解毒通络生津方治疗原发性干燥综合征血液系统损害的临床研究

A Clinical Study on the Treatment of Blood System Damage of Primary Sjögren's Syndrome with Jiedu Tongluo Shengjin Fang(解毒通络生津方)

目的:探讨解毒通络生津方治疗干燥综合征血液系统损害的疗效及安全性。方法:将72例原发性干燥综合征患者随机分为治疗组和对照组,每组36例。治疗组以解毒通络生津方联合羟氯喹治疗,对照组以醋酸泼尼松联合羟氯喹治疗。2组1个疗程均为12周。比较2组治疗前后血常规、红细胞沉降率、C-反应蛋白、补体、免疫球蛋白(Ig)、SSDDI评分、骨代谢、感染事件等,进行疗效及安全性评价。结果:治疗后,2组白细胞降低、贫血、血小板减少、红细胞沉降率、C-反应蛋白均有改善,但组间比较,差异无统计学意义(P>0.05)。治疗组可升高补体C3,对照组可升高补体C4,组间比较,差异无统计学意义(P>0.05)。2组治疗前后SSDDI评分均<4分,治疗前后均未出现其他系统损害。2组均可降低IgG,治疗组可降低IgA,对照组可降低IgM,但组间比较,差异无统计学意义(P>0.05)。对照组25羟基维生素D水平较基线值显著降低(P<0.05),治疗组无明显变化(P>0.05)。对照组的感染事件多于治疗组(P<0.05)。2组均可改善患者的中医症状,但治疗组疗效更显著(P<0.05)。结论:解毒通络生津方联合羟氯喹对干燥综合征血液系统损害有治疗作用,可改善患者的炎症指标、抑制自身免疫,对患者的骨代谢影响更小,安全性较好。

Objective：To investigate the curative effect and safety of Jiedu Tongluo Shengjin Fang（解毒通络生津方） in the treatment of blood system damage of primary sj？gren＇s syndrome.Methods：Seventy-two cases of primary sj？gren＇s syndrome were randomly divided into a treatment group and a control group,36 cases in each.The treatment group was treated with Jiedu Tongluo Shengjin Fang combined with hydroxychloroquine,while the control group with prednisone combined with hydroxychloroquine.The two groups were treated for 12 weeks.Both groups were compared on the aspects of blood routine index,erythrocyte sedimentation rate,Creactive protein,complement,immunoglobulin（Ig）,SSDDI score,bone metabolism and infection before and after treatment.The evaluation of efficacy and safety were made.Results：After treatment,both groups had a reduction of white blood cells,anemia,thrombocytopenia,and improvement of erythrocyte sedimentation rate and C-reactive protein,but there was no significant statistical difference between groups（P 〈0.05）.The treatment group could increase C3,the control group could increase C4,and there was no significant statistical difference between groups（P 〈0.05）.The SSDDI scores of the two groups were below 4 respectively before and after treatment,without other system damages.Both groups could lower IgG,the treatment group could decrease IgA,the control group could decrease IgM and there was no significant difference between the two groups（P 〈0.05）.The level of 25 hydroxy vitamin D in the control group was significantly lower than that of the baseline（P 〈0.05）,while there was no significant change in the treatment group（P 〈0.05）.The infection occurrence in the control group was more than that in the treatment group（P 〈0.05）.Symptoms from the angle of traditional Chinese medicine were improved,but the curative effect of the treatment group was more significant（P 〈0.05）.Conclusion：Jiedu Tongluo Shengjin Fang combined with hydroxychloroquine has a curative effect on the blood system damage of primary sj？gren＇s syndrome,improving patients＇ inflammatory index,suppressing autoimmunity,having less effect on bone metabolism,and being safe.