1.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 .
2.The relationship between the degree of basilar artery stenosis and the short-term prognosis in patients with isolated pontine infarction
Xinsheng HAN ; Gaocai ZHANG ; Ning LIU ; Baoli LIU ; Hongyang ZHANG ; Jianke XU ; Miao HAN
Chinese Journal of Geriatrics 2021;40(3):315-318
Objective:To investigate the relationship between the degree of basilar artery stenosis and the short-term prognosis in patients with isolated pontine infarction.Methods:One hundred and thirty-seven patients with isolated pontine infarction within 1 month after symptom onset admitted to our hospital from April 2016 to April 2018 were consecutively included.Based on modified Rankin scale(mRS)socres, patients were divided into the good outcome group(mRS score≤2)and the poor outcome group(mRS score>2). Venous blood samples were taken for biochemical testing on admission or the next day.Baseline National Institutes of Health Stroke Scale(NIHSS)scores and demographic data were recorded and compared between the two groups.The degree of basilar artery stenosis was assessed by magnetic resonance angiography(MRA), and subjects were divided into the non-stenosis, mild stenosis, middle stenosis and severe stenosis subgroups.Results:There were 108 patients in the good outcome group and 29 in the poor outcome group.The baseline NIHSS score(2.71±0.22 vs.7.10±0.59, t=6.99, P<0.01)and total cholesterol[(4.29±0.101)mmol/L vs.(4.76±0.17)mmol/L, t=2.21, P=0.03]were lower in the good outcome group than in the poor outcome group.The proportion of patients without stenosis was higher(76 or 70.4% vs.5 or 17.2%, χ2=26.70, P<0.01)and the proportion of patients with severe stenosis were lower(4 or 3.7% vs.7 or 24.1%, P=0.002)in the good outcome group than in the poor outcome group.Binary logistics regression analysis showed that baseline NIHSS score( OR=1.658, 95% CI: 1.327-2.071, P=0.000)and degree of basilar artery stenosis( OR=2.071, 95% CI: 1.159-3.701, P=0.014)were risk factors for the short-term prognosis. Conclusions:The degree of basilar artery stenosis is a risk factor for the short-term prognosis in patients with isolated pontine infarction, and patients with severer stenosis will have a poorer prognosis.
3.Is autologous blood transfusion drainage necessary after total knee arthroplasty:a meta-analysis
Minghui LUO ; Kunhao HONG ; Jianke PAN ; Jun LIU ; Weiyi YANG ; Da GUO
Chinese Journal of Tissue Engineering Research 2016;20(9):1336-1344
BACKGROUND: Total knee arthroplasty is a procedure for treatment of knee osteoarthritisa with standardized, mature technology and affirmative efficacy. Total knee arthroplasty can result in overt excessive bleeding, decreased hemoglobin levels, patient mouth infection and other complications. As a new technology, autologous blood transfusion device can effectively reduce the rate of blood transfusion through reinfusing the unwashed and filterable drainage blood after operation. Up to now, no systematic reviews incorporating meta-analyses have found directly sufficient evidence to compare autologous blood transfusion drainage and no drainage after primary total knee arthroplasty. OBJECTIVE: To study the clinical efficacy, safety and potential advantages of the application of autologous blood transfusion device/no drainage based on the meta-analysis. METHODS:PubMed, Embase, the Cochrane Library, CBMdisc, China HowNet, VIP, Wanfang database were searched comprehensively by computer. The search strategies were developed by the way of MeSH terms combining with free words: “total knee replacement” OR “total knee arthroplasty” OR “total knee prosthesis” OR “unicompartmental” OR “unicondylar” OR “unicompartmenta” OR “arthroplasty, replacement, knee” [MeSH terms] AND “autologous blood transfusion” OR “Autotransfusion” OR “blood transfusion, autologous” [MeSH Terms] OR “Intraoperative Blood Salvage” OR “Intraoperative Blood” OR “Postoperative Blood Salvage” OR “Intraoperative Blood Cel Salvage” OR “Operative Blood Salvage” [MeSH Terms]. Data included in the final literature were analyzed using RevMan 5.3.5 software recommended by Cochrane. The main outcome measure was the rate of transfusion. The secondary outcome measures were the average change in hemoglobin, hemoglobin levels at the 3rd day, hospitalization time and intraoperative mouth infection rate. RESULTS AND CONCLUSION:Five randomized controlled trials, a total of 667 patients were enroled. Meta-analysis results showed that there were no significant differences in the transfusion rate (OR=0.73, 95%CI: 0.47-1.13;Z=1.41,P=0.16), average change in hemoglobin (WMD=0.20, 95%CI:-0.28-0.68;Z=0.82,P=0.41), the hemoglobin levels at the 3rdday (WMD=0.41, 95%CI:-0.26-1.09;Z=1.20,P=0.23), hospitalization time (OR=1.01, 95%CI: 0.06-16.27;Z= 0.01,P=1.00), intraoperative mouth infection rate (OR=1.01, 95%CI: 0.06-16.27;Z=0.01,P=1.00) between the postoperative use of autologous blood transfusion and no drainage. These results suggest that the meta-analysis of outcome measures has not provided the evidence-based medical support for the clinical efficacy of autologous blood transfusion device (including blood transfusion rate, the average change in hemoglobin, average hemoglobin change at the 3rd day, hospitalization time). Given the inherent limitations of the quality of the included studies and the publication bias, future high-quality, large-volume, multi-center randomized controled trials are awaited to confirm and update the findings of this analysis.
