[1]袁小强,张献朝,赵丽萍.大剂量环磷酰胺冲击疗法联合右归丸治疗激素耐药型脾肾阳虚证原发性肾病综合征疗效观察[J].新乡医学院学报,2022,39(6):566-572.[doi:10.7683/xxyxyxb.2022.06.014]
　YUAN Xiaoqiang,ZHANG Xianchao,ZHAO Liping.Efficacy of high-dose cyclophosphamide pulse therapy combined with Yougui Pill in the treatment of hormone-resistant primary nephrotic syndrome patients with spleen and kidney yang deficiency syndrome[J].Journal of Xinxiang Medical University,2022,39(6):566-572.[doi:10.7683/xxyxyxb.2022.06.014]
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大剂量环磷酰胺冲击疗法联合右归丸治疗激素耐药型脾肾阳虚证原发性肾病综合征疗效观察
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《新乡医学院学报》[ISSN:1004-7239/CN:41-1186/R]

卷:
39
期数:
2022年6
页码:
566-572
栏目:
临床研究
出版日期:
2022-06-05

文章信息/Info

Title:
Efficacy of high-dose cyclophosphamide pulse therapy combined with Yougui Pill in the treatment of hormone-resistant primary nephrotic syndrome patients with spleen and kidney yang deficiency syndrome
作者:
袁小强; 张献朝; 赵丽萍
（平顶山市第一人民医院肾脏病风湿免疫科，河南　平顶山　467099）
Author(s):
YUAN Xiaoqiang; ZHANG Xianchao; ZHAO Liping
（Department of Nephrology,Rheumatology and Immunology,the First People′s Hospital of Pingdingshan,Pingdingshan 467099,Henan Province,China）
关键词:
环磷酰胺; 右归丸; 激素耐药型; 脾肾阳虚证; 原发性肾病综合征
Keywords:
cyclophosphamide; Yougui Pill; hormone-resistant; spleen and kidney yang deficiency syndrome; primary nephrotic syndrome
分类号:
R692
DOI:
10.7683/xxyxyxb.2022.06.014
文献标志码:
A
摘要:
目的　探讨大剂量环磷酰胺冲击疗法联合右归丸治疗激素耐药型脾肾阳虚证原发性肾病综合征（PNS）的疗效。方法　选择2018年3月至2019年9月平顶山市第一人民医院收治的激素耐药型脾肾阳虚证PNS患者94例为研究对象，采用随机数字表法将患者分为观察组和对照组，每组47例。2组患者均给予降压、利尿、抗凝等基础治疗，在此基础上，对照组患者静脉滴注环磷酰胺10 mg·kg-1，每日1次，连续2 d，每隔14 d重复1次，尿蛋白转阴后可1~3个月用药1次，累计最大剂量≤150 mg·kg-1;观察组患者在对照组治疗基础上口服右归丸 9 g，每日3次;所有患者治疗12个月。治疗12个月后评估2组患者的治疗效果。分别于治疗前和治疗6、12个月后评估2组患者的中医证候（神疲倦卧、面色无华、小便短少不利、全身水肿）。治疗前和治疗6、12个月后，采用流式细胞仪检测2组患者免疫功能指标（CD3+、CD4+水平及CD4+/CD8+），采用全自动生物化学分析仪检测2组患者肾功能指标，采用电化学发光法检测2组患者血清促肾上腺皮质激素（ACTH）、皮质醇（CORT）水平。记录2组患者不良反应发生情况。结果　观察组和对照组患者治疗总有效率分别为91.49%（43/47）、76.60%（36/47）,观察组患者的治疗总有效率显著高于对照组（χ2=3.887，P<0.05）。治疗前2组患者神疲倦卧、面色无华、小便短少不利、全身水肿评分比较差异均无统计学意义（P>0.05）。治疗6、12个月后，2组患者神疲倦卧、面色无华、小便短少不利、全身水肿评分均低于治疗前（P<0.05）；2组患者治疗12个月后的神疲倦卧、面色无华、小便短少不利、全身水肿评分均显著低于治疗6个月后（P<0.05）。治疗6、12个月后，观察组患者的神疲倦卧、面色无华、小便短少不利、全身水肿评分均显著低于对照组（P<0.05）。治疗前2组患者全血CD3+、CD4+水平及CD4+/CD8+比值比较差异无统计学意义（P>0.05）。治疗6、12个月后，2组患者的全血CD3+、CD4+水平及CD4+/CD8+比值均高于治疗前（P<0.05）； 2组患者治疗12个月后的全血CD3+、CD4+水平及CD4+/CD8+比值均高于治疗6个月后（P<0.05）。治疗6、12个月后，观察组患者全血CD3+、CD4+水平及CD4+/CD8+比值高于对照组（P<0.05）。治疗前2组患者的血尿素氮（BUN）、血肌酐（Scr）、白蛋白（Alb）、24 h尿蛋白定量(24 h Upro)、尿视黄醇结合蛋白(URBP)水平比较差异无统计学意义（P>0.05）。 治疗6、12个月后，2组患者的BUN、Scr、24 h Upro、URBP水平均显著低于治疗前，Alb水平显著高于治疗前（P<0.05）。 2组患者治疗12个月后的BUN、Scr、24 h Upro、URBP显著低于治疗6个月后，Alb水平显著高于治疗6个月后（P<0.05）。 治疗6、12个月后，观察组患者的BUN、Scr、24 h Upro、URBP水平显著低于对照组，Alb水平显著高于对照组（P<0.05）。治疗前2组患者血清中ACTH、CORT水平比较差异无统计学意义（P>0.05）。治疗6、12个月后，2组患者血清中ACTH水平低于治疗前，CORT水平高于治疗前（P<0.05）。2组患者治疗12个月后血清中ACTH水平显著低于治疗6个月后，CORT水平显著高于治疗6个月后（P<0.05）。治疗6、12个月后，观察组患者血清中ACTH水平低于对照组，CORT水平高于对照组（P<0.05）。观察组和对照组患者不良反应发生率分别为8.51%（4/47）、14.89%（7/47），2组患者的不良反应发生率比较差异无统计学意义（P>0.05）。结论　大剂量环磷酰胺冲击疗法联合右归丸治疗激素耐药型脾肾阳虚证PNS患者，能调节患者血清中ACTH、CORT水平，提高机体免疫功能，改善肾功能，缓解临床症状，疗效显著且具有一定安全性。
