健脾润燥通络方加减治疗脾虚络阻型原发性干燥综合征30例临床观察

Modified Jianpi Runzao Tongluo Formula(健脾润燥通络方)for Primary Sjogren's Syndrome of Spleen Deficiency and Collateral Obstruction Pattern in 30 Cases

目的观察健脾润燥通络方加减治疗脾虚络阻型原发性干燥综合征(pSS)的有效性及安全性。方法将60例脾虚络阻型pSS患者随机分为治疗组和对照组各30例。治疗组予口服健脾润燥通络方,每日1剂。对照组予口服硫酸羟氯喹片,每次200 mg,每日2次,两组疗程均为12周。观察治疗前后两组中医症状积分、患者报告指数(ESSPRI)、疾病活动指数(ESSDAI)、唾液流量、泪流量、血沉(ESR)、C反应蛋白(CRP)、免疫球蛋白G(IgG)、补体3(C3)、补体4(C4)的变化,判定临床疗效并观察不良反应。结果治疗组总有效率(90.0%)高于对照组(43.3%)(P<0.01)。治疗后治疗组各中医症状积分、ESSPRI、IgG,对照组关节肌肉疼痛评分较治疗前明显降低;治疗组唾液流量、双侧泪流量,对照组唾液流量均较治疗前明显增加(P<0.05或P<0.01)。治疗后除眼干外,治疗组各中医症状积分、ESSPRI均低于对照组,唾液流量、双侧泪流量均较对照组明显增加(P<0.05或P<0.01)。结论健脾润燥通络方加减可改善脾虚络阻型pSS患者的临床症状,增加唾液流量、泪流量,降低IgG,未见明显不良反应。

Objective To explore the effectiveness and safety of modified Jianpi Runzao Tongluo Formula(健脾润燥通络方)in treating primary Sjogren's syndrome(pSS)of spleen deficiency and collateral obstruction pattern.Methods Sixty pSS patients of spleen deficiency and collateral obstruction pattern were randomly divided into treatment group and control group,with 30 patents in each group.The treatment group was orally administered with Jianpi Runzao Tongluo Formula,one dose daily,while the control group was given oral hydroxychloroquine sulfate tablets,200 mg each time,twice daily,both groups treated for 12 weeks.The traditional Chinese medicine(TCM)symptom score,EULAR Sjogren's syndrome patient reported index(ESSPRI),EULAR Sjogren's syndrome disease activity index(ESSDAI),saliva flow,tear flow,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),immunoglobulin G(IgG),complement 3(C3),complement 4(C4),and adverse events were assessed before and after treatment.Results The total effective rate of treatment group was 90.0%,significantly higher than 43.3%of control group(P<0.01).Compared to those before treatment,TCM symptom score,ESSPRI and IgG in treatment group,as well as muscle pain scores in control group significantly decreased after treatment;the saliva flow,bilateral tear flow in treatment group,and saliva flow in control group significantly increased after treatment(P<0.05 or P<0.01).When compared to the control group,treatment group had significantly better improvement on all TCM symptoms except for dry eyes,lower ESSPRI,and higher saliva flow and bilateral tear flow(P<0.05 or P<0.01).Conclusion Jianpi Runzao Tongluo Formula can improve the clinical symptoms,increase saliva and tear flow,and reduce IgG when treating pSS patients of spleen deficiency and collateral obstruction pattern,and there are no significant adverse events.