1.Study of post marketing safety reevaluation of shenqi fuzheng injection.
Qing-Hua AI ; Yuan-Yuan LI ; Yan-Ming XIE
China Journal of Chinese Materia Medica 2014;39(18):3633-3636
In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.
Adverse Drug Reaction Reporting Systems
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Drug-Related Side Effects and Adverse Reactions
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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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Product Surveillance, Postmarketing
2.Evaluation of clinical efficacy of BAY 38-4766 for cytomegalovirus rentinitis
Ai-ping, YU ; Yun, XIAO ; Xiao-wei, GAO ; Ming, LI
Chinese Journal of Experimental Ophthalmology 2012;30(9):844-846
Background At present,researches about retinitis and acquired immunodeficiency syndrome (AIDS) mainly focus on observation and analysis of the cytomegalovirus (CMV)-induced ocular complication.To screen the effective drugs is very important for the treatment of AIDS-related CMV-induced retinitis.Objective This study was to describe the clinical features,diagnosis and treatment outcome of CMV-induced retinitis with BAY 38-4766 and evaluate the relationship between CMV retinitis and AIDS.Methods This was a case observational study.A total of 154 eyes of 84 patients with CMV retinitis and AIDS were enrolled in this study.Before the definitive diagnosis of CMV retinitis,the AIDS course of these patients were 4-26 months.In the initial examination,the visual acuity ranged from finger counting to 0.4,and the number of CD4+ T-lymphocyte was 0-30 cells/μl.The survival time in the patients ranged from 3 weeks to 18 months.BAY 38-4766 was used in 117 eyes of 62 patients,and 102 eyes of 53 patients showed the srinked of retinal lesion and improvement of vision (0.1-0.7).BAY 38-4766 was used to treat the CMV retinitis in 117 eyes of 62 patients with the initial intravenous dose of 5 mg/kg,twice per day for consecutive 2 weeks and followed by oral dose 1 gram per day.The follow-up duration was 2 weeks to 18 months.The fundus feature,visual acuity and CD4+ T-lymphocyte counts were analyzed.This study proposal was approved by Ethic Committee of the 474th Hospital of PLA,and written informed consent was obtained from each patient prior to entering this study.Results The numbers of CD4+T-lymphocytes increased to 12-402 eells/μl after administration of BAY 38-4766.The CMV retinitis aggravated and the vision decreased in the untreated 22 patients with the CD4+T-lymphocytes 0-30 cells/μl.Conclusions CMV retinitis is the most common intraocular complication in patients with AIDS.Diagnosis of CMV retinitis is based on the characteristics of necrotizing retinitis,which is typically associated with retinal hemorrhage and vasculitis.BAY 38-4766 is an effective drug for the treatment of CMV retinitis.
3.Investigation and analysis on current situation of clinical teaching
ming-min, GU ; ming-de, ZHU ; ai-li, NUER ; xiao-bo, LI ; hui, XIA ; gang, HUANG
Journal of Shanghai Jiaotong University(Medical Science) 2008;0(S1):-
Objective To investigate the clinical teaching situation by using developmental inspection of School of Medicine,Shanghai Jiaotong University(SJTU-SM),and to put forward some suggestions. Methods By checking questionnaires and informal discussions,the relevant information was collected and analyzed by using SPSS statistics sofware. Results The clinical teaching quality of SJTU-SM was basically satisfied.The satisfaction from internship of grade 2004 was better than that of grade 2003.However,some problems in clinical teaching must be improved.Conclusion The investigation showed that the clinical teaching quality of SJTU-SM is being improving.However,in order to achieve the international accreditation standards,the quality guarantee system of clinical teaching need to be further perfected.
4.Incidence rate of adverse reaction/event by Qingkailing injection: a Meta-analysis of single rate.
