1.Mechanisms of Sini San in Regulation of Gut Microbiota Against Depression and Liver Injury in CUMS Rats
Junling LI ; Yan ZHANG ; Lei WANG ; Fang QI ; Zhenzhen CHEN ; Tianxing CHEN ; Yuhang LIU ; Xueying WANG ; Xianwen TANG ; Yubo LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):33-40
ObjectiveTo explore the efficacy and mechanisms of Sini San in the treatment of depression and liver injury based on gut microbiota. MethodsThirty-two male Sprague-Dawley (SD) rats were randomly divided into a normal group, model group (M), Sini San group (MS, 2.5 g·kg-1), and fluoxetine group (MF, 2 mg·kg-1). Except for the normal group, rats in the other three groups were subjected to chronic unpredictable mild stress (CUMS). After 8 weeks, the open-field test and sucrose preference test were conducted. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum corticosterone (CORT), adrenocorticotropic hormone (ACTH), corticotropin-releasing factor (CRF), lipopolysaccharide (LPS), Zonulin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), γ-aminobutyric acid (GABA) levels in the hippocampus and prefrontal cortex, and brain-derived neurotrophic factor (BDNF) levels in the hippocampus. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect hippocampal BDNF mRNA expression. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were measured using the ultraviolet lactate dehydrogenase method. The ultrastructure of the intestinal epithelium was observed by electron microscopy, and gut microbiota in rat feces were analyzed using 16S rDNA high-throughput sequencing. ResultsCompared with the normal group, the sucrose preference of rats in the model group was significantly reduced (P0.01), whereas it was significantly increased in the Sini San group compared with the model group (P0.05). Compared with the normal group, hippocampal GABA protein levels and BDNF mRNA expression in the model group were significantly decreased (P0.05), and compared with the model group, both were significantly increased in the Sini San group (P0.05, P0.01). Compared with the normal group, serum LPS and Zonulin levels in the model group were significantly increased (P0.05, P0.01), and compared with the model group, Zonulin levels in the Sini San group were significantly decreased (P0.05). No obvious changes were observed in the ultrastructure of the jejunal mucosa among groups. Compared with the normal group, widened and blurred tight junctions, sparse and shortened microvilli, and mitochondrial swelling with cristae disruption in epithelial cells were observed in the ileal and colonic mucosa of the model group, which were markedly improved in the Sini San and fluoxetine groups. The results of 16S rDNA high-throughput sequencing showed that Sini San improved CUMS-induced dysbiosis of Bacteroidetes and Proteobacteria. Correlation analysis indicated that Bacteroidetes and Proteobacteria were significantly correlated with depression-related indicators, liver function, and intestinal mucosal permeability. ConclusionSini San exerts antidepressant and hepatoprotective effects by improving Bacteroidetes and Proteobacteria and inhibiting the increase in intestinal mucosal permeability in CUMS rats.
2.Mechanisms of Sini San in Regulation of Gut Microbiota Against Depression and Liver Injury in CUMS Rats
Junling LI ; Yan ZHANG ; Lei WANG ; Fang QI ; Zhenzhen CHEN ; Tianxing CHEN ; Yuhang LIU ; Xueying WANG ; Xianwen TANG ; Yubo LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):33-40
ObjectiveTo explore the efficacy and mechanisms of Sini San in the treatment of depression and liver injury based on gut microbiota. MethodsThirty-two male Sprague-Dawley (SD) rats were randomly divided into a normal group, model group (M), Sini San group (MS, 2.5 g·kg-1), and fluoxetine group (MF, 2 mg·kg-1). Except for the normal group, rats in the other three groups were subjected to chronic unpredictable mild stress (CUMS). After 8 weeks, the open-field test and sucrose preference test were conducted. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum corticosterone (CORT), adrenocorticotropic hormone (ACTH), corticotropin-releasing factor (CRF), lipopolysaccharide (LPS), Zonulin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), γ-aminobutyric acid (GABA) levels in the hippocampus and prefrontal cortex, and brain-derived neurotrophic factor (BDNF) levels in the hippocampus. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect hippocampal BDNF mRNA expression. