他克莫司联合济生肾气丸、四君子汤治疗脾肾亏虚证狼疮性肾炎的疗效观察

Clinical efficacy of tacrolimus combined with Jisheng Shenqi pills and Sijunzi decoction in treating spleen-kidney deficiency type lupus nephritis in patients

目的观察他克莫司联合济生肾气丸、四君子汤治疗脾肾亏虚证狼疮性肾炎患者的临床疗效。方法选择2019年1月至2023年12月渭南市中心医院收治的脾肾亏虚证狼疮性肾炎患者82例进行随机对照研究。按照掷硬币法分为对照组和观察组,每组41例。对照组采用他克莫司治疗,观察组在对照组基础上加用济生肾气丸、四君子汤治疗,疗程为2个月。比较两组患者临床疗效、中医证候积分、狼疮性肾炎活动性指数(SLE-DAI)评分、慢性化指数(SLE-CI)评分、肾功能水平[胱抑素C(CysC)、尿素氮(BUN)、血肌酐(SCr)]、超敏C反应蛋白(hs-CRP)、转化生长因子β1(TGF-β1)、降钙素原(PCT)、沉默信息调节蛋白4(SIRT4)水平和不良反应(胃肠道不适、头晕、皮疹、肝功能异常)的发生状况。结果观察组总有效率为95.12%(39/41),高于对照组的80.49%(33/41),差异有统计学意义(χ^(2)=4.10,P<0.05)。治疗后,观察组中医证候积分、SLE-DAI评分、SLE-CI评分分别为(4.24±0.96)分、(9.04±1.40)分、(1.22±0.17)分,均显著低于对照组的(8.13±1.06)分、(12.78±1.82)分、(1.37±0.19)分,差异均有统计学意义(t=17.41、10.42、3.76,均P<0.05);观察组CysC、BUN、SCr水平分别为(1.49±0.42)mg/L、(5.20±1.30)mmol/L、(93.27±5.22)μmol/L,均低于对照组的(2.16±0.46)mg/L、(6.26±1.27)mmol/L、(103.29±5.07)μmol/L,差异均有统计学意义(t=6.88、3.73、8.81,均P<0.05);观察组hs-CRP、TGF-β1和PCT水平分别为(3.24±0.87)mg/L、(32.27±6.57)μg/L、(14.11±2.34)μg/L,均低于对照组的(4.48±0.81)mg/L、(40.34±7.52)μg/L、(18.26±2.79)μg/L,SIRT4水平为(0.47±0.06)mg/L,高于对照组的(0.37±0.04)mg/L,差异均有统计学意义(t=6.67、5.17、7.29、8.87,均P<0.05)。观察组不良反应发生率为4.87%(2/41),低于对照组的14.63%(6/41),但差异无统计学意义(χ^(2)=2.21,P>0.05)。结论他克莫司联合济生肾气丸和四君子汤治疗脾肾亏虚证狼疮性肾炎患者,能够显著提高临床疗效,降低中医证候积分、SLE-DAI评分和SLE-CI评分,改善肾功能,减轻炎症程度,并且具有较好的安全性。

ObjectiveTo investigate the clinical efficacy of tacrolimus combined with Jisheng Shenqi pills and Sijunzi decoction in treating spleen-kidney deficiency type lupus nephritis in patients.MethodsA randomized controlled study was conducted on 82 patients with spleen-kidney deficiency type lupus nephritis admitted to Weinan Central Hospital from January 2019 to December 2023.The patients were divided into a control group(n=41)and an observation group(n=41)using the coin flip method.The control group was treated with tacrolimus,while the observation group received Jisheng Shenqi pills and Sijunzi decoction in addition to the control group's treatment.All patients were treated for 2 months.The clinical efficacy,traditional Chinese medicine(TCM)syndrome scores,systemic lupus erythematosus disease activity index(SLE-DAI)scores,chronicity index(SLE-CI)scores,renal function(cystatin C,blood urea nitrogen,serum creatinine),high-sensitivity C-reactive protein,transforming growth factorβ1,procalcitonin,silent information regulator 4(SIRT4)levels,and adverse reactions(gastrointestinal discomfort,dizziness,rash,liver function abnormalities)were compared between the two groups.ResultsThe total effective rate of clinical treatment in the observation group was significantly higher than that in the control group[95.12%(39/41)]vs.[80.49%(33/41),χ^(2)=4.10,P<0.05].After treatment,the TCM syndrome scores,SLE-DAI scores,and SLE-CI scores in the observation group were(4.24±0.96)points,(9.04±1.40)points,(1.22±0.17)points,respectively,which were significantly lower than those in the control group[(8.13±1.06)points,(12.78±1.82)points,(1.37±0.19)points,t=17.41,10.42,3.76,all P<0.05].The levels of cystatin C,blood urea nitrogen,and serum creatinine in the observation group were(1.49±0.42)mg/L,(5.20±1.30)mmol/L,(93.27±5.22)μmol/L,respectively,which were significantly lower than those in the control group[(2.16±0.46)mg/L,(6.26±1.27)mmol/L,(103.29±5.07)μmol/L,t=6.88,3.73,8.81,all P<0.05].The levels of high-sensitivity C-reactive protein,transforming growth factorβ1,and procalcitonin in the observation group were(3.24±0.87)mg/L,(32.27±6.57)μg/L,(14.11±2.34)μg/L,respectively,which were significantly lower than those in the control group[(4.48±0.81)mg/L,(40.34±7.52)μg/L,(18.26±2.79)μg/L,t=6.67,5.17,7.29,all P<0.05],while the level of SIRT4 was significantly higher in the observation group[(0.47±0.06)mg/L]compared with the control group[(0.37±0.04)mg/L,t=8.87,P<0.05].The incidence of adverse reactions in the observation group[4.87%(2/41)]was slightly,but not significantly,lower than that in the control group[14.63%(6/41),χ^(2)=2.21,P>=0.05].ConclusionTacrolimus combined with Jisheng Shenqi pills and Sijunzi decoction in treating spleen-kidney deficiency type lupus nephritis can significantly improve clinical efficacy,reduce TCM syndrome scores,SLE-DAI scores,and SLE-CI scores,improve renal function,alleviate inflammation,and has good safety.