To explore the effect of Kudiezi injection on renal function in the real world, in order to provide the basis for the clinical medication safety. Patient aged between 18-80 were selected from 18 large hospitals information system (HIS) databases established by clinical research institute for basic traditional Chinese medicine of China academy of Chinese medical sciences. The patients who were treated with Kudiezi injection (24 225 cases) were defined as the exposed group, whereas those who were not treated with Kudiezi injection (14,191 cases) were defined as the non-exposed group. The propensity score method was used to balance the confounding factors. Classic logistic regression, GBM weighted propensity score logistic regression, GBM propensity score weighted logistic regression with covariate and sensitivity analysis were adopted to study the effect of Kudiezi injection on renal function. The results showed no significant difference in the possibility in abnormality in serum creatinine (Scr) (P = 0.940, 0.679, 0.834) and urea nitrogen (BUN) (P = 0, 0.045, 0.164) between both groups. Therefore, the existing data indicated no damage of Kudiezi injection on renal function. Because this study is a retrospective study based on the real world, there may be unknown confounding factors and potential bias. Therefore, further studies shall be conducted to monitor whether Kudiezi injection causes damage on renal function, in order to ensure the clinical medication safety.
Blood Urea Nitrogen ; Drugs, Chinese Herbal ; adverse effects ; Hospital Information Systems ; Humans ; Injections ; Kidney ; drug effects ; physiology ; Kidney Function Tests ; Logistic Models ; Propensity Score ; Retrospective Studies

To explore the protective effects of trimetazidine on vascular endothelial cells injury induced by hydrogen peroxide (H2O2) and its pharmacological mechanisms of anti-oxidation.Methods Human umbilical vein endothelial cells (HUVECs) were injured by H2O2.Next,the cells were treated with three different concentrations of trimetazidine (1 μmol/L,10 μmol/L,100μmol/L,respectively).The viability of cells was detected by methyl thiazoeyl tetrazolium (MTT) assay.In addition,malondialdehyde (MDA)contents,superoxide dismutase (SOD) and secretion of NO were measured.Results Trimetazidine could enhance the viability of the injured HUVECs induced by oxidation,decrease the level of MDA,enhance the SOD activity,and increase the secretion of nitrogen monoxide.These effects were in a certain dose-dependent manner and the difference was significant among the three concentrations (P＜0.05).Conclusions Our results suggest that trimctazidine may protect lipid peroxidation and prevent oxidation-induced cellular dysfunction of HUVECs (J Geriatr Cardiol 2008;5:248-251)

This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
Drug Combinations ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing ; Prospective Studies

A total of 159 patients with acute coronary syndrome(ACS)were enrolled from December 2006 to June 2008 and divided into the percutaneous coronary intervention(PCI)group and the internal medicine treatment group.The participants in the two groups were further assigned to the Tirofiban or the placebo control group.The change in electrocardiograph within 48 hours,major adverse cardiac events (MACE)during hospital stay and 30 days' follow-up,and bleeding were compared between the sub-groups.As a result,in comparison with the placebo control groups,the Tirofiban sub-groups showed significant improvement in electrocardiography(P＜0.01).In the internal medicine treatment group,the rate of MACE during 30 days' follow-up was significantly decreased in patients treated with Tirofiban(P＜0.05),although no significant difference in bleeding rate was found.Our data suggest that Tirofiban may be safe and effective in the treatment of ACS.

Objective:To evaluate the efficacy and safety of cytoreductive surgery (CRS) in conjunction with hyperthermic intra-peritoneal chemotherapy (HIPEC) for treating patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC). Methods:A total of 62 CRC patients with complication of PC were divided into the CRS group, namely, Group One (n=29, CRS and systemic adju-vant chemotherapy) and the CRS+HIPEC group, namely, Group Two (n=33, CRS+HIPEC). The primary end point of the study was overall survival (OS) and the secondary end point was serious adverse events (SAE). Results:Patients' clinicopathologic characteris-tics, peritoneal carcinomatosis index, and completeness of cytoreduction therapy were well balanced and comparable between the two groups. The median follow-up was 41.9 mo (6.5 mo to 110.0 mo) in Group One and 32.0 mo (10.5 mo to 95.9 mo) in Group Two. The median OS was 8.5 mo (95%CI:4.9 mo to 12.1 mo) in Group One and 14.5 mo (95%CI:11.9 mo to 17.1 mo) in Group Two (P=0.007). Within 30 days after the surgery, SAE occurred in 3 of the 29 patients in Group One, and 9 of the 33 patients in Group Two (P=0.126). Multivariate analysis revealed that HIPEC, CC0-1 score, and chemotherapy over six cycles were the independent factors for OS improvement. Conclusion:The CRS+HIPEC method improves the OS of patients with PC from CRC, suggesting an acceptable safety.

