Sun Cheng-Yi, Yuan Ying, Yan Shi-Yan
College of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine, Beijing 100029, China.
Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102.
Zhen Ci Yan Jiu. 2022 Mar 25;47(3):274-81. doi: 10.10372/j.1000-0607.20210559.
To systematically evaluate the clinical effect and safety of filiform-fire needle in the treatment of peripheral facial paralysis at different stages.
Articles of the randomized controlled clinical trials (RCTs) about filiform fire needle treatment of peripheral facial paralysis published from the inception of the databases of CNKI, Wanfang, VIP, SinoMed, PubMed, Embase and Cochrane Library to December 20th, 2021 were retrieved first. The Cochrane Handbook 5.1 system was used to extract data and evaluate the quality (risk of bias) of the included papers. The overall effective rate, cure rate, Sunnybrook facial nerve function score, facial disability index scale, physical and social function score and related adverse reactions were used as the outcome indicators. The RevMan5.3 software was used for heterogeneity test and Meta-analysis was performed on papers with little clinical heterogeneity.
A total of eligible 9 RCTs were included, involving 519 patients. The results of Meta-analysis showed that: compared with the conventional acupuncture therapy, the filiform fire needle in the treatment of peripheral facial paralysis had significant advantages in raising the overall effective rate (=1.14, 95%[1.07,1.21], <0.000 1) and cure rate (=1.59, 95%[1.29,1.97], <0.000 1),and in improving Sunnybrook facial neurological function score (=17.85, 95%[15.72,19.97], <0.000 01), physical function score of facial disability index scale (=4.16, 95%[3.15,5.16], <0.000 01) and social function score (=2.47, 95%[1.53,3.41], <0.000 01). Safety analysis showed that there was no obvious adverse reaction during the filiform fire needle therapy, and the patients' tolerance to pain had no statistical difference relevant to the conventional acupuncture treatment (>0.05).
Filiform fire needle is superior to conventional acupuncture in the treatment of facial paralysis in all stages, but its reliability is limited due to fewer high-quality literature with scientific and rigorous methods and trial designs. Therefore, more large-sample and high-quality RCT studies are warranted for further verification.
系统评价毫火针治疗不同分期周围性面瘫的临床疗效及安全性。
首先检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase及Cochrane图书馆数据库建库至2021年12月20日发表的关于毫火针治疗周围性面瘫的随机对照临床试验(RCT)文献。采用Cochrane Handbook 5.1系统提取数据并评价纳入文献的质量(偏倚风险)。以总有效率、治愈率、Sunnybrook面神经功能评分、面部残疾指数量表、躯体及社会功能评分及相关不良反应作为结局指标。采用RevMan5.3软件进行异质性检验,对临床异质性较小的文献进行Meta分析。
共纳入符合标准的9项RCT,涉及519例患者。Meta分析结果显示:与传统针刺疗法相比,毫火针治疗周围性面瘫在提高总有效率(=1.14,95%[1.07,1.21],<0.000 1)、治愈率(=1.59,95%[1.29,1.97],<0.000 1),以及改善Sunnybrook面神经功能评分(=17.85,95%[15.72,19.97],<0.000 01)、面部残疾指数量表躯体功能评分(=4.16,95%[3.15,5.16],<0.000 01)和社会功能评分(=2.47,95%[1.53,3.41],<0.000 01)方面具有显著优势。安全性分析显示,毫火针治疗期间无明显不良反应,患者对疼痛的耐受性与传统针刺治疗相比无统计学差异(>0.05)。
毫火针治疗各期面瘫疗效优于传统针刺,但由于科学严谨方法及试验设计的高质量文献较少,其可靠性有限。因此,需要更多大样本、高质量RCT研究进一步验证。