白俊爽+张青川+郭丹丹+郑虎占+石晋丽+郭建友

[摘要] 觀察复方马蹄香对肝气郁结、心神不宁型广泛性焦虑患者的临床疗效。选择67例属肝气郁结、心神不宁型的广泛性焦虑症患者，随机分为治疗组（34例）和对照组（33例），治疗组给予复方马蹄香，对照组给予黛力新治疗，2组均采用药物治疗4周。治疗前及治疗第2，4周采用汉密尔顿焦虑量表（HAMA）进行疗效评价；以中医证候量表（肝气郁结、心神不宁型）观察焦虑评分；同时取患者唾液测定皮质醇（cortisol）含量；并于治疗前和治疗4周后测量生活事件量表（LES），进行药物安全性评价。通过测量生活事件量表剔除2例患者，中止5例，最终共60例患者纳入该研究（每组30例）。2组患者HAMA总分在治疗第2，4周时均有所改善（P<0.05，P<0.01）；中医证候量表积分改善情况在治疗2，4周后均具有显著统计学意义（P<0.01）；唾液皮质醇水平在治疗第2，4周时均有所下降（P<0.05，P<0.01）。治疗2周后与4周后2组间比较总有效率无统计学意义差异，HAMA积分、中医证候量表积分、唾液皮质醇水平改善方面组间差异也均无统计学差异。不良反应发生率方面，治疗组（6.67%）低于对照组（13.3%）（P<0.01），受试者治疗期间一般体检项目未见明显异常。因此，复方马蹄香对肝气郁结、心神不宁型广泛性焦虑症疗效确切。

[关键词] 复方马蹄香； 广泛性焦虑； 肝气郁结； 心神不宁； 临床研究

[Abstract] This study was aimed to observe the clinical efficacy of anxiolytic compound prescription with Valerianae Jatamansi Rhizoma et Radix （ACPV） in treating liver Qi stagnation and feel ill at ease type generalized anxiety disorder （GAD）. Sixty-seven patients diagnosed as GAD with stagnation of liver Qi and feel ill at ease were randomly divided into treatment group and control group. Patients in treatment group （n=34） was treated with ACPV decoction， and patients in control group （n=33） were treated with deanxit. Both groups were treated with respective drugs for 4 weeks. HAMA scale， traditional Chinese medicine （TCM） symptom scale （liver Qi stagnation and feel ill at ease type） and salivary cortisol levels were measured before and 2 weeks and 4 weeks after drug treatment. The life events scale （LES） and drug safety evaluation were performed before and after 4 weeks treatment. Two patients were excluded according to LES， and 5 patients were discontinued. Sixty patients were enrolled in the study finally （30 cases in each group）. As compared with baseline， HAMA scores in both groups were significantly decreased at 2 weeks and 4 weeks （P<0.05， P<0.01）. After 2 weeks and 4 weeks treatment， the TCM syndrome score in both group was also significantly improved （P<0.01）. Moreover， the salivary cortisol levels in both groups were also decreased at 2 weeks and 4 weeks （P<0.05， P<0.01）. The total efficiency between two groups had no statistically significant difference after 2 weeks treatment and 4 weeks treatment； moreover， no statistically significant differences were observed between two groups in HAMA scores， TCM syndrome scale scores and salivary cortisol levels between two groups. The incidence of adverse reactions in the treatment group was significantly lower than that in the control group （P<0.01）， and there were no obvious side effects in general physical examination during the period of treatment. Thus， anxiolytic compound prescription with Valerianae Jatamansi Rhizoma et Radix is effective for GAD （stagnation of liver Qi and feel ill at ease type）.endprint

[Key words] compound prescription with Valerianae Jatamansi Rhizoma et Radix； generalized anxiety disorder； stagnation of liver Qi； feel ill at ease； clinical research

广泛性焦虑（又称慢性焦虑，generalized anxiety disorder，GAD）是焦虑症的最常见表现形式。该病起病缓慢，表现为长期无固定内容、对象的紧张不安，不因具体情境所引起，并伴有躯体各方面的不适及植物神经功能紊乱的表现。广泛性焦虑在传统中医药理论中属“郁证”的范畴，中医药对焦虑症有较好的治疗效果。复方马蹄香源于“全国优秀中医临床人才”北京中医药大学郑虎占教授的临床经验方。该复方切中焦虑常见病机，以理气解郁，养血安神为治则，由蜘蛛香、合欢皮、酸枣仁和灯心草4味药组成。本文对复方马蹄香治疗肝气郁结、心神不宁型的广泛性焦虑症进行临床观察，现报道如下。

1 资料与方法