1.The pathgenetic role and potential clinical application of miRNAs in patients with Behcet's disease
Fudan University Journal of Medical Sciences 2017;44(4):538-541,547
As the endogenous mediators of RNA interference,miRNA play biological roles by inducing post-transcriptional silence of gene expression.Previous studies showed that miRNAs have multiple regulating potential to immune cells,involved in regulation of innate and adaptive immunity.Recently,aberrant expression of miRNAs have been confirmed to be relevant to the pathogenesis of Behcet's disease (BD) by regulating the expression of inflammatory cytokines in immune cells,which may become of its diagnostic marker and therapeutic target in the future.In this review,we discuss how miRNAs regulate autoimmunity.Several miRNAs associate with the pathogenesis of BD,thus they have the potential clinical application value.
2.Effects of transtheoretical model and motivational interviewing on medication compliance in patients with PCI post-operation
Liqun DAI ; Caixia YE ; Yan LAN ; Jingfen XIANG
The Journal of Practical Medicine 2016;32(6):1013-1016
Objective To evaluate the effects of transtheoretical model and motivational interviewing on medication?compliance in patients with percutaneous coronary intervention (PCI) post-operation. Methods One hundred patients with PCI post-operation were randomized into the observation group (n = 50) and the control group (n = 50). The medication compliance, 6-min walk test and major adverse cardiovascular events (MACE) were compared between two groups. Results At 1 month, 3 months and 6 months post-intervention, the medication compliance in the observation group was significantly increased (P < 0.05, respectively). The 6-min walk test in the observation group was significantly increased compared with the control group. The MACE rate in the observation group and the control group was 10.0% and 36.0%, respectively, with significant difference (P< 0.05). Conclusion The transtheoretical model and motivational interviewing can effectively increase the medication compliance, improve the postoperative rehabilitation, and decrease the MACE rate.
3.Second-line drug resistance associated mutations in multidrug-resistant Mycobacterium tuberculosis Beijing genotype strains
YE Jingfen ; FANG Qing ; HU Yaoren ; XU Xiaomin ; CHE Yang
Journal of Preventive Medicine 2021;33(10):983-987
Objective :
To learn the characteristics of second-line drug resistance and related gene mutations of multidrug-resistant Mycobacterium tuberculosis ( MDR-TB ) Beijing genotype strains.
Methods:
The MDR-TB isolates in Hwa Mei Hospital from 2017 to 2019 were enrolled and detected using RD105 deletion-targeted multiplex polymerase chain reaction (PCR). The proportion method for drug susceptibility test was used to detect the drug-resistant profiles against kanamycin, amikacin, capreomycin, ofloxacin and levofloxacin. The gene sequencing of rrs, tlyA, eis, gidB, gyrA and gyrB was conducted by PCR compared with H37RV strain. The differences in the rates of drug resistance and mutation between Beijing and non-Beijing genotype strains were examined to understand the characteristics of Beijing genotype strains.
Results:
There were 106 Beijing genotype and 27 non-Beijing genotype strains in 133 MDR-TB isolates. The drug resistance rates of kanamycin, amikacin, capreomycin, ofloxacin and levofloxacin in Beijing genotype strains were 9.43%, 7.55%, 3.77%, 32.08% and 32.08%, respectively. The rates of quasi-extensive and extensive drug resistance in Beijing genotype strains were 30.19% and 7.55%. The gene mutation rates of rrs, tlyA, eis, gidB, gyrA and gyrB in Beijing genotype strains were 7.55%, 7.55%, 1.89%, 2.83%, 36.79% and 2.83%, respectively. There were no significantly differences between Beijing and Non-Beijing genotype strains in the factors above ( P>0.05 ). The gene rrs, tlyA, eis, gidB, gyrA and gyrB had 2, 1, 2, 2, 5 and 3 mutation types, respectively, with single base substitution as the main type.
Conclusion
Beijing genotype strains are dominant in MDR-TB, with high resistance to fluoroquinolones and mainly gyrA gene mutation.
4.Executive opinion survey and analysis of diagnosis and treatment schemes of traditional Chinese medicine in diabetes mellitus complicated by sepsis
Guowei LI ; Xianshi ZHOU ; Jingfen CAI ; Guanghua TANG ; Xiaotu XI ; Yuntao LIU ; Changhai ZHAO ; Moming GUZAINUER ; Liuhua DUAN ; Simeng WU ; Ye YE
International Journal of Traditional Chinese Medicine 2019;41(5):502-505
Objective To prospectively survey the well-known experts of critical care and endocrine secretion to summarize their experience in treating diabetes mellitus complicated by sepsis for the purpose of providing guidance of theory and practice in making treatment schemes of traditional Chinese medicine for such disease.Methods The questionnaires were designed and submitted to the experts.The statistic analysis was undertook to investigate the rules.Results A total of 30 questionnaires were released and 28 were retrieved.The experts generally believed that eight-principle syndrome differentiation was the most useful method in the syndrome differentiation and treatment of this disease.The heat,stasis and toxin were usually acted as the main pathogenic factors while damp and phlegm commonly act as secondary pathogenic factors.They thought that weak body resistance under the invading of evil was the key mechanisms in the deterioration of the disease and they chose clearing heat,activating blood and detoxication as 3 core treatment principles.Conclusions The summarized opinions from the experts should be act as important reference in treating this disease,but its effectiveness and possibility for further generalization need to be validated in the clinical practice.
5.Construction and biological characterization of pore protein ompW,ompS and ompD gene mutant strains of Salmonella typhimurium
Shaobi WU ; Yuanfeng LINGHU ; Yong PAN ; Wan YANG ; Shixiong CHEN ; Jingfen YE ; Qi YANG
Chinese Journal of Veterinary Science 2024;44(6):1165-1174
In order to investigate the effects of porin genes ompW,ompS and ompD on the biological properties and virulence of Salmonella typhimurium,the corresponding mutant strains were con-structed using the λ Red homologous recombination system,and the growth curves,motility,bio-chemical properties,in vitro genetic stability,biofilm-forming ability,drug resistance,and lethal dose at half capacity(LD50)between the standard strain and each mutant strain were detected by comparative assays for Salmonella typhimurium.The results showed that,compared with the standard strain,the ompD and ompW mutation had less effect on the growth rate and motility of the bacteria,while the ompS mutation significantly reduced the growth rate and motility;none of the three genetic mutation affected the biochemical characteristics of Salmonella typhimurium,nor the genetic stability,but affected its susceptibility to a variety of commonly used antibiotics to varying degrees and caused a highly significant decrease(P<0.01)in the ability to form a biofilm,and the results showed that the three mutant strains had a significant reduction in the ability to form a biofilm.The result of LD50 virulence assay showed that all three genetic mutation led to a decrease in the virulence of Salmonella typhimurium,among which the ompS mutant strain showed the most obvious decrease in virulence,LD50 was 25 times that of the standard strain.In conclusion,mutations of the pore protein ompW,ompS,and ompD genes can affect some biological properties of Salmonella typhimurium.The results of this study laid an experimental foundation for further research on the biological functions of the pore protein ompW,ompS and ompD genes and Salmonella pathogenicity.
6.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.