1.Effect of Yang-Reinforcing and Blood-Activating Therapy on the Long-Term Prognosis for Dilated Cardio-myopathy Patients with Yang Deficiency and Blood Stasis Syndrome:A Retrospective Cohort Study
Shiyi TAO ; Jun LI ; Lintong YU ; Ji WU ; Yuqing TAN ; Xiao XIA ; Fuyuan ZHANG ; Tiantian XUE ; Xuanchun HUANG
Journal of Traditional Chinese Medicine 2026;67(1):53-59
ObjectiveTo evaluate the impact of yang-reinforcing and blood-activating therapy on the long-term prognosis for patients with dilated cardiomyopathy (DCM) of yang deficiency and blood stasis syndrome. MethodsA retrospective cohort study was conducted involving 371 DCM patients with yang deficiency and blood stasis syndrome. The yang-reinforcing and blood-activating therapy was defined as the exposure factor. Patients were categorized into exposure group (186 cases) and non-exposure group (185 cases) according to whether they received yang-reinforcing and blood-activating therapy combined with conventional western medicine for 6 months or longer. The follow-up period was set at 48 months, and the Kaplan-Meier survival analysis was used to assess the cumulative incidence of major adverse cardiovascular events (MACE) in both groups. Cox regression analysis was used to explore the impact of yang-reinforcing and blood-activating therapy on the risk of MACE, and subgroup analysis was performed. Changes in traditional Chinese medicine (TCM) syndrome score, left ventricular ejection fraction (LVEF), left ventricular fractional shortening (LVFS), left ventricular end-diastolic diameter (LVEDD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score were compared between groups at the time of first combined use of yang-reinforcing and blood-activating therapy (before treatment) and 1 year after receiving the therapy (after treatment). ResultsMACE occurred in 31 cases (16.67%) in the exposure group and 47 cases (25.41%) in the non-exposure group. The cumulative incidence of MACE in the exposure group was significantly lower than that in the non-exposure group [HR=0.559, 95%CI(0.361,0.895), P=0.014]. Cox regression analysis showed that yang-reinforcing and blood-activating therapy was an independent factor for reducing the risk of MACE in DCM patients [HR=0.623, 95%CI(0.396,0.980), P=0.041], and consistent results were observed in different subgroups. Compared with pre-treatment, the exposure group showed decreased TCM syndrome score and MLHFQ score, reduced LVEDD, and increased LVEF and LVFS after treatment (P<0.05); in the non-exposure group, TCM syndrome score decreased, LVEF and LVFS increased, and LVEDD reduced after treatment (P<0.05). After treatment, the exposure group had higher LVEF and LVFS, smaller LVEDD, and lower TCM syndrome score and MLHFQ score compared with the non-exposure group (P<0.05). ConclusionCombining yang-reinforcing and blood-activating therapy with conventional western medicine can reduce the risk of MACE in DCM patients with yang deficiency and blood stasis syndrome, meanwhile improving their clinical symptoms, cardiac function, and quality of life.
