1.Mechanisms of Bushen Tongluo Jiangzhuo Prescription in Improving Renal Fibrosis in Rats with Chronic Kidney Disease Based on PI3K/Akt/mTOR Signaling Pathway
Xincui BAO ; Baosheng ZHAO ; Lingling QIN ; Haiyan WANG ; Jing YANG ; You WANG ; Lijia WU ; Yujin LI ; Ming GAO ; Cuiyan LYU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):100-108
ObjectiveTo investigate the mechanisms by which Bushen Tongluo Jiangzhuo prescription improves renal fibrosis in rats with chronic kidney disease (CKD) through the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway. MethodsSeventy specific pathogen-free (SPF) Sprague-Dawley (SD) rats were randomly divided into a control group (n=15) and a modeling group (n=55). Rats in the modeling group were administered a 2.5% adenine suspension at a dose of 200 mg·kg-1·d-1 by gavage for 4 weeks to establish a CKD model. Successfully modeled rats were randomly divided into a model group, an irbesartan group (20.25 mg·kg-1·d-1), and Bushen Tongluo Jiangzhuo prescription low-, medium-, and high-dose groups (5.82, 11.64, and 23.28 g·kg-1·d-1, respectively), with 10 rats in each group. Each group was administered an equal volume of physiological saline, the corresponding concentration of irbesartan, or Bushen Tongluo Jiangzhuo prescription by gavage for 12 weeks. Body weight and renal function indices were dynamically monitored. Serum creatinine (SCr), blood urea nitrogen (BUN), urine albumin-to-creatinine ratio (ACR), 24-hour urinary total protein (24 hUTP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) levels were measured using an automatic biochemical analyzer. Renal histopathological changes were observed by hematoxylin-eosin (HE) and Masson staining. Immunohistochemistry (IHC) was used to detect the expression of PI3K, Akt, phosphorylated Akt (p-Akt), and mTOR in renal tissues. Western blot was performed to assess the protein expression of PI3K, p-Akt, Akt, phosphorylated mTOR (p-mTOR), and mTOR in renal tissues. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to determine the mRNA expression levels of PI3K, Akt, and mTOR in renal tissues. ResultsCompared with the model group, rats in the irbesartan group and the low-, medium-, and high-dose Bushen Tongluo Jiangzhuo prescription groups showed significantly decreased levels of SCr, BUN, ACR, 24 hUTP, IL-1β, IL-6, and TNF-α (P<0.01). AST levels were significantly increased (P<0.01), while no significant difference was observed in ALT levels. Histopathological examination revealed that, compared with the model group, renal tubular epithelial cell edema and necrosis and Bowman's capsule dilation were alleviated, inflammatory cell infiltration was reduced, and interstitial and glomerular fibrosis was markedly improved in all treatment groups, with the most pronounced effect observed in the high-dose Bushen Tongluo Jiangzhuo prescription group. Real-time PCR results showed that mRNA expression levels of PI3K, Akt, and mTOR were significantly downregulated in the high-dose group (P<0.01). IHC results demonstrated that PI3K and p-Akt expression levels in renal tissues were significantly decreased in the high-dose group (P<0.01). Western blot analysis further confirmed that the expression levels of PI3K, p-Akt/Akt, and p-mTOR/mTOR were significantly reduced in the high-dose group (P<0.01). ConclusionBushen Tongluo Jiangzhuo prescription improves renal function indices in CKD rats, reduces collagen deposition in renal tissues, and decreases serum inflammatory factor levels. Its protective effect on renal function may be achieved by activating autophagy through downregulation of the PI3K/Akt/mTOR signaling pathway, thereby alleviating renal fibrosis.
