中药治疗创伤后应激障碍临床试验的系统评价  

Systematic review of clinical trials of traditional Chinese medicine in the treatment of posttraumatic stress disorder

作　　者：高俊巧 李峰[1] 刘燕[1] 吴卓耘 王淑艳[1] 宋月晗[1] 

机构地区：[1]北京中医药大学基础医学院,硕士研究生100029

出　　处：《环球中医药》2016年第8期1027-1032,共6页Global Traditional Chinese Medicine

基　　金：国家自然科学基金(81001501);教育部高等学校博士学科点专项科研基金(20100013120005);北京中医药大学校内自主项目(2016-JYB-JSMS-002)

摘　　要：目的中药被广泛应用于创伤后应激障碍(posttraumatic stress disorder,PTSD)的治疗,但对其疗效和安全性尚缺乏系统的评价。笔者就中药治疗PTSD这一疾病的安全及其有效做一系统分析。方法检索CNKI、CBM、Pub Med等数据库中以中药为治疗措施,以不治疗、安慰剂、常规药物等为对照措施治疗PTSD的随机平行对照试验。对纳入的研究进行质量评价及资料提取,采用Rev Man5.2.0软件进行Meta分析。结果的效应指标为标准化均数差(standardized mean difference,SMD),均以95%(confidence interval,CI)表示。结果共纳入7篇随机对照试验(randomized controlled trails,RCTs)文章,1500例PTSD患者随机分配到治疗组和对照组。对纳入研究进行描述分析和Meta分析。Meta分析结果显示,3项随机对照临床试验,中药治疗PTSD与对照组相比,在改善患者PTSD-SS得分方面{SMD(random)-3.52,95%CI[-3.85,-3.19]}、HAMD得分方面{SMD(random)-3.66,95%CI[-4.00,-3.32]}有显著的优势。其中对于HAMA,SAS,SDS,SCL-90量表的研究进行了描述性分析,中药组在改善SAS、SDS、SCL-90量表得分方面有显著的优势,且有统计学意义(P<0.05)。1个研究在HAMA得分方面,两组无统计学意义,但中药组副作用明显低于对照组,且有显著差异(P<0.01)。结论纳入分析的文章方法学质量不高,样本量偏小,不同研究结果一致性不强,因此,现有的临床证据不能够肯定或者否定中药在改善PTSD患者的临床症状及结局指标方面的作用,其临床有效性和安全性尚需高质量的研究结果支持。Objective Chinese herbal medicine is widely used in posttraumatic stress disorder（ PTSD） treatment,but the efficacy and safety were lacked of system for evaluation. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating PTSD. Methods Retrieval of CNKI,CBM,Pub Med and other databases to Chinese medicine as a treatment measure,with no treatment,placebo,conventional drugs as control measures for the treatment of PTSD randomized parallel controlled trials. Quality rating and data extraction were performed. Rev Man5. 2. 0 software was used for meta-analysis. Standardized mean difference（ SMD） at 95% confident interval（ CI） was used to indicate results. Results A total of 7 randomized controlled trials were included,and 1500 patients with PTSD were randomly assigned to the treatment group and the control group. Descriptive and meta-analyseswere performed in inclusive trials. Meta analysis of 3 randomized controlled clinical trials showed that the treatment of Chinese herbal medicine showed an obvious advantage compared with the control group on improving PTSD-SS function rating score{ SMD（ random）- 3. 66 95% CI [- 4. 00,- 3. 32]}. For HAMD scale,Meta analysis showed that Chinese herbal medicine was obvious advantage compared with the control group { SMD（ random）- 3. 66 95% CI [- 4. 00,- 332]}. The cognitive function was assessed in studying HAMA,SAS,SDS,SCL- 90 scale. The results Showed SAS,SDS,SCL-90 score were better in the Chinese herbal medicine group than in the control group,the results had significant difference（ P〈0. 05）.One study indicated HAMA score in the Chinese herbal medicine group had no significant differences compared with control group. But the adverse reactions were less than control group,the result had significant difference（ P〈0. 05）. Conclusions The article quality of included trials is poor and the samples were small. Results of different trials were lack of consistency. Present evidence is not sufficient to pr

关 键 词：中药 创伤后应激障碍 系统综述 随机对照试验 

分 类 号：R749[医药卫生—神经病学与精神病学]