1.Surveillance of antifungal resistance in clinical isolates of Candida spp.in East China Invasive Fungal Infection Group from 2018 to 2022
Dongjiang WANG ; Wenjuan WU ; Jian GUO ; Min ZHANG ; Huiping LIN ; Feifei WAN ; Xiaobo MA ; Yueting LI ; Jia LI ; Huiqiong JIA ; Lingbing ZENG ; Xiuhai LU ; Yan JIN ; Jinfeng CAI ; Wei LI ; Zhimin BAI ; Yongqin WU ; Hui DING ; Zhongxian LIAO ; Gen LI ; Hui ZHANG ; Hongwei MENG ; Changzi DENG ; Feng CHEN ; Na JIANG ; Jie QIN ; Guoping DONG ; Jinghua ZHANG ; Wei XI ; Haomin ZHANG ; Rong TANG ; Li LI ; Suzhen WANG ; Fen PAN ; Jing GAO ; Lu JIANG ; Hua FANG ; Zhilan LI ; Yiqun YUAN ; Guoqing WANG ; Yuanxia WANG ; Liping WANG
Chinese Journal of Infection and Chemotherapy 2024;24(4):402-409
Objective To monitor the antifungal resistance of clinical isolates of Candida spp.in the East China region.Methods MALDI-TOF MS or molecular methods were used to re-identify the strains collected from January 2018 to December 2022.Antifungal susceptibility testing was performed using the broth microdilution method.The susceptibility test results were interpreted according to the breakpoints of 2022 Clinical and Laboratory Standards Institute(CLSI)documents M27 M44s-Ed3 and M57s-Ed4.Results A total of 3 026 strains of Candida were collected,65.33%of which were isolated from sterile body sites,mainly from blood(38.86%)and pleural effusion/ascites(10.21%).The predominant species of Candida were Candida albicans(44.51%),followed by Candida parapsilosis complex(19.46%),Candida tropicalis(13.98%),Candida glabrata(10.34%),and other Candida species(0.79%).Candida albicans showed overall high susceptibility rates to the 10 antifungal drugs tested(the lowest rate being 93.62%).Only 2.97%of the strains showed dose-dependent susceptibility(SDD)to fluconazole.Candida parapsilosis complex had a SDD rate of 2.61%and a resistance rate of 9.42%to fluconazole,and susceptibility rates above 90%to other drugs.Candida glabrata had a SDD rate of 92.01%and a resistance rate of 7.99%to fluconazole,resistance rates of 32.27%and 48.24%to posaconazole and voriconazole non-wild-type strains(NWT),respectively,and susceptibility rates above 90%to other drugs.Candida tropicalis had resistance rates of 29.55%and 26.24%to fluconazole and voriconazole,respectively,resistance rates of 76.60%and 21.99%to posaconazole and echinocandins non-wild-type strains(NWT),and a resistance rate of 2.36%to echinocandins.Conclusions The prevalence and species distribution of Candida spp.in the East China region are consistent with previous domestic and international reports.Candida glabrata exhibits certain degree of resistance to fluconazole,while Candida tropicalis demonstrates higher resistance to triazole drugs.Additionally,echinocandins resistance has emerged in Candida albicans,Candida glabrata,Candida tropicalis,and Candida parapsilosis.
2.Analysis of the Collation Records for Proof-Reading Method in Song's Edition of Bei Ji Qian Jin Yao Fang(Invaluable Prescriptions for Emergencies)
Feng PAN ; Nan LI ; Wen-Fei LI ; Feng ZENG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(1):257-261
With reference to Xin Diao Sun Zhen Ren Qian Jin Fang,the Xindiao's edition of Bei Ji Qian Jin Yao Fang(Invaluable Prescriptions for Emergencies)which was the popular edition before official block printing of the Northern Song Dynasty),we analyzed the collation for proof-reading method in Song's edition of Bei Ji Qian Jin Yao Fang(Invaluable Prescriptions for Emergencies)printed by Bureau of Correcting Medical Books in Northern Song Dynasty.The results showed that there are many omissions and erroneous annotations in the collation records of the Song's edition,indicating that the judgment of the scholarly value of textual difference and the criteria of selecting and omitting the annotations of textual difference in the Song's edition require further studies.Some of the collation records in the Song's edition were consistent with those of the Xindiao's edition,suggesting that the Xindiao's edition was referenced during the collation by the officials of the Song Dynasty.In compiling Bei Ji Qian Jin Yao Fang,the original edition and the collated edition were not defined by the officials of the Song Dynasty,multiple hand copies in Tang Dynasty were collected for reference,and multiple medical records in Tang Dynasty and before Tang Dynasty were referenced.For the proofreading work of the Bureau for Revising Medical Books was in charge by scholars and Confucian ministers,we proposed that the complexity during compiling the book and the uncertainty of the text should be paid more attention.It is necessary to further clarify the basic issues such as the origin,basic structure,references and citation methods of the Song's edition,so as to provide reference for understanding the characteristics of the edition correctly and making effective use of the literature.