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were measured using the ultraviolet lactate dehydrogenase method. The ultrastructure of the intestinal epithelium was observed by electron microscopy, and gut microbiota in rat feces were analyzed using 16S rDNA high-throughput sequencing. ResultsCompared with the normal group, the sucrose preference of rats in the model group was significantly reduced (P<0.01), whereas it was significantly increased in the Sini San group compared with the model group (P<0.05). Compared with the normal group, hippocampal GABA protein levels and BDNF mRNA expression in the model group were significantly decreased (P<0.05), and compared with the model group, both were significantly increased in the Sini San group (P<0.05, P<0.01). Compared with the normal group, serum LPS and Zonulin levels in the model group were significantly increased (P<0.05, P<0.01), and compared with the model group, Zonulin levels in the Sini San group were significantly decreased (P<0.05). No obvious changes were observed in the ultrastructure of the jejunal mucosa among groups. Compared with the normal group, widened and blurred tight junctions, sparse and shortened microvilli, and mitochondrial swelling with cristae disruption in epithelial cells were observed in the ileal and colonic mucosa of the model group, which were markedly improved in the Sini San and fluoxetine groups. The results of 16S rDNA high-throughput sequencing showed that Sini San improved CUMS-induced dysbiosis of Bacteroidetes and Proteobacteria. Correlation analysis indicated that Bacteroidetes and Proteobacteria were significantly correlated with depression-related indicators, liver function, and intestinal mucosal permeability. ConclusionSini San exerts antidepressant and hepatoprotective effects by improving Bacteroidetes and Proteobacteria and inhibiting the increase in intestinal mucosal permeability in CUMS rats.
3.Effect of Yangjing Tongluo Prescription on Oxidative Damage of Endometrium in Rats with Intrauterine Adhesion Based on Keap1/Nrf2/HO-1 Signaling Pathway
Jiaying CHEN ; Jing ZENG ; Zhaoling YOU ; Yonglian WANG ; Muya LIU ; Fang ZHOU ; Li TANG ; Sainan TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):100-108
ObjectiveTo explore the mechanisms of Yangjing Tongluo prescription (YJTL) in the treatment of intrauterine adhesion (IUA) from the perspective of oxidative stress mediated by the Kelch-like ECH-associated protein 1/nuclear factor erythroid 2-related factor 2/heme oxygenase-1 (Keap1/Nrf2/HO-1) signaling pathway. MethodsA total of 48 rats with normal estrous cycles were selected and randomly divided into a normal group (n=8) and a modeling group (n=40). An IUA rat model was established using a dual-injury method combining surgical curettage and infection. Eight rats were randomly selected from the modeling group for a pilot experiment to confirm successful model establishment. After successful modeling, the remaining 32 rats were randomly divided into a model group, a low-dose YJTL group (YJTL-L), a high-dose YJTL group (YJTL-H), and a Progynova group. Rats in the normal and model groups were administered purified water (15 mL·kg-1) by gavage daily, while rats in the YJTL-L, YJTL-H, and Progynova groups received YJTL at doses of 6.43 and 12.86 g·kg-1 and Progynova at 2.06 × 10-4 g·kg-1, respectively, for 14 consecutive days. The general condition, uterine morphology, and uterine index of the rats were monitored. Histopathological changes in uterine tissue were observed using hematoxylin-eosin (HE) staining. Serum levels of reactive oxygen species (ROS) and glutathione peroxidase (GSH-Px) were measured by enzyme-linked immunosorbent assay (ELISA). Protein expression levels of Keap1, Nrf2, and HO-1 in endometrial tissue were detected by Western blot. Immunofluorescence (IF) was used to assess the distribution of Nrf2 and HO-1, as well as the expression of Nrf2 in the cytoplasm and nucleus. ResultsCompared with the normal group, rats in the model group exhibited poor mental status and reduced mobility, markedly edematous and tortuous uterine morphology, decreased gland number, and inflammatory reactions in the endometrium, along with an increased uterine organ index (P<0.05). Serum ROS levels were significantly increased (P<0.05), while serum GSH-Px levels were significantly decreased (P<0.05). In endometrial tissue, Keap1 protein expression was increased (P<0.05), whereas Nrf2 and HO-1 protein expression was decreased. Mild nuclear translocation of Nrf2 was observed, accompanied by increased relative fluorescence intensity of nuclear Nrf2 and decreased relative fluorescence intensity of cytoplasmic HO-1. Compared with the model group, all treatment groups showed varying degrees of improvement in the above symptoms and pathological changes. Serum ROS levels were reduced (P<0.05), serum GSH-Px levels were increased (P<0.05), Keap1 protein expression in endometrial tissue was decreased, and Nrf2 and HO-1 protein expression was increased in a dose-dependent manner (P<0.05). Notably, significant nuclear translocation of Nrf2 was observed, with correspondingly increased relative fluorescence intensity of nuclear Nrf2 and enhanced relative fluorescence intensity of cytoplasmic HO-1. ConclusionYJTL may enhance antioxidant capacity and repair oxidative damage to the endometrial basal layer by regulating the Keap1/Nrf2/HO-1 signaling pathway.
