脱氧核苷酸注射液治疗急性脑梗死的多中心随机、单盲、安慰剂对照临床试验

目的评价脱氧核苷酸注射液治疗急性脑梗死的有效性和安全性。方法本研究采用目的评价脱氧核苷酸注射液治疗急性脑梗死的有效性和安全性。方法本研究采用多中心、随机单盲对照的方法，于2013年5月至2014年5月共入选144例脑梗死患者，随机分为对照组和治疗组，对照组（n=72煸人给予溶栓、抗凝、抗血小板、活血化瘀等方法进行治疗，治疗组（n=72）在对照组基础上给予脱氧核苷酸注射液（200mg／d），连续21d，评价患者的神经功能缺损状况并检测血清蛋白含量，记录医院感染发生情况。结果治疗后，两组美国国立卫生院神经功能缺损评分（national institutes of health neurological function，NIHSS）均显著下降、日常生活活动评分（Baahel指数）均明显提高，但治疗组NIHSS评分下降以及Barthel指数提高更显著（P〈0．05）。治疗组与对照组在基本痊愈率（26．0％vs10．3％）、总有效率（91．3％vs73．5％）方面比较差异有统计学意义（P〈0．05）。血清蛋白检测显示，两组总蛋白（total protein，TP）、白蛋白（albumin，ALB）水平均显著下降，但治疗组TP、ALB水平下降程度显著低于对照组（P〈0．05）。治疗21d后，治疗组CD^3＋、CD^4＋、自然杀伤（naturalkiller，NK）细胞水平均显著高于对照组，而医院感染发生率显著低于对照组（P〈0．05）。治疗期间两组除发生低热、皮疹、头痛、轻微恶心呕吐外，均未见其他严重不良反应。结论脱氧核苷酸注射液可改善急性脑梗死患者神经功能缺损状况，增加血清蛋白水平，增强机体免疫力，减少医院感染发生率，治疗过程基本无不良反应。

A multi-center randomized,placebo-controlled trial of deoxynucleotides and granulocyte colony stimulating factor in treatment of cute cerebral infarction

Objective To evaluate the effectiveness and safety of deoxynucleotide injection in treatment of acute cerebral infarction. Methods Through a muhicentcr, randomized, single-blind controlled method, 144 cases of cerebral infarction patients were enrolled in the control group （n=72） patients who received thrombolysis, anticoagulation, antiplatelet, blood circulation and other standard therapy. Experimental group （n=72） was given deoxynucleotide acid injection （200 mg/d） based on the control group therapy, for continuous 21 days, neurological deficit status of patients was evaluated and serum protein content was detected, and hospital infection rate was also recorded. Results NIHSS scores before and after treatment were significantly decreased in both groups, but the treatment group decreased more significantly compared with the control group （P 〈 0.05）. Barthel indexes before and after treatment were all significantly increased in both groups, but the control group improved more significantly （P 〈 0.05）. The basieal recovered rates before and after treatment were 26.0% and 10.3%, the total efficiency were 91.3% and 73.5% respectively, two groups showed statistical significant difference （P 〈 0.05）. Serum protein detection display, TP, ALB levels had decreased to some extent （P 〈 0.05）. After treatment, the TP, ALB levels of the treatment group dropped below the level of the control group, showing a statistical significant difference between the two groups （P 〈 0.05）. After treatment, the 21d, the treatment group CD3＋, CD4＋, NK cells levels were higher, with a significant difference between the two groups （P 〈 0.05）. Nosoeomial infection rates of two groups were 2.9% and 11.7% respectively, with a statistical significant difference （Х^2=3.979, P=0.046）. Conclusion Deoxynucleotide injection can improve neurological impairment of patients, increase their serum protein levels, improve their immunocompetence, and reduce the incidence of nosoeomial infection. And it