3.Expression of Serum FABP4 and FGF19 Levels in Patients with β-Thalassemia and Their Relationship with Prognosis
Yixin CHEN ; Feng PAN ; Ya XU ; Xin PENG ; Lu LIANG ; Rujing LI ; Cong LI ; Hongxin ZENG
Journal of Modern Laboratory Medicine 2024;39(5):96-101
Objective To explore the expression of serum fatty acid-binding protein 4(FABP4)and fibroblast growth factor 19(FGF19)in patients with β-thalassemia and their relationship with clinical prognosis.Methods A total of 112 cases ofβ-thalassemia patients diagnosed and treated in Qianjiang Hospital Affiliated to Chongqing University from January 2018 to August 2020 were selected as the case group,and 60 healthy individuals who underwent physical examinations during the same period were taken as the control group.Enzyme-linked immunosorbent assay was used to detect levels of serum FABP4 and FGF19 expression.Multivariate logistic regression analysis was used to analyze factors affecting the prognosis of patients with β-thalassemia.Receiver operating characteristic curve was used to analyze the prognostic value of FABP4 and FGF19 in patients with β-thalassemia.Results The serum FABP4 level(67.13±11.35 μg/L)in the case group was higher than that in the control group(22.01±4.16μg/L),while the serum FGF19 level(104.24±21.46 ng/L)was lower than that in the control group(218.01±36.79 ng/L),with significant differences(t=29.708,25.620,all P<0.05).The serum FABP4 levels(54.20±12.63 μ g/L,66.83±10.5 μ g/L,79.72±11.05 μ g/L)in the mild group,intermediate group,and severe group were increased sequentially,while FGF19 levels(122.53±22.36 ng/L,103.16±20.37 ng/L,86.53±18.14 ng/L)were decreased sequentially,and the differences were significant(F=39.701,24.231,all P<0.05).Compared to the survival group,serum FGF19 level(62.80±22.09 ng/L vs 110.16±20.69 ng/L),Hb and the proportion of heterozygous genotypes in the death group patients(β CD17/β N,β CD41-42/β N)was lower,while serum FABP4(116.69±12.30 ng/L vs 60.05±10.17 ng/L),ferritin and the proportion of cardiac enlargement were higher,with significant differences(t/x2=4.436~18.981,all P<0.05).FGF19(OR=0.634,95%CI:0.451~0.891)was an independent protective factor for β-thalassemia patients(P<0.001),and serum FABP4(OR=1.840,95%CI:1.193~2.838)was an independent risk factor for prognosis(P<0.001).The area under the curve(95%CI)of serum FABP4 and FGF19 combination in prognosis evaluation for β-thalassemia patients was 0.897(0.853~0.951),which was greater than the single serum indicator detection of 0.842(0.801~0.879)and 0.814(0.762~0.858),with significant differences(Z=4.864,5.270,P=0.002,0.001).Conclusion The serum FABP4 expression is increased,but serum FGF19 expression is decreased in patients with β-thalassemia.The combination of serum FABP4 and FGF19 may have a high predictive value for the prognosis of patients with β-thalassemia.
4.Status of fungal sepsis among preterm infants in 25 neonatal intensive care units of tertiary hospitals in China.
