Post-marketed Drug Safety Re-evaluation For Shuxuetong Injection Based On Hospital Centralized Monitoring Method

BackgroundTraditional Chinese medicine (TCM) has thousands of years of clinical application history in our country, and has the characteristics of efficacy and relatively rare adverse reactions, is widely used in the treatment of acute and chronic disease. TCM injections have the benefits of fast absorption, high bioavailability, and their effectiveness in clinical application has been approved. However, with the enlargement of its application range, reports of adverse drug reactions (ADRs) gradually increased, incidences of adverse reactions becomes the first of TCM preparations, and safety problems of the TCM injections becomes one of the hot topics in modern medicine.Shuxuetong injection is produced by a Pharmaceutical Co. Ltd. Its main components are extrations of pberetima and leeches. The combination of the two medicinal materials has been indicated efficacy of activating blood circulation to dissipate blood stasis and vein relaxing, which apply to the ischemic strokes with blood stasis syndrome. The adverse reaction of the medicine is not confirmed in the label claim of the injection. Through the comprehensive analysis on the safety evaluation methods of the medicine before and after its going into the market, the intensive hospital monitoring is the best way to monitor the adverse reactions of medicines. The post-marketed revaluation of Shuxuetong injection with multiple centers, large sample, and intensive hospital monitoring is need. Provide truthful and reliable data concerning the safety evaluation of Shuxuetong injection by a scientific and comprehensive information collection method.OjectivesIn order to regulate the clinical proper use of Shuxuetong injection and control risks in a timely, and then provide evidence for clinical safety application, we conducted this monitoring study. Through hospital information system and clinical observation, collect the basic information and adverse events and other influencing factors of inpatients staying in the hospital’s neurology department after prescribing Shuxuetong injection, obtain the incidence rate of ADRs, and analyze the influencing factors of ADRs.MethodThis study was designed as a multiple centers, registered intensive hospital monitoring research. The research target population is patients who have been prescribed Shuxuetong injection for at least once when they were in neurology department of Guangdong Provicial Hospital of Chinese Medicine during May 2013 to February 2014. With the hospital information system of Guangdong Provincial Hospital of Chinese Medicine, we collected the general information of patients (include gender, age, allergic history and medical history) and pharmacy history (whether there is drug combination or not, days of pharmacy, dosage of pharmacy and so on), monitored whether there are reports of adverse events during the period of monitoring, calculated the incedence rate of adverse reactions/serious adverse reactions, and analyzed the relationship between ADRs and possible impact factors.ResultDuring May 2013 to February 2014, seven neurological department wards and 962 hospitalized patients in the hospital were monitored in all, among which there were 539 males and 423 female patients. The youngest patient was 10 years old and the oldest patient was 91 years old; the patients who was diagnosed with acute cerebral infarction were 310; the ones who were diagnosed with stroke were 445; the ones who were the TCM syndrome of blood stasis were 830; the ones who had a history of allergies were 121; the ones who had a medical history of chronic diseases were 848; the shortest period of medicine treatment was 1 day and the longest were 34 days; the cases who had 6 ml of medication dosage were 950; the ones who had the medicine combination were 961; the cases who used other injections during the period of injection Shuxuetong injection were 489. Twenty-seven cases of adverse events (AEs) have been reported, among which there are 8 cases of severe adverse events (SAEs). Causalities of 7 AEs were assessed as "possible". The incidence rate of ADRs was 0.73%, and the incidence rate of severe adverse reactions is 0.10%. Single factor analysis and multiple variate analysis have been done on the ADRs and its influence factors. It was found that the incidence of ADRs has no statistically relationship with gender, age, diagnosis, allergic history, medical history, course of treatment and drugs combination.ConclusionAccording to the result of this research, the incidence rate of ADRs caused by Shuxuetong injection is low, which belongs to rare, and the medication is comparatively safe. There are places which need to be improved in this research, including the safety of combination medication, and the following-upping of delayed adverse reactions. It is hoped that the future research can expand the amount and the following up period, in order to find more new and rare adverse reactions and guide clinical safety application of the injection.