世界中医药

目的:观察内消连翘丸治疗原发干燥综合征的临床疗效。方法:采用随机、单盲对照法,将原发干燥综合征患者60例,随机分为2组,观察组30例,应用内消连翘丸治疗;对照组30例,应用硫酸羟氯喹治疗,共治疗6个月。分别在治疗前、治疗后4周、12周、24周对患者进行10 cm视觉模拟量表测定口干、眼干症状,检测患者C反应蛋白（CRP）、红细胞沉降率（ESR）、免疫球蛋白（IgG、IgA、IgM）,唾液流率、Schirmer试验及泪膜破碎时间等指标。结果:临床总有效率观察组优于对照组（P<0.05）。治疗早期（4周）口干症状改善观察组优于对照组（P<0.05）,长期应用口干眼干症状的改善在2组患者间比较,差异无统计学意义（P>0.05）。观察组降低免疫球蛋白G指标优于对照组（P<0.05）,观察组未发现明显不良反应。结论:内消连翘丸能早期有效改善原发干燥综合征患者的临床症状,且可不同程度改善患者免疫指标。

English Summary:

To observe the clinical effect of Neixiao Lianqiao pills in the treatment of primary xerosis syndrome. Methods:Sixty cases of primary xerosis syndrome patients were randomly divided into 2 groups with 30 cases in each. The treatment group takes Neixiao Lianqiao pills and the control group takes hydoxychloroquine sulfate. Treatment course lasts for 6 months. Monitor and measure dry mouth and dry eye symptom, C Reactive Protein （CRP）, Erythrocyte Sedimentation Rate （ESR）, immunoglobulin （IgG, IgA, IgM）, salivary flow rate, Schirmer test and tear film broken time with 10 cm VAS （visual analogue scale） method before and after 4 weeks, 12 weeks and 24 weeks of treatment. Results:The total effective rate of the treatment group was better than that of the control group （P<0.05）. During early treatment period （4 weeks）, dry mouth symptom was better improved in the treatment group than in the control group （P<0.05）. During long period of treatment, improvement in dry mouth and dry eye symptoms of two groups had no statistically significant difference （P>0.05）. The immunoglobulin （IgG） decrease of treatment group was larger than that of the control group （P<0.05）, and no significant adverse reactions were found in the treatment group. Conclusion:Neixiao Lianqiao pills can effectively improve the clinical symptoms of patients with primary xerosis syndrome and the immune indexes of patients.

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