1.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
2.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
3.Association of outdoor activity level and myopia among children and adolescents in Shanghai
Chinese Journal of School Health 2025;46(1):18-23
Objective:
To analyze the status of outdoor activities on weekends among children and adolescents of different educational stages in Shanghai and their impact on myopia, so as to provide a basis for formulating more specific prevention and control protocol of myopia.
Methods:
From September to October 2022, a stratified cluster random sampling method was employed to select 84 schools (27 kindergartens, 21 primary schools, 15 junior high schools and 21 high schools) across Shanghai, enrolling a total of 28 654 children and adolescents aged 4 to 18 for the study. Ophthalmic examinations were conducted to ascertain the prevalence of myopia among children and adolescents. Additionally, a questionnaire survey was administered to collect data on outdoor activity duration and associated factors. Multivariate Logistic regression analysis was utilized to investigate the associated factors of outdoor activity levels on weekends.
Results:
The overall myopia detection rate among children and adolescents was 58.4%, with a higher rate observed in girls (59.2%) compared to boys (57.6%). The myopia detection rates for children and adolescents with an average daily outdoor activity duration of ≥2 h and <2 h on weekends were 54.6% and 68.8%, and the differences were statistically significant ( χ 2=8.12,460.89, P <0.01). Multivariable Logistic regression analysis revealed that girls ( OR =0.80), those with a myopic parent ( OR =0.68), schools from urban districts ( OR =0.72), higher education stages (primary school: OR =0.65, junior high school: OR =0.24, high school: OR =0.14) and spending≥2 h/d on homework during weekends ( OR =0.57) among children and adolescents were less likely to engage in outdoor activities for ≥2 h on weekends ( P <0.01). After incorporating gender, parental myopia status, educational stage, school location, average daily duration on weekends for spending on homework, electronic product usage and outdoor activities as dependent variables in a multivariate Logistic regression analysis, the results showed that children and adolescents with an average outdoor activity duration for ≥2 h on weekends had a lower risk of myopia ( OR =0.86, P < 0.01).
Conclusions
The level of outdoor activity among children and adolescents on weekends needs to be improved. Outdoor activities on weekends is an associated factor for myopia among children and adolescents. Particularly, girls, those with myopic parents, schools from urban districts, and spending long hours on homework during weekends among children and adolescents require increased attention.
4.Human amniotic mesenchymal stem cells overexpressing neuregulin-1 promote skin wound healing in mice
Taotao HU ; Bing LIU ; Cheng CHEN ; Zongyin YIN ; Daohong KAN ; Jie NI ; Lingxiao YE ; Xiangbing ZHENG ; Min YAN ; Yong ZOU
Chinese Journal of Tissue Engineering Research 2025;29(7):1343-1349
BACKGROUND:Neuregulin 1 has been shown to be characterized in cell proliferation,differentiation,and vascular growth.Human amniotic mesenchymal stem cells are important seed cells in the field of tissue engineering,and have been shown to be involved in tissue repair and regeneration. OBJECTIVE:To construct human amniotic mesenchymal stem cells overexpressing neuregulin 1 and investigate their proliferation and migration abilities,as well as their effects on wound healing. METHODS:(1)Human amniotic mesenchymal stem cells were in vitro isolated and cultured and identified.(2)A lentivirus overexpressing neuregulin 1 was constructed.Human amniotic mesenchymal stem cells were divided into empty group,neuregulin 1 group,and control group,and transfected with empty lentivirus and lentivirus overexpressing neuregulin 1,or not transfected,respectively.(3)Edu assay was used to detect the proliferation ability of the cells of each group,and Transwell assay was used to detect the migration ability of the cells.(4)The C57 BL/6 mouse trauma models were constructed and randomly divided into control group,empty group,neuregulin 1 group,with 8 mice in each group.Human amniotic mesenchymal stem cells transfected with empty lentivirus or lentivirus overexpressing neuregulin-1 were uniformly injected with 1 mL at multiple local wound sites.The control group was injected with an equal amount of saline.(5)The healing of the trauma was observed at 1,7,and 14 days after model establishment.Histological changes of the healing of the trauma were observed by hematoxylin-eosin staining.The expression of CD31 on the trauma was observed by immunohistochemistry. RESULTS AND CONCLUSION:(1)Human amniotic mesenchymal stem cells overexpressing neuregulin-1 were successfully constructed.The mRNA and protein expression of intracellular neuregulin 1 was significantly up-regulated compared with the empty group(P<0.05).(2)The overexpression of neuregulin 1 promoted the migratory ability(P<0.01)and proliferative ability of human amniotic mesenchymal stem cells(P<0.05).(3)Human amniotic mesenchymal stem cells overexpressing neuregulin 1 promoted wound healing in mice(P<0.05)and wound angiogenesis(P<0.05).The results showed that overexpression of neuregulin 1 resulted in an increase in the proliferative and migratory capacities of human amniotic mesenchymal stem cells,significantly promoting wound healing and angiogenesis.
