Comprehensive Evaluation Of Safflower Yellow Injection(Sodium Chloride Injection Of Safflower Yellow)

Objective:To respectively evaluate the application status, efficacy and safety of two formulations of safflower yellow(SY)(Safflower Yellow Injection and Sodium Chloride Injection of Safflower Yellow) through literature research and overview.Analyze the similarities and differences between two formulations of SY in basic informations,clinical applications and adverse reactions(ADR),to provide comprehensive and scientific references for rational application of SY and perfecting instructions,to increase clinical drug safety and reduce irrational drug cases. Develop standardized application guide for single species of TCM injections.Try to develop comprehensive evaluation system and research methods of TCM injections.Promote standardization and healthy development of Chinese medicine injection industry.Method:1.Basic information studies:Refer to all the literature of safflower yellower pigment between September 1979 to September 2014.Summarize all the documents and research clinical status quo. To study similarities and differences between the two formulations of SY in composition, pharmacology, toxicology, formulation, pharmacokinetics, manufacturers, transportation, valid, Indications, dosage, contraindications, adverse reactions and precautions.To grasp the latest developments of them.2. Extracted patient cases information with respect to SY from three hospitals’ HIS system and analysis them.Filter studies relatd to Safflower Yellow Injection about clinical application and assort them by indications.Study indications in instructions and which are used efficient in clinical by meta-analysis. Evaluate the clinical efficacy exactly and Contrast efficacy between different SY formulations of the same indications.3.Security research:Filter studies relatd to Safflower Yellow Injection about ADR. Induction adverse performances between two formulations and to sum up the similarities and differences between two formulations. Analysis Safflower Yellow Injection’s ADR which are mentioned in effectiveness literatures.4. Comprehensive above all research content.Recommendate level according to the results of evidences.Recommend indications and solvents by ☆ levels.Compile Injection of Safflower Yellow standardized Application Criterion(The Criterion).Results:1. Basic studies:There are two dosage forms of SY for injection in three specifications. They are Safflower Yellow Injection and Sodium Chloride Injection of Safflower Yellow,which are producted by Yongning Pharmaceutical production enterprise and Huahuikade Pharmaceutical production enterprise.The instructions of three specifications’ SY for injection are basically the same information. From the search results, SY’s current studies focus on the pharmacological effects and clinical applications. At present the studies aspects of toxicology and pharmacokinetics, incompatibility, combination therapy, etc. are few. 2. Effectiveness studies:Have retrieved 194 literatures,contended 7 meta-analyses and 152 literatures of RCT.There are 62 valid literatures of RCT after preparation by screening,including 46 literatures about Safflower Yellow Injection and 16 literatures about Sodium Chloride Injection of Safflower Yellow Both formulations of SY injections can be effective in treating stable angina, unstable angina, angina pectoris, cerebral these four kinds of indications. Both formulations’ cinical efficacies are not significantly different,so, it is worthy of clinical application. SY’s effectiveness for Diabetic Nephropathy requires more clinical randomized trials to validate because of the presence of publication bias study. Through high-quality RCT found two formulations are certain effect for six kinds of indications,just like diabetic peripheral vascular disease, acute coronary syndrome, pulmonary heart disease, nephrotic syndrome, sudden deafness and lower extremity arterial occlusive disease and there no significant differences between them.3. Security Research:No significant difference between the two formulations in patients’ gender, age distribution of performance,ADR occur much less time 5 ~ 30 min.The main manifestation is allergy,in addition to involving the respiratory system, circulatory system, digestive system, nervous system, mental system;The reason for the higher constituent ratio of Sodium Chloride Injection of Safflower Yellow’s ADR in anaphylactic shock need’s further research. The results found that regulating the use of drugs and enhancing drug monitoring can reduce the adverse reactions.4. Clinical findings show that the patients,who use safflower yellow pigment,aged over 60 years are mainly. This result is consistent with the literature that SY is more used for infarction, coronary heart disease, posterior circulation ischemia, diabetes, vertebrobasilar arterial insufficiency, pulmonary infections and other diseases 。 4 、 Compiled The Criterion:Divided 19 indictions,for example, stable angina, unstable angina, angina pectoris and cerebral,ect,in 5 levals.Described ADR in detail.Conclusion:Dosage of Safflower Yellow for Injection are universally used over drug instruction manual. The drug instruction can not direct drug use effectively.This study had appraise a dosage successfully.Studise of basic informations,effectiveness and security are needed to estabilshing a comprehensive evaluation framework. At present the studies aspects of toxicology and pharmacokinetics, incompatibility, combination therapy, etc. are few.,so more in-depth studies are needed to improve the The Criterion content, do guidance for the rational use of safflower yellow preparations.