1.Ethical Issues on Informed Consent in Biobank Research
Hui LI ; Zhaohui LIANG ; Lingfeng ZENG ; Jun LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2013;(4):729-734
The biobank for medical researchers is a resource of significant utility , which also causes a series of ethical issues. For example, the question of what kind of informed consent should be adopted for the biobanking tissue residue, whether related study can be conducted without the donors' consent and how to accomplish the biobank research. Based on ethical principles of donation, individual rights of donor and common interest of the society, this study suggested the informed consent that to which extent can be accepted for biobank and which type should be adopted in different scenes with two feasible choices. One is the irreversible, and the other is the reversible anonymization process for samples. The necessity and rationality of informed consent for biobank con-struction were also evaluated in order to provide references for the ethical practice of biobank research.
2.Ethical Issues Caused by Cultural Differences in Clinical Studies of Chinese Medicine
Zhaohui LIANG ; Lingfeng ZENG ; Jianke PAN ; Jun LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2013;(4):702-707
Issues related to bioethics research often involve four basic principles , which are the value and integri-ty of the research, respect for human being, risk to benefit ratio, and the justice in subject selection. These prin-ciples contribute to the basis of bioethics for human-involved studies and they are capable of being applied to other relevant fields including complementary and alternative medicine (CAM) researches. The World Health Orga-nization (WHO) guidelines related to CAM studies clarify that the consideration should be taken for the human rights based on different value systems caused by social, cultural and historical problems, and the ethical prob-lem involved in CAM clinical studies should be properly handled in the further studies. Based on the four prin-ciples and Chinese traditional culture, the author attempted to discuss controversial bioethical issues such as the understanding and setting of informed consent, risk and benefit in western culture bioethics in order to analyze possible issues in the ethical review of Chinese medicine clinical research. We hoped that these considerations can provide references to the bioethical understanding of Chinese medicine clinical studies and ethical review on Chinese medicine practice .
3.The cytotoxic effects of IL-2 combined with different dosages of sorafenib on renal cellular carcinoma
Benhe WU ; Yiao TAN ; Lingfeng SUN ; Shuhan LIU ; Linyu ZHOU
The Journal of Practical Medicine 2014;(19):3049-3052
Objective To investigate the cytotoxic effects of IL-2 combined with different dosages of sorafenib on renal cellular carcinoma cell line 786-0. Methods Renal carcinoma cell 786-0 was cultured. Then , IL-2 (20 μmol/L) combined with different dosages of sorafenib (6.9, 13.8, 20.8 μmol/L) were used to treat tumor cell 786-0. The inhibitory effect on cell proliferation was determined by MTT assay. Cell apoptosis was measured by Annexin V-FITC kit. The tumor-bearing mice models were established and divided into four groups. Results The tumor cell growth was inhibited with the time-course correlation in all groups. In the 48-hour high doses group, the inhibitory rate was up to (74.67±1.87) %. The rates of cell proliferation inhibition and cell apoptosis were higher in the high dosages group than those in the other groups. Conclusions Immunotherapy combined with target therapy could significantly inhibit the growth of renal cellular carcinoma. But we should find a proper dosage, which could improve the clinical effect and reduce the adverse effect.
