培元消癥方治疗慢性肾脏病5期透析合并CKD-MBD骨痛临床疗效研究

Clinical effect of Peiyuan Xiaozheng Formula on bone pain in patients with stage 5 chronic kidney disease on dialysis complicated with mineral and bone disorder

目的研究培元消癥方对慢性肾脏病5期透析(Chronic Kidney Disease stage 5 Dialysis,CKD 5D)合并慢性肾脏病-矿物质与骨异常(Chronic Kidney Disease-Mineral and Bone Disorder,CKD-MBD)骨痛脾肾两虚兼毒瘀证患者的临床疗效。方法选取2018年10月—2020年5月就诊于重庆市中医院血液透析中心的CKD 5D合并CKD-MBD骨痛脾肾两虚兼毒瘀证患者,共76例,按入组时间顺序编号,随机分为对照组30例和试验组46例。对照组采用对症治疗方案,试验组在对照组基础上加服培元消癥方,共治疗12周。观察2组治疗前后中医证候积分、疼痛视觉模拟量表(VAS)评分的变化情况,检测血中钙(Ca)、磷(P)、全段甲状旁腺激素(iPTH)、血清骨特异性碱性磷酸酶(BAP)含量的变化情况。结果对照组、试验组总有效率分别为60.71%、90.9%,试验组临床疗效优于对照组(P<0.01)。中医证候积分:与治疗前比较,治疗后试验组各项症状积分均下降(P<0.05,P<0.01),对照组仅水肿、食少纳呆、大便稀溏、恶心呕吐、肢体困重、胸痛喘息、皮肤瘙痒积分下降(P<0.05,P<0.01);与对照组比较,治疗后试验组除胸痛喘息、皮肤瘙痒外,其余症状积分均下降,差异均具有统计学意义(P<0.05,P<0.01)。VAS评分:与治疗前比较,试验组治疗8、12周后,VAS评分下降(P<0.05,P<0.01);对照组治疗12周后,VAS评分下降(P<0.05)。矿物质骨代谢指标:与治疗前比较,试验组治疗8周后,血清Ca上升(P<0.01),血清P、BAP、iPTH下降(P<0.05,P<0.01);治疗12周后,血清Ca仍上升(P<0.01),血清P、BAP及iPTH下降(P<0.01)。对照组治疗12周后血清Ca上升(P<0.05),血清P、BAP及iPTH下降(P<0.05)。结论培元消癥方能有效改善CKD 5D合并CKD-MBD骨痛症状,其机制可能与调节矿物质与骨代谢、改善继发性甲状旁腺功能亢进症引发的骨过度转换有关。

Objective To study clinical effect of Peiyuan Xiaozheng Formula(Original Qi-Nourishing and Abdominal Mass-Eliminating Formula,PYXZF)on bone pain in patients at chronic kidney disease stage 5 dialysis(CKD 5 D)complicated with chronic kidney disease-mineral and bone disorder(CKD-MBD),presenting the patterns of spleen-kidney deficiency and toxin stasis.Methods A total of 76 CKD 5 D patients complicated with CKD-MBD bone pain,presenting patterns of spleen kidney deficiency and toxin stasis,were selected from hemodialysis center of Chongqing Hospital of Traditional Chinese Medicine from October 2018 to May 2020.They were randomly divided into control group(CG)(n=30)and experimental group(EG)(n=46).In 12 weeks,CG was given symptomatic treatment,while EG was given an additional PYXZF.The changes of traditional Chinese medical(TCM)pattern scores,visual analogue scale(VAS),serum calcium(Ca),phosphorus(P),parathyroid hormone(iPTH)and serum bone specific alkaline phosphatase(BAP)were observed before treatment,as well as after treatment.Results The total effective rates of CG and EG were 60.71%and 90.9%respectively.The clinical efficacy of EG was better than that of CG(P<0.01).After treatment,the scores of pattern in EG were significantly lower than those before treatment(P<0.05,P<0.01).The scores of edema,lack of appetite,loose stool,nausea and vomiting,heavy cumbersome limbs,chest pain and wheezing,pruritus in CG were decreased(P<0.05,P<0.01).Compared with those before treatment,VAS scores of EG decreased after 8 weeks and 12 weeks of treatment(P<0.05,P<0.01).The VAS scores of CG decreased after 12 weeks of treatment(P<0.05).Compared with that before treatment,serum Ca in EG was increased(P<0.01),and serum P,BAP and iPTH were decreased(P<0.05,P<0.01)after 8 weeks of treatment.Furthermore,serum Ca still was increased(P<0.01),and serum P,BAP and iPTH were decreased(P<0.01)in EG after 12 weeks of treatment.Serum Ca of CG was increased(P<0.05),serum P,BAP and iPTH were decreased(P<0.05)after 12 weeks of treatment.Conclusion PYXZF can effectively improve CKD-MBD bone pain in CKD 5 D patients.The mechanism may be related to the regulation of abnormal mineral and bone metabolism and the improvement of excessive bone turnover caused by secondary hyperparathyroidism.