大黄泄浊颗粒保留灌肠对非透析慢性肾脏病肾性骨病湿热证患者骨密度及血清骨形成蛋白-7的影响

Effects of Dahuang Xiezhuo Granule Retention Enema on Bone Mineral Density and Serum Bone Morphogenetic Protein-7 in Non-dialysis Chronic Kidney Disease and Renal Osteodystrophy Patients with Damp-heat Syndrome

目的观察非透析慢性肾脏病（chronic kidney diseases，CKD）肾性骨病湿热证患者腰椎骨密度（bone mineral density，BMD）和血清骨形成蛋白-7（bone morphogenetic protein-7，BMP-7）水平及大黄泄浊颗粒保留灌肠的干预作用。方法将64例非透析CKD3～5期湿热证患者随机分为治疗组和对照组各32例（结果每组失访2例），并设正常组20例。两组均给予基础治疗，治疗组加用大黄泄浊颗粒保留灌肠，每日1次，疗程均为8周。治疗前后分别观察两组血尿素氮（blood urea nitrogen，BUN），血清肌酐（serum creatinine，SCr）、钙（calcium，Ca）、磷（phosphorus，P）、碱性磷酸酶（alkaline phosphatase，ALP）、甲状旁腺激素（parathyroid hormone，iPTH）、BMP-7水平及第24腰椎BMD。结果治疗组临床疗效显著优于对照组（P〈0．05）。治疗4周末和8周末，两组中医证候积分均较前一时点显著降低（P〈0．05），且治疗组积分均显著低于对照组（P〈0．05）。治疗组在降低BUN、SCr和血清P、iPTH、ALP方面，以及在升高血清Ca和肾小球滤过率估算值方面均显著优于对照组（P〈0．05）。与正常组比较，CKD病例组BMD和BMP-7均显著降低（P〈0．05）；两组治疗后BMD和BMP-7均显著升高（P〈0．05），而治疗组BMD和BMP-7升高值均显著大于对照组（P〈0．05）。结论非透析CKD肾性骨病湿热证患者BMD和BMP-7水平均显著低于健康人群；大黄泄浊颗粒保留灌肠可防治非透析CKD肾性骨病，其机制可能与改善肾功能及升高血清BMP-7含量有关。

Objective To observe the lumbar vertebral bone mineral density （BMD） and serum bone morphogenetic protein-7 （BMP-7） in non-dialysis chronic kidney disease （CKD） and renal osteodystrophy pa tients with damp-heat syndrome, and to investigate the interventional effect of Dahuang Xiezhuo Granule retention enema. Methods Sixty-four non-dialysis CKD （stages 3 5） patients with damp-heat syndrome were randomly, divided into treatment group （n=32） and control group （n= 32）, with 2 cases lost to follow-up in each group, and 20 healthy persons were selected as normal group. The treatment group and control group received basic treatment; additionally, the treatment group received Dahuang Xiezhuo Granule retention enema once daily. The course of treatment was 8 weeks for both groups. The changes in blood urea nitrogen （BUN）, serum ereatinine （SCr） , calcium （Ca）, phosphorus （P）, alkaline phosphatase （ALP）, parathyroid hormone （iPTH）, BMP-7, and lumbar vertebral BMD （L24） of the two groups were determined before and after the treatment. Results The treatment group had a significantly better clinical outcome than the control group （P〈0.05）. After 4 and 8 weeks of treatment, both groups showed significant decreases in traditional Chinese medicine （TCM） syndrome score compared with the previous time points （P%0.05）, and the treatment group had a significantly lower TCM syndrome score than the control group （P〈0.05）. The treatment group was significantly superior to the control group in terms of decreases in BUN, SCr, and serum P, iPTH, and ALP and increases in serum Ca and estimated glomerular filtration rate （P〈 0.05）. The L24 BMD and BMP-7 level were significantly lower in the patients than in the normal group （P〈 0.05） ; the two indices increased significantly after treatment in the treatment group and control group （P〈0.05）, and significantly higher increases were observed in the treatment group （P〈0.05）. Conclusion The L2-4 BMD and BMP-7 level in non-dialysis CKD and renal osteodystrophy patients with damp-heat syndrome are significantly lower than those in healthy persons. Dahuang Xiezhuo Granule retention enema can effectively prevent non-dialysis CKD and renal osteodystrophy, and its mechanism of action may be related to the improvement in renal function and the increase in serum BMP-7 level.