厚针疗法对贝尔氏面瘫恢复期患者的疗效：一项多中心随机对照试验。
Effect of Thick-Needle Therapy in Patients with Bell's Palsy at Recovery Stage: A Multi-center Randomized Controlled Trial.
机构信息
Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
出版信息
Chin J Integr Med. 2020 Jun;26(6):455-461. doi: 10.1007/s11655-020-3081-z. Epub 2020 Apr 14.
OBJECTIVE
To compare the clinical effects of thick-needle therapy (TNT) and acupuncture therapy (AT) on patients with Bell's palsy (BP) at the recovery stage.
METHODS
A total of 146 eligible participants from 3 hospitals in China were randomized into the TNT group (73 cases) and the AT group (73 cases) using a central randomization. Both groups received Western medicine thrice a day for 4 weeks. Moreover, patients in the TNT group received subcutaneous insertion of a thick needle into Shendao (GV 11) acupoint, while patients in the AT group received AT at acupoints of Cuanzhu (BL 2), Yangbai (GB 14), Dicang (ST 4), Xiaguan (ST 7), Jiache (ST 6), Yingxiang (LI 20) and Hegu (LI 4), 4 times a week, for 4 weeks. Both groups received 2 follow-up visits, which were arranged at 1 month and 3 months after treatment, respectively. The primary outcome measure was House-Brackmann Facial Nerve Grading System (HBFNGS) grade. And the clinical recovery rates of both groups were evaluated according to the HBFNGS grades after treatment. The secondary outcome measures included the facial disability index (FDI) and electroneurogram (EnoG). The adverse events were observed and recorded in both groups.
RESULTS
Three cases withdrew from the trial, 2 in the TNT group and 1 in the AT group. There was no signifificant difference in the clinical recovery rates between the TNT and AT groups after 4-week treatment [40.85% (29/71) vs. 34.72% (25/72), P>0.05]. At the 2nd follow-up visit, more patients in the TNT group showed reduced HBFNGS grades than those in the AT group (P<0.01). No significant difference was observed between the two groups in FDI score, EnoG latency and maximum amplitude ratio at all time points (all P>0.05).
CONCLUSION
The clinical effect of TNT was equivalent to that of AT in patients with BP at recovery stage, while the post-treatment effect of TNT was superior to that of AT. (Registration No. ChiCTR-INR-16008409).
目的
比较厚针疗法（TNT）和针刺疗法（AT）治疗恢复期贝尔麻痹（BP）患者的临床疗效。
方法
采用中央随机分组法，将来自中国 3 家医院的 146 名符合条件的患者随机分为 TNT 组（73 例）和 AT 组（73 例）。两组均接受西医治疗，每日 3 次，持续 4 周。此外，TNT 组患者接受 Shendao（GV 11）穴位皮下插入粗针，而 AT 组患者每周 4 次接受 Cuanzhu（BL 2）、Yangbai（GB 14）、Dicang（ST 4）、Xiaguan（ST 7）、Jiache（ST 6）、Yingxiang（LI 20）和 Hegu（LI 4）穴位针刺治疗，持续 4 周。两组均进行 2 次随访，分别安排在治疗后 1 个月和 3 个月。主要结局指标为 House-Brackmann 面神经分级系统（HBFNGS）评分。根据治疗后 HBFNGS 分级评估两组的临床恢复率。次要结局指标包括面部残疾指数（FDI）和电神经图（EnoG）。观察并记录两组的不良事件。
结果
3 例患者退出试验，TNT 组 2 例，AT 组 1 例。治疗 4 周后，TNT 组和 AT 组的临床恢复率无统计学差异[40.85%（29/71）比 34.72%（25/72），P>0.05]。在第 2 次随访时，TNT 组患者的 HBFNGS 评分降低的比例明显高于 AT 组（P<0.01）。两组 FDI 评分、EnoG 潜伏期和最大振幅比在各时间点均无统计学差异（均 P>0.05）。
结论
TNT 治疗恢复期 BP 患者的临床疗效与 AT 相当，而 TNT 的治疗后效果优于 AT。（注册号：ChiCTR-INR-16008409）。
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