灯盏细辛注射液与灯盏花素注射液治疗缺血性中风急性期临床疗效间接比较的Meta分析(1)
[摘要]系統比较灯盏细辛注射液(DZXI)和灯盏花素注射液(DZSI)治疗缺血性中风急性期临床有效性和安全性。采用Meta分析和间接比较法(ITC)，以复方丹参注射液(FDI)为中介，查找相关临床随机对照试验(RCT)，纳入DZXI或DZSI对比FDI治疗缺血性中风急性期的临床RCTs文献进行间接Meta分析。结果共纳入文献39篇，包括4 180个病例。Meta分析结果显示：DZXI和DZSI在治疗缺血性中风急性期的疗效均优于FDI；通过间接比较，DZSI总有效率高于DZXI，具有显著统计学差异[OR=0634，95%CI=(0432，0928)，P<0000 01]；而在改善神经功能缺损方面无明显统计学差异；安全性方面，所纳入的研究中DZXI不良反应率为114%，主要不良反应为头胀、发热、畏寒等；DZSI无明显不良反应。目前有限的证据表明灯盏花素注射液总有效率和安全性高于灯盏细辛注射液；但由于所纳入的RCT质量不高，全面评估二者的临床作用特点仍需高质量的临床试验。
[关键词]灯盏细辛注射液； 灯盏花素注射液； 缺血性中风； Meta分析； 间接比较
, 百拇医药
[Abstract]Erigeron breviscapus injection(DZXI) and Breviscapus injection(DZSI) are two popular injections in treatment of acute ischemic stroke in China Both of them are manufactured from a same herbal medicine， E breviscapus， but DZXI is an herbal extract(mixture) preparation and DZSI is a pure compound injection This article was aimed to systemically evaluate and compare their efficacy and safety in treatment of acute ischemic stroke The randomized controlled trials(RCTs) were collected for comparing DZXI and DZSI with Salvia miltiorrhiza injection(FDI) as the medium， and they were compared with indirect Metaanalysis(ITC) Thirtynine RCTs with 4 180 patients were included Metaanalysis results showed that both DZXI and DZSI had better efficacy than FDI in acute ischemic stroke In the indirect comparison， DZSI had a higher total efficacy than DZXI， with significantly statistical differences[OR=0634， 95%CI = (0432，0928)， P<0000 01]， but there was no significant difference in improvement of neurological deficit On the safety aspect， adverse reaction rate of DZXI was 114%， mainly including head swelling， fever and chills while DZSI had no significant adverse reactions The limited evidences in this study showed that Breviscapine injection had higher total efficiency and safety than E breviscapine injection， but due to the low quality of the included RCTs， these two medicines should be comprehensively compared in further highquality clinical trials
, 百拇医药
[Key words]Erigeron breviscapus injection； Breviscapus injection； ischemic stroke； Metaanalysis； indirect comparison
中风是一种常见脑血管疾病，分为缺血性中风和出血性中风，大多数中风(约占85%)属于缺血性中风[1]。缺血性中风的发病机制主要是由于动脉粥样硬化等形成血栓，使血管被完全或部分堵塞所致。缺血性中风具有发病率、致残率、死亡率高的特点[2]。
灯盏细辛又名灯盏花， 系菊科飞蓬属植物短葶飞蓬Erigeron breviscapus(Vant) HandMazz的干燥全草， 具有散寒解表、祛风除湿、活络止痛的功效[3]。灯盏细辛注射液是灯盏花中酚酸类提取物，主要含有多种咖啡酰衍生物和以灯盏乙素为主的黄酮类成分，其中灯盏乙素约占1667%[4]。灯盏花素注射液是从灯盏细辛中提取出的黄酮类成分，主成分灯盏乙素含量在98%以上，是一类几乎为单体化合物的中药制剂[5]。灯盏细辛注射液的临床常用剂量为每日20～40 mL，其中约含灯盏乙素8～24 mg，灯盏花素注射液的临床常用剂量为每日20～50 mg [4]。两药在临床上均可以治疗缺血性中风，且均具有较好疗效。然而，二者化学成分的差异(提取物vs单体)，是否引起临床治疗效果和安全性的差异一直是临床医生和药物生产、研究者感兴趣的问题，但是未见到系统评价比较的文章发表。本研究以复方丹参作为公共比较组，先采用直接比较的方法对灯盏细辛注射液与复方丹参注射液，灯盏花素注射液与复方丹参注射液进行Meta分析，再间接比较灯盏细辛和灯盏花素治疗缺血性中风急性期的临床疗效和安全性。, http://www.100md.com(章瑜芳 柯细彤 李宝才 向诚 赵淞)
