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 ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing

OBJECTIVETo investigate the salvage therapy for a child with refractory and ( or) repeatedly-relapsed Langerhans cell histiocytosis.

METHODData of a patient with Langerhans cell histiocytosis whose disease relapsed repeatedly treated with cladribine was collected and analyzed and the related literature was reviewed.

RESULTThe initial symptoms developed 3 months after his birth, multiple systems (skin, skeleton, lung, liver) were involved; he was sequentially treated with LCH-III-Group I, JLSG-96, DAL-HX90 chemotherapeutic regimens. The patient got relapses for more than 3 times, but the disease got completely controlled after being treated with cladribine when the patient was 6 years old. The dosage was 10 mg/(m2 · d) for 4 days, and one course lasted for 28 days, the third to fifth courses of treatment used Arac in combination, the whole treating time lasted for 5 months. The patient remained in persistent remission for 8 months since discontinuation of treatment. "Langerhans cell histiocytosis" "refractory" "cladribine" were used as the key words to search in the data bases CNKI, Wanfangdata and Pubmed, 11 articles were picked. According to the literature, the effective rate of cladribine in treatment of repeatedly relapsing Langerhans cell histiocytosis was 44%-100%, with a good response of 22%-86%, the dose was 5-13 mg/(m2 · d). The main side effects were hematological system damages and infection.

CONCLUSIONThe effect of commonly used chemotherapeutic regimens is limited for children with refractory and (or) repeatedly-relapsed Langerhans cell histiocytosis and cladribine can be used as an alternative therapeutic option of the salvage therapy.

Child ; Cladribine ; therapeutic use ; Histiocytosis, Langerhans-Cell ; drug therapy ; Humans ; Immunosuppressive Agents ; therapeutic use ; Male ; Recurrence ; Skin

Objective To analyze the statistical correlation between 25-hydroxyl vitamin D and bone metabolism parameters in-cluding parathyroid hormone(PTH),N-terminal osteocalcin (N-MID),calcitonin(CT),bone alkaline phosphatase(BALP),and dis-cuss the significance in clinical diagnosis,prevention and treatment.Methods 411 cases of hospitalized patients were collected from January to September in 2014,including 316 women,95 men,age arranged from 37 to 96,the average age was(69.29±12.21).Use electro chemiluminescence immunoassay(ECLIA)method to detect the levels of 25-hydroxyl vitamin D,PTH,N-MID,CT,and BALP in hospitalized patients and explore the relationship of 25-hydroxyl vitamin D and serum bone markers in osteoporosis pa-tients.Results It was showed that vitamin D and PTH,BALP were negative correlation(P <0.05);There was no significant corre-lation between calcitonin and N-terminal osteocalcin(N-MID)(P >0.05 ).Regression analysis showed that regression equation for vitamin D and blood bone markers was:Y =19.02-0.066PTH-0.09BALP.Conclusion There was some correlation between 25-hydroxyl vitamin D and PTH,BALP in patients with osteoporosis.By taking a combination test of these markers,it can provide some basic data for clinical osteoporosis diagnosis,prevention and control.

Objective To prepare 68Ga-PSMA-617 and perform its microPET imaging on both normal BALB/c mice and BGC-823 (PSMA expression) tumor bearing mice.Methods 68GaCl3 was eluted from 68Ge-68Ga generator by 0.05 mol/L HCl,then added to the DKFZ-PSMA-617 and heated at 85 ℃ for 5 min.The labeling efficiency and in vitro stability of 68Ga-PSMA-617 in sodium chloride solution and HAS were analyzed by radio-HPLC.Water partition coefficient and plasma protein binding rate were also evaluated.MicroPET imaging was performed in normal female BALB/c mice and human gastric tumor (BGC-823) bearing mice at 60 min post-injection of 68Ga-PSMA-617.18F-FDG was also injected to BGC-823 tumor bearing mice to acquire microPET imaging for contrast.Results The labeling yield of 68Ga-PSMA-617 was 97.9％,and it could be used directly without purification.68Ga-PSMA-617 showed good in vitro stability in sodium chloride solution and 5％ HAS,the radiochemical purities were 94.9％ and 81.0％ respectively at 80 min post-incubation.68Ga-PSMA-617 was water-solubility substance,and it cleared mainly through the kidneys.MicroPET imaging showed that 68Ga-PSMA-617 could be accumulated in tumor (T/NT=2.28),which was better than 18F-FDG.Conclusions Preparation of 68Ga-PSMA-617 is convenient and has a high labeling yield.It can specifically target to PSMA expression tumors and has a promising prospect in clinical application.

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

To study the effects of conjee and cooked rice on postprandial glucose and plasma insulin levels in type 2 diatetes,and to help diabetic patients select reasonably food.41 diabetes were divided into cooked rice group ( group A),conjee with steamed bread group ( group B),and oatmeal group ( group C ).At 1 h after meal,the values of postprandial plasma glucose (PPG) was significantly lower in group C than those in group A and group B [ ( 11.17± 2.30 vs 12.88 ± 1.29,13.29 ± 1.97 ) mmol/L,P ＜ 0.05 ].At 2 h after meal,the value of PPG was significantly lower in group C than in group A [ ( 8.88 ± 2.66 vs 10.87 ± 1.63 ) mmol/L,P ＜0.05 ].At 1 h and 2 h after meal,there was no significant difference between the value of PPG in goup A and group B ( P＞0.05 ).At 1 h after meal,the value of plasma insulin was significantly lower in group C than those in group B [ (46.02 ± 26.32 vs 88.56 ± 68.75 )μU/ml,P ＜0.05 ],and there was a littler higher in group B than group A ( P＞0.05 ).At 2 h after meal,there was no statistical difference of plasma insulin among group A,B,C [ ( 57.10 ± 33.56,62.26 ± 24.42,54.16 ± 41.35 )μU/ml,P＞0.05 ) ].Isocaloric oat food is potentially beneficial in sustaining blood glucose status and decreasing insulin secretion.It is the ideal choice for type 2 diabetes.Meanwhile,there were no statistical differences in PPG and insulin levels between the individuals taking conjee with steam bread and cooked rice.

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

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 ; Adult ; Aged ; Aged, 80 and over ; Alanine Transaminase ; metabolism ; Aspartate Aminotransferases ; metabolism ; Blood Urea Nitrogen ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Hospital Information Systems ; Humans ; Injections ; Kidney ; drug effects ; metabolism ; Liver ; drug effects ; metabolism ; Male ; Middle Aged ; Prospective Studies ; Retrospective Studies ; Young Adult

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