Objective To develop and validate a prediction model to identify high-risk individuals who are at-risk to develop acute liver injury(ALI)within 180 days in new statin users,and to support early clinical intervention.Methods Data were sourced from the Yinzhou Regional Health Information Platform,covering statin initiators aged 18 years and older from January 1,2010,to October 31,2021.The dataset was divided into a derivation cohort and a temporal validation cohort based on the time of statin initiation.Predictors were selected using LASSO regression,and the model was constructed using the extreme gradient boosting(XGBoost)algorithm combined with cost-sensitive learning.Model performance was evaluated using Brier scores,Harrell's C-index,and calibration curves.Results A total of 126,440 statin initiators were included,with 90,542 in the derivation cohort and 35,898 in the validation cohort.Within 180 days of initial statin use,412(0.33％)patients developed ALI,including 305(0.34％)in the derivation cohort and 107(0.30％)in the validation cohort.The final model incorporated 16 predictors,which included demographic characteristics,lifestyle factors,family history,medical history,statin use,and concomitant medication use.The model demonstrated excellent overall performance[Brier score=0.0043,95％CI(0.0038,0.0049)],discrimination[Harrell's C-index=0.761,95％CI(0.725,0.794)],and calibration in internal validation.In temporal validation,the model also performed well[Brier score=0.0044,95％CI(0.0036,0.0052),Harrell's C-index=0.703,95％CI(0.614,0.781)].Conclusion This study develope and validate a prediction model for ALI in statin users,providing clinicians with a reliable tool for individualized risk assessment.This model can help achieve risk stratification and reduce the occurrence of ALI.

Objective:To explore the application value of Jiedu Jiangtang Futan Decoction combined with acupuncture and moxibustion in the treatment of acute cerebral infarction patients with diabetes(qi deficiency and blood stasis type).Methods:All pa-tients with acute cerebral infarction complicated with diabetes(type of qi deficiency and blood stasis)were treated in Hongdu Tradi-tional Chinese Medicine Hospital from October 2020 to September 2022 and randomly divided into two groups,with 69 cases in each group.The control group was treated with conventional western medicine,and the observation group was treated with Jiedu Jiangtang Futan Decoction and acupuncture and moxibustion,and the efficacy was compared after two weeks of treatment.Results:Compared with before treatment,the serum levels of superoxide dismutase(SOD),vascular endothelial growth factor(VEGF)and brain-derived neurotrophic factor(BDNF)were increased in the two groups after treatment.The levels of serum matrix metalloproteinase-9(MMP-9),IL-6,fasting blood glucose(FBG),2-hour postprandial glucose(2 h PG)and glycated hemoglobin(HbA1c)were decreased.The Barthel index(BI)was increased,and the modified Rankin score(mRS)and National Institutes of Health Stroke Scale(NIHSS)were decreased(P<0.05).Compared with the control group,the levels of SOD,VEGF,BDNF and other indicators in the observation group were higher after treatment.The levels of MMP-9,IL-6,FBG,2 h PG and HbA1c were lower.BI was higher,mRS and NIHSS were lower,the difference were statistically significant(P<0.05).The total effective rate in the observation group was 94.20%(65/69),higher than 84.06%(58/69)in the control group(P<0.05).Conclusion:For patients with acute cerebral infarction complicated with diabetes(type of qi deficiency and blood stasis),the combination of Jiedu Jiangtang Futan Decoction and acupuncture and moxi-bustion treatment is helpful to promote blood supply to the brain,correct the imbalance of oxidative stress,regulate blood sugar level and improve clinical efficacy.

In the past decade, real-world data (RWD) research has undergone significant transformations due to data aggregation and processing technologies. However, there is still a lack of consensus regarding the scope of RWD applications and the value of real-world evidence (RWE). This study briefly outlined the origins of the concept of RWD study and its early research scope to promote further development in this area. We also reviewed the understanding of RWD applications and research models from the five perspectives of healthcare professionals, medical institutions, decision-making departments, cross-regional cooperation model, and the practice of the One-Health model. Finally, we systematically summarized the renewed understanding of the value of RWE while looking ahead to the challenges and future developments in this field.

