补肾活血清热方联合西医一体化方案治疗肾虚血瘀兼湿热证慢性肾脏病4 期临床研究
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R692.5

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湖州市公益性应用研究项目(2022GY48)


Clinical Study on Bushen Huoxue Qingre Prescription Combined with Integrated Western Medicine Therapy for Phase 4 Chronic Kidney Disease with Kidney Deficiency and Blood Stasis Complicated with Damp-Heat Syndrome
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    目的:观察补肾活血清热方联合西医一体化方案治疗肾虚血瘀兼湿热证慢性肾脏病(CKD) 4期 的临床效果。方法:纳入安吉县中医医院2023年1月—2024年7月收治的CKD 4期患者共102例,按随机数字 表法分为对照组与观察组各51例。试验期间2组均剔除2例,最终完成研究各49例。对照组给予常规西医一体 化方案治疗,观察组在常规西药基础上给予补肾活血清热方治疗。治疗1个月后评估2组临床疗效、中医证候 评分、肾功能指标[血肌酐(SCr)、尿素氮(BUN)、肾小球滤过率(eGFR)]、血钾、血红蛋白(Hb)、尿蛋 白指标[24 h尿蛋白定量(24 h UTP)、尿α1-微球蛋白(Uα1-MG)、β2-微球蛋白(Uβ2-MG)] 水平及不良反 应发生率。结果:治疗后,观察组总有效率为89.80%(44/49),高于对照组73.47%(36/49),组间差异有统计 学意义(P<0.05)。治疗后,2组主症、次症证候评分及总分均较治疗前降低(P<0.05),且观察组各项评分 均低于对照组(P<0.05)。治疗后,2组血清BUN、SCr水平均较治疗前降低(P<0.05),eGFR水平较治疗前升 高(P<0.05);且观察组BUN、SCr水平均低于对照组(P<0.05),eGFR水平高于对照组(P<0.05)。治疗 后,2 组Hb 水平均较治疗前升高,且观察组高于对照组,差异均有统计学意义(P<0.05)。治疗后,2 组 24 h UTP、Uα1-MG、Uβ2-MG水平均较治疗前降低(P<0.05),且观察组3项指标水平均低于对照组(P< 0.05)。2组血钾水平治疗前后比较,差异无统计学意义(P>0.05)。治疗期间,对照组不良反应发生率(20.40%, 10/49) 高于观察组(6.12%,3/49),组间比较,差异有统计学意义(P<0.05)。结论:补肾活血清热方联合常 规西医一体化方案治疗肾虚血瘀兼湿热证CKD 4期患者疗效显著,可有效轻减中医证候,改善肾功能及贫血, 降低尿蛋白水平,并能降低不良反应发生率。

    Abstract:

    Abstract:Objective:To observe the clinical effect of the combination of Bushen Huoxue Qingre Prescription and integrated western medicine therapy on phase 4 chronic kidney disease(CKD)with kidney deficiency and blood stasis complicated with damp-heat syndrome. Methods:A total of 102 patients with phase 4 CKD admitted to Anji County Hospital of Chinese Medicine from January 2023 to July 2024 were included and divided into the control group and the observation group according to the random number table method,with 51 cases in each group. During the trial,2 cases were excluded from both groups,and finally 49 cases in each group were included in the analysis. The control group was treated with conventional integrated western medicine therapy,and the observation group was additionally treated with Bushen Huoxue Qingre Prescription in addition to the conventional western medicine. After one month of treatment,the clinical efficacy, traditional Chinese medicine syndrome scores, kidney function indexes [serum creatinine(SCr), blood urea nitrogen(BUN)and estimated glomerular filtration rate(eGFR)],serum potassium,hemoglobin(Hb),urine protein indexes [24-hour urine total protein (24 hUTP), urinary α1-microglobulin (Uα1-MG) and urinary β2- microglobulin(Uβ2 -MG)] and the incidence of adverse reactions were evaluated in the two groups. Results: After treatment,the total effective rate was 89.80%(44/49)in the observation group,higher than that of 73.47%(36/49)in the control group,and the difference between the two groups being significant(P<0.05). After treatment,the scores of main symptoms and secondary symptoms and the total scores in the two groups were decreased when compared with those before treatment(P < 0.05), and each score in the observation group was lower than that in the control group(P < 0.05). After treatment, the levels of serum BUN and SCr in the two groups were down-regulated when compared with those before treatment(P<0.05), and the levels of eGFR were increased when compared with those before treatment(P<0.05);the levels of BUN and SCr in the observation group were lower than those in the control group(P<0.05),and the level of eGFR in the observation group was higher than that in the control group(P<0.05). After treatment,the levels of Hb in the two groups were up-regulated when compared with those before treatment,and the level of Hb in the observation group was higher than that in the control group, differences being significant(P< 0.05). After treatment,the levels of 24 hUTP,Uα1-MG and Uβ2-MG in the two groups were reduced when compared with those before treatment(P<0.05),and the above three levels in the observation group were lower than those in the control group(P<0.05). There was no significant difference being found in the comparison of level of serum potassium between the two groups before and after treatment(P>0.05). During the treatment,the incidence of adverse reactions in the control group was 20.40%(10/49),higher than that of 6.12%(3/49)in the observation group,the difference being significant(P<0.05). Conclusion: The combination of Bushen Huoxue Qingre Prescription and conventional integrated western medicine therapy has a significant curative effect on patients with phase 4 CKD with kidney deficiency and blood stasis complicated with damp-heat syndrome, this combined therapy can effectively reduce the traditional Chinese medicine syndromes of patients,improve the kidney function and anemia,and reduce the level of urine protein and the incidence of adverse reactions.

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王悦,陈建军,陈小平,季景,邱建.补肾活血清热方联合西医一体化方案治疗肾虚血瘀兼湿热证慢性肾脏病4 期临床研究[J].新中医,2025,57(20):70-76

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  • 在线发布日期: 2025-10-31
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