Abstract:
Objective　To investigate the efficacy of high-dose cyclophosphamide pulse therapy combined with Yougui Pill in the treatment of hormone-resistant primary nephrotic syndrome (PNS) patients with spleen and kidney yang deficiency syndrome.Methods　A total of 94 hormone-resistant PNS patients with spleen and kidney yang deficiency syndrome in the First People′s Hospital of Pingdingshan City from March 2018 to September 2019 were selected as subjects.The patients were divided into observation group and control group,with 47 cases in each group.All patients were given basic treatment such as reducing blood press,diuresis and anticoagulation and so on;on this basis,the patients in the control group were intravenously injected with cyclophosphamide 10 mg·kg-1,once daily for 2 days and repeated every 14 days；if the urine protein turned negative，the drug could be administered once every 1-3 months,with a cumulative maximum dose ≤150 mg·kg-1.On the basis of treatment of the control group,the patients in the observation group tool Yougui Pill 9 g orally,3 times a day.All patients were treated for 12 months.The therapeutic effect of patients in the two groups was evaluated after 12 months of treatment.The traditional Chinese medicine syndromes (tiredness,bleak complexion,lack of urine，systemic edema) of patients in the two groups were evaluated before treatment and after 6,12 months of treatment.Before treatment and after 6,12 months of treatment,the immune function indexes (CD3+,CD4+ levels and CD4+/CD8+) of patients in the two groups were detected by flow cytometry;the renal function indexes of patients in the two groups were detected by automatic biochemical analyzer and the serum adrenocorticotropic hormone (ACTH)，cortisol (CORT) levels of patients in the two groups were detected by electrochemiluminescence method.The adverse reactions of patients in the two groups were recorded.Results　The total effective rate of patients in the observation group and the control group was 91.49% (43/47),76.60% (36/47),respectively;the total effective rate of patients in the observation group was higher than that in the control group (P<0.05).There was no significant difference in the scores of tiredness,bleak complexion,lack of urine and systemic edema of patients between the two groups before treatment(P>0.05).The scores of tiredness,bleak complexion,lack of urine and systemic edema of patients after 6,12 months of treatment were lower than those before treatment in the two groups (P<0.05);the scores of tiredness,bleak complexion,lack of urine and systemic edema of patients after 12 months of treatment were lower than those after 6 months of treatment in the two groups (P<0.05).The scores of tiredness,bleak complexion,lack of urine and systemic edema of patients in the observation were lower than those in the control group after 6,12 months of treatment(P<0.05).There was no significant difference in the levels of CD3+,CD4+ and the ratio of CD4+/CD8+ in whole blood of patients