环孢素注射液联合泼尼松片和吗替麦考酚酯胶囊治疗原发性肾病综合征儿童患者的临床研究  

Clinical trial of cyclosporine injection combined with prednisone tablets and mycophenolate mofetil capsules in the treatment of children with primary nephrotic syndrome

作　　者：唐晓岩[1] 欧阳卫芳[1] 步静芸 TANG Xiao-yan;OUYANG Wei-fang;BU Jing-yun(Department of Pediatrics,Changzhou Fourth People's Hospital,Changzhou 213100,Jiangsu Province,China)

机构地区：[1]常州市第四人民医院儿科,江苏常州213100

出　　处：《中国临床药理学杂志》2021年第11期1326-1329,共4页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省自然科学基金资助项目(BK20170562)。

摘　　要：目的观察环孢素注射液联合泼尼松片和吗替麦考酚酯胶囊治疗原发性肾病综合征(PNS)儿童患者的临床疗效及安全性。方法将92例PNS儿童患者随机分为对照组46例和试验组46例。对照组给予晨起口服泼尼松,初始剂量2 mg·kg^(-1)·d^(-1),最大剂量应低于60 mg·d^(-1),每4~8周减量2.5~5.0 mg,直至0.5~1.0 mg·kg^(-1)维持治疗3个月,随后每周减量2.5~5.0 mg,直至停药+吗替麦考酚酯胶囊20~30 mg·kg^(-1)·d^(-1),分为2次口服;试验组在对照组治疗的基础上,从第4周开始加用环孢素2~3 mg·kg^(-1)·d^(-1),qd,静脉滴注。2组儿童患者均治疗1年。比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗3个月后,试验组和对照组的总有效率分别为95.56%(43例/45例)和79.07%(34例43例),差异有统计学意义(P<0.05)。试验组发生的药物不良反应有感染、白细胞降低、胃肠道不适和肝功能损害,对照组发生的药物不良反应有感染、白细胞降低和胃肠道不适。试验组和对照组的总药物不良反应发生率分别为22.22%和30.23%,差异无统计学意义(P>0.05)。结论环孢素注射液联合泼尼松片和吗替麦考酚酯胶囊治疗PNS儿童患者的临床疗效确切,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of cyclosporine injection combined with prednisone tablets and mycophenolate mofetil capsules in the treatment of children with primary nephrotic syndrome(PNS).Methods A total of 92 children with PNS were randomly divided into control and treatment groups with 46 cases per group.The control group was given prednisone,the initial dose was 2 mg·kg^(-1)·d^(-1),the maximum dose should be less than 60 mg·d^(-1),reduction 2.5-5.0 mg per 4-8 weeks,then 0.5^(-1).0 mg·kg^(-1)maintenance treatment for 3 months,finally reduce the dose with 2.5-5.0 mg per week,until the drug is stopped+mycophenolate mofetil capsules 20-30 mg·kg^(-1)·d^(-1),divided into two oral doses.On the basis of control group,the treatment groups was given oral cyclosporine 2-3 mg·kg^(-1)·d^(-1),once a day,intravenous drip,from the fourth week.Two groups were treated for 1 year.The clinical efficacy and adverse drug reactions were compared between two groups.Results After 3 months of treatment,the total effective rates of treatment and the control groups were 95.56%(43 cases/45 cases)and 79.07%(34 cases/43 cases)with significant difference(P<0.05).The adverse drug reactions of treatment group were infection,leukopenia,gastrointestinal discomfort and liver function damage,which in control group were infection,leukopenia and gastrointestinal discomfort.The incidences of total adverse drug reactions in the treatment and control groups were22.22%and 30.23%without significant difference(P>0.05).Conclusion Cyclosporine injection combined with prednisone tablets and mycophenolate mofetil capsules has a definitive clinical efficacy in the treatment of children with PNS,without increasing the incidence of adverse drug reactions.

关 键 词：环孢素注射液 泼尼松片 吗替麦考酚酯胶囊 原发性肾病综合征 安全性评价 

分 类 号：R983[医药卫生—药品]