疏肝解郁颗粒治疗轻中度抑郁症多中心随机双盲安慰剂对照临床观察  

A Multi-center Double-blind Randomized Controlled Trials of Shugan Jieyu Granules in the Treatment of Moderate Depression

作　　者：方妤[1] 杨东东[1] 唐裕[1] 孙鸿辉[1] 陈卫银[1] 周媛 王巧灵[3] FANG Yu1, YANG Dongdong1, TANG Yu1 ,SUN Honghui1, CHEN Weiyin1, ZHOU Yuan2 ,WANG Qiaoling3(1. Neurology Department, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Province, Chengdu 610072, China; 2. Grade 2017 Graduate, Chengdu University of Traditional Chinese Medicine, Sichuan Province, Chengdu 610000, China; 3. GCP Center, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Province, Chengdu 610072, China)

机构地区：[1]成都中医药大学附属医院神经内科,四川成都610072 [2]成都中医药大学 [3]成都中医药大学附属医院GCP中心,四川成都610072

出　　处：《光明中医》2018年第20期2958-2962,共5页GUANGMING JOURNAL OF CHINESE MEDICINE

摘　　要：目的评价疏肝解郁颗粒在治疗轻中度抑郁症方面的临床疗效与安全性。方法采用随机双盲、安慰剂对照、多中心临床试验。选择符合轻中度抑郁症受试者480例,按照3∶1的比例分为试验组360例,安慰剂对照组120例。试验组服用疏肝解郁颗粒,安慰剂对照组服用疏肝解郁颗粒模拟剂,疗程均为6周。在治疗前后进行17项汉密尔顿抑郁量表(HAMD-17)评分、汉密尔顿焦虑量表(HAMA)评分及中医证候评分,治疗后对临床疗效、中医证候疗效和临床总体印象量表(CGI-GI)的疗效进行疗效总评。安全性评估包括:评估不良事件、实验室检查和心电图检查等。结果本试验共入组病例数456例(试验组342例,对照组114例)。治疗结束后,2组HAMD及HAMA评分均降低,其中试验组的HAMD下降(8. 56±3. 29)分,对照组降低(6. 21±3. 61)分;试验组总有效率为53. 39%,对照组总有效率为27. 19%,组间差异均有统计学意义(P <0. 05)。试验组中医证候疗效总有效率为83. 18%,对照组总有效率为45. 61%。2组在各访视点CGI严重程度评分差异皆有统计学意义(P <0. 05)。发生不良事件9例,试验组6例、对照组3例,2组比较差异无统计学意义(P=0. 6977)。结论疏肝解郁颗粒治疗轻中度抑郁症疗效可靠,能有效的缓解临床症状,不良反应小,安全性好。Objective To evaluate the efficacy and safety of Shugan Jieyu granules in the treatment of moderate depression. Methods This study was a randomized,double-blind,multi-center,placebo controlled clinical trials. 480 mild and moderate-grade depression patients were randomly divided into treatment group and the control group by a ratio of 3∶ 1. The treatment group was given 10 g Shugan Jieyu granules 3 times daily,and the control group was given 10 g Shugan Jieyu granules simulation agent 3 times daily. The course of treatment was both 6 weeks. HAMD scores,HAMA scores and TCM syndrome scores were evaluated before and after treatment respectively. Clinic efficacy,TCM syndrome efficacy,clinical global impressions scale were evaluated after treatment. Safety evaluation includes adverse events,laboratory examination and ECG examination. Results A total of 456 patients were enrolled in this clinical trial. After treatment,HAMD scores and HAMA scores in two groups were significantly decreased,HAMD scores were drop（8. 56 ± 3. 29） in the treatment group,（6. 21 ± 3. 61） in control group. The clinical efficacy in the treatment group and control group were 53. 39% and 27. 19% respectively,and there had statistical difference（P〈0. 05）. TCM syndrome efficacy in the treatment group and control group were 83. 18% and 45. 61% respectively.Clinical global impressions scales were significantly difference between two groups（P〈0. 05）. Nine patients had side effects during the treatment,and had no statistical difference between two groups（P = 0. 6977）. Conclusion Shugan Jieyu granules has certain clinical effects in treating depression of mild and moderate-grade,and can effectively relive the clinical symptoms with less adverse reactions.

关 键 词：疏肝解郁颗粒 轻中度抑郁 随机对照试验 双盲 多中心 

分 类 号：R277.7[医药卫生—中医学]