4.Pharmacodynamic Substances and Mechanisms of Xinglou Chengqi Tang in Treating Post-stroke Complications: A Review
Yujin ZHANG ; Xiangzhuo LIU ; Zhouyang CHEN ; Zihao SONG ; Xinyi LIU ; Yizhi YAN ; Chaoya LI ; Yingyan FANG ; Shasha YANG ; Xueqin CHENG ; Zhou XIE ; Sijie TAN ; Peng ZENG ; Yue ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):327-337
Stroke is the leading cause of death and disability among adults in China, and its common complications include digestive system abnormalities, cognitive impairment, depression, stroke-associated pneumonia, and hemiplegia. The combination of traditional Chinese and Western medicine has great potential in treating post-stroke complications. Xinglou Chengqitang (XLCQT) is a representative prescription of alleviating the disease in the upper part by treating the lower part. It has definite therapeutic effect and high safety. Clinically, XLCQT is often used to treat stroke and its complications. However, the quantity and quality of clinical trials of XLCQT in treating post-stroke complications need to be improved. Additionally, since the basic research is weak, the material basis and multi-target mechanism for the efficacy of this prescription are unknown. This article reviews XLCQT in terms of the pharmacodynamic basis, medicinal properties, safety evaluation, and progress in clinical research and mechanisms in treating post-stroke complications. This article summarizes 22 key active ingredients of XLCQT in treating acute stroke complicated with syndrome of phlegm heat and fu-organ excess. Among these key active ingredients, resveratrol, kaempferol, luteolin, chrysoeriol, apigenin, (+)-catechin, and adenosine have good pharmacokinetic properties and high bioavailability. The mechanisms of XLCQT in treating post-stroke complications are complex, including inflammatory response, brain-gut axis, hypothalamic-pituitary-adrenal (HPA) axis, intestinal flora, neurotrophic factors, autophagy, oxidative stress, and free radical damage. This review helps to deeply understand the pharmacodynamic basis and mechanisms of XLCQT in treating post-stroke complications and provides a theoretical basis for the clinical application of XLCQT against post-stroke complications and the development of drugs.
5.Visual evaluation of medical humanistic care based on the concept of implementation science
Xuancheng CHEN ; Yangyi CHEN ; Huiling LI ; Mengyun PENG ; Fanli TIAN ; Xiaojun ZHOU ; Zhisong HE ; Chen FANG
Chinese Medical Ethics 2026;39(2):194-200
ObjectiveTo introduce visual teaching into the course design of medical humanistic care based on the concept of implementation science, evaluate the teaching implementation effect and feedback, and provide references for optimizing course teaching outcomes and improving students’ humanistic care competence. MethodsA visual teaching program for medical humanistic care was designed, with key steps including clarifying teaching objectives, content, methods, and curriculum assessment. This program was implemented in the medical humanistic care course teaching involving 50 elective students. Multi-dimensional evaluation of teaching effectiveness was conducted through course grades, visual teaching evaluation, and humanistic workshop assessment, combined with inductive content analysis of students’ learning experiences in the workshops. ResultsThe 50 students achieved above-average course grades (89.60±3.41) and demonstrated high satisfaction with the overall course and visual teaching. All the 6 groups obtained relatively high scores in the medical humanistic care workshops. Four themes were extracted, namely, enhancing humanistic care competencies, deepening familial and interpersonal relationships, realizing emotional expression and self-growth, and strengthening integration of humanistic care concepts with practice. ConclusionThe teaching of medical humanistic care course has achieved favorable effects, which contributes to deepening students’ understanding of humanistic care and enhancing their humanistic care competence. Students demonstrate high levels of recognition and satisfaction with the course.