Chun-ling AI ; Yan-ming XIE ; Ming-quan LI ; Lian-xin WANG ; Xing LIAO
China Journal of Chinese Materia Medica 2015;40(24):4770-4778
To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data. Then, Meta-analysis was performed by using the R 3.2.0 software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Sixty-three studies involving 9,793 patients with Qingkailing injection were included, 367 cases of adverse reactions/events were reported in total. The incidence rate of adverse reaction in skin and mucosa group was 2% [95% CI (0.02; 0.03)]; the digestive system adverse reaction was 6% [95% CI(0.05; 0.07); the injection site adverse reaction was 4% [95% CI (0.02; 0.07)]. In the digestive system as the main types of adverse reactions/events, incidence of children and adults were 4.6% [0.021 1; 0.097 7] and 6.9% [0.053 5; 0.089 8], respectively. Adverse reactions to skin and mucous membrane damage as the main performance/event type, the observation time > 7 days and ≤ 7 days incidence of 3% [0.012 9; 0.068 3] and 1.9% [0.007 8; 0.046 1], respectively. Subgroup analysis showed that different types of adverse reactions, combination in the incidence of adverse reactions/events were higher than that of single drug, the difference was statistically significant (P < 0.05). This study suggested the influence factors of adverse reactions occur, and clinical rational drug use, such as combination, age and other fators, and the influence factors vary in different populations. Therefore, clinical doctors for children and the elderly use special care was required for a clear and open spirit injection, the implementation of individualized medication.
Adolescent
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Adult
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Aged
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Child
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Child, Preschool
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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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Incidence
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Infant
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Infant, Newborn
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Injections
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Male
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Middle Aged
5.Full-factor design of experiment application in the development of printing ink for binder jetting 3D printed preparation
Zeng-ming WANG ; Xian-fu LI ; Xiao-lu HAN ; Ai-ai LIU ; Xiao-xuan HONG ; Cong-hui LI ; Ai-ping ZHENG
Acta Pharmaceutica Sinica 2021;56(5):1460-1469
The development of printing ink is a challenge for binder jetting 3D printed preparations, which directly determines the quality of the printed product. This study adopted a 23 full-factor Design of Experiment (DoE) with three central points to optimize the printing ink composition of levetiracetam 3D printed dispersible tablet based on the concept of Quality by Design. Firstly, using polyvinyl pyrrolidone K30, glycerin and polysorbate 20 as independent variables based on 40% (
6.Impact analysis of shenqi fuzheng injection of course on liver function based on hospital information system data.
Qing-Hua AI ; Yan-Ming XIE ; Li YOU ; Yuan-Yuan LI ; Wei YANG
China Journal of Chinese Materia Medica 2014;39(18):3606-3608
OBJECTIVEUse propensity score methods to explore the effect of Shenqi Fuzheng injection (SQFZ) on ALT and AST lever of real worlds.
METHODHIS data from 18 hospitals was analyzed. Patients ranging from 18 to 80 years, it were divided into the cases group was used Shenqi Fuzheng injection > 21 days under the instruction, and control group used SQFZ ≤ 21 days. A large number of confounding biases are taken into account through the generalized boosted models (GBM) and multiple logistic regression model to estimate the treatment effects of SQFZ on abnormal changes in ALT and AST index and to explore possible influencing factors.
RESULTSventy and one confounding factors had been counterpoised, stratified analysis showed that the abnormal changes of cases group lower than control group, but not statistically significant.
CONCLUSIONAnalysis of HIS database showed that significant effects of SQFZ on abnormal changes in ALT and AST have not been found. The results of this study form the retrospective data, for the purpose of validating its clinical safety should be have a prospective clinical study of large sample.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Hospital Information Systems ; Humans ; Injections ; Liver ; Male ; Middle Aged ; Retrospective Studies ; Young Adult
7.Clinical application value of transesophageal atrial pacing combined with atropine load experiment in the diagnosis of the lesions of sinoatrial node and atrioventricular node
Hongyu SHENG ; Zhijun LI ; Qiqiong WANG ; Ming XU ; Siya AI ; Xinquan BAN ; Huirong LI
Clinical Medicine of China 2015;31(10):934-937
Objective To evaluate the clinical application value of transesophageal atrial pacing (TEAP) combined with atropine load experiment in the diagnosis of the lesions of sinoatrial node and atrioventricular node.Methods One hundred and forty-four cases selected from the outpatient and hospitalized patients in the People's Hospital of Changji Hui Autonomous Prefecture from September 2009 to December 2012,who with dizziness, syncope and other clinical symptoms and electrocardiogram showe.TEAP combined with atropine load experiment were given to these patients.Results (1) The authors detected in all patients,83 cases (57.6%) were positive, among which, 48 cases (57.8%) male, 35 cases (42.2%) female.(2) The authors detected 57 cases(39.6%) non-increased vagus nerve tension cases in 83 positive cases,among which 33 cases (57.9%) male, 24 cases (42.1%) female;Among which 29 cases (20.1%) were sinoatrial node hypofunction, and 16 cases(55.2%) male;8 cases(5.6%) were atrioventricular node hypofunction,and 4 cases(50%) male;14 cases(9.7%) were double node hypofunction, and 10 cases (71.4%) male;6 cases (4.2%) were tachycardia-bradycardia syndrome, and 3 cases (50%) male;among which, a long interval of greater than 3 seconds appeared when we stimulate one 84 years old man with S1S1 stimulate way, immediately pressed protective pacemaker until his own sinus rhythm was restored, as a safety precaution, stoped further examination and classified him as sick sinus group.Conclusion Detect the common causes of slow sinus and atrioventricular block,such as the sinoatrial node dysfunction, atrioventricular node dysfunction, double node dysfunction and increased vagus nerve tension through TEAP combined with atropine load experiment.Consider that this methods have the best diagnostic value in decreasing its rate of false positivity,and should be used as a necessary check before implantation of pacemaker in such patients, suitable used in clinical, especially in basic general hospitals.
