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目的评价应用不同剂量范围巴曲酶(20 BU、40 BU、50 BU)治疗不同程度缺血性脑卒中的有效性、安全性以及合理性,以期为其临床应用提供基于循证医学方面的可靠参考。方法计算机检索Pub Med、EMbase、Cochrane Library、CNKI、VIP、Wan Fang Data、CSCD及临床试验注册库。人工检索相关杂志、内部报告和会议论文,联系有关文献作者或专家获得未发表的文献质料。所有检索时间均从建库至2015年8月1日。采用Cochrane风险偏倚评估工具评价分析收集到的文献质量。采用Reviews Manager 5.3对最后纳入的文献进行Meta分析。结果(1)巴曲酶比常规治疗更能有效的降低治疗后3个月时的死亡及残疾率,但无统计学意义(P>0.05);(2)大剂量40 BU巴曲酶组治疗后20 d时的神经功能缺损评分的总显效率优于20 BU巴曲酶治疗组,且有统计学意义(P<0.01);(3)大剂量40 BU巴曲酶组治疗后1周及2周后ESS评分均优于20 BU巴曲酶治疗组,且有统计学意义(P均<0.01);(4)大剂量50 BU巴曲酶组治疗后2周时的神经功能缺损评分优于20 BU巴曲酶治疗组,且有统计学意义(P<0.05);(5)在重型脑梗死治疗方面大剂量50 BU巴曲酶组治疗后2周时的神经功能缺损评分优于常规治疗组,且有统计学意义(P<0.05);(6)急性进展性脑梗死治疗方面20 BU巴曲酶组治疗后2周时的神经功能缺损评分的总有效率优于常规治疗组,且有统计学意义(P<0.01);(7)在脑梗死发病24 h内、24~48 h二个时间段巴曲酶治疗组的总显效率均优于常规治疗组,有统计学意义(P均<0.01),48~72 h巴曲酶治疗组的总显效率优于常规治疗组,但无统计学意义(P>0.05),提示开始使用巴曲酶的时间越早,效果越显著。结论不同剂量范围巴曲酶(20 BU、40 BU、50 BU)是急性缺血性脑卒中患者的安全、有效的治疗方法。
Objective To evaluate the efficacy, safety and rationality of different doses of batroxobin (20 BU, 40 BU, 50 BU) in the treatment of ischemic stroke of varying severity in order to provide reliable evidence-based medicine for its clinical application reference. Methods PubMed, EMbase, Cochrane Library, CNKI, VIP, Wan Fang Data, CSCD and clinical trial registries were searched by computer. Manually retrieve relevant journals, internal reports, and conference proceedings, and contact unpublished literature sources with relevant literature authors or experts. All search time from the database to August 1, 2015. The quality of the literature collected was assessed using the Cochrane Risk Bias Assessment Tool. Meta-analysis of the last-mentioned articles was conducted using Reviews Manager 5.3. Results (1) Batroxobin was more effective than conventional treatment in reducing the death and disability rate at 3 months after treatment, but there was no significant difference (P> 0.05). (2) Treatment with high dose of 40 BU Batroxobin The total effective rate of neurological deficit score on the 20th day was better than that of the 20-BU Batroxobin group (P <0.01). (3) In the high-dose 40-hour Batroxobin group, After 2 weeks, ESS score was better than that of 20-BU Batroxobin group (P <0.01). (4) The score of neurological deficit in high-dose 50-BU Batroxobin group (P <0.05). (5) In the treatment of severe cerebral infarction, the neurological deficit score of the 50-day treatment with batroxobin given 50 BU was superior to that of the routine (P <0.05). (6) In the treatment of acute progressive cerebral infarction, the total effective rate of neurological deficit score of 20-BU Batroxobin group at 2 weeks after treatment was better than that of the conventional treatment group, (P <0.01). (7) The total effective rate of Batroxobin group was better than that of conventional treatment group within 24 h and 48 h after 24 h of onset of cerebral infarction, with statistical significance (All P <0.01), 48 ~ 72 h The total effective rate batroxobin treated group is superior to conventional treatment group, but no statistical significance (P> 0.05), suggesting Batroxobin started sooner, the more significant. Conclusions Batroxobin at different dosage ranges (20 BU, 40 BU, 50 BU) is a safe and effective treatment for patients with acute ischemic stroke.