1.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
2.Analysis of prognostic factors of extranodal NK/T-cell lymphoma treated with pegaspargase/L-asparaginase: a multicenter retrospective study.
Zi Yuan SHEN ; Xi Cheng CHEN ; Hui Rong SHAN ; Tao JIA ; Wei Ying GU ; Fei WANG ; Qing Ling TENG ; Ling WANG ; Chun Ling WANG ; Yu Ye SHI ; Hao ZHANG ; Yu Qing MIAO ; Tai Gang ZHU ; Chun Yan JI ; Jing Jing YE ; Ming Zhi ZHANG ; Xu Dong ZHANG ; Liang WANG ; Kai Lin XU ; Wei SANG
Chinese Journal of Hematology 2023;44(8):642-648
Objective: To explore the prognostic factors of extracellular NK/T cell lymphoma (ENKTL) treated with pegaspargase/L-asparaginase. Methods: The clinical data of 656 ENKTL patients diagnosed at 11 medical centers in the Huaihai Lymphoma Working Group from March 2014 to April 2021 were retrospectively analyzed. The patients were randomly divided into two groups: a training set (460 cases) and a validation set (196 cases) at 7∶3, and the prognostic factors of the patients were analyzed. A prognostic scoring system was established, and the predictive performance of different models was compared. Results: Patients' median age was 46 (34, 57) years, with 456 males (69.5% ) and 561 nasal involvement (85.5% ). 203 patients (30.9% ) received a chemotherapy regimen based on L-asparaginase combined with anthracyclines, and the 5-year overall survival rate of patients treated with P-GEMOX regimen (pegaspargase+gemcitabine+oxaliplatin) was better than those treated with SMILE regimen (methotrexate+dexamethasone+cyclophosphamide+L-asparaginase+etoposide) (85.9% vs 63.8% ; P=0.004). The results of multivariate analysis showed that gender, CA stage, the Eastern Cooperative Oncology Group performance status (ECOG PS) score, HGB, and EB virus DNA were independent influencing factors for the prognosis of ENKTL patients (P<0.05). In this study, the predictive performance of the prognostic factors is superior to the international prognostic index, Korean prognostic index, and prognostic index of natural killer lymphoma. Conclusion: Gender, CA stage, ECOG PS score, HGB, and EB virus DNA are prognostic factors for ENKTL patients treated with pegaspargase/L-asparaginase.
Male
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Humans
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Middle Aged
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Asparaginase/therapeutic use*
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Prognosis
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Retrospective Studies
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Lymphoma, Extranodal NK-T-Cell/drug therapy*
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Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Etoposide
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Cyclophosphamide
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Methotrexate/therapeutic use*
;
DNA/therapeutic use*
;
Treatment Outcome
3.Observation of liver indexes in patients with relapsed/refractory multiple myeloma treated with CAR-T-cells based on BCMA.
Qian SUN ; Yue Kun QI ; Kun Ming QI ; Zhi Ling YAN ; Hai CHENG ; Wei CHEN ; Feng ZHU ; Wei SANG ; De Peng LI ; Jiang CAO ; Ming SHI ; Zhen Yu LI ; Kai Lin XU
Chinese Journal of Hematology 2023;44(10):832-837
Objective: To observe the characteristics of the evolution of liver indexes in patients with relapsed/refractory multiple myeloma (RRMM) treated with CAR-T-cells based on BCMA. Methods: Retrospective analysis was performed of patients with RRMM who received an infusion of anti-BCMA CAR-T-cells and anti-BCMA combined with anti-CD19 CAR-T-cells at our center between June 1, 2019, and February 28, 2023. Clinical data were collected to observe the characteristics of changes in liver indexes such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and direct bilirubin (DBIL) in patients, and its relationship with cytokine-release syndrome (CRS) . Results: Ninety-two patients were included in the analysis, including 41 patients (44.6%) in the group receiving a single infusion of anti-BCMA CAR-T-cells, and 51 patients (55.4%) in the group receiving an infusion of anti-BCMA combined with anti-CD19 CAR-T-cells. After infusing CAR-T-cells, 31 patients (33.7%) experienced changes in liver indexes at or above grade 2, which included 20 patients (21.7%) with changes in one index, five patients (5.4%) with changes in two indexes, and six patients (6.5%) with changes in three or more indexes. The median time of peak values of ALT and AST were d17 and d14, respectively, and the median duration of exceeding grade 2 was 5.0 and 3.5 days, respectively. The median time of peak values of TBIL and DBIL was on d19 and d21, respectively, and the median duration of exceeding grade 2 was 4.0 days, respectively. The median time of onset of CRS was d8, and the peak time of fever was d9. The ALT, AST, and TBIL of patients with CRS were higher than those of patients without CRS (P=0.011, 0.002, and 0.015, respectively). CRS is an independent factor that affects ALT and TBIL levels (OR=19.668, 95% CI 18.959-20.173, P=0.001). The evolution of liver indexes can be reversed through anti-CRS and liver-protection treatments, and no patient died of liver injury. Conclusions: In BCMA-based CAR-T-cell therapy for RRMM, CRS is an important factor causing the evolution of liver indexes. The evolution of liver indexes after CAR-T-cell infusion is transient and reversible after treatment.
