1.Study of cognitive functional changes in children with spastic cerebral palsy using diffusion tensor imaging based graph theory analysis
Yanli YANG ; Jie HU ; Jingjing ZHANG ; Ying PENG ; Lisha NIE ; Cheng HE ; Hua YANG ; Heng LIU
Chinese Journal of Radiology 2024;58(3):266-272
Objective:To explore brain network properties and their relationship with cognitive function in children with spastic cerebral palsy (SCP) using diffusion tensor imaging (DTI) based graph theory analysis.Methods:The study was a cross-sectional study. Clinical and imaging data of 21 children with SCP (SCP group) and 32 healthy children (control group) who underwent cranial MRI at the Affiliated Hospital of Zunyi Medical University from August 2020 to April 2022 were analyzed retrospectively. 3D-T 1WI, DTI and Wechsler Intelligence Scale were assessed for all subjects. The Wechsler Intelligence Scale included the verbal comprehension index (VCI), the processing speed index (PSI), the work memory index (WMI), and the perceptual reasoning index (PRI), etc., and ultimately the full scale intelligence quotient (FSIQ) scores were obtained based on the indices of each subscale. Independent samples t-test was used to analyze the differences in the small world attributes [small-world index (σ), normalized shortest path length (λ), normalized clustering coefficients (γ)], global attributes [global efficiency (Eglob), local efficiency (Eloc), characteristic path length (Lp), clustering efficiency (Cp)] and node attributes [degree centrality(DC), nodal efficiency (Ne), betweeness centrality (Bc), nodal shortest path length (NLp), nodal clustering efficiency, nodal local efficiency] between two groups of children′s brain networks. Brain network indicators with statistically significant differences between the 2 groups were correlated with Wechsler Intelligence Scale scores using Spearman. Results:The FSIQ scores on the Wechsler Intelligence Scale and the VCI, WMI, PSI, and PRI were lower in the SCP group than in the control group, and the differences were all statistically significant (all P<0.05). Both groups of children′s brain networks had small world properties. Compared with the control group, Eglob decreased, Lp and λ increased in the SCP group (all P<0.05). Compared with the control group, DC and Ne in multiple brain regions decreased, NLp increased in the SCP group (all P<0.05, FDR corrected). Correlation analysis showed that DC in the right parsopercularis was positively correlated with FSIQ, VCI, WMI and PRI( r=0.53, 0.47, 0.47, 0.60, P=0.019, 0.045, 0.044, 0.020, respectively); NLp in the right parsopercularis was negatively correlated with PRI( r=-0.56, P=0.030); Ne in left paracentral, the right parsopercularis, right precentral, right postcentra were positively correlated with PRI( r=0.62, 0.56, 0.53, 0.54, P=0.015, 0.031, 0.044, 0.039, respectively); Ne in the right precentral was positively correlated with WMI ( r=0.48, P=0.039) in the SCP group. Conclusions:There are changes in the topological attributes of global and multiple regional brain networks in SCP. The changes in the attributes of nodes in the right parsopercularis, right precentral, right postcentral, and left paracentral could reflect cognitive dysfunction in children with SCP.
2.Risk signal mining of adverse events related to azithromycin in children based on US FDA Adverse Event Reporting System database and establishment of related pharmaceutical care process
Qinglan LIU ; Jianing ZHANG ; Jingsai SONG ; Zhifeng NIE ; Yanli REN ; Wenhui YANG
Adverse Drug Reactions Journal 2024;26(12):737-742
Objective:To mine the adverse events (AE) risk signal of azithromycin in children, establish the corresponding pharmaceutical care process, and provide reference for the safe use of azithromycin in clinic.Methods:AE caused by azithromycin in children (<18 years) were searched from the US FDA Adverse Event Reporting System (FAERS) database from the 1st quarter of 2004 to the 4th quarter of 2023. The AE was standardized and classified using the preferred term (PT) and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 26.1 version. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of azithromycin. AE that simultaneously met the following conditions was considered as a risk signal: the number of reports≥3, lower limit of the 95% confidence interval of ROR≥1, PRR>2, and χ2>4. Descriptive analysis on the signals was performed. The pharmaceutical care process of azithromycin for children was established based on the results of signal mining and satisfaction survey was conducted. Results:A total of 1 457 AE reports related to azithromycin in children were collected, involving 127 PTs and 18 SOCs. The top 5 PTs in the number of reports were rash, pruritus, urticaria, drug hypersensitivity and diarrhea. The top 5 PTs in signal intensity were infantile diarrhea, myasthenia gravis crisis, intermittent explosive disorder, diarrhea neonatal, and infantile vomiting. A total of 16 risk signals that were not recorded in the label were mined out, and the top 5 PTs according to signal intensity were intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis. The analysis of 79 AE reports with death outcomes showed that drug-induced liver injury, Stevens-Johnson syndrome, rash, vomiting, nausea, cyanosis, and diarrhea were related risk signals. Based on the signal mining results mentioned above, the medication safety officer team in our hospital established a pharmaceutical care process of azithromycin application for children, including pre-medication assessment (indications, medical history, heart and liver function, etc.), speed and mode of administration monitoring during the medication, and intervention measures after the occurrence of adverse reactions, and 178 hospitalized children who received azithromycin treatment were monitored. The satisfaction survey results showed the degree of satisfaction was 100%.Conclusions:The main AEs related to azithromycin in children are rash, pruritus, urticaria, drug hypersensitivity, and diarrhea, all of which are recorded in the label. In addition, we should also be vigilant against the risk signals such as intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis, which are not recorded in the label. The pharmaceutical care process for azithromycin use in children based on the risk signal mining results is feasible and effective.