2.Effects of Yishen paidu formula on renal fibrosis in rats with chronic renal failure by regulating the ROS/TXNIP/NLRP3 pathway
Li FENG ; Bowen PENG ; Bin PENG ; Xue FENG ; Shuangyi ZHU ; Wei XIONG ; Xi HU ; Xiaohui SUN
China Pharmacy 2026;37(2):174-179
OBJECTIVE To investigate the effects and mechanism of the Yishen paidu formula on renal fibrosis in rats with chronic renal failure (CRF) through the reactive oxygen species (ROS)/thioredoxin-interacting protein (TXNIP)/NOD-like receptor thermal protein domain associated protein 3 (NLRP3) pathway. METHODS Rats were randomly divided into control group, model group, Yishen paidu formula low-dose (Yishen paidu formula-L) group, Yishen paidu formula high-dose (Yishen paidu formula- H) group, Yishen paidu formula-H+pcDNA-NC group, and Yishen paidu formula-H+ pcDNA-TXNIP group, with 10 rats in each group. Except for control group, all other rats were fed a diet containing 0.5% adenine to establish a CRF model; the rats were then administered corresponding drugs or normal saline intragastrically or via tail vein, once daily, for 8 consecutive weeks. After the last administration, the levels of serum creatinine (Scr), blood urea nitrogen (BUN), ROS, superoxide dismutase (SOD), malondialdehyde (MDA), tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and IL-1β were measured in each group. Pathological changes in renal tissue were observed, and the protein expression levels of Collagen Ⅲ, α-smooth muscle actin (α-SMA), transforming growth factor-β1 (TGF-β1), TXNIP and NLRP3 in renal tissue were detected. RESULTS Compared with model group, the renal histopathological damage and fibrosis of rats in Yishen paidu formula-L group and Yishen paidu formula-H group were significantly alleviated. The levels of Scr, BUN, ROS, MDA, TNF- α, IL-6 and IL-1β, and the protein expressions of Collagen Ⅲ, α-SMA, TGF-β1, TXNIP and NLRP3 were significantly decreased, while SOD levels were significantly increased (P<0.05). Moreover, the changes were more pronounced in the Yishen paidu formula-H group (P<0.05). Compared with Yishen paidu formula-H+pcDNA-NC group, above indexes of rats in Yishen paidu formula-H+pcDNA-TXNIP group were reversed significantly (P<0.05). CONCLUSIONS Yishen paidu formula can inhibit renal fibrosis in CRF rats by suppressing the ROS/TXNIP/NLRP3 pathway.
3.Advances in perioperative nutritional management for patients with esophageal cancer
Zuyu ZHANG ; Bo YANG ; Rong NIU ; Jijun XUE ; Jian CHEN ; Dong LI ; Wentao ZHAO ; Wenfeng HAN ; Yue BAI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(01):157-162
Esophageal cancer is a prevalent malignant tumor of the digestive tract in China, and radical surgery remains the cornerstone of its comprehensive treatment. However, multifactorial challenges such as postoperative gastrointestinal tract reconstruction, traumatic stress, and tumor-related metabolic disturbances render esophageal cancer patients highly susceptible to malnutrition. Perioperative nutritional support therapy plays a crucial role in enhancing surgical safety, improving clinical outcomes, and elevating patients' quality of life by regulating metabolic homeostasis, preserving organ function, and optimizing the immune microenvironment. This article reviews the mechanisms underlying malnutrition in esophageal cancer, methods for nutritional status assessment, and precision intervention pathways based on multi-omics evaluations. The aim is to strengthen clinicians' awareness of standardized perioperative nutritional management for esophageal cancer patients and promote its clinical implementation, thereby facilitating postoperative recovery and improving long-term quality of life.
