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目的:观察甘皂口服液对干燥综合征患者症状改善情况和实验室指标的变化的临床研究。方法:选取2012年6月—2014年6月淮安市第一人民医院收治的82例原发性干燥综合征患者,按简单随机的方法分为实验组(40例)和对照组(42例),其中对照组给予常规对症替代治疗,实验组再给予甘皂液。两组疗程均为3个月,分别于治疗前和治疗后观察指标的变化及其差异性。结果:给药前后,实验组给药后临床症状眼干、口干、便秘、舌质干等明显改善(P<0.01);对照组给药后亦有所改善(P<0.05),实验组疗效优于对照组(P<0.05)。实验组总有效率为85.00%,对照组总有效率为59.52%,两组疗效经统计学比较,具有显著性差异(P<0.01)。实验室Anti-SSA(Ro)、Anti-SSB(La)、免疫球蛋白、ANA等指标阳性率经统计学比较未见明显差异(P>0.05);治疗后两组患者的ESR、CRP都有所下降,且实验组较对照组降低得更为明显(P<0.05),有统计学意义。结论:甘皂口服液能改善干燥综合征患者的临床症状,降低中医证候学积分,抑制炎症反应,改善部分实验室指标,故甘皂口服液能临床治疗原发性干燥综合征,提高人们的生活质量。
Objective: To observe the clinical effect of Ganshuang Oral Liquid on the improvement of symptoms and laboratory indexes in patients with Sjogren’s syndrome. Methods: A total of 82 patients with primary Sjogren’s syndrome who were treated in Huai’an First People’s Hospital from June 2012 to June 2014 were selected and randomly divided into experimental group (40 cases) and control group (42 cases) , In which the control group was given conventional symptomatic replacement therapy, and the experimental group was given the soap solution again. The two courses of treatment were 3 months, respectively, before and after treatment to observe the changes of indicators and their differences. Results: Before and after administration, the clinical symptoms such as dry eye, dry mouth, constipation and dry tongue were significantly improved (P <0.01); the experimental group also improved after administration (P <0.05) The curative effect is better than the control group (P <0.05). The total effective rate was 85.00% in the experimental group and 59.52% in the control group. There was significant difference between the two groups (P <0.01). The positive rates of Anti-SSA (Ro), Anti-SSB (La), immunoglobulin and ANA in laboratory had no statistical difference (P> 0.05). After treatment, ESR and CRP in both groups had Decreased, and the experimental group decreased more significantly than the control group (P <0.05), with statistical significance. Conclusion: Ganshuang oral liquid can improve the clinical symptoms of patients with Sjogren’s syndrome, reduce TCM syndrome score, inhibit inflammatory reaction and improve some laboratory indexes. Therefore, Ganshuang oral liquid can clinically treat primary Sjogren’s syndrome The quality of life