| BackgroundAccording to the statistic of WHO, the incidence of cardiovascular and cerebrovascular diseases increased year by year, which is the primary reason to lead death. Conventional therapy with Western Medicine (WM) can treat well, but it may still have a large relict risk that easily resulting in smaller embolism or bleeding caused by excessive antithrombosis. Recently, Chinese herbal injection has played an irreplaceable role in the treatment of cardiovascular and cerebrovascular diseases, which is with good economic and social benefits. More and more clinicians tend to combined WM with Chinese herbal injection to improve the efficacy of cardiovascular and cerebrovascular diseases. However, Chinese herbal injection in clinical practice, research outcomes based on clinical trials concerning its efficacy and safety vary, which are needed to be scientificly evaluated randomized control trials (RCTs) to provide reliable evidence.Based on the speculativism, this study selected Chinese herbal medicine for treating cardiovascular and cerebrovascular diseases as penetration point, and used the methods of Meta-analysis and literature review to comprehensively evaluated the appropriateness of the combined use of it and WM in the treatment of cardiovascular and cerebrovascular diseases, and promote safe and reasonable medication.Objective:1. To evaluate the efficacy and safety of the combine use of Chinese herbal injection and WM in the treatment of cardiovascular and cerebrovascular diseases;2. To provide the basis of rational use of Chinese herbal injection for treating cardiovascular and cerebrovascular diseases.Methods1. Literature reviewWe took statistical analysis for the retrieved literature of Chinese herbal injection in the treatment of cardiovascular and cerebrovascular diseases, including the quantity of literature, market share, the published systematic reviews, and so on.2. Meta-analysisRelevant RCTs were systematically searched in Chinese and English electronic databases from 1979 to 2014, such as China National Knowledge Infrastructure, Chinese Scientific Journals Database, Chinese Biomedical Literature Database, Wan fang database, PubMed, and Cochrane Library. Then include the RCTs that meeting the standards, and extract information. The Cochrane risk of bias method was used to assess the quality of the included studies, and a Meta-analysis was conducted with Review Manager 5.2 software. The results were presented by forest plots. Sensitivity analysis was used to assess the stability of results, and funnel plot analysis was to test whether publication bias exist.ContentsThis study was composed of two main parts:literature review and systematic review.1. Literature reviewOne review stated the basic information of 34 varieties Chinese herbal injections for treating cardiovascular and cerebrovascular diseases. According to the classification of varieties, the quantity of RCTs, and the "cardio-cerebral vascular drugs market research report in 2012, 2013 ", we chose 10 Chinese herbal injections to compare and analysis their effects, pharmacological actions, and adverse drug reactions (ADRs).Another one was to analysis the general situation regarding the published systematic reviews of Chinese herbal injection in the treatment of cardiovascular and cerebrovascular diseases.2. Systematic reviewIn this part, we would make systematic review of 10 Chinese herbal injections to evaluate their efficacy and safety, which were:Fufang Danshen Injection (FD), Danhong Injection (DH), Danshen Chuanxiongqin Injection (DCI), Shuxuening Injecion (SXN), Xuesaitong Injection (XST), Puerarin Injection, Dengzhanxixin Injeciton (DZXX), Shengmai Injection, Shuxuetong Injection (SXT), and Qingkailing Injection (QKL).(1) Fufang Danshen Injection for treating unstable angina pectorisA total of 13 studies with 1156 participants were included. The Meta-analysis indicated that, the combined use of FD and WM can increase the total effective rate [7RCTs, RR=1.32,95% CI(1.21,1.43), P<0.00001]. And the clinical effective rate that combined use of FD with low molecular weight heparin and WM comparing WM also had significant difference between two groups [4RCTs, RR=1.29,95%CI(1.17,1.42),P<0.00001]. There were 9 ADRs in the experimental group, and 9 in control group.(2) Danhong injection for treating acute coronary syndrome27 RCTs with 2660 participants were included. The Meta-analysis indicated that on the basis of WM, DH was more effective in increasing the total effective rate [11RCTs, RR=1.25, 95%CI(1.16,1.35),P<0.00001]. Additionally, DH can decrease high sensitive C-reactive protein (Hs-CRP) [14RCTs, MD=-1.43,95%CI(-1.19,-1.08), P＜0.00001], and so on. There was no ADR reported in the experimental group, while one case occurred in the control group.Danhong injection for treating stable angina pectorisA total of 9 studies with 596 participants were included. The Meta-analysis indicated that the results of DH were significantly superior to WM in increasing the total effective rate [9RCTs, RR=1.30,95%CI(1.21,1.41), P＜0.00001], and so on. There were 6 ADRs in the experimental group, none series ADR occurrence.