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

Objective To evaluate the effectiveness and safety of deoxynucleotide injection in treatment of acute cerebral infarction.Methods Through a multicenter,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 basical 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).Nosocomial infection rates of two groups were 2.9％ and 11.7％ respectively,with a statistical significant difference (x 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 nosocomial infection.And it substantially has no adverse reaction during treatment.