2025 年第 8 期 第 20 卷

珍珠通络丸治疗脊髓和根神经及马尾神经压迫引起疼痛的临床效果和安全性评估研究

The clinical efficacy and safety of Zhenzhu Tongluo pill in the treatment of pain caused by spinal cord, root nerve and cauda equina nerve compression

作者：周霖1张凯博2王肖辉3董鹏飞4王丹2

英文作者：Zhou Lin1 Zhang Kaibo2 Wang Xiaohui3 Dong Pengfei4 Wang Dan2

单位：1郑州大学第一附属医院药学部，郑州450052；2郑州大学第一附属医院骨科，郑州450052；3郑州大学第一附属医院超声科，郑州450052；4郑州大学第二附属医院中医科，郑州450000

英文单位：1Department of Pharmacy the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China; 2Department of Orthopedics the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China; 3Department of Ultrasound the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China; 4Department of Traditional Chinese Medicine the Second Affiliated Hospital of Zhengzhou University Zhengzhou 450000 China

关键词：脊髓压迫；根神经压迫；马尾神经压迫；珍珠通络丸；疼痛

英文关键词：Spinalcordcompression;Rootnervecompression;Caudaequinanervecompression;ZhenzhuTongluopill;Pain

• 摘要：

• 目的 本研究旨在评估珍珠通络丸治疗脊髓、根神经及马尾神经压迫引起疼痛的临床效果与安全性。方法 采用随机、双盲、安慰剂对照试验，选取2024年8—10月在郑州大学第一附属医院就诊的160例年龄25～65岁、确诊为脊髓、根神经或马尾神经压迫引发疼痛的患者。采用计算机随机分组法将患者随机分为观察组和对照组，各80例。观察组在常规用药的基础上给予珍珠通络丸，对照组在常规用药的基础上给予安慰剂，疗程均为12周。比较2组患者治疗前后疼痛视觉模拟量表（VAS）评分、改良的日本骨科协会评估治疗分数（mJOA）、简明健康调查量表（SF-36）评分、疼痛缓解时间、疗效和安全性。结果 治疗4、8、12周后，2组患者VAS评分均低于治疗前，mJOA评分均高于治疗前，且观察组各时点的VAS评分均显著低于对照组，mJOA评分均高于对照组（均P＜0.05）。治疗12周后，2组患者SF-36评分均较治疗前升高，且观察组的SF-36评分显著高于对照组（均P＜0.05）。观察组疼痛缓解时间显著短于对照组（P＜0.001）。观察组总有效率显著高于对照组［83.8%（67/80）比38.8%（31/80）］（P＜0.001）。治疗前后2组患者血常规、尿常规、肝肾功能、凝血功能各项指标均在正常范围内。结论  珍珠通络丸治疗脊髓、根神经或马尾神经压迫引发疼痛具有显著效果和良好安全性，为临床治疗提供了有力依据。

• Objective To evaluate the clinical efficacy and safety of Zhenzhu Tongluo pill in the treatment of pain caused by spinal cord, root nerve and cauda equina nerve compression. Methods A randomized, double-blind, placebo-controlled trial was conducted to select 160 patients aged 25-65 years who were diagnosed with pain caused by spinal cord, root nerve, or cauda equina nerve compression and treated at the First Affiliated Hospital of Zhengzhou University from August to October 2024. The patients were randomly divided into the observation group and the control group by computer randomization method, with 80 cases in each group.The observation group was given Zhenzhu Tongluo pill on the basis of conventional medication, and the control group was given placebo on the basis of conventional medication. The course of treatment was 12 weeks for both groups. The visual analogue scale (VAS) score, modified Japanese Orthopaedic Association Evaluation of Treatment Score (mJOA), Short Form Health Survey (SF-36) scores, pain relief time, efficacy and safety were compared between the two groups before and after treatment. Results After 4, 8 and 12 weeks of treatment, the VAS scores of the two groups were lower than those before treatment, the mJOA scores were higher than those before treatment, the VAS scores of the observation group at each time point were significantly lower than those of the control group, and the mJOA scores were higher than those of the control group (all P＜0.05). After 12 weeks of treatment, the SF-36 scores of the two groups were higher than those before treatment, and the SF-36 score of the observation group was significantly higher than that of the control group (all P＜0.05). The pain relief time of the observation group was significantly shorter than that of the control group (P＜0.001). The total effective rate of the observation group was significantly higher than that of the control group ［83.8%(67/80) vs 38.8%(31/80)］(P＜0.001). Before and after treatment, the blood routine, urine routine, liver and kidney function, and coagulation function of patients in the two groups were within the normal range. Conclusion Zhenzhu Tongluo pill has significant effect and good safety in the treatment of pain caused by spinal cord, root nerve or cauda equina nerve compression, which provides a strong basis for clinical treatment.