2.Analysis of Risk Factors and Establishment of Prediction Model for Turbidity Toxicity Accumulation Syndrome in Patients with Chronic Atrophic Gastritis
Yican WANG ; Chenggong ZHAO ; Pengli DU ; Jie WANG ; Yuxi GUO ; Haiyan BAI ; Yongli HUO ; Xiaomeng LANG ; Zheng ZHI ; Bolin LI ; Jianping LIU ; Yanru CAI ; Jianming JIANG ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):288-295
ObjectiveThis paper aims to explore the risk factors for chronic atrophic gastritis (CAG) with turbidity toxin accumulation syndrome and establish a prediction model. MethodsClinical data of 180 patients with CAG who participated in the "clinical study of Xianglian Huazhuo Particles blocking CAG cancer transformation" of Hebei Sheng Zhong Yi Yuan from July 2021 to March 2022 were collected. After confounding factors were controlled by propensity score matching, patients were divided into a training set (namely dev) and a validation set (namely vad) in a seven to three ratio. The risk factors for CAG with turbidity toxin accumulation syndrome in the training set were investigated by using univariate Logistic regression analysis and least absolute shrinkage and selection operator (namely Lasso) regression algorithms. Subsequently, a model, named model 1se, was developed by using the training set data to predict the risk factors for CAG with turbidity toxin accumulation syndrome. The accuracy of the prediction model was assessed by using various methods, including the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test (H-L), calibration plot, and decision curve analysis (DCA). ResultsAge, body mass index (BMI), family history of cancer, job and life satisfaction, yellow and greasy fur with slippery pulse, and heavy body sensation were independent risk factors of the model. The prediction model showed excellent predictive value for both the training and validation sets. ConclusionThe established prediction model for CAG with turbidity toxin accumulation syndrome has high discrimination and excellent calibration, which could provide an excellent clinical basis for disease diagnosis and individualized treatment of patients.
3.Analysis of Risk Factors and Establishment of Prediction Model for Turbidity Toxicity Accumulation Syndrome in Patients with Chronic Atrophic Gastritis
Yican WANG ; Chenggong ZHAO ; Pengli DU ; Jie WANG ; Yuxi GUO ; Haiyan BAI ; Yongli HUO ; Xiaomeng LANG ; Zheng ZHI ; Bolin LI ; Jianping LIU ; Yanru CAI ; Jianming JIANG ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):288-295
ObjectiveThis paper aims to explore the risk factors for chronic atrophic gastritis (CAG) with turbidity toxin accumulation syndrome and establish a prediction model. MethodsClinical data of 180 patients with CAG who participated in the "clinical study of Xianglian Huazhuo Particles blocking CAG cancer transformation" of Hebei Sheng Zhong Yi Yuan from July 2021 to March 2022 were collected. After confounding factors were controlled by propensity score matching, patients were divided into a training set (namely dev) and a validation set (namely vad) in a seven to three ratio. The risk factors for CAG with turbidity toxin accumulation syndrome in the training set were investigated by using univariate Logistic regression analysis and least absolute shrinkage and selection operator (namely Lasso) regression algorithms. Subsequently, a model, named model 1se, was developed by using the training set data to predict the risk factors for CAG with turbidity toxin accumulation syndrome. The accuracy of the prediction model was assessed by using various methods, including the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test (H-L), calibration plot, and decision curve analysis (DCA). ResultsAge, body mass index (BMI), family history of cancer, job and life satisfaction, yellow and greasy fur with slippery pulse, and heavy body sensation were independent risk factors of the model. The prediction model showed excellent predictive value for both the training and validation sets. ConclusionThe established prediction model for CAG with turbidity toxin accumulation syndrome has high discrimination and excellent calibration, which could provide an excellent clinical basis for disease diagnosis and individualized treatment of patients.
