5.033,11.273,both P<0.05). Conclusions:Gallbladder cancer remains the most common biliary tract cancer with a relatively favorable prognosis after radical resection. There are significant differences in the clinical and pathological features of biliary tract cancer in different locations,and patients with adjuvant therapy effectively improving prognosis.

Objective:To evaluate the long-term outcomes and predictors of coronary atherosclerotic lesions deemed functionally non-ischemic (quantitative flow ratio(QFR)>0.80) and deferred from intervention.Methods:This study is a post-hoc analysis of the FAVOR Ⅲ China trial, which enrolled 3 825 patients with stable or unstable angina pectoris or with myocardial infarction occurring at least 72 hours prior to screening, between December 5, 2018 and January 9, 2020 from 26 research centers in China. Coronary vessels with QFR>0.80 and without interventional treatment were analyzed in this study. The primary endpoint was 3-year target vessel revascularization. Vessels with revascularization (revascularized group) during follow-up were matched 1∶1 using propensity score matching to comparable vessels without revascularization (non-revascularized group). Multivariate Cox regression analysis was used to identify the risk factors for target vessel revascularization (TVR).Results:A total of 6 212 functionally negative vessels with deferred intervention were included in the final analysis, among which 153 vessels (2.5%) underwent TVR during a 3-year follow-up. Prior to propensity score matching, 6 059 vessels comprised the non-revascularized group. At the vessel level, compared to the non-revascularized group, the revascularized group exhibited a significantly higher proportion of males (79.1% (121/153) vs. 70.2% (4 253/6 059), P=0.018), higher body mass index ((25.6±4.0) kg/m2 vs. (24.3±5.2) kg/m2, P=0.003), and a higher prevalence of hypertension (73.9% (113/153) vs. 65.1% (3 944/6 059), P=0.025). And 152 pairs of vessels were successfully matched. Multivariate Cox regression analysis identified in-stent restenosis lesions ( HR=2.59, 95% CI 1.28-5.23, P=0.008) as an independent risk factor for target vessel revascularization. Conclusions:Coronary lesions classified as functionally non-ischemic at baseline are not entirely stable and may progress to lesions that requiring revascularization over time. In-stent restenosis emerges as a critical independent predictor of revascularization.

Objective:Investigate the impact of calcification on the long-term outcomes of patients with coronary chronic total occlusion (CTO) after percutaneous coronary intervention (PCI).Methods:A retrospective cohort study was conducted. Patients who underwent PCI and had at least one CTO lesion at Fuwai Hospital between January 2010 and December 2013 were consecutively enrolled. Calcification was evaluated by coronary angiography, and patients were divided into two groups: moderate/severe calcification group and non/mild calcification group. Clinical follow-up was completed up to 5 years. Incidence of PCI-related complications and immediate procedural outcomes were compared between two groups, and the primary endpoint was the target lesion failure (TLF) at 5 years after PCI. Clinical follow-up endpoint events were analyzed using Kaplan-Meier survival analysis with log-rank test, and Cox multivariate regression model was used to evaluate the relationship between calcification and TLF.Results:The study included 2 659 CTO patients with an age of (57.2±10.5) years, of whom 442 (16.6%) were female, and among whom 13.5% (360/2 659) had moderate/severe calcification. Compared with the non/mild calcification group, the moderate/severe calcification group had a higher incidence of PCI-related complications (43.2% (156/361) vs. 32.5% (772/2 374), P<0.001) and procedural failure (34.3% (124/361) vs. 24.3% (577/2 374), P<0.001). Additionally, the moderate/severe calcification group showed a higher risk of the primary endpoint event (TLF) during the 5-year follow-up (19.8% vs. 15.3%, log-rank P=0.028). Higher incidence of cardiac death was observed in moderate/severe calcification group (5.7% vs. 2.7%, log-rank P=0.003). Cox multivariate regression analysis revealed that moderate/severe calcified plaques remained an independent risk factor for 5-year TLF after CTO-PCI ( HR=1.34, 95% CI: 1.01-1.79, P=0.043). Conclusion:Compared with CTO patients with non/mild calcification, those with moderate/severe calcification have higher procedural failure and complication rates, as well as poorer long-term prognosis, mainly due to an increase in cardiac death.