Objective:To analyze the characteristics of Hashimoto thyroiditis(HT)and Graves disease(GD),two autoimmune thyroid diseases aged 10-59 in Qingdao City from 2022 to 2024,and to provide scientific basis for making targeted prevention and treatment measures.Methods:A cross-sectional study design was adopted,based on the data of the Regional Health Information Platform in Qingdao,the con-firmed cases of HT and GD from 2022 to 2024 were included,and combined with the data of the seventh population census,the three-year and annual prevalence rates of HT and GD were calculated,and the time trend of annual prevalence was analyzed by Cochran-Armitage trend test.The distribution characte-ristics of HT and GD prevalence in different age groups and regions were analyzed,and Chi-square test was used to compare the differences between the groups.Results:The total number of HT patients among women aged 10-59 in Qingdao City from 2022 to 2024 was 40 362.The proportion of HT patients in 30-34 years old was the highest(19.83％).The proportion of HT patients in Huangdao District was the highest(17.72％).The three-year prevalence of HT was 1 206.53/100 000.In 2022-2024,the annual prevalence of HT increased significantly(P＜0.001),from 385.32/100 000 in 2022 to 1 206.32/100 000 in 2024.The three-year prevalence of HT was significantly different in age distribution(P＜0.001).The three-year prevalence of HT in 25-29 years(2 354.44/100 000)and 35-39 years(2 022.20/100 000)was higher than that in other age groups,showing a bimodal distribution.There were significant differences in the three-year prevalence of HT in different regions(P＜0.001),among which the three-year prevalence of HT in Shinan District was the highest(2 392.90/100 000),followed by Licang Dis-trict(1 492.41/100 000),and Laixi City was the lowest(659.940/100 000).The total number of GD patients was 2 095,among which the proportion of GD patients in the 35-39 age group was the highest(15.42％),and the proportion of GD patients from Jimo District was the highest(12.27％).From 2022 to 2024,the three-year prevalence rate of GD was 62.63/100 000,and the annual prevalence rate of GD showed an increasing trend(P＜0.001),from 20.33/100 000 in 2022 to 62.63/100 000 in 2024.There were significant differences in the prevalence of GD by age(P＜0.001).The three-year prevalence of GD reached the highest value in the 25-29 age group(98.90/100 000),followed by the 35-39 age group(85.21/100 000),and the lowest in the 10-14 age group(14.43/100 000).In the regional distribution,there were significant differences in the 3-year prevalence of GD(P＜0.001).Laoshan District had the highest three-year prevalence of GD(107.58/100 000),followed by Shinan District(97.83/100 000)and Huangdao District(28.92/100 000).Conclusion:The three-year pre-valence of HT and GD in females aged 10-59 years in Qingdao City from 2022 to 2024 is low,but the annual prevalence is on the rise,and the three-year prevalence of HT and GD in females aged 25-39 years is higher than that in other age groups,so it is necessary to strengthen the screening and monitoring of this population.

A 61-year-old patient was admitted in November 2024 with the chief complaint of “marked enlargement of uterine myoma for 2 months after menopause”. This patient was diagnosed with uterine myoma 8 years ago and underwent modified radical mastectomy for right breast cancer in April 2023. Postoperative pathology revealed invasive carcinoma (SBR grade Ⅲ). Upon admission, examination results showed a cystic-solid mass in the posterior wall of the uterus and an elevated CA153 level of 273 U/mL. Transabdominal total hysterectomy and bilateral adnexectomy were performed. HE staining postoperatively indicated uterine myoma with involvement of invasive lobular carcinoma. Immunohistochemistry showed positivity for pan-cytokeratin (CKpan, ＋), GATA3 (＋), desmin (muscle＋), and estrogen receptor (ER, 90%＋ ＋ ＋), confirming the diagnosis of breast cancer metastasis to the uterine myometrium. CDK4/6 inhibitor, anastrozole, and zoledronic acid were used after surgery. Metastasis of invasive lobular carcinoma to the uterine myometrium is rare. Rapid enlargement of uterine myoma in breast cancer patients should alert clinicians to consider the possibility of metastasis, which must be confirmed by pathological examination.

In the past decade, real-world data (RWD) research has undergone significant transformations due to data aggregation and processing technologies. However, there is still a lack of consensus regarding the scope of RWD applications and the value of real-world evidence (RWE). This study briefly outlined the origins of the concept of RWD study and its early research scope to promote further development in this area. We also reviewed the understanding of RWD applications and research models from the five perspectives of healthcare professionals, medical institutions, decision-making departments, cross-regional cooperation model, and the practice of the One-Health model. Finally, we systematically summarized the renewed understanding of the value of RWE while looking ahead to the challenges and future developments in this field.

