1.Expression change of stromal cell-derived factor 1α in retinas after partial optic nerve injury
Dongchao PAN ; Yongyan BI ; Dongfu FENG ; Ertao CHEN ; Shenghua CHU ; Yang WANG
Journal of Shanghai Jiaotong University(Medical Science) 2009;29(12):1424-1427
Objective To investigate the changes of expression of stromal cell-derived factor 1α (SDF-1α) in retinas after partial optic nerve injury in rats. Methods Models with injury of partial optic nerve were induced in rats. Retinal tissues were collected 1,2,3,5,7,10 and 14 d after injury. Enzyme linked immunosorbent assay and Real-time quantitative PCR were employed to detect the expression of SDF-1α protein and mRNA in retinal tissues respectively in injury group (n=28), sham operated group (n=28) and normal control group (n=12). Results The expression of SDF-1α protein and mRNA in retinas was higher than that in sham operated group and normal control group at different time points after injury (P<0.01), and it reached the peak at the 5th day after injury. The expression of SDF-1α protein and mRNA maintained a high level at the 14th day after injury. Conclusion The expression of SDF-1α protein and mRNA is up-regulated after partial optic nerve injury, and may last for a long time.
2.Guiding principles of clinical research on mild cognitive impairment (protocol)
Jinzhou TIAN ; Jing SHI ; Xinqing ZHANG ; Qi BI ; Xin MA ; Zhiliang WANG ; Xiaobin LI ; Shuli SHENG ; Lin LI ; Zhenyun WU ; Liyan FANG ; Xiaodong ZHAO ; Yingchun MIAO ; Pengwen WANG ; Ying REN ; Junxiang YIN ; Yongyan WANG
Journal of Integrative Medicine 2008;6(1):9-14
Mild cognitive impairment (MCI), as a nosological entity referring to elderly people with MCI but without dementia, was proposed as a warning signal of dementia occurrence and a novel therapeutic target. MCI clinical criteria and diagnostic procedure from the MCI Working Group of the European Alzheimer's Disease Consortium (EADC) may better reflect the heterogeneity of MCI syndrome. Beijing United Study Group on MCI funded by the Capital Foundation of Medical Developments (CFMD) proposed the guiding principles of clinical research on MCI. The diagnostic methods include clinical, neuropsychological, functional, neuroimaging and genetic measures. The diagnostic procedure includes three stages. Firstly, MCI syndrome must be defined, which should correspond to: (1) cognitive complaints coming from the patients or their families; (2) reporting of a relative decline in cognitive functioning during the past year by the patient or informant; (3) cognitive disorders evidenced by clinical evaluation; (4) activities of daily living preserved and complex instrumental functions either intact or minimally impaired; and (5) absence of dementia. Secondly, subtypes of MCI have to be recognized as amnestic MCI (aMCI), single non-memory MCI (snmMCI) and multiple-domains MCI (mdMCI). Finally, the subtype causes could be identified commonly as Alzheimer disease (AD), vascular dementia (VaD), and other degenerative diseases such as frontal-temporal dementia (FTD), Lewy body disease (LBD), semantic dementia (SM), as well as trauma, infection, toxicity and nutrition deficiency. The recommended special tests include serum vitamin B12 and folic acid, plasma insulin, insulin-degrading enzyme, Abeta40, Abeta42, inflammatory factors. Computed tomography (or preferentially magnetic resonance imaging, when available) is mandatory. As measurable therapeutic outcomes, the primary outcome should be the probability of progression to dementia, the secondary outcomes should be cognition and function, and the supplement outcome should be the syndrome defined by traditional Chinese medicine. And for APOE epsilon4 carrier, influence of the carrier status on progression rate to dementia and the effect of treatment should be evaluated.
3.An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)"
Jinzhou TIAN ; Jing SHI ; Xinqing ZHANG ; Qi BI ; Xin MA ; Zhiliang WANG ; Xiaobin LI ; Shuli SHENG ; Lin LI ; Zhenyun WU ; Liyan FANG ; Xiaodong ZHAO ; Yingchun MIAO ; Pengwen WANG ; Ying REN ; Junxiang YIN ; Yongyan WANG
Journal of Integrative Medicine 2008;6(1):15-21
In order to provide the "guiding principles of clinical research on mild cognitive impairment (MCI) (protocol)" edited by Beijing United Study Group on MCI of the Capital Foundation of Medical Developments (CFMD) with evidence support, clinical criteria, subtypes, inclusion and exclusion of MCI, and use of rating scales were reviewed. The authors suggested that MCI clinical criteria and new diagnosis procedure from the MCI Working Group of the European Alzheimer's disease Consortium (EADC) may better reflect the heterogeneity of MCI syndrome. Diagnostic rating scales including Clinical Dementia Rating (CDR), Global Deterioration Scale (GDS), Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Instrumental Activities of Daily Living (IADL) are very useful in definition of MCI but can not replace its clinical criteria. Absence of major repercussions on daily life in patients with MCI was emphasized, but the patients may have minimal impairment in complex IADL. According to their previous research, the authors concluded that highly recommendable neuropsychological scales with cut-off scores in the screening of MCI cases should include Mini-Mental State Examination (MMSE), logistic memory test such as Delayed Story Recall (DSR), executive function test such as Clock Draw Test (CDT), language test such as Verbal Category Fluency Test (VCFT), etc. And finally, the detection of biological and neuroimaging changes, including atrophy in hippocampus or medial temporal lobe in patients with MCI, was introduced.
