Guideline for postmarketing Chinese medicine pharmacoeconomic evaluation.

Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.

[Demonstration of nested case-control study design in mechanisms research of allergic reaction of tanreqing injection].

The paper is focused on the clinical applications of Tanreqing injection after listing, detecting and analyzing the related blood indicators of patients with allergic reactions based on prospective, multi-center, large sample, registration-type clinical safety monitoring nested case-control study (NCCS) to explore the possible mechanisms of allergic reaction of Tanreqing injection, 3 006 patients cases used with Tanreqing injection were monitored, including 3 cases of adverse reactions and 2 cases of allergic reactions. Each patient of allergic reactions, according to the ratio of 1:4 matches four cases of not adverse reactions as a control group of patients, while 5 healthy and 5 cases of volunteers into the healthy group. We examined the correlation detection of cases of allergic reactions among groups such as T-IgE, IgA, IgG, C3, C4, IFN-g, IL-2, IL-4, IL-6, IL-10. Allergic reactions of Tanreqing injection may be mediated by IgE as type I based on existing research data. This results and conclusions will promote the justifiability and safety of clinical applications.

[Registration study on analysis of adaptation syndromes and medication characteristics of tanreqing injection].

Tanreqing injection is suitable for early pneumonia, acute bronchitis, acute exacerbations of chronic, and upper respiratory tract infection which are classified with phlegm-heat obstructing lung syndrome of traditional Chinese medicine. To understand the clinical adaptation syndromes and medication characteristics of the post-market Tanreqing injection, the research team of the paper monitored the patients who are used with Tanreqing injection from September 2012 to October 2013 in four leader hospitals based on the method--prospective, multi-center, large sample, registration-type hospital centralized monitoring,and analyzes the general information, diagnostic information and medication characteristics of patients, in order to produce evidence for clinical practice and medication decisions and to establish the foundation of rational drug use.

[Analysis of questionable allergic factors to parenterally administered salvianolate--a nested case control study using hospital information system data].

This study aims to assess if adverse drug reactions (ADRs) to parenterally administered salvianolate are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a retrospective nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered salvianolate. 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 admission had a significant effect, P values was < 0.000 1 on suspected cases of allergic reactions in the first subgroup analysis. For the second subgroup analysis, we found condition on solvents had a significant effects, P values was 0.005 1 on suspected cases of allergic reactions. We also found that using other four injections at the same time as parenterally administered salvianolate could be risky factors in suspected cases of allergic reactions. For the second subgroup analysis combining using three injections could increase risks. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered salvianolate.

[Systematic report on re-evaluating parenterally administered salvianolate].

There are few articles or reports collecting evidence about parenterally administered salvianolate from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about parenterally administered salvianolate. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data) and literature analysis. All the four aspects build an evidence body for Kudiezi Solution in order to inform its safety use in clinical practice and further study.

Expert consensus for postmarketing Chinese medicine intensive hospital safety monitoring.

It is of vital significance to conduct active postmarketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China Food and Drug Administration. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The expert consensus for postmarketing surveillance focuses on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

[The significance of introducing registry study in the post-marketing safety research for Chinese medicine and pharmacy].

There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.

[Technical specifications for post-marketing pharmacoeconomic evaluation of Chinese medicine (draft version for comments)].

Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.

[Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments)].

It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

[Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

[Pharmacovigilance of parenterally administered salvianolate based on analysis of spontaneous reporting system data].

Spontaneous reporting system (SRS) is currently a basic method to monitor and find adverse drug reactions (ADR) signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively prevent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported promptly, ADR information in the national ADR monitoring center's SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern. This study uses BCPNN and PRR to detect early warning signals. S739 ADR case reports were identified. There were 106 types, 1 310 events, and 24 serious ADR cases ( 3.25% of 739 case reports) There wre no deaths. The ten most frequent ADRs were: rash, dizziness, itch, headache, chills and breath, nausea, palpitation, anaphylactic reaction and hot. The drugs early warning signs were dizziness, headache, nausea, itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.

[Real world study of affect on liver function of overdose of salvianolate extract injection].

OBJECTIVE: To understand the affect on liver function of using salvianolate injection above the recommended dose. METHOD: Nationwide, research of hospital information system (HIS) data from 18 general hospitals comprising 14 191 patients was carried out. Two groups of patients were studied and their blood tests monitored before and after injections. One group received the recommended dose of 200 mg, the other exceeded it. To take into account group differences the propensity score method and logstic regression was used alongside liver function. RESULT: When salvianolate injection was administered above the recommended dose patients were more likely to have abnormal AST and ALT levels. However, the difference between the groups was not statistically significant. CONCLUSION: According to our data the affect of exceeding the recommended dose of salvianolate injection on liver function is not significant. However, monitoring of liver function should be carried out in clinic.

[Retrospective real world study to explore use of parenterally administered kudiezi in combination with other medications based on hospital information study data].

OBJECTIVE: Parenterally administered Kudiezi (KDZ) is used in real world clinical situations to treat coronary heart disease and cerebral infarction. This paper analyzes its clinical use with other drug combinations. Clinicians' experiences of using such treatments are also referred to. METHOD: Hospital information system (HIS) data from 18 hospitals, comprising records of 6 032 patients with Coronary heart disease and 3 468 patients with cerebral infarction were analyzed. RESULT: Comparison and analysis between varying courses of KDZ plus different drug combinations was carried out. The mean single dose of KDZ, death rate and improvement rates along with drug combinations were ascertained with various illustrations given. CONCLUSION: Although data showed some clinical correlations between factors analyzed, strong causal relationships are yet to be found. Hence, there is a need for further exploration and analysis.

