Effect of Yishen Shuli Formula on Microinflammatory State in Patients of 3rd-4th Stage Chronic kidney Disease with Syndromes of Spleen-Kidney Deficiency Combined with Internal Stasis and Turbidity Obstruction
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摘要:
目的 观察益肾疏利方对脾肾亏虚、瘀浊内阻型慢性肾脏病(Chronic kidney disease, CKD)3-4期患者的疗效及微炎症状态的影响。 方法 收集脾肾亏虚、瘀浊内阻型CKD 3-4期患者61例, 随机分为治疗组31例, 对照组30例(脱落1例); 对照组给予西医基础治疗, 治疗组在对照组治疗基础上加用益肾疏利方, 连续干预24周。治疗前后观察2组患者中医证候积分, 检测肾功能指标[血肌酐(Serum creatinine, Scr)、尿素氮(Blood urea nitrogen, BUN)、肾小球滤过率(Estimated glomerular filtration rate, eGFR)]及微炎症指标[超敏C反应蛋白(Hypersensitive C-reactive protein, hs-CRP)、白介素-6(Interleukin-6, IL-6)、肿瘤坏死因子α(Tumor necrosis factor-α, TNF-α)]水平变化情况。 结果 治疗后, 2组患者中医证候总积分均有改善(P < 0.01), 治疗组优于对照组(P < 0.05);治疗组中医证候及临床综合疗效优于对照组(P < 0.05,P < 0.01);2组肾功能指标均显著改善(P < 0.01), 治疗组优于对照组(P < 0.05);2组患者血清微炎症指标均显著降低(P < 0.01), 治疗组低于对照组(P < 0.05, P < 0.01)。 结论 益肾疏利方联合西医常规治疗能改善CKD 3-4期脾肾亏虚、瘀浊内阻证患者中医证候,提高临床总疗效, 其疗效机制可能与调节患者微炎症状态有关。 -
关键词:
- 慢性肾脏病 /
- 益肾疏利方 /
- 脾肾亏虚、瘀浊内阻证 /
- 微炎症状态
Abstract:OBJECTIVE To observe the effect of Yishen Shuli Formula on microinflammatory state in patients of 3rd-4th stage chronic kidney disease (CKD) with syndromes of spleen-kidney deficiency and internal stasis and turbidity obstruction. METHODS A total of 61 3rd-4th stage CKD patients with syndromes of spleen-kidney deficiency and internal stasis and turbidity obstruction were randomly divided into 31 cases in the treatment group and 30 cases in the control group (with 1 case dropped out). The control group was given basic western medicine treatment, while the treatment group was treated with Yishen Shuli Formula on top of the therapies in the control group. The intervention course lasted for 24 weeks. Before and after treatment, to both groups, we observed the traditional Chinese medicine (TCM) syndrome scores, and measured the renal function indexes [Serum creatinine (Scr), blood urea nitrogen (BUN), Estimated glomerular filtration rate (eGFR)], microinflammation indexes [Changes in the levels of hypersensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), as well as tumor necrosis factor-α (TNF-α). RESULTS After treatment, the total TCM syndrome scores showed improved tendency in both groups (P < 0.01), but the results in the treatment group were better than those in the control group (P < 0.05). in addition, the TCM syndromes and clinical comprehensive efficacy of the treatment group were better than those of the control group (P < 0.05, P < 0.01). The renal function indexes of both groups showed significantly improved tendency (P < 0.01), while the results in the treatment group were better than those in the control group (P < 0.05). Besides, the serum microinflammation indexes of both groups were decreased significantly (P < 0.01), but the