等离子射频消融髓核成形术加舒筋活血药治疗腰椎间盘突出症的临床和实验研究
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摘要
研究内容本文回顾了腰椎间盘突出症相关文献，首先着重从中医基本理论出发，就中医对腰椎间盘突出症的记载和病因病机临床症状论述，明确提出腰椎间盘突出症为肾虚为本，风、寒、湿邪侵袭，跌仆闪挫为标的发病特点。据此，临床常分为肾虚、寒湿、湿热、血瘀四型辩证施治疗。并就现代医学对椎间盘的解剖结构、生理病理、生物力学、椎间盘退变等方面进行系统分析和阐述。虽然导致椎间盘髓核突出的病理原因一直没有被完全了解。但退变的椎间盘弹性降低、椎间盘隆凸是重要的一步。成人椎间盘是体内最大的无血管结构，在成人椎间盘内，有些细胞与最近的血管的距离可以长达6～8mm，这些血管位于相邻椎体的软骨终板内。除终板外，在纤维环的外围尚有一个血管网，但距离更远。即终板的中心区域是椎间盘代谢物转运的主要路径。因此，可以认为椎间盘的营养，从解剖生理角度考虑，是非常脆弱的。椎间盘很易受各种营养因子的影响，而适当的运动可对营养起辅助作用，但过度的运动和劳损也可以影响椎间盘细胞营养和代谢，从而导致椎间盘的退变。此外，椎间盘的退变因素尚与年龄、机械负荷生物力学因素、基质酶活性改变、自身免疫反应等诸多因素密切相关。关于椎间盘突出的致痛原因虽然不是很清楚，但目前比较公认的认识是与机械压迫学说和化学炎症介质学说，并可能与某些电生理机制、自身免疫反应有关。其次，对腰椎间盘突出症治疗方法和治疗进展，对手术与非手术疗法进行了系统回顾，并就目前运用手术疗法中微创手术方法(含显微腰椎间盘髓核摘除术、皮穿刺髓核摘除术、经皮穿刺椎间盘切除术、经皮穿刺激光椎间盘减压术、脊柱内窥镜下腰椎间盘手术、化学髓核溶解术)进行比较，指出各种、各类治疗方法的优缺点，进一步明确中医中药在治疗腰椎间盘突出症中的作用和地位的同时，确立经皮低温等离子射频消融髓核消融成形术在治疗腰椎间盘突出症在目前微创治疗领域中独特的作用和地位。设想运用现代微创手术，即经皮低温等离子射频消融髓核消融成形术加中医中药治疗腰椎间盘突出症，来替代该手术术后传统使用非甾甙类解热镇痛药，解决非甾甙类解热镇痛药带来的某些副作用。因此，本研究临床试验采用经皮低温等离子射频消融髓核消融成形术加上我院自制中药制剂舒筋活血药治疗腰椎间盘突出症，观察临床疗效，分析其作用机理。
研究目的本研究运用中西结合理论为指导，通过临床和实验研究，观察腰椎间盘突出症运用现代经皮低温等离子射频消融髓核成形术加用中药复方剂“舒筋活血药”的疗效，并解决经皮低温等离子射频消融髓核成形术后，化学炎症介质等致痛因子不能快速消除的缺憾，而使术后疼痛缓解。期望其作用疗效与使用非甾甙类解热镇痛药相近或有所提高。
研究方法本分实验研究与临床研究二部分。实验研究对“舒筋活血药”进行抗炎、镇痛作用的小鼠动物实验，采用小鼠热板法镇痛试验、小鼠耳肿胀法抗炎试验，分别与非甾甙类解热镇痛药“美洛昔康分散片”、糖皮质激素“强的松”进行分组对照，进一步明确“舒筋活血药”作用和疗效，并使用“舒筋活血药”对小鼠急性毒性试验，进行LD_(50)测定。临床研究有选择地观察60例腰椎间盘突出症患者，随机分两组各30例进行治疗和观察对比，一组为经皮低温等离子射频消融髓核成形术治疗腰椎间盘突出症加口服美洛昔康，另一组为经皮低温等离子射频消融髓核成形术加口服舒筋活血药治疗腰椎间盘突出症。两组进行治疗后疼痛等症状改善和临床疗效进行比较，观察时间为二个月。所有数据应用Microsoft Excel记录数据，SPSS9.0统计软件计算治疗前后的平均值、范围和标准误，95％的意义区限和成对t检验用来比较治疗前后疼痛分值的变化。当P值＜0.05时具有统计学意义。
研究结果临床研究表明：经皮低温等离子射频消融髓核成形术是治疗腰椎间盘突出症的有效方法之一，具有安全、微创的特点，符合当今对脊柱疾病的治疗潮流。运用经皮低温等离子射频消融髓核消融成形术结合自制中药复方制剂舒筋活血药治疗腰椎间盘突出症，临床疗效肯定，特别是术后疼痛缓解作用明显，可以为临床治疗提供新的思路和方法。“舒筋活血药”镇痛抗炎实验中，可明显延长小鼠在热板上的痛阈值，显示了“舒筋活血药”明显的镇痛作用；对于二甲苯引起的小鼠耳廓肿胀，“舒筋活血药”高剂量与中剂量亦表现出明显的抑制作用，抗炎作用明显。并且，在相当于人临床剂量的900倍的最大给药对小鼠无致死作用，可以认为“舒筋活血药”是一种安全、低毒、有效的中药复方制剂。
Content: This is a report on the use of integrated Chinese medicine and Westernmedicine for the treatment of lumbar intervertebale disc protrusion(LIDP), includinga historical literature review, laboratory experiment and clinical trial. First of all, itdiscusses the original historical references, etiology, pathology and clinicalpresentation based on the fundamental theory of traditional Chinese medicine(TCM). It states the LIDP has root of deficiency of the kidney in etiology andpathology, however, invasion of wind, cold, dampness as well as trauma are alsocontributing factors, which are the characteristics of LIDP as far as TCM isconcerned. In light of this pathological condition, four diagnostic syndromes/patternsare usually differentiated according to the clinical manifestations of LIDP, such as'pattern of deficiency of the kidney', 'pattern of cold in combination with dampness','pattern of heat in combination with dampness' and 'pattern of blood stagnation'.Modern medicine in anatomical structure of intervertebral disc, biomechanics ofintervertebral disc, path-physiology of LIDP, and degeneration effect of intervertebraldisc are also reviewed