摘要
目的比较昆仙胶囊与他克莫司治疗特发性膜性肾病(IMN)的疗效及安全性。方法选择2019年3月至2020年1月在新乡医学院第一附属医院肾脏病医院行肾活检确诊为IMN的患者60例为研究对象,将患者随机分为昆仙胶囊组和他克莫司组,每组30例。昆仙胶囊组患者给予昆仙胶囊联合糖皮质激素治疗,他克莫司组患者给予他克莫司联合糖皮质激素治疗。记录2组患者治疗前及治疗1、3、6、12个月的24 h尿蛋白定量、血清白蛋白水平,比较2组患者的总有效率、完全缓解率及不良反应。结果昆仙胶囊组共28例患者完成随访,他克莫司组共30例患者完成随访。治疗1、3、6、12个月时,2组患者的完全缓解率比较差异均无统计学意义(χ^(2)=1.047、0.259、0.074、0.006,P>0.05)。治疗1个月时,昆仙胶囊组患者的总有效率高于他克莫司组(χ^(2)=5.557,P<0.05);治疗3、6、12个月时,2组患者的总有效率比较差异无统计学意义(χ^(2)=1.479、0.265、0.251,P>0.05)。治疗前,2组患者24 h尿蛋白、血清白蛋白水平比较差异无统计学意义(P>0.05)。昆仙胶囊组患者治疗1、3、6、12个月时24 h尿蛋白水平均低于治疗前(P<0.05);治疗12个月时,昆仙胶囊组患者24 h尿蛋白水平低于治疗1个月时(P<0.05)。他克莫司组患者治疗6、12个月时24 h尿蛋白水平低于治疗前及治疗1、3个月时(P<0.05)。治疗1、3个月时,他克莫司组患者24 h尿蛋白水平高于昆仙胶囊组(P<0.05);治疗6、12个月时,2组患者的24 h尿蛋白水平比较差异无统计学意义(P>0.05)。治疗3、6、12个月时,昆仙胶囊组患者的血清白蛋白水平均高于治疗前及治疗1个月时(P<0.05);治疗6、12个月时,昆仙胶囊组患者血清白蛋白水平均高于治疗3个月时(P<0.05)。治疗1、3、6、12个月时,他克莫司组患者的血清白蛋白水平均高于治疗前(P<0.05);治疗6、12个月时,他克莫司组患者血清白蛋白水平均高于治疗1、3个月时(P<0.05)。治疗1、3个月时,他克莫司组患者血清白蛋白水平高于昆仙胶囊组(P<0.05);治疗6、12个月时,2组患者的血清白蛋白水平比较差异无统计学意义(P>0.05)。昆仙胶囊组患者不良反应发生率为21.4%(6/28),他克莫司组患者不良反应发生率为46.7%(14/30);昆仙胶囊组患者不良反应发生率低于他克莫司组(χ^(2)=4.083,P<0.05)。结论昆仙胶囊联合糖皮质激素治疗IMN的疗效与他克莫司联合糖皮质激素方案相当,且起效更快、安全性好,是治疗IMN的有效方案之一。
Objective To compare the efficacy and safety of Kunxian capsule and tacrolimus in the treatment of idiopathic membranous nephropathy(IMN).Methods A total of 60 patients who were diagnosed as IMN by renal biopsy at the Nephrology Hospital of the First Affiliated Hospital of Xinxiang Medical University from March 2019 to January 2020 were selected as study subjects and they were randomly divided into Kunxian capsule group and tacrolimus group,with 30 cases in each group.Patients in the Kunxian capsule group were treated with Kunxian capsule combined with glucocorticoids,and the patients in the tacrolimus group were treated with tacrolimus combined with glucocorticoids.The 24-hour urine protein quantification and serum albumin level of patients in the two groups were recorded before treatment and 1,3,6,12 months of treatment;the total effective rate,complete remission rate and adverse reactions of the patients between the two groups were compared.Results A total of 28 patients in the Kunxian capsule group completed the follow-up,and a total of 30 patients in the tacrolimus group completed the follow-up.There was no significant difference in the complete remission rate of patients between the two groups at 1,3,6 and 12 months of treatment(χ^(2)=1.047,0.259,0.074,0.006;P>0.05).At 1 month of treatment,the total effective rate of patients in the Kunxian capsule group was significantly higher than that in the tacrolimus group(χ^(2)=5.557,P<0.05);at 3,6 and 12 months of treatment,there was no significant difference in the total effective rate of patients between the two groups(χ^(2)=1.479,0.265,0.251;P>0.05).Before treatment,there was no significant difference in the levels of 24-hour urine protein and serum albumin levels of patients between the two groups(P>0.05).The 24-hour urine protein level of patients in the Kunxian capsule group at 1,3,6,and 12 months of treatment was lower than that before