Humans
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Antigens, CD19
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B-Cell Maturation Antigen/therapeutic use*
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Bilirubin
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Immunotherapy, Adoptive
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Liver
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Multiple Myeloma/drug therapy*
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Retrospective Studies
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T-Lymphocytes
4.Allogeneic hematopoietic stem cell transplantation combined with CD7 CAR-T for the treatment of T lymphoblastic lymphoma: a case report and literature review.
Xiang Min WANG ; Yi ZHOU ; Jiao Li ZHANG ; Hong Yuan ZHOU ; Qing ZHANG ; Qian SUN ; Hu Jun LI ; Lin Yan XU ; Shu Na YAO ; Zhi Hua YAO ; Dong Mei YAN ; Kai Lin XU ; Wei SANG
Chinese Journal of Hematology 2023;44(10):864-865
5.Large- scale prospective clinical study on prophylactic intervention of COVID-19 in community population using Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules.
Bo-Hua YAN ; Zhi-Wei JIANG ; Jie-Ping ZENG ; Jian-Yuan TANG ; Hong DING ; Jie-Lai XIA ; Shao-Rong QIN ; Si-Cen JIN ; Yun LU ; Na ZHANG ; Zhi-Hong WANG ; Hai-Yan LI ; Xiao-Ya SANG ; Li-Na WU ; Shi-Yun TANG ; Yan LI ; Meng-Yao TAO ; Qiao-Ling WANG ; Jun-Dong WANG ; Hong-Yan XIE ; Qi-Yuan CHEN ; Sheng-Wen YANG ; Nian-Shuang HU ; Jian-Qiong YANG ; Xiao-Xia BAO ; Qiong ZHANG ; Xiao-Li YANG ; Chang-Yong JIANG ; Hong-Yan LUO ; Zheng-Hua CAI ; Shu-Guang YU
China Journal of Chinese Materia Medica 2020;45(13):2993-3000
To scientifically evaluate the intervention effect of Chinese medicine preventive administration(combined use of Huo-xiang Zhengqi Oral Liquid and Jinhao Jiere Granules) on community population in the case of coronavirus disease 2019(COVID-19), a large cohort, prospective, randomized, and parallel-controlled clinical study was conducted. Total 22 065 subjects were included and randomly divided into 2 groups. The non-intervention group was given health guidance only, while the traditional Chinese medicine(TCM) intervention group was given two coordinated TCM in addition to health guidance. The medical instructions were as follows. Huoxiang Zhengqi Oral Liquid: oral before meals, 10 mL/time, 2 times/day, a course of 5 days. Jinhao Jiere Granules: dissolve in boiling water and take after meals, 8 g/time, 2 times/day, a course of 5 days, followed up for 14 days, respectively. The study found that with the intake of medication, the incidence rate of TCM intervention group was basically maintained at a low and continuous stable level(0.01%-0.02%), while the non-intervention group showed an overall trend of continuous growth(0.02%-0.18%) from 3 to 14 days. No suspected or confirmed COVID-19 case occurred in either group. There were 2 cases of colds in the TCM intervention group and 26 cases in the non-intervention group. The incidence of colds in the TCM intervention group was significantly lower(P<0.05) than that in the non-intervention group. In the population of 16-60 years old, the incidence rate of non-intervention and intervention groups were 0.01% and 0.25%, respectively. The difference of colds incidence between the two groups was statistically significant(P<0.05). In the population older than 60 years old, they were 0.04% and 0.21%, respectively. The incidence of colds in the non-intervention group was higher than that in the intervention group, but not reaching statistical difference. The protection rate of TCM for the whole population was 91.8%, especially for the population of age 16-60(95.0%). It was suggested that TCM intervention(combined use of Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules) could effectively protect community residents against respiratory diseases, such as colds, which was worthy of promotion in the community. In addition, in terms of safety, the incidence of adverse events and adverse reactions in the TCM intervention group was relatively low, which was basically consistent with the drug instructions.