4.Analysis of the Burden of Acute Lymphoid Leukemia in China and Globally from 1990 to 2021
Derong LIN ; Jingya FANG ; Yue LI ; Xiaohua XIE ; Xiaolin YE ; Xiaowen ZHANG ; Jiexuan LI ; Aiguo XUE
Medical Journal of Peking Union Medical College Hospital 2026;17(2):463-475
To analyze the disease burden of acute lymphoid leukemia(ALL) and its changing trends in China and globally from 1990 to 2021, aiming to provide a theoretical basis for disease prevention, treatment, and policy formulation. Data on the incidence, prevalence, mortality, and disability adjusted life years(DALYs) of ALL in China and globally from 1990 to 2021 were extracted from the Global Burden of Disease(GBD) 2021 database. The Joinpoint regression model was used to calculate the average annual percentage change(AAPC) to assess the trends in disease burden. Decomposition analysis was employed to identify and quantify the contributions of different factors to the changes in ALL disease burden. The population attributable fraction(PAF) was used to compare the risk factors for ALL in China and globally in 1990 and 2021. Stratified by the sociodemographic index(SDI), the locally estimated scatterplot smoothing(LOESS) method was used to assess the association between age-standardized incidence rate(ASIR), age-standardized mortality rate(ASMR), and SDI. The incidence-mortality ratio(IMR) was calculated to evaluate the diagnostic level and current treatment status of ALL. From 1990 to 2021, ASIR of ALL in the Chinese population increased from 3.385/100 000 to 3.637/100 000(AAPC: 0.005), the age-standardized prevalence rate(ASPR) increased from 6.596/100 000 to 22.022/100 000(AAPC: 0.478), the ASMR decreased from 3.051/100 000 to 1.357/100 000(AAPC: -0.056), and the age-standardized DALYs rate(ASDR) decreased from 195.792/100 000 to 74.063/100 000(AAPC: -3.996). Globally, the corresponding figures were: ASIR decreased from 1.789/100 000 to 1.371/100 000(AAPC: -0.014), ASPR increased from 4.122/100 000 to 5.425/100 000(AAPC: 0.039), ASMR decreased from 1.551/100 000 to 0.898/100 000(AAPC: -0.021), and ASDR decreased from 94.894/100 000 to 48.858/100 000(AAPC: -1.494). During this period, the aforementioned disease burden indicators were generally higher in males than in females, both in China and globally.In 2021, the peak incidence of ALL in China and globally was primarily concentrated in the 0-19 years age group, with the highest rate observed in those under 5 years of age. The burden of prevalence and DALYs was also mainly concentrated in this age group. Regarding mortality, the death burden in China was predominantly observed in the older adult age group, particularly among those aged ≥60 years. Globally, the mortality burden was highest in the under-5 age group, while remaining at a relatively high level in the older adult population. SDI correlation analysis based on data from 204 countries/regions globally from 1990 to 2021 showed that ASIR gradually increased with increasing SDI, whereas ASMR showed an initial increase followed by a decreasing trend. The ASIR and ASMR for the overall Chinese population and by sex were higher than expected. PAF results indicated that smoking and high body mass index were the main attributable risk factors for ALL mortality and DALYs burden, with their contribution consistently increasing. Decomposition analysis revealed that population growth and epidemiological changes were the primary drivers behind the changes in ALL incidence and mortality burden. Compared with 1990, the IMR for ALL in both China and globally increased in 2021. Over the past three decades, the ASMR and ASDR for ALL in China and globally have generally declined. During the same period, the ASIR and ASPR for ALL increased in China, while globally, the ASIR decreased and the ASPR increased. However, the disease burden of ALL remains high in males, children, and the older adult population. Differentiated prevention and control measures should be implemented in accordance with changes in SDI. The findings highlight the importance of strengthening prevention and early diagnosis, and suggest the need for targeted screening and treatment strategies for different age and sex groups. Concurrently, attention should be paid to the role of weight management and tobacco control in comprehensive prevention and control efforts to further reduce the disease burden of ALL.
5.The Potential Role of Immune Checkpoint Molecules in the Pathogenesis of Autoimmune Hepatitis and in Targeted Therapy
Haixia LI ; Aiping TIAN ; Miao XUE ; Ziyi LI ; Xiaorong MAO
Medical Journal of Peking Union Medical College Hospital 2026;17(2):512-518
Autoimmune hepatitis (AIH) is a chronic, immune-mediated liver injury of unknown etiology. The onset of this disease involves the activation and recruitment of diverse immune and non-immune cells, which in turn trigger hepatic damage. Immune checkpoint molecules (ICM) are expressed on the surface of multiple cell types. By regulating cellular functional states, they help limit the intensity and duration of immune responses, thereby preventing excessive inflammation and tissue damage, and maintaining immune homeostasis. In AIH, however, this natural "braking" mechanism is impaired, leading to aberrant activation of both immune and non-immune cells and the breakdown of immune homeostasis. Consequently, ICM are likely to play a critical role in the pathogenesis of AIH. A deeper understanding of the function of ICM in AIH not onlyadvances our insight into the disease mechanism, but also suggests that targeting these molecules may represent a promising therapeutic strategy for the treatment of AIH.
