耳穴压丸联合生脉胶囊改善血液透析患者瘙痒程度的临床研究

Clinical study of ear pills combined with Shengmai Capsules in treating pruritus of hemodialysis patients

目的观察耳穴压丸联合生脉胶囊改善血液透析患者瘙痒程度的临床疗效。方法将118例规律血液透析3个月以上且伴有瘙痒症状的患者随机分为A组、B组,进行两阶段交叉临床试验,每个阶段治疗时间为8周。第一阶段A组为治疗组、B组为对照组;第二阶段B组为治疗组、A组为对照组。第一阶段的治疗完成后,经过4周的洗脱期,2组交叉接受下一阶段的治疗。治疗组在规律血液透析基础上给予耳穴压丸及口服生脉胶囊治疗,对照组仅进行常规血液透析治疗。观察尿素清除指数(KT/V)、尿素清除率(URR)、瘙痒程度评分、透析前Ca2+浓度、透析前P3+浓度。结果 KT/V和URR 2组治疗后与本组治疗前比较差异均无统计学意义(P>0.05),治疗组治疗前后差值与对照组比较差异均无统计学意义(P>0.05),说明2组在整个治疗过程中透析充分性方面无差异。瘙痒程度评分治疗组治疗后较本组治疗前降低(P<0.05)。对照组治疗后与本组治疗前比较差异无统计学意义(P>0.05)。治疗后治疗组较对照组降低明显(P<0.05)。透析前Ca2+浓度2组治疗后较本组治疗前均降低(P<0.05),治疗组治疗前后差值与对照组比较差异无统计学意义(P>0.05)。透析前P3+浓度治疗组治疗后较本组治疗前降低(P<0.05),对照组治疗后与本组治疗前比较差异无统计学意义(P>0.05),治疗组治疗前后差值与对照组比较差异无统计学意义(P>0.05),说明干预治疗后瘙痒程度的改善不是通过控制Ca2+,P3+浓度改变来实现的。结论耳穴压丸联合生脉胶囊对于改善血液透析患者的瘙痒症状具有较好的疗效。

Objective To observe the clinical therapeutic effect of ear pills combined with Shengmai Capsules on hemodialysis patients with pruritus. Methods 118 pruritus patients who got regularly dialysis for more than three months were involved in this study. The patients were randomly divided into group A and group B,and they were given 2-stage clinical crossover tests. At the first stage,group A was treatment group and group B was control group,and at the second stage,they were in reverse. Every stage lasted 8 weeks. After the first phase of treatment completed and 4 weeks elution period,two groups were crossed and started the next stage of treatment. The treatment group was given ear pills combined with Shengmai capsules on the basis of regular hemodialysis. The control group was given only regular hemodialysis. KT/V,URR,the changes of pruritus score,and calcium,phosphorusion concentration before and after the treatment were observed. Results After treatment,KT/V and URR of two groups showed no statistical difference（P 0. 05）. Compared with control group,the differentials before and after treatment showed no statistically significant（P 0. 05）,which indicated no difference about dialysis adequacy effect. After treatment,the pruritus scores in treatment group decreased significantly（P 0. 05）. And in control group,there was no statistically significant after treatment（P 0. 05）,and the treatment group decreased significantly（P 0. 05）. The calcium ion concentration before dialysis of two groups decreased significantly（P 0. 05）,compared with control group,the differentials before and after treatment in treatment group had no statistically difference（P 0. 05）. Before dialysis,the phosphate ion concentration of treatment group decreased significantly after treatment（P 0. 05）. In control group,no statistical differences showed after treatment（P 0. 05）. Compared with control group,the differentials before and after treatment in treatment group had no statistically difference（P 0. 05）,which indicated the improvement of pruritus degree was not achieved by controlling the concentration of calcium and phosphate ion.Conclusion Ear pills combined with Shengmai capsules can improve the symptoms of hemodialysis patients with pruritus.