ABSTRACT
OBJECTIVE:To explore the idea and method of post-marketing safety reevaluation of TCM injection in our hospi-tal. METHODS:In case-control study,salvianolate for injection was chosen for practice. 1 000 patients with stable angina receiv-ing Salvianolate for injection in our hospital during May 2012-Oct. 2013 were selected as subjects. The occurrence of ADR/ADE were observed and Logistic regression analysis was conducted by using SPSS 20.0 software. RESULTS:The incidence of ADR/ADE was 0.6%,and rare(0.1%-1%). The ADR/ADE were general and mainly manifested as erythra(66.67%). Skin and its ap-pendants were main organs involved in ADR(66.67%). Logistic regression analysis showed that gender,drug combination and age are risk factors of ADR/ADE. CONCLUSIONS:The post-marketing safety reevaluation of TCM injection not only make up for the deficiency of pre-marketing safety evaluation of TCM injection and find out potential delayed and severe ADR/ADE and drug inter-action,but also provide reference for rational drug use in the clinic and guarantee the safe and rational drug use.
ABSTRACT
OBJECTIVE:To evaluate the cost and effectiveness of Shenmai injection and Salvianolate for injection in adjuvant treatment of coronary heart disease with heart failure. METHODS:In prospective randomized controlled clinical study,103 pa-tients with coronary heart disease with heart failure were randomized into 2 groups:55 patients in group A received Shenmai injec-tion 50 ml added into 5% Glucose solution 250 ml intravenously on the basis of routine treatment,once a day;48 patients in group B received Salvianolate for injection 200 mg added into 5% Glucose solution 250 ml intravenously on the basis of routine treatment,once a day;treatment course lasted for 2 weeks. The improvement of clinical indicators and ADR were observed before and after treatment;2 drug treatment programs were evaluated and analyzed with pharmacoeconomics. RESULTS:Total effective rates of group A and B were 89.09% and 72.92%,with statistical significance(P0.05). The cost-effectiveness ratio of group A was significantly lower than that of group B,with statistical significance(P<0.05);the results of sensitivity analysis was consistent with it,indicat-ing the cost of Shenmai injection was in low level. CONCLUSIONS:Shenmai injection is more economic in adjuvant treatment of coronary heart disease with heart failure.