in this report.Although the pathology of protrusion of nucleuspulposus in intervertebral disc has never been thoroughly understood, it is howeverunderstood that the protrusion of lumbar intervertebral disc as the consequence ofreduction of elasticity of lumbar intervertebral disc plays a key role in developmentof this disorder. Adult intervertebral disc is the largest non-blood vessel structure inhuman body. Inside the adult disc, the distance between some cells and theirnearest vessel can be as long as 6 to 8 mm. These vessels reside in the cartilageendplate of the neighboring vertebra. Besides endplate, outside of the fibre circle there is also a network of blood vessels. The center of endplate is the main path oftransportation of metabolite of the disc. Therefore, from anato-biological point ofview, the intervertebral disc's nutrition is very fragile. The intervertebral disc iseasily affected by various nutrition factors. Appropriate amount of exercise assistsnutrition, but excess amount of exercises and strain will impact the disc cells'nutrition and metabolization, and thus cause degrading of the intervertebraldisc.Other than that, factors of degrading of the intervertebral disc are also relatedto age, bio-mechanics, changed activity of matrix enzyme, autoimmunity, etc. Whilethe cause of LIDP pain is not clear, many believe it's related to mechanical pressureand stimulation from chemical inflammation media, some electrical physiologymechanism and autoimmunity may also be involved.Secondly, this article providesa comprehensive report on treatment and progress of LIDP, and comparisonbetween surgery and non-surgery therapeutics is also made. The minimallyinvasive technique (including microscope intervertebral disc nucleus pulposusablation, Percutaneous nucleus pulposus ablation, Percutaneous intervertebral discresection, Percutaneous intervertebral disc laser decompression, spinal endoscopicintervertebral disc surgery, chemical nucleus pulposus dissolution) is reviewed. Thebenefits and disadvantages of different treatments are also discussed. Theimportance of Traditional Chinese Medicine in treating LIDP is further clarified andthe special effect of percutaneous hypothermal plasma radio frequency nucleuspulposus ablation and reformation is confirmed.The application of modern minimallyinvasive technique, via percutaneous hypothermal plasma radio frequency nucleuspulposus ablation and reformation in combination with Chinese herbal medicine forILDP in this project is to attempt to replace the traditionalnon-steroidalanti-inflammatorydrugs (NSAIDs) because of its side effects.In clinicalresearch, the percutaneous hypothermal plasma radio frequency nucleus pulposusablation and reformation combined with Chinese herbal medicine in promotingblood circulation and relaxing tendons was used. The herbal formulation was madeand prepared by our hospital and used in the laboratory experiment and clinical trialin orderto understand the mechanism and observe its clinical efficacy
