CAJ | 학술논문

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。
목적관찰소우혈거단백제취물치료2형당뇨병수면장애적림상료효급안전성。방법채용단맹법，장76례2형당뇨병수면장애환자수궤분성관찰조(n=38)화대조조(n=38)，량조재상규강당적기출상，관찰조여소우혈거단백제취물주사액(0.8g,정적，1차/d)화대조조여안위제(0.9%록화납주사액250ml，정적，1차/d),료정균위2w，관찰량조환자치료전후필현보수면질량지수(PS0I)평분、총료효급불량반응정황。결과관찰조여대조조총유효솔분별위71.1%화7.9%，량조간비교차이유통계학의의(χ2=31.7222，=0.000)；관찰조치료후수면질량、입수시간、수면시간、수면효솔、수면장애、최면약물、일간공능평분화PSOI총분균교치료전명현개선，차이유통계학의의(P<0.05)；대조조치료전후상술각지표비교차이무통계학의의(P>0.05)；치료기간량조균무명현불량반응。결론소우혈거단백제취물치료2형당뇨병수면장애안전유효，치득림상추엄。
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.