6.Preliminary application of histological evaluation of donor pancreas biopsy tissue in simultaneous pancreas-kidney transplantation
Jiao WAN ; Hui GUO ; Jiali FANG ; Guanghui LI ; Luhao LIU ; Yunyi XIONG ; Wei YIN ; Tong YANG ; Junjie MA ; Zheng CHEN
Organ Transplantation 2026;17(2):250-256
Objective To preliminarily investigate the safety and efficacy of donor pancreas needle biopsy in simultaneous pancreas-kidney transplantation. Methods Clinical data of 7 cases undergoing donor pancreas biopsy were collected retrospectively. All cases underwent donor pancreas biopsy before or during simultaneous pancreas-kidney transplantation. Frozen section or paraffin sectioning techniques were used for tissue preparation, and hematoxylin-eosin and Masson staining were performed to histologically evaluate the donor pancreas. The quality of donor pancreas was comprehensively assessed by combining histological findings with the donor's clinical data. Postoperative follow-up data of 5 simultaneous pancreas-kidney transplant recipients were collected to summarize the safety of donor pancreas biopsy and the prognosis of transplant recipients. Results The 7 pancreas donors were aged 28 to 62 years, with a body mass index ranging from 20.76 to 27.68 kg/m2. Liver ultrasound indicated fatty liver in 3 cases, while pancreatic ultrasound did not reveal any significant abnormalities. Among them, biopsy was performed on 2 donors after completion of pancreatic procurement and processing, and the frozen section histology showed moderate acute pancreatitis changes (edema of acinar cells, necrosis and inflammatory cell infiltration). Combined with a serum amylase level elevated more than 3 times the upper limit of normal value, these two donor pancreases were finally discarded. The remaining 5 cases underwent biopsy immediately after pancreatic vascular anastomosis during simultaneous pancreas-kidney transplantation, and histological evaluation was performed on paraffin-embedded sections. No biopsy-related complications (such as bleeding, pancreatic fistula, etc.) occurred after transplantation. One recipient died of severe infection 2 months after transplantation, while the other 4 recipients were followed up for more than 5 years, with well-functioning transplant kidneys and pancreases. Conclusions Donor pancreas biopsy is relatively safe, and the risk of biopsy-related complications after transplantation is controllable. Comprehensive assessment of donor pancreas quality by combining histological evaluation with the donor's clinical indicators is conducive to improving the accuracy of donor pancreas selection and organ utilization.
7.Relationship between non-suicidal self-injury behaviors, impulsivity, and emotional regulation in adolescents with depressive disorder
Mingfei ZHANG ; Xinyu CHEN ; Fang LIANG ; Zhe CHEN ; Lu QIAN ; Zhijia LI
Sichuan Mental Health 2026;39(1):21-26
BackgroundAdolescents with depressive disorder often engage in non-suicidal self-injury (NSSI) behaviors, which severely impacts their physical and mental health. Impulsivity and emotional regulation are key factors influencing NSSI behaviors. However, research on the mechanisms through which impulsivity and emotional regulation affect NSSI behaviors in adolescent depressive disorder patients with NSSI remains insufficient, limiting the development of effective intervention strategies. ObjectiveTo explore the differences in impulsivity and emotion regulation abilities between adolescent patients with depressive disorder accompanied by and without NSSI behaviors, and to analyze the association between NSSI behaviors and impulsivity and emotion regulation abilities in adolescent patients with depressive disorder accompanied by NSSI behaviors. MethodsA total of 184 adolescents hospitalized in the child and adolescent psychiatry department of Wuxi Mental Health Center from October 2023 to August 2024, who met the diagnostic criteria for depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), were consecutively