1.Literature review on premarketing and postmarketing evidence of xiyanping injection.
Zhi-Fei WANG ; Xiao CHEN ; Wen ZHANG ; Yan-Ming XIE
China Journal of Chinese Materia Medica 2014;39(18):3637-3640
This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system (HIS) data, literature analysis, etcetera This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection.
Drugs, Chinese Herbal
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administration & dosage
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adverse effects
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Injections
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Medicine, Chinese Traditional
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methods
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Product Surveillance, Postmarketing
2.Analysis of influencing factors on adverse reaction of Shengfu injection based on prospective active safety monitoring.
Zhi-fei WANG ; Wei ZHAO ; Yin ZHANG ; Yan-ming XIE
China Journal of Chinese Materia Medica 2015;40(24):4746-4751
This study collected demographic data, past history, personal history, family history, dosage, solvent, combined medication information of adverse reaction cases from a prospective, multi center, large sample intensive hospital monitoring, and found the influencing factors with cross-tab analysis. The results showed that in the medication group of 19-45, patients with allergic histories had a higher proportion in ADR; in the medication group of 46-65, male patients with allergic histories had a higher proportion in ADR; indication and non-indication group, patients of 19-45 years old, with combined medications and allergy histories had a higher proportion in ADR; Non-indication medication group, patients with combined medication, higher concentration, out-instruction solvent and dosage, had a higher proportion in ADR. So, the ADRs of Shenfu injection were related to the history of drug allergy, and also related to the indication, dosage, solvent, concentration when it was used.
Adult
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Aged
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Drug Hypersensitivity
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etiology
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Drugs, Chinese Herbal
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adverse effects
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Female
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Humans
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Injections
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Male
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Middle Aged
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Prospective Studies
3.Preparation and bioevaluation of 111 In-DTPA-avastin for non-invasive tumor targeted imaging
Hua ZHU ; Jinming ZHANG ; Fei LIU ; Xuedi HAN ; Zhi YANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2017;37(1):5-9
Objective To label human VEGF targeted bevacizumab (avastin) with 111In and to evaluate the application of 111 In?DTPA?avastin SPECT imaging for tumor diagnosis. Methods DTPA?avastin was prepared by coupling with a bifunctional chelating agent, and then labeled with 111 In to obtain 111 In?DTPA?avastin. The stability and molecular integrity of the labeled radiotracer were studied. Human hepatoma cell ( BEL7404) bearing nude mice tumor model was employed for tumor targeting evaluation. Gamma imaging was acquired after intravenous injection of 18.5 MBq probe. At the end of the observation, animals were sac?rificed for bio?distribution study. Results 111 In?DTPA?avastin tracer was synthesized and purified to a?chieve a radiochemical purity yield above 98% and specific activity up to 185 GBq/nmol. Its stability in 5%BSA was optimal, and the radiochemical purity after incubation for 96 h was over 90%. Gamma imaging re?sults showed that the tracer possessed definite tumor targeting property. Its biodistribution was consistent with that of normal in vivo antibody metabolism while possessing a good tumor?targeting property with a relatively high uptake of (3.8±0.8) %ID/g in tumor tissues 96 h after injection. Conclusions 111 In?DTPA?avastin tracer has good physicochemical properties, in vivo stability and good VEGF targeted binding. 111 In?DTPA?avastin has potential to be a new molecular probe for SPECT imaging.