4.Effect of kidney-tonifying recipe on tendon-bone healing after anterior cruciate ligament reconstruction
Weiyi YANG ; Jianke PAN ; Hui XIE ; Zhimian ZHANG ; Xuewei CAO ; Jun LIU
Chinese Journal of Tissue Engineering Research 2017;21(4):591-597
BACKGROUND:Kidney-tonifying herbs have been reported to promote tendon-bone healing in rabbits after anterior cruciate ligament reconstruction (ACLR). OBJECTIVE:To verify the effects of kidney-tonifying herbs on tendon-bone healing after ACLR. METHODS:Seventy patients with anterior cruciate ligament injury undergoing ACLR were randomly assigned to study group (administration of Liuwei dihuang pil s+celecoxib) and control group (administration of celecoxib alone). Preoperative, postoperative 6-and 12-month assessments of patients by the Lysholm Knee Scoring Scale, International Knee Documentation Committee (IKDC) Subjective Knee Form and MRI imaging were performed. RESULTS AND CONCLUSION:Postoperative Lysholm scores were significantly increased compared with preoperation in the study and control groups (P<0.05), and the scores of sections stair-climbing and instability and total scores of the Lysholm Knee Scoring Scale in the study group were superior to those in the control group (P<0.05). Postoperative IKDC scores were significantly increased compared with pre-operation in the study and control groups (P<0.05), and the scores of section flaccid leg and subjective function and total scores of the IKDC in the study group were superior to the control group (P<0.05). The enlargement rate of middle and proximal parts of grafts was significantly increased in the study group compared with the control group 6 months postoperatively (P<0.05), and the enlargement rate of middle and distal parts of grafts was significantly increased in the study group compared with the control group 12 months postoperatively (P<0.05). The tibial and femoral tunnel enlargement was observed in both groups at 6 and 12 months postoperatively (P<0.05). The enlargement rate of the tibial tunnel was significantly decreased in the study group compared with in the control group (P<0.05). The signal-noise ratio of the femoral end and middle part of grafts in the study group was significantly higher than that in the control group 6 months postoperatively (P<0.01). In contrast, the signal-noise ratio of the femoral end and middle part of grafts in the study group was significantly lower than that in the control group 12 months postoperatively (P<0.05). Our results indicate that kidney-tonifying herbs can improve the tendon-bone healing after ACLR.
5.Effect of Longbie Capsule on proliferation of bone marrow mesenchymal stem cells
Jianke PAN ; Baiming GUO ; Jun LIU ; Xian ZHANG ; Hui XIE ; Da GUO
Chinese Journal of Tissue Engineering Research 2015;(28):4439-4444
BACKGROUND:Longbie Capsule has satisfactory outcomes in the treatment of osteoarthritis, but its mechanism is stil unclear.
OBJECTIVE:To study the effect of Longbie Capsule on proliferation of bone marrow mesenchymal stem cel s. METHODS:The bone marrow mesenchymal stem cel s from SD rats were separated and expanded by whole adherence culture, then subcultured and confirmed by morphological observation and flow cytometry. Passage 4 cel s were cultured in complete media containing 5 g/L, 1 g/L, 250 mg/L, 50 mg/L, 10 mg/L Longbie Capsule, respectively, for 24 hours. Then, MTT assay was used to detect cel viability.
