新风胶囊治疗干燥综合征30例

Treating 30 Cases of sjogren's Syndrome with Xinfeng Capsule

目的:观察新风胶囊治疗干燥综合征的临床疗效。方法:将60例干燥综合征患者随机分为治疗组和对照组,每组30例。治疗组给予新风胶囊每次3粒,每日3次,口服;对照组给予白芍总苷每次0.6 g,每日3次,口服。两组均以3个月为1个疗程。分别观察两组患者治疗前后中医证候积分、测定静态唾液流率、双眼荧光素角膜评分、泪膜破碎时间、血常规、尿常规、抗核抗体谱(ANA)、C-反应蛋白(CRP)、类风湿因子(RF)、红细胞沉降率(ESR)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、血清肌肝(Cr)及免疫球蛋白IgG、IgA、IgM,补体C3、C4。结果:治疗组临床治愈7例,显效11例,有效10例,无效2例,有效率占93.33%;对照组临床治愈3例,显效10例,有效12例,无效5例,有效率占83.33%,治疗组明显优于对照组(P<0.05)。在改善症状、体征、中医证候、静态唾液流率、双眼荧光素角膜评分、泪膜破碎时间方面,两组均较治疗前好转,且治疗组优于对照组,差异有统计学意义(P<0.05);治疗组在治疗后IgG、IgA、IgM、CRP、RF、ESR等实验室指标均低于治疗前,差异有统计学意义(P<0.05);对照组治疗后IgG、IgA、RF、ESR等实验室指标低于治疗前,差异有统计学意义(P<0.05);与对照组比较,治疗组治疗后IgG、IgA、IgM、CRP、ESR等实验室指标均明显降低,差异有统计学意义(P<0.05)。两组ALT、AST、Cr、C3、C4治疗前后比较,差异无统计学意义(P>0.05)。两组治疗后血常规、尿常规、ANA均较前好转,且治疗组优于对照组(P<0.05)。治疗组无明显不良反应发生,对照组5例出现大便次数增多。结论:新风胶囊治疗干燥综合征安全有效,具有良好的临床应用前景。

Objective：To observe the clinical curative effects of Xinfeng Capsule in the treatment of sj？gren＇s syndrome.Methods：60 cases of sj？gren＇s syndrome were randomly and equally divided into a treatment group and a control group.The treatment group were given Xinfeng Capsule orally,3 capsules each time and 3 times a day;and the control group were given total glucosides of paeony orally,0.6 g each time and 3 times a day,observing,after three months（a course of treatment）,their TCM syndrome scores before and after treatment and determining their static salivary flow rate,binocular corneal fluorescein score,tear breakup time,blood routine,urine routine,antinuclear antibodies,C- reactive protein（CRP）,rheumatoid factor（RF）,erythrocyte sedimentation rate（ESR）,alanine aminotransferase（ALT）,aspartate amino-transferase（AST）,creatinine（Cr）,immunoglobulin IgG,IgA,IgM,complement C3,C4.Results：In the treatmentgroup,7 cases were cured,11 cases were markedly effective,10 cases were effective and 2 cases were invalid,the effective rate accounting for 93.33%.In the control group,3 cases were cured,10 cases were markedly effective,12 cases were effective,and 5 cases were invalid,the effective rate accounting for 83.33%.The treatment group was significantly better than the control group（P〈0.05）.The two groups were both improved on the aspects of symptoms,signs,TCM syndromes,salivary flow rate,static binocular corneal fluorescein score and tear break-up time,the treatment group being better than the control group,the difference between them being statistically significant（P〈0.05）;IgG,IgA,IgM,CRP,RF,ESR and other laboratory indexes of the treatment group after treatment were lower than those before treatment,the difference being statistically significant（P〈0.05）;IgG,IgA,RF,ESR and other laboratory indexes of the control group after treatment were lower than that those before treatment,the difference being statistically significant（P〈0.05）;compared with the control group,IgG,IgA,IgM,CRP,ESR and other laboratory indexes of the treatment group after treatment significantly decreased,the difference being statistically significant（P〈0.05）.The difference between ALT,AST,Cr,C3 and C4 of two groups before and after the treatment had no significant difference（P〈0.05）.The blood routine,urine routine,and antinuclear antibodies of the two groups after treatment were better than before,and the treatment group was better than the control group（P〈0.05）.There were no obvious adverse reactions in the treatment group,and 5 cases in the control group had increased stool frequency.Conclusion：Xinfeng Capsule was safe and effective to treat sj？gren＇s syndrome,having good prospects for clinical application.