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Abstract：
Ranirestat, an aldose reductase inhibitor evaluated in several randomised controlled trials (RCTs) in diabetic peripheral neuropathy (DPN). However, to date, no meta-analysis has evaluated the efficacy and safety of ranirestat in DPN. We undertook this meta-analysis to address this knowledge gap. Detailed search of electronic databases for RCTs published till December 2021 was done at Cochrane register, Medline, PubMed, Embase, clinicaltrials.gov, ctri.nic.in, global health and Google Scholar using the Boolean search strategy: ((ranirestat) OR (aldose reductase inhibitor)) AND ((diabetes) OR (\"diabetes mellitus\")). The primary outcome was to evaluate changes in nerve conduction velocities (NCV) of different nerves. The secondary outcomes were to evaluate alterations in amplitudes, F-wave latencies of nerves, modified Toronto Clinical Neuropathy Score (mTCNS) and adverse events. Data from 5 studies involving 1461 patients with DPN was analysed to establish the impact of ranirestat (20-40 mg/day) as compared to placebo on different electrophysiologic outcomes over a median follow-up of 52 weeks. Patients receiving ranirestat had significantly greater improvement in proximal median sensory NCV [MD 0.77 m/s (95%CI: 0.50-1.05); P < 0.01; I2 = 26%], distal median sensory NCV [MD 0.91 m/s (95%CI: 0.87-0.95); P < 0.01; I2 = 0%], median motor NCV [MD 0.63 m/s (95%CI: 0.60-0.66); P < 0.01; I2 = 0%], tibial motor NCV [MD 0.46 m/s (95%CI: 0.43-0.49); P < 0.01; I2 = 0%] and peroneal motor NCV [MD 0.80 m/s (95%CI: 0.66-0.93); P < 0.01; I2 = 0%]. mTCNS was not significantly different among groups. Treatment-emergent adverse events [risk ratio (RR) 0.85 (95%CI: 0.63-1.14); P = 0.28; I2 = 0%] and severe adverse events [RR 1.35 (95%CI: 0.86-2.11); P = 0.20; I2 = 0%] were comparable across study groups. In people with established DPN with long-standing diabetes, ranirestat is safe and effective in improving electrophysiologic but not clinical DPN.
摘要：
Ranirestat,一项醛糖还原酶抑制剂在糖尿病性周围神经病变(DPN)的多项随机对照试验(RCT)中进行了评估.然而,到目前为止,没有荟萃分析评估了拉尼司他在DPN中的有效性和安全性。我们进行了这项荟萃分析来解决这一知识差距。在Cochrane登记册上详细搜索了截至2021年12月发布的RCT的电子数据库，Medline,PubMed,Embase,clinicaltrials.gov,ctri.nic.in,全球健康和谷歌学者使用布尔搜索策略：（（拉尼司他）或（醛糖还原酶抑制剂））和（（糖尿病）或（“糖尿病”））。主要结果是评估不同神经的神经传导速度（NCV）的变化。次要结果是评估振幅的改变，神经的F波潜伏期，改良多伦多临床神经病变评分（mTCNS）和不良事件。分析了涉及1461例DPN患者的5项研究的数据，以确定与安慰剂相比，雷尼司他（20-40mg/天）在52周的中位随访中对不同电生理结果的影响。接受拉尼司他的患者近端中位感觉NCV有显著改善[MD0.77m/s(95CI:0.50-1.05);P<0.01;I2=26%],远端中位感觉NCV[MD0.91m/s（95CI：0.87-0.95）；P<0.01；I2=0%]，中位运动NCV[MD0.63m/s（95CI：0.60-0.66）；P<0.01；I2=0%]，胫骨运动NCV[MD0.46m/s(95CI:0.43-0.49);P<0.01;I2=0%]和腓骨运动NCV[MD0.80m/s(95CI:0.66-0.93);P<0.01;I2=0%]。mTCNS组间无显著差异。治疗中出现的不良事件[风险比(RR)0.85(95CI:0.63-1.14);P=0.28;I2=0%]和严重不良事件[RR1.35(95CI:0.86-2.11);P=0.20;I2=0%]在各研究组之间具有可比性。在患有长期糖尿病的DPN患者中，拉尼司他在改善电生理方面是安全有效的，但在临床上不是。