RESULTS AND CONCLUSION:The primary cel s were adherent cel s characterized by irregular shape, passage 2 cel s were typical y fibrous-shaped, passage 3 cel s grew in long fibrous and swirl-type shape. Passage 4 cel s were strongly positive for CD29 and CD90, positive for CD44, and negative for CD34 and CD45. 5 g/L and 1 g/L Longbie Capsule promoted the proliferation of bone marrow mesenchymal stem cel s. These findings indicate that Longbie Capsule may promote the proliferation and differentiation of bone marrow mesenchymal stem cel s, thereby playing a therapeutic effect on osteoarthritis.
6.Comparison between autologous blood transfusion drainage and closed-suction drainage/no drainage in total knee arthroplasty: a Meta-analysis
Kunhao HONG ; Jianke PAN ; Biqi PAN ; Weiyi YANG ; Jun LIU ; Hui XIE ; Da GUO
The Journal of Practical Medicine 2015;31(15):2545-2550
Objective To assess the clinical efficiency , safety and potential advantages of autologous blood transfusion (ABT) drains compared with the closed-suction/no drainage. Methods Pubmed, Embase, Cochrane Library, CBMdisc, CNKI, VIP and WANGFANG were searched comprehensively. The statistical anal-ysis was conducted by using the Cochrane Collaboration review Manager 5.3.5. Results The pooled data of seventeen RCTs including a total of 1 993 patients showed that the patients in the ABT drainage group might benefit from the low rate of blood transfusion [ 16 . 59% and 37 . 47%, OR: 0 . 28 ( 0 . 14 ~ 0 . 55 ); 13 . 05% and 16.91%, OR: 0.73 (0.47 ~ 1.13), respectively]. The ABT drainage and the closed-suction drainage/no drainage have the similar clinical efficiency and safety length of hospital stay and wound infection on days 3 post-operative haemoglobin. Conclusion This systematic review provides the evidence that the ABT drainage offers a safe and efficient alternative to CS/no drainage with the lowered blood transfusion rate.
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.Comparison of acute toxicity of extract of unprocessed indian atringbush root and its two different processed products.
Jinjuan ZHANG ; Ying XIONG ; Wei LI ; Guilin ZHANG ; Jianke WANG ; Chang LIN ; Yan LIU
China Journal of Chinese Materia Medica 2011;36(9):1172-1174
OBJECTIVETo compare the acute toxicity and content of daphnoretin among extracts of unprocessed indian string-bush root and its two different processed products, and to provide a basis for discussion of the mechanism of two processed methods.
METHODExtracts of unprocessed indian stringbush root and processed indian stringbush root with "sweat" and "artificial sweat" were prepared. The mice were intragastrically administrated once with these three extracts, the mortalities of mice were observed, and the median lethal dose (LD50) of different extracts were calculated with Bliss method. The determination of daphnoretin in these three samples was performed by high performance liquid chromatography.
RESULTThe LD50 of indian stringbush root extracts, indian stringbush root processed with "sweat" and with "artificial sweat" were 46.678, 72.190, 67.953 g x kg(-1), respectively. The contents of daphnoretin in unprocessed indian stringbush root, indian stringbush root processed with "sweat" and with "artificial sweat" were 0.189%, 0.407% and 0.345%, respectively.
CONCLUSIONThe toxicity of indian stringbush root processed with both "sweat" and "artificial sweat" is lower than that of the original rude drug. But the decreasion of toxicity of processed products is not by the reduced daphoretin content.
