|Place of Conferral||中国科学院心理研究所|
|Keyword||复方马蹄香 广泛性焦虑 肝气郁结 心神不宁 临床研究|
复方马蹄香源自“全国优秀中医临床人才”郑虎占教授的临床经验方。该复方以理气解郁，养血安神为治则，山蜘蛛香、合欢皮、酸枣仁和灯心草四味药组成。本研究系统梳理其治疗厂‘泛性焦虑的理论基础，同时运用随机、安全性、阳性药物对照临床研究初步探讨其临床疗效。实验选择属肝气郁结、心神不宁型的广泛性焦虑症患者67名，随机分为治疗组(34例)给予复方马蹄香治疗，对照组(33例)给予黛力新治疗，两组给药4周。治疗前及治疗第2周、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。最后对患者的评分情况进行统计处理，得出结论。(1)病例完成情况:治疗组2例因生活突发事件影响，4周内LES中单项生活事件刺激量增减大于4分予以剔除，2例因自行改变用药剂量予以排除;对照组1例入组后加用SSRls类药品予以中止试验，2例失访。最终纳入病例数60例，治疗组与对照组各30例。(2)两组治疗方案治疗指数比较:经过2周治疗，治疗组临床治愈、显效、有效、无效例数分别为3, 4, 13, 10，总有效率66.7%，对照组临床治愈、显效、有效、无效例数分别为0, 3, 12, 15，总有效率50%，两组患者总有效率经IVlan} }Jl}itnoy U检验(P>0.05),不存在统计学意义差异;治疗4周后，治疗组临床治愈、显效、无效例数分别为10, 10, 7, 3，总有效率90%;对照组临床治愈、显效、有效、无效例数分别为4, 20, 3, 3,总有效率亦为90%，治疗组与对照组总有效率相等，组间比较无统计学意义差异(P>0.05 )。在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意义(P>0.05 )。(3)组.内比较:两组患者HAMA总分在治疗第2周、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周后、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周、4周时均有所下降(P<0.05;P<0.01)。(4)不良反应发生率方面:受试者治疗期间及治疗结束2周后心率、血压、呼吸、脉搏等一般情况未见明显异常。在4周的治疗过程中，治疗组第1周有2名患者出现不良反应，包括轻度胃院部刺激感(1例)、轻度咽干((1例)，经过分多次、饭后服用等调整，上述症状消失。对照组有4例出现不良反应，包括便秘(Cl例)、口干(I例)、头晕(Cl例)、中度出汗((1例)，均在可耐受程度，未予特殊处理。治疗组不良反应发生率低于对照组C 6.67% vs. l 3.3%,P<0.01)。
Generalized anxiety disorder (GAD) is a common and frequently occurring disease in clinic. It has the characteristics of easy recurrence and difficult to cure. The onset of the disease is slow, long-term performance for non fixed object content, nervous, no specific situation and cause discomfort and autonomic dysfunction associated with all aspects of physical performance. Most of the GAD patients are sensitive to stimulus and have significant sleep disorder. Freud believes that the vast majority of the pain experience stems from childhood or juvenile period of various desires, instincts and emotions caused by repression. The family is the main place in the process of individual socialization. It is the background of individual life. Therefore, there is a certain genetic predisposition and familial aggregation in anxiety.At present, Chinese and Western medicine treatment for GAD has its limitations, the development of effective and less side effects of anti anxiety drugs have been the future direction.
Antianxietic compound prescription with hale}ianae Jatamansi Rhizoma et Radix(ACPV) is from professor Zheng Iluzhan's clinical experience, the "National outstanding clinical talents of Chinese medicine", Professor of Beijing University of Chinese Medicine. ACPV is composed of valeriana jatamansi Jones, Ziziphi Spinosae Semen, Albiziae Coy^tex and Junci Medulla. This study explored the theoretical basis for the treatment of GAD and explored the clinical efficacy of randomized, safe, positive drug controlled clinical study. This study selected 67 GAD patients of stagnation of liver qi and feel ill at ease type, who were randomly divided into treatment group (34 cases) treated with ACPV treatment, the control group (33 cases) with deanxit. Both groups were treated with respective drugs for 4 weeks. HAMA scale, traditional Chinese medicine (TCM) symptom scale and salivary cortisol levels were measured before and 2 weeks and 4 weeks after drug treatment.The life events scale (L,ES) and drug safety evaluation were performed before and after 4 weeks treatment. Finally, a statistical method was used to assess the patient's scores and draw conclusions: (1)the completion of cases: excluded according to LES, within 4 weeks, the nmnber of single event stimuli in LES changed by snore than 4 points and was eliminated,2 cases were excluded by changing the dosage; The control group (1 cases) was discontinued because of the use of SSRIs drugs,2 cases were lost.The final number of cases included 60 cases, the treatment group and the control group 30 cases each. (2) Comparison of clinical efficacy between the two groups:After 2 weeks of treatment, the number of cured, markedly effective, effective and ineffective cases in treatment group was 3, 4, 13 and 10 respectively, the total efficiency is 66.7%; the number of cured, markedly effective, effective and ineffective cases in the control group was 0, 3, 12 and 15, respectively, the total efficiency is 50%, there is no statistically significant difference between the total effective rate of two groups by Mann Whitney U test (P>0.05); after 4 weeks of Treatment, the number of cured, markedly effective, effective and ineffective cases in treatment group was 10, 10, 7 and 3 respectively, the total efficiency is 90%; the number of cured, markedly effective, effective and ineffective cases in control group was 4, 20, 3 and 3 respectively, the total efficiency is also 90%, the total efficiency of treatment group and control group is equal, no statistically significant difference between groups (P>0.05). There were no statistically significant differences in HAMA scores, TCM Syndrome Scale scores and salivary cortisol levels (P>0.05). (3)Group comparison: Compared with baseline, HAMA scores in both groups were significantly decreased at 2 weeks and 4 weeks (P<0.05 and P<0.01，respectively).After 2 weeks and 4 weeks treatment, the TCM syndrome in both group was also significantly reduced (P< 0.01).Moreover, the salivary cortisol levels in both groups were also decreased at 2 weeks and 4 weeks (P<0.05 and P<0.01，respectively). (4)The incidence of adverse reactions: there was no significant abnormal in heart rate,blood pressure, respiration and pulse between the treatment and ? weeks after treatment. In the course of treatment for 4 weeks, first weeks of treatment group 2 patients had adverse reactions, including mild epigastric irritation (1 cases), mild throat (1 cases), after multiple points, after meals and other adjustments, the symptoms disappeared. There were 4 cases of adverse reactions in the control group,including constipation (1 cases), dry mouth (1 cases), dizziness (1 cases) and moderate sweating (1 cases), and all of them were not treated with special treatment. The incidence of side effects in the treatment group was lower than that of control group (6.6}%, vs.13.3%, P<0.01).
In summary, ACPV is effective drug for treatment of GAD (stagnation of liver qi and feel ill at ease type).
|白俊爽. 复方马蹄香治疗广泛性焦虑症的临床研究[D]. 中国科学院心理研究所. 中国科学院大学,2017.|
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