百令胶囊联合硫代硫酸钠治疗慢性肾脏病维持性血液透析患者临床研究

Clinical Study of Bailing Capsules Combined with Sodium Thiosulfate for Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis

目的:观察百令胶囊联合硫代硫酸钠对慢性肾脏病(CKD)维持性血液透析患者心血管钙化及钙磷代谢的影响。方法:选取84例接受维持性血液透析的CKD患者,按随机数字表法分为观察组和对照组各42例。对照组给予硫代硫酸钠治疗,观察组在对照组基础上予以百令胶囊治疗。比较2组治疗前后肾脏病生活质量评分(KDQOL-SF)、血钙(S-Ca)、血磷(S-P)、血钙磷乘积(Ca×P)、血清全段甲状旁腺激素(iPTH)、冠状动脉钙化积分(ACS)、心脏瓣膜钙化率、营养指标水平,并比较2组不良反应。结果:治疗后,观察组KDQOL-SF评分升高(P<0.05),且高于对照组(P<0.05);对照组KDQOL-SF评分与治疗前比较,差异无统计学意义(P>0.05)。治疗后,对照组S-P、Ca×P水平及观察组S-Ca、S-P、Ca×P、iPTH水平均降低(P<0.05),且观察组S-Ca、S-P、Ca×P、iPTH水平均低于对照组(P<0.05)。治疗后对照组S-Ca、iPTH水平与治疗前比较,差异无统计学意义(P>0.05)。治疗后,2组ACS降低(P<0.05),对照组心脏瓣膜钙化率升高(P<0.05),且观察组ACS、心脏瓣膜钙化率低于对照组(P<0.05)。对照组治疗后心脏瓣膜钙化率与治疗前比较,差异无统计学意义(P>0.05)。治疗后2组尿肌酐水平降低(P<0.05),观察组血清白蛋白水平升高(P<0.05),且观察组尿肌酐水平低于对照组(P<0.05),血清白蛋白水平高于对照组(P<0.05);对照组治疗后血清白蛋白水平与治疗前比较,差异无统计学意义(P>0.05)。2组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:百令胶囊联合硫代硫酸钠治疗CKD维持性血液透析疗效好,可改善患者生活质量,降低Ca×P和iPTH水平,减轻患者心血管钙化。

Objective:To observe the effect of the therapy of Bailing Capsules combined with Sodium Thiosulfate on the cardiovascular calcification and calcium phosphorus metabolism of chronic kidney disease(CKD) patients on maintenance hemodialysis.Methods:A total of 84 patients with CKD receiving maintenance hemodialysis were selected and divided into the observation group and the control group according to the random number table method,with 42 cases in each group.The control group was treated with Sodium Thiosulfate,and the observation group was additionally given Bailing Capsules based on the treatment of the control group.Before and after treatment,the scores of Kidney Disease Quality of Life Short Form(KDQOL-SF),and levels of serum calcium(S-Ca),serum phosphorus(S-P),product of serum calcium and phosphorus(Ca × P),intact parathyroid hormone(iPTH),coronary artery calcification score(ACS),incidence of calcified heart valves,nutrition indexes and incidence of adverse reactions were compared between the two groups.Results:After treatment,the KDQOL-SF score in the observation group was increased(P<0.05) and higher than that in the control group(P<0.05).There was no significant difference being found in the comparison of KDQOL-SF score in the control group with that before treatment(P>0.05).After treatment,the levels of S-P and Ca×P in the control groups and the levels of S-Ca,S-P,Ca×P and iPTH in the observation group were decreased(P<0.05),and the levels of S-Ca,S-P,Ca×P and iPTH in the observation group were lower than those in the control group(P<0.05).After treatment,there was no significant difference being found in the comparisons of levels of S-Ca and iPTH in the control group with those before treatment(P>0.05).After treatment,the ACS in the two groups were decreased(P<0.05),and incidence of calcified heart valves in the control group were increased(P<0.05),and the ACS and incidence of calcified heart valves in the observation group were lower than those in the control group(P<0.05).After treatment,there was no significant difference being found in the comparison of incidence of calcified heart valves in the control group with that before treatment(P>0.05).After treatment the levels of urine creatinine in both groups were decreased(P<0.05),and the level of serum albumin in the observation group was increased(P<0.05);the level of urine creatinine in the observation group was lower than that in the control group(P<0.05),and the level of serum albumin was higher than that in the control group(P<0.05).After treatment,there was no significant difference being found in the comparison of level of serum albumin in the control group with that before treatment(P<0.05).There was no significant difference being found in the comparison of incidence of adverse reactions between the two groups(P>0.05).Conclusion:The therapy of Bailing Capsules combined with Sodium Thiosulfate has a good curative effect on patients with CKD receiving maintenance hemodialysis,which can improve the quality of life of patients,reduce the levels of Ca×P and iPTH and mitigate the cardiovascular calcification.