2.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
3.Predictive Value of Cerebrospinal Fluid Neuron Specific Enolase on Long-Term Neurodevelopment Outcome in Neonates with Hyperbilirubinemia
qing-hui, LU ; ai-xia, PENG ; hong-hua, YANG
Journal of Applied Clinical Pediatrics 2006;0(24):-
Objective To study the long-term neurodevelopment in term neonates with hyperbilirubinemia and explore the predictive value of cerebrospinal fluid neuron specific enolase (CSF-NSE) on long-term neurodevelopment outcome.Methods A mental and psychomotor scale for 0-4 years old was performed to evaluate the intelligence development of 39 neonates with hyperbilirubinemia and 39 randomly selected healthy controls when they were at 3 to 24 months old. The former were tested for the level of CSF-NSE in jaundice climax.Results There was significant difference between 2 groups in total development quotient (DQ) tested at 3 month and 24 month old (P=0, 0.047). It was shown that the DQ scores for fine activity and social behavior were significantly lower in the study group than those in the control group (Pa=0). Furthermore, within the hyperbilirubinemia group, CSF-NSE was significantly associated with DQ of 3 month and 24 month old, while there was not association with TSB. The correlation coefficients were -0.46(P=0.04) and -0.32(P=0.047),respectively.Conclusions Hyperbilirubinemia may influence long-term neurodevelopment of term infants and CSF-NSE can predict this outcome.
4.Preliminary study on integration of traditional Chinese medicine and western medicine in patients with coronary heart disease in real world.
Gui-Hua LI ; Hong-Yan JIANG ; Yan-Ming XIE ; Qing-Hua AI ; Wei ZHAO
China Journal of Chinese Materia Medica 2014;39(18):3474-3478
OBJECTIVEObserve and analyze the informations of western medicine and traditional Chinese medicine in patients with coronary heart disease (CHD), in order to provide reference for clinical treatment.
METHODSelect patients with CHD in diagnosis of the first place in 17 hospitals, drug informations of these patients were analyzed using frequency method and association rules.
RESULTIn 84 697 patients,there were 47 564 males and 32 882 females. The median age was 71 years old, 76 172 patients have medicine records, including 278 kinds of western medicine and 331 kinds of traditional Chinese medicine. Aspirin was the most common used western medicine (51 132 patients, 67.08%), followed by isosorbide dinitrate, clopidogrel etc. The most common used traditional Chinese medicine was danhong injection, followed by shuxuetong injection. After classified the drugs, at the forefront of western medicine were antiplatelet drugs, nitrates drugs, statins, beta blockers, calcium antagonists, ACEI; the most used in traditional Chinese medicine was injection of blood-activating and stasis-resolving, followed by oral preparations of blood-activating and stasis-resolving medicine, Fuzheng class oral medicine, purgation medicine etc. After association rules, combination therapy among western medicine was the most common, combination of western medicine with blood-activating and stasis-resolving was very commonly, especially antiplatelet drugs and nitrates drugs.
CONCLUSIONWestern medicine in the treatment of patients with CHD was in accordance with the guidelines recommend, but with the lower utilization rate. Traditional Chinese medicine has become an important method for the treatment of CHD, promoting blood circulation and removing blood stasis is an important part of traditional Chinese medicine treatment in patients with CHD.
Adrenergic beta-Antagonists ; therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Animals ; Aspirin ; therapeutic use ; Combined Modality Therapy ; Coronary Disease ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; therapeutic use ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Nitrates ; therapeutic use ; Platelet Aggregation Inhibitors ; therapeutic use
5.Analysis of the literature in West China Journal of Stomatology cited by science periodical embodied by Chinese biological medical disc.
West China Journal of Stomatology 2005;23(2):175-176
OBJECTIVEThe literature published in West China Journal of Stomatology (WCJS) cited by science periodical from 1983 to 2001 were analyzed to evaluate the academic level and quality of WCJS.