Xin Cheng CAO ; Si Yuan JIANG ; Shu Juan LI ; Jun Yan HAN ; Qi ZHOU ; Meng Meng LI ; Rui Miao BAI ; Shi Wen XIA ; Zu Ming YANG ; Jian Fang GE ; Bao Quan ZHANG ; Chuan Zhong YANG ; Jing YUAN ; Dan Dan PAN ; Jing Yun SHI ; Xue Feng HU ; Zhen Lang LIN ; Yang WANG ; Li Chun ZENG ; Yan Ping ZHU ; Qiu Fang WEI ; Yan GUO ; Ling CHEN ; Cui Qing LIU ; Shan Yu JIANG ; Xiao Ying LI ; Hui Qing SUN ; Yu Jie QI ; Ming Yan HEI ; Yun CAO
Chinese Journal of Pediatrics 2023;61(1):29-35
Objective: To analyze the prevalence and the risk factors of fungal sepsis in 25 neonatal intensive care units (NICU) among preterm infants in China, and to provide a basis for preventive strategies of fungal sepsis. Methods: This was a second-analysis of the data from the "reduction of infection in neonatal intensive care units using the evidence-based practice for improving quality" study. The current status of fungal sepsis of the 24 731 preterm infants with the gestational age of <34+0 weeks, who were admitted to 25 participating NICU within 7 days of birth between May 2015 and April 2018 were retrospectively analyzed. These preterm infants were divided into the fungal sepsis group and the without fungal sepsis group according to whether they developed fungal sepsis to analyze the incidences and the microbiology of fungal sepsis. Chi-square test was used to compare the incidences of fungal sepsis in preterm infants with different gestational ages and birth weights and in different NICU. Multivariate Logistic regression analysis was used to study the outcomes of preterm infants with fungal sepsis, which were further compared with those of preterm infants without fungal sepsis. The 144 preterm infants in the fungal sepsis group were matched with 288 preterm infants in the non-fungal sepsis group by propensity score-matched method. Univariate and multivariate Logistic regression analysis were used to analyze the risk factors of fungal sepsis. Results: In all, 166 (0.7%) of the 24 731 preterm infants developed fungal sepsis, with the gestational age of (29.7±2.0) weeks and the birth weight of (1 300±293) g. The incidence of fungal sepsis increased with decreasing gestational age and birth weight (both P<0.001). The preterm infants with gestational age of <32 weeks accounted for 87.3% (145/166). The incidence of fungal sepsis was 1.0% (117/11 438) in very preterm infants and 2.0% (28/1 401) in extremely preterm infants, and was 1.3% (103/8 060) in very low birth weight infants and 1.7% (21/1 211) in extremely low birth weight infants, respectively. There was no fungal sepsis in 3 NICU, and the incidences in the other 22 NICU ranged from 0.7% (10/1 397) to 2.9% (21/724), with significant statistical difference (P<0.001). The pathogens were mainly Candida (150/166, 90.4%), including 59 cases of Candida albicans and 91 cases of non-Candida albicans, of which Candida parapsilosis was the most common (41 cases). Fungal sepsis was independently associated with increased risk of moderate to severe bronchopulmonary dysplasia (BPD) (adjusted OR 1.52, 95%CI 1.04-2.22, P=0.030) and severe retinopathy of prematurity (ROP) (adjusted OR 2.55, 95%CI 1.12-5.80, P=0.025). Previous broad spectrum antibiotics exposure (adjusted OR=2.50, 95%CI 1.50-4.17, P<0.001), prolonged use of central line (adjusted OR=1.05, 95%CI 1.03-1.08, P<0.001) and previous total parenteral nutrition (TPN) duration (adjusted OR=1.04, 95%CI 1.02-1.06, P<0.001) were all independently associated with increasing risk of fungal sepsis. Conclusions: Candida albicans and Candida parapsilosis are the main pathogens of fungal sepsis among preterm infants in Chinese NICU. Preterm infants with fungal sepsis are at increased risk of moderate to severe BPD and severe ROP. Previous broad spectrum antibiotics exposure, prolonged use of central line and prolonged duration of TPN will increase the risk of fungal sepsis. Ongoing initiatives are needed to reduce fungal sepsis based on these risk factors.
Infant
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Infant, Newborn
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Humans
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Birth Weight
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Intensive Care Units, Neonatal
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Retrospective Studies
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Tertiary Care Centers
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Infant, Extremely Low Birth Weight
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Gestational Age
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Infant, Extremely Premature
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Sepsis/epidemiology*
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Retinopathy of Prematurity/epidemiology*
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Bronchopulmonary Dysplasia/epidemiology*
5.To compare the efficacy and incidence of severe hematological adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia.