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 ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Male

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 ; Aged ; Case-Control Studies ; Drug-Related Side Effects and Adverse Reactions ; diagnosis ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Hospital Information Systems ; Humans ; Hypersensitivity ; diagnosis ; Injections ; Male ; Middle Aged

OBJECTIVETo explore a new experimental method for screening of allergens in post-market traditional Chinese medicine injections by confirming allergens in Huachansu injection.

METHODFirst of all, the serum of patients allergic to Huachansu injection were collected, at the same time, the dubious allergen was conjugated to bovine serum albumin (BSA) by EDC coupling procedure to form complete antigen (BNP-BSA), which makes it possible to reproduce the allergic reaction of Huachansu injection in vitro. The histamine liberation ratio, the level of TNF-alpha and Histamine released from RBL-2H3 mast cell were detected; the above data were compared with those obtained in vivo.

RESULTThe difference of the histamine liberation ratio, the levels of TNF-alpha and histamine of the resibufogenin-BSA group, group of patients allergic to Huachansu injection were not significant compared with those of normal control group. However, there were significant difference in those data among the cinobufagin-BSA group, the blank control and normal control group (P<0.05).

CONCLUSIONThe allergen in the serum collected from patients allergic to Huachansu injection is resibufogenin.

Allergens ; adverse effects ; immunology ; Amphibian Venoms ; adverse effects ; immunology ; Animals ; Anura ; Bufanolides ; adverse effects ; immunology ; Drug Hypersensitivity ; immunology ; Histamine Release ; Humans ; Mast Cells ; immunology ; Medicine, Chinese Traditional

The paper is to evaluate the efficacy and safety of Shenmai injection for chronic heart failure, retrieving the Pubmed, CBM, CNKI, Wanfang database and VIP database to comprehensively collect all types research report of Shenmai injection for chronic heart failure (CHF). Particularly wishing to point out, randomized controlled trials are include for the evaluation of effectiveness, which are statistically analyzed and evaluated by Rev-Man 5. 2. The current studies show that the improvement rate of NYHA classification of cardiac function of CHF patients and their related indexes figure such as LVEF, SV, CO, BNP, 6 min walking test value are all improved by the combination of Shenmai injection and foundation treatment. However, HR is almost no improvement. Meanwhile, serious ADR/AE of Shenmai injection for CHF isn't appear.
Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Heart Failure ; drug therapy ; Humans

OBJECTIVETo discuss the protective effect of Mailuoning injection on ischemia/reperfusion (I/R) injury in rats and its mechanism.

METHODHealthy male adult Sprague-Dawley (SD) rats were randomly divided into the sham operation group, the model group, the edaravone (3 mg x kg(-1)) control group, and Mailuoning high, middle and low-dose groups (4, 2, 1 mL x kg(-1)), with 10 rats in each group, and administered with drugs through tail intravenous injection. The middle cerebral artery occlusion (MCAO) was adopted to establish the rat ischemia/reperfusion model. After the ischemia for 2 h and reperfusion for 24 h, the pathological changes in neurovascular units (NVU) of brain tissues at the ischemia side was observed by HE staining. The expressions of glialfibrillary acidic protein (GFAP) and ionized calcium-binding adaptor molecule 1 (Ibal) were detected by the immunohistochemical method. The expressions of tumor necrosis factor-alpha (TNF-alpha), interleukin 1beta (IL-1beta), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) were detected by the western blotting technique.

RESULTMailuoning injection could significantly improve the pathological changes in cortical penumbra brain tissue UVN of (I/R) rats, reduce the number of GFAP and Ibal positive cells, and significantly decrease the expressions of TNF-alpha, IL-1beta, VCAM-1 and ICAM-1 of brain tissues of I/R rats.

CONCLUSIONMailuoning injection shows an obvious protective effect on UVN of I/R rats. Its mechanism may involve the inhibition of the activation of astrocyte and microglia and the secretion and expression of various inflammatory factors.

Animals ; Brain ; drug effects ; metabolism ; Brain Ischemia ; surgery ; Drugs, Chinese Herbal ; administration & dosage ; Humans ; Infarction, Middle Cerebral Artery ; genetics ; metabolism ; Intercellular Adhesion Molecule-1 ; genetics ; metabolism ; Male ; Protective Agents ; administration & dosage ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; genetics ; metabolism ; prevention & control ; Tumor Necrosis Factor-alpha ; genetics ; metabolism ; Vascular Cell Adhesion Molecule-1 ; genetics ; metabolism