摘要
目的评价普瑞巴林治疗糖尿病性周围神经痛的有效性和安全性。方法采用循证医学的文献分析评价方法,计算机检索Cochrane图书馆、MEDLINE、EMbase、PUBMED、中国科技期刊全文数据库、维普电子期刊全文数据库、万方数据库等文献数据库以及手工检索相关会议的论文集,采用RevMan5.1进行Meta分析。结果纳入研究8项,共1 596例患者。Meta分析结果显示,普瑞巴林组的反应有效率[OR=2.81,95%CI(2.03,3.89),P<0.000 01]、患者总体印象变化比例[OR=2.94,95%CI(2.05,4.20),P<0.000 01]和临床总体印象变化比例[OR=2.42,95%CI(1.53,3.82),P=0.000 1]明显高于安慰剂组,研究终点疼痛评分明显低于安慰剂组[WMD=-1.08,95%CI(-1.52,-0.63),P<0.000 01]。亚组分析显示,600 mg·d-1组的治疗效果优于300 mg·d-1组。不良反应发生率高于安慰剂组[OR=5.71,95%CI(4.05,6.60),P<0.000 01],为轻到中度,可耐受。普瑞巴林与含5%利多卡因药膏、度洛西汀相比,治疗效果相似。不良反应方面,普瑞巴林较5%利多卡因药膏发生率高,与度洛西汀相似。结论普瑞巴林治疗糖尿病性周围神经痛效果显著,安全性好。
OBJECTIVE To compare the effects and safety of pregabalin for the treatment of diabetic peripheral neuropathic pain. METHODS Cochrane library, MEDLINE, Embase, PUBMED, CNKI, VIP database, Wan fang database and paper manual of related conferences were searched. The Meta-analysis was performed by RevMan 5.1. RESULTS Eight studies were included (n = 1 596). The analysis indicated that there were significant differences between pregabaliu and placebo in respondent rate[ OR=2. 81, 95% CI( 2. 03,3.89) ,P 〈 0. 000 011, endpoint mean pain scores [ WMD = - 1.08,95% CI ( - 1.52, -0. 63 ), P 〈 0. 000 01 ], pa- tient global impression of change [ OR = 2. 94,95% CI (2. 05,4. 20 ), P 〈 0. 000 01] and clinical global impression of change [ OR = 2. 42,95% CI(1. 53,3. 82) ,P =0. 000 11. The subgroup analysis showed that the efficacy treated with 600 mg·d-l is superior to that with 300 mg· d -2. The adverse event rate is higher treated with pregabalin than that with placebo [ OR = 5.71,95% CI (4. 05,6. 60) , P 〈 0. 000 01 ]. Compared with 5% lidocaine(Lignocaine) medicated plaster, the efficacy of pregabalin is similar while adverse event rate is higher. There were similar efficacy and safety between pregabalin and duloxetine. CONCLUSION With superior effects, similar safety, pregabalin may be preferred for the patients with diabetic peripheral neuropathic pain.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第21期1881-1885,共5页
Chinese Pharmaceutical Journal