6.Quality control of Sagina japonica by HPLC fingerprint combined with quantitative analysis of multi-components by single-marker
Junhong LIU ; Xue LI ; Meiqin ZHANG ; Han HU ; Chunmei BAI ; Chunhua LIU ; Yongjun LI
China Pharmacy 2026;37(7):883-888
OBJECTIVE To establish the high-performance liquid chromatography (HPLC) fingerprint of Sagina japonica , and to establish a quantitative analysis of multi-components by single-marker (QAMS) method for simultaneous determination of six componen ts in S. japonica , aiming to provide references for the quality control of this medicinal herb. METHODS HPLC method was used to establish the fingerprints of 12 batches (No. S1-S12) of S . japonica according to Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine . The similarity evaluation and identification of common peaks were conducted, followed by cluster analysis (CA) and principal component analysis (PCA) for 12 batches of samples. Using vicenin-2 as internal reference, the contents of p-hydroxy cinnamic acid, apigenin-6-C-arabinoside-8-C-glucoside, isoorientin, vitexin and 20-hydroxyecdysone were determined by QAMS method. The results were then compared with those obtained by the external standard method. RESULTS The similarities of HPLC fingerprints for 12 batches of S . japonica ranged from 0.828-0.998. A total of 17 common peaks were calibrated, and 6 common peaks were identified. Specifically, peak 5 was identified as vicenin-2, peak 7 as p-hydroxycinnamic acid, peak 10 as apigenin-6-C-arabinoside-8-C-glucoside, peak 11 as isoorientin, peak 13 as vitexin, and peak 15 as 20-hydroxyecdysone. The results of CA showed that S1-S5, S7 and S9-S11 were clustered into one category, S6 was clustered into one category, and S8 and S12 were clustered into one category. The results of PCA revealed that the accumulative contribution rate of the four main components was 89.430%. The content ranges measured by QAMS method for p-hydroxy cinnamic acid, apigenin-6-C-arabinoside-8-C-glucoside, isoorientin, vitexin and 20-hydroxyecdysone were 0.017 4-0.269 4, 0.568 8-4.240 3, 0.503 2-5.040 3, 0.024 0-0.132 0 and 2.551 3-4.881 1 mg/g, respectively. There was no significant difference in the contents of components measured between QAMS method and the external standard method ( P >0.05). CONCLUSIONS The established HPLC fingerprint and QAMS method can be used for quality evaluation and quality control of S . japonica.