treatment(P<0.05);the 24-hour urine protein level of patients in the Kunxian capsule group at 12 months of treatment was lower than that at 1 month of treatment(P<0.05).The 24-hour urine protein level of patients in the tacrolimus group at 6 and 12 months of treatment was significantly lower than that before treatment at 1 and 3 months of treatment(P<0.05).At 1 and 3 months of treatment,the 24-hour urine protein level of patients in the tacrolimus group was significantly higher than that in the Kunxian capsule group(P<0.05);at 6 and 12 months of treatment,there was no significant difference in the 24-hour urine protein level between the two groups(P>0.05).At 3,6,and 12 months of treatment,the serum albumin level of patients in Kunxian capsule group was significantly higher than that before treatment and at 1 month of treatment(P<0.05).At 6 and 12 months of treatment,the serum albumin level of patients in the Kunxian capsule group was significantly higher than that at 3 months of treatment(P<0.05).The serum albumin level of patients in the tacrolimus group at 1,3,6,and 12 months of treatment was significantly higher than before treatment(P<0.05);the serum albumin level of patients in the tacrolimus group at 6 and 12 months of treatment was significantly higher than that at 1 and 3 months of treatment(P<0.05).At 1 and 3 months of treatment,the serum albumin level of patients in the tacrolimus group was significantly higher than that in the Kunxian capsule group(P<0.05);at 6 and 12 months of treatment,there was no significant difference in the serum albumin level of patients between the two groups(P>0.05).The incidence rate of adverse reactions of patients in the Kunxian capsule group was 21.4%(6/28),and the incidence rate of adverse reactions of patients in the tacrolimus group was 46.7%(14/30);the incidence rate of adverse reactions of patients in the Kunxian capsule group was significantly lower than that in the tacrolimus group(χ^(2)=4.083,P<0.05).Conclusion The efficacy of Kunxian capsule combined with glucocorticoid in the treatment of IMN is equivalent to the tacrolimus combined glucocorticoid regimen,with faster onset and good safety,and it is one of the effective regimens for the treatment of IMN.
作者
姬萌
马媛媛
郭醉爽
吴茜彤
孟园园
马东红
侯玉龙
尚瑞华
郭明好
JI Meng;MA Yuanyuan;GUO Zuishuang;WU Xitong;MENG Yuanyuan;MA Donghong;HOU Yulong;SHANG Ruihua;GUO Minghao(Nephrology Hospital,the First Affiliated Hospital of Xinxiang Medical University,Xinxiang 453100,Henan Province,China;Department of Nephrology,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,Henan Province,China;Department of Nephrology,the First People's Hospital of Xinxiang City,Xinxiang 453000,Henan Province,China)
出处
《新乡医学院学报》
CAS
2021年第5期472-476,共5页
Journal of Xinxiang Medical University
基金
北京康盟慈善基金会医学科研发展基金项目(编号:WS666A)。
关键词
特发性膜性肾病
昆仙胶囊
他克莫司
糖皮质激素
疗效
idiopathic membranous nephropathy
Kunxian capsule
tacrolimus
glucocorticoid
curative effect
作者简介
姬萌(1994-),女,河南南阳人,硕士研究生在读,住院医师,研究方向:膜性肾病;通信作者:郭明好(1964-),男,河南封丘人,硕士,主任医师,硕士研究生导师,研究方向:肾小球疾病的基础与临床,E-mail:guomh@163.com。