4.Expression of osteopontin in different metastatic potential uveal melanoma and its significance
Xu, ZHANG ; Xiao-lin, XU ; Bin, LI ; Fei, GAO ; Zhi-bao, ZHANG ; Liang, LI
Chinese Journal of Experimental Ophthalmology 2012;30(3):199-203
BackgroundOsteopontin is highly expressed in many metastatic tumors,but its expression in uveal melanoma and the relationship of osteopontin with metastasis is still under investigation.Objective This study was to investigate the relationship between osteopontin expression and uveal melanoma metastatic potential.Methods Fifty samples of uveal melanoma were collected in Beijing Tongren Hospital.The expressions of osteopontin in the samples were detected using immunohistochemistry,and expressions of osteopontin mRNA in different metastatic potential uveal melanoma cell lines (MU M-2B,C918,OCM-1A) were analyzed using quantitative polymerase chain reaction (Q-PCR).ResultsOsteopontin was positively expressed in 10 samples of 13 patients with metastasis and 14 samples of 37 patients without metastasis,showing a significant difference between them (x2=5.888,P=0.000).There were 11 samples and 13 samples exhibiting the positive expression of osteopontin in 15 epithelial type and 35 non-epithelial type of uveal melanoma respectively with the significant difference (x2=5.510,P =0.000).The positive expressing numbers of osteopontin were 20 tumors of 30 affected tumors and 4 tumors of 20unaffected ciliary tumors with the significant difference (x2 =10.470,P =0.000 ).No significant differences in the expression of osteopontige were found between different gender,age,eyes,largest basal diameters and invasion of scleral canal( P =0.536,0.256,0.802,0.848,0.555 ).The relative expression value of osteopontin mRNA was in turn 1.00±0.04,0.91 ±0.03,0.08±0.01 in MUM-2B,C918,OCM-1A with the significant difference among three cell lines( F=33.135,P<0.05).The osteopontige mRNA expression was significant enhanced in high metastatic potentialcell lines( MUM-2B,C918 ) compared with low metastatic potential cell lines( OCM-1 A) (P<0.05 ),but no significant difference was seen between two high metastatic potential cell lines(MUM-2B,C918) (P=0.804).Conclusions Osteopontige expression is associated with the uveal melanoma cell line invasion and metastasis potential.These results imply that osteopontige expression maybe an indicator of uveal melanoma invasion and metastasis ability.
5.Chemical constituents from a Tibetan medicine Meconopsis horridula.
Zhi-Qin GUO ; Qiang GUO ; Zhi-Xiang ZHU ; Shui-Ying ZHANG ; Chun LI ; Xing-Yun CHAI ; Peng-Fei TU
China Journal of Chinese Materia Medica 2014;39(7):1152-1156
A phytochemical investigation on the aerial parts of a Tibetan medicine Meconopsis horridula, by solvent extraction, repeated chromatographies on silica gel, Sephadex LH-20, and preparative TLC techniques, led to the isolation of 9 compounds. By spectroscopic analysis and comparison of its 1H and 13C-NMR data with those in literatures, their structures were identified as oleracein E(1), N-( trans-p-coumaroyl) tyramine (2), chrysoeriol (3), apigenin (4), hydnocarpin (5), p-coumaric acid glucosyl ester (6), stigmast-5-ene-3beta-ylformate (7), 3beta-hydroxy-7alpha-ethoxy-24beta-ethylcholest-5-ene (8), and beta-sitosterol (9), respectively, among which compounds 6-8 were isolated from the genus for the first time,and 1,3 were isolated from the species for the first time. A MTT method was applied to evaluate the cytotoxic activity of compounds 14 against the human hepatocellular liver carcinoma cell line (HepG2), and compound 1 showed significant cytotoxicity against HepG2,with its inhibitory rate of 52.2% at 10 micromol x L(-1).
