从“双心”探析柴胡加龙骨牡蛎颗粒对冠心病合并焦虑状态的临床研究

Clinical study of “double heart” theory with “Chaihu jia Longmu granules” in the treatment of coronary heart disease complicated with anxiety state

目的基于双心学说,探讨在冠心病常规治疗的基础上加用柴胡加龙骨牡蛎颗粒对冠心病合并焦虑状态患者心绞痛及其精神心理状态的影响。方法本研究为随机双盲安慰剂平行对照试验设计。将符合纳入标准的64例冠心病合并焦虑状态患者通过随机数字表法分为治疗组(32例)和安慰剂组(32例)。治疗组在冠心病常规治疗的基础上加用中药颗粒剂柴胡加龙骨牡蛎颗粒1袋/天;安慰剂组在常规治疗的基础上加用同等剂量的安慰剂,持续治疗6周后,比较两组患者治疗前后西雅图心绞痛量表(SAQ)、汉密尔顿焦虑量表(HAMA)、症状自评量表(SCL-90)、中医证候量表评分、不良事件发生数。结果 (1)SAQ量表评分:治疗组治疗6周后,组内前后比较在西雅图心绞痛五个维度评分均明显增高,差异有统计学意义(P<0.05)。组间比较两组疗效差异具有统计学意义(P<0.05)。(2)HAMA量表评分:治疗组HAMA量表评分明显降低,组内前后比较及组间比较差异有统计学意义(P<0.05);(3)症状自评量表评分:治疗组相对治疗前在症状总分及躯体化、强迫、人际关系、抑郁、焦虑、恐怖、偏执七个维度评分下降,组内比较差异有统计学意义(P<0.05);组间比较,治疗组在症状总分及躯体化、强迫、抑郁、焦虑、恐怖五个维度评分低于安慰剂组;差异具有统计学意义(P<0.05)。(4)中医证候评分:治疗组中医证候评分相较治疗前明显下降,差异在组内比较及组间比较均具有统计学意义(P<0.05);(5)不良事件:两组患者均未出现严重不良反应,治疗组出现3例腹泻,2例恶心;安慰剂组出现1例腹泻,1例心悸。但各不良事件构成比组间差异无统计学意义(P>0.05)。结论在冠心病常规治疗的基础上加用柴胡加龙骨牡蛎颗粒可改善冠心病合并焦虑状态患者的心绞痛及其精神心理状态。

Objective To study the effects of Chaihu jia Longmu granules on the basis of routine treatment in the treatment of the coronary heart disease complicated with the anxiety state based on the theory of double heart. Methods This study was designed as a randomized,double blind,placebo controlled trial. 64 patients with coronary heart disease and anxiety state were randomly divided into treatment group（32 cases） and placebo group（32 cases）. The treatment group was treated with Chaihu jia Longmu granules（1 bag/d） on the basis of routine therapy; the placebo group was treated with the same dose of place-bo for 6 weeks. After treatment,Seattle Angina Questionnaire（ SAQ）,Hamilton Anxiety Scale（ HAMA）,symptom checklist（SCL-90）,TCM syndrome score,the number of adverse events was compared. Results（1） The SAQ scale score： after 6 weeks treatment,the scores of five dimensions of angina pectoris in SAQ were significantly higher,the difference was statistically significant. The result of curative effect between two groups was statistically significant.（2） HAMA score： HAMA score of the treatment group was decreased significantly,the result was statistically significant;（3） SCL-90 score： total symptom score,the score of somatization,compulsion,interpersonal relationship,depression,anxiety,terror,paranoia of treatment group was decreased than before,the difference was statistically significant; total symptom score and score of somatization,compulsion,depression,anxiety,terror of treatment group was lower than the placebo group; the difference was statistically significant.（4） TCM syndrome score： the TCM syndrome score of treatment group was significantly decreased compared with before treatment,the difference was statistically significant;（5） adverse events： there were no serious adverse reaction in two groups,there were 3 cases of diarrhea,2 cases of nausea in treatment group; there was 1 cases of diarrhea and1 case of palpitation in the placebo group,. But there was no significant difference between the groups.Conclusion Chaihu jia Longmu granules combine with routine treatment of coronary heart disease can improve angina pectoris and psychological state in patients with coronary heart disease and anxiety state.