目的观察培元通络方对糖尿病肾脏病(DKD)IV期临床疗效及微炎症状态的影响,探讨培元通络方治疗DKD的作用机制。方法采用SAS软件随机程序,将106例DKD-IV期患者分为治疗组(培元通络方颗粒组)和对照组(尿毒清颗粒组),每组53例,实际完成98例,治疗组和对照组各49例。2组患者除基础治疗外,治疗组予培元通络方颗粒,对照组予尿毒清颗粒,疗程均为8周。观察2组患者治疗前后的中医证候疗效、血肌酐(SCr)、肾小球滤过率(e GFR)、24 h尿蛋白定量(24 h U-pro)、微量尿蛋白(U-Alb)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)的变化情况,并进行统计分析。结果与本组治疗前比较,治疗后治疗组各项中医证候明显减轻(P<0.05或P<0.01),优于对照组同期(P<0.05或P<0.01)。与本组治疗前比较,治疗后治疗组SCr、24 h U-pro及U-Alb水平明显下降(P<0.01),e GFR水平上升(P<0.05),且优于对照组同期(P<0.05或P<0.01)。与本组治疗前比较,治疗后治疗组hs-CRP、TNF-α、IL-6水平均明显降低(P<0.01),且优于对照组同期(P<0.05)。治疗组临床疗效总有效率73.47%,优于对照组的44.90%,差异有统计学意义(P<0.05)。2组患者均未出现明显不良反应情况。结论培元通络方结合西医基础治疗能有效降低DKD-IV期患者尿蛋白,保护肾脏,改善微炎症状态。
Objectives:To observe the clinical effect on opioid-induced constipation of liver stagnation and spleen deficiency treated with the ultrasonic penetration of the No.1 constipation herbal formula at Tiānshū(天枢ST25).Methods:A total of 126 patients that were in compliance with the inclusion criteria were randomized into an acupoint group(41 cases),a Chinese medication group(42 cases)and a western medication group(43 cases).In the acupoint group,the ultrasonic penetration of the No.1 constipation herbal formula at bilateral Tiānshū(天枢ST25)were given.In the Chinese herbal medication group,the No.1 constipation herbal formula was prescribed for oral administration.In the western medication group,polyethylene glycol electrolyte powder was prescribed for oral administration.The treatment was given once a day,for 14 days totally.Before and after treatment,the constipation symptom score,the score of the patient assessment of constipation quality of life(PAC-QOL),the situation of nitric oxide synthetase(NOS)in serum were observed in each group.The safety indicators in the observation included diarrhea,allergic reaction,liver dysfunction,skin lesions,etc.Results:A total of 122 cases accomplished the trial.The total effective rate was 82.5%in the acupoint group,80.48%in the Chinese medication group and 78.04%in the western medication group.The constipation symptoms were all relieved in the three groups,indicating the statistical significance as compared with those before treatment(P<0.01,P<0.05).In the acupoint group and the western medication group,the improvements in the three symptom items,i.e.distention or scurrying pain in the chest,hypochondriac region or the bilateral sides of the abdomen,depression or irritability and poor appetite,were better than the western medication group(P<0.01,P<0.05).The improvements in all of the symptoms in the acupoint group were better than the Chinese medication group(all P<0.05).The PACQOL score was improved in each group after treatment and it was different significantly in