4.Characteristics of chromosome karyotype and marker chromosome of human breast cancer cell lines Bcap-37 and MCF-7
Junhua ZOU ; Junzheng YANG ; Lingfeng MIN ; Jiaying LIU
Chinese Journal of Tissue Engineering Research 2005;9(18):258-259
BACKGROUND: Cytogenetic evidence suggests that chromosomal alteration are not randomly occurring events and some malignancies are characterized by specific chromosome abnormalities, which provides cytogenetic basis for the expression of oncogenes.OBJECTIVE: To investigate the characteristics of chromosomal karyotype and marker chromosome of breast cancer cell lines Bcap-37and MCF-7 by means of G-banding chromosomal analysis.DESIGN: A controlled experiment with breast cancer cells as observation subjects.SETTING: Department of Medical Genetics, Peking University Health Science Center.MATERIALS: This study was carried out in the Department of Medical Genetics of Peking University Health Science Center from April 1991 to May 1992 using breast cancer cell lines MCF-7 and Bcap-37.METHODS: The chromosomes of human breast cancer cell lines Bcap-37and MCF-7 were obtained by growth synchronization induced by hypothermia and colchicines treatment. The cells at prometaphase or metaphase underwent G-banding chromosomal analysis. For each cell line, 50 to 60 mitotic figures were counted and 15 or 16 G-binding karyotypes were analyzed, including the mitotic figure at the level of about 320- and 500-band .MAIN OUTCOME MEASURES:Abnormality in chromosome number and structural aberration of the two breast cancer cell lines.RESULTS:The modal chromosomal number of Bcap-37 cell line was 63, of which 17 marker chromosomes had identifiable structure, as compared with 13 out of 56 chromosomes in modal number of MCF-7 cell line.CONCLUSION: Both of the two breast cancer cell lines have complex cytogenetic abnormality in the modal number and structure of the chromosomes, which might result in the rearrangement of DNA sequence of the cancer-related genes or DNA depletion, so as to play important roles in the pathogenesis and development of breast cancer.
5.The short-long term therapeutic effects of endovascular therapy for in-stent restenosis of superficial femoral artery
Lingfeng ZHAO ; Wei YE ; Weiwei WU ; Rong ZENG ; Changwei LIU
Chinese Journal of General Surgery 2014;29(8):588-591
Objective To evaluate therapeutic effects of endovascular therapy for in-stent restenosis of superficial femoral artery,and the risk factors of restenosis of re-intervention therapy.Methods We retrospectively summarized the clinical data of 35 patients(38limbs)who suffered from in-stent restenosis of superficial femoral artery(SFA)stent from 2010 to 2012.Results 35 patients (38 limbs)were enrolled in this study,there were 24 males and 11 females.Mean age was (68 ±8)years.The success rate of endovascular therapy was 89.5% (34/38),including in-stent angioplasty in 14 limbs,in-stent and beyond-stent angioplasty in 5 limbs,in-stent angioplasty and beyond-stent re-stenting in 15 cases.The primary patency and sencondary patency rate for 6,12 and 24 months was 65.2%,46.5%,46.5%,and 87.5%,80.2%,55.8% respectively.The independent risk factors for re-obliteration were age > 70 years (P < 0.05) and diabetes mellitus (P < 0.05).Conclusions Endovascular therapy is effective and safe in treatment in-stent restenosis of superficial femoral artery.The long-term in-stent patency is not satisfactory,with age > 70 years and diabetes mellitus as independent risk factors.
6.Effect of Qishen-Qinggan decoction on proliferation and apoptosis of human hepatocellular carcinoma cellline SMMC-7721
Lingfeng WAN ; Boyu XUE ; Zhangpu LIU ; Ming SHAO
International Journal of Traditional Chinese Medicine 2013;35(12):1079-1081
Objective To investigate effect of Qishen-Qinggan decoction on proliferation and apoptosis of human hepatocellular carcinoma cellline SMMC-7721.Methods SMMC-7721 cells were cultivated in vitro.Logarithmic growth phase cells were divided into a drug intervention group and a control group.SMMC-7721 cells were treated with Qishen-Qinggan decoction of 0.135、0.27、0.54、1.08、2.16 g/ml respectively for 12、24、48 hours in the drug intervention group while the control group remained untreated.The inhibition rate of SMMC-7721 cells were detected by MTT assay,cell apoptotic rate were measured by flow cytometry analysis.Results Qishen-Qinggan decoction of 0.135,0.27,0.54,1.08,2.16 g/ml had a significantly inhibitory effect on SMMC-7721 cells in a dose and time dependent manner.OD values of 12 hours were 0.89±0.05,0.85±0.05,0.80±0.06,0.78± 0.02,0.69±0.07,OD values of 24 hours were 0.77±0.07,0.74±0.07,0.59±0.07,0.50±0.09,0.39±0.08,OD values of 48 hours were 0.78±0.05,0.61±0.08,0.44±0.10,0.39±0.08,0.34±0.07 respectively.Each drug intervention group had significant difference compared with control group.Qishen-Qinggan decoction of 0.27,0.54 g/ml could induce apoptosis of SMMC-7721 were 11.19 ± 2.23,15.69 ± 2.51,compared with control group of 1.41 ± 0.22.Apoptotic rates of Qishen-Qinggan decoction of 1.08 g/ml had extremely significant difference with the control group (41.83 ± 7.11 vs 1.41 ± 0.22).Conclusion Qishen-Qinggan decoction could inhibit the proliferation of SMMC-7721 cells probably by inducing cell apoptosis.