Objective:To analyze the characteristics of Hashimoto thyroiditis(HT)and Graves disease(GD),two autoimmune thyroid diseases aged 10-59 in Qingdao City from 2022 to 2024,and to provide scientific basis for making targeted prevention and treatment measures.Methods:A cross-sectional study design was adopted,based on the data of the Regional Health Information Platform in Qingdao,the con-firmed cases of HT and GD from 2022 to 2024 were included,and combined with the data of the seventh population census,the three-year and annual prevalence rates of HT and GD were calculated,and the time trend of annual prevalence was analyzed by Cochran-Armitage trend test.The distribution characte-ristics of HT and GD prevalence in different age groups and regions were analyzed,and Chi-square test was used to compare the differences between the groups.Results:The total number of HT patients among women aged 10-59 in Qingdao City from 2022 to 2024 was 40 362.The proportion of HT patients in 30-34 years old was the highest(19.83％).The proportion of HT patients in Huangdao District was the highest(17.72％).The three-year prevalence of HT was 1 206.53/100 000.In 2022-2024,the annual prevalence of HT increased significantly(P＜0.001),from 385.32/100 000 in 2022 to 1 206.32/100 000 in 2024.The three-year prevalence of HT was significantly different in age distribution(P＜0.001).The three-year prevalence of HT in 25-29 years(2 354.44/100 000)and 35-39 years(2 022.20/100 000)was higher than that in other age groups,showing a bimodal distribution.There were significant differences in the three-year prevalence of HT in different regions(P＜0.001),among which the three-year prevalence of HT in Shinan District was the highest(2 392.90/100 000),followed by Licang Dis-trict(1 492.41/100 000),and Laixi City was the lowest(659.940/100 000).The total number of GD patients was 2 095,among which the proportion of GD patients in the 35-39 age group was the highest(15.42％),and the proportion of GD patients from Jimo District was the highest(12.27％).From 2022 to 2024,the three-year prevalence rate of GD was 62.63/100 000,and the annual prevalence rate of GD showed an increasing trend(P＜0.001),from 20.33/100 000 in 2022 to 62.63/100 000 in 2024.There were significant differences in the prevalence of GD by age(P＜0.001).The three-year prevalence of GD reached the highest value in the 25-29 age group(98.90/100 000),followed by the 35-39 age group(85.21/100 000),and the lowest in the 10-14 age group(14.43/100 000).In the regional distribution,there were significant differences in the 3-year prevalence of GD(P＜0.001).Laoshan District had the highest three-year prevalence of GD(107.58/100 000),followed by Shinan District(97.83/100 000)and Huangdao District(28.92/100 000).Conclusion:The three-year pre-valence of HT and GD in females aged 10-59 years in Qingdao City from 2022 to 2024 is low,but the annual prevalence is on the rise,and the three-year prevalence of HT and GD in females aged 25-39 years is higher than that in other age groups,so it is necessary to strengthen the screening and monitoring of this population.

Objective To develop and validate a prediction model to identify high-risk individuals who are at-risk to develop acute liver injury(ALI)within 180 days in new statin users,and to support early clinical intervention.Methods Data were sourced from the Yinzhou Regional Health Information Platform,covering statin initiators aged 18 years and older from January 1,2010,to October 31,2021.The dataset was divided into a derivation cohort and a temporal validation cohort based on the time of statin initiation.Predictors were selected using LASSO regression,and the model was constructed using the extreme gradient boosting(XGBoost)algorithm combined with cost-sensitive learning.Model performance was evaluated using Brier scores,Harrell's C-index,and calibration curves.Results A total of 126,440 statin initiators were included,with 90,542 in the derivation cohort and 35,898 in the validation cohort.Within 180 days of initial statin use,412(0.33％)patients developed ALI,including 305(0.34％)in the derivation cohort and 107(0.30％)in the validation cohort.The final model incorporated 16 predictors,which included demographic characteristics,lifestyle factors,family history,medical history,statin use,and concomitant medication use.The model demonstrated excellent overall performance[Brier score=0.0043,95％CI(0.0038,0.0049)],discrimination[Harrell's C-index=0.761,95％CI(0.725,0.794)],and calibration in internal validation.In temporal validation,the model also performed well[Brier score=0.0044,95％CI(0.0036,0.0052),Harrell's C-index=0.703,95％CI(0.614,0.781)].Conclusion This study develope and validate a prediction model for ALI in statin users,providing clinicians with a reliable tool for individualized risk assessment.This model can help achieve risk stratification and reduce the occurrence of ALI.

Objective:To explore the application value of Jiedu Jiangtang Futan Decoction combined with acupuncture and moxibustion in the treatment of acute cerebral infarction patients with diabetes(qi deficiency and blood stasis type).Methods:All pa-tients with acute cerebral infarction complicated with diabetes(type of qi deficiency and blood stasis)were treated in Hongdu Tradi-tional Chinese Medicine Hospital from October 2020 to September 2022 and randomly divided into two groups,with 69 cases in each group.The control group was treated with conventional western medicine,and the observation group was treated with Jiedu Jiangtang Futan Decoction and acupuncture and moxibustion,and the efficacy was compared after two weeks of treatment.Results:Compared with before treatment,the serum levels of superoxide dismutase(SOD),vascular endothelial growth factor(VEGF)and brain-derived neurotrophic factor(BDNF)were increased in the two groups after treatment.The levels of serum matrix metalloproteinase-9(MMP-9),IL-6,fasting blood glucose(FBG),2-hour postprandial glucose(2 h PG)and glycated hemoglobin(HbA1c)were decreased.The Barthel index(BI)was increased,and the modified Rankin score(mRS)and National Institutes of Health Stroke Scale(NIHSS)were decreased(P<0.05).Compared with the control group,the levels of SOD,VEGF,BDNF and other indicators in the observation group were higher after treatment.The levels of MMP-9,IL-6,FBG,2 h PG and HbA1c were lower.BI was higher,mRS and NIHSS were lower,the difference were statistically significant(P<0.05).The total effective rate in the observation group was 94.20%(65/69),higher than 84.06%(58/69)in the control group(P<0.05).Conclusion:For patients with acute cerebral infarction complicated with diabetes(type of qi deficiency and blood stasis),the combination of Jiedu Jiangtang Futan Decoction and acupuncture and moxi-bustion treatment is helpful to promote blood supply to the brain,correct the imbalance of oxidative stress,regulate blood sugar level and improve clinical efficacy.

Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.