Adolescent
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Adult
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Betacoronavirus
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Coronavirus Infections
;
drug therapy
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Drugs, Chinese Herbal
;
Humans
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Medicine, Chinese Traditional
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Middle Aged
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Pandemics
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Pneumonia, Viral
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drug therapy
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Prospective Studies
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Young Adult
6.Expression and Significance of PD-1, TIM-3 and VISTA on T Cell of Acute Myeloid Leukemia Patients.
Meng-Jun GE ; Kai-Lin XU ; Ting XU ; Ya-Nan TANG ; ZHen-Yu LI ; Zhi-Ling YAN ; Hai-Ying SUN ; Hai CHENG ; Feng ZHU ; Wei SANG ; Yi-Hong HUANG ; Ting-Ting QIU ; De-Peng LI
Journal of Experimental Hematology 2020;28(3):748-752
OBJECTIVE:
To study the expression of multiple negative costimulatory molecules on peripheral blood T cells in patients with acute myeloid leukemia (AML) and its affection on prognosis.
METHODS:
The peripheral blood samples from patients with newly diagnosed AML, complete remission (CR), and no-remission (NR) were collected, the expression levels PD-1、VISTA and TIM-3 in CD4 and CD8 T cells were detected by flow cytometry , and the clinical data of patients were analyzed.
RESULTS:
The expression levels of PD-1、VISTA and TIM-3 of CD4 and CD8 T cells in the newly diagnosed AML patients were significantly higher than those in control group (P<0.05). The expression levels of PD-1、TIM-3 and VISTA of CD4 and CD8 T cells in the CR group were significantly lower than those in newly diagnosed and the NR group (P<0.05). The TIM-3 expression level positively correlated with VISTA expression level of CD4 and CD8 T cells in newly diagnosed AML patients (r=0.85 and 0.73). The VISTA and PD-1 expression level of CD4 T cells in newly diagnosed AML, NR after first induction chemotherapy and high risk patients significantly increased (P<0.05), the TIM-3 expression level of CD8 T cells in high risk group significantly increased (P<0.05), and the VISTA expression level of CD8 T cells in CBFβ-MYH11 mutation-positive group significantly decreased (P<0.05).
CONCLUSION
The expression of PD-1、TIM-3 and VISTA in AML peripheral blood T cells may be involved in the immune escape of AML and can be the targets of treatment for acute myeloid leukemia patients.
B7 Antigens
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CD8-Positive T-Lymphocytes
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Flow Cytometry
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Hepatitis A Virus Cellular Receptor 2
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Humans
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Leukemia, Myeloid, Acute
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Programmed Cell Death 1 Receptor
7.Multivariate Analysis of Factors Influencing Recovery from Hemorrhagic Cystitis after Allo-HSCT.
Bing ZHANG ; Chen-Yuan HU ; Di YU ; Huan-Xin ZHANG ; Dong-Mei YAN ; Wei SANG ; Zhen-Yu LI ; Zhi-Ling YAN ; Kai-Lin XU
Journal of Experimental Hematology 2019;27(3):976-982
OBJECTIVE:
To analyze the incidence of hemorrhagic cystitis (HC) after allogeneic hematopoietic stem cell transplantation and the factors affecting HC, so as to provide clinical evidence for further treatment of HC.
