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

Asphyxia Neonatorum ; complications ; Biomarkers ; urine ; Dinoprost ; analogs & derivatives ; urine ; Disease Progression ; Female ; Humans ; Hypoxia-Ischemia, Brain ; diagnosis ; etiology ; urine ; Infant, Newborn ; Male ; Predictive Value of Tests ; Severity of Illness Index ; Time Factors

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.

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

OBJECTIVETo observe the impacts of the acupoint catgut implantation on postpartum pain of uterine contraction with qi and blood deficiency.

METHODSOne hundred and ten primiparas of natural delivery differentiated as qi and blood deficiency pattern in TCM were selected as the subjects. They were randomized into an acupoint catgut implantation group (55 cases) and a routine nursing group (55 cases). In the acupoint catgut implantation group, the catgut was implanted in Zigong (EX-CA 1), Zusanli (ST 36), Sanyinjiao (SP 6), Pishu (BL 20) and Geshu (BL 17) in 6 h after delivery; additionally, the routine post-delivery nursing was adopted. In the routine nursing group, the routine post-delivery nursing was applied simply. Visual analogue scale (VAS) and the pain relief time of uterine contraction were compared in 24 h, 48 h, 72 h and 96 h after acupoint catgut implantation between the two groups.

RESULTSVAS Scores in 24 h, 48 h, 72 h and 96 h after acupoint catgut implantation in the acupoint catgut implantation group were lower apparently than those in the routine nursing group (3.31 +/- 0.39 vs 4.31 +/- 0.29, 1.86 +/- 0.29 vs 2.66 +/- 0.25, 0.89 +/- 0.21 vs 1.59 +/- 0.24, 0.35 +/- 0.10 vs 0.69 +/- 0.13, all P < 0.05). The pain relief was achieved in (72.06 +/- 6.83) h in the acupoint catgut implantation group and was (123.42 +/- 11.12) h in the routine nursing group. The pain relief in the acupoint catgut implantation group was achieved more quickly (P < 0.01).

CONCLUSIONThe intervention of acupoint catgut implantation in 6 h after natural delivery in primiparas prevents effectively postpartum pain of uterine contraction.

Acupuncture Points ; Acupuncture Therapy ; Adolescent ; Adult ; Catgut ; utilization ; Female ; Humans ; Labor Pain ; therapy ; Pain ; prevention & control ; Postpartum Period ; physiology ; Pregnancy ; Qi ; Uterine Contraction ; Uterus ; physiopathology ; Young Adult

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

This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.
Case-Control Studies ; Drug Hypersensitivity ; etiology ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing ; Prospective Studies

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