3.Risk signal mining of adverse events related to azithromycin in children based on US FDA Adverse Event Reporting System database and establishment of related pharmaceutical care process
Qinglan LIU ; Jianing ZHANG ; Jingsai SONG ; Zhifeng NIE ; Yanli REN ; Wenhui YANG
Adverse Drug Reactions Journal 2024;26(12):737-742
Objective:To mine the adverse events (AE) risk signal of azithromycin in children, establish the corresponding pharmaceutical care process, and provide reference for the safe use of azithromycin in clinic.Methods:AE caused by azithromycin in children (<18 years) were searched from the US FDA Adverse Event Reporting System (FAERS) database from the 1st quarter of 2004 to the 4th quarter of 2023. The AE was standardized and classified using the preferred term (PT) and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 26.1 version. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of azithromycin. AE that simultaneously met the following conditions was considered as a risk signal: the number of reports≥3, lower limit of the 95% confidence interval of ROR≥1, PRR>2, and χ2>4. Descriptive analysis on the signals was performed. The pharmaceutical care process of azithromycin for children was established based on the results of signal mining and satisfaction survey was conducted. Results:A total of 1 457 AE reports related to azithromycin in children were collected, involving 127 PTs and 18 SOCs. The top 5 PTs in the number of reports were rash, pruritus, urticaria, drug hypersensitivity and diarrhea. The top 5 PTs in signal intensity were infantile diarrhea, myasthenia gravis crisis, intermittent explosive disorder, diarrhea neonatal, and infantile vomiting. A total of 16 risk signals that were not recorded in the label were mined out, and the top 5 PTs according to signal intensity were intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis. The analysis of 79 AE reports with death outcomes showed that drug-induced liver injury, Stevens-Johnson syndrome, rash, vomiting, nausea, cyanosis, and diarrhea were related risk signals. Based on the signal mining results mentioned above, the medication safety officer team in our hospital established a pharmaceutical care process of azithromycin application for children, including pre-medication assessment (indications, medical history, heart and liver function, etc.), speed and mode of administration monitoring during the medication, and intervention measures after the occurrence of adverse reactions, and 178 hospitalized children who received azithromycin treatment were monitored. The satisfaction survey results showed the degree of satisfaction was 100%.Conclusions:The main AEs related to azithromycin in children are rash, pruritus, urticaria, drug hypersensitivity, and diarrhea, all of which are recorded in the label. In addition, we should also be vigilant against the risk signals such as intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis, which are not recorded in the label. The pharmaceutical care process for azithromycin use in children based on the risk signal mining results is feasible and effective.