Objective: Based on the principle of integration of TCM and modern medicine,this research project was to observe the efficacy of percutaneous hypothermalplasma radio frequency nucleus pulposus ablation and reformation in combinationwith Chinese herbal medicine in promoting blood circulation and relaxing tendons. Italso aimed to resolve the post-surgery pain due to stimulation of remainingchemical inflammation media. It was anticipated that the effect from the combinedtherapies was similar or even better than NSAIDs.
Method: This project was divided into two different phases conducted both in alaboratory or clinic. The laboratory study is an animal study by experimenting ratsused with prepared Chinese herbal formula to observe the anti-inflammatory andanalgesic effects. Rats with pain induced by the hot plate, and ear-engorgementinduced by inflammation were conducted. Control groups using MeloxiamDispersible tablets and Prednisolone were set up for comparisons to further verifythe effectiveness of Chinese herbal medicine with natures in promoting bloodcirculation and relaxing tendons. In addition, the acute toxicity test of which withLD_(50) was also carried out.In clinical research, 60 patients with LIDP were recruitedand randomized into two groups. One group received the precutaneoushypothermal plasma radio frequency nucleus pulposus ablation and reformation incombination with Chinese herbal medicine; the other group was given percutaneoushypothermal plasma radio frequency nucleus pulposus melt combined withMeloxiam Dispersible tablets as control. The whole clinical intervention ranthrough a period of two months. The outcomes of intensity of pain and relevantsymptoms were measured at two end-points, that is prior and post to the clinicalintervention. The data were recorded on Microsoft Excel sheet, and analyzed by theSPSS9.0 statistics software. The P value less than 0.05 was set up as to show anydifference is statistically significant.
Result: The Clinical study shows that percutaneous hypothermal plasma radiofrequency nucleus pulposus melt is one of the effective and safe therapies. This technology in combination with the Chinese herbal medicine with natures inpromoting blood circulation and relaxing tendons as developed by our hospital, hasdemonstrated obvious effect with significant relief for post-surgery pain for somepatients with LIDP. This combined treatment may provide innovative thinking andmethod for clinical practice. The study showed that the Chinese herbal medicinewith natures in promoting blood circulation and relaxing tendons may obviouslyextend the pain threshold when the pain induced in rats by the hot plate. Thisdemonstrates its analgesic effect. The high or media dosage of the herbalmedicine showed visible restraint and anti-inflammatory effect to the rat models ofear engorgement caused by dimethylbenzene. In addition, when dosage of herbsincreased into 900 times of human doses was given to the experimental rats, nodeath casualty occurred. It is therefore reasonable to conclude that the Chineseherbal formula is safe, less toxic, and effective.