METHODS:
The HC of 113 patients after allogeneic hematopoietic stem cell transplantation in Affiliated Hospital of Xuzhou Medical University between the years 2014-2016 was analyzed respectively. All cases of HC were divided into HC group and non-HC(control) group. The follow-up time: from preeonditionig day to 180 d after transplantation. The 10 clinical parameters were selected for univariate analysis with COX regression analysis: sex, age (<25 years and 25 years), primary disease, conditioning regimen with anti-thymoglobulin(ATG), sex-mismatch in recipients, haploidential HSCT, cytomegalovirus (CMV) viremia, EB viremia, graft-versus-host disease (GVHD), and primary disease relapse, the factors significant at the 0.1 level in univariate analysis should be further evaluated by multivariate analysis using a COX regression analysis. The difference was significant at P<0.05 in multivariate analysis.
RESULTS:
The HC occured in 31 of 113 patients (27.4%), with 5 cases of grade I (5.5%), 19 of grade II (16.8%), 5 of grade III (4.4%), and 2 of grade IV (1.8%). The median time of HC onset was 37 days (26-70 d) after transplantation. The median duration of HC was 14 days (5-55d). Univariate analysis showed that conditioning with anti-thymoglobulin (ATG) (RR=6.170, 95%CI: 1.875-20.306, P<0.01), CMV viremia (RR=7.633, 95%CI:2.318-25.133) (P<0.01), haploidentical HSCT (RR=0.307, 95%CI:0.137-0.686, P<0.01), GVHD (RR=1.891, 95%CI:0.918-3.898, P>0.05) were the risk factors for recovery from HC. The multivatiate analysis of above-mentioned risk factors with statistical significance showed that only CMV viremia (RR=4.770, 95%CI: 1.394-16.326, P<0.05) was the indentified risk factor affecting the recovery from HC.
CONCLUSION
Monitoring CMV viremia and antivirotic treatment are effective measurs to prevent the occurrence of HC and promote the recovery from HC.
Cystitis
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Graft vs Host Disease
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Hematopoietic Stem Cell Transplantation
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Humans
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Multivariate Analysis
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Retrospective Studies
;
Risk Factors
8.Ethical considerations of cellular immunotherapy for cancer.
Sang-Sang REN ; Jing-Wen DENG ; Meng HONG ; Yan-Li REN ; Hai-Jing FU ; Yan-Ning LIU ; Zhi CHEN
Journal of Zhejiang University. Science. B 2019;20(1):23-31
With the rapid development of immunology, molecular biology, and associated technologies such as next-generation sequencing, cellular immunotherapy has recently become the fourth major cancer treatment. Immunotherapies based on T cells, natural killer cells, and dendritic cells play key roles in cancer immunotherapy. However, their application in clinical practice raises several ethical issues. Thus, studies should focus on proper adherence to basic ethical principles that can effectively guide and solve related clinical problems in the course of treatment, improve treatment effects, and protect the rights and interests of patients. In this review, we discuss cellular immunotherapy-related ethical issues and highlight the ethical practices and current status of cellular immunotherapy in China. These considerations may supplement existing ethical standards in cancer immunotherapy.
China
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Dendritic Cells/immunology*
;
Humans
;
Immunity, Cellular
;
Immunotherapy/methods*
;
Killer Cells, Natural/immunology*
;
Neoplasms/therapy*
;
Patient Selection/ethics*
;
T-Lymphocytes/immunology*
9.Accuracy Assessment of Three-dimensional Surface Reconstructions of In vivo Teeth from Cone-beam Computed Tomography.
Yan-Hui SANG ; Hong-Cheng HU ; Song-He LU ; Yu-Wei WU ; Wei-Ran LI ; Zhi-Hui TANG ;
Chinese Medical Journal 2016;129(12):1464-1470
BACKGROUNDThe accuracy of three-dimensional (3D) reconstructions from cone-beam computed tomography (CBCT) has been particularly important in dentistry, which will affect the effectiveness of diagnosis, treatment plan, and outcome in clinical practice. The aims of this study were to assess the linear, volumetric, and geometric accuracy of 3D reconstructions from CBCT and to investigate the influence of voxel size and CBCT system on the reconstructions results.
