1.Study thought of pharmaceutical preparations quality standards by dynamic quality control technology.
Dan-Hong YU ; Chen-Mei MAO ; Cheng-Zhe LV ; Hui-Zhen JIN ; Xin YAO ; Xiao-Bin JIA
China Journal of Chinese Materia Medica 2014;39(14):2787-2790
Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.
Drug Compounding
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standards
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Medicine, Chinese Traditional
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standards
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Quality Control
2.Measurement of avidity of serum autoantibodies to Aβs and its significance in patients with Alzheimer's disease
Jian-Ping LV ; Zhi-Kai CAO ; Wei QUAN ; Jun-Tao ZOU ; Zhi-Bin YAO
Chinese Journal of Neuromedicine 2009;8(11):1152-1155
Objective To measure the avidity of serum autoantibodies to Aβs in patients with Alzheimer's disease (AD). Methods Enzyme-linked immtmoserbent assay (ELISA) combined with thiocyanate elution technique was employed to detect the avidity of serum autoantibodies to Aβs in patients with AD, middle-aged and healthy elderly adults (n=20). Results The avidity of serum autoantibodies to Aβs in patients with AD (avidity index, 1.6 [1.15 to 2.05]) was significantly lower as compared with that in healthy elderly subjects (avidity index, 2.45 [1.75 to 3.08]) (P=0.020) and no significant difference was showed in the avidity of autoantibodies to Aβs between the elderly and middle-aged healthy adults (P=0.221). An evident shift to the low section was observed in patients with AD in the avidity distribution histogram. The proportion of low affinity antibodies was significantly higher in patients with AD (13% [5% to 18%]) than that in healthy elderly subjects (5% [3% to 10%]) (P =0.000), and the proportion of high affinity antibodies was significantly lower in patients with AD (15% [5% to 24%]) than that in elderly adults (35% [26% to 44%]) (P=0.006). Conclusion Low avidity of autoantibodies to Aβs is confirmed in AD patients. Patients with AD show a significantly high proportion of low affinity antibodies than normal adults and the components of polyclonal antibodies change in patients with AD, probably resulting from incomplete immune tolerance of B cells.
3.Integrative molecular characterization of Chinese prostate cancer specimens.
Shi-Dong LV ; Hong-Yi WANG ; Xin-Pei YU ; Qi-Liang ZHAI ; Yao-Bin WU ; Qiang WEI ; Wen-Hua HUANG
Asian Journal of Andrology 2020;22(2):162-168
Prostate cancer (PCa) exhibits epidemiological and molecular heterogeneity. Despite extensive studies of its phenotypic and genetic properties in Western populations, its molecular basis is not clear in Chinese patients. To determine critical molecular characteristics and explore correlations between genomic markers and clinical parameters in Chinese populations, we applied an integrative genetic/transcriptomic assay that combines targeted next-generation sequencing and quantitative real-time PCR (qRT-PCR) on samples from 46 Chinese patients with PCa. Lysine (K)-specific methyltransferase 2D (KMT2D), zinc finger homeobox 3 (ZFHX3), A-kinase anchoring protein 9 (AKAP9), and GLI family zinc finger 1 (GLI1) were frequently mutated in our cohort. Moreover, a clinicopathological analysis showed that RB transcriptional corepressor 1 (RB1) deletion was common in patients with a high risk of disease progression. Remarkably, four genomic events, MYC proto-oncogene (MYC) amplification, RB1 deletion, APC regulator of WNT signaling pathway (APC) mutation or deletion, and cyclin-dependent kinase 12 (CDK12) mutation, were correlated with poor disease-free survival. In addition, a close link between KMT2D expression and the androgen receptor (AR) signaling pathway was observed both in our cohort and in The Cancer Genome Atlas Prostate Adenocarcinoma (TCGA-PRAD) data. In summary, our results demonstrate the feasibility and benefits of integrative molecular characterization of PCa samples in disease pathology research and personalized medicine.
