单中心随机对照研究左卡尼汀对持续非卧床腹膜透析患者生存质量的影响

Effects of oral L-carnitine supplements on quality of life in patients subject to continuous ambulatory per-itoneal dialysis：A single-center, randomized,controlled study

目的探讨口服左卡尼汀对腹膜透析患者生存质量的影响。方法选择2011年1月至2011年12月在我院腹膜透析中心收治的慢性肾衰竭进行规律腹膜透析治疗且有肉碱缺乏症状的患者89例，采用数字随机表法分为治疗组45例，对照组44例。治疗组给予口服左卡尼汀每次1g（10m1），2次／d；对照组口服5％葡萄糖注射液每次10ml，2次／d，2组疗程3个月。分别于治疗前、治疗后3个月及治疗后6个月评价患者的生存质量及药物不良反应。结果2组患者的人口学指标、主要生化指标均无差异；体力状况指标对照组高于治疗组，但总的SF-36没有差异。与基线水平相比，治疗后3个月对照组的SF-36及体力状况、情感与精神状态，治疗组的SF-36及体力状况、总体健康、情感与精神状态、精力状况均较治疗前显著提高；治疗后6个月，对照组的体力状况、情感作用、精力状况仍较治疗前提高，但SF-36与治疗前并无差异；治疗组的SF-36及体力状况、体力作用、总体健康、情感与精神状态、情感作用、社会功能均较治疗前显著提高；治疗后3个月，治疗组的体力状况、体力作用、情感作用、精力状况均明显高于对照组（P〈（）．05或P％0．01），但SF-36无显著差异；治疗后6个月，治疗组的SF-36及体力状况、总体健康及社会功能明显高于对照组（P〈0．05或P〈0．01）。观察期内，所有患者均未出现与药物有关的不良反应及过敏反应。结论口服左卡尼汀在腹膜透析有肉碱缺乏表现的患者中应用对生存质量的提高有明显的效果且耐受性良好。

Objective To explore the impact of oral levocarnitine supplements on quality of life （QOL） of patients subiect to continuous ambulatory peritoneal dialysis （CAPD）. Methods This was a randomized and controlled clinical trial conducted on 89 CAPD patients with levocarnitine deficiency symptoms who were treated in our centre during Jan. 2011 to Dec. 201 l. They were randomly assigned to receive oral levocarnitine E 1 g（10 ml）, twice every day~ （treated group, 45 cases） or 5% glucose in- jection（ 10 ml, twice every day） （control group, 44 cases）for 3 months. QOL and adverse drug reactions were estimated at baseline, and 3rd and 6th month after drug delivery. Results There was no signifi- cant difference in demographic characteristics,biochemical indicators and QOL between two groups at the baseline. As compared with the baseline, the SF-36 score and some of the QOL scales were in- creased in both groups after treatment {or 3 months, and SF-36 scores in treated group were still high- er, but those in the control group showed no significant difference after treatment for 6 months. At 3rd month, physical functioning, general health, role-physical and energy in the treated group were signifi- cantly improved as compared with the control group （P〈0. 05 or P〈0. 01）, but there was no signifi- cant difference in SF-36. At 6th month, SF-36 and physical functioning, general health and social func-tion in the treated group were apparently improved as compared with the control group （P（0. 05 or P （0. 01）. No adverse drug reaction occurred during the course of study. Conclusions Oral supplemen- tation of levoearnitine to CAPD patients with carnitine deficiencies can increase their QOL, and he well- tolerated.