Animals ; Chromatography, High Pressure Liquid ; Coumarins ; chemistry ; toxicity ; Female ; Lethal Dose 50 ; Male ; Mice ; Plant Extracts ; chemistry ; toxicity ; Plant Roots ; chemistry ; Toxicity Tests ; Wikstroemia ; chemistry
9.Correlation between serum uric acid level and short-term outcome of acute isolated pontine infarction
Xinsheng HAN ; Ning LIU ; Jianke XU ; Gaocai ZHANG ; Hongyang ZHANG ; Miao HAN ; Yun ZHANG ; Yan ZHANG
International Journal of Cerebrovascular Diseases 2019;27(7):509-513
Objective To investigate the correlation between serum uric acid level and short-term outcome of acute isolated pontine infarction. Methods From April 2016 to April 2018, consecutive patients with acute isolated pontine infarction admitted to the Department of Neurology, Kaifeng Central Hospital were enrolled. The baseline clinical data were collected. Fasting venous blood was collected on the day of admission or the morning of the next day for blood biochemical tests. The National Institutes of Health Stroke Scale (NIHSS) was used to assess the severity of neurological deficit. According to the modified Rankin Scale score at discharge or 14 dafter onset, the patients were divided into good outcome group (≤2) and poor outcome group ( > 2 ). Multivariate logistic regression analysis was used to determine the independent risk factors for short-term poor outcome. Results A total of 137 patients were enrolled in the study, 108 (78.8% ) had a good outcome, and 29 (21.2% ) had a poor outcome. The baseline NIHSS score (median [ interquartile range]: 2.5 [1.0-4.0] vs. 8.5 [5.5-10.0 ]; Z= 6.092, P< 0.001 ) and total cholesterol levels (4.290 ± 0.101 mmol/L vs. 4.763 ± 0.171 mmol/L; t=2.214, P=0.028] in the good outcome group were significantly lower than those in the poor outcome group, while serum uric acid level (329.769 ± 8.122μmol/L vs. 257.103 ± 14.290μmol/L; t=4.190, P<0.001) was significantly higher than that in the poor outcome group. Multivariate logistic regression analysis showed that high serum uric acid levels were independently associated with short-term good outcomes in patients with isolated pontine infarction (odds ratio [ OR] 0.377, 95% confidence interval [ CI] 0.203-0.702; P=0.002), while high NIHSS score (OR 1.762, 95% CI 1.375-2.258; P<0.001) and hypertension (OR 5. 353, 95% CI 1.333-21.502; P= 0.018 ) were independently associated with short-term poor outcomes. Conclusion High baseline serum uric acid levels are associated with short-term good outcomes in patients with acute isolated pontine infarction.
10.Role of repressor element 1-silencing transcription factor/repressor element 1-silencing transcription factor coinhibitory factor in reparation of cortical neural axons after traumatic brain injury: an in vitro study
Jun HE ; Jie LIU ; Jianke KUAI ; Yuqin YE ; Yongxiang YANG ; Xiaosheng HE
Chinese Journal of Neuromedicine 2018;17(9):897-904
Objective To explore the effects of repressor element 1-silencing transcription factor (REST)/REST coinhibitory factor (CoREST) on axonal regeneration and repairmen of mouse cortical neurons after traumatic brain injury (TBI).Methods (1) The primary cortical neurons were obtained from fetal C57BL/6 mice;one,three,5,7,9,and 11 d after cultivation,miR-124 expression was detected by quantitative-(q-) PCR.(2) Neurons cultured for 5 d were divided into miR-124 mimics group,blank control group,and miR-124 inhibitor group,and miR-124 mimics,nonsense control sequences and miR-124 inhibitor were transfected,respectively;0,6,12,24,48,and 72 h after transfection,miR-124 expression was detected by q-PCR.(3) Neurons cultured for 7 d were divided into blank control group Ⅰ,oxygen glucose deprivation (OGD) model group,up-regulated miR-124+OGD model group,and down-regulated miR-124+OGD model group,and neurons in the later two groups were transfected with miR-124 mimics and miR-124 inhibitor;48 h after transfection,OGD models in the later three groups were prepared;0,6,12,24,48,and 72 h after OGD,miR-124 expression was detected by q-PCR;GAP-43,REST and CoREST expressions were detected by Western blotting 48 h after OGD;the REST and CoREST expressions were measured by immunofluorescent staining 48 h after OGD.Results (1) One,three,5,and 7 d after cultivation,miR-124 expression gradually increased,and 7,9,and 11 d after cultivation,miR-124 expression gradually decreased,with significant differences (P<0.05).(2) Twenty-four and 48 h after transfection,miR-124 expression in the miR-124 inhibitor group was significantly lower than that in the blank control group (P<0.05);12,24,48 and 72 h after transfection,miR-124 expression in the miR-124 mimics group was significantly higher than that in the blank control group (P<0.05),and peak level was noted at 48 h.(3) The miR-124 expression in the OGD model group was significantly higher than that in the blank control group Ⅰ at 12,24,48 and 72 h after OGD (P<0.05),and peak level was noted at 48 h;0,6,12,24,48,and 72 h after OGD,the miR-124 expression in the up-regulated miR-124+OGD model group was significantly higher than that in the blank control group Ⅰ (P<0.05),and peak level was noted at 48 h;Western blotting indicated that GAP-43 and CoREST gradually increased,and REST gradually decreased in blank control group Ⅰ,OGD model group and down-regulated miR-124+OGD model group,with significant differences (P<0.05);neurons in the up-regulated miR-124+OGD model group had significantly lower GAP-43 and CoREST expressions,and significantly higher REST expression than those in the OGD model group (P<0.05);the results of immunofluorescence staining were consistent with those of Western blotting.Conclusion REST/CoREST,as a pair regulator,may play a key role in the repairment and regeneration of neuron axons after TBI.