A Kinase Anchor Proteins/genetics*
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Adult
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Aged
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Biomarkers, Tumor/genetics*
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China
;
Cytoskeletal Proteins/genetics*
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DNA-Binding Proteins/genetics*
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Gene Amplification
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High-Throughput Nucleotide Sequencing
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Homeodomain Proteins/genetics*
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Humans
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Male
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Middle Aged
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Mutation
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Neoplasm Proteins/genetics*
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Prostatic Neoplasms/pathology*
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Proto-Oncogene Mas
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Receptors, Androgen/genetics*
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Signal Transduction/genetics*
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Zinc Finger Protein GLI1/genetics*
4.Phosphoglycerate mutase 1 knockdown inhibits prostate cancer cell growth, migration, and invasion.
Yao-An WEN ; Bo-Wei ZHOU ; Dao-Jun LV ; Fang-Peng SHU ; Xian-Lu SONG ; Bin HUANG ; Chong WANG ; Shan-Chao ZHAO
Asian Journal of Andrology 2018;20(2):178-183
Phosphoglycerate mutase 1 (PGAM1) is upregulated in many cancer types and involved in cell proliferation, migration, invasion, and apoptosis. However, the relationship between PGAM1 and prostate cancer is poorly understood. The present study investigated the changes in PGAM1 expression in prostate cancer tissues compared with normal prostate tissues and examined the cellular function of PGAM1 and its relationship with clinicopathological variables. Immunohistochemistry and Western blotting revealed that PGAM1 expression was upregulated in prostate cancer tissues and cell lines. PGAM1 expression was associated with Gleason score (P = 0.01) and T-stage (P = 0.009). Knockdown of PGAM1 by siRNA in PC-3 and 22Rv1 prostate cancer cell lines inhibited cell proliferation, migration, and invasion and enhanced cancer cell apoptosis. In a nude mouse xenograft model, PGAM1 knockdown markedly suppressed tumor growth. Deletion of PGAM1 resulted in decreased expression of Bcl-2, enhanced expression of Bax, caspases-3 and inhibition of MMP-2 and MMP-9 expression. Our results indicate that PGAM1 may play an important role in prostate cancer progression and aggressiveness, and that it might be a valuable marker of poor prognosis and a potential therapeutic target for prostate cancer.
Animals
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Apoptosis/genetics*
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Caspase 3/metabolism*
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Cell Line, Tumor
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Cell Movement/genetics*
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Cell Proliferation/genetics*
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Gene Deletion
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Gene Knockdown Techniques
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Humans
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Male
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Matrix Metalloproteinase 2/metabolism*
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Matrix Metalloproteinase 9/metabolism*
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Mice
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Mice, Nude
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Neoplasm Invasiveness/genetics*
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Neoplasm Transplantation
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PC-3 Cells
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Phosphoglycerate Mutase/genetics*
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Prostatic Neoplasms/pathology*
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Proto-Oncogene Proteins c-bcl-2/metabolism*
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RNA, Small Interfering
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Transplantation, Heterologous
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bcl-2-Associated X Protein/metabolism*
5.Transanal drainage tube for prevention of anastomotic leak after anterior resection for rectal cancer: a meta-analysis.
