目的 观察自拟金菊清润胶囊治疗原发性干燥综合征的临床疗效.方法 将60例原发性干燥综合征患者,按照随机原则,分为治疗组(中药自拟金菊清润胶囊组)与对照组(硫酸羟氯喹组)各30例予以相应治疗,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、免疫指标的变化.结果 治疗组临床、中医证候疗效总有效率优于对照组(86.2% vs 57.1%,89.6% vs 46.4%,P<0.05,P<0.01);单症状起效时间短于对照组(P<0.01);唾液流率、泪流率改善治疗组优于对照组(3.6 mm/5 min±1.4 mm/5 min vs 2.8 mm/5 min±1.5 mm/5 min,2.9 g/5 min±2.4 g/5 min vs 1.2 g/5 min±0.3 g/5 min,P均<0.05),2组间免疫指标比较差异无统计学意义(P>0.05),均未发现明显不良反应.结论 自拟金菊清润胶囊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,缩短临床起效时间,改善唾液流率及泪流率.%Objective To observe the clinical therapeutic effect of self-made Jinjuqingrun capsule on primary Sjogrens syndrome. Methods 60 patients who were diagnosed as primary Sjogrens syndrome were enrolled and randomly divided into treatment group ( with self-made traditional Chinese medicine of Jinjuqingrun capsule )and control group( hydroxychloroquine sulfate group )with 30 patients in each group. The courses of treatment were 3 months. The changes of clinical effect, TCM syndrome effect, salivary flow, tear flow, immune and other index were observed. Results The clinical and TCM syndrome effect were better than the control group( 86. 2% vs. 57.1%,89.6% vs46.4%,P <0.05,P <0. 01 ); single symptom onset time were shorter than that of control group( P <0. 01 ). The improvement of salivary flow and tear flow were better than the control group(3.6 mm/5 min±1.4 mm/5 min vs. 2.8 mm/5 min±1.5 mm/5 min, 2.9 g/5 min±2.4 g/5 min vs. 1.2 g/ 5 min ±0. 3 g/5 min, P <0. 05 ). There were no statistical differences of immune indexes comparison between the two groups ( P >0.05 ), no significant adverse reactions were found. Conclusion Self-made Jinjuqingrun capsule can effectively improve the clinical and TCM syndrome effect in patients with primary Sjogrens syndrome, shorten the clinical onset time and improve the salivary flow and tear flow.
展开▼
