舒肝解郁胶囊治疗老年抑郁与焦虑共病的研究

Study about Shugan Jieyu Capsule in Treating Elderly Depression and Anxiety

目的探讨舒肝解郁胶囊治疗老年抑郁与焦虑共病的疗效与安全性。方法将符合CCMD-3诊断标准、年龄≥60岁、首次发病、HAMD17得分≥17分,≤24分、HAMA14得分≥14分,≤29分,且无严重躯体疾病的71例老年抑郁症患者,应用随机数字表法分为舒肝解郁胶囊治疗组(治疗组)36例,帕罗西汀治疗组(对照组)35例。治疗组给予舒肝解郁胶囊每天4粒(早、晚餐后各2粒)。对照组给予帕罗西汀第1 d 10 mg、第4 d 20 mg、第7 d后如有必要可增加到30～40 mg(早上餐后1次顿服)。有睡眠障碍的患者允许使用唑吡坦5～10 mg/d(临睡前顿服)。研究全程为期6周,禁止应用任何抗精神病药物,或者联合其他的抗抑郁的药物。入组前及疗后的第1、2、4、6周末分别进行HAMD17、HAMA14、TESS评定。疗效以HAMD17、HAMA14总分减分率来衡量,减分≥50%为有效、≤49%为无效,总分≤7为治愈。治疗后的第6周末复查血、尿常规、肝、肾功能、心电图。治疗前后的各量表分的数据用SPSS 11.5统计软件进行统计学分析,计数资料采用χ2检验,计量资料采用t检验,均数用(x珋±s)表示,有效率用经Ridit分析,P<0.05为有统计学意义。结果:两组患者应用唑吡坦例数、时间、剂量均无统计学意义(χ2=0.12、t=1.24、0.89,P>0.05)。两组基线HAMD17、HAMA14得分无明显差异(P>0.05),治疗后组内比较,两组HAMD17、HAMA14得分在第1周末就出现了明显的下降并持续到研究结束,有统计学意义(P<0.01)。组间比较,两组HAMD17、HAMA14得分治疗后无明显差异(P>0.05)。在疗后第1周末治疗组的TESS得分明显低于对照组并持续至第4周末,有统计学意义(P<0.01)。研究结束时两组TESS得分无明显差异(P>0.05)。治疗组治愈20例,治愈率55.56%,总有效率83.33%。对照组治愈18例,治愈率51.43%,总有效率85.71%。经Ridit分析两组患者的治愈率无统计学意义(R=0.51,P>0.05)。结论舒肝解郁胶囊对老年抑郁症患者的抑郁与焦虑的共病有快速缓解的作用,且不良反应轻微,是一个疗效确切既有抗抑郁又有抗焦虑的新型的中成药。

Objective： To research Shugan Jieyu Capsule＇s safety and efficacy for the treatment of elderly depression and anxiety.Methods： According to the principle of random,71 elderly depression patients,who met the requirements of CCMD-3 diagnostic criteria,age≥60,the first onset,17≤HAMD-17≤24,14≤HAMA-14≤29,and without other serious physical diseases,were randomly divided into the treatment group（36 patients,treated with Shugan Jieyu Capsule） and the control group（35 patients,treated with paroxetine）.Patients in treatment group were given 4 Shugan Jieyu Capsules twice a day（2 after breakfast and 2 after supper）.Patients in control group were given 10 mg paroxetine at the first day,20mg on the fourth day and 30~40 mg after 6 days if necessary（once after breakfast）.Patients with sleep disturbances were allowed to take zolpidem 5~10 mg/d before sleeping.The research took 6 weeks.Anti-psychiatric drugs were forbidden,neither the other anti-depression drugs.At the end of the 1st,2nd,4th,6th week and before the research,the evaluations were taken with HAMD-17,HAMA-14 and TESS.The effects were evaluated with the reduction in total score of HAMD-17 and HAMA-14.The reduction which was equal and more than 50% was regarded as effective,while less than 50% was no effect.Total score less than 7 was regarded as being cured.At the end of the 6th week,blood routine,urine routine,liver function,kidney function and electrocardiogram were checked.The data from the beginning and end of the research were managed with the software of SPSS 11.5,and counting data were examined with χ2 and average numbers were represented with（±s）.The effective rate was analyzed with Ridit,and had statistic meaning（P0.05）.Results： For the patients taking zolpidem,the quantity,the time and the dose had no statistic meaning（χ2=0.12,t=1.24,0.89,P0.05）.The scores of HAMD-17 and HAMA-14 of the two groups at the base line had no statistic meaning.Compared with the results in the two groups,the scores of HAMD-17 and HAMA-14 in the two groups had obvious decrease from the beginning to the end,which gained statistic meaning（P0.01）,while between the two groups,the scores of HAMD-17 and HAMA-14 of the two groups before and after the treatment had no statistic meaning（P0.05）.The TESS score of the treatment group at the end of the 1st week was lower than that of the 4th week,which had statistic meaning（P0.01）.At the end of the research,the TESS scores between the two groups had no obvious significance（P0.05）.In the treatment group,there were 20 cured patients,and the cured rate was 55.56%,and total effective rate was 83.33%,while there were 18 cured patients,and the cured rate was 51.43%,and total effective rate was 85.71%.With the analysis of Ridit,the cured rates between the two groups had no statistic meaning（R=0.51,P0.05）.Conclusion： Shugan Jieyu Capsule has not only the rapid remission effect on elderly depression and anxiety,meanwhile,the capsule has few adverse reactions.Shugan Jieyu Capsule is a new Chinese patent medicine with a definite effect on depression disorders and anxiety disorders.