4.Report quality assessment and study characteristic analysis of randomized controlled trials published in Chinese Journal of Health Management
Yanli NIE ; Jie YANG ; Zhanying SHI ; Lin ZENG
Chinese Journal of Health Management 2020;14(4):339-344
Objective:To evaluate the report quality and study characteristics of randomized controlled trials (RCT) published in the Chinese Journal of Health Management.Methods:All studies published in the Chinese Journal of Health Management from January 2007 to July 2019 were retrieved via Wanfang data. Two researchers screened the articles strictly according to the inclusion and exclusion criteria independently. Based on the Consolidated Standards of Reporting Trials (CONSORT) statement 2010, the report quality and characteristics of the articles (including the type of participants, recruiting site, interventions, outcome measure, etc.) were extracted and summarized. Then the report quality, study characteristics were analysed among three periods based on the publishing date (2008—2011 , 2012—2015 , 2016—2019). Results:Titles, abstracts, and full text manuscripts were screened against inclusion criteria by two independent reviewers and 57 studies were included. There were 13/25 items of the CONSORT statement were fulfilled completely, the other 8/25 items were partly fulfilled, and the else 4/25 items were not met the standards in these studies. There was statistically significant difference in the description ratio of ‘randomization sequence generation’ (16.7% vs. 47.6% vs. 66.7%), foundation (25.0% vs. 33.3% vs. 75.0%) and informed consent (50.0% vs. 76.2% vs. 100.0%) during the three periods (all P<0.05). There was no statistically significant difference in the proportion of chronic diseases (58.3% vs. 85.7% vs. 66.7%), the description ratio of participant flow (41.7% vs. 33.3% vs. 75.0%) and baseline data (83.3% vs. 95.2% vs. 100.0%) in the studies from different periods, however, the description situation of participant flow and baseline data has been improved along the time. Conclusion:According to the CONSORT statement, it is found that the quality of research in health management still needs to be improved, especially in the concealment of randomization and trial registration.
5.Correlation between quantitative expression of T lymphoma invasion and metastasis inducing factor 1 mRNA and lymph node micrometastasis and prognosis in patients with colorectal cancer
Shaoping LIU ; Hai ZHANG ; Lei NIE ; Yahua HU ; Xianfeng ZHANG ; Yanli ZHU
Chinese Journal of Digestion 2016;36(8):526-531
Objective To investigate the relationship between the changes of expression of T lymphoma invasion and metastasis inducing factor 1 (Tiam1) mRNA and lymph node micrometastasis and prognosis in patients with node-negative colorectal cancer(CRC).Methods From June 2008 to August 2010,a total of 63 patients with lymph node-negative CRC,20 patients with lymph node-positive CRC and 25 patients with colorectal benign lesions were enrolled.The relative quantity expression (RQ) of Tiam1 mRNA in CRC cancer tissues and colorectal benign lesions were detected by real-time quantitative polymerase chain reaction (PCR).The lymph node micrometastasis was determined by cytokeratin 20 detection in lymph nodes tissues.The five-year postoperative prognosis was evaluated by followed-up in the patients with lymph node-negative CRC.The correlation between the expression of Tiam1 mRNA and lymph node micrometastasis and prognosis was analyzed.The t-test,univariate analysis,multivariate analysis and Log-rank test were performed for statistical analysis.Results Lymphnode micrometastasis occurred in 33 from 63 patients with lymph node-negative CRC.The RQ of Tiam1 mRNA in the patients with lymph node-positive CRC was 9.84±-2.36,which was higher than that of patients with lymph node-negative CRC (5.15±3.58),and the difference was statistically significant (t=5.479,P<0.01).The RQ of Tiam1 mRNA of these two groups were both higher than that of colorectal benign lesion (0.30± 0.21),and the difference was statistically significant(t=20.169,6.745;both P<0.01).The RQ of Tiam1 mRNA of positive lymph node micrometastasis group was 6.30±1.95,which was higher than that of negative lymph node micrometastasis group (3.88 ± 1.63),and the difference was statistically significant (t=5.330,P<0.01).In the patients with lymph node-negative CRC,the lower degree of tumor difference,the deeper invasion,the shorter survival time after surgery and postoperative recurrence and metastasis were related with the higher RQ of Tiam1 mRNA in tumor tissues (t=2.536,3.112,3.213,2.676;all P<0.05).Univariate analysis revealed that the expression of Tiam1 mRNA in cancer tissues was correlated with lymph node micrometastases(x2=11.878,P =0.001).Multivariate analysis showed that it was an independent risk factors of lymph node micrometastases in CRC (relative risk:9.782).The five-year postoperative cumulative survival rate of high Tiaml mRNA expression group was 75.8 %,which was lower than that of low expression group (97.1 %),and the difference was statistically significant (x2 =4.575,P<0.05).Conclusions Tiam1 may participate in the regulation of lymph node metastasis in CRC.Elevated expression of Tiam1 promotes lymph node metastasis and is closely relatived with poor prognosis of node-negative CRC,and which can be considered as an indicator of prognosis.