enrolled as study subjects. Based on the diagnostic criteria for NSSI in DSM-5, patients were divided into NSSI group (n=108) and non-NSSI group (n=76). The Barratt Impulsiveness Scale-11 (BIS-11), the Emotion Regulation Questionnaire (ERQ), the Adolescent Self-Harm Questionnaire, and the Positive and Negative Suicide Ideation (PANSI) were used for assessment. Spearman correlation analysis was employed to explore the correlation between the scores of the Adolescent Self-Harm Questionnaire and the scores of BIS-11 and ERQ in the NSSI group. Multiple regression analysis was conducted to examine the effects of impulsivity and emotion regulation on NSSI behaviors in the NSSI group. ResultsCompared to the non-NSSI group, the NSSI group showed significantly higher scores in BIS-11 non-planned impulsivity (Z=-4.181, P<0.05), action impulsivity (t=4.944, P<0.05), cognitive impulsivity (Z=-3.392, P<0.05), and total score (t=4.763, P<0.05), and lower scores in the cognitive reappraisal of ERQ (t=-4.094, P<0.05) and total score (Z=-2.299, P<0.05), and higher scores in the expression inhibition of ERQ (Z=-3.019, P<0.05). The correlation analysis results showed that the score of the adolescent self-harm questionnaire in the NSSI group was positively correlated with the behavioral impulsivity factor score in the BIS-11 (r=0.434, P<0.05). Multiple regression analysis indicated that action impulsivity factor was a significant correlate of self-injury behaviors in the NSSI group (B=0.855, P<0.05), explaining 22.30% of the total variance. ConclusionAdolescent patients with depressive disorder accompanied by NSSI behaviors exhibit higher levels of impulsivity and poorer emotional regulation abilities. Action impulsivity may play a significant role in the mechanism of NSSI behaviors. [Funded by Wuxi Municipal Health Commission Research Project (number, Q202320)]
8.Exploring the pathogenesis and treatment methods of irritable bowel syndrome from the
Yan XU ; Fang YANG ; Rongshi SHAO ; Huili SUN ; Juan LI ; Xin CHEN ; Jing HAN
Journal of Beijing University of Traditional Chinese Medicine 2026;49(1):10-15
This article adopts Professor CHEN Chaozu′s " sanjiao composed by membrane-striae" theory as its foundation to explore the relationship between irritable bowel syndrome and functional/structural abnormalities of the membrane-striae. Sanjiao encompasses both the tangible membrane and the intangible striae. These striae permeate the entire body,and their pathological changes comprehensively reflect qi,body fluids,and fasciae. Based on the physiological function of the membrane-striae in regulating qi and fluids,the pathogenesis of irritable bowel syndrome is characterized by a disharmony of membrane-striae and an imbalance of the qi-fluid interactions. In the early stage,external pathogens,emotional factors,or dietary stimuli often cause membrane-striae constriction and disordered qi-fluid circulation. In the middle stage,stagnant fluids gradually transform into phlegm retention,leading to membrane-striae obstruction. In the late stage,deficiency of vital qi becomes predominant,manifesting as laxity of membrane-striae with impaired control or weakened conduction. The treatment of irritable bowel syndrome should adopt " unblocking" as the guiding principle. In the early stage,therapy should focus on eliminating pathogenic factors and soothing membrane-striae to promptly restore qi-fluid circulation,thereby attaining unblocking through spasm relief. In the middle stage,treatment should focus on resolving tangible obstructions in membrane-striae,achieving unblocking via dredging. In the late stage,the emphasis should shift to reinforcing healthy qi,particularly by strengthening spleen-kidney yang qi,and achieving unblocking through supplementation. Concurrently,throughout the entire treatment process,the regulation of mental state and easing of emotional tension should be integrated to alleviate patient′s anxiety,achieving the goal of holistic treatment of both body and mind.