(3) Danshen Chuanxiongqin Injection for treating angina pectorisA total of 12 RCTs with 1145 participants were included. The Meta-analysis indicated that the combined use of DCI and WM was more effective in the outcomes of the total effective rate [12RCTs, RR=1.27,95%CI(1.19,1.35), P<0.00001], and so on. There were no ADR reports.Danshen Chuanxiongqin Injection for treating unstable angina pectoris11 RCTs involving 1034 participants were included. The Meta-analysis indicated that the combined use of DCI and WM was more efficacious in the outcomes of the total effective rate [9RCTs, RR=1.27,95%CI(1.18,1.35), P＜0.00001], total cholesterol [4RCTs, MD=-0.58,95%CI (-0.83,-0.33), P＜0.00001], and so on. There were 2 ADRs reported in experimental group.(4) Shuxuening Injecition for treating acute ischemic stroke22 RCTs with 2172 participants were included. The Meta-analysis indicated that on the basis of WM, SXN was more effective in increasing the total effective rate [16RCTs, RR=1.24, 95%CI(1.18,1.30), P＜0.00001], decrease neurological damage degree [6RCTs, MD=-2.49, 95%CI(-3.59,-1.39), P＜0.00001], and so on. There were 12 ADRs reported in the experimental group, none series ADR occurrence.(5) Xuesaitong Injection for treating acute ischemic stroke23 RCTs, involving 2196 participants were included. The Meta-analysis indicated that compared to WM, the combined use of XST and WM was more effective in terms of the total clinical effective rate [23RCTs, RR=1.21,95%CI(1.16,1.25), P<0.00001], neurological deficit scores [7RCTs, MD=-3.31,95%CI (-4.10,-2.52), P<0.00001], and so on. The included studies reported 37 adverse events,17 of which belonged to experimental groups.(6) Puerarin Injection for treating acute anterior wall myocardial infarctionA total of 6 studies with 354 participants were included. The Meta-analysis indicated that the results of puerarin group were significantly superior to the WM in decreasing the score of QRS [6RCTs,MD=-1.69,95%CI(-2.07,-1.32), P＜0.00001], reducing the infarct size [6RCTs, MD=-9.46,95%CI(-11.37,-7.55), P＜0.00001], and increasing the LVEF [4RCTs, MD=12.18, 95%CI (2.97,21.39), P=0.010]. There was one ADR reported in experimental group.(7) Dengzhanxixin Injection for treating acute ischemic strokeA total of 14 RCTs with 1454 participants were included. The Meta-analysis indicated that on the basic of WM, DZXX was more effective than FD in the outcomes of markedly effective rate [12RCTs, RR=1.54,95%CI(1.39,1.71), P＜0.00001], neurological deficit score [7RCTs, MD=-4.22,95%CI(-5.65,-2.79), P＜0.00001], and so on. There were 13 ADRs reports in experimental group, but no serious ADRs occurred.(8) Shengmai Injection for treating angina pectoris A total of 9 RCTs with 932 participants were included. The quality of the studies was generally not high. The Meta-analysis indicated that on the basic of WM, Shengmai Injection was more effective than WM in the outcomes of the total effective rate [9RCTs, RR=1.24, 95%CI(1.17,1.32), P＜0.00001], and so on. There were no ADR in the included studies.(9) Shuxuetong Injection for treating acute ischemic stroke21 studies involving 2292 participants were included. The Meta-analysis indicated that the combined use of SXT and WM was significantly superior to WM only for acute ischemic stroke in terms of the total effective rate [17RCTs,RR=1.23,95%CI(1.18,1.28), P<0.00001]. Additionally, SXT can also decrease neurological damage [15RCTs, MD=-3.91,95%CI (-4.90,-2.91), P<0.00001], and so on.19 ADRs were reported, in which 14 were in experimental group, while 5 in control group.(10) Qingkailing Injection for treating acute ischemic strokeA total of 8 studies with 633 participants were included. After the Meta-analysis, the results of QKL were significantly superior to the WM in the total effective rate [8RCTs, RR=1.28, 95%CI(1.18,1.39), P＜0.00001], and so on. One study reported 8 ADRs,3 of which in the experiment group. Conclusion1. On the basis of WM, the combined use of Chinese herbal injection can improve the efficacy of treating cardiovascular and cerebrovascular diseases.2. From the literature review of included studies, the safety of Chinese herbal injection combined with WM was varies, but none serious ADRs occurred. The ADRs mostly caused by patients’allergies physique, and factors of clinical using, which still need further study. It also suggests that it should be cautious, and given strict monitoring and care, when used in combination of Chinese herbal injection and Western medicines.3. Under the guidance of Traditional Chinese Medicine (TCM) theory, the Chinese herbal injection can be combined use with WM to form a safe and effective clinical decision support solution to deal with the cardiovascular and cerebrovascular events.Innovation1. In this study, integrated using of literature review and Meta-analysis methods to explore the new methods and new ideas to evaluate clinical efficacy and safety of Chinese herbal injections for treating cardiovascular and cerebrovascular diseases, and promote the rational drug use.2. This study had broken the routine mode that only evaluating the efficacy of Chinese herbal injection. We combined clinical multifactor to comprehensive evaluation, especially combined therapy of TCM and WM, which may have a more practical guidance for clinic.3. Parts of the research are the first time to conduct in the field, such as the systematic review of Fufang Danshen injection in the treatment of unstable angina pectoris, Danhong injection in the treatment of acute coronary syndrome, Puerarin injection the treatment of acute anterior wall myocardial infarction, and so on.
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