4.Mechanism of Bushen Kaixuan Tongluo Prescription in Improving Diabetic Nephropathy Based on cAMP Signaling Pathway
Miao XU ; Baosheng ZHAO ; You WANG ; Yuzhuo CHANG ; Zehao LIU ; Lingling QIN ; Haiyan WANG ; Ming GAO ; Cuiyan LYU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):87-96
ObjectiveTo investigate the molecular mechanism by which the Bushen Kaixuan Tongluo prescription exerts a renal protective effect in mice with diabetic kidney disease (DKD) by regulating the cyclic adenosine monophosphate (cAMP) signaling pathway. MethodsThirty specific pathogen-free (SPF) male db/db mice were adaptively fed for three weeks. Mice with a random tail vein blood glucose level ≥ 11.1 mmol·L-1 and urinary albumin-creatinine ratio (ACR) ≥ 30 mg·g-1 were considered successfully modeled. The successfully modeled mice were randomly divided into five groups with six mice in each group: the model group, the low-, medium-, and high-dose Bushen Kaixuan Tongluo prescription groups (administered at doses of 7, 14, 28 g·kg-1·d-1 respectively), and the positive drug irbesartan group (administered at a dose of 20 mg·kg-1·d-1). Additionally, six db/m mice were selected as the blank group. Mice in each group were given intragastric administration of the Bushen Kaixuan Tongluo prescription at the corresponding concentrations, irbesartan, or an equal volume of pure water, and the intervention lasted for 12 weeks. During the experiment, the general conditions, body weight changes, and renal function indicators of the mice were dynamically monitored. After the intervention, a blood glucose meter was used to measure the fasting blood glucose (FBG) of the mice. An automatic biochemical analyzer was employed to detect the levels of serum creatinine (SCr), blood urea nitrogen (BUN), urinary microalbumin (uALB), ACR, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), triglycerides (TG), leptin (LEP), glycosylated serum protein (GSP), and insulin (INS) in the mice. Renal tissues were collected for hematoxylin-eosin (HE) staining, periodic acid-Schiff (PAS) staining, and Masson's trichrome staining to observe the histopathological changes. Immunohistochemistry (IHC) was used to detect the expressions of protein kinase A (PKA) and cAMP response element-binding protein (CREB) in the mice. Western blot analysis was performed to determine the expression levels of PKA, phosphorylated protein kinase A (p-PKA), CREB, phosphorylated cAMP response element-binding protein (p-CREB), and B-cell lymphoma-2 (Bcl-2) proteins in the renal tissues of the mice. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression levels of PKA, CREB, and Bcl-2 in the renal tissues of the mice. ResultsCompared with the blank group, the mice in the model group showed listlessness, decreased activity, and a significant increase in body weight (P<0.01). Biochemical indicators revealed that the levels of BUN, uALB, ACR, AST, ALT, TC, TG, FBG, LEP, GSP, and INS were significantly increased (P<0.01), while SCr showed an increasing trend with no statistically significant difference. Compared with the model group, the mice in the Bushen Kaixuan Tongluo prescription intervention groups had improved general conditions and a decreasing trend in body weight. Biochemical indicators showed that the levels of BUN, uALB, ACR, TC, GSP, and INS were significantly decreased (P<0.05), while SCr, AST, ALT, TG, and LEP showed a decreasing trend with no statistically significant difference. Renal histopathological analysis showed that the model group exhibited typical DKD pathological features such as thickening of the glomerular basement membrane, expansion of the mesangial matrix, and deposition of collagen fibers in the renal tubulointerstitium, and all treatment groups could alleviate the above pathological damages. The IHC results showed that compared with the blank group, the expression levels of p-PKA and p-CREB in the renal tissues of the model group were significantly decreased (P<0.01). Compared with the model group, the expression level of p-PKA in the medium-dose Bushen Kaixuan Tongluo prescription group was significantly increased (P<0.01), while the expression level of p-CREB showed an increasing trend with no statistically significant difference. Western blot results showed that compared with the blank group, the expression levels of p-PKA/PKA, p-CREB/CREB, and Bcl-2 in the model group were significantly decreased (P<0.05). Compared with the model group, the expression levels of these proteins in the medium-dose Bushen Kaixuan Tongluo prescription group were significantly increased (P<0.01). Real-time PCR results showed that compared with the blank group, the mRNA expressions of PKA, CREB, and Bcl-2 in the model group were significantly down-regulated (P<0.05). Compared with the model group, the mRNA expressions of these genes in the medium-dose Bushen Kaixuan Tongluo prescription group were significantly up-regulated (P<0.05). ConclusionThe Bushen Kaixuan Tongluo prescription can improve the liver and kidney functions of db/db mice, correct lipid metabolism disorders and glucose metabolism imbalance. Its renal protective effect is associated with up-regulating the cAMP signaling pathway to improve renal fibrosis and reduce the level of oxidative stress, thereby protecting renal function.