4.Post-marketing re-evaluation of Kudiezi injection study on early treatment in patients with ischemic stroke.
Xiaoqin YE ; Xu WEI ; Yanming XIE ; Yihuai ZOU ; Xingquan ZHAO ; Jianhua HAN ; Xinzhi WANG ; Yunzhi MA ; Qi BI ; Qingfan XIE ; Jianjun ZHAO ; Xiaolan CAO ; Hongxia CHEN ; Shizhong WANG ; Rongmei YAN ; Zucheng HAN ; Danhui YI ; Yongyan WANG
China Journal of Chinese Materia Medica 2011;36(20):2793-2795
OBJECTIVETo study the effect and safety of Kudiezi injection on patients with acute ischemic stroke.
METHODSeven hundreds patients were divided into two groups by central randomization system. The study group, 346 cases, was treated with kudiezi injection plus traditional Chinese medicine (TCM) synthesis rehabilitation project, and the control group, 354 cases, was treated with synthetic rehabilitation project. The patients were treated for 10 to 21 days. Before treatment and at the 7th, 14th and 21th day of treatment, the indexes include NIHSS used for evaluating the neurological deficit degree and the motor function score (Fugl-Meyer) for evaluating motor function were observed. The safety index is defined by adverse observation event and laboratory test. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time.
RESULTApplication of generalized estimating equation model, we found that as the treatment time, NIHSS score and FMI score of the two groups showed a trend of improvement. And at the 14th days and 21th days of treatment, compared to the control group the treatment group showed significant statistical difference on the impact of NIHSS and FMI (P<0.05). No serious adverse events were observed.
CONCLUSIONKudiezi injection plus TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the neurological deficit and motor function. Kudiezi injection is safe and effective in the treatment of acute ischemic stroke.
Aged ; Brain Ischemia ; drug therapy ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Injections ; Male ; Medicine, Chinese Traditional ; adverse effects ; Middle Aged ; Product Surveillance, Postmarketing ; Stroke ; drug therapy
5.Post-marketed re-evaluation of fleabane injection and Dengzhan Shengmai capsule study on treatment in patients with ischemic stroke.
Xu WEI ; Xiaoqin YE ; Yanming XIE ; Yihuai ZOU ; Xingquan ZHAO ; Jianhua HAN ; Xinzhi WANG ; Yunzhi MA ; Qi BI ; Qingfan XIE ; Jianjun ZHAO ; Xiaolan CAO ; Hongxia CHEN ; Shizhong WANG ; Rongmei YAN ; Zucheng HAN ; Danhui YI ; Yongyan WANG
China Journal of Chinese Materia Medica 2011;36(20):2789-2792
OBJECTIVETo verify the efficacy and safety of post-marketed fleabane injection combined with Dengzhan Shengmai capsules in the treatment of ischemic stroke (IS).
METHODA multicentre, prospective, practical, randomized controlled study was carried out to compare the efficacy and safety of Dengzhan group (n = 343) and western medicine group (n = 335), appling "clinical study central stochastic system". The treatment of Dengzhan group is using fleabane injection in acute stage and Dengzhan Shengmai capsules in convalescence. The primary indexes of effect evaluation are the important outcome events in 360 days' follow-up, including mortality, recurrence, disability and quality of life to reflect the effect of clinical study. The indexes of safety evaluation involve laboratory examination results and incidence of adverse events.
RESULTAfter 360 days' follow-up, 4 people died of IS in Dengzhan group, and the mortality rate of which is 1.17%, while 16 died in Western medicine group (WM group), and the mortality rate is 4.78%, suggesting that the mortality rate of Dengzhan group is significantly lower than WM group (P<0.05). Eleven cases recurred in Dengzhan group, and the recurrence rate of which is 3.21%, while 12 recurred in WM group, and the recurrence rate is 3.59%, indicating that the recurrence rate of Dengzhan group is slightly lower than WM group. The disability rate of Dengzhan group is 39.53%, among which the rate of severely disabled cases are 1.49%, while the disability rate of WM group is 40.13%, among which the rate of severely disabled cases are 3.13%, suggesting that the disability rate of Dengzhan group is lower and the severity of disability is also lighter than WM group. In the field of quality of life, the activity ability and the upper limb function store of stroke patients in Dengzhan group improved far much better than WM group (P<0.05). Analysis of safety suggested that, adverse events occurred in 11 cases in Dengzhan group, among which 4 cases is related with the drug treatment, the incidence of adverse events of which is 1.17%, and the main manifestations involve fever and chilling, rash, nausea, dizziness, palpitation, etc. which were all appeared after the treatment of fleabane injection, and disappeared 1 to 2 days after drug withdrawal. 13 cases occurred abnormal liver function and 2 cases abnormal kidney function in Dengzhan group. According to the judgment of clinical physicians, 3 case of ALT abnormality is possibly related to the treatment, the others are all unrelated with the treatment.
CONCLUSIONFleabane injection and Dengzhan Shengmai capsules are all safe and effective TCM in the treatment of ischemic stroke.
Adult ; Aged ; Brain Ischemia ; drug therapy ; Capsules ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Erigeron ; adverse effects ; Female ; Humans ; Injections ; Male ; Middle Aged ; Product Surveillance, Postmarketing ; Prospective Studies ; Stroke ; drug therapy