between the two groups before treatment(P>0.05).The levels of CD3+,CD4+ and the ratio of CD4+/CD8+ in whole blood of patients after 6,12 months of treatment were higher than those before treatment in the two groups (P<0.05);the levels of CD3+,CD4+ and the ratio of CD4+/CD8+ in whole blood of patients after 12 months of treatment were higher than those after 6 months of treatment in the two groups (P<0.05).The levels of CD3+,CD4+ and the ratio of CD4+/CD8+ in whole blood of patients in the observation group were higher than those in the control group after 6,12 months of treatment(P<0.05).There was no significant difference in the serum levels of blood urea nitrogen(BUN),albumin(Alb),the serum creatinine(Scr) and the 24-hour urine protein quantitative(24 h Upro),urine retinol binding protein levels of patients between the two groups before treatment(P>0.05).The levels of BUN,Scr,24 h Upro and URBP of patients after 6,12 months of treatment were lower than those before treatment,and the level of Alb of patients was higher than that before treatment in the two groups (P<0.05);the BUN,Scr,24 h Upro and URBP of patients after 12 months of treatment were significantly lower than those after 6 months of treatment and the Alb level was significantly higher than that after 6 months of treatment in the two group(P<0.05).After 6,12 months of treatment,the levels of BUN,Scr,24 h Upro and URBP of patients in the observation group were lower than those in the control group,and the level of Alb was higher than that in the control group(P<0.05).There was no significant difference in the serum ACTH and CORT levels of patients between the two groups before treatment (P>0.05).The serum ACTH level of patients after 6,12 months of treatment was lower than that before treatment,and the serum CORT level of patients was higher than that before treatment in the two groups (P<0.05);the serum ACTH level of patients after 12 months of treatment was lower than that after 6 months of treatment and the serum CORT level of patients after 12 months of treatment was higher than that after 6 months of treatment in the two groups(P<0.05).After 6,12 months of treatment,the serum ACTH level of patients in the observation group was lower than that in the control group,and the serum level of CORT was higher than that in the control group(P<0.05).The incidence of adverse reactions of patients in the observation group and the control group was 8.51% (4 / 47) and 14.89% (7 / 47),respectively;there was no significant difference in the incidence of adverse reactions of patients between the two group (P>0.05).Conclusion　High-dose cyclophosphamide pulse therapy combined with Yougui Pill in the treatment of hormone-resistant PNS patients with spleen and kidney yang deficiency syndrome can regulate serum ACTH and CORT levels,improve immune function and renal function,and relieve clinical symptoms.It has significant curative effect and has certain safety.

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更新日期/Last Update: 2022-06-05