METHODSThe cited literature was searched by Chinese biological medical disc (CBMDisc) from 1983 to 2001. The distributions of the times, the periodical and the authors were described.
RESULTSThe quantities of cited literature were 1 338 and increased with years. The periodical and the authors were 266 and 1 003 respectively from 1998 to 2001. The cited frequencies of stomatological periodicals were more than that of other academic periodical. The authors scattered in 32 provinces and 448 units of China. The medical university and affiliated hospital were 32.14%, the local hospital and stomatological dispensary were 54.69%, the military hospital was 10.71%, and other unit was 2.46%.
CONCLUSIONThe literature published in WCJS are superior in quality. The cited frequency of WCJS is high relatively. WCJS is one of the most important informational source of stomatology.
Bibliometrics ; China ; Hospitals ; Humans ; Oral Medicine ; Publishing ; trends ; Schools, Medical ; Universities
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.Analysis of kudiezi injection different dosage impact on patient's liver and kidney function based on hospital information system.
Xing LIAO ; Hao TANG ; Yan-Ming XIE ; Wei YANG ; Qing-Hua AI
China Journal of Chinese Materia Medica 2014;39(18):3585-3592
This study aims to explore the impact on patient's liver and kidney function by different dosage of Kudiezi injection. This study retrospectively analyzed 15 228 patients' records from 18 nationwide general hospital information system (HIS). All patients were treated with Kudiezi injection, 1 956 patients that were given doses of > 40 mL, which is above the recommended dose, acted as the observation group. Fifty-five patients receiving the recommended dose of < 40 mL were the control group. Data about alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr) and blood urea nitrogen (BUN) were collected before and after using Kudiezi injection, changes after treatment were outcomes. Also recorded were: age, costs, length of hospitalization and the patients' condition on admission. Propensity score method was used to balance 71 confounding variables such as gender, age, mortality, and costs. There were no significant difference on the four indexes between the two groups. It is hard to conclude that the use of Kudiezi injection over the recommended dose could influence the four indexes of liver and kidney from this data analysis. More conclusive evidence should be collected by further prospective study.
Adolescent
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Adult
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Aged
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Aged, 80 and over
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Alanine Transaminase
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metabolism
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Aspartate Aminotransferases
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metabolism
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Blood Urea Nitrogen
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Drugs, Chinese Herbal
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adverse effects
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therapeutic use
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Female
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Hospital Information Systems
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Humans
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Injections
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Kidney
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drug effects
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metabolism
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Liver
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drug effects
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metabolism
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Male
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Middle Aged
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Prospective Studies
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Retrospective Studies
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Young Adult
8.Analysis suspected allergic factors to shenqi fuzheng injection based on prescription sequence analysis and nested case control study.
Qing-Hua AI ; Xian-Bin ZENG ; Yan-Ming XIE ; Wei YANG
China Journal of Chinese Materia Medica 2014;39(18):3563-3566
This study based on twenty 3A grade hospital information system (HIS) database in China, adopt toprescription sequence analysis (PSA) with nested case control study (NCCS) to analysis mainly suspected allergy factor of Shenqi Fuzheng injection (Shenqi Fuzheng). Study design according to start to stop using Shenqi Fuzheng whether using dexamethasone injection will crowd divided into cases group and control group, each case matched 4 controls were selected, two groups according to the ratio of the age and sex matched well. Square test, Fisher exact test, single factor and multiple factor logistic regression were used to analyze data Condition on admission, allergic history, dosage and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the single dose (P = 0.000 2) and the combined use of matrine (P < 0.000 1, OR = 14.312, confidence interval [8.184, 25.029]) had significant effects on the suspected allergic reaction. Study on the existing HIS data and the study method based on screening suspected risk factors for allergic reaction. This study can provide guidance for Shenqi Fuzheng injection safety using in clinical practice, and it can also provides new method for the clinical safety reevaluation of post-marketing Chinese medicine injection.