Medicine, Tibetan Traditional
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Molecular Structure
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Papaveraceae
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chemistry
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Plant Extracts
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chemistry
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Spectrometry, Mass, Electrospray Ionization
6.Seroepidemiological survey of F1 antibody of indicator animals in wild rodents loci of plague in YunnanProvince
Yun, LIANG ; Zhi-zhong, SONG ; Ying, GUO ; Zhi-ming, YANG ; WUAIGUO ; Fu-xin, ZHANG ; Zheng-fei, ZHANG ; Ying-tian, HE ; Wei, HE ; Zhi-jun, CHENG
Chinese Journal of Endemiology 2008;27(6):644-646
Objective To study on the effect of indicator animals in plague surveillance throngh detecting F1 antibody against Yersiniapestis(Y.pestis)in indicator animals in wild rat plague foci,provide scientific evidence for plague control and determining the range of epidemic area.Methods According to investigation scheme of wild rodents plagne foci in Yunnan Province,indicator animals Canis familiarils and Felis catu(C.familiarils and F.catus)related to the plague were investigated in 75 villages,14 township and 10 counties around Yulong County,and living rodents were captured by cage,sera of indicator animals and rodents relevant to plague were simultaneously collected and detected for F1 antibody against Y.pestis using indirect hemagglutination(IHA).Results Seropositivity rate of indicator animals were 6.76%(202/2987),being 24.69% in C.familiaris and 24.69% in F.catus,there were statistical significance(X2=87.32,P<0.01)between C familiaris and F catus,the latter beingmore than the former.But F1 antibody of rodents sera were not detected,its seropositivity rate was zero.there was a statistical significance(P<0.01)between indicator animals and rodents.Conclusions Through serocpidemiological survey of indicator animals,new wild rat plague natural focus has been confirmed in YuLong County and Gucheng District in LiJiang City,therefore,serocpidemiological surveillance of indicator animals is very important for plague control and prevention.
7.The role of combination of traditional Chinese and western medicine on severe allergic rhinitis
Yuyan FAN ; Xiangdong WANG ; Lin XI ; Nan ZHI ; Feifei CAO ; Fei HE ; Luo ZHANG
International Journal of Traditional Chinese Medicine 2013;35(4):306-309
Objective To explore the effects of combination of traditional Chinese medicine (TCM)and western medicine on a variety of allergen induced severe perennial seasonal allergic rhinitis patients who were treated invalidly with antihistamines and intranasal flixonase for more than two years.Methods 16 patients with moderate to severe allergic rhinitis who were uncontrolled with antihistamines and intranasal flixonase for one week were treated by combination with TCM of Xin-Yi-Qing-fei San or Gyokubeifu-san mixed formula for two weeks.Nasal symptoms,its effects on the quality of daily life,and telephone follow-up half a year later were evaluated.Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) were used to evaluate the quality of life.Results After 2 weeks combination-treatment,the nasal symptoms of congestion,rhinorrhea,sneezing,nasal itching,and nasal obstruction were significantly improved compared with combination-before [(52.0± 11.1)%,(69.1±5.3)%,(68.3±12.3)%,(55.5±10.0)%to (10.9±2.4)%,(8.9±3.2)%,(12.5±4.3)%,(13.2±5.3)%,respectively].The before and after treatment of nasal function of nasal minimum cross-sectional area (MCA),nasal cavity volume (V5) and nasal airway resistance (R75 and R150) respectively were (0.58±0.12)cm2,(0.38 ± 0.23) Pa/cm3 · s-1,(0.44 ± 0.32) Pa/cm3 · s-1,(3.50 ± 2.33) cm2 to (0.48 ± 0.23) cm2,(0.31 ±0.33) Pa/cm3 · s-1,(0.31 ±0.37)Pa/cm3 · s-1,(2.24± 1.03) cm2 (P<0.01).In addition,findings of patients with nasal symptoms by half year follow-up were significantly better than those of before.Conclusion The interventionof TCM can effectively control the perennial and seasonal severe symptoms of patients with AR,and improve the quality of life of patients.
8.Cervical carcinoid with high-grade intraepithelial neoplasia: report of a case.
Hai LI ; Fang BAO ; Yu-fei LI ; Yi-long DAI ; Ying XIANG ; Zhi-hong ZHANG
Chinese Journal of Pathology 2013;42(5):347-348
Adult
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Breast Neoplasms
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metabolism
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pathology
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secondary
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Carcinoid Tumor
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metabolism
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pathology
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surgery
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Carcinoma, Adenoid Cystic
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pathology
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Carcinoma, Lobular
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metabolism
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pathology
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secondary
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Cervical Intraepithelial Neoplasia
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metabolism
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pathology
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surgery
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Chromogranin A
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metabolism
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Diagnosis, Differential
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Female
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Humans
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Hysterectomy
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Keratins
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metabolism
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Neoplasms, Multiple Primary
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metabolism
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pathology
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surgery
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Ovarian Neoplasms
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metabolism
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pathology
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Sex Cord-Gonadal Stromal Tumors
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metabolism
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pathology
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Synaptophysin
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metabolism
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Uterine Cervical Neoplasms
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metabolism
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pathology
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surgery
9.Research and practice about risk control of shenfu injection.
