【目的】 探讨益气活血方（由圣愈汤化裁而来）治疗气虚血瘀型轻度脊髓型颈椎病（CSM）的临床疗效。【方法】 将2022年 1月至2024年1月就诊于广东省中医院的128例气虚血瘀型轻度CSM患者按随机数字表法随机分为对照组和试验组，每组各 64例。对照组给予口服甲钴胺片治疗，试验组在对照组的基础上联合益气活血方治疗，疗程为 4周，并于疗程结束后随访 3个月。观察2组患者治疗前、治疗2周后、治疗4周后以及治疗结束3个月的日本骨科学会（JOA）CSM评分和中医证候积分 的变化情况，并进行临床疗效评定以及病情进展和不良反应情况评估。【结果】（1）脱落情况方面：研究过程中，对照组脱落 2例，试验组脱落3例，最终纳入病例共123例，其中对照组62例，试验组61例。（2）疗效情况方面：治疗结束3个月后，试 验组的总有效率为93.44%（57/61），对照组为82.26%（51/62），组间比较（χ2检验），试验组的疗效明显优于对照组，差异有统 计学意义（P < 0.05）。（3）JOA评分改善情况方面：治疗2周和4周后以及治疗结束3个月，2组患者的JOA评分均较治疗前升 高（P < 0.05），且试验组在治疗2周和4周后以及治疗结束3个月的JOA评分均高于对照组，差异均有统计学意义（P < 0.05）。 （4）中医证候积分改善情况方面：治疗 2 周和 4 周后以及治疗结束 3 个月，2 组患者的中医证候积分均较治疗前降低 （P < 0.05），且试验组在治疗2周和4周后以及治疗结束3个月的中医证候积分均低于对照组，差异均有统计学意义（P < 0.05）。 （5）随访期间，2组患者均未出现病情明显加重或发展至中重度的病例；同时也均未见过敏、胃肠道反应等其他不良事件发 生。【结论】 益气活血方治疗气虚血瘀型轻度CSM患者临床疗效确切，可以有效改善患者脊髓功能和气虚血瘀证候，减缓患 者病情进展，且具有较高的安全性。

Objective To investigate the clinical efficacy of Yiqi Huoxue Prescription （derived from Shengyu Decoction）in the treatment of mild cervical spondylotic myelopathy（CSM）with qi deficiency and blood stasis type. Methods A total of 128 patients with mild CSM of qi deficiency and blood stasis type who admitted to Guangdong Provincial Hospital of Chinese Medicine from January 2022 to January 2024 were randomly divided into the control group and the trial group according to the random number table method，with 64 cases in each group. The control group was treated with oral administration of Mecobalamin Tablets，and the trial group was treated with Yiqi Huoxue Prescription orally on the basis of treatment for the control group. The two groups were all treated for four weeks，and then were followed up for three months after the completion of treatment. The CSM scores of the Japanese Orthopedic Association（JOA）and the traditional Chinese medicine（TCM）syndrome scores in the two groups were observed before treatment，after two weeks of treatment，after four weeks of treatment，and three months after the completion of treatment. And then the clinical efficacy，progression of CSM and the incidence of adverse reactions of the two groups were evaluated. Results（1）During the trial，two cases in the control group and three cases in the trial group fell off，and eventually a total of 123 cases were included，62 cases in the control group and 61 cases in the trial group.（2）Three months after the completion of treatment，the total effective rate of the trial group was 93.44%（57 / 61）and that of the control group was 82.26%（51 / 62）， and the intergroup comparison（tested by chi-square test）showed that the efficacy of the trial group was significantly superior to that of the control group， the difference being statistically significant（P < 0.05）. （3）After two and four weeks of treatment as well as three months after the completion of treatment，JOA scores in the two groups were increased compared with those before treatment（P < 0.05）， and JOA scores of the trial group at various time points mentioned above were higher than those of the control group，the difference being statistically significant（P < 0.05）.（4）After two and four weeks of treatment as well as three months after the completion of treatment，TCM syndrome scores in the two groups were decreased compared with those before treatment（P < 0.05），and TCM syndrome scores of the trial group at various time points mentioned above were lower than those of the control group， the difference being statistically significant（P < 0.05）.（5）During the follow-up period，there was none case of significant aggravation or progression to moderate-severe illness in the two groups， and there were no adverse events such as allergies and gastrointestinal reactions. Conclusion Yiqi Huoxue Prescription exerts certain efficacy in treating patients with mild CSM of the qi deficiency and blood stasis type，and the treatment method is effective on improving the spinal cord function and symptoms of qi deficiency and blood stasis type，and slowing down the progression of disease in the patients，with high safety.

R274.9

国家自然科学基金项目（编号：82174396）；广州市科技局青年博士“启航”项目（编号：2024A04J3298）；广东省中医院院内专项 （编号：YN2023QN16）；韦以宗名医工作室建设项目