补肾清热润燥汤治疗原发性干燥综合征阴虚燥热证的随机对照研究

A randomized controlled trial on the treatment of primary Sjögren syndrome with yin deficiency and dryness-heat pattern with Bushen Qingre Runzao Decoction

目的评价补肾清热润燥汤(生地黄、麦冬、石斛、牡丹皮、淡竹叶、连翘、桑叶、砂仁)治疗原发性干燥综合征(PSS)阴虚燥热证患者的有效性和安全性。方法采用随机对照试验的方法,纳入2020年9月—2023年1月于中日友好医院中医风湿病科就诊的PSS阴虚燥热证患者,按照随机数字表法1∶1分为试验组和对照组。试验组予以补肾清热润燥汤治疗,对照组予以硫酸羟氯喹片治疗,疗程12周。比较2组患者口干、眼干、疲乏、肢体疼痛、整体干燥症状视觉模拟评分法(VAS)评分,欧洲抗风湿病联盟干燥综合征患者报告指数(ESSPRI)、疾病活动指数(ESSDAI),唾液流率,Schirmer试验,免疫炎症指标[血清免疫球蛋白(IgG、IgA、IgM),补体(C3、C4),红细胞沉降率及C-反应蛋白]及健康调查简表(SF-36)各项评分的差异,并观察不良反应。结果共纳入96例PSS患者,每组48例。治疗12周后,试验组口干VAS评分、眼干VAS评分、整体干燥症状VAS评分均低于对照组(均P<0.05)。试验组治疗12周后,口干VAS评分、眼干VAS评分、ESSPRI、整体干燥症状VAS评分较治疗前降低(均P<0.05),且Schirmer试验结果、SF-36中健康变化评分较治疗前升高(均P<0.01)。对照组治疗12周后,疲乏VAS评分较治疗前降低(P<0.01),血清IgA、C3、C4、SF-36中健康变化评分较治疗前升高(均P<0.05)。试验组仅见1例腹泻及1例稀便,对照组见1例皮疹及1例皮肤颜色变黑。2组均未见严重不良反应。结论补肾清热润燥汤能够有效改善PSS阴虚燥热证患者的口、眼干燥等症状,增加泪液分泌量,且安全性高。

Objective This study aimed to evaluate the efficacy and safety of Bushen Qingre Runzao Decoction(rehmanniae radix,ophiopogonis radix,dendrobii caulis,moutan cortex,lophatheri herba,forsythiae fructus,mori folium,and amomi fructus)in treating primary Sjögren syndrome(PSS)with yin deficiency and dryness-heat pattern.Methods A randomized controlled trial was conducted.PSS patients with yin deficiency and dryness-heat pattern who were admitted to TCM Department of Rheumatism of China-Japan Friendship Hospital from September 2020 to January 2023,were enrolled.Patients were randomized 1∶1 into the treatment and control groups.The treatment group was treated with Bushen Qingre Runzao Decoction,and the control group was administered hydroxychloroquine sulfate tablets.The duration of intervention in both groups was 12 weeks.The differences in Vision Analog Scale(VAS)scores of dry mouth,dry eyes,fatigue,body pain,overall dry symptoms,and European League Against Rheumatism(EULAR)Sjögren Syndrome Patient-Reported Index(ESSPRI),Sjögren Syndrome Disease Activity Index(ESSDAI),salivary flow rate,Schirmer’s test,and immune inflammation index[serum immunoglobulins(IgG,IgA,IgM),complements(C3,C4),erythrocyte sedimentation rate,Creactive protein]between the two groups were compared,and adverse reactions were observed.Results A total of 96 patients were included,with 48 cases per group.After 12 weeks of intervention,the VAS scores of dry mouth,dry eyes,and overall dryness symptoms were lower in the treatment group than those in the control group(all P<0.05).In the treatment group,after 12 weeks of intervention,the VAS scores of dry mouth,dry eyes,and overall dryness symptoms and ESSPRI were significantly lower than those before treatment(all P<0.05),and the Schirmer’s test result and health change scores of SF-36 were significantly higher than those before treatment(both P<0.01).In the control group,after 12 weeks of intervention,the VAS score of fatigue(P<0.01)was lower than that before treatment,and serum levels of IgA,C3,C4,and health change score of SF-36 were higher than those before treatment(all P<0.05).There was only one case of diarrhea and one case of loose stool in the experimental group,and one case of rash and one case of skin color darkening in the control group.No serious adverse reactions were observed in both groups.Conclusion Bushen Qingre Runzao Decoction has a high safety profile and can effectively improve dryness symptoms such as dry mouth and eyes and increase tear secretion in PSS patients with yin deficiency and dryness-heat pattern.