Effect and Mechanism of Action of Shenshuaining Tablet to Prognosis of Patients at CKD3-4 Period

WANG Xiao-liang; SUN Yu-man; CHEN Lin

doi:10.13422/j.cnki.syfjx.2017030159

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Effect and Mechanism of Action of Shenshuaining Tablet to Prognosis of Patients at CKD3-4 Period

更新时间：2024-01-04

- Effect and Mechanism of Action of Shenshuaining Tablet to Prognosis of Patients at CKD3-4 Period
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 23, Issue 3, Pages: 159-164(2017)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2017030159
  CLC： R277.5
- Published：2017
- 稿件说明：
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WANG Xiao-liang, SUN Yu-man, CHEN Lin. Effect and Mechanism of Action of Shenshuaining Tablet to Prognosis of Patients at CKD3-4 Period[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(3): 159-164.
DOI：

WANG Xiao-liang, SUN Yu-man, CHEN Lin. Effect and Mechanism of Action of Shenshuaining Tablet to Prognosis of Patients at CKD3-4 Period[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(3): 159-164. DOI： 10.13422/j.cnki.syfjx.2017030159.

摘要

目的：观察肾衰宁片对CKD3-4期患者转归的影响及对转化生长因子-β1（TGF-β1），白细胞介素-6（IL-6），肿瘤坏死因子-α（TNF-α），超氧化物歧化酶（SOD）和谷胱甘肽过氧化物酶（GSH-Px）的影响。方法：132例慢性肾脏病（CKD）3~4期患者随机分为观察组（67例）和对照组（65例），对照组采用西医综合处理措施，包括控制血脂、血压、血糖，纠正贫血及钙磷代谢紊乱等，并给予复方α酮酸片，6~8片/次，用餐期间整片吞服，3次/d；氯沙坦钾片，100 mg/次，1次/d，口服。观察组在对照组的基础上加服肾衰宁片，6片/次，3次/d。连续治疗12个月或至CKD5期需要透析治疗。记录CKD3期转为CKD4期，CKD4转为CKD5期情况；进行治疗前后中医证候评分和生活质量评分；于治疗前和治疗6，12个月检测尿素氮（BUN），血肌酐（SCr），血红蛋白（Hb），血浆白蛋白（Alb），24 h尿蛋白定量（24 h Upr），eGFR，TGF-β1，IL-6，TNF-α，SOD和GSH-Px。结果：观察组中医证候疗效总有效率为88.06%，高于对照组的70.77%（P<0.05）；观察组疾病疗效总有效率为85.07%，高于对照组的67.69%（P<0.05）；观察组终点事件发生率低于对照组（P<0.05）；治疗后观察组SF-36量表各维度评分均升高（P<0.01），并高于同期对照组（P<0.05）；治疗后6个月，观察组Alb，Hb和eGFR均高于对照组，SCr低于同期对照组（P<0.05）；治疗后12个月，观察组Alb，Hb和eGFR高于同期对照组水平（P<0.01），BUN和SCr低于同期对照组水平（P<0.05，P<0.01）；两组上述指标治疗后6，12个月与治疗前差值比较，组间差异显著（P<0.01）；治疗后6，12个月，观察组TNF-α，IL-6，TGF-β1均低于对照组，SOD和GSH-Px高于对照组（P<0.05，P<0.01）。结论：在西医常规综合治疗的基础上，采用肾衰宁片长期干预CKD3-4期患者，能起到延缓CKD病程的作用，能提高患者的临床疗效和生活质量，其作用机制可能与其减轻炎症反应，提高机体的抗氧化能力有关。

Abstract

Objective: To observe the effect of Shenshuaining tablet on patients' prognosis during chronic kidney disease (CKD) at CKD3-4 stage and levels of transforming growth factor-β1 (TGF-β1)

interleukin-6 (IL-6)

tumor necrosis factor-α (TNF-α)

superoxide dismutase (SOD) and glutathion peroxidase (GSH-Px). Method: Totally 132 patients at CKD3-4 stage were randomly divided into observation group (67 cases) and control group (65 cases) by random number table. Patients in control group got comprehensive western medicine therapy

including controlling blood lipid

blood pressure and blood glucose

correctting anemia and calcium-phosphorus metabolism disorder

and were provided with compound keto acid tablets during the meal

6-8 tablets/time

3 times/day

and losartan potassium tablets

100 mg/time

1 time/day. In addition to the therapy of control group

patients in observation group were also given Shenshuaining tablet

6 tablets/time

3 times/day. Courses of treatment were 12 months

or until the next dialysis treatment at CKD5 period. Patients' conditions from CKD3 to CKD4 and from CKD4 to CKD5 were recorded. Before and after treatment

scores of traditional Chinese medicine(TCM) syndrome and quality of live were recorded. And levels of blood urea nitrogen (BUN)

serum creatinine (SCr)

hemoglobin (Hb)

plasma albumin (Alb)

24 hours' urine protein quantitation (Upr)

eGFR

TGF-β1

IL-6

TNF-α

SOD and GSH-Px were detected before treatment and at the 6th and 12th month after treatment. Result: The total effect rate of TCM symptoms in observation group was 88.06%

which was higher than 70.77% in control group (P<0.05). The total effect rate of disease in observation group was 85.07%

which was higher than 67.69% in control group (P<0.05). And incidence rate of outcome event in observation group was 29.85%

which was lower than 49.23% in control group (P<0.05). After treatment

scores of SF-36 scale in observation group increased (P<0.01)

which was higher than that in control group (P<0.01) in the same period. At the 6th month after treatment

levels of Alb

Hb and eGFR in observation group were higher than those in control group

and level of SCr was lower than that in control group (P<0.05). At the 12th month after treatment

levels of Alb

Hb and eGFR were higher than those in control group (P<0.01)

and BUN and SCr were lower than those in control group (P<0.05 or P<0.01). Compared with the data before treatment

there were statistical significant differences between two groups at the 6th and 12th months after treatment (P<0.01)

and levels of TNF-α

IL-6 and TGF-β1 were higher than those in control group

and levels of SOD and GSH-Px were higher than those in control group (P<0.05 or P<0.01). Conclusion: In addition to the routine western medicine therapy

Shenshuaining tablet can delay course of disease of patients at CKD3-4

and improve clinical effect and quality of live. Its mechanism of action may be correlated with relief in inflammatory response and improvement of antioxidant capacity.

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