7.Quantitative Molecular Detection of Angelicae Sinensis Radix and Its Processed Products Based on Herb-Q Method
Mingyu ZHANG ; Wenjun JIANG ; Baoyu JI ; Yue WANG ; Haitao ZHANG ; Haobo ZHANG ; Xue FENG ; Xiwen LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):192-200
ObjectiveAngelicae Sinensis Radix, a commonly used medicinal herb with both medicinal and edible properties, is frequently adulterated in the market, severely affecting the clinical efficacy of preparations. While qualitative identification techniques for adulterants and counterfeits are now relatively mature, quantitative detection methods for adulterated processed products remain unexplored. Quantitative detection research of Angelicae Sinensis Radix and its primary closely related adulterant, "Tu Danggui" (Angelica gigas), was conducted to establish a herbal quantitative molecular detection (Herb-Q) method for Angelicae Sinensis Radix and its processed products, providing a model for the establishment of quantitative detection technologies for Angelicae Sinensis Radix and related health products. MethodsThe specific single-nucleotide polymorphism (SNP) loci of Angelicae Sinensis Radix and Angelica gigas Nakai were screened based on the complete chloroplast genome sequence. The specific SNP loci of Angelicae Sinensis Radix were selected for quantitative methodological investigations (linearity, limit of quantification, limit of detection, and reproducibility) by mixing the powder of the herbs with different adulteration ratios. Huoxue Zhitong powder with three distinct adulteration ratios (15%, 25%, and 35%) was utilized to ascertain the precision of the Herb-Q method for the quantitative detection of Chinese patent medicines containing Angelicae Sinensis Radix. ResultsBy comparing the 123 chloroplast genome sequences of Angelicae Sinensis Radix, based on the principles of intraspecies conservation, interspecies specificity, and meeting the requirements of pyrophosphate high-throughput sequencing, it was determined that 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 and 38 592nd locus (T/C) in the chloroplast genome sequence NC_029393.1 could be the exclusive molecular identification loci of Angelicae Sinensis Radix and Angelica gigas Nakai, respectively. The linear relationship R2 of the Herb-Q method established by selecting the specific 9 674th locus (A/G) of Angelicae Sinensis Radix was 0.997 4 (R2>0.99), indicating an excellent linear relationship. The limits of quantification and detection were established at 2.0%, exhibiting excellent reproducibility [relative standard deviation(RSD)<2.0%]. The established quantitative system based on the Herb-Q method detected the adulteration amount of counterfeit A. gigas in the Huoxue Zhitong powder, with an average deviation of 1.3% for three molecular quantitative replicates. ConclusionThis research demonstrates that the Herb-Q quantitative detection method established based on the 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 of Angelicae Sinensis Radix has good applicability, objectivity, and accuracy for Angelicae Sinensis Radix and A. gigas, and its processed products. This method has the capacity to provide technical support for the quantitative detection of commercially available Angelicae Sinensis Radix derivatives, including traditional Chinese medicinal preparations, dietary supplements, and nutraceuticals.
8.Quantitative Molecular Detection of Angelicae Sinensis Radix and Its Processed Products Based on Herb-Q Method
Mingyu ZHANG ; Wenjun JIANG ; Baoyu JI ; Yue WANG ; Haitao ZHANG ; Haobo ZHANG ; Xue FENG ; Xiwen LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):192-200
ObjectiveAngelicae Sinensis Radix, a commonly used medicinal herb with both medicinal and edible properties, is frequently adulterated in the market, severely affecting the clinical efficacy of preparations. While qualitative identification techniques for adulterants and counterfeits are now relatively mature, quantitative detection methods for adulterated processed products remain unexplored. Quantitative detection research of Angelicae Sinensis Radix and its primary closely related adulterant, "Tu Danggui" (Angelica gigas), was conducted to establish a herbal quantitative molecular detection (Herb-Q) method for Angelicae Sinensis Radix and its processed products, providing a model for the establishment of quantitative detection technologies for Angelicae Sinensis Radix and related health products. MethodsThe specific single-nucleotide polymorphism (SNP) loci of Angelicae Sinensis Radix and Angelica gigas Nakai were screened based on the complete chloroplast genome sequence. The specific SNP loci of Angelicae Sinensis Radix were selected for quantitative methodological investigations (linearity, limit of quantification, limit of detection, and reproducibility) by mixing the powder of the herbs with different adulteration ratios. Huoxue Zhitong powder with three distinct adulteration ratios (15%, 25%, and 35%) was utilized to ascertain the precision of the Herb-Q method for the quantitative detection of Chinese patent medicines containing Angelicae Sinensis Radix. ResultsBy comparing the 123 chloroplast genome sequences of Angelicae Sinensis Radix, based on the principles of intraspecies conservation, interspecies specificity, and meeting the requirements of pyrophosphate high-throughput sequencing, it was determined that 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 and 38 592nd locus (T/C) in the chloroplast genome sequence NC_029393.1 could be the exclusive molecular identification loci of Angelicae Sinensis Radix and Angelica gigas Nakai, respectively. The linear relationship R2 of the Herb-Q method established by selecting the specific 9 674th locus (A/G) of Angelicae Sinensis Radix was 0.997 4 (R2>0.99), indicating an excellent linear relationship. The limits of quantification and detection were established at 2.0%, exhibiting excellent reproducibility [relative standard deviation(RSD)<2.0%]. The established quantitative system based on the Herb-Q method detected the adulteration amount of counterfeit A. gigas in the Huoxue Zhitong powder, with an average deviation of 1.3% for three molecular quantitative replicates. ConclusionThis research demonstrates that the Herb-Q quantitative detection method established based on the 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 of Angelicae Sinensis Radix has good applicability, objectivity, and accuracy for Angelicae Sinensis Radix and A. gigas, and its processed products. This method has the capacity to provide technical support for the quantitative detection of commercially available Angelicae Sinensis Radix derivatives, including traditional Chinese medicinal preparations, dietary supplements, and nutraceuticals.