Objective To evaluate the cost-effectiveness of toripalimab plus axitinib compared to sunitinib in the first-line treatment of advanced renal cell carcinoma patients.Methods Based on the RENOTORCH trial,constructed a partitioned survival model to evaluate the long-term costs and health outcomes of toripalimab plus axitiniband sunitinib in the first-line treatment of advanced renal cell carcinoma(RCC)patients from the Chinese healthcare system perspective.The cycle length of the model was 3weeks,simulating the total cost,quality adjusted life years(QALYs),and incremental cost-effectiveness ratio(ICUR)for patients over 25 years.The costs were derived from the average bidding price of Yaozhi database in 2023 and published literature.The health state utility values were derived from clinical trials.The discount rate was 5%,and the willingness to pay(WTP)threshold was 3 times the per capita gross domestic product(GDP)in 2022.One-way and probability sensitivity analyses were used to test the robustness of the model.Results Based on the progression free survival(PFS)evaluated by the Independent Review Committee(IRC)and Investigator(IA),the ICUR values were 239 436.39 yuan/QALY and 175 440.39 yuan/QALY,respectively,both lower than the WTP threshold.One-way sensitivity analysis showed that the health state utility values of PFS status and the price of axitinib had a significant impact on the model.Probability sensitivity analysis showed that the probability of toripalimab plus axitinib being cost-effective was 63.64%and 98.03%according to the IRC and IA assessments,respectively.Conclusion Toripalimab plus axitinib was cost-effective in the first-line treatment of advanced RCC patients.

Objective:To investigate the efficacy of cytoreductive radical prostatectomy (CRP) in patients with oligometastatic prostate cancer, and to assess its impact on progression-free survival (PFS), overall survival (OS), as well as the incidence and severity of complications.Methods:A prospective, monocentric non-randomized controlled trial including 80 cases of oligometastatic prostate cancer admitted to the Second Affiliated Hospital of Air Force Military Medical University from January 2020 to June 2024 was conducted. There were 40 patients each assigned to CRP group and no local treatment (NLT) group. The study used multivariate analysis to account for potential biases, analyzed the effects of CRP on PFS, OS as well as circulating tumor cell (CTC) and DNA methylation status. Meanwhile, the incidence and severity of complications were recorded. Measurement data were expressed as mean ± standard deviation ( ± s), and t-test was used for inter-group comparison. Count data and rank data were expressed as number of cases and percentage, and Chi-test was used for comparison between groups. Kaplan-Meier method was used to calculate PFS and OS, and Log-rank test was used to compare differences between groups. Multivariate analysis was performed using Cox proportional hazard regression model. A time-dependent Cox regression model was used to consider the effect of follow-up time on the results. Results:The PFS and OS in the CRP group were significantly better than those in the NLT group. The PFS rates in CRP group and NLT group at 12 months were 60% and 35% ( P=0.030). The OS rates at 12 months in the CRP group reached 80%, compared to 50% in the NLT group ( P=0.040). The level of CTC in the CRP group decreased from 50 cells/mL at first month to 5 cells/mL at 12th month, and the DNA methylation status decreased from 0.75 at first month to 0.30 at 12th month, which were significantly better than those in the NLT group ( P<0.05). The incidence of complications decreased gradually from first month to 12th month, with the CRP group from 30% to 10%, and the NLT group from 25% to 12% ( P=0.080). Although the severity of complications was slightly higher in the CRP group than in the NLT group at the early stage, the difference in severity gradually narrowed and eventually became similar between the two groups by the 12th month of follow-up. Conclusion:CRP significantly prolonged PFS and OS in patients with oligometastatic prostate cancer, reduced tumor burden, and despite a higher incidence of early complications, overall safety was good.

Objective: To investigate the timing of puberty onset among primary school students, so as to provide the reference data for early identification of children with suspected precocious puberty. Methods: A study was conducted from October 23 to November 7, 2023, involving 10 225 students(5 412 boys, 4 813 girls) from grade 1 to 6 of four campuses in Meiling Primary School in Yangzhou. Breast development in girls and external genitalia in boys was assessed via visual inspection and palpation, with pubertal stages classified using the Tanner staging method. Puberty onset timing was determined based on age/sex reference values from Chinese Han children s pubertal milestone indicators. Descriptive analysis was performed using SPSS 26.0. Results: The median age for testicular volume reaching 4 mL in boys was 10.49 years, while the median age for breast development onset in girls was 9.70 years. Among boys with testicular volume ≥4 mL, 16.6%( n =217) were identified as suspected early puberty cases; among girls with Tanner stage Ⅱ and Ⅲ, 123(9.4%) and 165(18.5%) showed earlier breast development than the reference range. Overall, 14.4% of students exhibited suspected precocious puberty. Conclusion The onset age of puberty for girls in primary schools of Yangzhou aligns with findings from other regions, while boys show earlier pubertal initiation.