METHODSFifty teeth from 18 orthodontic patients were assigned to three groups as NewTom VG 0.15 mm group (NewTom VG; voxel size: 0.15 mm; n = 17), NewTom VG 0.30 mm group (NewTom VG; voxel size: 0.30 mm; n = 16), and VATECH DCTPRO 0.30 mm group (VATECH DCTPRO; voxel size: 0.30 mm; n = 17). The 3D reconstruction models of the teeth were segmented from CBCT data manually using Mimics 18.0 (Materialise Dental, Leuven, Belgium), and the extracted teeth were scanned by 3Shape optical scanner (3Shape A/S, Denmark). Linear and volumetric deviations were separately assessed by comparing the length and volume of the 3D reconstruction model with physical measurement by paired t- test. Geometric deviations were assessed by the root mean square value of the imposed 3D reconstruction and optical models by one-sample t-test. To assess the influence of voxel size and CBCT system on 3D reconstruction, analysis of variance (ANOVA) was used (μ = 0.05).
RESULTSThe linear, volumetric, and geometric deviations were -0.03 ± 0.48 mm, -5.4 ± 2.8%, and 0.117 ± 0.018 mm for NewTom VG 0.15 mm group; -0.45 ± 0.42 mm, -4.5 ± 3.4%, and 0.116 ± 0.014 mm for NewTom VG 0.30 mm group; and -0.93 ± 0.40 mm, -4.8 ± 5.1%, and 0.194 ± 0.117 mm for VATECH DCTPRO 0.30 mm group, respectively. There were statistically significant differences between groups in terms of linear measurement (P < 0.001), but no significant difference in terms of volumetric measurement (P = 0.774). No statistically significant difference were found on geometric measurement between NewTom VG 0.15 mm and NewTom VG 0.30 mm groups (P = 0.999) while a significant difference was found between VATECH DCTPRO 0.30 mm and NewTom VG 0.30 mm groups (P = 0.006).
CONCLUSIONSThe 3D reconstruction from CBCT data can achieve a high linear, volumetric, and geometric accuracy. Increasing voxel resolution from 0.30 to 0.15 mm does not result in increased accuracy of 3D tooth reconstruction while different systems can affect the accuracy.
Cone-Beam Computed Tomography ; methods ; Humans ; Image Processing, Computer-Assisted ; methods ; Imaging, Three-Dimensional ; methods ; Tooth ; anatomy & histology ; pathology
10.Protective effects of luteolin against acetaminophen-induced damage in L02 liver cells.
Lan-Zhi HE ; Ya-Kun MENG ; Yan-Zhong HAN ; Zhen-Fang ZHANG ; Ping YIN ; Xiu-Xiu SANG ; Xiao-He XIAO ; Zhao-Fang BAI
China Journal of Chinese Materia Medica 2016;41(22):4234-4239
This paper was aimed to investigate the protective effects of luteolin (Lut) against acetaminophen(APAP)-induced damage in L02 liver cells. CCK-8 was used to detect the cell activation of L02 cells treated by different Lut. The concentration and time of APAP induced L02 cell damage was screened. The effect of Lut on APAP induced apoptosis of L02 cells was detected by cell morphological observation, CCK-8 assay and flow cytometry. The contents of MDA, GSH and SOD activity in cell supernatant were detected by colorimetric assay. The expression of apoptosis-related genes Bax, Bcl-2 and caspase-3 was detected by RT-PCR. The results showed that Lut in 2.5-40 μmol•L⁻¹ range does not affect the activity of L02 cells; 12 mmol•L⁻¹ APAP incubated with L02 cell 12 h to establish damage model. Compared with the model group, the cell status of Lut group was significantly improved, the cell body was increased, the adherence ability was recovered, and the apoptosis rate was obviously decreased. MDA content decreased significantly (P<0.05, P<0.01), GSH and SOD activity significantly increased (P<0.05, P<0.01), at the same time, it could up-regulate expression of Bcl-2 mRNA and down-regulate the expression of Bax and caspase-3 mRNA. In conclusion,Lut has protective effect on APAP induced L02 cell injury, and its mechanism may be related to the reduction of oxidative stress and inhibition of apoptosis.

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