仲景“酸甘化阴”法治疗原发性不宁腿综合征随机对照研究

Randomized Study on Method of Zhongjing "Yin converted by sour and sweet combination" in the Treatment of Primary Restless Legs Syndrome

目的:通过阳性药物对照,观察仲景"酸甘化阴"法治疗原发性不宁腿综合征(RLS)临床疗效及安全性。方法:64例原发性RLS患者被随机分为观察组和对照组各32例,对照组给予普拉克索;观察组给予加味芍药甘草汤颗粒。以6周为1个疗程,共2个疗程。以RLS严重程度量表(IRLS)、匹兹堡睡眠质量指数量表(PSQI)总分为观察指标,比较两组疗效及安全性。结果:治疗6周后,观察组PSQI总分低于对照组(P<0.05),但IRLS总分与对照组比较差异无统计学意义(P>0.05);治疗12周后,两组IRLS、PSQI总分比较有统计学差异(P<0.05),观察组IRLS、PSQI总分均低于对照组;治疗6周后观察组总有效率(50.0%)虽高于对照组(46.9%),但无统计学差异(P>0.05);治疗12周后观察组总有效率(78.1.0%)高于对照组(53.1%),两组间差异具有显著性(P<0.05)。对两组进行病情严重程度的亚组分析可见,治疗6周后,无论是轻、中度组还是重、极重度组,两组间临床疗效无统计学差异(P>0.05),而治疗12周后轻、中度组两组间临床疗效有统计学差异(P<0.05),中药组优于普拉克索组,而重、极度组两组间临床疗效比较无统计学差异(P>0.05)。结论:仲景"酸甘化阴"法治疗原发性不宁腿综合征,不仅能减轻RLS患者的症状,同时也能提高睡眠质量,且不良反应少。

Objective： By comparison,It＇s observated that clinical efficacy and safety of method of Zhongjing ＂ Yin converted by sour and sweet combination＂ in the treatment of primary restless legs syndrome（RLS）. Methods： 64 cases of patients with primary RLS from January 2016 to July 2017 in Jiangxi Province Chinese medicine hospital and Nanchang sixth hospital outpatient,were randomly divided into treatment group and control group with 32 cases in each group,the control group was given pramipexole; the treatment group was given jiaweishaoyaoganchao Decoction granules. 6 weeks for 1 courses,a total of 2 courses of treatment. With the RLS severity scale（IRLS）,Pittsburgh sleep quality index scale（PSQI） score were observed,compared two groups of curative effect and safety. Results：After 6 weeks of treatment,the treatment group PSQI score lower than the control group（P 0. 05）,but no significant difference was found in IRLS score compared with control group（P 0. 05）; after 12 weeks of treatment,two groups of IRLS and PSQI scores were statistically significant difference（P 0. 05）; After 6 weeks of treatment,the total effective rate of treatment group（50%） was higher than that of the control group（46. 9%）,but no significant difference（P 0. 05）; after 12 weeks of treatment,the total effective rateof treatment group（78. 1%） was higher than the control group（53. 1%）,the difference between the two groups was significant（P 0. 05）. Subgroup analysis of the severity of the disease showed that,After 6 weeks of treatment,both groups of mild and moderate or heavy,very severe group,the clinical efficacy of the two groups had no significant difference（P 0. 05）,there is significant difference after 12 weeks of treatment of mild and moderate group clinical curative effect between the two groups（P 0. 05）,The Chinese medicine group is better than that of pramipexole group,While heavy and extreme group clinical curative effect between the two groups had no significant difference（P 0. 05）. Conclusion： method of Zhongjing ＂ Yin converted by sour and sweet combination＂ effectively not only can reduce the symptoms of patients with RLS,but also can improve the quality of sleep,and less adverse reactions.