6.Relationship between quantitative detection of hTERT mRNA in peripheral blood and metachronous liver metastasis and prognosis of patients with colorectal cancer
Shaoping LIU ; Hai ZHANG ; Lei NIE ; Xianfeng ZHANG ; Yanli ZHU ; Yahua HU
Journal of Chinese Physician 2016;18(1):47-51
Objective To investigate the correlation between quantitative detection of human telomerase reverse transcriptase (hTERT) mRNA in peripheral blood and metachronous liver metastasis and prognosis of colorectal cancer (CRC).Methods The quantitative expression of hTERT mRNA in pre-and post-operative peripheral blood were detected with real-time fluorescence quantitative real-time polymerase chain reaction (RT-PCR) in 168 patients with CRC and normal controls.The postoperative 3 years,prognosis of the CRC patients were followed-up.The relationship between peripheral blood hTERT mRNA expression levels and the metachronous liver metastasis and prognosis of CRC were analyzed.Results The hTERT mRNA expressions in preoperative,6 month postoperative peripheral blood in postoperative liver metastases group were significantly higher than those in the postoperative non-metachronous liver metastases group in the same term [(8.35 ± 5.86) (2-△ △Ct) vs (4.42 ± 2.88) (2-△ △Ct),(1.87 ± 1.85) (2-△ △Ct) vs (1.03 ± 0.92) (2-△△Ct),P < 0.01].The hTERT mRNA expressions in preoperative peripheral blood of CRC group were positively related to the differentiated degree of tumor,tumor size,lymph node metastasis(P < 0.05 or P < 0.01),and were negatively related to the postoperative survival(P < 0.01).Univariate analysis revealed that hTERT mRNA expressions in preoperative and 6 months postoperative peripheral blood were all correlated with postoperative liver metastases from CRC.Multivariate Cox analysis showed that they were independent risk factors for postoperative CRC liver metastases(EXP =4.282,9.171).The 3 year survival rate of the postoperative CRC liver metastases group was significantly lower than that of the postoperative non-CRC liver metastases group.Conclusions hTERT mRNA expressions in preoperative peripheral blood are related to the important pathologic feature,postoperative liver metastasis and prognosis of CRC.hTERT mRNA expressions in preoperative and 6 months postoperative peripheral blood might be a predictive biomarker for CRC metachronous liver metastases.The elevation of hTERT mRNA expression levels in postoperative peripheral blood were related to postoperative CRC liver metastasis.
7.The study of the association of impairment of cognition and performance-based skills with clinical symp- toms in drug-na?ve first-episode schizophrenia patients
Dachun CHEN ; Kebing YANG ; Yanli LI ; Ning WANG ; Ying NIE ; Jiefeng CUI ; Xiangyang ZHANG
Chinese Journal of Nervous and Mental Diseases 2015;(1):26-31
Objective To evaluate cognitive impairment and performance-based skills and to explore their rela?tionships with clinical phenotypes in drug-na?ve first-episode patients with schizophrenia. Methods One hundred and forty-five inpatients and 65 healthy controls matched for age, gender and education were recruited. The MATRICS Con?sensus Cognitive Battery (MCCB), Stroop, digit span test, emotional recognition test, University of California, San Diego, Performance-based Skill Assessment (UPSA) and Positive Negative Syndrome Scale scale (PANSS) were used to evaluate cognitive function, life skill and symptoms, respectively. Results Compared with the controls, total score of MCCB and scores of 10 subscales, scores of digit span, emotional recognition and Stroop were significantly lower in patients (all P<0.05). The UPSA total score and scores of financial skill and communication skill were lower in patients than in controls (all P<0.05). Verbal memory, visual memory , Stroop, communication skill scores and total UPSA standard score were sig?nificantly higher in patients with paranoid subtype of schizophrenia than in patients with non-paranoid subtype of schizo? phrenia (all P<0.05). The score of MCCB associated with education years (OR=1.29, 95%CI: 1.13~1.47) and PANSS (OR=0.95, 95%CI:0.92~0.97). Conclusions First-episode, drug-naive patients with schizophrenia have markedly cog?nitive and performance-based skills deficits, which are associated with clinical symptoms. These deficits are differences between paranoid subtype and non-paranoid subtype of schizophrenia.