5.The predictive value of Naples prognostic score and prognostic nutritional index for postoperative recurrence and survival in endometrial cancer patients
Yajuan SHA ; Yingyan ZHAO ; Haiyan LI
Tianjin Medical Journal 2025;53(6):634-639
Objective To investigate the impact of Naples prognostic score(NPS)and prognostic nutritional index(PNI)on postoperative recurrence and survival in patients with endometrial cancer(EC).Methods A total of 258 EC patients were selected for surgical treatment.Clinical data such as the patients' age at admission,pathological grade,depth of myometrial invasion,lymphovascular space invasion(LVSI),lymph node metastasis and clinical stage of the International Society of Gynecological Oncology(FIGO)were collected.One week before the operation,the laboratory indicators were detected in patients,and NPS and PNI were calculated.The patients were followed up and divided into the recurrence group(n=72)and the non-recurrence group(n=186)according to whether there was recurrence after the operation.The recurrence curves were plotted using Kaplan-Meier method,and the Log-rank test was used to compare the differences in recurrence curves between patients with different NPS and PNI.The Cox proportional hazards regression model was used to analyze the influencing factors of postoperative recurrence in patients with EC.The receiver operating characteristic(ROC)curve was used to evaluate the predictive efficacy of PNI and NPS scores for postoperative recurrence in patients with EC.Results The proportion of patients with high-risk NPS scores was significantly higher in the recurrence group than that in the non-recurrence group(41.7%vs.19.4%,P<0.05).The PNI was significantly lower in the recurrence group than that in the non-recurrence group(42.1±7.6 vs.47.2±8.9,P<0.01).Multivariate Cox regression analysis showed that advanced age,elevated serum carbohydrate antigen 125(CA125),pathological grades G2 and G3,myometrial invasion depth>1/2,positive LVSI,FIGO stage Ⅲ-Ⅳ and medium-high risk patients with NPS score were independent risk factors for recurrence.Postoperative radiotherapy and chemotherapy and elevated PNI were independent protective factors for recurrence in patients.ROC curve analysis showed that the combined predictive value of NPS score and PNI for postoperative recurrence in patients with EC was superior to that of individual predictions.Conclusion Both NPS and PNI can be used as potential indicators to predict the prognosis of patients with endometrial cancer.
6.The association between urinary levels of arsenic, selenium, and chromium in populations with past endemic arsenic exposure and the risk of diabetes mellitus and predisposing factorsns
Aiyun YAN ; Haiyan ZHANG ; Yu CAI ; Ya TU ; Pujun WANG ; Wenbo ZHAO
Chinese Journal of Endemiology 2025;44(11):872-876
Objective:To investigate the association between urinary arsenic, selenium, and chromium levels and the risk and predisposing factors of diabetes mellitus in people with previous endemic arsenic exposure.Methods:From September to December 2024, 240 residents in the drinking-water-borne endemic arsenic disease area in Hohhot were taken as the study subjects. They were divided into an exposed group ( n = 91) and a non-exposed group ( n = 149) based on whether they had suffered from arsenism in the past. The exposed group was further divided into diabetes and non diabetes subgroups ( n = 54, 37) based on the prevalence of diabetes, and the diabetes subgroup was further divided into type 1 and type 2 diabetes subgroups ( n = 23, 31) based on the type of diabetes. Questionnaire survey was conducted to investigate the basic situation, measure fasting blood glucose, and determine the levels of arsenic, selenium, and chromium in urine by inductively coupled plasma mass spectrometry. Multivariate logistic regression analysis was used to assess the risk factors of diabetes mellitus. Results:The difference of prevalence of