Cheng Ren ZHANG ; Shi Yun XU ; Yao Chun LV ; Bin Bin DU ; De Wang WU ; Jing Jing LI ; Cheng Zhang ZHU ; Xiong Fei YANG
Chinese Journal of Gastrointestinal Surgery 2023;26(7):689-696
Objective: To assess the effectiveness of transanal drainage tube (TDT) in reducing the incidence of anastomotic leak following anterior resection in patients with rectal cancer. Methods: We conducted a systematic search for relevant studies published from inception to October 2022 across multiple databases, including PubMed, Embase, Web of Science, Cochrane Library, CNKI, Wanfang, and VIP. Meta-analysis was performed using Review Manager 5.4 software. The primary outcomes included total incidence of anastomotic leak, grade B and C anastomotic leak rates, reoperation rate, anastomotic bleeding rate, and overall complication rate. Results: Three randomized controlled trials involving 1115 patients (559 patients in the TDT group and 556 in the non-TDT group) were included. Meta-analysis showed that the total incidences of anastomotic leak and of grade B anastomotic leak were 5.5% (31/559) and 4.5% (25/559), respectively, in the TDT group and 7.9% (44/556) and 3.8% (21/556), respectively, in the non-TDT group. These differences are not statistically significant (P=0.120, P=0.560, respectively). Compared with the non-TDT group, the TDT group had a lower incidence of grade C anastomotic leak (1.6% [7/559] vs. 4.5% [25/556]) and reoperation rate (0.9% [5/559] vs. 4.3% [24/556]), but a higher incidence of anastomotic bleeding (8.2% [23/279] vs. 3.6% [10/276]). These differences were statistically significant (P=0.003, P=0.001, P=0.030, respectively). The overall complication rate was 26.5%(74/279) in the TDT group and 27.2% (75/276) in the non-TDT group. These differences are not statistically significant (P=0.860). Conclusions: TDT did not significantly reduce the total incidence of anastomotic leak but may have potential clinical benefits in preventing grade C anastomotic leak. Notably, placement of TDT may increase the anastomotic bleeding rate.
Humans
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Anastomotic Leak/etiology*
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Rectal Neoplasms/complications*
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Drainage
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Anastomosis, Surgical/adverse effects*
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Reoperation/adverse effects*
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Hemorrhage
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Retrospective Studies
6.Establishing a nonlethal and efficient mouse model of male gonadotoxicity by intraperitoneal busulfan injection.
Yun XIE ; Cun-Can DENG ; Bin OUYANG ; Lin-Yan LV ; Jia-Hui YAO ; Chi ZHANG ; Hai-Cheng CHEN ; Xiao-Yan LI ; Xiang-Zhou SUN ; Chun-Hua DENG ; Gui-Hua LIU
Asian Journal of Andrology 2020;22(2):184-191
An ideal animal model of azoospermia would be a powerful tool for the evaluation of spermatogonial stem cell (SSC) transplantation. Busulfan has been commonly used to develop such a model, but 30%-87% of mice die when administered an intraperitoneal injection of 40 mg kg-1. In the present study, hematoxylin and eosin staining, Western blot, immunofluorescence, and quantitative real-time polymerase chain reaction were used to test the effects of busulfan exposure in a mouse model that received two intraperitoneal injections of busulfan at a 3-h interval at different doses (20, 30, and 40 mg kg-1) on day 36 or a dose of 40 mg kg-1 at different time points (0, 9, 18, 27, 36, and 63 days). The survival rate of the mice was 100%. When the mice were treated with 40 mg kg-1 busulfan, dramatic SSC depletion occurred 18 days later and all of the germ cells were cleared by day 36. In addition, the gene expressions of glial cell line-derived neurotrophic factor (GDNF), fibroblast growth factor 2 (FGF2), chemokine (C-X-C Motif) ligand 12 (CXCL12), and colony-stimulating factor 1 (CSF1) were moderately increased by day 36. A 63-day, long-term observation showed the rare restoration of endogenous germ cells in the testes, suggesting that the potential period for SSC transplantation was between day 36 and day 63. Our results demonstrate that the administration of two intraperitoneal injections of busulfan (40 mg kg-1 in total) at a 3-h interval to mice provided a nonlethal and efficient method for recipient preparation in SSC transplantation and could improve treatments for infertility and the understanding of chemotherapy-induced gonadotoxicity.
Adult Germline Stem Cells/transplantation*
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Animals
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Azoospermia/chemically induced*
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Busulfan/toxicity*
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Disease Models, Animal
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Infertility, Male/chemically induced*
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Injections, Intraperitoneal
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Male
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Mice
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Spermatogenesis/drug effects*
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Spermatogonia/drug effects*
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Stem Cell Transplantation/methods*
7.Mediation effect of inflammatory biomarkers on the association between blood lead levels and blood pressure changes in Chinese adults.
