Registration of 30 026 cases of Shenqi Fuzheng injection combined with other drugs in real world / 中国中药杂志

Prospective, multi-center, large-sample and registered design was used to analyze the drug combination features of Shenqi Fuzheng injection in the real world clinical application, and comprehend the drug combination in the real world. A total of 30 026 patients with the use of Shenqi Fuzheng injection were registered, where the chemical drugs were used for 57 436 times (accounting for 82.76%), and the Chinese patent medicines were used for 11 962 times (accounting for 17.24%), mainly including anti-acid drugs and anti-ulcer drugs, nutritional agent, immune enhancement agent, etc. According to the association rules, drug combinations of 2 drugs were closely related to inhibiting gastric acid secretion and anti-tumor; drug combinations of 3 drugs were closely related to inhibiting gastric acid secretion, antiemetic and anti tumor; drug combinations of 4 drugs were closely related to inhibiting gastric acid secretion, antiemetic, anti-tumor, and immune enhancement. The above results were consistent with the Instruction, providing clues for accurate treatment, and laying the foundation for clinical rational drug use.

Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS / 中国中药杂志

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.

Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background / 中国中药杂志

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.

Analysis of the allergic reaction types of Chinese medicine injection based on immunotoxicty / 中国中药杂志

The purpose of the study is to find the allergic reaction types and characteristics of Chinese medicine injection ( CMI). The authors monitored patients who used Shuxuetong injection, Dengzhan Xixin injection, Shenqi Fuzheng injection, Shenmai injection, Ciwujia injection, Shuxuening injection, Tanreqing injection, Reduning injection, a total of 150,000 cases were monitored. They used a nested case-control design to group the patients and obtained the serum samples from 14 allergic patients and 55 matched patients. They used enzyme-linked immunosorbent assay (ELISA) to detect serum C3, C4, IgE, IgG, MCT-P, and judge the allergic reaction types: Shuxuetong injection hypersensitivity (1 case), can not determine (1 case); Dengzhan Xixin injection hypersensitivity (1 case), hypersensitivity & anaphylactoid reaction (1 case), can not determine (1 case); Shenqi Fuzheng injection hypersensitivity (3 cases), can not determine (1 case); Shenmai injection anaphylactoid reaction (1 case); Ciwujia injection can not determine (1 case), Shuxuening injection can not determine (1 case), Tanreqing injection can not determine (1 case), Reduning injection can not determine (1 case). The results showed that the main type of allergic reaction of CMI was hypersensitivity, the type of allergic reaction was closely related to the varieties of CMI, the hypersensitivity and anaphylactoid reaction might occur in one patient at the same time which used Dengzhan Xixin injection.

Preliminary study on integration of traditional Chinese medicine and western medicine in patients with coronary heart disease in real world / 中国中药杂志

<p><b>OBJECTIVE</b>Observe 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.</p><p><b>METHOD</b>Select 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.</p><p><b>RESULT</b>In 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.</p><p><b>CONCLUSION</b>Western 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.</p>

Analysis of questionable allergic factors to kudiezi injection--nested case control study using hospital information system data / 中国中药杂志

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.

Analysis suspected allergic factors to shenqi fuzheng injection based on prescription sequence analysis and nested case control study / 中国中药杂志

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.

Analysis of kudiezi injection different dosage impact on patient's liver and kidney function based on hospital information system / 中国中药杂志

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.

Impact analysis of shenqi fuzheng injection of course on liver function based on hospital information system data / 中国中药杂志

<p><b>OBJECTIVE</b>Use propensity score methods to explore the effect of Shenqi Fuzheng injection (SQFZ) on ALT and AST lever of real worlds.</p><p><b>METHOD</b>HIS 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.</p><p><b>RESULT</b>Sventy 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.</p><p><b>CONCLUSION</b>Analysis 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.</p>

Study of post marketing safety reevaluation of shenqi fuzheng injection / 中国中药杂志

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.

Spontaneous reporting system data analysis of parenterally administered Shenmai / 中国中药杂志

Spontaneous reporting system (SRS) datais currently an important source of monitoring and finding ADRs signals throughout the world. This method can promptly and effectively discover ADR signals, thus preventing and avoiding ADRs effectively. Parenterally administered Shenmai has the functions of benefiting vital energy, nourishing Yin and generating body fluids, and activating the pulse. Clinically it is used in various diseases including shock, coronary heart disease, viral myocarditis, chronic pulmonary heart disease, and granulocytopenia. The large, national SRS database of ADRs needs effective evaluation methods. We report on the use of Bayesian confidence propagation neural network method (BCPNN) and proportional reporting ration (PRR) with propensity score to control for confounding variables. Early warning signs of an ADR are, a feeling of suffocation (difficulty exhaling), anaphylactoid reactions and flushing. Furthermore, relevant relationships between the different factors is analysed by association rules (AR). It is found that there is a close relationship between past history of ADRs, a family history of ADRs and itching.