研究目的本研究运用中西结合理论为指导，通过临床和实验研究，观察腰椎间盘突出症运用现代经皮低温等离子射频消融髓核成形术加用中药复方剂“舒筋活血药”的疗效，并解决经皮低温等离子射频消融髓核成形术后，化学炎症介质等致痛因子不能快速消除的缺憾，而使术后疼痛缓解。期望其作用疗效与使用非甾甙类解热镇痛药相近或有所提高。
研究方法本分实验研究与临床研究二部分。实验研究对“舒筋活血药”进行抗炎、镇痛作用的小鼠动物实验，采用小鼠热板法镇痛试验、小鼠耳肿胀法抗炎试验，分别与非甾甙类解热镇痛药“美洛昔康分散片”、糖皮质激素“强的松”进行分组对照，进一步明确“舒筋活血药”作用和疗效，并使用“舒筋活血药”对小鼠急性毒性试验，进行LD_(50)测定。临床研究有选择地观察60例腰椎间盘突出症患者，随机分两组各30例进行治疗和观察对比，一组为经皮低温等离子射频消融髓核成形术治疗腰椎间盘突出症加口服美洛昔康，另一组为经皮低温等离子射频消融髓核成形术加口服舒筋活血药治疗腰椎间盘突出症。两组进行治疗后疼痛等症状改善和临床疗效进行比较，观察时间为二个月。所有数据应用Microsoft Excel记录数据，SPSS9.0统计软件计算治疗前后的平均值、范围和标准误，95％的意义区限和成对t检验用来比较治疗前后疼痛分值的变化。当P值＜0.05时具有统计学意义。
研究结果临床研究表明：经皮低温等离子射频消融髓核成形术是治疗腰椎间盘突出症的有效方法之一，具有安全、微创的特点，符合当今对脊柱疾病的治疗潮流。运用经皮低温等离子射频消融髓核消融成形术结合自制中药复方制剂舒筋活血药治疗腰椎间盘突出症，临床疗效肯定，特别是术后疼痛缓解作用明显，可以为临床治疗提供新的思路和方法。“舒筋活血药”镇痛抗炎实验中，可明显延长小鼠在热板上的痛阈值，显示了“舒筋活血药”明显的镇痛作用；对于二甲苯引起的小鼠耳廓肿胀，“舒筋活血药”高剂量与中剂量亦表现出明显的抑制作用，抗炎作用明显。并且，在相当于人临床剂量的900倍的最大给药对小鼠无致死作用，可以认为“舒筋活血药”是一种安全、低毒、有效的中药复方制剂。
Content: This is a report on the use of integrated Chinese medicine and Westernmedicine for the treatment of lumbar intervertebale disc protrusion(LIDP), includinga historical literature review, laboratory experiment and clinical trial. First of all, itdiscusses the original historical references, etiology, pathology and clinicalpresentation based on the fundamental theory of traditional Chinese medicine(TCM). It states the LIDP has root of deficiency of the kidney in etiology andpathology, however, invasion of wind, cold, dampness as well as trauma are alsocontributing factors, which are the characteristics of LIDP as far as TCM isconcerned. In light of this pathological condition, four diagnostic syndromes/patternsare usually differentiated according to the clinical manifestations of LIDP, such as'pattern of deficiency of the kidney', 'pattern of cold in combination with dampness','pattern of heat in combination with dampness' and 'pattern of blood stagnation'.Modern medicine in anatomical structure of intervertebral disc, biomechanics ofintervertebral disc, path-physiology of LIDP, and degeneration effect of intervertebraldisc are also reviewed in this report.Although the pathology of protrusion of nucleuspulposus in intervertebral disc has never been thoroughly understood, it is howeverunderstood that the protrusion of lumbar intervertebral disc as the consequence ofreduction of elasticity of lumbar intervertebral disc plays a key role in developmentof this disorder. Adult intervertebral disc is the largest non-blood vessel structure inhuman body. Inside the adult disc, the distance between some cells and theirnearest vessel can be as long as 6 to 8 mm. These vessels reside in the cartilageendplate of the neighboring vertebra. Besides endplate, outside of the fibre circle there is also a network of blood vessels. The center of endplate is the main path oftransportation of metabolite of the disc. Therefore, from anato-biological point ofview, the intervertebral disc's nutrition is very fragile. The intervertebral disc iseasily affected by various nutrition factors. Appropriate amount of exercise assistsnutrition, but excess amount of exercises and strain will impact the disc cells'nutrition and metabolization, and thus cause degrading of the intervertebraldisc.Other than that, factors of degrading of the intervertebral disc are also relatedto age, bio-mechanics, changed activity of matrix enzyme, autoimmunity, etc. Whilethe cause of LIDP pain is not clear, many believe it's related to mechanical pressureand stimulation from chemical inflammation media, some electrical physiologymechanism and autoimmunity may also be involved.Secondly, this article providesa comprehensive report on treatment and progress of LIDP, and comparisonbetween surgery and non-surgery therapeutics is also made. The minimallyinvasive technique (including microscope intervertebral disc nucleus pulposusablation, Percutaneous nucleus pulposus ablation, Percutaneous intervertebral discresection, Percutaneous intervertebral disc laser decompression, spinal endoscopicintervertebral disc surgery, chemical nucleus pulposus dissolution) is reviewed. Thebenefits and disadvantages of different treatments are also discussed. Theimportance of Traditional Chinese