复方生地合剂对轻中度系统性红斑狼疮患者的临床疗效  

Clinical effects of Compound Shengdi Mixture on patients with mild to moderate systemic lupus erythematosus

作　　者：徐星宇 张娜[1] 于博 孙蓓蓓 唐华燕[1] XU Xing-yu;ZHANG Na;YU Bo;SUN Bei-bei;TANG Hua-yan(Department of Rheumatology,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)

机构地区：[1]上海中医药大学附属市中医医院风湿病科,上海200071

出　　处：《中成药》2024年第12期3992-3996,共5页Chinese Traditional Patent Medicine

基　　金：国家重点研发计划中医药现代化研究专项(2018YFC1705501,2018YFC1705502);上海市名中医沈丕安学术经验传承创新提质升级项目(上海市中医药管理局)(C231012N)。

摘　　要：目的 考察复方生地合剂对轻中度系统性红斑狼疮患者的临床疗效。方法 120例患者随机分为对照组和观察组,每组60例,对照组给予基础治疗,观察组在对照组基础上加用复方生地合剂,疗程12周。检测临床疗效、SLEDAI评分、中医证候评分、泼尼松剂量、实验室指标(WBC、 HGB、 PLT、抗ds-DNA、 ANA滴度、 ESR、 IL-6、TNF-α、 C3、 C4、 IgG)、 24 h PRO、不良反应发生率变化。结果 观察组总有效率高于对照组(P<0.05)。治疗后,2组SLEDAI评分、中医证候评分、泼尼松剂量、 IL-6、 TNF-α降低(P<0.05,P<0.01),以观察组更明显(P<0.05,P<0.01);观察组抗ds-DNA、 ANA滴度、 24 h PRO降低(P<0.05,P<0.01),HGB升高(P<0.01);2组WBC、PLT、 ESR、 C4、 C3、 IgG及不良反应发生率比较,差异无统计学意义(P>0.05)。结论 复方生地合剂可安全有效地抑制轻中度系统性红斑狼疮患者免疫炎症反应,改善临床症状,减轻疾病活动度。AIM To investigate the clinical effects of Compound Shengdi Mixture on patients with mild to moderate systemic lupus erythematosus.METHODS One hundred and twenty patients were randomly assigned into control group(60 cases) for 12-week intervention of basic treatment,and observation group(60 cases) for 12-week intervention of both Compound Shengdi Mixture and basic treatment.The changes in clinical effects,SLEDAI score,TCM syndrome score,prednisone dose,laboratory indices(WBC,HGB,PLT,anti-ds-DNA,ANA titer,ESR,IL-6,TNF-α,C3,C4,IgG),24 h PRO and incidence of adverse reactions were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05).After the treatment,the two groups displayed decreased SLEDAI score,TCM syndrome score,prednisone dose,IL-6,TNF-α(P<0.05,P<0.01),especially for the observation group(P<0.05,P<0.01);the observation group displayed decreased anti-ds-DNA,ANA titer,24 h PRO(P<0.05,P<0.01),along with increased HGB(P<0.01).No significant differences in WBC,PLT,ESR,C4,C3,IgG and incidence of adverse reactions were found between the two groups(P> 0.05).CONCLUSION For the patients with mild to moderate systemic lupus erythematosus,Compound Shengdi Mixture can safely and effectively inhibit immunological inflammatory responses,improve clinical symptoms and alleviate disease activity.

关 键 词：复方生地合剂 基础治疗 轻中度系统性红斑狼疮 

分 类 号：R287[医药卫生—中药学]