Effects of parenterally administered shenqi fuzheng on patient outcomes with tumor using propensity score / 中国中药杂志

<p><b>OBJECTIVE</b>Use propensity score methods to explore the effect of parenterally administered Shenqi Fuzheng on clinical outcome of patients with tumor.</p><p><b>METHOD</b>HIS data from 20 hospitals was analyzed. Patients suffering from malignant tumor, ranging from 18 to 80 years, Were divided into the treatment group and control group. The treatment group was given parenterally administered Shenqi Fuzheng, the control group received other parenterally administered anti-cancer medicines. Various levels of controls for confounding factors were applied, including chi-square test, Fisher exact test, stratified analysis, logistic regression, and logistic regression based on adjusted propensity score, to assess parenterally administered Shenqi Fuzheng's clinical effects.</p><p><b>RESULT</b>Stratified analysis showed that among elderly patients whose condition was classified as either 'urgent' or 'dangerous'. Comparing these two sub-groups it was found that the test P < 0.05. The treatment group had a significantly lower mortality rate than the control group. After adjusting for 72 confounding factors, the statistical results also show that the mortality rate overall in the treatment group was significantly lower than in the control group.</p><p><b>CONCLUSION</b>Analysis of HIS data showed that parenterally administered Shenqi Fuzheng can reduce mortality due to malignant cancer when compared to other available treatments.</p>

Adverse drug reactions case reports for parenterally administered shuxuening based on analysis of literature / 中国中药杂志

Parenterally administered Shuxuening had made important contributions in the treatment of ischemic cardiovascular and cerebrovascular diseases since its use in 1995. Parenterally administered Shuxuening is widely used in clinical practice hence concern over its safety has gradually arisen. Based on published adverse drug reaction (ADR) case reports, this article analyzes cpatient characteristics and other data including: gender, age, history of allergies, primary disease, dose, treatment course, solvent, ADR occurrence and time scales. This will provide a clinical reference regarding ADRs to parenterally administered Shuxuening and influencing factors on their occurrence. Analysis showed that ADRs clinical symptoms include systemic damage, with damage to the skin, mucous membranes and respiratory system most common. ADRs occurred earliest after 1 minute of infusion, and after the 11th day at the latest. 70% cases of ADR occurred within 1 hour, therefore rapid occurrence is a primary clinical characteristic. The medication was largely used in accordance with the drug manual, and of the association of ADRs with allergies or different drug combination was not high. The occurrence of ADRs may not be entirely associated with the drug but the solvent used in its manufacture may be an important factor.

Parenterally administered shenqi fuzheng for heart failure: a systematic review and meta-analysis / 中国中药杂志

<p><b>OBJECTIVE</b>To assess the efficacy and safety of parenterally administered Shenqi Fuzheng for heart failure.</p><p><b>METHOD</b>We searched for all clinical studies, up to February 2013, of parenterally administered Shenqi Fuzheng in the Cochrane library, Medline, EMbase, CBM, CNKI, VIP and Wanfang. Quality assessment and information extraction was completed and screened by two independent reviewers. The quality of the included studies was evaluated according to the Cochrane collaboration's tool for assessing risk of bias and allocation concealment. Revman 5. 2. 4 software was used for data analysis.</p><p><b>RESULT</b>A total of 21 randomized controlled trials were included in this systematic review, all of them were of low quality. Meta-analysis showed that the group receiving parenterally administered Shenqi Fuzheng in addition to conventional treatment had better therapeutic effectiveness rates than the conventional treatment group [OR = 3.91, 95% Cl (2.63, 5.83)], with enhanced LVEF [MD = 0.08, 95% Cl (0.05, 0.12)], SV [MD = 9.42, 95% Cl (6.61, 12.22)], CI [MD = 0.60, 95% Cl (0.46,0.73)], CO [MD = 0.98, 95% Cl (0.61, 1.36)], reduced BNP [MD = -139.05, 95% Cl (-211.08, - 67.02)]. The ADR/ADE information of parenterally administered Shenqi Fuzheng in all studies showed that the symptoms of ADR/ADE were mild.</p><p><b>CONCLUSION</b>Conclusions from this review may have a high risk of bias due to the low quality of thestudies. Hence, reliable conclusions cannot be drawn about the efficacy of parenterally administered Shenqi Fuzheng in the treatment of heart failure. More trials of high quality are required.</p>