Oroxylin A (OA), a natural compound extracted from Scutellaria baicalensis, demonstrates preventive potential against ultraviolet B (UVB)-induced non-melanoma skin cancer (NMSC), the most prevalent cancer worldwide with increasing incidence. Utilizing SKH-1 hairless mice exposed to UVB, this study showed that OA delayed NMSC onset and alleviated acute skin damage. Mechanistic investigations revealed its dual action: inhibiting inflammation and enhancing nucleotide excision repair (NER) by stabilizing XPA, a crucial deoxyribonucleic acid (DNA) repair protein. This stabilization occurred through OA's interaction with glucose-regulated protein 94 (GRP94), which disrupted murine double minute 2 (MDM2)-mediated XPA ubiquitination and proteasomal degradation. By maintaining XPA levels, OA expedited photoproduct clearance and diminished genomic instability, ultimately impeding NMSC development. These findings suggest OA as a promising chemopreventive agent targeting the GRP94/MDM2-XPA axis to counteract UVB-induced carcinogenesis.
Animals ; Ultraviolet Rays/adverse effects* ; Skin Neoplasms/prevention & control* ; Flavonoids/pharmacology* ; Mice ; Xeroderma Pigmentosum Group A Protein/genetics* ; Humans ; Proto-Oncogene Proteins c-mdm2/genetics* ; DNA Repair/drug effects* ; Scutellaria baicalensis/chemistry* ; Mice, Hairless ; Skin/radiation effects*

BACKGROUND: The FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach for estimating fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. This study aimed to assess the cost-effectiveness of QFR-guided PCI from the perspective of the current Chinese healthcare system. METHODS: This study is a pre-specified analysis of the FAVOR III China trial, which included 3825 patients randomized between December 25, 2018, and January 19, 2020, from 26 centers in China. Patients with stable or unstable angina pectoris or those ≥72 hours post-myocardial infarction who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment were randomized to a QFR-guided strategy or an angiography-guided strategy with 1:1 ratio. During the two-year follow-up, data were collected on clinical outcomes, quality-adjusted life-years (QALYs), estimated costs of index procedure hospitalization, outpatient cardiovascular medication use, and rehospitalization due to major adverse cardiac and cerebrovascular events (MACCE). The primary analysis calculated the incremental cost-effectiveness ratio (ICER) as the cost per MACCE avoided. An ICER of ¥10,000/MACCE event avoided was considered economically attractive in China. RESULTS: At two years, the QFR-guided group demonstrated a reduced rate of MACCE compared to the angiography-guided group (10.8% vs . 14.7%, P <0.01). Total two-year costs were similar between the groups (¥50,803 ± 21,121 vs . ¥50,685 ± 23,495, P = 0.87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability of QFR being economically attractive was 64% at a willingness-to-pay threshold of ¥10,000/MACCE avoided. Sensitivity analysis showed that QFR-guided PCI would become cost-saving if the cost of QFR were below ¥3682 (current cost: ¥3800). Cost-utility analysis yielded an ICER of ¥56,163 per QALY gained, with a 53% probability of being cost-effective at a willingness-to-pay threshold of ¥85,000 per QALY gained. CONCLUSION: In patients undergoing PCI, a QFR-guided strategy appears economically attractive compared to angiographic guidance from the perspective of the Chinese healthcare system. TRIAL REGISTRATION ClinicalTrials.gov , NCT03656848.
Humans ; Cost-Benefit Analysis ; Percutaneous Coronary Intervention/methods* ; Male ; Female ; Coronary Angiography/methods* ; Middle Aged ; Aged ; Coronary Artery Disease/surgery* ; Quality-Adjusted Life Years ; Fractional Flow Reserve, Myocardial/physiology*

Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires