1.Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines.
Hong-jiao LI ; Li-yun HE ; Bao-yan LIU
China Journal of Chinese Materia Medica 2015;40(12):2461-2463
The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal
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adverse effects
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economics
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therapeutic use
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Humans
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Medicine, Chinese Traditional
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Product Surveillance, Postmarketing
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methods
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Quality Control
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Randomized Controlled Trials as Topic
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Respiratory Tract Infections
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drug therapy
2.Effects of Gastrodin on BDNF Expression in AD Tree Shrew
Baoli HE ; Jianlin JIAO ; Bo LI ; Jintao LI ; Limei WANG
Journal of Kunming Medical University 2013;(9):29-30,37
Objective To investigate the effect of gastrodin on brain-derived neurotrophic factor (BDNF) expression in Alzheimer's disease ( AD) tree shrew. Methods AD tree shrew model was established by intracerebroventricular injection with amyloid-βpeptide (Aβ) . Since the eighth day after injection, the tree shrews were treated with gastrodin for thirty days. The expression of BDNF in tree threw hippocampus was detected by reverse transcription polymerase chain reaction (RT-PCR) . Results The expression of BDNF mRNA in the treatment group was higher than that in the model group ( <0.05) . Conclusion Gastrodin can increase some degree of the expression of BDNF.
3.Embedded information service for research on aviation medicine
Li YU ; Yan JIAO ; Jiabo YE ; Qing HE ; Fanhu ZHONG
Chinese Journal of Medical Library and Information Science 2015;24(12):35-37
Described in this paper are the contents and objectives of embedded information service for research on aviation medicine in light of information access, identification and analysis in persons engaged in research on aviation medicine.
4.Sequence pattern mining of doctor's advice for Chinese traditional medicine in HIS
Jun ZHUANG ; Feng LI ; Shiqing YE ; Kan LIU ; Jiao HE
Chinese Medical Equipment Journal 2004;0(07):-
Extensive functions can be provided to hospital management,medical treatment and teaching when massive data are reasonably processed and analyzed. Knowledge mined from sequence of doctor's advice for medicine can not only evaluate treatment quality but also provide necessary basis for establishing a safety and effective medicine treatment plan. This paper analyzes some common information of doctor's advice for medicine,mines the doctor's advice for medicine by using sequence pattern mining method,and explains the mining results.
5.Ectopic over-expression of oncogene Pim-2 induce malignant transformation of LO2
Xiuyun LI ; Tianjin CHEN ; Yongping WANG ; Jiao LIU ; Peisheng HE
Chinese Journal of Current Advances in General Surgery 2017;20(4):253-258
Objective:To research whether ectopic over-expression of Pim-2 could cause chang-liver cell (LO2) malignant transformation,to explore the relationship between Pim-2 protein and hepatocellular carcinoma.Methods:Three groups of cells were arranged including human chang liver cell line LO2 (group C),LO2 cells transfected with empty-vector (group B) and LO2 cells transfected with Pim-2 gene (group A).Pim-2 expression levels were detected.The morphology,proliferation level,apoptosis rate and migration ability of the cells were detected respectively.The cells were subcutaneously inoculated into athymic mice and the microstructures of the neoplasm were observed by optical and electron microscopy.Results:Compared with group B,Pim-2 expression levels were significantly higher in group A (P<0.05),and their morphology had obvious malignant changes.They also showed a significantly increased proliferation rate (P<0.05) and migration capacity (P<0.05),as well as a significantly decreased apoptosis rate (P<0.05).Only the athymic mice inoculated with group A could generate neoplasm,and the morphology of the neoplasm coincided with that of the hepatoma.Conclusion:Both the morphological and biological changes of LO2/Pim-2 cells indicate the trend of malignant transformation,which could generate hepatoma in athymic mice.Pim-2 could induce malignant transformation of human liver.
6.Application of Clinical Nursing Pathway in Stroke
Fengying WANG ; He JIAO ; Dan LI ; Xiaomei ZENG
Chinese Journal of Rehabilitation Theory and Practice 2013;19(12):1194-1196
Objective To explore the effect of clinical nursing path (CNP) on stroke patients. Methods 80 stroke patients were divided into control group and experimental group with 40 cases in each group. The control group received functional nursing, while the experimental group received care in accordance with the design of CNP map. Results The mastery rate of health knowledge and the satisfaction rate were higher, and the hospitalization time was shorter in the experimental group than in the control group (P<0.05). Conclusion The implementation of CNP could increase the mastery degree of health knowledge, improve the satisfaction rate of patients for nursing service, and shorten the hospitalization time.
7.Mitochondria-targeted antioxidant Mitoquinone protects post-thaw human sperm against oxidative stress injury.
Li LIU ; Mei-jiao WANG ; Ting-he YU ; Zhi CHENG ; Min LI ; Qian-wen GUO
National Journal of Andrology 2016;22(3):205-211
OBJECTIVETo investigate the potential protective effect of the mitochondria-targeted antioxidant Mitoquinone (MitoQ) on post-thaw human sperm.
METHODSSemen samples were collected from 60 normal fertile men, each divided into six parts of equal volume to be incubated at 37 °C in normal saline (G0, control) or in the extender with 2 nmol/L (G1), 20 nmol/L (G2), 200 nmol/L (G3), 2 µmol/L (G4), and 20 µmol/L of MitoQ (G5). After one hour of incubation, the samples were subjected to computer-assisted semen analysis (CASA) for sperm motility, flow cytometry for reactive oxygen species (ROS), thiobarbituric acid assay for the concentration of malondialdehyde (MDA), and MitoTracker fluorescent staining and flow cytometry for the sperm mitochondrial membrane potential (MMP). Then, the semen were cryopreserved with none (B0), 200 nmol/L (B1), and 2 µmol/L of MitoQ (B2), followed by detection of the changes in the ROS, MDA, and MMP of the post-thaw sperm.
RESULTSThe percentage of progressively motile sperm and total rate of sperm motility were significantly higher in G3 ([30.8 ± 10.2]% and [70.6 ± 9.0]%) and G4 ([32.7 ± 13.5]% and [70.3 ± 11.9]%) than in G0 ([17.6 ± 5.0]% and [54.9 ± 11.5]%) (P < 0.05). The level of ROS dropped markedly with the increased concentration of MitoQ, 86.5 ± 31.6 in G3, 93.6 ± 42.0 in G4, and 45.1 ± 15.0 in G5, as compared with 160.8 ± 39.7 in G0 (P < 0.05). The content of MDA was remarkably lower in G3 ([0.9 ± 0.5] µmol/mg) and G4 ([0.9 ± 0.5] µmol/mg) than in G0 ([1.9 ± 1.1] µmol/mg) (P < 0.05), but not in G5 ([1.7 ± 0.7] µmol/mg), which was even higher than in G3 and G4 (P < 0.05). The MMP showed a significant reduction in G5 (1156 ± 216) in comparison with G0 (1701 ± 251) (P < 0.05) but exhibited no remarkable difference between G0 and G1 (1810 ± 298), G2 (1995 ± 437), G3 (1950 ± 334), or G4 (1582 ± 314). The percentage of progressively motile sperm and total rate of sperm motility after freezing-thawing were significantly decreased as compared with those of the fresh semen (P < 0.01), but both were remarkably higher in B1 ([3.2 ± 2.3]% and [ 43.0 ± 9.5]%) than in B0 ([0.8 ± 0.6]% and [26.5 ± 11.4]%) (P < 0.05). The ROS level was significantly lower in B1 and B2 than in B0 (34.6 ± 12. 3 and 37.0 ± 10.5 vs 56.9 ± 14.3, P < 0.05), and so was the MDA content ([1.4 ± 0.5] and [1.4 ± 0.6] µmol/mg vs [2.6 ± 1.0] µmol/mg, P < 0.05), but the MMP was markedly higher in B1 and B2 than in B0 (1010.0 ± 130.5 and 880.6 ± 128.6 vs 721.1 ± 24.8, P < 0.05).
CONCLUSIONAddition of MitoQ to the freezing extender at 200 nmol/L may effectively improve the quality of human sperm and MitoQ is a good protective addictive for human sperm cryopreservation.
Antioxidants ; Cryopreservation ; Humans ; Male ; Malondialdehyde ; analysis ; Membrane Potential, Mitochondrial ; Mitochondria ; Organophosphorus Compounds ; pharmacology ; Oxidative Stress ; drug effects ; Reactive Oxygen Species ; Semen ; Semen Analysis ; Semen Preservation ; Sperm Motility ; Spermatozoa ; drug effects ; Ubiquinone ; analogs & derivatives ; pharmacology
8.Determination of ellagic acid, flavonoids and goshonoside-F5 in Rubi Fructus by HPLC.
Jian-Ming HE ; Nan SUN ; Wen-Dan WU ; Li-Jiao FAN ; Mei-Li GUO
China Journal of Chinese Materia Medica 2013;38(24):4351-4356
High-performance liquid chromatographic coupled with variable wavelength detection (HPLC-VWD) has been developed for simultaneous determination of 5 analytes including ellagic acid, quercetin, kaempferol-3-O-beta-D-rutinoside, tiliroside and kaempferol, and high-performance liquid chromatographic with an evaporative light scattering detector (HPLC-ELSD) has been established to determine goshonoside-F5 in extract of Rubi Fructus. Chromatographic separations were carried out on an Agilent ZORBAX SB-C18 column (4.6 mm x 250 mm, 5.0 microm). All calibration curves of reference standards revealed good linearity (R2 > 0.999 5) within the concentration ranges tested. The method limits of detection ranged 0.297-90.144 ng and the method limits ofquantitation ranged 0.990-300.480 ng, respectively. Recoveries of 6 analytes were from 97.11% to 101.7%, with RSD less than 2.1%. The result shows that amounts of the 6 analytes in the samples from 16 localities were found to be different. The higher latitude of growing environment, the more ellagic acid in herb. The content of total flavonoids in sample from east localities were higher than that in middle and west localities, and the content of goshonoside-F5 in Bozhou, Anhui province was higher than others. This method was found to be simple, accurate, sensitive with good repeatability. Those results might serve as a sound foundation for further study, quality control and application of Rubi Fructus.
Chromatography, High Pressure Liquid
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Ellagic Acid
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analysis
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Flavonoids
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analysis
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Geography
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Rosaceae
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chemistry
9.Related research on corneal higher-order aberrations after different ways refractive surgery
Shu-Xi, HE ; Dong-Wei, LI ; Hua, WANG ; Dong-Qiang, LUO ; Jiao, CHEN ; Qian, LI
International Eye Science 2015;(8):1382-1384
AIM: To evaluate the changes of corneal high - order aberration (including Coma, Spab, RMSh) after laser in situ keratomileusis (LASIK) with femtosecond laser, sub- Bowman keratomileusis ( SBK ) and laser epithelial keratomileusis (LASEK). METHODS: Of 82 myopic patients ( 164 eyes ), 31 patients (62 eyes) were treated by FS-LASIK, 31 patients (62 eyes) were treated by SBK, 20 patients (40 eyes) were treated by LASEK. Sirius system was used for measuring the coma aberration, spherical aberration, and high order aberration at 1, 15d,1, 3mo after surgery. RESULTS: 1) Vision: The uncorrected visual acuity of the three groups had no differences (P>0. 05). 2) Corneal aberrations: Three kinds of surgical procedure for patients with corneal aberration had significant impact. The C7, C8, C12 and RMSh of three groups were increased significantly (P<0. 05). The C7, C8, C12 and RMSh were not recovered to preoperative levels after 3mo. But the increase of patients after FS- LASIK was smaller than the other two groups, with statistical significance (P<0. 05). CONCLUSION: Compared with SBK and LASEK, FS - LASIK has better visual acuity in the early postoperative and corneal higher-order aberrations increase is relatively small.
10.Effect analysis of the technique of retrograde puncture of popliteal artery applied in the interventional therapy of lower extremity arteriosclerosis obliterans patients
Xuemin ZHANG ; Jingjun JIANG ; Xiaoming ZHANG ; Wei LI ; Qingle LI ; Yang JIAO ; Zhibin HE ; Changshun HE ; Tao ZHANG
Chinese Journal of General Practitioners 2016;15(3):215-218
To investigate the effectiveness of retrograde puncture of popliteal artery in lower extremity arteriosclerosis obliterans ( ASO ) patients classified as TASC ( Tans-Atlantic Inter-Society Consensus) C/D.Retrospective analysis of 35 lower extremity ASO patients, 28 male and 7 female , the mean age was 72 ±8, 23 cases of Rutherford 3, 8 cases of Rutherford 4 and 4 cases of Rutherford 5. Preoperative ABI was 0.35 ±0.14, Lesion length in CT angiography ( CTA ) was ( 18 ±5 ) cm.The technique success rate of 35 cases was 100%.The puncture time was (6 ±4) min.6 cases used 4 F sheath and 29 cases used no sheath technology at the puncture site.In 27 cases guide wires passed retrograde through the occluded superficial femoral artery lesion and returned to the true lumen.8 cases of SAFARI technology to established the guild wire track.The complication rate of retrograde puncture was 14.2%( 5/35), 2 cases of postoperative hematoma appeared at the puncture site the next day, 2 cases of pseudoaneurysms emerged and 1 case of postoperative arteriovenous fistula at the puncture site of popliteal area were found by Doppler ultrasonography before discharged.All 5 patients were recovered by conservative treatment.The retrograde puncture of popliteal artery is a safe and reliable method.