头针治疗急性脑出血的有效性和安全性的系统评价及Meta分析

Systematic Evaluation and Meta-analysis of the Efficacy and Safety of Scalp Acupuncture in the Treatment of Acute Cerebral Hemorrhage

目的系统评价头针(Scalp acupuncture,SA)治疗急性脑出血(Intracerebral hemorrhage,ICH)的疗效和安全性。方法从Cochrane Library、Pubmed、Embase中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、万方数据(WANFANG DATA)、维普网(VIP)数据库中检索随机对照试验(Randomized controlled trial,RCT)和半随机对照试验(Quasi-randomized controlled trial,q-RCT),时间截止至2018年5月。用Rev Man 5.3软件对数据进行分析,结果以相对风险和95%置信区间的平均差表示。结果研究共涉及11个试验中的740名患者,包括8个随机对照试验和3个q-RCT。连续性资料显示,SA结合其他治疗的试验组神经功能缺损程度评分优于与其他单纯治疗的对照组,差异有统计学意义[MD=-3.24,95%置信区间(-4.27,-2.22),I2=48%,P<0.00001];SA结合其他治疗的试验组日常生活活动能力评分优于与其他单纯治疗的对照组,差异有统计学意义[MD=11.64,95%置信区间(6.24,17.05),I2=55%,P<0.0001]。二分类资料显示,SA结合其他治疗的试验组神经功能缺损程度评分与其他单纯治疗的对照组比较,差异无统计学意义[OR=8.55,95%置信区间(0.18,400.39),I2=80%,P=0.27];SA结合其他治疗的试验组日常生活活动能力评分优于与其他单纯治疗的对照组,差异有统计学意义[OR=3.78,95%置信区间(2.22,6.45),I2=0%,P<0.00001]。结论考虑到ICH的高死亡率,临床研究应进一步实施严格的RCT设计,并且死亡或复发率应作为主要结果进行报告。

Objective To systematically evaluate the efficacy and safety of scalp acupuncture(SA)in the treatment of acute intracerebral hemorrhage(ICH).Methods Randomized controlled trials(RCT)and quasi-randomized controlled trials(Q-RCTs)were searched from ten databases up to May 2018.The data were analyzed with Rev Man 5.3 software for effect estimate presented as relative risk and mean difference with a 95%confidence interval.Results In this study,740 patients of 11 trials were involved including eight RCTs and three Q-RCTs.Continuous data showed that the neurological impairment score of the test group with SA combined with other treatments was better than that of the control group with other treatments alone,and the difference was statistically significant[MD=-3.24,95%confidence interval(-4.27,-2.22),I2=48%,P<0.00001].The scores of activities of daily living in the trial group with SA combined with other treatments were better than those in the control group with other treatments alone,and the difference was statistically significant[MD=11.64,95%confidence interval(6.24,17.05),I2=55%,P<0.0001].The binary data showed that there was no significant difference in neurological impairment scores between the test group with SA combined with other treatments and the control group with other treatments alone[OR=8.55,95%confidence interval(0.18,400.39),I2=80%,P=0.27].The scores of daily living ability of the test group with SA combined with other treatments were better than those of the control group with other treatments alone,and the difference was statistically significant[OR=3.78,95%confidence interval(2.22,6.45),I2=0%,P<0.00001].Conclusion Considering high mortality of ICH,the further the rigorously designed RCTs are warranted and death or recurrence rate should be reported as primary outcome.