Xiao Shuai ZHANG ; Bing Cheng LIU ; Xin DU ; Yan Li ZHANG ; Na XU ; Xiao Li LIU ; Wei Ming LI ; Hai LIN ; Rong LIANG ; Chun Yan CHEN ; Jian HUANG ; Yun Fan YANG ; Huan Ling ZHU ; Ling PAN ; Xiao Dong WANG ; Gui Hui LI ; Zhuo Gang LIU ; Yan Qing ZHANG ; Zhen Fang LIU ; Jian Da HU ; Chun Shui LIU ; Fei LI ; Wei YANG ; Li MENG ; Yan Qiu HAN ; Li E LIN ; Zhen Yu ZHAO ; Chuan Qing TU ; Cai Feng ZHENG ; Yan Liang BAI ; Ze Ping ZHOU ; Su Ning CHEN ; Hui Ying QIU ; Li Jie YANG ; Xiu Li SUN ; Hui SUN ; Li ZHOU ; Ze Lin LIU ; Dan Yu WANG ; Jian Xin GUO ; Li Ping PANG ; Qing Shu ZENG ; Xiao Hui SUO ; Wei Hua ZHANG ; Yuan Jun ZHENG ; Qian JIANG
Chinese Journal of Hematology 2023;44(9):728-736
Objective: To analyze and compare therapy responses, outcomes, and incidence of severe hematologic adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia (CML) . Methods: Data of patients with chronic phase CML diagnosed between January 2006 and November 2022 from 76 centers, aged ≥18 years, and received initial flumatinib or imatinib therapy within 6 months after diagnosis in China were retrospectively interrogated. Propensity score matching (PSM) analysis was performed to reduce the bias of the initial TKI selection, and the therapy responses and outcomes of patients receiving initial flumatinib or imatinib therapy were compared. Results: A total of 4 833 adult patients with CML receiving initial imatinib (n=4 380) or flumatinib (n=453) therapy were included in the study. In the imatinib cohort, the median follow-up time was 54 [interquartile range (IQR), 31-85] months, and the 7-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.2%, 88.4%, 78.3%, and 63.0%, respectively. The 7-year FFS, PFS, and OS rates were 71.8%, 93.0%, and 96.9%, respectively. With the median follow-up of 18 (IQR, 13-25) months in the flumatinib cohort, the 2-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.4%, 86.5%, 58.4%, and 46.6%, respectively. The 2-year FFS, PFS, and OS rates were 80.1%, 95.0%, and 99.5%, respectively. The PSM analysis indicated that patients receiving initial flumatinib therapy had significantly higher cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) and higher probabilities of FFS than those receiving the initial imatinib therapy (all P<0.001), whereas the PFS (P=0.230) and OS (P=0.268) were comparable between the two cohorts. The incidence of severe hematologic adverse events (grade≥Ⅲ) was comparable in the two cohorts. Conclusion: Patients receiving initial flumatinib therapy had higher cumulative incidences of therapy responses and higher probability of FFS than those receiving initial imatinib therapy, whereas the incidence of severe hematologic adverse events was comparable between the two cohorts.