7.Ethical Issues of Privacy Protection Caused by Biobanks Research in Data Context
Lingfeng ZENG ; Jun LIU ; Jianke PAN ; Lu WANG ; Ye CAO ; Qubo CHEN ; Xing ZENG ; Weixiong LIANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2015;(7):1567-1576
In traditional biomedical research, a series of mechanism and measures had been taken for identity protection of data subjects, such as data disclosure in aggregated methods, information restricted in public only after identified variables removal and etc. The purpose of such process was aimed to properly keep confidentiality of health information for the target subjects in research. As the protection of subject privacy was viewed as one of the most essential principle of medical ethics in human research, the effects to fulfill and accomplish such process can help to maintain the trust and support among participants and social public. Currently, such traditional modes of privacy safeguard are widely-applied in genetics and genomics study. However, the universal applicability also causes a number of controversies, and the effectiveness remains to be proven. Nowadays, the risk assessments of data subjects’ privacy call for taking the whole“data context” into consideration, not just self-restricted in isolation and confined to quality control of data disclosure. With the soaring increasing of data resources in research involved human subjects, the issues of releasing genetic data have caused more and more public attention, especially for the sensitive domains of privacy protection. Based on the core problem and principles, this article attempted to discuss the controversial bioethical issues such as data context, data-intruder concept, privacy of data subject, identity control of releasing data, potential risk of individual identification, privacy protection of data subject, and etc. We hope these considerations can provide references to the bioethical understanding of biobanks research and decision-making of ethic review.
8.Efficacy and safety of surgical radiofrequency ablation for atrial fibrillation during cardiac surgery: a meta-analysis
Yanhai MENG ; Yanbo ZHANG ; Shuiyun WANG ; Haibo HUANG ; Shuo CHANG ; Chen SHI ; Lingfeng LIU
Chinese Journal of Thoracic and Cardiovascular Surgery 2015;31(10):594-599
Objective The purpose of this sturdy was to conduct a meta-analysis of published randomised controlled trials(RCT) comparing the clinical outcomes of radiofrequency ablation(RFA) versus surgery alone(SA) in all patients with cardiac surgery.Methods PubMed, Embase, the Cochrane Controlled Trials Register databases, CNKI, CBM disc and VIP datebases were searched, and study eligibility and conducted data abstraction were determined independently and in duplicate.Literature searches from database establishment to November 2014.The heterogeneity and data were analyzed by the software of Rev Man 5.2.Results Of 564 studies identified, 8 studies met eligibility criteria, and included a total of 591 patients.In efficacy, The number of patients in sinus rhythm(SR) was signifcantly improved in RFA group compared to SA group at discharge(OR =10.59;95% CI: 3.81-29.45).This effect on SR remained at all follow-up periods until > 1 year.In safety, there was no significant difference in the incidence of hospital mortality(OR =1.17;95% CI: 0.41-3.35) and mortality rate in follow up period(OR =0.77;95% CI: 0.35-1.69) between RFA group and SA group.Similar results were shown in the incidence of permanent pacemaker(OR =0.65;95 % CI: 0.28-1.52;P =0.32) , thromboembolic events (OR =1.61;95 % CI: 0.54-4.84;P =0.40), postoperative re-intervention for bleeding (OR =0.45;95 % CI: 0.12-1.70;P =0.24).Conclusion The results of the current randomized trials demonstrates that concomitant surgical radiofrequency ablation and cardiac surgery is safe and effective at restoring sinus rhythm.
