α-硫辛酸注射液对2型糖尿病患者周围神经病变的疗效和安全性
α-류신산주사액대2형당뇨병환자주위신경병변적료효화안전성
Efficacy and safety of α-lipoic acid on peripheral neuropathy in patients with type 2 diabetes mellitus
  • 万方数据
    中华糖尿病杂志 중화당뇨병잡지
    CHINES JOURNAL OF DLABETES MELLITUS
    2012年 7期 412-415 ,共4页

    谷伟军%陆菊明%关小宏%时立新%管庆波%王颜刚%邹大进%葛家璞%任伟%罗湘杭%余学锋%向光大%刘春燕%薛元明%罗巧云%李光伟

    곡위군%륙국명%관소굉%시립신%관경파%왕안강%추대진%갈가박%임위%라상항%여학봉%향광대%류춘연%설원명%라교운%리광위

    糖尿病,2型%硫辛酸%周围神经系统疾病 糖尿病,2型%硫辛痠%週圍神經繫統疾病
    당뇨병,2형%류신산%주위신경계통질병
    Diabetes mellitus,type 2%Thioctic acid%Peripheral nervous system diseases
    目的 观察α-硫辛酸对合并周围神经病变的2型糖尿病患者的疗效和安全性.方法 于2009年8月至2010年3月入选16家医院284例合并周围神经病变的2型糖尿病患者,在基础降糖治疗上加用α-硫辛酸600 mg,静脉滴注1次/d,共10 ～14 d,考察治疗前后周围神经病变的总症状评分(TSS)等疗效指标和不良反应.治疗前后疗效比较采用配对t检验.结果 研究中有15例患者因自身原因提前出院而退出研究,故实际共269例患者完成研究.α-硫辛酸注射液治疗至少10 d后的平均TSS较治疗前明显降低[(3.4±2.2)比(6.7±2.6)分,t =25.31,P＜0.01],有效率为73.2％.TSS评分中刺痛、烧灼感、感觉减退和麻木症状评分均较治疗前明显缓解,差异均有统计学意义(t=20.82、16.29、16.82、22.49,均P＜0.01).Pearson相关分析显示,α-硫辛酸的疗效(即TSS评分改善)与患者的疗程满14 d、治疗前神经症状严重程度、血糖降低幅度、治疗前血糖水平呈显著正相关(r=0.125、0.602、0.150、0.172,均P＜0.05),与尿微量白蛋白呈显著负相关(r=-0.200,P＜0.05),与患者的年龄、性别、糖尿病病程、肥胖无关(r=-0.027、- 0.083、- 0.076、-0.115,均P＞0.05).99.2％ (267/269)的医师和97.8％( 263/269)的患者对疗效满意.研究过程中仅有2例患者出现轻度头晕和皮疹,未经特殊处理自行缓解.结论 α-硫辛酸治疗2型糖尿病合并周围神经病变可以显著改善患者的神经病变症状,且具有良好的安全性.
    목적 관찰α-류신산대합병주위신경병변적2형당뇨병환자적료효화안전성.방법 우2009년8월지2010년3월입선16가의원284례합병주위신경병변적2형당뇨병환자,재기출강당치료상가용α-류신산600 mg,정맥적주1차/d,공10 ～14 d,고찰치료전후주위신경병변적총증상평분(TSS)등료효지표화불량반응.치료전후료효비교채용배대t검험.결과 연구중유15례환자인자신원인제전출원이퇴출연구,고실제공269례환자완성연구.α-류신산주사액치료지소10 d후적평균TSS교치료전명현강저[(3.4±2.2)비(6.7±2.6)분,t =25.31,P＜0.01],유효솔위73.2％.TSS평분중자통、소작감、감각감퇴화마목증상평분균교치료전명현완해,차이균유통계학의의(t=20.82、16.29、16.82、22.49,균P＜0.01).Pearson상관분석현시,α-류신산적료효(즉TSS평분개선)여환자적료정만14 d、치료전신경증상엄중정도、혈당강저폭도、치료전혈당수평정현저정상관(r=0.125、0.602、0.150、0.172,균P＜0.05),여뇨미량백단백정현저부상관(r=-0.200,P＜0.05),여환자적년령、성별、당뇨병병정、비반무관(r=-0.027、- 0.083、- 0.076、-0.115,균P＞0.05).99.2％ (267/269)적의사화97.8％( 263/269)적환자대료효만의.연구과정중부유2례환자출현경도두훈화피진,미경특수처리자행완해.결론 α-류신산치료2형당뇨병합병주위신경병변가이현저개선환자적신경병변증상,차구유량호적안전성.
    Objective To observe the efficacy and safety of α-lipoic acid(ALA) on diabetic peripheral neuropathy ( DPN ).Methods All of 284 type 2 diabetic inpatients with DPN in sixteen hospitals were selected from August 2009 to March 2010.The patients received ALA 600 mg/d in 250 ml normal saline by intravenous drip infusion once a day for 10 - 14 days.Before and after the management,total symptom score(TSS) was used to evaluate the nervous symptoms,including numbness,sting sensation,burning sensation and hypoesthesia.The clinical data before and after treatment was compared using paired t test.Results Total of 269 patients completed the trial.After at least 10-day treatment,the TSS decreased significantly compared with that at the baseline(3.4 ±2.2 vs 6.7 ±2.6,P＜0.01).The symptom scores of numbness,sting sensation,hypoesthesia and burning sensation reduced significantly after ALA treatment( t =20.82,16.29,16.82,22.49,respectively,all P ＜ 0.01 ).About 99.2％ (267/269) doctors and 97.8％(263/269) patients were satisfied with the treatment effect.One patient complained of dizziness and one presented cutaneous eruption,the symptoms were mild and recovered spontaneously.The efficacy of ALA was positively correlated with course of treatment,the severity of nervous symptoms,decline of blood glucose and blood glucose level before treatment (r =0.125,0.602,0.150,0.172,all P ＜0.05),and negatively correlated with the urine microalbuminuria ( r =- 0.200,P ＜ 0.01 ).Conclusions α-lipoic acid can improve the symptoms of DPN in type 2 diabetic patients effectively and safely,especially for numbness,sting sensation.
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