[关键词]灯盏细辛注射液； 灯盏花素注射液； 缺血性中风； Meta分析； 间接比较
, 百拇医药
[Abstract]Erigeron breviscapus injection(DZXI) and Breviscapus injection(DZSI) are two popular injections in treatment of acute ischemic stroke in China Both of them are manufactured from a same herbal medicine， E breviscapus， but DZXI is an herbal extract(mixture) preparation and DZSI is a pure compound injection This article was aimed to systemically evaluate and compare their efficacy and safety in treatment of acute ischemic stroke The randomized controlled trials(RCTs) were collected for comparing DZXI and DZSI with Salvia miltiorrhiza injection(FDI) as the medium， and they were compared with indirect Metaanalysis(ITC) Thirtynine RCTs with 4 180 patients were included Metaanalysis results showed that both DZXI and DZSI had better efficacy than FDI in acute ischemic stroke In the indirect comparison， DZSI had a higher total efficacy than DZXI， with significantly statistical differences[OR=0634， 95%CI = (0432，0928)， P<0000 01]， but there was no significant difference in improvement of neurological deficit On the safety aspect， adverse reaction rate of DZXI was 114%， mainly including head swelling， fever and chills while DZSI had no significant adverse reactions The limited evidences in this study showed that Breviscapine injection had higher total efficiency and safety than E breviscapine injection， but due to the low quality of the included RCTs， these two medicines should be comprehensively compared in further highquality clinical trials
, 百拇医药
[Key words]Erigeron breviscapus injection； Breviscapus injection； ischemic stroke； Metaanalysis； indirect comparison
中风是一种常见脑血管疾病，分为缺血性中风和出血性中风，大多数中风(约占85%)属于缺血性中风[1]。缺血性中风的发病机制主要是由于动脉粥样硬化等形成血栓，使血管被完全或部分堵塞所致。缺血性中风具有发病率、致残率、死亡率高的特点[2]。
灯盏细辛又名灯盏花， 系菊科飞蓬属植物短葶飞蓬Erigeron breviscapus(Vant) HandMazz的干燥全草， 具有散寒解表、祛风除湿、活络止痛的功效[3]。灯盏细辛注射液是灯盏花中酚酸类提取物，主要含有多种咖啡酰衍生物和以灯盏乙素为主的黄酮类成分，其中灯盏乙素约占1667%[4]。灯盏花素注射液是从灯盏细辛中提取出的黄酮类成分，主成分灯盏乙素含量在98%以上，是一类几乎为单体化合物的中药制剂[5]。灯盏细辛注射液的临床常用剂量为每日20～40 mL，其中约含灯盏乙素8～24 mg，灯盏花素注射液的临床常用剂量为每日20～50 mg [4]。两药在临床上均可以治疗缺血性中风，且均具有较好疗效。然而，二者化学成分的差异(提取物vs单体)，是否引起临床治疗效果和安全性的差异一直是临床医生和药物生产、研究者感兴趣的问题，但是未见到系统评价比较的文章发表。本研究以复方丹参作为公共比较组，先采用直接比较的方法对灯盏细辛注射液与复方丹参注射液，灯盏花素注射液与复方丹参注射液进行Meta分析，再间接比较灯盏细辛和灯盏花素治疗缺血性中风急性期的临床疗效和安全性。, http://www.100md.com(章瑜芳 柯细彤 李宝才 向诚 赵淞)