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中药外敷联合抗生素治疗下肢丹毒的Meta及试验序贯分析
周淑怡,黎颖娴,卢蔚起,赵先明
广州中医药大学广州 510000;广州中医药大学第一附属医院二外科广州 510000
摘要:
目的:对中药外敷联合抗生素治疗下肢丹毒的临床疗效作系统评价。方法:计算机检索CNKI、VIP、Wanfang、Web of Science、PubMed及Embase数据库自2011年1月—2021年7月收录的中药(TCM)外敷联合抗生素治疗下肢丹毒的随机对照试验(RCT)。采用RevMan 5.3软件进行Meta分析,使用TSA0.9软件进行试验序贯分析。结果:共纳入16项RCT研究文献,涉及1165例患者,Meta分析结果显示:与对照组相比,治疗组显著提高了临床有效率[RR=1.15, 95% CI(1.11,1.21),P<0.001];治疗组治愈时间[SMD=-2.65, 95% CI(-3.67,-1.62),P<0.001]、患肢疼痛缓解时间[SMD=-5.18, 95% CI(-5.69,-4.67),P<0.001]、患肢肿胀缓解时间[SMD=-2.03, 95% CI(-2.45,-1.61),P<0.001]、治疗后白细胞数目[SMD=-0.81, 95% CI(-1.10,-0.53),P<0.001]、C反应蛋白[SMD=-1.01, 95% CI(-1.39,-0.63),P<0.001]、中性粒细胞计数[MD=-1.66, 95% CI (-2.22,-1.10),P<0.001]均较对照组明显改善。两组均未出现严重的不良反应。试验序贯分析表明,中药外敷治疗下肢丹毒具有确切疗效,能排除假阳性可能。结论:中药外敷治疗下肢丹毒具有良好疗效,且不良反应少,但仍需日后开展更多高质量、多中心、大样本、严谨的RCT研究进一步验证。
关键词:  下肢丹毒  中药外敷  Meta分析  试验序贯分析
DOI:10.3969/j.issn.1007-6948.2022.01.006
投稿时间:2021-06-22
基金项目:
Meta and Trial Sequential Analysis on External Application of Traditional Chinese Medicine Combined with Antibiotics in the Treatment of Lower Limb Erysipelas
ZHOU Shu-yi,LI Ying-xian,LU Wei-qi
Abstract:
Objective To systematically evaluate the clinical efficacy of external application of traditional Chinese medicine (TCM) and antibiotics in the treatment of erysipelas of lower limbs. Methods Randomized controlled trials (RCTs) of external application of TCM and antibiotics in the treatment of erysipelas of lower limbs were searched from January 2011 to July 2021 of establishment of CNKI, VIP, Wanfang, Web of Science, PubMed and EMBASE database. RevMan 5.3 was used for meta-analysis and TSA 0.9 was used for trial sequential analysis (TSA). Results A total of 16 RCTs involving 1165 patients were included. The results of meta-analysis showed that the clinical efficiency of the treatment group was significantly higher than that of the control group [RR=1.15, 95% CI (1.11, 1.21), P<0.001]. The cure time [SMD=-2.65, 95% CI (-3.67, -1.62), P<0.001], pain relief time of affected limb [SMD=-5.18, 95% CI (-5.69, -4.67), P<0.001], swelling relief time[SMD=-2.03, 95% CI (-2.45, -1.61), P<0.001], number of white blood cells after treatment [SMD=0.81, 95% CI (-1.10, -0.53), P<0.001], C-reactive protein [SMD=-1.01, 95% CI (-1.39, -0.63), P<0.001] and neutrophil count [MD=-1.66, 95% CI (-2.22, -1.10), P<0.001] in the treatment group were significantly better than those in the control group. There were no serious adverse reactions in the two groups. TSA showed external application of TCM had definite curative effect on erysipelas of lower limbs, which can eliminate the possibility of false positive. Conclusion External application of TCM in the treatment of erysipelas of lower extremities has good curative effect and less adverse reactions, but more high-quality, multi center, large sample and rigorous RCTs should be carried out in the future to further verify.
Key words:  erysipelas of lower limbs  external use of TCM  meta-analysis  trial sequential analysis

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