路氏润燥汤治疗原发性干燥综合征口干症状疗效对照研究

Controlled Research of Dry Mouth in Primary Sjogren's Syndrome Treated with Lushi Runzao Decoction

目的对比研究硫酸羟氯喹与路氏润燥汤对原发性干燥综合征口干症状的疗效。方法平均将116例原发性干燥综合征气阴两虚、瘀血阻络证患者随机分为治疗组和对照组,治疗组以润燥汤辨证加减治疗,对照组服用硫酸羟氯喹片,连续治疗3个月后,观察两组患者每月口干症状VAS评分、中医证候积分表症状评分、实验室检测指标改善情况及安全性指标。结果经3个月治疗后,治疗组口干症状VAS评分、中医证候积分与治疗前比较差异有统计学意义(P<0.01);实验室指标虽有改善,但与治疗前比较差异无统计学意义(P>0.05);安全性指标与治疗前比较差异无统计学意义(P>0.05)。治疗组治疗2、3个月后口干症状评分优于对照组(P<0.05,P<0.01)。结论路氏润燥汤对原发性干燥综合征患者口干症状的VAS评分、中医证候积分疗效满意,且安全可靠,但对非刺激性混合唾液流率、血清免疫球蛋白、类风湿因子及血沉改善疗效不明显。

Objective To compare the efficacy on dry mouth in primary Sjorgren＇s syndrome（pSS） between Hydroxychloroquine Sulfate and lushi runzao decoction. Methods One hundred and sixteen cases of pSS differentiated as qi and yin deficiency and blood stagnation in collaterals were randomized into a treat- ment group and a control group. In the treatment group, the cases were treated with modified runzao decoc- tion. In the control group, Hydroxychloroquine Sulfate Tablets were prescribed for oral administration. After continuous treatment for 3 months, the dry mouth monthly VAS score, symptom score of Chinese medicine syndrome integral scale, improvement of laboratory test indexes and safety indexes were observed for the pa- tients in two groups. Results In 3 months of treatment, the dry mouth monthly VAS score and the symptom score of Chinese medicine syndrome integral scale in the treatment group were different significantly as com- pared with those before treatment （P 〈 0.01 ）. Although the laboratory test indexes were improved in the treat- ment group, the difference was not significant statistically as compared with that before treatment （P 〉 0.05 ）. The differences in the safety indexes were not significant statistically as compared with that before treatment （ P 〉 0.05 ）. The score of dry mouth in 2 and 3 months treatment in the treatment group was superior to the control group （ P 〈 0.05,P 〈 0.01 ）. Conclusion Lushi runzao decoction achieves the satisfactory efficacy in dry mouth VAS score and Chinese medicine syndrome integral in the patients of pSS. It is safe and reliable. But this decoction does not achieve the obvious efficacy in terms of unstimulated mixed saliva flow rate, serum immunogloblin,rheumatoid factor and improvement in blood sedimentation.