摘要
目的观察肾衰Ⅱ号颗粒治疗慢性肾脏病(CKD)3~4期脾肾气虚、湿热瘀阻证患者的临床疗效及对游离脂肪酸(FFA)水平的影响。方法采用随机双盲的临床试验设计将84例患者分为对照组和治疗组各42例。2组均予西医一体化治疗,对照组加安慰剂颗粒,治疗组加肾衰Ⅱ号颗粒,每次1袋,每日2次,温水冲服;2组疗程均为3个月。观察2组患者临床疗效及中医证候疗效,于治疗前后检测2组患者肾功能指标[血肌酐(SCr)、尿素氮(BUN)、肾小球滤过率(eGFR)、24 h尿蛋白定量(24 hUP)]、脂代谢指标[血清FFA、总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、脂蛋白(a)(Lp(a))、载脂蛋白(Apo)A1、ApoB]水平,并监测2组安全性指标。结果治疗组临床总有效率为83.33%(35/42),对照组为35.71%(15/42),2组比较差异有统计学意义(P<0.01);治疗组中医证候疗效总有效率为88.10%(37/42),对照组为40.48%(17/42),2组比较差异有统计学意义(P<0.01)。与本组治疗前比较,治疗组治疗后SCr、BUN、24 hUP、FFA下降,eGFR上升(P<0.05,P<0.01);对照组治疗后SCr上升,eGFR下降(P<0.01)。2组治疗后比较,治疗组SCr、BUN、FFA低于对照组(P<0.01)。2组患者治疗前后TC、TG、LDL-C、HDL-C、Lp(a)、ApoA1、ApoB比较差异均无统计学意义(P>0.05)。2组患者安全性指标未见异常变化(P>0.05)。结论肾衰Ⅱ号颗粒联合西医一体化治疗具有改善CKD 3~4期脾肾气虚、湿热瘀阻证患者临床症状及肾功能相关指标,降低FFA,延缓CKD进展的作用。
Objective To observe the clinical efficacy of ShenshuaiⅡGranules on patients with stage 3-4 chronic kidney disease(CKD)with spleen-kidney qi deficiency and damp-heat stasis syndrome and its effects on free fatty acid(FFA)levels.Methods A randomized double-blind clinical trial design was adopted,and 84 cases were included and randomly divided into a control group and a treatment group,with 42 cases in each group.The control group was given placebo granules,and the treatment group was given Shenshuai Ⅱ Granules,once a bag,twice a day,orally taken with warm water;the treatment for both groups lasted 3 months.Clinical efficacy and TCM syndrome efficacy of the two groups were evaluated.Renal function indicators(SCr,BUN,eGFR,24 hUP)and lipid metabolism indicators(FFA,TC,TG,LDL-C,HDL-C,LP(a),ApoA1 and ApoB)were detected and compared before and after treatment.The safety indicators of both groups were monitored.Results The total clinical effective rate of the treatment group was 83.33%(35/42),and the rate of the control group was 35.71%(13/42),with statistical significance(P<0.01);the therapeutic effect of TCM syndrome efficacy of the treatment group was 88.10%(37/42),and the rate of the control group was 40.48%(17/42),with statistical significance(P<0.01).Compared with before treatment,the levels of SCr,BUN,24-hour UP,FFA decreased in the treatment group,and eGFR increased(P<0.05,P<0.01).After treatment in the control group,SCr increased,while eGFR decreased(P<0.01).After treatment,the SCr,BUN and FFA levels in the treatment group were lower than those in the control group(P<0.01).There was no statistical significance in TC,TG,LDL-C,HDL-C,Lp(a),ApoA1 and ApoB between the two groups before and after treatment(P>0.05).No abnormal changes were observed in the safety indicators of the two groups of patients(P>0.05).Conclusion ShenshuaiⅡGranules integrated treatment with Western medicine can improve clinical symptoms and renal function-related indicators on patients with stage 3-4 CKD with spleen-kidney qi deficiency and damp-heat stasis syndrome,reduce serum FFA,and delay the progression of CKD.
作者
丁晓璐
蔡峥
王琛
DING Xiaolu;CAI Zheng;WANG Chen(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国中医药信息杂志》
2025年第4期152-156,共5页
Chinese Journal of Information on Traditional Chinese Medicine
基金
国家自然科学基金(81973770)
上海市进一步加快中医药事业发展三年行动计划(ZY(2018-2020)-FWTX-7005)。
关键词
慢性肾脏病
肾衰Ⅱ号颗粒
脂代谢
血清游离脂肪酸
chronic kidney disease
ShenshuaiⅡGranules
lipid metabolism
serum free fatty acids
作者简介
通讯作者:王琛,E-mail:chenwang42@163.com。
