双丹明目胶囊治疗2型糖尿病视网膜病变的有效性和安全性评价

Efficacy and safety evaluation of Shuangdan Mingmu Capsule in the treatment of type 2 diabetic retinopathy

目的对双丹明目胶囊治疗2型糖尿病视网膜病变(DR)肝肾阴虚、瘀血阻络证的安全性和有效性进行再评价。方法采用单臂、自身前后对照、多中心临床试验研究方法,在62家医院收集2,353例肝肾阴虚、瘀血阻络型DR患者,予双丹明目胶囊每次4粒,每日3次,疗程16周,以7个方位彩色眼底照相检查(微血管瘤、出血灶、渗出)、最佳矫正视力(BCVA)评分、中医证候积分和单项症状评分等指标综合评价疗效,同时检测血、尿、便常规及心电图、肝肾功能等安全性指标。结果(1)BCVA:与基线比较,用药8周、16周后,受试者的视力改善均有统计学意义(S_(8周)=397,580.00,S_(16周)=787,220.00,均P=0.000),视力改善、自觉症状评分上升幅度均与治疗疗程呈正相关,可改善不同病程的DR患者的视力。(2)眼底检查:与基线比较,治疗16周后,眼底检查中微血管瘤、出血灶、渗出改善,病灶数量减少差异,均有统计学意义(S_(微血管瘤)=64,063.00,S_(出血灶)=44,634.50,S_(渗出)=31,700.50,均P=0.000);眼底病变分级的下降无论基线糖化血红蛋白水平及病程长短,治疗后差异均有统计学意义(P<0.05)。(3)中医证候和单项症状评分:可改善DR中医证候和单项症状评分,中医证候积分治疗前后进行比较,差异有统计学意义(S=-624,162.50,P=0.000),对视物模糊(S=96,125.00,P=0.000)、双目干涩(S=187,296.50,P=0.000)的症状改善明显,均有统计学意义。(4)安全性评价:无药物相关严重不良反应(SAE)发生,与药物相关的不良反应主要为轻度腹部不适。结论双丹明目胶囊治疗2型糖尿病视网膜病变(肝肾阴虚、瘀血阻络证)安全有效。

OBJECTIVE To reevaluate the safety and efficacy of Shuangdan Mingmu Capsule in the treatment of type 2 diabetic retinopathy(DR)with the syndrome type of liver and kidney yin deficiency and blood stasis blocking collaterals.METHODS Using the methods of single arm,self pre-and post-control observation and multicenter clinical trial,2,353 patients with diabetes retinopathy with the syndrome type of liver and kidney Yin deficiency and blood stasis blocking collaterals were collected in sixty-two hospitals.They were given Shuangdan Mingmu Capsule four capsules each time,three times a day for sixteen weeks.The therapeutic effect was comprehensively evaluated by color fundus photography including microangioma(mic),bleeding focus(bf),and exudation(exu),the scores of best corrected visual acuity(BCVA),the scores of Traditional Chinese Medicine(TCM)syndrome and the scores of single symptom in seven directions.Also,the blood,routine urine and stool,ECG,liver and kidney function and other safety indicators were tested.RESULTS(1)BCVA:Compared with the baseline,the visual acuity of the participants improved significantly after eight and sixteen weeks of treatment(S_(8w)=397,580.00,S_(16w)=787,220.00,all P=0.000).The improvement of visual acuity and the increase of subjective symptom score were positively correlated with the course of treatment,which could improve the visual acuity of DR patients with different disease course.(2)Fundus examination:Compared with the baseline,after sixteen weeks of treatment,the microangioma,bleeding focus and exudation in fundus examination were improved,and the number of lesions decreased,and the differences were all statistically significant(S_(mic)=64,063.00,S_(bf)=44,634.50,S_(exu)=31,700.50,all P=0.000).There was significant difference in the decrease of fundus lesion grade after treatment regardless of baseline glycosylated hemoglobin level and course of disease(P<0.05).(3)Scores of TCM syndrome and single symptom:The scores of TCM syndrome and single symptom of DR patients could be improved.Compared with that before and after treatment,the TCM syndrome scores were increased,and the difference was statistically significant(S=-624,162.50,P=0.000).Also,the symptoms of blurred vision(S=96,125.00,P=0.000)and dry eyes(S=187,296.50,P=0.000)are significantly improved.(4)Safety evaluation:No drug-related serious adverse event(SAE)occurred,and the drug-related adverse reactions were mainly mild abdominal discomfort.CONCLUSIONS Shuangdan Mingmu Capsule is safe and effective in the treatment of type 2 diabetic retinopathy with the syndrome type of liver and kidney Yin deficiency,blood stasis blocking collaterals.