昆仙胶囊联合糖皮质激素治疗狼疮性肾炎的临床研究  

Clinical Study on Kunxian Capsule Combined with Glucocorticoids in the Treatment of Lupus Nephritis

作　　者：刘枚[1,2] 潘文友[1] 孟德钎[1] 蒋真[1] 李鞠[1] 李永胜[1] 李慧[1] 刘焱[1] LIU Mei;PAN Wen-you;MENG De-qian;JIANG Zhen;LI Ju;LI Yong-sheng;LI Hui;LIU Yan(Department of Rheumatology and Immunology,The Affiliated Huai'an No.1 People's Hospital of Nanjing Med-ical University,Jiangsu,223300;Department of Traditional Chinese Medicine,the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University,Jiangsu,223300)

机构地区：[1]南京医科大学附属淮安第一医院风湿免疫科,江苏223300 [2]南京医科大学附属淮安第一医院中医科,江苏223300

出　　处：《中国中西医结合杂志》2020年第8期919-922,共4页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：江苏省中医药局科技项目(No.YB2015124)。

摘　　要：目的评价昆仙胶囊联合糖皮质激素治疗狼疮性肾炎(LN)的疗效及安全性。方法将66例LN患者随机分为环磷酰胺(CTX)组和昆仙组,每组33例。所有患者均给予泼尼松或等效激素治疗,在此基础上CTX组加用CTX 0.4 g/2周静脉滴注,昆仙组加昆仙胶囊1.8 g/d口服,疗程均为24周。治疗前及治疗后4、12、24周时使用系统性红斑狼疮疾病活动度评分表(SLEDAI)、24 h尿蛋白定量、血补体C3、C4评估LN病情活动情况,血清抗苗勒氏管激素(AMH)评价患者生殖系统毒性,同时记录药物不良反应发生情况。结果治疗后两组患者SLEDIA评分、24 h尿蛋白定量、AMH随时间逐渐降低,血清C3、C4逐渐升高(P<0.05),具有时间依赖性;两组间同一时间SLEDAI评分、24 h尿蛋白定量、血补体C3、C4、血清AMH水平比较,差异无统计学意义(P>0.05)。昆仙组不良反应发生率[30.0%(9/30)]低于CTX组[56.7%(17/30),χ^2=4.344,P<0.05]。结论昆仙胶囊和环磷酰胺联合糖皮质激素治疗LN疗效相似,可改善患者病情活动度,但昆仙胶囊不良反应更低。Objective To evaluate the effectiveness and safety of Kunxian Capsule(KXC)combined with glucocorticoids in the treatment of lupus nephritis(LN).Methods Totally 66 LN patients were randomly assigned to cyclophosphamide(CTX)group(intravenous injection of CTX 0.4 g per 2 weeks)and KXC group(oral KXC 1.8 g daily).Both groups received prednisone or its equivalent hormone,and the treatment course was 24 weeks.The activity of LN was judged by Systemic Lupus Erythematosus Disease Activity Index(SLEDAI),24-hour urine protein quantification,blood complement C3,C4 before and 4,12,24 weeks after treatment.Reproductive system toxicity of LN patients was evaluated by anti-mullerian hormone(AMH).The occurrence of adverse drug reactions during medication was recorded as well.Results The SLEDAI scores,24-hour urinary protein quantification,and serum AMH levels of two groups gradually decreased,and blood complement C3,C4 gradually increased(P<0.05),and in a time dependent manner.There were no statistical differences in the SLEDAI scores,24-hour urinary protein quantification,blood complement C3,C4,and serum AMH levels between the two groups at the same time(P>0.05).The incidence rate of adverse reactions in the KXC group was less than that of the CTX group[30.0%(9/30)vs.56.7%(17/30),χ^2=4.344,P<0.05].Conclusions KXC and CTX combined with glucocorticoids have similar effects in treating LN,which can improve the patients′disease activity;however,the KXC have lower adverse reactions.

关 键 词：昆仙胶囊 狼疮肾炎 抗苗勒氏管激素 

分 类 号：R593.242[医药卫生—内科学]