8.Correlation between cognitive function and P50 sensory gating in patients with drug-na¨ive first-episode schizophrenia
Dachun CHEN ; Yanli LI ; Kebing YANG ; Ning WANG ; Ying NIE ; Jinguo ZHANG ; Xiangyang ZHANG
Chinese Mental Health Journal 2015;(10):733-737
Objective:To explore the relation of cognitive function correlates to P50 sensory gating in patients with schizophrenia.Methods:Totally 106 patients with drug-na¨ive first-episode schizophrenia and 86 healthy con-trol subjects matched for age,sex and education were recruited.All patients met the Diagnostic and Statistical Man-ual of Mental Disorders,Fourth Edition (DSM-IV)criteria for schizophrenia.Their cognitive function were assessed with the MATRICS Consensus Cognitive Battery (MCCB).The P50 auditory gating potential were recorded in all subjects using conditioning-testing stimulus paradigm and stimulus train paradigm.The P50 components were meas-ured in S1 S2 latency,S1 S2 amplitude and P50 suppression ratios.Results:Compared with the controls subjects, the patients with schizophrenia had significantly longer S1[60.8 ±7.8)ms vs.(56.3 ±7.0)ms,P <0.05]S2 la-tency [(59.1 ±10.2)ms vs.(55.7 ±10.7)ms,P <0.05],lower S1 amplitude [(2.8 ±1.8)μV vs.(3.5 ±1.6)μV,P <0.05],less amplitude difference (S1-S2)[(1.5 ±1.8)μV vs.(2.2 ±1.4)μV,P <0.05]and higher P50 suppression ratios (S2 /S1 )[(59.7 ±65.6)vs.(37.6 ±30.0),P <0.05].Schizophrenia patients had lower score than control subjects in all cognitive domains of MCCB (Ps <0.05).No differences in neurocognitive performance were found between subjects in the normal P50 ratio and the abnormal in healthy controls or patients with schizo-phrenia (Ps >0.05).No significant correlation was found between P50 gating measures (P50 ratio and P50 ampli-tude difference)and neuropsychological measures in MCCB scores (Ps >0.05).Conclusion:There may be no as-sociation between P50 deficits and cognitive measures in patients with drug-na¨ive first-episode schizophrenia.
9.Comparison of the characteristics of several polymer materials used in hydrophilic matrix tablets.
Shufang NIE ; Hui LIU ; Yanli LIU ; Weisan PAN
Acta Pharmaceutica Sinica 2011;46(3):338-43
Pure and drug hydrophilic matrix tablets were prepared by direct compression method with theophylline as a model drug. The characteristics of four hydrophilic matrix polymers, hydroxypropylmethylcellulose (HPMC), polyethylene oxide (PEO), sodium alginate (NaAlg) and xanthan gum (XG), were compared by investigating the water absorption, swelling, erosion and gel layer strength. The sequence of water absorption rate was XG >> NaAlg (H) > PEO > NaAlg (L) >> HPMC; The sequence of swelling index was XG >> PEO >> HPMC >> NaAlg; The sequence of erosion rate was NaAlg (L) > NaAlg (H) >> PEO80 > PEO200 > PEO300 > XG approximately PEO400 approximately K4M > K15M > PEO600 approximately K100M; The sequence of the gel layer strength was PEO > HPMC > XG >> NaAlg. For the PEO and HPMC matrix tablets, with the polymer molecular weight increased, the drug release mechanism was gradually transferred from mainly depending on the erosion to the diffusion; for SAL matrix tablets, the drug release mainly depends on erosion mechanism; and for XG matrix tablets, the drug release mainly depends on non-Fick diffusion mechanism. Comparison of the performance difference between the polymer materials will contribute to rational design and prediction of drug release behaviors from matrix tables and ultimately to achieve clinical needs.
10.Study on the anti-tumor effect of paclitaxel mixed micelle by using in vivo optical imaging technique.
Wen TAI ; Minmin SUN ; Nan LIU ; Zhiqi HUANG ; Shanghai NIE ; Yanli HAO ; Xiaoning ZHANG
Acta Pharmaceutica Sinica 2010;45(4):530-4
In vivo tumor imaging technique method based on bioluminescence principle was established to evaluate the anti-tumor effect of paclitaxel mixed micelle (PMM). MDA-MB-231 tumor cells with luciferase reporter vectors were firstly implanted into nude mice, and subsequently the luciferase substrate was regularly injected during intraperitoneal administration of PMM. Then the tumor size, growth and the intensity of light signals were monitored with in vivo imaging technique. The method of luciferase tumor in vivo imaging could be real-time, reliable and exact in labeling and reflecting the growth of tumors, and the observed results were consistent with that by conventional method, so it would be a feasible approach to study anti-tumor effect of drugs. The anti-tumor effect of paclitaxel mixed micelle was observed by this method, and the results showed that this formulation could inhibit growth of tumor, and the anti-tumor rate of it was about 85%.

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