Adult
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Humans
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Adolescent
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Imatinib Mesylate/adverse effects*
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Incidence
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Antineoplastic Agents/adverse effects*
;
Retrospective Studies
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Pyrimidines/adverse effects*
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy*
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Treatment Outcome
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Benzamides/adverse effects*
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Leukemia, Myeloid, Chronic-Phase/drug therapy*
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Aminopyridines/therapeutic use*
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Protein Kinase Inhibitors/therapeutic use*
6.Diagnostic value of LP(a),D-D combined LAD for LATH in atrial fibrillation
Hong-Bin PAN ; Xiu-Feng LUO ; Lian ZENG ; Meng-Ju SHI
Chinese Journal of cardiovascular Rehabilitation Medicine 2023;32(6):600-603
Objective:To study diagnostic value of left atrial diameter(LAD),lipoprotein(a)[LP(a)]combined D-dimer(D-D)for left atrial thrombus(LATH)in patients with atrial fibrillation(AF).Methods:According to results of transesophageal echocardiography,a total of 367 AF patients treated in our hospital were divided into LATH group(n=67)and no LATH group(n=300).General clinical data,LAD,serum Lp(a)level and positive D-D rate were compared between two groups,and diagnostic value of above indexes for LATH in AF was ana-lyzed.Results:Compared with no LATH group,there were significant rise in LAD[(40.93±4.69)mm vs.(44.65±4.31)mm],serum Lp(a)level[(17.05±2.31)mg/dl vs.(27.42±3.06)mg/dl]and positive D-D rate(5.67%vs.22.34%)in LATH group(P=0.001 all).ROC curve indicated that AUC of Lp(a),positive D-D,LAD single detection and triple combined detection diagnosing LATH in AF was 0.711,0.584,0.728 and 0.801 respectively;sensitivity was 43.28%,22.39%,64.18%and 65.67%respectively;and specificity was 92.00%,94.33%,76.67%and 80.67%respectively.AUC of triple combined detection was significantly higher than that of any single detection,and sensitivity and specificity were significantly higher than those of Lp(a)and positive D-D single detection(P<0.05 or<0.01).Conclusion:Combined detection of Lp(a),positive D-D and LAD possess high diagnostic value for left atrial thrombus in atrial fibrillation.
7.Etiology detection and epidemiological analysis of influenza in Hainan Province,2013-2021
Ru-Min WANG ; Lei CUI ; Jia-Xing PAN ; Dan-Dan LI ; Chu-Yang SUN ; Fang-Li FENG ; Yan MA ; Xiang-Jie ZENG
Chinese Journal of Zoonoses 2023;39(12):1188-1195
The purpose of this study was to investigate the epidemiological characteristics and risk factors of influenza in Hainan province,to provide evidence to support influenza prevention and control efforts.Pathogen monitoring data of influenza-like illness(ILI)in six national sentinel hospitals in Hainan province from 2013 to 2021 were analyzed in SPSS 20.0 software.A total of 50 415 ILI cases were detected during the 2013-2021 season,of which 5 581 were positive for influenza viruses,with a positivity rate of 11.07%.The dominant strains were type B,type A(H1N1)pdm09 and type A(H3N2).The positivi-ty rate of influenza virus was highest in people 5-14 years of age(17.56%)and lowest in people 0-4 years of age(7.32%).Influenza activity showed both a summer peak and a winter-spring peak in the 2014-2016,2017-2018 and 2019-2020 sea-sons,and was concentrated in April to September,with a maximum peak of 53.64%,and in November to March of the next year,with a peak of 47.30%.The 2013-2014,2016-2017 and 2018-2019 seasons showed only a winter-spring peak concen-trated between October and March of the next year,with a maximum peak of 54.17%,but no obvious summer peak.The pre-dominant influenza viruses during the eight surveillance seasons varied among H1N1,H3N2 and type B.The positive detection rate of influenza virus steeply declined during the 2020-2021 season:the positive detection rate was only 0.25%,and no obvi-ous epidemic period was observed.The intensity of influenza epidemic varied among monitoring years,and the dominant strains changed rapidly in Hainan Province.People 5-14 years of age were the key population affected.Summer,winter and spring were the key periods for influenza prevention and control.Etiological surveillance of influenza should continue to be strength-ened,the roles of health education and publicity should be emphasized,and the dual measures of influenza vaccination and non-drug intervention should be actively promoted to decrease the occurrence of influenza.
8.MC1R is highly expressed in esophageal squamous cell carcinoma.
Xiao Shi ZHOU ; Jiang CHANG ; Li Xiong PENG ; Xi Lin LIU ; Fa Zheng YU ; Jian Feng XU ; Sha Sha ZHANG ; Pan HU ; Zeng Shan LIU ; Guo Jun ZHANG
Journal of Southern Medical University 2022;42(10):1552-1559
OBJECTIVE:
To investigate the expression of MC1R in esophageal squamous cell carcinoma and its correlation with the clinicopathological parameters.
