中药补益类方药治疗肌萎缩侧索硬化症的Meta分析

Meta Analysis on Traditional Chinese Medicine Tonic Class Prescriptions in Treatment of Amyotrophic Lateral Sclerosis

目的:系统评价中药补益类方药用于治疗肌萎缩侧索硬化(ALS)的疗效及安全性。方法:以"肌萎缩侧索硬化,运动神经元病(MND),中药,中草药,中医,Drugs,Chinese Herbal"为检索词在多个外文网站包括Pubmed,EMBASE医药数据库,Cochrane图书馆,CBM等,以及中文数据库例如CNKI,维普中文科技期刊数据库,万方医学数据平台中进行全面检索,主要检索关于中药治疗ALS的相关随机对照研究,检索时间从建库到2014年12月31日,语言不限。应用Revman Manager 5.2软件进行Meta分析。结果:共筛选出符合纳入条件的随机对照研究7项,涉及病例411例,其中治疗组257例,对照组154例。Meta分析结果显示:治疗组给予补益类方药(不限剂型)进行治疗,在症状改善方面优于对照组[RR=1.42,95%CI(1.11,3.38)];治疗组Norris评分降低的幅度小于对照组,应用补益类方药控制ALS疾病较西药组好,使疾病进展更缓慢[MD=2.1,95%CI(0.65,3.54)];补益类方药在改善ALS患者中医痿证证候方面效果明显优于西药组[MD=3.29,95%CI(1.57,5.01)];差异均有统计学意义。本文所纳入研究有3项研究从胃肠道症状及肝肾功能角度对用药安全性进行评价,结果均未出现严重不良反应。结论:目前有限的证据表明补益类中药具有延缓ALS疾病发展的作用,在延缓疾病进程方面优于西药利鲁唑,但不能显著改善症状及根治肌萎缩侧索硬化。中药相比西药具有价格低廉,保存方便的优点,可以减轻患者的经济负担。但由于本研究所纳入的文献质量总体不高,影响了本研究的可靠性,还有待于进一步大规模高质量的临床研究。

Objective： To systemically evaluate the effie （TCM） tonic class prescriptions in the treatment of amyotrophic late acy and safety of traditional Chinese medicine ral sclerosis （ALS）. Method ： Several foreign language electronic databases such as Pubmed, EMBASE, Cochrane Library and CBM, as well as some Chinese databases such as CNKI, VIP, Wanfang Data Knowledge Service Platform were searched from the date of database creating to December 31, 2014, with amyotrophic lateral sclerosis, motor neuron disease （MND）, traditional Chinese medicine, herbs, Chinese medicine, drugs, and Chinese herbal as the key words, to select the randomized control trials on treatment of ALS by Chinese medicine. Meta analysis was performed using Revman Manager 5.2 software. Result： The 7 RCTs involving 411 patients were selected, including 257 cases in treatment group and 154 cases in control group. Meta analysis results showed that the patients in treatment group were treated with TCM tonic class prescriptions （without limiting dose types）, better than the control group in terms of symptoms improvement [ RR = 1.42, 95% CI （ 1.11, 3.38） ]. The reduction degree of Norris score in treatment group was less than the control group, so the tonic class prescriptions had better effect than western medicine in controlling ALS, making the disease progress more slowly [ MD = 2. 1, 95% CI （0.65, 3.54）]; tonic class prescriptions had significant better effect than western medicine in terms of improving impotent disease syndrome [ MD = 3.29, 95% CI （ 1.57, 5.01 ） ] ; with statistically significant differences. In 3 of the included studies, drug safety was evaluated from the perspective of gastrointestinal symptoms and liver and kidney functions, and no severe adverse reactions were found. Conclusion： The current limited evidences show that TCM tonic class prescriptions could delay the development of ALS, with better effect than Riluzole, but can not significantly improve symptoms and completely cure ALS. Compared with the western medicine, the TCM is cheaper, and can be preserved easily, so it can reduce the financial burden for patients. However, the low quality of included literature has affected the reliability of this present study. Therefore, further clinical application studies with large size and high quality are still needed.