8.RECOMMENDATION OF A KIND OF SYNTHETIC MEINTENANCE LIQUOR TO PRESERVE BACTERIUM LONG
Hong-Min LI ; Jun LIU ; Ming-Gui LIN ; Shu-Mei LI ; Ai-Hua TONG ;
Microbiology 1992;0(03):-
This Synthetic Meintenance Liquor contains all kinds of nutritive substance that subsist the bacterium, and can preserve the bacterium for nearly ten years by providing energy needed by metabolism. It is a favorable culture medium to preserve bacterum long.
9.Comparison of Inhibitory Activity between Daidzein and Puerarin on LPS Induced NO Production in RAW264 . 7 Cells
Ming ZHANG ; Di WANG ; Yizeng WAN ; Hao AI ; Junxiang LI ; Jian LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2013;(4):648-652
This study was aimed to compare the activation of daidzein and puerarin on antioxidation, NO and NOS suppression in vitro . The RAW264 . 7 cell line was used to prepare radical reaction model induced by LPS (1 μg/mL). MTT method was adopted to detect cytotoxicity of daidzein and puerarin. The DCFH-DA probe and confocal microscopy were used to examine the antioxidant ability of daidzein and puerarin. Griess reagent was adopted to test the NO level in the culture medium. And chemical colorimetry was used to detect the content in RAW264.6 cells. The results showed that daidzein and puerarin can significantly suppress the NO and T-NOS expression in RAW264.7 cells induced by LPS. It was concluded that there was no difference on the activation of antioxidant free radical between daidzein and puerarin . In this regard , daidzein can be the used as substitutes of puerarin .
10.Residue decline dynamics and safety utilization of carbendazim in cultivation of Anoectochilus roxburghii.
Qing-Song SHAO ; Hong-Bo LIU ; Yu-Yun ZHANG ; Ai-Lian ZHANG ; Ming-Yan LI
China Journal of Chinese Materia Medica 2014;39(9):1559-1563
The paper aimed to study the residue decline dynamic and standards for safety utilization of carbendazim in roots, stems, leaves of Anoectochilus roxburghii and in growth media. Samples extracted with methanol were purified by liquid-liquid extraction and analysed by HPLC. The results showed that average rate of recovery was 82.9% - 95.7% and RSD were 2.0% - 6.3% with add of carbendazim in respectively diverse concentration, which meets inspection requirement of pesticide residue. Two kinds of dosages of carbendazim were treated, varying from recommended dosage (1.0 kg x hm(-2)) to 1.5 times recommended dosage (1.5 kg x hm(-2)). Results of two years test showed that the half-life period of carbendazim were 7.01 - 8.51 d in the growth media of A. roxburghii, 3.58 - 4.27 d in stems and 3.50 - 3.91 d in leaves, 4.93 - 5.71 d in roots. Providing max recommended residue of carbendazim in the cultivation of A. roxburghii is 0.5 mg x kg(-1), sprayed 4 times a year with the dosage of 1.0 kg x hm(-2), 28 days is proposed for the safety interval of the last pesticide application's and harvest's date.
Benzimidazoles
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metabolism
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pharmacology
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Carbamates
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metabolism
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pharmacology
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Chromatography, High Pressure Liquid
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Culture Media, Conditioned
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chemistry
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Dose-Response Relationship, Drug
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Fungicides, Industrial
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metabolism
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pharmacology
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Liquid-Liquid Extraction
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Orchidaceae
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drug effects
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metabolism
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Pesticide Residues
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analysis
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metabolism
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Plant Leaves
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drug effects
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metabolism
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Plant Roots
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drug effects
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metabolism
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Plant Stems
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drug effects
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metabolism