甲钴胺片联合木丹颗粒治疗糖尿病周围神经病变有效性和安全性的系统评价  

Systematic Review on Efficacy and Safety of Mecobalamin Tablets Combined with Mudan Granules in the Treatment of Diabetic Peripheral Neuropathy

作　　者：郑子恢[1] 潘慧杰[2] 张丹静[3] 张亚同[1] 张碧华[1] 李琼[1] 金鹏飞[1] ZHENG Zihui;PAN Huijie;ZHANG Danjing;ZHANG Yatong;ZHANG Bihua;LI Qiong;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China;Dept.of Laboratory,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Dept.of Traditional Chinese Medicine,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [2]北京医院检验科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730 [3]北京医院中医科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730

出　　处：《中国医院用药评价与分析》2022年第3期356-363,共8页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家卫生健康委药政司委托课题(No.NHC-YZS-202103)。

摘　　要：目的:系统评价甲钴胺片联合木丹颗粒治疗糖尿病周围神经病变的有效性和安全性。方法:计算机检索Embase、PubMed、the Cochrane Library、万方数据库、中国知网和中国生物医学文献数据库,收集从建库至2022年3月发表的甲钴胺片联合木丹颗粒治疗糖尿病周围神经病变的随机对照试验(RCT)研究(研究组患者采用甲钴胺片联合木丹颗粒治疗,对照组患者单纯使用甲钴胺片治疗),中文数据库限定为中国科技论文统计源期刊,英文数据库不做期刊限制。选取文献、提取资料并评价纳入文献的偏倚风险后,采用RevMan 5.4软件进行Meta分析。结果:共纳入13项研究,包括1438例患者,研究组745例,对照组693例。Meta分析结果显示,有效性方面,研究组患者在总有效率(OR=3.31,95%CI=2.41~4.55,P<0.00001)、显效率(OR=2.23,95%CI=1.72~2.90,P<0.00001)、正中神经运动传导速度(MD=2.91,95%CI=2.22~3.59,P<0.00001)、腓总神经运动传导速度(MD=4.94,95%CI=2.84~7.03,P<0.00001)、胫前神经运动传导速度(MD=2.87,95%CI=2.22~3.52,P<0.00001)、正中神经感觉传导速度(MD=3.95,95%CI=3.42~4.48,P<0.00001)、腓总神经感觉传导速度(MD=5.11,95%CI=1.84~8.38,P=0.002)和胫前神经感觉传导速度(MD=4.81,95%CI=3.89~5.73,P<0.00001)等方面显著优于对照组,差异均有统计学意义;安全性方面,研究组患者的不良反应发生率显著低于对照组,差异有统计学意义(OR=0.34,95%CI=0.14~0.83,P=0.02)。结论:现有证据表明,甲钴胺片联合木丹颗粒治疗糖尿病周围神经病变安全、有效,较单纯使用甲钴胺片有显著优势。因选取的研究数量和质量的限制,上述结论有待今后更多高质量RCT进行验证。OBJECTIVE:To systematically evaluate the efficacy and safety of Mecobalamin tablets combined with Mudan granules in the treatment of diabetic peripheral neuropathy.METHODS:Embase,PubMed,the Cochrane Library,Wanfang Data,CNKI and CBM databases were retrieved to collect the randomized controlled trial(RCT)of Mecobalamin tablets combined with Mudan granules in the treatment of diabetic peripheral neuropathy(the study group was treated with Mecobalamine tablets combined with Mudan granules,while the control group received Mecobalamine tablets alone),the retrieval time was from the establishment of the database to Mar.2022.The Chinese database was limited to the statistical source journals of Chinese scientific and technical papers,and the English database did not make journal restrictions.After literature selection,data extraction and bias risk evaluation of included literature,RevMan 5.4 software was used for Meta-analysis.RESULTS:A total of 13 studies were enrolled,including 1438 patients,with 745 cases in the study group and 693 cases in the control group.In terms of efficacy,the total effective rate(OR=3.31,95%CI=2.41-4.55,P<0.00001),significant effective rate(OR=2.23,95%CI=1.72-2.90,P<0.00001),motor conduction velocity(MCV)of median nerve(MD=2.91,95%CI=2.22-3.59,P<0.00001),MCV of common peroneal nerve(MD=4.94,95%CI=2.84-7.03,P<0.00001),MCV of anterior tibial nerve(MD=2.87,95%CI=2.22-3.52,P<0.00001),sensory conduction velocity(SCV)of median nerve(MD=3.95,95%CI=3.42-4.48,P<0.00001),SCV of common peroneal nerve(MD=5.11,95%CI=1.84-8.38,P=0.002)and SCV of anterior tibial nerve(MD=4.81,95%CI=3.89-5.73,P<0.00001)in the study group were significantly better than those in the control group,the differences were statistically significant.In terms of safety,the incidence of adverse drug reactions in the study group was significantly lower than that in the control group,with statistically significant difference(OR=0.34,95%CI=0.14-0.83,P=0.02).CONCLUSIONS:The available evidence suggests that Mecobalamin tablets combined with

关 键 词：甲钴胺片 木丹颗粒 糖尿病周围神经病变 META分析 随机对照试验 

分 类 号：R932[医药卫生—生药学] R977.2[医药卫生—药学]