5.Mid-long term follow-up reports on head and neck rhabdomyosarcoma in children
Chao DUAN ; Sidou HE ; Shengcai WANG ; Mei JIN ; Wen ZHAO ; Xisi WANG ; Zhikai LIU ; Tong YU ; Lejian HE ; Xiaoman WANG ; Chunying CUI ; Xin NI ; Yan SU
Chinese Journal of Pediatrics 2025;63(1):62-69
Objective:To analyze the clinical characteristics of children with head and neck rhabdomyosarcoma (RMS) and to summarize the mid-long term efficacy of Beijing Children′s Hospital Rhabdomyosarcoma 2006 (BCH-RMS-2006) regimen and China Children′s Cancer Group Rhabdomyosarcoma 2016 (CCCG-RMS-2016) regimen.Methods:A retrospective cohort study. Clinical data of 137 children with newly diagnosed head and neck RMS at Beijing Children′s Hospital, Capital Medical University from March 2013 to December 2021 were collected. Clinical characteristic of patients at disease onset and the therapeutic effects of patients treated with the BCH-RMS-2006 and CCCG-RMS-2016 regimens were compared. The treatments and outcomes of patients with recurrence were also summarized. Survival analysis was performed by Kaplan-Meier method, and Log-Rank test was used for comparison of survival rates between groups.Results:Among 137 patients, there were 80 males (58.4%) and 57 females (41.6%), the age of disease onset was 59 (34, 97) months. The primary site in the orbital, non-orbital non-parameningeal, and parameningeal area were 10 (7.3%), 47 (34.3%), and 80 (58.4%), respectively. Of all patients, 32 cases (23.4%) were treated with the BCH-RMS-2006 regimen and 105 (76.6%) cases were treated with the CCCG-RMS-2016 regimen. The follow-up time for the whole patients was 46 (20, 72) months, and the 5-year progression free survival (PFS) and overall survival (OS) rates for the whole children were (60.4±4.4)% and (69.3±4.0)%, respectively. The 5-year OS rate was higher in the CCCG-RMS-2016 group than in BCH-RMS-2006 group ((73.0±4.5)% vs. (56.6±4.4)%, χ2=4.57, P=0.029). For the parameningeal group, the 5-year OS rate was higher in the CCCG-RMS-2016 group (61 cases) than in BCH-RMS-2006 group (19 cases) ((57.3±7.6)% vs. (32.7±11.8)%, χ2=4.64, P=0.031). For the group with meningeal invasion risk factors, the 5-year OS rate was higher in the CCCG-RMS-2016 group (54 cases) than in BCH-RMS-2006 group (15 cases) ((57.7±7.7)% vs. (30.0±12.3)%, χ2=4.76, P=0.029). Among the 10 cases of orbital RMS, there was no recurrence. In the non-orbital non-parameningeal RMS group (47 cases), there were 13 (27.6%) recurrences, after re-treatment, 7 cases survived. In the parameningeal RMS group (80 cases), there were 40 (50.0%) recurrences, with only 7 cases surviving after re-treatment. Conclusions:The overall prognosis for patients with orbital and non-orbital non-parameningeal RMS is good. However, children with parameningeal RMS have a high recurrence rate, and the effectiveness of re-treatment after recurrence is poor. Compared with the BCH-RMS-2006 regimen, the CCCG-RMS-2016 regimen can improve the treatment efficacy of RMS in the meningeal region.