METHODS:
We analyzed the expression of MC1R in esophageal cancer based on data from TCGA databse and examined its expression levels using RT-PCR and Western blotting in a human esophageal epithelial cell line BAr-T, human esophageal squamous cell carcinoma cell lines ECA109, KYSE30, KYSE150, KYSE510, TE-1, TE-13, and EC9706, a human gastric cancer cell line SGC7901 and 19 pairs of esophageal squamous cell carcinoma tissues and adjacent tissues.Immunohistochemistry was used to detect MC1R expression levels in 32 pairs of paraffin-embedded sections of esophageal squamous cell carcinoma and adjacent tissues, and the correlation of MC1R expression and the patients'clinicopathological characteristics was analyzed.
RESULTS:
Bioinformatics analysis showed that MC1R was significantly overexpressed in esophageal cancer tissues (P < 0.05).MC1R expression was also increased in 5 esophageal squamous cell carcinoma cell lines ECA109, KYSE30, KYSE510, TE-13, EC9706 and the gastric cancer cell line SGC7901 as compared with that in esophageal epithelial cells (P < 0.05).Immunohistochemistry revealed significantly increased MC1R expression in esophageal squamous cell carcinoma tissue sections in comparison with the adjacent tissue sections (P < 0.05).In patients with esophageal squamous cell carcinoma, a high MC1R expression was detected mainly in those with an old age, positive for middle-thoracic involvement, and with moderately differentiated tumor cells, and showed a correlation with T stage of tumor (P < 0.05), but not with the other clinicopathological parameters such as gender, age, degree of cell differentiation, primary tumor site, or TNM stage (P>0.05).
CONCLUSION
MC1R is highly expressed in esophageal squamous cell carcinoma and may serve as a molecular biomarker to assist in the diagnosis of esophageal squamous cell carcinoma.
Humans
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Esophageal Squamous Cell Carcinoma
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Esophageal Neoplasms/metabolism*
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Stomach Neoplasms
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Cell Line, Tumor
;
Immunohistochemistry
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Cell Proliferation
;
Gene Expression Regulation, Neoplastic
9.Ganhai Weikang capsule in the treatment of functional dyspepsia: a prospective randomized, double-blind, placebo-controlled parallel clinical study
Yanbo ZENG ; Yiqi DU ; Yang PAN ; Huayi LIU ; Yanqing LI ; Xiuli ZUO ; Feng JI ; Hangyong WANG ; Yang DING ; Luqing ZHAO ; Xiaoyan WANG ; Xiong CHEN ; Zhaoshen LI ; Shengsheng ZHANG
Chinese Journal of Digestion 2022;42(8):557-564
Objective:To explore the efficacy and safety of Ganhai Weikang capsule (GWC) in the treatment of functional dyspepsia (FD).Methods:A randomized, double-blind, placebo-controlled parallel, multi-center, superiority clinical trial was conducted. From March 2018 to April 2020, totally 324 patients with dyspepsia symptoms, who were diagnosed as chronic non-atrophic gastritis by endoscopy and pathology and met the Rome Ⅳ diagnostic criteria for FD from 7 top hospitals were enrolled, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Heilongjiang Hospital of Traditional Chinese Medicine, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Qilu Hospital of Shandong University, the First Affiliated Hospital of Zhejiang University, Beijing Hospital of Traditional Chinese Medicine of Capital Medical University and the Third Xiangya Hospital of Central South University. The patients were randomly divided into the GWC group and the placebo group according to the ratio of 1∶1. The patients of GWC group were given GWC and the patients of placebo group were given GWC capsule simulant. The patients of both groups orally took capsules before meals, 2.4 g each time and 3 times per day, and the course of treatment was 4 weeks. The main efficacy index was the total clinical effective rate after 4 weeks, and the secondary efficacy index was the changes of clinical symptom scores of upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety. The safety index included laboratory tests and adverse events. Chi-square test and Wilcoxon rank sum test were used for statistical analysis.Results:A total of 320 FD patients were enrolled in the full analysis set (FAS), which included 161 cases in GWC group and 159 cases in placebo group. A total of 298 cases were in the per-protocol set (PPS), 149 cases each in GWC group and placebo group. The results of FAS and PPS both showed that the total clinical effective rates of the GWC group were higher than those of the placebo group (84.5%, 136/161 vs. 44.0%, 70/159 and 83.9%, 125/149 vs. 