理气安神方治疗恶性肿瘤患者伴抑郁焦虑的随机对照临床研究

Randomized Controlled Clinical Study on the Treatment of Patients with Malignant Tumor with Depression and Anxiety by LiQiAnShenFang

摘要: 目的：评价理气安神方治疗恶性肿瘤患者伴抑郁焦虑情绪的疗效。方法：将60例恶性肿瘤伴抑郁焦虑情绪的患者，用1:1随机、平行对照的方法分为治疗组和对照组，对照组患者仅予常规肿瘤治疗，治疗组在原有肿瘤治疗基础上，加服中药小复方-理气安神方(八月扎、玫瑰花、娑罗子、夜交藤)，每日2剂，水煎服，疗程为6周。观察两组患者的治疗前后汉密顿抑郁量表(HAMD)、汉密顿焦虑量表(HAMA)积分及无疾病进展生存时间(PFS)。结果：经6周治疗后，两组HAMD、HAMA量表得分均较治疗前减少(P < 0.01)。HAMD、HAMA总有效率：治疗组(90%、80%)优于对照组(3.33%、33.33%)，组间比较差异有统计学意义(P < 0.01)。治疗组中位PFS长于对照组(P < 0.05)。结论：理气安神能改善恶性肿瘤患者的抑郁焦虑情绪；改善患者的易激惹、心神不宁、主动性减退、失眠和绝望感等临床症状。通过缓解抑郁焦虑状态来减轻其对恶性肿瘤患者中位PFS的影响，延缓抑郁焦虑状态可能导致的疾病复发进展。

Abstract: Objective: Evaluation of the curative effect of LiQiAnShenFang on patients with malignant tumor with depression and anxiety. Methods: 60 patients with malignant tumor associated with depression and anxiety were selected, and divided into 2 groups (Treatment Group and Control Group) by the principles of randomized controlled. The patients of Treatment Group are given the LiQiAnShenFang (FructusAkebiae, Rose, Aesculi, Caulis Polygoni) treatment on the basis of conventional cancer treatment, decoction was taken twice a day with water, the course of treatment was 6 weeks. The patients of Control Group are only given the conventional cancer treatment. The entire course of treatment is six weeks. We use scales (HAMD, HAMA) to assess. We observed difference between before and after treatment, calculated the efficiency for each group, and compared the two groups’ PFS. Results: After 6 weeks treatment, HAMD and HAMA scale score of two groups was reduced, and the difference was statistically significant (P < 0.01). Total effective rate of HAMD, HAMA: the treatment group was 90%, 80%, control group was 3.33%, 33.33%, by the chi- square test, the difference between groups was statistically significant (P < 0.01). Median PFS of the reatment group was longer than control group (P < 0.05). Conclusion: LiQiAnShenFang has good clinical efficacy to treat the malignant tumors associated with depression and anxiety; improve the patient’s irritability, loss, insomnia, hung up the initiative and sense of despair and other clinical symptoms; through relief depression and anxiety to reduce the effect of median PFS on patients with malignant tumor patients, and to delay the progression of the disease.