9.Study on the correlation between HLA antibodies and pregnancy-related factors, and the predictive value of a random-forest model among female blood donors in Nanning
Fang LU ; Huihui MO ; Wujin SU ; Zhoulin ZHONG ; Hengcong LI ; Yuchen HUANG ; Yuxi CHEN ; Lilan LI ; Yan ZHOU
Chinese Journal of Blood Transfusion 2026;39(3):367-372
Objective: To explore the association between the HLA antibody positivity rate in female blood donors and pregnancy history, number of pregnancies, interval from the last pregnancy to blood donation, and age, to identify associated variables using a univariate generalized additive model (GAM), and to further analyze the predictive role of characteristic variables for HLA antibody positivity using a random forest model. Methods: HLA antibody detection was performed on 391 female blood donors using the Luminex immunomagnetic bead method. The correlation between pregnancy-related factors and HLA antibodies was analyzed using the Chi-square test. Based on R software, a univariate GAM was first constructed to analyze the association types between characteristic variables and the HLA antibody positivity rate, followed by the construction of a random forest model to evaluate the predictive value of the variables. Results: Among the 391 female blood donors without a transfusion history, the overall HLA antibody positivity rate was 26.34%. The positivity rate in donors with a pregnancy history was significantly higher than that in those without (30.09% vs 9.72%, P<0.05), and HLA antibody positivity rate increased linearly with the number of pregnancies (P<0.05). In the univariate GAM, age and number of deliveries exhibited a non-linear association with the HLA antibody positivity rate (the positivity rate increased sharply between 25-35 years of age and stabilized after 3 deliveries). Besides, the interval from the last pregnancy to blood donation showed a linear association with the HLA antibody positivity rate, and the positivity rate decreased as the interval prolonged (P<0.05). In the random forest model, age (mean decrease gini=29.26) and interval from the last pregnancy to blood donation (mean decrease gini=22.02) were core predictive variables: age was more conducive to identifying positive samples, while the interval from the last pregnancy to blood donation was more helpful for excluding negative samples. The number of deliveries (mean decrease accuracy=16.98) made a significant contribution to predicting positive samples, whereas the number of abortions had no impact. The model had an AUC of 0.583 (95% CI: 0.593 8-0.770 2), indicating a certain predictive value. Conclusion: The associated variables identified by the univariate GAM model, including age, interval from the last pregnancy to blood donation, and number of deliveries, provide a basis for key variables in the random forest model. All three variables have predictive value for HLA antibody positivity, which can provide evidence-based support for personalized transfusion management and stratified screening of female blood donors in this region.
10.Evidence-based evaluation and hierarchical management of off-label use of 5-aminolevulinic acid in photodynamic therapy
Jing MA ; Tingting LIU ; Xiaoshuang GOU ; Xue YANG ; Chen LI ; Fang LIU ; Yao LIU
China Pharmacy 2026;37(8):1056-1061
OBJECTIVE To provide reference for medical institutions to establish the record management mode and review rules of off-label use of 5-aminolevulinic acid (ALA) in photodynamic therapy based on the level of evidence. METHODS All ALA-containing outpatient prescriptions in the rational drug use system in our hospital from January 1, 2024 to December 31, 2025 were retrospectively collected. Based on the drug instructions, the current status of off-label use of ALA in photodynamic therapy was identified . The relevant studies in Micromedex, PubMed, CNKI, Wanfang Data and other databases were systematically searched as the relevant evidence-based evidence of ALA off-label use. According to the Off-label Drug Use Filing Standard of the hospital,the evidence-based evaluation method was used to evaluate the evidence-based evidence of ALA off-label use and carry out hierarchical management. RESULTS A total of 1 803 effective prescriptions were included, of which 676 (37.49%) were off-label use, distributed in the dermatology department (564 prescriptions,83.43%) and the plastic surgery department (112 prescriptions,16.57%). All 676 prescriptions were off-indications medication, involving ten types of skin diseases, primarily including moderate to severe acne (39.94%), skin warts (25.44%), Bowen’s disease (11.98%), and others. According to evidence-based evidence,off-label uses such as moderate to severe acne, actinic keratosis, and Bowen’s disease were managed according to the evidence categoryⅠ orⅡ.The uses of extramammary Paget’s disease and rosacea were managed according to the evidence category Ⅲ.The uses of lichen sclerosus and keloids were managed according to the evidence category Ⅳ.The results of evidence-based evaluation showed that 92.01% of off-label use in our hospital had high-level evidence-based support ( evidence category was gradeⅠ-Ⅱ). CONCLUSIONS Off-label uses supported by high-level evidence, such as moderate to severe acne, skin warts, and Bowen’s disease, can be managed under filing category Ⅰ or Ⅱ. For the use of lichen sclerosus and keloids, evidence-based evidence is insufficient and should be strictly restricted.The vast majority of ALA off-label use in our hospital has sufficient evidence-based basis.


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