46.3%, 69/149), and the differences were statistically significant ( χ2=57.07 and 46.32, both P<0.001). In addition, the differences of the total score of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (FAS: 10 (7, 14) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 3); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs. 1 (0, 3). PPS: 10 (7, 13) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 2); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs.1 (0, 3)), and the differences were statistically significant (FAS: Z=5.80, 5.91, 3.19, 3.72 and 3.30; PPS: Z=5.14, 5.11, 2.86, 3.21 and 2.84; all P<0.01). The results of FAS and PPS indicated that the improvement rates of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) of GWC group were all higher than those of the placebo group (FAS: 77.8% (54.6%, 91.3%) vs. 42.9% (28.6%, 61.5%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 60.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 41.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%). PPS: 77.8% (54.2%, 89.5%) vs. 44.0% (28.6%, 65.0%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 46.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%)), and the differences were statistically significant (FAS: Z=8.60, 7.72, 4.98, 4.24 and 5.61; PPS: Z=7.90, 7.03, 4.49, 3.88 and 4.83; all P<0.001). After 2 weeks of treatment, the differences of the total score of main symptoms and score of each symptom (upper abdominal pain, upper abdominal burning and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (5.0 (3.0, 8.0) vs. 4.0 (2.0, 6.0); 2.0 (1.0, 2.0) vs. 2.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0)), and the differences were statistically significant ( Z=2.95, 3.44, 2.43 and 2.79, all P<0.05). There was no significant difference in the incidence of adverse events between the GWC group and the placebo group (0.6%, 1/163 vs. 0, 0/159). Conclusion:The clinical total effective rate of GWC in the treatment of FD is superior to that of placebo and it has good safety.
10.Network Meta-analysis of oral Chinese patent medicine in treatment of knee osteoarthritis.
Jin-Long ZHAO ; Gui-Hong LIANG ; Jian-Ke PAN ; He-Tao HUANG ; Wei-Yi YANG ; Ming-Hui LUO ; Ling-Feng ZENG ; Jia-Hui LI ; Jun LIU
China Journal of Chinese Materia Medica 2021;46(4):981-999
To evaluate the efficacy and safety of Chinese patent medicine in the treatment of knee osteoarthritis(KOA) with network Meta-analysis, and provide evidence-based medicine evidences for clinical practice. PubMed, Cochrane Library, EMbase, CNKI, Wanfang, VIP and CBM were used to search for clinical randomized controlled trials(RCTs) on Chinese patent medicines for treatment of knee osteoarthritis, with a time limit from the establishment of each database to March 2020. The bias risk assessment tool recommended by Cochrane was used to evaluate the quality of the included RCTs. The network Meta-analysis was performed by Stata 14.0 software. A total of 5 788 patients in 58 RCTs were included, involving 9 kinds of Chinese patent medicines. The results of the network Meta-analysis indicated that in terms of total effective rate, the top three optimal medication regimens were Jinwu Gutong Capsules + Amino Acid Glucose(AAG), Xianling Gubao + AAG and Biqi Capsules; the top three interventions to reduce the VAS score were Panlongqi Tablets > Xianling Gubao + AAG > Xianling Gubao + non steroidal anti-inflammatory drugs(NSAIDs); the top three interventions to reduce the total score of WOMAC were Jintiange Capsules+NSAIDs> Jinwu Gutong Capsules + AAG > Biqi Capsules + NSAIDs; the top three medication schemes with better curative effect to reduce Lequesnse index were Xianling Gubao + NSAIDs > Biqi Capsules + NSAIDs > Jintiange Capsules + NSAIDs; the top three interventions to reduce TNF-α level Xianling Gubao + AAG > Jintiange Capsules > Jintiange Capsules + AAG=Jinwu Gutong Capsules + AAG. In terms of safety, the top five interventions with the least adverse reactions were Biqi Capsules > Jinwu Gutong Capsules > Biqi Capsules + NSAIDs > Xianling Gubao + NSAIDs > Jintiange Capsules. The combined application of Chinese patent medicine and NSADIs or AAG can improve the clinical treatment effect and reduce adverse reactions in KOA patients.
Biological Products
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China
;
Drugs, Chinese Herbal
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Humans
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Network Meta-Analysis
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Nonprescription Drugs
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Osteoarthritis, Knee/drug therapy*

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