| Acute coronary syndrome (ACS) is a clinical pathologic syndrome that based on coronary atherosclerotic plaque rupture or erosion, secondary complete or incomplete occlusion of thrombosis. Salvia is a representative of Traditional medicine and the main treatment of Chest Pain. Danshen injection is the essence extract of Salvia, is a common and effective drugs for ACS. In treatment guidelines of ACS, anti-thrombosis drugs are recommended the level A, and the evidence level gradeⅠ. It must be considered for use in the absence of contraindications. Commonly used clinical antithrombotic drug are anti-platelet drugs and anticoagulants. The "triple" therapy of aspirin and clopidogrel and low molecular weight heparin has become routine.Danshen injection and antithrombotic drug in clinical practice is often used in conjunction. The safety of combined treatment, weather increase the risk of bleeding in patients, is a can not be evaded reality question for integrative medicine researchers. Systematic review of the literature of the subject and the report of case data, and through retrospective cohort study and further prospective randomized controlled trial are to discuss the effect of Salvia injection in combination with western medicine on the antithrombotic mechanism of blood coagulation and bleeding risk in patients with ACS. It gives a useful reference for exploring the joint use of Chinese and western medicine safety evaluation method.1 Danshen Injection Adverse Reaction Case Report and Literature Database StudyMethod:①To "(subject:Salvia miltiorrhiza injection or injection powder) and (subject:side effects or adverse events or bleeding or blood clotting or coagulation)" as the search type to search in Chinese Biological Medical Disc (CBM).—limited date:1979.01 to 2009.08.②Retrieve documents through secondary screening, and reading the full text to decide whether it will be included. Establishing a database by incorporated into the basic categories of documents (clinical study, experimental research, theoretical study). Record the document type, source, title, author, published time, research method, report the number of cases, primary disease, the type of adverse events, the lasting period, processing methods.③Record data on the descriptive statistics.Result:①1659 documents are retrieved. After two screening,491 articles are finally selected. Use Access 2003 to establish literature database.86 medical reports are selected for statistic in accordance with inclusion criteria. ①Reported in the literature 86 cases of 7900 cases of adverse reactions, adverse reactions involving Danshen injection cases 395 cases, accouting for 0.05% of the total number of cases reported, the number of cases in the 1-4 cases of 47(54.65%),5-9 cases of 23(26.75%).③To study the primary disease of medical adverse records, including cerebrovascular disease 38 records (44.2%), cardiovascular disease 12 records (13.9%), also include liver disease 8 records (9.3%), respiratory disease 4 records (4.6%), cancer, kidney disease, diabetes and vascular disease each 3 records (3.5%), blood disease 1 record (1.2%), and other diseases 11 records (12.8%).④Adverse event type and the ratio of all literature:Bleeding 16 records (18.6%), rash 14 records (16.3%), shock, death each 7 records (8.1%), other unwell acts like impaired liver and kidney function, neutropenia and gastrointestinal reactions 48 records (55.8%).⑤The relation between adverse event and use Danshen injection:the maybe related and certainly related of bleeding each has 1 record (2.3%), maybe unrelated 8 records, and unrelated 6 records. Rash may be related to 4, may be unrelated to 8, independent 2; shock may be related to 6, may be unrelated to 1; death may be related to 1, or may not be 4, unrelated 14, can not be determined 3.Conclusion:Danshen injection adverse reaction were reported in 86 cases, a total of 7900 cases, involving various types of diseases, to study the cardiovascular and cerebrovascular disease literature the most (58.1%) and Danshen injection cases of 395 cases of adverse reactions, accouting for the total number of 0.05%, report the number of patients with a primary(54.65%). Danshen injection may cause adverse events, but is the case. Danshen injection can cause bleeding events related to the proportion of 17.4% of literature, evaluation of bleeding events related to a positive correlation may be related to one, accouting for 2.3% reported in the literature. Previous adverse reactions reported in the literature occurred SM was 1.22%, traditional Chinese medicine injection adverse reaction rates in the lowest 0.25%. Case report literature Danshen injection caused by the low proportiong of adverse events.2 Retrospective Cohort StudyMethod:①The study objects are patients who were cured in Dongfang Hospital due to ACS from 2008.01 to 2009.10, totally 301 cases. According to whether use Salvia injection naturally occurring SMI group (114 cases) and control group (187 cases).②Collect and record the general medical information, medical history, treatment conditions, adverse events and the treatment on adverse events.③Use chi-square test on the qualitative data, and t test for quantitative data. Result:①There are no differences (P>0.05) on SM group and control group in such aspects, such as age, sex, ACS event classification, blood, liver and kidney function, blood coagulation, echocardiography and history of coronary heart disease, diabetes, dyslipidemia, cerebrovascular and smoking.②There are no significant differences on SM group and the control group of conventional western medicine and Chinese medicine treatments (P>0.05).③The ratio of adverse events about SM group and the control group is 2 cases:1 case, including the ratio of bleeding is 1 case:1 case. In SM group, there is 1 case of bleeding and 1 case of cardiogenic shock, and in the control group, there is 1 case of upper gastrointestinal bleeding. After symptomatic treatment, they all got better. There are no other adverse events.Conclusion:Retrospective cohort study showed that Danshen injection did not increase adverse events, nor increase the risk of bleeding events. It also reported bleeding events and adverse events were monitored SM or blood circulation drugs, but because of information in drug use can not be a single control, certain restrictions which can not fully explain the safety issues of Danshen injection on ACS patients. It is necessary to do further prospective study.3 Prospective Randomized StudyMethod:①Select the patients in Dongfang Hospital with diagnosis of ACS and use no other Traditional Chinese herbs or its preparations from 2009.11-2010.3. Use sub-stratified randomized clinical trail, which 23 patients are in SM group and 24 in control group.②Both groups use aspirin+clopidogrel +low molecular heparin for the treatment of primary disease. The treatment group add Danshen injection (lyophilized) 0.4g+250ml NS or 5% GS intravenously; Control group with cinepazide 160mg+250ml NS or 5% GS intravenously, once a day. Seven days later, to evaluate the treatment efficacy and safety.Result:①Coagulation-related indicators:in the treatment group after treatment, platelet aggregation rate max (ADP and AA) significant lower than before treatment (P<0.05);and the treatment group, platelet aggregation rate max (ADP and AA) decreased significantly compared with the control group(P<0.05). The two groups of PT,APTT and platelet adhesion rate had no significant difference (P>0.05) before and after treatment. Comparison group ACS type on platelet aggregation after treatment had no significant effect (P>0.05), PCI operation on platelet aggregation after treatment were not significantly affected (P>0.05).②The score of Chinese blood stasis:The scores after the treatments compared with the ones before the treatments, the differences are significant (P<0.01, P<0.05). The efficiency of the treatment group is 95.7%, while the control group is 87.5%.③Overall incidence of adverse events on treatment group and control group is 7 cases:5 cases; while bleeding event is 3 cases:2 cases and the other adverse reactions is 4 cases:3 cases.Conclusion:After treatment, the rate of platelet aggregation with treatment group decreased much more than the control group. It indicates that Danshen injection can reduce platelet aggregation and has no significant effect on blood coagulation. ACS type and whether the line of PCI patients on platelet aggregation after treatment had no significant effect. The stasis of treatment group improved significantly, the effective rate was 95.7%. In the treatment group, there were 3 cases of minor bleeding events (13.04%), and had no significant defference with the control group. The experimental results showed that the use with Danshen injection and thrombosis on ACS without increasing the incidence of adverse events and the risk of bleeding. |
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