| Objective Using the method of evidence-based medicine to systematically review the clinical effect of TCM Tongfu combined with routine western therapy for the treatment of acute ischemic cerebral infraction.Method We electronically searched The Pub Med, Web of science, The Cochrane Library(Issue 2,2016),CBM,CNKI,VIP and Wan Fang Data for randomized controlled trials(RCTs) of Tongfu in treatment of acute ischemic cerebral infraction, The duration of search was from the inception of the databases to February 2016, besides, we also searched the reference of included studies and related reviews for the literature of potential requirements. After literature selection, the data extraction and quality assessment were conducted by two reviewers independently, and then the meta-analysis was conducted for the total effect rate, TCM effect score, NHISS score、ADL-BI score, hs-CRP et al, using Revman 5.2 software. However, for the adverse effect of few studies, we just done the descriptive analysis.Results 711 related studies were primary included, however, just 26 studies were finally elected according to the inclusion criteria and exclusion criteria. There were 2831 patients in our research, and 1493 patients were in Tongfu groups(treatment groups), the rest of 1338 patients were in routine western therapy group(control group), The results of Meta-analysis showed that the rates of clinical effect were significantly improved when we additional used the Tongfu method [RR=1.24,95%CI(1.18,1.30),P<0.00001]. Comparing with the control groups, the treatment groups could significantly improve the TCM symptom curative effect [RR=3.51,95%CI(2.23,5.31),P<0.05], and the control groups can also improve the TCM score [WMD=-4.23,95%CI(-6.08,-2.38),P<0.05]. And our results also showed that the Tongfu groups can significantly decrease he patients’ NHISS results [WMD=-3.99, 95 %CI(-4.89,-3.09),P<0.05], decrease the level of patients’ Hcy [WMD=-2.76,95%CI(-3.46,-2.06),P<0.00001], improve the patients’ ability of daily living[WMD=5.41,95%CI(4.65,5.16),P<0.00001], decrease the level of patients’ hs-CRP [WMD=-1.47,95%CI(-2.88,-0.07),P<0.05]. And in blood dynamics, the Tongfu also showed great advantage in high shearrate blood viscosity[WMD=-1.13,95%CI(-1.85,0.41),P>0.05], in low shearrate blood viscosity [WMD=-2.63, 95 % CI(-4.90,-0.35), P < 0.05], in plasma viscosity[WMD=-0.28,95%CI(-0.39,-0.16),P<0.05]. Because the studies were too few to do meta-analysis about adverse reactions, we just done the descriptive analysis, and the results showed that there was no adverse reactions in both groups.Conclusion 1. Comparing with the routine western therapy for the treatment of acute ischemic cerebral infraction, additional using the method of Tongfu can significantly improve the rate of clinical effect, improve the symptoms of patients with nerve function defect, improve the TCM score, improve the patients’ ability of daily living, besides, it can also decrease patients’ level of Hcy and improve patients’ level of hemorheology, meaning that it maybe can decrease the risk of recurrence of cerebral infarction to some extent, and the results can also show that the Tongfu groups can significantly improve the inflammatory response.. 2. At present, the evidence-based medicine of traditional Chinese medicine is still in its preliminary stage, the theoretical system is also not perfect, and the standard of meta-analysis was based on high quality, double blind, well-designed RCTs, however, the whole studies of our research aren’t conformed to the standard, so which would affect the authenticity and reliability of the meta-analysis results. Therefore, the clinical effect of Hua Tan Tongluo need further large sample-size, high quality and well-designed RCTs to confirm and update. |
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