diabetes mellitus was statistically significant between the exposed group and non-exposed group [59.3% (54/91) vs. 41.6% (62/149), χ2 = 7.11, P = 0.008]. The levels of urinary arsenic, selenium, and chromium in the exposed group were higher than those in the non-exposed group ( t = - 2.00, - 2.14, - 2.18, P < 0.05). There were statistically significant differences in urinary arsenic level, body mass index (BMI), the distribution of age, smoking status, and gender between the diabetes patients and non-diabetes patients in the exposed group ( t = 2.20, 3.57, χ2 = 10.76, 5.23, 4.01, P < 0.05). The difference of urinary arsenic levels were statistically significant between patients with type 1 diabetes and type 2 diabetes in the exposed group ( t = - 2.06, P = 0.048). Multivariate logistic regression analysis showed that BMI, age, sex, smoking, and urinary arsenic levels were risk factors for diabetes ( P < 0.05). For every 1-unit increase in urinary arsenic, fasting blood glucose levels increased by 0.057 times (95% CI: 0.018 - 0.103, P = 0.029). Conclusions:There is a significant correlation between the urine arsenic level of people with previous endemic arsenic exposure and diabetes, especially type 2 diabetes. Men, smoking, overweight, age ≥65 years, and high urinary arsenic level are risk factors for diabetes.
7.Clinical efficacy of laparoscopic left hemi-fundoplication for gastroesophageal reflux disease
Weixue ZHANG ; Guolei LI ; Hao FENG ; Yuan LIU ; Lihui JIA ; Haiyan BAI ; Wei XING ; Zhao XU
Chinese Journal of Digestive Surgery 2025;24(10):1333-1337
Objective:To explore the clinical efficacy of laparoscopic left hemi-fundoplica-tion for gastroesophageal reflux disease (GERD).Method:The retrospective and descriptive study was conducted. The clinical data of 45 patients with GERD who were admitted to Hebei Provincial Hospital of Traditional Chinese Medicine from July 2019 to July 2022 were collected. There were 26 males and 19 females, aged (46±12) years. All patients underwent laparoscopic left hemi-fundoplication. Observation indicators: (1) intraoperative and postoperative conditions; (2) follow-up. Measurement data with normal distribution were expressed as Mean± SD. Count data were expressed as absolute numbers. The paired samples t-test was used for comparison of indicators before and after surgery. Result:(1) Intraoperative and postoperative conditions. All 45 patients successfully underwent the operation, with no conversion to open surgery or intraoperative complications. The operation time was (86±8)minutes, volume of intraoperative blood loss was (12±3)mL, and time to postoperative first flatus was (2.2±0.8)days. Among the 45 patients after surgery, 4 cases had fever, 3 cases had retrosternal dull pain and discomfort, 4 cases had dysphagia, 3 cases had abdominal distension, and 5 cases had constipation. All these symptoms were cured or relieved spontaneously after sympto-matic treatment. The duration of postoperative hospital stay was (3.5±0.5)days. There was no patient with infection, delayed bleeding or perforation.(2) Follow-up. All 45 patients were followed up for 1 year after surgery, with no recurrence of GERD. Gastroscopy showed no esophageal mucosal damage such as erosion or ulcer, and no hiatal hernia occurred. Before surgery, the reflux symptom index score, GERD questionnaire score, reflux disease questionnaire score, lower esophageal sphincter resting pressure, and DeMeester score of 24-hour esophageal pH monitoring were 24.3±1.9, 12.5±2.1,20.1±4.5, (7.1±1.1)mmHg (1 mmHg=0.133 kPa), and 31.4±6.4, respectively. At 1 year after surgery, the above indicators were 2.2±0.7, 6.5±0.5, 4.0±2.6, (23.2±2.9)mmHg, and 6.0±1.4, respectively. There were significant differences before and after surgery ( t=80.75, 18.70,20.09, -33.45, 26.15, P<0.05). Conclusion:Laparoscopic left hemi-fundoplication is safe and feasible for GERD, which can improve the clinical symptoms of patients.