results in the treatment group were lower than those in the control group (P < 0.05, P < 0.01). CONCLUSION The combination of Yishen Shuli Formula with conventional western medicine treatment can relieve the TCM syndromes and improve overall clinical efficacy in 3rd-4th stage CKD patients with syndromes of spleen-kidney deficiency and internal stasis and turbidity obstruction, and its efficacy mechanism may be related to the amelioration of patients' microinflammatory state. -
表 1 2组患者性别、年龄、CKD分期比较(x±s)
Table 1. Comparison of gender, age and CKD stage between 2 groups (x±s)
组别 例数 男 女 年龄/岁 CKD 3期 CKD 4期 对照组 29 20 9 60.86±13.32 18 11 治疗组 31 16 15 60.90±11.42 12 19 表 2 2组患者原发病分布情况比较
Table 2. Comparison of primary disease distribution between 2 groups
组别 例数 慢性肾小球肾炎 糖尿病肾病 高血压肾病 IgA肾病 高尿酸血症肾病 狼疮性肾炎 多囊肾 病因不明 对照组 29 5 6 9 2 2 1 2 2 治疗组 31 5 8 11 1 5 0 0 1 表 3 2组患者治疗前后中医证候积分比较(x±s)
Table 3. Comparison of symptom scores of TCM between 2 groups before and after treatment (x±s)
组别 时间 面色晦暗 倦怠乏力 腰膝酸软 食少纳呆 夜尿清长 肌肤甲错 肢体麻木 脘腹胀满 总积分 对照组 治疗前 0.97±0.32 3.93±0.19 3.45±0.20 2.83±0.29 2.90±0.25 0.97±0.29 1.52±0.31 0.76±0.23 17.31±3.26 n=29 治疗后 0.62±0.25* 2.07±0.12** 2.14±0.20** 1.45±0.26** 2.55±0.22* 0.83±0.23 0.83±0.23* 0.34±0.17* 10.83±3.32** 治疗组 治疗前 1.16±0.30 3.94±0.20 3.48±0.23 3.03±0.29 2.77±0.24 0.71±0.20 1.10±0.24 1.41±0.28 17.61±3.56 n=31 治疗后 0.45±0.15** 2.06±0.20** 1.81±0.14** 1.42±0.19** 1.87±0.23*# 0.45±0.15*## 0.52±0.16* 0.32±0.16*# 8.90±2.06**# 注: 组内比较, *P < 0.05, * *P < 0.01;组间比较, #P < 0.05, ##P < 0.01。 表 4 2组患者治疗后中医证候疗效比较
Table 4. Comparison of the efficacy of TCM symptoms between 2 groups before and after treatment
组别 例数 显效 有效 无效 总有效率/% 对照组 29 1 16 12 58.62 治疗组 31 3 25 3 90.32** 注: 组间比较, χ2=8.031, * *P < 0.01。 表 5 2组患者治疗前后肾功能指标比较(x±s)
Table 5. Comparison of renal function indexes between 2 groups before and after treatment (x±s)
组别 时间 例数 BUN/(mmol·L-1) Scr/(μmmol·L-1) eGFR/(mL·min-1·1.73 m-2) 治疗组 治疗前 31 15.50±4.88 194.14±63.84 31.62±12.22 治疗后 31 10.06±3.34**# 139.69±49.33**# 48.00±20.31**# 对照组 治疗前 29 13.41±3.49 190.59±71.06 34.23±10.51 治疗后 29 11.97±3.83** 180.02±68.90** 36.85±11.69** 注: 组内比较, * *P < 0.01;组间比较, #P < 0.05。 表 6 2组患者临床综合疗效比较
Table 6. Comparison of clinical comprehensive efficacy between 2 groups
组别 例数 显效 有效 稳定 无效 总有效率/% 对照组 29 1 9 13 6 79.31 治疗组 31 19 9 2 1 96.77* 注: 组间比较, χ2=4.434, *P < 0.05。 表 7 2组患者治疗前后微炎症指标比较(x±s)
Table 7. Comparison of micro-inflammation indexes between 2 groups before and after treatment (x±s)
组别 时间 例数 hs-CRP/(mg·L-1) IL-6/(pg·mL-1) TNF-α/(pg·mL-1) 治疗组 治疗前 31 6.67±1.58 43.05±6.73 43.73±11.13 治疗后 31 4.31±1.42**## 33.47±5.10**## 33.31±5.69**# 对照组 治疗前 29 6.57±1.67 44.15±6.12 42.30±10.31 治疗后 29 5.71±1.36** 39.83±5.51** 37.26±6.06** 注: 组内比较, * *P < 0.01;组间比较, #P < 0.05, ##P < 0.01。 -
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