| This paper evaluate the clinical efficacy and safety of Shuxuetong and Shuxuening injection in treating acute cerebral ischemic (ACI) and analyse the characteristics and safety issues of the two drugs.First, based on the way of systematic reviews, analyse the currently available clinical studies in treating the ACI in order to learn the clinical efficacy and safety. Through the cohort study to describes the treatment characteristics and security issues, to provide a reference for clinical drug selection. Finally, analyse the ADR of the two drugs collected from our hospital and Beijing ADR center to grasp the ADR characteristics, and then give targeted intervention to the two drugs in application to avoid the risk. Part1 Literature ReviewSummarizes literatures of recent years of commonly used traditional Chinese medicine injection (Danshen and compound Danshen injection, TMP injection, PNS injection, ginkgo injection, Dengzhanhua injection, leech and earthworm injection) for treating ischemic stroke in mechanism of action and clinical efficacy, result:The injections of above mentioned in treating the ischemic stroke have the pharmacological basis and clinical efficacy, but there are still lacking the descriptions of characteristics of each traditional Chinese medicine injection in treating ischemic stroke. More research should give focus to this field, to provide the assistance and guidance for clinical use. Part2 The analysis of two traditional Chinese injections in Clinical Efficacy and Safety based on the systematic review.Objective:based on the way of systematic reviews, analyse the currently available clinical studies in treating the ACI in order to learn the clinical efficacy and safety. Method::by searching the database, In English and Chinese literature to find systematic reviews of two drug in the treatment of ACI. The results retrieved relevant systematic reviews are Shuxuetong 2, Shuxuening 0. According to this result, in this part:(1) no longer to repeat the evaluation of Shuxuetong. (2) to systematic evaluate the shuxuening injection in treating the ACI, through developing Search programs and systems and strict inclusion and exclusion criteria. utilizing the meta-analysis software RevMan 5.0 to analyze the 21 studies be selected. Results:(1) The two systematic review of shuxuetong all describe total effective and adverse events, which are all better than the controlled group; one of the two systematic review describe the impact to the hemorheology, which is better than the controlled group; Another review on neurological deficit scores were compared, scores improved significantly better than the control group. (2)Totaleffective[RR=1.22,95%(1.17,1.26)], MESS score [RR=-2.83,95%(-3.11,-2.56)] of Shuxuening in treating the acute ischemic stroke have statistically significant differences compared with the controlled group; rate of adverse events of Shuxuening injection is higher than controlled group [RD=0.01,95%(0.00,0.03)]; the effects of Shuxuening different course of treatment(14 days [RR=1.17,95%(1.09,1.26), Z=4.50]and 28 days[RR=1.37,95%(1.19,1.58),Z=4.42])are similar. Conclusion:shuxuetong and shuxuening injection are more effective than the other same kind of traditional Chinese medicine injection in the treatment of acute ischemic stroke. Shuxuetong with High safety and the total effect (Z) of efficacy of shuxuening is much higher than its Z of ADR, so we can tentative approve the efficacy is greater than the risk. Part3 Retrospective Cohort study of Shuxuetong and Shuxuening Injection in the Treatment of Acute Ischemic StrokeObjective:Through the cohort study to describes the treatment characteristics and security issues, to provide a reference for clinical drug selection. Method: Investigating, a first class Western Hospital of Beijing, the information hospitalized patients about Shuxuetong and Shuxuening injection in treating acute ischemic stroke in 2008-2009, including the natural situation of patients, vital signs, adverse events NIH-NIDS score comparison before and after treatment. Results:the effect Shuxuetong and Shuxuening injection in the treatment of acute ischemic stroke patients has no significant difference (P>0.05); in the treatment of vertebrobasilar artery occlusion, the effect of Shuxuening injection is significantly better than the shuxuetong injection (P<0.05); in the treatment of ischemic stroke patients with impaired fasting glucose, the effect of Shuxuetong injection is better than Shuxuening injection (P<0.05); in the treatment of ischemic stroke patients with hyperhomocysteinemia, the efficacy of Shuxuening injection is better than Shuxuetong injection (P <0.05).Conclusion:Shuxuetong and shuxuening injection have their own characteristics in the treatment of acute ischemic stroke. Clinicians should be combined with the treatment characteristics and specific conditions of patients to select the two drugs. Part4 Analysis of ADR of Shuxuetong and Shuxuening InjectionObjective:The drug of choice of similar clinical indications is not only based on the efficacy of drugs, but also should be based on the safety of drugs. In this part will keep focus on the safety of drugs. Method:Though Adverse reaction central database of Beijing, collected adverse reaction information of Shuxuetong and shuxuening injection during 2006.1.1-2010.1.1. According to the analysis of two adverse reactions, published "clinical drug safety information feedback," to prevent the occurrence of adverse reactions. Results:the rate of adverse reactions of Shuxuening injection is higher than that in Shuxuetong injection, rates were 0.61% and 0.19%, serious adverse reactions occurred in Shuxuening, including anaphylactic shock, and the case of death; the number of female of both Shuxuetong and shuxuening injection are larger than male, proportion are 1:1.3 and 1:1.5; the adverse reaction of shuxuetong in nervous system is higher than that of shuxuening, the percentage is 36.5% and 25.8%. the adverse reaction of shuxuening in phlebitis is higher than that of shuxuetong, the percentage is 11.9% and 1.8%. adverse reactions of the two drugs mainly occurred in the first day administration(shuxuetong 71.8%, shuxuening 63.9%), the adverse reactions are mainly occurred in 6 hours of the last administration (shuxuetong 82.9%, shuxuening 76%). Shuxuening injection adverse reaction improve relatively quickly, but the skin and its annexes adverse reactions are relatively improved slowly; Shuxuetong injection bleeding-related adverse events is relatively improved slowly; adverse reaction of bleeding and nervous system in Shuxuetong injection are more than that of Shuxuening injection(shuxuetong 6.4%, shuxuening 1.4%); through effective feedback, the number of adverse events in the two drugs significantly decreased. Conclusion: Shuxuening injection prone to adverse reactions compared with Shuxuetong injection; The adverse reactions performance of the two drugs are vary; There .is a certain difference in the recovery of patients. According to the above features of the two drugs, to prevent adverse the reactions. Reliable and timely feedback of drug safety information is effective measures to reduce adverse drug reactions Part5 Overall AnalysisTo sum up the findings of the upper three parts, Respectively overall evaluate clinical efficacy and safety of the Shuxuetong and Shuxuening Injection in treating the ACI. Analysis and compare the characteristics of the two drugs and safety problems, and propose the recommendations for rational drug use. |
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