2种不同中药复方治疗轻度原发性干燥综合征随机双盲对照研究

A randomized double-blind controlled study of two different Chinese herbal medicines in the treatment of mild primary Sjogren's syndrome

目的对比解毒通络生津颗粒与桑珠滋阴口服液治疗轻度原发性干燥综合征(pSS)的临床疗效。方法将60例轻度pSS患者随机分为2组。解毒通络生津颗粒组30例予解毒通络生津颗粒和安慰剂治疗;桑珠滋阴口服液组30例予桑珠滋阴口服液和安慰剂治疗。2组均连续服用3个月后统计临床疗效,比较2组治疗前后干燥综合征疾病活动度指数(ESSDAI)、唾液流率、泪膜破裂时间、血清免疫球蛋白G(IgG)及IgA水平,中医证候积分变化。结果解毒通络生津颗粒组总有效率66.67%,桑珠滋阴口服液组总有效率68.97%,2组总有效率比较差异无统计学意义(P>0.05),临床疗效相当。治疗后,2组ESSDAI均较本组治疗前下降(P<0.05),唾液流率升高(P<0.05),左眼及右眼泪膜破裂时间延长(P<0.05),IgA、IgG水平及中医证候积分下降(P<0.05),但2组组间比较及治疗前后差值比较差异均无统计学意义(P>0.05)。结论解毒通络生津颗粒及桑珠滋阴口服液治疗活动期轻度p SS疗效相当。

Objective To compare the clinical efficacy of Jiedu-Tongluo-Shengjin granules and Sangzhu Ziyin Oral Liquid on mild primary Sj9 gren＇s syndrome（ pS S）. Methods 60 patients with pS S were randomly divided into two groups. 30 cases in Jiedu-Tongluo-Shengjin granule group were treated by Jiedu-Tongluo-Shengjin granule and placebo,and 30 cases in Sangzhu Ziyin oral liquid group were treated by Sangzhu Ziyin oral liquid and placebo. The clinical efficacy was statistically evaluated after continuous treatment for 2 months in two groups. The scores of Sj9 gren ＇s syndrome disease activity index（ ESSDAI）,tear film rupture time,serum immunoglobulin G（ IgG） and serum immunoglobulin A（ IgA） levels,and TCM syndrome scores before and after treatment were compared. Results The total effective rate was 68. 97 % in Jiedu-Tongluo-Shengjin granules group and 66. 67 % in Sangzhu Ziyin oral Liquid group. There was no significant difference in the total effective rate between the two groups（ P〉0. 05）,the clinical efficacy was comparable. After treatment,both groups of ESSDAI were lower than that before treatment（ P〈0. 05）,salivary flow rate was increased（ P〈0. 05）,tear film rupture time was prolonged in left and right eyes（ P〈0. 05）,IgA,IgG levels and the scores of TCM syndromes were decreased（ P〈0. 05）,but there was no significant difference in the comparison between the two groups and no significant difference in the D-value of two groups before and after treatment（ P〉0. 05）. Conclusion The therapeutic effect of Jiedu-Tongluo-Shengjin granules and Sangzhu Ziyin oral liquid in the treatment of mild pS S at activity stage was equal.