9.Probability of premature death due to four types of chronic diseases and its impact on life expectancy in Yangpu District from 2010 to 2021
QIN Yongfa ; ZHAO Jia ; LI Hui ; CHEN Jing ; HAN Xue
Journal of Preventive Medicine 2026;38(2):130-134,139
Objective:
To analyze the impact of premature death due to four major chronic diseases on life expectancy in Yangpu District, Shanghai Municipality from 2010 to 2021, so as to provide the evidence for formulating chronic disease prevention and control strategies.
Methods :
Mortality data of registered residents in Yangpu District from 2010 to 2021 were collected through the Death Information Registration and Management System of the Shanghai Municipal Disease Control and Prevention Information Management Platform. The premature death probability of malignant tumors, diabetes, cardiovascular and cerebrovascular diseases, and chronic respiratory diseases, and life expectancy of residents were calculated using the abridged life table method. Trends in premature death probability for four types of chronic diseases were analyzed using the average annual percent change (AAPC). The impact of premature death probability due to four chronic diseases on life expectancy was assessed by Arriaga's decomposition method.
Results :
The premature death probability due to four major chronic diseases in Yangpu District decreased from 9.88% in 2010 to 9.22% in 2021, showing an overall declining trend (AAPC=-0.540%, P<0.05). Among females, the premature death probability declined from 6.71% to 4.90% (AAPC=-2.715%, P<0.05), whereas no statistically significant trend was observed in males (P>0.05). Life expectancy increased from 82.52 years in 2010 to 84.50 years in 2021, with an overall upward trend (AAPC=0.244%, P<0.05). Life expectancy rose by 1.71 years for males and 2.34 years for females (AAPC=0.197% and 0.303%,both P<0.05). Declines in premature death probability from malignant tumors (AAPC=-0.967%, P< 0.05) and chronic respiratory diseases (AAPC=-3.071%, P<0.05) contributed to gains in life expectancy of 0.30 years and 0.03 years, with contribution rates of 12.18% and 1.29%, respectively. Changes in premature death probability due to diabetes as well as cardiovascular and cerebrovascular diseases were not statistically significant (both P>0.05), resulting in reductions in life expectancy of 0.05 years and 0.10 years, with contribution rates of -2.40% and -5.05%, respectively. Notably, an increase in premature death probability due to cardiovascular and cerebrovascular diseases among males (AAPC=1.673%) contributed to a decrease of 0.22 years in male life expectancy, whereas a decrease among females (AAPC=-3.824%) contributed to an increase of 0.03 years in female life expectancy, with contribution rates of -13.03% and 1.14%, respectively.
Conclusions
From 2010 to 2021, Yangpu District experienced an overall decline in premature death probability due to four major chronic diseases and an increase in life expectancy. Greater attention should be paid to the negative impacts of premature death probability from diabetes as well as cardiovascular and cerebrovascular diseases among males on life expectancy.
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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