内消连翘丸治疗原发干燥综合征的临床研究

Clinical Study of Neixiao Lianqiao Pills in the Treatment of Primary Xerosis Syndrome

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。

Objective ： 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 hydoxyehloroquine sulfate. Treatment course lasts for 6 months. Mo- nitor and measure dry mouth and dry eye symptom, C Reactive Protein （CRP） , Erythroeyte Sedimentation Rate （ ESR）, immuno- globulin （IgG, IgA, IgM） , salivary flow rate, Schirmer test and tear film broken time with 10 em 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 im- proved 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 treat- ment group. Conclusion ：＇Neixiao Lianqiao pills can effectively improve the clinical symptoms of patients with primary xerosis syn- drome and the immune indexes of patients.