Clinical Study of the Supplemented Shenling Baizhu Powder on Patients of Spleen Deficiency and Turbidity Obstruction treated with Continuous Ambulatory Peritoneal Dialysis Combined with Suffering from Protein-energy Wasting
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摘要:
目的 观察加味参苓白术散治疗脾虚瘀浊型持续性不卧床腹膜透析(Continuous ambulatory peritoneal dialysis，CAPD)合并蛋白质-能量消耗(Protein-energy wasting，PEW)的临床疗效及对机体微炎症状态的影响。 方法 91例脾虚瘀浊型CAPD合并PEW患者随机分为治疗组45例、对照组46例，每组各脱落3例。对照组应用CAPD、口服复方α-酮酸及常规对症治疗，治疗组在对照组治疗基础上予加味参苓白术散口服，疗程均为12周。治疗前后观察2组患者中医证候积分和营养不良-炎症(Malnutrition-inflammation score, MIS)、总尿素清除指数(Kt/V)评分的变化，检测2组患者治疗前后外周血营养相关指标[血红蛋白(Hemoglobin, HGB)、血清白蛋白(Albumin, ALB)、转铁蛋白(Transferrin, TRF)、前白蛋白(Prealbumin, PA)]及血清微炎症指标[白介素6(Interleukin-6, IL-6)、超敏C反应蛋白(Hypersensitive c-reactive protein, hs-CRP)、肿瘤坏死因子α(Tumor necrosis factor α, TNF-α)和白介素10(Interleukin-10, IL-10)]水平变化情况。 结果 治疗后，治疗组中医证候积分明显下降(P < 0.01)，优于对照组(P < 0.01)，治疗组中医临床疗效总有效率显著优于对照组(P < 0.05)；治疗组MIS显著降低、Kt/V明显增加(P < 0.01)，优于对照组(P < 0.05，P < 0.01)；治疗组ALB、PA、TRF及HGB含量均显著增加(P < 0.01)，对照组ALB、PA含量明显增加(P < 0.01)，治疗组优于对照组(P < 0.05，P < 0.01)；2组患者血清hs-CRP、IL-6、TNF-α水平均明显降低(P < 0.01)，IL-10水平均升高(P < 0.05，P < 0.01)，治疗组优于对照组(P < 0.05，P < 0.01)。 结论 加味参苓白术散能够显著改善脾虚瘀浊型CAPD合并PEW患者的中医证候，改善患者PEW，缓解机体微炎症状态，提高腹膜透析充分性。 Abstract:OBJECTIVE To observe the clinical efficacy of the supplemented Shenling Baizhu Powder on the microinflammatory state in patients of spleen deficiency and turbidity obstruction treated with continuous ambulatory peritoneal dialysis (CAPD) combined with suffering from protein-energy wasting (PEW). METHODS A total of 91 patients of spleen deficiency and turbidity obstruction treated with CAPD combined with suffering from PEW were randomly divided into 45 cases in the treatment group and 46 cases in the control group, with shedding three cases in each group. The control group's treatments include CAPD, orally taken compound alpha ketoacid, and other conventional therapies. However, the treatment group was administrated with the supplemented Shenling Baizhu powder by orally taken on the basis of the treatments in the control group. The course of treatment was 12 weeks in both groups. Before and after treatment, we observed the changes in the traditional Chinese medicine (TCM) syndrome score, malnutrition-inflammation score (MIS) and overall urea clearance index scores (Kt/V) of the two groups of patients. In addition, we measured the patients' peripheral blood nutrition-related indexes [hemoglobin (HGB), albumin (ALB), transferrin (TRF), prealbumin (PA)], as well as the levels of microinflammatory indexes [interleukin-6 (IL-6), hypersensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α) and interleukin-10 (IL-10)]. RESULTS After treatment, the TCM syndrome score in the treatment group was reduced significantly (P < 0.01), whose result was better than that in the control group (P < 0.01). In addition, the total clinical efficacy of TCM in the treatment group was remarkably better than that in the control group (P < 0.05). The MIS in the treatment group was reduced significantly but with significantly increased Kt/V (P < 0.01), whose results were also better than those in the control group (P < 0.05, P < 0.01). At the same time, ALB, PA, TRF and HGB levels were