摘要
目的观察金菊清润胶囊治疗原发性干燥综合征的临床疗效。方法将100例原发性干燥综合征患者按照随机双盲安慰剂对照原则,分为治疗组与对照组各50例。治疗组口服金菊清润胶囊与强的松模拟剂,对照组口服金菊清润胶囊模拟剂与强的松,两组均配合滴眼液,疗程3个月。观察患者临床疗效、中医证候疗效、唾液流量、泪流量、免疫等指标的变化。结果临床总有效率治疗组优于对照组(P<0.05),中医证候疗效总有效率治疗组优于对照组(P<0.01)。改善唾液流率、泪流率方面两组比较差异有统计学意义(P<0.05);两组患者治疗后免疫指标比较差异无统计学意义(P>0.05),治疗组未发现明显不良反应。结论金菊清润胶囊不仅能有效改善原发性干燥综合征患者的临床症状及中医证候,且可通过调节免疫平衡治疗原发性干燥综合征。
Objective To explore the clinical therapeutic effect of Jinju Qingrun Capsule （Capsule for Clearing Heat and Moistening Dryness） on primary Sjogren＇s syndrome （PSS）. Methods In the double blind placebo controlled trial, 100 PSS cases were randomized into a treatment and a control group with 50 in each. The treatment group was administrated Jinju Qingrun Capsule and prednisone simulation agent and the control group was given Jinju Qingrun Capsule simulation agent and prednisone. Eye drops was used for both groups. The course of treatment was 3 months. The clinical effect, TCM syndrome effect, and changes in saliva flow rate and tears flow rate and immunity indices were observed. Results The clinical total effective rate of the treatment group was better than that of the control group （P〈0.05） and total effective rate of TCM syndrome effect of the treatment group was better than that of the control group （P〈0.01）. There was a significant difference between two groups in improving the saliva flow rate and tears flow rate （P〈0.05）. There was no significant difference between two groups in immunity indices after treatment （P〉0.05）. Untoward reactions were not found in the treatment group. Conclusion Jinju Qingrun Capsule is effective in improving the clinical symptoms and TCM syndromes of PSS patients and it treats PSS through regulating the immunity system of patients.
出处
《中医杂志》
CSCD
北大核心
2009年第8期708-711,共4页
Journal of Traditional Chinese Medicine
关键词
原发性干燥综合征
金菊清润胶囊
络病理论
强的松
中医药疗法
Primary Sjogren＇s syndrome （PSS）
Jinju Qingrun Capsule（Capsule for Clearing Heat and Moistening Dryness）
TCM theory of collateral diseases
Prednisone
TCM therapy
