1.北京中医药大学第三附属医院,北京市朝阳区安外小关街51号,100029
2.北京中医药大学东直门医院
3.北京中医药大学针灸推拿学院
baipeng1978@163. com
收稿:2026-02-27,
修回:2026-05-19,
录用:2026-03-30,
纸质出版:2026-06-17
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马莉,李笑楠,苏晨阳等.针刺治疗重度Bell麻痹的临床疗效评价及对血清GDNF、NGF的影响——一项随机对照试验[J].中医杂志,2026,67(12):1297-1304.
MA Li,LI Xiaonan,SU Chenyang,et al.Acupuncture Treatment for Severe Bell's Palsy and Its Impact on Serum GDNF and NGF:A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2026,67(12):1297-1304.
马莉,李笑楠,苏晨阳等.针刺治疗重度Bell麻痹的临床疗效评价及对血清GDNF、NGF的影响——一项随机对照试验[J].中医杂志,2026,67(12):1297-1304. DOI: 10.13288/j.11-2166/r.2026.12.010.
MA Li,LI Xiaonan,SU Chenyang,et al.Acupuncture Treatment for Severe Bell's Palsy and Its Impact on Serum GDNF and NGF:A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2026,67(12):1297-1304. DOI: 10.13288/j.11-2166/r.2026.12.010.
目的
2
观察针刺治疗重度Bell麻痹的临床疗效与安全性,并从血清胶质细胞源性神经营养因子(GDNF)及神经生长因子(NGF)水平探讨其可能作用机制。
方法
2
采用随机、受试者盲法、安慰针对照的试验设计,纳入130例重度Bell麻痹患者,随机分为试验组和对照组各65例。两组在西药基础治疗的同时,试验组给予针刺治疗,对照组给予安慰针,每次30 min。两组疗程均为8周,于第12周进行随访。主要观察指标为第8周House-Brackmann面神经功能分级(H-B分级)Ⅱ级及以下的患者比例。次要观察指标包括第0、4、8、12周时Sunnybrook面神经评定系统评分;面部恢复至达到满意恢复的时间,即H-B分级为Ⅱ级及以下所需的时间;第0、4、8、12周时H-B分级分布情况、面部残疾指数(FDI)评分[包括躯体功能(FDIP)、社会生活功能(FDIS)];治疗第0、4、8周时血清GDNF、NGF因子水平。记录不良事件及受试者自我疗效评估。
结果
2
最终共完成研究122例,试验组62例,对照组60例。采用意向性分析方法,取末次观测值结转法对缺失值进行处理。第8周试验组H-B分级在Ⅱ级及以下的患者占78.5%(51/65),对照组占49.2%(32/65),试验组显著高于对照组(
P
<0.05)。与本组第0周时比较,第4、8、12周时两组Sunnybrook评分、FDIP评分、FDIS评分升高,H-B分级降低,且试验组各指标改善均优于对照组(
P
<0.05)。试验组患者满意中位恢复时间为6周(95%
CI
:5.697,6.303),对照组为12周(95%
CI
:8.314,15.686),试验组快于对照组(
P
<0.05)。试验组第4、8周时血清GDNF、NGF因子水平均高于对照组(
P
<0.05)。治疗期间两组均未发生与针刺相关的严重不良事件,试验组发生不良事件5例(5/65,7.69%),对照组4例(4/65,6.15%),两组比较差异无统计学意义(
P
>0.05)。第8周治疗结束后受试者对治疗效果的自我评估,试验组优于对照组(
P
<0.05)。
结论
2
针刺可改善重度Bell麻痹患者的面神经功能,缩短恢复时间,且安全性良好。其作用机制可能与提高血清GDNF、NGF因子水平有关。
Objective
2
To evaluate the clinical efficacy and safety of acupuncture in treating severe Bell's palsy and to explore its potential mechanism by investigating the effect on serum levels of glial cell line-derived neurotrophic factor (GDNF) and nerve growth factor (NGF).
Methods
2
A randomized, subject-blinded, sham-acupuncture controlled trial was conducted. A total of 130 patients with severe Bell's palsy were randomly allocated into a treatment group or a control group at a 1∶1 ratio. Both groups received conventional western medicine. In addition, the treatment group received acupuncture, while the control group received sham acupuncture, with each session lasting 30 minutes. The treatment course lasted 8 weeks for both groups, followed by a follow-up assessment at week 12. The primary outcome was the proportion of patients achieving House-Brackmann (H-B) grade Ⅱ or lower at week 8. Secondary outcomes included Sunnybrook facial grading system scores at week 0, 4, 8, and 12, the time to satisfactory recovery(the time required to achieve H-B grade≤Ⅱ), distribution of H-B grades and facial disability index (FDI) scores including the physical function subscale (FDIP) and social/well-being function subscale (FDIS) scores at week 0, 4, 8, and 12, and serum GDNF and NGF levels at week 0, 4, and 8. Adverse events and participants' self-assessments of treatment efficacy were also recorded.
Results
2
A total of 122 participants completed the study, including 62 in the treatment group and 60 in the control group. An intention-to-treat (ITT) analysis was performed, and missing data were handled using the last observation carried forward (LOCF) method. The proportion of patients achieving H-B grade ≤grade Ⅱ at week 8 was 78.5% (51/65) in the treatment group, significantly higher than 49.2% (32/65) in the control group (
P
<0.05). The Sunnybrook scores, FDIP and FDIS scores increased, while H-B grades decreased at week 4, 8, and 12 in both groups compared to week 0; moreover, improvements in all outcome measures were significantly greater in the treatment group than in the control group (
P
<0.05). The median time to satisfactory recovery was 6 weeks (95%
CI
: 5.697-6.303) in the treatment group, significantly shorter than 12 weeks (95%
CI
: 8.314-15.686) in the control group (
P
<0.05). Serum levels of GDNF and NGF were significantly higher in the treatment group at weeks 4 and 8 (
P
<0.05). No serious acupuncture-related adverse events occurred in either group. Adverse events were reported in 5 patients (7.69%) in the treatment group and 4 patients (6.15%) in the control group, with no statistically significant difference between groups (
P
>0.05). Patients' self-assessment of treatment efficacy after 8 weeks treatment was significantly better in the treatment group (
P
<0.05).
Conclusion
2
Acupuncture can effectively improve facial nerve function and shorten recovery time in patients with severe Bell's palsy, with a favorable safety profile. The therapeutic mechanism may be associated with the upregulation of serum GDNF and NGF levels.
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