摘要
目的观察小牛血去蛋白提取物治疗2型糖尿病睡眠障碍的临床疗效及安全性。方法采用单盲法,将76例2型糖尿病睡眠障碍患者随机分成观察组(n=38)和对照组(n=38),两组在常规降糖的基础上,观察组予小牛血去蛋白提取物注射液(0.8g,静滴,1次/d)和对照组予安慰剂(0.9%氯化钠注射液250ml,静滴,1次/d),疗程均为2w,观察两组患者治疗前后匹玄堡睡眠质量指数(PS0I)评分、总疗效及不良反应情况。结果观察组与对照组总有效率分别为71.1%和7.9%,两组间比较差异有统计学意义(χ2=31.7222,=0.000);观察组治疗后睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍、催眠药物、日间功能评分和PSOI总分均较治疗前明显改善,差异有统计学意义(P<0.05);对照组治疗前后上述各指标比较差异无统计学意义(P>0.05);治疗期间两组均无明显不良反应。结论小牛血去蛋白提取物治疗2型糖尿病睡眠障碍安全有效,值得临床推广。
Objective To observe ef icacy and safety of deproteinized calf blood protein extract treatment in type 2 diabetes with sleep disorders.Methods Using single-blind method,76 sleep disorders patients with type 2 diabetes were randomly divided into observation group(n=38)and control group(n=38);On the basis of conventional hypoglycemic,the therapy of deproteinized calf blood protein extract injection in observation group(0.8g,intravenous infusion,once a day)and in the control group were given placebo(0.9%sodium chloride injection,250ml,intravenous infusion,once a day),a course of two weeks,observing Pit sburgh sleep quality index,total ef iciency and adverse reactions in two groups before and after treatment.Results The total ef ective rate was 71.1%in observation group and 7.9%in control group,the difference between the two groups was statistical y significant(χ2=31.7222,=0.000);after treatment,Sleep quality,sleep time,sleeping time,sleep ef iciency,sleep disorders,hypnotic drugs,daytime function score and PSOI score improved significantly than in observation group,the dif erence was statistical y significant(P<0.05);these indexes was no significant dif erence in the control group(P>0.05);in two groups,no significant adverse reactions during treatment.Conclusion The treatment of deproteinized calf blood extract was safe and effective in sleep disorders patients of type 2 diabetes and Worthy of promotion.
作者
唐景华
TANG Jing-hua(Department of Endocrinology,Gaoming District People's Hospital,Foshang 528500,Guangdong,China)
