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目的采用Meta分析法综合评价度洛西汀治疗糖尿病周围神经痛(DPNP)的有效性和安全性。方法检索Cochrane Library、Pub Med、EMBase、Web of Science、FDA等数据库及中国期刊全文数据库和万方数据库,采用改良版Jadad法评价纳入的文献质量。以总反应有效率、治疗24 h疼痛评估量表评分周平均改变量和不良反应退出发生率为主要评价指标,应用Revman5.2软件对有关度洛西汀治疗糖尿病周围神经痛的随机对照试验研究文献进行Meta分析。结果共检出文献39篇,符合标准5篇纳入Meta分析,共包括1 834例患者。分析结果显示,与安慰剂相比,度洛西汀组30%和50%的反应有效率均有显著差异(P<0.000 1),危险差(RD)分别为[RD=0.20,95%CI(0.16,0.24),需治疗人数(NNT)=5]和[RD=0.19,95%CI(0.15,0.23),NNT=5]。度洛西汀治疗组的24 h疼痛评分周平均改变量较安慰剂组改变显著[加权均数差(WMD)=-1.07,95%CI(-1.28,-0.85),P<0.000 1]。24 h最严重疼痛评分、简明疼痛评估量表(BPI)评分、BPI最严重疼痛评分、BPI最小疼痛评分、CGI-S评分以及PGI-I评分改变量在度洛西汀组与安慰剂组之间的差异均有显著意义(P<0.000 1)。因不良反应退出率两组差异显著[RD=0.08,95%CI(0.06,0.11),P<0.000 1,NNH=12.5]。结论度洛西汀治疗糖尿病周围神经痛疗效显著优于安慰剂;度洛西汀60 mg·d-1剂量组疗效略低于120 mg·d-1剂量组,但是减轻疼痛的疗效不呈剂量依赖性。度洛西汀60 mg·d-1剂量组安全性略高于120 mg·d-1剂量组。
Objective To evaluate the efficacy and safety of duloxetine in the treatment of diabetic peripheral neuralgia (DPNP) by Meta-analysis. Methods The databases of Cochrane Library, Pub Med, EMBase, Web of Science, FDA and other databases of China Journal and Wanfang Database were searched. The quality of the included documents was evaluated by the modified Jadad method. The overall response rate, 24 h pain assessment scale treatment week average change and withdrawal rate of adverse reactions as the main evaluation indicators, the application of Revman5.2 software on duloxetine in the treatment of diabetic peripheral neuralgia randomized controlled trial Meta-analysis of the literature. Results A total of 39 articles were found, of which 5 were standard. Meta-analysis included a total of 1 834 patients. The results showed that compared with placebo, the response rates of 30% and 50% in duloxetine group were significantly different (P <0.0001), and the difference in risk (RD) were [RD = 0.20,95% CI (0.16, 0.24), NNT = 5] and [RD = 0.19, 95% CI (0.15,0.23), NNT = 5]. Weekly mean changes in 24 h pain scores in duloxetine-treated groups were significantly more variable than placebo (WMD = -1.07, 95% CI, -1.28, -0.85, P <0.0001). The 24 h worst pain score, the Concise Pain Rating Scale (BPI) score, the BPI Most Severe Pain Score, the BPI Minimal Pain Score, the CGI-S Score, and the PGI-I score change were higher in the duloxetine and placebo groups There was significant difference between the two groups (P <0.000 1). The rate of withdrawal due to adverse events was significantly different between the two groups [RD = 0.08, 95% CI (0.06, 0.11), P <0.0001, NNH = 12.5]. Conclusion Duloxetine is superior to placebo in the treatment of diabetic peripheral neuropathic pain. Duloxetine 60 mg · d-1 slightly lower than the 120 mg · d-1 dose group, but the pain relief efficacy was not dose Dependency. Duloxetine 60 mg · d-1 dose group safety slightly higher than 120 mg · d-1 dose group.