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[摘要]
【目的】观察加味参芪地黄汤与沙库巴曲缬沙坦联用对慢性心肾综合征(CRS)患者的治疗效果及其对血清半乳糖凝集素 3(Gal-3)、生长分化因子15(GDF-15)水平的影响。【方法】采用随机数字表法将2024 年1 月至2025 年1 月陕西省中医医院收 治的120 例慢性CRS 气阴两虚、血瘀水停证患者随机分为西药组和中药组,每组各60 例。在常规基础治疗的基础上,西药 组给予沙库巴曲缬沙坦治疗,中药组给予加味参芪地黄汤联合沙库巴曲缬沙坦治疗,2 组疗程均为12 周。观察2 组患者治疗 前后中医证候积分、超声心动图、心肾功能、炎症反应及氧化应激相关指标的变化情况,并评价2 组患者的临床疗效。 【结果】(1)脱落情况方面,治疗期间,西药组脱落1 例,中药组脱落2 例,最终共有117 例患者纳入疗效统计,其中西药组 59 例,中药组58 例。(2)疗效方面,治疗12 周后,中药组的总有效率为93.10%(54/58),西药组为83.05%(49/59);组间比较 (秩和检验),中药组的疗效明显优于西药组(P<0.05)。(3)中医证候积分方面,治疗后,2 组患者的中医证候积分均较治疗 前明显降低(P<0.01),且中药组的降低幅度明显优于西药组(P<0.01)。(4)超声心动图方面,治疗后,2 组患者的左心室射 血分数(LVEF)、每搏输出量(SV)均较治疗前升高(P<0.05),左室舒张末期内径(LVEDD)、肾动脉血流阻力指数(RRI)均较 治疗前降低(P<0.05),且中药组对LVEF、SV 的升高幅度及对LVEDD、RRI 的降低幅度均明显优于西药组(P<0.05 或P< 0.01)。(5)心肾功能指标方面,治疗后,2 组患者的血清N 末端脑钠肽前体(NT-proBNP)、血肌酐(Scr)、尿素氮(BUN)、胱抑 素C(Cys-C)水平均较治疗前降低(P<0.05),且中药组的降低幅度均明显优于西药组(P<0.05 或P<0.01)。(6)炎症相关指标 方面,治疗后,2 组患者的血清可溶性生长刺激表达基因2 蛋白(sST2)、Gal-3、GDF-15 水平均较治疗前降低(P<0.05),且 中药组的降低幅度均明显优于西药组(P<0.01)。(7)氧化应激指标方面,治疗后,2 组患者的血清丙二醛(MDA)水平均较治 疗前降低(P<0.05),血清超氧化物歧化酶(SOD)水平均较治疗前升高(P<0.05),且中药组对血清MDA 水平的降低幅度及对 血清SOD 水平的升高幅度均明显优于西药组(P<0.01)。【结论】加味参芪地黄汤与沙库巴曲缬沙坦联用治疗慢性CRS 气阴两 虚、血瘀水停证患者疗效确切,能够显著改善患者心肾功能,有效降低患者血清中GDF-15、Gal-3 等炎症反应及氧化应激 指标水平。
[Key word]
[Abstract]
Objective To observe the therapeutic effect of Modified Shenqi Dihuang Decoction combined with Sacubitril Valsartan in treating patients with chronic cardiorenal syndrome(CRS)and to assess its impact on serum levels of galectin-3(Gal-3)and growth differentiation factor 15(GDF-15). Methods Using a random number table method, 120 patients with chronic CRS manifesting as qi-yin deficiency with blood stasis and water retention syndrome,admitted to Shaanxi Traditional Chinese Medicine Hospital from January 2024 to January 2025,were randomly divided into a western medicine group and a traditional Chinese medicine(TCM)group, with 60 cases in each group. On the basis of conventional foundational treatment,the western medicine group was treated with Sacubitril Valsartan,while the TCM group was treated with Modified Shenqi Dihuang Decoction combined with Sacubitril Valsartan.The treatment duration for both groups was 12 weeks. Changes in TCM syndrome scores,echocardiographic parameters,cardiac and renal function indicators,and markers related to inflammatory response and oxidative stress were observed before and after treatment in both groups,and the clinical efficacy was evaluated. Results(1)Regarding dropouts,during the treatment period,1 case dropped out from the western medicine group and 2 cases from the TCM group,resulting in a total of 117 patients included in the efficacy analysis(59 in the western medicine group,58 in the TCM group).(2)In terms of efficacy,after 12 weeks of treatment,the total effective rate was 93.10%(54/58)in the TCM group and 83.05%(49/59)in the western medicine group;intergroup comparison(by rank sum test)showed that the efficacy of the TCM group was significantly superior to that of the western medicine group(P<0.05).(3)Regarding TCM syndrome scores,after treatment,the scores in both groups were significantly decreased compared to before treatment(P<0.01),and the reduction in the TCM group was significantly greater than that in the western medicine group(P<0.01). (4)Concerning echocardiography,after treatment,left ventricular ejection fraction(LVEF)and stroke volume (SV)were significantly increased in both groups compared to before treatment(P<0.05),while left ventricular end-diastolic diameter(LVEDD)and renal resistive index(RRI)were significantly decreased(P<0.05). The increases in LVEF and SV,as well as the decreases in LVEDD and RRI,were significantly greater in the TCM group compared to the western medicine group(P<0.05 or P<0.01).(5)Regarding cardiac and renal function indicators,after treatment,serum levels of N-terminal pro-brain natriuretic peptide(NT-proBNP),serum creatinine(Scr),blood urea nitrogen(BUN),and cystatin C(Cys-C)were significantly decreased in both groups compared to before treatment(P<0.05),and these reductions were significantly greater in the TCM group than in the western medicine group(P<0.05 or P<0.01).(6)Regarding inflammation-related markers,after treatment, serum levels of soluble suppression of tumorigenicity 2(sST2),Gal-3,and GDF-15 were significantly decreased in both groups compared to before treatment(P<0.05),and the reductions were significantly greater in the TCM group than in the western medicine group(P<0.01).(7)Regarding oxidative stress indicators,after treatment, serum malondialdehyde(MDA)level was significantly decreased(P<0.05)and serum superoxide dismutase (SOD)level was significantly increased(P<0.05)in both groups compared to before treatment. The reduction in MDA and the increase in SOD were significantly greater in the TCM group than in the western medicine group(P< 0.01). Conclusion The combination of Modified Shenqi Dihuang Decoction and Sacubitril Valsartan demonstrates definitive efficacy in treating patients with chronic CRS manifesting as qi-yin deficiency with blood stasis and water retention syndrome. It can significantly improve cardiac and renal function,and effectively reduce serum levels of inflammatory markers such as GDF-15 and Gal-3,as well as oxidative stress indicators.
[中图分类号]
R259.416
[基金项目]
国家重大疑难疾病慢性肾功能衰竭中西医协作项目(编号:国中医药办医政发[201813]号);陕西省慢性肾病临床医学研究中心 项目(编号:2021LCZX-13)