中医药治疗气阴两虚型干燥综合征临床疗效及安全性的系统评价

The clinical efficacy and safety of traditional Chinese medicine in treating Sj?gren's syndrome with dual deficiency of qi and yin:a systematic review

[目的]系统评价中医药治疗气阴两虚型干燥综合征的疗效及安全性。[方法]通过中国知网(CNKI)、维普(VIP)、万方(Wanfang)、PubMed等中英文数据库检索自建库至2023年11月26日符合纳入标准的随机对照试验(RCT)。[结果]纳入17项RCT,共1 282例患者。结果显示:与单纯西药治疗比较,中医药治疗在增加临床有效率[RR=1.40,95%CI(1.25,1.57),P<0.000 01]、改善泪液分泌[SMD=0.57,95%CI(0.27,0.88),P=0.000 2]、增加唾液分泌[SMD=0.77,95%CI(0.35,1.19),P=0.000 3]、改善免疫球蛋白G(IgG)[MD=-1.57,95%CI(-2.41,-0.73),P=0.000 3]及血沉(ESR)[MD=-6.19,95%CI(-9.46,-2.92),P=0.000 2]、降低干燥综合征患者自我报告指数(ESSPRI)评分[MD=-1.61,95%CI(-1.87,-1.36),P<0.000 01]6个方面具有优势,且未增加不良反应发生率[RR=0.54,95%CI(0.29,1.02),P=0.06]。[结论]中医药(汤剂、外敷、针灸等)单用或联合西药治疗气阴两虚型干燥综合征比单纯西药治疗的临床疗效更加显著,且安全性相当。

[Objective] To systematically evaluate the efficacy of traditional Chinese medicine(TCM) in the treatment of Sj?gren's syndrome with deficiency of both qi and yin.[Methods] Chinese and English databases such as China National Knowledge Infrastructure(CNKI),VIP,Wanfang data,and PubMed were searched for randomized controlled trials that met the inclusion criteria from the establishment of the database to November 26,2023.[Results] Seventeen RCTs involving 1 282 patients were included.The results showed that compared with the simple Western medicine treatment,the TCM treatment had advantages in increasing clinical effective rate [RR=1.40,95%CI(1.25,1.57),P<0.000 01],improving tear secretion [SMD=0.57,95%CI(0.27,0.88),P=0.000 2],increasing saliva secretion[SMD=0.77,95%CI(0.35,1.19),P=0.000 3],improving IgG [MD=-1.57,95%CI(-2.41,-0.73),P=0.0003] and ESR [MD=-6.19,95%CI(-9.46,-2.92),P=0.000 2],and reducing ESSPRI scores [MD=-1.61,95%CI(-1.87,-1.36),P<0.000 01],and the safety was equivalent [RR=0.54,95%CI(0.29,1.02),P=0.06].[Conclusion] Chinese medicine(decoction,external application,acupuncture,etc.)alone or combined with Western medicine in the treatment of Sj?gren's syndrome with dual deficiency of qi and yin is more effective than Western medicine alone,and the safety is comparable.