8.Surgical treatment for trichiasis caused by eyelid aging
Xifei QIAN ; Jingyi TU ; Jue HOU ; Chongxiang FAN ; Yirui PAN ; Haiyan SHEN ; Qinyuan ZHAO ; Jufang ZHANG
Chinese Journal of Plastic Surgery 2025;41(5):524-528
Senile trichiasis is primarily manifested by eyelid laxity, decreased horizontal elasticity and tension of the eyelids, leading to friction between the eyelashes and the cornea, which subsequently causes corneal damage and vision decline. Surgical intervention remains the most effective therapeutic approach for senile trichiasis. This article elaborates on the epidemiological characteristics, pathological mechanisms, and clinical manifestations of senile trichiasis and systematically reviews the surgical treatment method for upper and lower eyelid trichiasis, including traditional surgical techniques and emerging minimally invasive procedures combined with personalized therapies. Through a literature review, the effectiveness and recurrence rates of surgical treatment are summarized, emphasizing the importance of preoperative assessment and individualized treatment. Additionally, strategies and recommendations for preventing senile trichiasis are proposed.
9.Effect of remote ischemic conditioning combined with binaural beat music training in patients with cognitive dys-function after cerebral infarction
Xing XUE ; Haiyan ZHAO ; Shuling YUE ; Jie CHENG ; Qiqun TANG ; Xiaohua CHENG ; Zonghai GUO ; Pingping LIU
Chinese Journal of Rehabilitation Theory and Practice 2025;31(9):1057-1065
Objective To explore the effect of remote ischemic conditioning(RIC)combined with binaural beat music(BBM)train-ing in patients with cognitive dysfunction after cerebral infarction.Methods From June,2024 to January,2025,200 patients with cognitive dysfunction after cerebral infarction in the Affil-iated Hospital of North China University of Science and Technology were randomly divided into control group(n=50),RIC group(n=50),BBM group(n=50)and combined group(n=50).All the groups received stan-dardized routine training,RIC group received RIC,BBM group received BBM,and the combined group received RIC+BBM,for 14 days.They were assessed with Montreal Cognitive Assessment(MoCA)and Stroke-Specific Quality of Life Scale(SS-QOL)at baseline,day 14,and day 90.Results Two cases in the control group,four in RIC group,three in BBM group and three in the combined group dropped out.For MoCA scores,the inter-group effect,intra-group effect and interaction effect were all significant(F>13.463,P<0.001).After intervention,on both day 14 and day 90,the score of MoCA was higher in each in-tervention group than in the control group(P<0.05),and was higher in the combined group than in both BBM and RIC groups(P<0.05);and on day 90,it was higher in RIC group than in BBM group(P<0.05).For SS-QOL,the score increased with time in all the groups(χ2>75.182,P<0.001).After intervention,there was signif-icant difference at each time point among four groups(H>18.260,P<0.001).On day 14 and day 90,the score of SS-QOL was higher in the combined group than in the control and BBM groups(|Z|>3.149,P<0.05);on day 90,the score was higher in RIC group than in the control group(|Z|=3.590,P<0.05),and it was higher in the combined group than in RIC group(|Z|=3.186,P<0.05).Conclusion RIC,BBM and their combination all improved cognitive function after cerebral infarction.RIC was superior to BBM,and the combined intervention yielded the greatest benefit.Both RIC and the combined intervention im-proved quality of life,with the combined approach being the most effective.
10.Advances and future research prospects in regulatory policies for clin-ical trials of artificial intelligence medical devices
Hao LIANG ; Shun WANG ; Cheng CUI ; Ling SONG ; Ailin SUN ; Man LI ; Jie QIAO ; Chun-li SONG ; Haiyan LI ; Yangguang ZHAO ; Haiyan LI ; Chenguang ZHANG ; Dongyang LIU
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(3):427-431
Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Result Analysis
Print
Save
E-mail