Medicine in treating LIDP is further clarified andthe special effect of percutaneous hypothermal plasma radio frequency nucleuspulposus ablation and reformation is confirmed.The application of modern minimallyinvasive technique, via percutaneous hypothermal plasma radio frequency nucleuspulposus ablation and reformation in combination with Chinese herbal medicine forILDP in this project is to attempt to replace the traditionalnon-steroidalanti-inflammatorydrugs (NSAIDs) because of its side effects.In clinicalresearch, the percutaneous hypothermal plasma radio frequency nucleus pulposusablation and reformation combined with Chinese herbal medicine in promotingblood circulation and relaxing tendons was used. The herbal formulation was madeand prepared by our hospital and used in the laboratory experiment and clinical trialin orderto understand the mechanism and observe its clinical efficacy
Objective: Based on the principle of integration of TCM and modern medicine,this research project was to observe the efficacy of percutaneous hypothermalplasma radio frequency nucleus pulposus ablation and reformation in combinationwith Chinese herbal medicine in promoting blood circulation and relaxing tendons. Italso aimed to resolve the post-surgery pain due to stimulation of remainingchemical inflammation media. It was anticipated that the effect from the combinedtherapies was similar or even better than NSAIDs.
Method: This project was divided into two different phases conducted both in alaboratory or clinic. The laboratory study is an animal study by experimenting ratsused with prepared Chinese herbal formula to observe the anti-inflammatory andanalgesic effects. Rats with pain induced by the hot plate, and ear-engorgementinduced by inflammation were conducted. Control groups using MeloxiamDispersible tablets and Prednisolone were set up for comparisons to further verifythe effectiveness of Chinese herbal medicine with natures in promoting bloodcirculation and relaxing tendons. In addition, the acute toxicity test of which withLD_(50) was also carried out.In clinical research, 60 patients with LIDP were recruitedand randomized into two groups. One group received the precutaneoushypothermal plasma radio frequency nucleus pulposus ablation and reformation incombination with Chinese herbal medicine; the other group was given percutaneoushypothermal plasma radio frequency nucleus pulposus melt combined withMeloxiam Dispersible tablets as control. The whole clinical intervention ranthrough a period of two months. The outcomes of intensity of pain and relevantsymptoms were measured at two end-points, that is prior and post to the clinicalintervention. The data were recorded on Microsoft Excel sheet, and analyzed by theSPSS9.0 statistics software. The P value less than 0.05 was set up as to show anydifference is statistically significant.
Result: The Clinical study shows that percutaneous hypothermal plasma radiofrequency nucleus pulposus melt is one of the effective and safe therapies. This technology in combination with the Chinese herbal medicine with natures inpromoting blood circulation and relaxing tendons as developed by our hospital, hasdemonstrated obvious effect with significant relief for post-surgery pain for somepatients with LIDP. This combined treatment may provide innovative thinking andmethod for clinical practice. The study showed that the Chinese herbal medicinewith natures in promoting blood circulation and relaxing tendons may obviouslyextend the pain threshold when the pain induced in rats by the hot plate. Thisdemonstrates its analgesic effect. The high or media dosage of the herbalmedicine showed visible restraint and anti-inflammatory effect to the rat models ofear engorgement caused by dimethylbenzene. In addition, when dosage of herbsincreased into 900 times of human doses was given to the experimental rats, nodeath casualty occurred. It is therefore reasonable to conclude that the Chineseherbal formula is safe, less toxic, and effective.
引文
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5．新药(西药)临床前研究指导原则汇编，中华人民共和国卫生部药政管理局制
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