[Clinical outcomes research on parenterally administered kudiezi in treatment of cerebral infarction].

OBJECTIVE: To investigate the curative effect of Kudiezi Injection in the treatment of cerebral infarction. METHOD: Hospital information system (HIS) data from 18 national, general hospitals were used to compare patients with and without the use of parenterally administered Kudiezi injection in treating cerebral infarction. To balance confounding factors between the two groups propensity score method was used; effectiveness evaluation of parenterally administered Kudiezi in treatment of cerebral infarction was carried out using Logistic regression method. RESULT: There was a statistically significant difference (P < 0.05) between positive curative outcomes in those receiving conventional therapy plus Kudiezi injection compared to those using other parenterally received medications on cerebral infarction. CONCLUSION: According to the current data conventional therapy combined with parenterally administered Kudiezi has a better outcome to cure cerebral infarction than other parenterally administered medications. This data provides a reference for clinical medication. However, the exact conclusions still need further verification.

[Analysis of salvianolate injection combined with usual drugs in treatment of coronary heart disease in real world].

OBJECTIVE: Based on real world research the circumstances of the clinical use of usual drugs combined with salvianolate injection are surveyed. METHOD: Descriptive statistics on the use of salvianolate injection in 18 general hospitals in China. RESULT: In 1 605 patients with coronary heart disease (CHD), salvianolate injection was most frequently (51%) combined with clopidogrel and isosorbide dinitrate. In addition this combination showed a higher clinical effectiveness as compared with other drug combinations. CONCLUSION: In the real world, salvianolate injection combined with usual treatment was found to be more effective than other treatment combinations. In addition practice conformed to the clinical treatment of coronary heart disease (CHD) guidelines for drug use. However, liver and kidney function, routine blood tests and the blood's coagulation function require ongoing monitoring.

[Overview of pharmacoeconomic studies on traditional Chinese medicines and western medicines in treatment of stroke].

In recent years, pharmacoeconomic studies have drawn increasing attention from experts in clinical medicine, pharmacy, health economics and health management. Their findings play an important role in drug pricing, drafting of the List of Essential Medicines and rational selection of clinical drugs. The essay summarizes the literatures published in recent years concerning pharmacoeconomics of traditional Chinese medicines on stroke, in order to make clear the current development of the latest studies on traditional Chinese medicines on treating stroke and rehabilitation methods and provide basis for further studies on pharmacoeconomics of traditional Chinese medicines on stroke and reference for rational clinical drug use.

[Clinical outcomes research on data analysis from hospital information system about Kudiezi injection].

OBJECTIVE: To describe the reality of clinical use for Kudiezi injection based on analyzing hospital information system from 18 hospitals in China. METHOD: Descriptive statistic methods were used in the analysis of 24 225 cases. RESULT: Patients using Kuediezi injection were mainly between 46 years old to 65 years old and there was a gender balance. Kuediezi injection was used most in neurology department and department of cardiology to treat coronary heart diseases and cerebral infarction. Patients who had Chinese medicine diagnosis were most about "Xiongbi"with syndrome qi-yin deficiency, and also more patients with syndrome qi-yin stagnation were treated by Kudiezi injection. The dosage of using Kudiezi was between 10 to 40 mL and treating course was between 1 to 3 days, with 0.9% sodium chloride. CONCLUSION: Although most of the patients received a right treatment of Kudiezi injection in clinical practice, there is still using Kudiezi injection for some diseases not on its drug instruction. We must remind those doctors who should be careful of using Kudiezi injection treating other diseases not on the instruction. This is just a retrospective and descriptive study, so prospective studies need to be developed in future to validate the results from this study.

[Analysis of Kudiezi injection's security literature].

By retrieving the relevant database, aim was to achieve the security reported of Kudiezi injection (Yueanxin). To analysis the gender, age, underlying disease, medication dosage, solvent, adverse event/adverse reaction time of occurrence, clinical presentation of patients, It was found the adverse event/adverse reaction usually occur in older people, involving the organs and systems include skin and its appendages, digestive system, nervous system, circulatory system, respiratory system, systemic reaction, part of the adverse event/adverse reaction's cause were not according to the instructions. It was found on the adverse event/adverse reaction of the judgment on the lack of objective evidence, to produce certain effect for objective evaluation of security of Kudiezi injection (Yueanxin).

[Toxical research of Kudiezi injection in safety re-evaluation].

OBJECTIVE: To explore the toxic effect on mouse administrated Kudiezi injection multy times a day, and on rats repeat administrated for many days. METHOD: Mouse tail intravenous injection of Kudiezi, 0.04 mL x g(-1), 3 times a day, rats tail intravenous injection of Kudiezi, 20, 10, 4 mL x kg(-1), once a day, for 6 weeks. RESULT: There is no abnormal to the mouses administrated many times a day. The rats administrated large doses of drug for many days have certain effects on hematology, blood biochemistry. Some animals appear liver, kidney lesions mild, injection local appear haemorrhage, edema and inflammatory reaction. CONCLUSION: The mouse which was intravenous injection in the dose of 180 times Kudiezi injection as much as people used, revealed no toxicity reaction. Repeated large-dose administration, rats caused by lesions of the main target organs may be for kidney, liver. But the recovery result on liver, kidney toxicity was reversible, no delayed toxicity. At the same time, large doses of long-term administration of local have a certain irritation. Tips the medication should be under the guidance of doctors, and pay attention to replace the injection site. This research will provide safety basis for the clinical use of Kudiezi injection.