9.Study on multiple drug resistance gene of Acinetobacter baumanii isolated from hospital
Guangrong LI ; Lingfeng LU ; Chengyu XIANG ; Kui YANG ; Zhenghua DENG ; Jinbo LIU
International Journal of Laboratory Medicine 2016;37(5):602-605
Objective To study the drug resistance of multiple‐drug‐resistant Acinetobacter baumannii(MDR‐Ab) and its rela‐tive carbapenemases genes ,in order to provide references for rational use of antibacterial agents .Methods A total of 98 strains of Acinetobacter baumannii(Ab) were identified by using the MicroScan WalkAway96 automated microbial identification susceptibility testing system ,and the resistance genes ,including OXA‐23 ,OXA‐24 ,IMP ,VIM ,TEM and SHV ,were detected by using the poly‐merase chain reaction .DNA sequences of positive amplification products of the resistance gene were analysed .Results The drug re‐sistance rates of 98 strains of MDR‐Ab to penicillin class and cephalosporin class both were 100 .0% ,to imipenem and meropenem were 55 .1% and 54 .1% respectively ,to gentamicin ,amikacin and tobramycin were 100 .0% ,100 .0% and 87 .8% respectively ,to ciprofloxacin ,levofloxacin and gatifloxacin were 89 .8% ,91 .8% and 77 .6% respectively ,to sulfamethoxazole and rifampicin were 91 .8% and 100 .0% respectively ,to polymyxin B and polymyxin were 14 .3% and 11 .2% respectively ,to tetracycline ,minocycline and tigecycline were 100 .0% ,6 .1% and 4 .1% respectively .The results of resistance genes detection in 98 strains of MDR‐Ab showed that 70 strains carried TEM and OXA‐23 gene ,53 strains carried VIM gene ,41 strains carried IMP gene ,while OXA‐24 and SHV genes were not detected .DNA sequence analysis showed that the homology of OXA‐23 ,TEM ,IMP and VIM genes were 98% ,98% ,99% and 99% .Conclusion The condition of antibacterial resistance of MDR‐Ab in this area is very serious ,and TEM and OXA‐23 are the main drug resistance genes .Carrying multiple resistance genes is an important cause of MDR‐Ab resistance . The treatment of patients with Ab infection should be based on the results of drug sensitivity test for rational use of antibacterial a‐gents .
10.Preliminary Application of Lauromacrogol in the Treatment of Varicose Veins of Lower Limb
Juan PENG ; Lei YANG ; Xiaoyan LIU ; Jinqin ZHAN ; Mei ZHU ; Lingfeng ZHAO
Progress in Modern Biomedicine 2017;17(27):5283-5286,5318
Objective:To investigate the application value of lauromacrogol in the treatment of varicose veins of lower limb.Methods:The medical records of 75 patients (75 affected limbs) with varicosis of great saphenous vein of lower limbs confirmed between September 2013 and September 2015 were analyzed retrospectively.According to the treatment regimen,the patients were divided into two groups.Among them,33 cases (33 limbs) treated by ultrasound guided injection of foam sclerosing agent lauromacrogol were included in the lauromacrogol group while 42 cases (42 limbs) treated by high ligation of great saphenous vein combined with stripping were included in the operation group.The operation time,intraoperative blood loss,off-bed time,treatment costs and incidence of postoperative complications were recorded.Patients were followed up for 6 to 12 months after operation,and the recurrence rate was recorded.Results:The operation time,off-bed and length of hospital stay of the lauromacrogol group were shorter than those of the operation group;the intraoperative blood loss and hospitalization expenses were less than those of the operation group (P<0.05);The incidence rates of subcutaneous hematoma and skin numbness in the lauromacrogol group were significantly lower than those in the operation group (P<0.05);The 12-month recurrence rate in the lauromacrogol group (12.12%) was lower than that in the operation group (33.33%)(P<0.05).Conclusion:Injection of foam sclerosing agent lauromacrogol is an alternative minimally invasive therapy for treating varicosis of great saphenous vein of lower limbs.