肾炎康复片辅助标准激素治疗气阴两虚证肾病综合征80例临床观察

Clinical Observation of Shenyan Kangfu Tablet Combined with Standard Hormone Scheme in Treatment of Nephrotic Syndrome with Syndrome of Deficiency of Both Qi and Yin

目的：探讨肾炎康复片辅助标准激素治疗气阴两虚型肾病综合征（NS）的临床疗效以及对血小板数量（PLT）和血浆垂体腺苷酸环化酶激活肽（PACAP）的影响。方法：152例NS患者参照随机按分层随机法分为治疗组80例和对照组72例;两组患者均采取常规支持治疗和对症处理;对照组采用泼尼松,首始剂量l mg·kg-1·d-1,最大剂量不超过60 mg·d-1,连续口服8~12周,再以每2周减少原使用量的10%内服,最后以10 mg·d-1的剂量维持治疗,根据具体情况维持6~12个月,同时给予对症治疗。治疗组在对照组治疗的基础上加服肾炎康复片,5片/次,3次/d,两组均连续治疗12个月。检测治疗前后两组患者的24 h尿蛋白定量,血清白蛋白（ALB）,总胆固醇（TC）和甘油三脂（TG）水平;监测两组肝功能,记录治疗过程中不良反应发生率;比较两组治疗前后中医（TCM）单项症状评分;检测两组治疗前后PLT和血浆PACAP水平。结果：治疗组临床总有效率为97.5%,对照组为79.17%,治疗组明显优于对照组（P〈0.01）;治疗组治疗后24 h尿蛋白定量,TG和TC水平明显低于对照组,血清ALB水平显著高于对照组（P〈0.01）;治疗后治疗组患者的向心性肥胖和总体不良反应发生率明显少于对照组（P〈0.05）;治疗组治疗后TCM各单项指标评分均明显低于对照组,比较差异均有统计学意义（P〈0.01）;治疗组治疗后PLT数量明显低于对照组,血浆PACAP水平显著高于对照组,比较差异均有统计学意义（P〈0.01）。结论：肾炎康复片辅助标准激素治疗气阴两虚型NS能提高临床疗效,减少不良反应发生,降低患者血小板数量和升高血浆PACAP水平。

Objective： To investigate the clinical efficacy of Shenyan Kangfu tablet combined with standard hormone scheme in the treatment of nephrotic syndrom（ NS） with syndrome of deficiency of both Qi and Yin and its influece on platelet count（ PLT） and plasma level of pituitary adenylate cyclase-activating polypeptide（ PACAP）. Method： One hundred and fifty-two patients with NS were divided into treatment group（ 80 cases）and control group（ 72 cases） according to stratified random method. Both groups were given with supportive treatment and symptomatic treatment. The patients in control group were treated with prednisone at initial dose of 1mg·kg- 1once a day,with maximum dose not more than 60 mg·d- 1,orally for 8 to 12 weeks. Then the dose of prednisone was decreased by 10 percent every 2 weeks,and finally the dose was used with 10 mg·d- 1for 6 to 12 months. At the same time,symptomatic treatment was allocated. Patients in treatment group were added with Shenyan Kangfu tablet for 12 months,5 pills / time and tid. Urine protein quantitation for 24 hours,level of albumin（ ALB）,total cholesterol（ TC）,and triglyceride（ TG） before and after treatment were measured in both groups. Liver function was monitored and incidence of adverse reactions in the treatment process was recorded.Scores of single symptoms in traditional Chinese medical（ TCM） before and after treatment were compared for both groups. PLT and plasma PACAP levels were detected for both groups. Result： The total effective rate of treatment group was 97. 5%,significantly higher than 79. 17% in control group（ P〈0. 01）. After treatment,levels of urine protein quantitation for 24 hours,TC,and TG in treatment group were significantly lower than those in control group,and ALB level was significantly higher than that in control group（ P〈0. 01）. After treatment,the incidence of central obesity and overall incidence of adverse reactions were in treatment group were significantly lower than those in control group,（ P〈0. 05）. After treatment,scores of TCM single indexes in treatment group were significantly lower than those in control group,with statistically significant difference（ P〈0. 01）. After treatment,PLT in treatment group was significantly lower than that in control group,while plasma PACAP level was significantly higher than that in control group,with statistically significant difference（ P〈0. 01）. Conclusion：Shenyan Kangfu tablet combined with standard hormone scheme could remarkably improve therapeutic efficacy of NS with syndrome of deficiency of both Qi and Yin,reduce adverse reactions,and reduce PLT and increase plasma PACAP level.