Clinical Medical School of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Shenzhen Bao'an Traditional Chinese Medicine Hospital, The Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518101, China.
Chin J Integr Med. 2021 Dec;27(12):947-955. doi: 10.1007/s11655-021-3443-1. Epub 2021 Apr 24.
To evaluate the safety of thread embedding acupuncture therapy (TEAT) and discuss the prevention and treatment of some adverse events (AEs).
Review of databases, including China National Knowledge Infrastructure (CNKI), CBMdisc, Wanfang, VIP databases and English literature published in PubMed, MEDLINE, EMBASE and Web of Science, were searched from their inception to January 2020, randomized controlled trials (RCTs) and case reports in which AEs with TEAT were included. Cochrane Collaboration's tool and RevMan V.5.3.3 software were used to evaluate the quality of the studies.
A total of 61 studies (45 RCTs and 16 case reports) with 620 cases of AEs were included in this review. These studies were published in two countries: China and South Korea. Twenty eight kinds of AEs were summarized. The most common AEs were induration, bleeding and ecchymosis, redness and swelling, fever, and pain. They were accounted for 75.35% (425/564) in the review, and most of them were mild. The rarest AEs were epilepsy, irregular menstruation, skin ulcer, thread malabsorption, and fat liquefaction, with 1 case each. But not all of them had clear causal relationship with TEAT. Most of the AEs were local reactions [with incidence of 9.83% (480/4,882)] and systemic reactions accounted for only 1.27% (62/4,882). Although the included studies showed that AEs were very commonly encountered (11.09%), only 5 cases of severe AEs reported from 2013 to 2017 (0.1%) by using catgut thread, which are rarely seen nowdays with the wide use of new absorbable surgical suture. All of the severe AEs were recovered after symptomatic treatment with no sequelae.
The evidence showed that TEAT is a relatively safe and convenient therapy especially since application of new absorbable surgical suture. Improving practitioner skills, regulating operations, and paying attention to the patients' conditions may reduce the incidence of AEs and improve safety of TEAT.
评估埋线疗法（TEAT）的安全性，并探讨一些不良反应（AEs）的预防和治疗方法。
检索中国知网（CNKI）、CBMdisc、万方、维普数据库和 PubMed、MEDLINE、EMBASE 和 Web of Science 英文文献数据库，时间均从建库至 2020 年 1 月，纳入 TEAT 相关 AEs 的随机对照试验（RCTs）和病例报告。采用 Cochrane 协作网偏倚风险评估工具和 RevMan V.5.3.3 软件对纳入研究进行质量评价。
共纳入 61 项研究（45 项 RCT 和 16 项病例报告），620 例 AEs。研究来自中国和韩国 2 个国家，总结 AEs 共 28 种，最常见的 AEs 为硬结、出血瘀斑、红肿热痛，占纳入研究的 75.35%（425/564），多为轻度；罕见的 AEs 为癫痫、月经不调、皮肤溃疡、线体不吸收、脂肪液化各 1 例，与 TEAT 均无明确因果关系。AEs 多为局部反应[发生率为 9.83%（480/4,882）]，全身反应仅占 1.27%（62/4,882）。纳入研究虽均表明 AEs 发生率较高（11.09%），但仅 2013 年至 2017 年 5 例严重 AEs 报告[0.1%（5/4,882）]，且现今随着新型可吸收缝线的广泛应用，已很少见。所有严重 AEs 均经对症治疗后痊愈，无后遗症。
证据表明，TEAT 是一种相对安全、便捷的疗法，尤其是新型可吸收缝线的应用。提高操作技能、规范操作流程、关注患者病情等可降低 AEs 发生率，提高 TEAT 的安全性。