Ying Li QU ; Feng ZHAO ; Sai Sai JI ; Xiao Jian HU ; Zheng LI ; Miao ZHANG ; Ya Wei LI ; Yi Fu LU ; Jia Yi CAI ; Qi SUN ; Hao Can SONG ; Dan Dan LI ; Xu Lin ZHENG ; Bing WU ; Yao Bin LV ; Ying ZHU ; Zhao Jin CAO ; Xiao Ming SHI
Chinese Journal of Preventive Medicine 2022;56(11):1591-1596
Objective: To investigate the role of inflammatory biomarkers in the relationship between blood lead levels and blood pressure changes. Methods: A total of 9 910 people aged 18-79 years who participated in the China National Human Biomonitoring in 2017-2018 were included in this study. A self-made questionnaire was used to collect demographic characteristics, lifestyle and other information, and the data including height, weight and blood pressure were determined through physical examination. Blood and urinary samples were collected for the detection of blood lead and cadmium levels, urinary arsenic levels, white blood cells, neutrophils, lymphocytes, and hypersensitive C-reactive protein (hs-CRP). Weighted linear regression models were used to evaluate the associations between blood lead, inflammatory biomarkers and blood pressure. Mediation analysis was performed to investigate the role of inflammation in the relationship between blood lead levels and blood pressure changes. Results: The median (Q1, Q3) age of all participants was 45.4 (33.8, 58.4)years, including 4 984 males accounting for 50.3%. Multivariate logistic regression model analysis showed that after adjusting for age, gender, residence area, BMI, education level, smoking and drinking status, family history of hypertension, consumption frequency of rice, vegetables, and red meat, fasting blood glucose, total cholesterol, triglycerides, blood cadmium and urinary arsenic levels, there was a positive association between blood lead levels, inflammatory biomarkers and blood pressure (P<0.05). Each 2.71 μg/L (log-transformed) increase of the lead was associated with a 2.05 (95%CI: 0.58, 3.53) mmHg elevation in systolic blood pressure (SBP), 2.24 (95%CI: 1.34, 3.14) mmHg elevation in diastolic blood pressure (DBP), 0.25 (95%CI: 0.05, 0.46) mg/L elevation in hs-CRP, 0.16 (95%CI: 0.03, 0.29)×109/L elevation in white blood cells, and 0.11 (95%CI: 0.02, 0.21)×109/L elevation in lymphocytes, respectively. Mediation analysis showed that the levels of hs-CRP significantly mediated the association of blood lead with SBP, with a proportion about 3.88% (95%CI: 0.45%, 7.32%). The analysis also found that the levels of hs-CRP and neutrophils significantly mediated the association of blood lead with SBP, with a proportion about 4.10% (95%CI: 1.11%, 7.10%) and 2.42% (95%CI: 0.07%, 4.76%), respectively. Conclusion: This study suggests that inflammatory biomarkers could significantly mediate the association of blood lead levels and blood pressure changes.
Adult
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Male
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Humans
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Blood Pressure/physiology*
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C-Reactive Protein/analysis*
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Lead
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Arsenic/analysis*
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Cadmium
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Biomarkers
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Hypertension/epidemiology*
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China/epidemiology*
8.Clinical practice guideline for body composition assessment based on upper abdominal magnetic resonance images annotated using artificial intelligence.
Han LV ; Mengyi LI ; Zhenchang WANG ; Dawei YANG ; Hui XU ; Juan LI ; Yang LIU ; Di CAO ; Yawen LIU ; Xinru WU ; He JIN ; Peng ZHANG ; Liqin ZHAO ; Rixing BAI ; Yunlong YUE ; Bin LI ; Nengwei ZHANG ; Mingzhu ZOU ; Jinghai SONG ; Weibin YU ; Pin ZHANG ; Weijun TANG ; Qiyuan YAO ; Liheng LIU ; Hui YANG ; Zhenghan YANG ; Zhongtao ZHANG
Chinese Medical Journal 2022;135(6):631-633