6.Diagnostic value of miR-128-3p, SIRT1, and AMPK in patients with type 2 diabetes mellitus comorbid with nonalcoholic fatty liver disease
Juyi LI ; Yingqun NI ; Yuanyuan ZHANG ; Huaizhen LIU
Journal of Clinical Hepatology 2025;41(3):453-460
ObjectiveTo investigate the expression levels of miR-128-3p, SIRT1, and AMPK in the peripheral blood of patients with type 2 diabetes mellitus (T2DM) comorbid with nonalcoholic fatty liver disease (NAFLD), as well as the role of miR-128-3p in predicting NAFLD in T2DM patients. MethodsA total of 80 patients with T2DM who were hospitalized in The First Affiliated Hospital of Anhui University of Chinese Medicine from September 2022 to August 2023 were enrolled and divided into T2DM group with 40 patients and NAFLD group with 40 patients, and according to the NAFLD fibrosis score (NFS), the patients were further divided into progressive liver fibrosis group with 16 patients and non-progressive liver fibrosis group with 64 patients. General data and biochemical parameters were collected; quantitative real-time PCR was used to measure the mRNA expression levels of miR-128-3p, SIRT1, and AMPK in peripheral blood, and Western blot was used to measure the protein expression levels of SIRT1 and AMPK. The independent-samples t test was used for comparison of normally distributed data between two groups, and the Mann-Whitney U test was used for comparison of data with skewed distribution between two groups; the chi-square test was used for comparison of categorical data between two groups. The logistic regression analysis was used to identify the influencing factors for the presence of NAFLD and progressive liver fibrosis, and the receiver operating characteristic (ROC) curve analysis was used to determine the optimal cut-off value of miR-128-3p for predicting NAFLD. ResultsThere were significant differences between the NAFLD group and the non-NAFLD group in body mass index, fasting plasma glucose, glycated hemoglobin, fasting insulin, fasting C-peptide, alanine aminotransferase (ALT), aspartate aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, fibronectin, triglycerides, high-density lipoprotein cholesterol, total triiodothyronine (TT3), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and NFS (all P<0.05). Compared with the non-NAFLD group, the NAFLD group had a significantly higher mRNA expression level of miR-128-3p in peripheral blood (t=-8.765, P<0.001) and significant reductions in the mRNA and proteins expression levels of SIRT1 and AMPK (P<0.001). There were significant differences between the progressive liver fibrosis group and the non-progressive liver fibrosis group in age, ALT, free triiodothyronine, TT3, superoxide dismutase, and miR-128-3p (all P<0.05). The logistic regression analysis showed that miR-128-3p was an independent risk factor for the development of NAFLD (odds ratio [OR]=8.221, 95% confidence interval [CI]: 2.735 — 24.714, P<0.001) and progressive liver fibrosis (OR=1.493, 95%CI: 1.117 — 1.997, P=0.007). The ROC curve analysis showed that miR-128-3p had an area under the ROC curve of 0.890 (95%CI: 0.829 — 0.950), with an optimal cut-off value of 13.165, a sensitivity of 89.3%, and a specificity of 72.7%. ConclusionThere is an increase in the expression of miR-128-3p in peripheral blood of T2DM patients with NAFLD, while there are reductions in the expression levels of SIRT1 and AMPK, suggesting that miR-128-3p has a certain diagnostic value in identifying NAFLD and liver fibrosis in such population.
7.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
8.Discovery and investigation of six polio vaccine derived viruses in Guangzhou City
Min CUI ; Chunhuan ZHANG ; Wei ZHANG ; Jun LIU ; Jialing LI ; Jianxiong XU ; Wenji WANG ; Qing HE ; Lihong NI ; Xuexia YUN ; Huanying ZHENG
Journal of Public Health and Preventive Medicine 2025;36(2):22-25
Objective To understand the surveillance situation of poliovirus in Guangzhou from 2011 to 2024, and to further strengthen polio surveillance and ensure the continued maintenance of a polio-free status. Methods An analysis was conducted on the discovery and investigation results of six cases of vaccine-derived poliovirus (VDPV) detected in Guangzhou. Results A total of 6 VDPV incidents were reported in Guangzhou from 2011 to June 2024, among which 5 incidents were from sewage sample testing in the Liede Sewage Treatment Plant in Guangzhou, all of which were confirmed as VDPV, with 1 for type I, 1 for type II, and 3 for type III. In addition, one confirmed HFMD case was identified as a type VDPV II carrier. No presence of any wild poliovirus (WPV), VDPV cases, or circulating VDPV (cVDPV) was reported. Conclusion Guangzhou City has maintained a high level of vigilance and effectiveness in the monitoring and prevention of polio. Continuously strengthening the construction of the polio monitoring network, optimizing vaccination strategies, and comprehensively improving public health awareness are still the focus of the prevention and control work in the future.