Zhi-Fei WANG ; Da-Li TIAN ; Wen ZHANG ; Yan-Ming XIE
China Journal of Chinese Materia Medica 2014;39(18):3641-3644
Shenfu injection is developed by improving dosage form of ancient prescription "Shenfu Tang" and is mainly derived from extracts of both traditional Chinese medicine red ginseng and prepared lateral root of monkshood with polysorbate 80 as auxiliary material. Shenfu injection may be administered through intramuscular injection, intravenous drip or intravenous injection. It produces good effects in restoring Yang and rescuing patients from collapse, tonifying Qi and preventing exhaustion. It is mainly used to treat not only syncope and prostration resulting from sudden Yang collapse (infectious, hemorrhagic and water depletion shock etc), but also pavor, palpitation, dyspnea with cough, stomachache, diarrhea and arthralgia etc caused by deficiency of Yang (deficiency of vital energy). Research group has audited the monitored hospitals and has carried out postmarketing study of Shenfu solution from many aspects including literature review, spontaneous reporting system (SRS) and hospital information system (HIS) data analysis etc. A summary is shown below.
Drugs, Chinese Herbal
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administration & dosage
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adverse effects
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Humans
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Injections
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Medicine, Chinese Traditional
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methods
10.Clinical effect of staged repair and reconstruction of multiple ligament injuries in knee joints.
Zhen LAI ; Zhi-xiang LIU ; Jun-long YANG ; Zhao-fei ZHANG ; Yi-liang CHANG
China Journal of Orthopaedics and Traumatology 2016;29(5):404-407
OBJECTIVETo evaluate clinical outcomes of anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction under arthroscopy combined with limited open repair of medial collateral ligament (MCL) for the treatment of multiple ligament injuries of knee joints.
METHODSFrom March 2006 and June 2012,the data of 14 patients (14 knees) with multiple injuries of ACL, PCL, and MCL were collected. There were 8 males and 6 females with an average age of (31.8 +/- 8.1) years old (ranged, 20 to 49 years old). All the patients were performed with X-ray and MRI examination, and the results showed that 10 patients had combined with injuries of anterior cruciate ligament (ACL), posterior cruciate ligament (PCL) and medial collateral ligament (MCL); 4 patients had ALC,PCL and posterolateral corner (PLC) injuries. Four patients had medial meniscus injuries and 2 patients had lateral meniscus injuries. The MCL,PLC and meniscus injuries were treated with operation on the first stage, and functional exercises were performed 3 weeks after fixation. The reconstruction operation of ACL and (or) PCL was performed at the second stage under arthroscopy 3 to 6 months later when the movement range of knee joint recovered to the normal level with obvious relaxation.
RESULTSAll incisions healed by primary intention. All the patients were followed up with a mean duration of 48.9 months (ranged, 24 to 80 months). The Lysholm score was improved from preoperative 19.6 +/- 0.9 to the latest follow-up 87.1 +/- 2.8 (t=12.3, P<0.01). The International Knee Documentation Committee (IKDC) rating: 9 cases nearly recovered to normal, 5 cases were abnormal.
CONCLUSIONFor multiple ligament injuries in the knee, staged repair and reconstruction can effectively restore knee joint stability and function.
Adult ; Anterior Cruciate Ligament ; surgery ; Anterior Cruciate Ligament Injuries ; Female ; Follow-Up Studies ; Humans ; Knee Injuries ; physiopathology ; surgery ; Knee Joint ; physiopathology ; surgery ; Male ; Middle Aged ; Posterior Cruciate Ligament ; injuries ; surgery ; Reconstructive Surgical Procedures ; Treatment Outcome ; Young Adult