significantly increased in the treatment group (P < 0.01), while only ALB and PA levels were significantly increased in the control group (P < 0.01). Thus, the results in the treatment group were better than those in the control group (P < 0.05, P < 0.01). On top of that, serum hs-CRP, IL-6 and TNF-α levels were significantly reduced in both groups (P < 0.01), and IL-10 levels were increased in two groups (P < 0.05, P < 0.01). In conclusion, the results in the treatment group were superior to those in the control group (P < 0.05, P < 0.01). CONCLUSION The supplemented Shenling Baizhu powder can notably alleviate the TCM syndromes in patients of spleen deficiency and turbidity obstruction treated with CAPD combined with suffering from PEW. In addition, it can relieve their PEW, alleviate the microinflammatory state, and strengthen the adequacy of peritoneal dialysis. -
表 1 2组患者治疗前后中医证候积分比较(x±s)
Table 1. Comparison of TCM symptom scores before and after treatment between the 2 groups (x±s)
组别 时间 恶心呕吐 食少纳差 肢体困重 脘腹胀满 疲倦乏力 面色晦暗 气短懒言 总积分 治疗组 治疗前 2.25±0.76 2.46±0.71 2.19±0.67 2.32±0.75 2.35±0.62 1.98±0.63 2.46±0.74 16.98±5.23 (n=42) 治疗后 1.18±0.42**## 1.35±0.46**## 1.15±0.42**## 1.25±0.52**## 1.18±0.42**## 1.26±0.35**## 1.23±0.48**## 8.62±4.11**## 对照组 治疗前 2.15±0.63 2.48±0.67 2.27±0.62 2.36±0.71 2.32±0.59 2.15±0.68 2.52±0.68 17.25±5.48 (n=43) 治疗后 1.97±0.52 2.11±0.51** 1.85±0.54** 2.18±0.63 2.19±0.52 1.93±0.60 2.07±0.61** 14.35±5.12* 注: 组内比较, *P < 0.05，* *P < 0.01;组间比较, ##P < 0.01。 
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表 2 2组患者中医临床疗效比较
Table 2. Comparison of TCM clinical curative effect between the 2 groups
组别 例数 显效 有效 无效 总有效率/% 治疗组 42 12 22 8 80.95# 对照组 43 7 17 19 55.81 注: 组间比较, #P < 0.05。
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表 3 2组患者治疗前后MIS评分、Kt/V值比较(x±s)
Table 3. Comparison of MIS and Kt/V scores before and after treatment between the 2 groups (x±s)
组别 时间 例数 MIS Kt/V 治疗组 治疗前 42 23.25±5.32 1.25±0.46 治疗后 42 15.58±4.46**## 1.52±0.42**# 对照组 治疗前 43 22.78±4.61 1.29±0.38 治疗后 43 19.83±5.72* 1.33±0.35 注: 组内比较, *P < 0.05，* *P < 0.01;组间比较, #P < 0.05, ##P < 0.01。
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表 4 2组患者治疗前后血清ALB、PA、TRF及HGB比较(x±s)
Table 4. Comparison of ALB, PA, TRF and HGB before and after treatment between the 2 groups (x±s)
组别 时间 例数 ALB/(g·L-1) PA/(mg·L-1) TRF/(g·L-1) HGB/(g·L-1) 治疗组 治疗前 42 26.35±4.28 186.36±38.45 1.49±0.32 95.32±13.28 治疗后 42 33.19±5.85**# 242.80±40.37**## 1.81±0.35**# 108.95±15.65**# 对照组 治疗前 43 27.31±4.57 179.66±43.65 1.52±0.29 97.86±14.56 治疗后 43 30.36±5.31** 212.37±45.18** 1.60±0.33 101.68±14.88 注: 组内比较, * *P < 0.01;组间比较, #P < 0.05, ##P < 0.01。
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表 5 2组患者治疗前后血清hs-CRP、IL-6、IL-10及TNF-α比较(x±s)
Table 5. Comparison of hs-CRP、IL-6、IL-10 and TNF-α before and after treatment between the 2 groups (x±s)
组别 时间 例数 hs-CRP/(mg·L-1) IL-6/(ng·L-1) IL-10/(ng·mL-1) TNF-α/(ng·L-1) 治疗组 治疗前 42 7.25±2.35 45.89±13.24 68.29±31.28 50.16±11.26 治疗后 42 4.82±1.86**## 29.18±10.25**## 102.25±35.24**# 33.65±10.64**## 对照组 治疗前 43 7.48±2.18 46.38±11.58 65.43±29.39 52.62±12.68 治疗后 43 6.18±2.12** 37.43±9.98** 82.63±33.87* 42.58±11.92** 注: 组内比较, *P < 0.05, * *P < 0.01;组间比较, #P < 0.05, ##P < 0.01。
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