Case-Control Studies
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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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Male
9.Analysis of questionable allergic factors to kudiezi injection--nested case control study using hospital information system data.
Xing LIAO ; Xian-Bin ZENG ; Yan-Ming XIE ; Wei YANG ; Qing-Hua AI
China Journal of Chinese Materia Medica 2014;39(18):3559-3562
This study aims to assess if adverse drug reactions (ADRs) to Kudiezi injection are allergic in origin. Hospital information system (HIS) data from 18 hospitals in China were used to carry out a nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving Kudiezi injection. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission, allergic history, dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the condition on solvents had a significant effect, P values were 0.005 5 and < 0.000 1 on suspected cases of allergic reactions. For the first subgroup analysis, we found using other eight injections at the same time as Kudiezi injection could be risk factors in suspected cases of allergic reactions. For the second subgroup analysis combining using mannitol or fructose could increase risks. Based on this current research, condition on admission as well as the concomitant use of some other drugs may be the risk factors in suspected cases of allergic reactions. However, further research for verification is required. This study can provide guidance for safe clinical practice in using Kudiezi injection.
Adult
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Aged
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Case-Control Studies
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Drug-Related Side Effects and Adverse Reactions
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diagnosis
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Drugs, Chinese Herbal
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administration & dosage
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adverse effects
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therapeutic use
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Female
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Hospital Information Systems
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Humans
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Hypersensitivity
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diagnosis
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Injections
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Male
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Middle Aged
10.Compound danshen injection regulated the expression of AQP3 in the human amnion epithelium cells through JNK signal pathway.
Jing-Jing WANG ; Ying HUA ; Qing-Feng ZHOU ; Ai-Lan XIE ; Xue-Qiong ZHU
Chinese Journal of Integrated Traditional and Western Medicine 2014;34(8):931-935
OBJECTIVETo explore the role of Compound Danshen Injection (CDI) in regulating the expression of aquaporin 3 (AQP3) in human amnion epithelium cells (hAECs), and to study the relation between c-Jun N-terminal kinase (JNK) signal pathway and AQP3.
METHODShAECs were isolated and primarily cultured from term pregnancy with normal amniotic fluid volume and from term pregnancy with oligohydramnios, and then hAECs were further divided into four groups, i.e., the blank control group (A), the SP600125 group (B), the CDI group (C), and the SP600125 +CDI group (D). The cell viability was measured by cell counting kit-8 assay (CCK-8). The expression of total JNK, phosphorylated JNK, and AQP3 were determined by Western blot.
RESULTS(1) In hAECs with normal AFV or with oligohydramnios: There was no statistical difference in the cell viability or the expression of total JNK among the 4 groups (P > 0.05). But there was statistical difference in the expression of p-JNK (P < 0.05). Compared with A group, the expression of p-JNK was obviously down-regulated in B group, but obviously up-regulated in C group (P < 0.05). The expression of p-JNK was significantly lower in D group than in C group, but higher than that in A group or B group (P < 0.05).The AQP3 expression in the hAECs with normal amniotic fluid volume of C group and D group were higher than that in the A group (P < 0.05). However, there was no statistical difference in the AQP3 expression between C group and D group (P > 0.05). In hAECs with oligohydramnios, the expression of AQP3 obviously decreased in B group, but up-regulated in C group (both P < 0.05). The expression of AQP3 was lower in D group than in C group, but higher than in B group (P < 0.05).
CONCLUSIONCDI could regulate the AQP3 expression in hAECs with oligohydramnios via activating the JNK signal pathway.
Amnion ; cytology ; drug effects ; Aquaporin 3 ; metabolism ; Cells, Cultured ; Drugs, Chinese Herbal ; pharmacology ; Epithelial Cells ; drug effects ; metabolism ; Female ; Humans ; JNK Mitogen-Activated Protein Kinases ; metabolism ; MAP Kinase Signaling System ; physiology