9.Diquafosol sodium eye drops combined with sodium hyaluronate eye drops in the treatment of dry eye after cataract surgery
Jiufa CAO ; Yan NI ; Gaoqin LIU
International Eye Science 2025;25(5):839-842
AIM: To explore the therapeutic effects of diquafosol sodium eye drops combined with sodium hyaluronate eye drops on dry eye syndrome after cataract surgery.METHODS:This study is a prospective randomized controlled study. Totally 360 patients(360 eyes)with dry eye syndrome after cataract surgery admitted to the ophthalmology department of our hospital from November 2022 to October 2024 were selected as the research subjects, and they were randomly divided into a control group(n=180)and an observation group(n=180). The control group received postoperative treatment with sodium hyaluronate eye drops, while the observation group received postoperative treatment with diquafosol sodium eye drops combined with sodium hyaluronate eye drops. Both groups of patients were treated for 4 wk. The clinical efficacy, dry eye clinical symptom score and ocular surface disease index(OSDI)questionnaire, Schirmer's test(SⅠt), tear film break-up time(BUT), corneal fluorescence staining(FL)score, hexagonality(HEX), coefficient of variation(CV)of corneal endothelial cells were compared between the two groups before and after treatment, and the occurrence of adverse reactions during treatment in both groups was recorded.RESULTS:Both groups were followed up for 4 wk, and no cases were lost. The total clinical effective rate of the observation group was 93.9%, which was higher than 84.5% of the control group(P<0.05). After treatment for 4 wk, the clinical symptom score, OSDI scores and FL scores in both groups decreased, and the observation group had lower scores than those of the control group(all P<0.001); both SⅠt and BUT increased in both groups, and the observation group had a higher value than those of the control group(all P<0.001). After treatment for 4 wk, the HEX in both groups increased(P<0.05), and those in the observation group were higher(P<0.05); the CV of the two groups decreased(P<0.05), and the observation group was lower(P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).CONCLUSION:Compared to sodium hyaluronate eye drops alone, diquafosol sodium eye drops combined with sodium hyaluronate eye drops have a better therapeutic effect on patients with dry eye syndrome after cataract surgery. It can significantly improve the patient's eye symptoms, promote the recovery of eye surface function, stabilize the tear film, and regulate corneal endothelial cell status.
10.Causal relationship between mental disorders and hypercholesterolemia: a Mendelian randomization analysis
Qian ZOU ; Ni TANG ; Huanhui LIU ; Hanjing ZHANG ; Xiaojie MA
Sichuan Mental Health 2025;38(2):123-130
BackgroundMetabolic syndrome (MetS) is highly prevalent in patients with mental disorders, including elevated diastolic or systolic blood pressure, elevated fasting glucose, hypercholesterolemia, abdominal obesity and so on. As an important component of MetS, the relationship between hypercholesterolemia and mental disorder has been extensively reported, whereas few genome-wide association studies (GWAS) have been conducted to identify the causal role of mental disorders in hypercholesterolemia. ObjectiveTo explore the potential causal relationship between mental disorders and hypercholesterolemia by two-sample Mendelian randomization (MR) method. MethodsSummary data from GWAS were analyzed. Single nucleotide polymorphisms (SNPs) strongly associated with mental disorders were chosen as instrumental variables, and hypercholesterolemia was used as outcome variable. MR analysis utilized inverse-variance weighted (IVW), MR-Egger regression and weighted median estimation (WME) as the primary analytical tool, and supplemented by simple mode (SM) and weighted mode (WM). The causal relationship between mental disorders and the risk of hypercholesterolemia was illustrated in terms of odds ratio (OR). ResultsA total of 36 SNPs associated with mental disorders were identified as instrumental variables. The primary findings from IVW revealed existence of a causal relationship between mental disorders and hypercholesterolemia (IVW: OR=1.067, 95% CI: 1.026~1.109, P=0.001). Findings from the additional methods (MR-Egger regression, WME, SM, WM) were basically consistent with those reported in IVW method. Further verification indicated that the causal relationship between mental disorders and the risk of hypercholesterolemia was not affected by genetic polymorphism (P>0.05). The absence of heterogeneity was confirmed through Cochran's Q test and MR-Egger regression (P>0.05). Furthermore, no causal association in the reverse direction was found (P>0.05). ConclusionThere is a causal relationship between mental disorders and hypercholesterolemia, and patients with mental disorders may have an increased probability of suffering from hypercholesterolemia.


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