经皮激光椎间盘减压术治疗腰椎间盘突出症的实验与临床研究
摘要
腰椎间盘突出症(Lumbar disc herination,LDH)是一种常见病及多发病,在人群中的发病率约为15%。传统的治疗方法包括牵引、推拿、按摩疗法及外科手术等;微创治疗方法则有胶原酶溶解术、经皮腰椎间盘摘除术及激光椎间盘减压术等。近年来,我们采用经皮激光椎间盘减压术(Percutaneous Lasers DiskDecompression,PLDD)治疗腰椎间盘突出症与传统方法比较具有操作简便、创伤小、有效率高、无严重并发症等优点。
一、研究目的:
分别采用实验动物研究和临床研究分析说明PLDD术前、后腰椎间盘压力、气化腔横截面积、温度的变化,对所得数据进行统计学分析,并采用MacNab标准和JOA评分标准对临床疗效进行评价分析,从而说明PLDD为治疗腰椎间盘突出症安全有效的微创方法。
二、材料和研究方法:
1.一般资料
实验动物研究的对象为40只羊脊柱,而临床研究的病例为北京东直门医院骨科表现为腰背痛或和患侧及双侧下肢麻痛,直腿抬高及加强试验阳性,经CT或MRI检查证实为腰椎间盘突出症并进行PLDD术的40例患者。
2.研究方法
实验动物研究的动物模型随机分为A组和B组两组,每组各20例,其中A组为进行单点气化,B组为两点气化,从而分别比较A、B两组PLDD术前后椎间盘压力、温度、气化腔截面积的变化。
临床研究的40例病人也随机分为A组和B组两组,每组各20例,其中A组为进行单点气化,B组为两点气化,从而分别比较A、B两组PLDD术前术后椎间盘压力的变化。
三、治疗方法。
1.实验动物研究的方法:在麻醉下切取羊脊柱充分切除附着在脊柱椎旁的骶棘肌等,保留前纵韧带、后纵韧带,在L4～5椎间盘前外侧中点水平面用直径为18G长度为18cm的穿刺针以45°角穿入至椎间盘髓核中央,将压力传感器与穿刺针相连接,再将压力传感器与压力表相连,将光导纤维与激光发射机相连接,开机后PPT 10次/秒,间隔时间为1秒进行操作。并进行数据记录(1)椎间盘气化腔截面积(2)激光气化中不同部位温度(3)椎间盘的组织形态学观察(4)椎间盘压力的变化。
2.临床研究的方法为:A、B组均采用患肢向上侧卧位,局麻下穿刺针与身体矢状面夹角约为45°～60°,穿刺部位在后正中线侧方8～12cm(约4横指),进行患侧椎间盘的穿刺,并在患侧相对称的健侧按同样的方法进行穿刺,连接测压仪,进行压力测定,A组进行单点气化,B组进行两点气化,采用统计分析的方法对结果进行比较分析。
四.统计方法与数据处理
实验和临床研究中的A、B组均采用SPSS11.5统计分析软件,所有数据均采用统计检验方法,P值小于或等于0.05被认为所检验差别有统计学意义。
五.结果
1实验动物的研究结果
1.1椎间盘气化腔截面积随能量的增加而增加,A、B两组间有非常显著性差异(P＜0.01)。
1.2激光气化椎间盘过程中,椎间盘前缘、后缘和椎间孔内壁温度变化不大,均在2℃以内,组内变化无显著性意义(P＞0.05),而不同能量组间变化也无显著性意义(P＞0.05)。
1.3在大体标本上,激光辐射后的椎间盘前缘表面及穿刺孔未见炭化痕迹,椎间盘中央可见空腔形成,空腔壁上有炭化组织,气化的空腔基本局限在髓核内,空腔与周边界限较清楚,其边缘纤维环、软骨终板未见明显破坏(见附图3),另可见进行多点气化后气化腔面积较单点面积大。
1.4椎间盘气化后随着能量的增加,椎间盘压力下降的幅度也随之增大,200J与500J有显著差异性(P＜0.01),但A组和B组之问压力变化的幅度无明显差异(P＞0.05)。
2.临床研究结果
2.1 PLDD的有效率与患者年龄的关系:患者年龄越小,有效率越高,尤其以＜40岁的有效率最高,达到93%。
2.2 PLDD的有效率与病程的关系:病程越短有效率越高,尤以＜2年为最高,达到88%,经MRI检查术后3个月椎间盘无明显回纳。
2.3 PLDD的有效率与椎间盘突出程度的关系:椎间盘突出程度越小有效率越高,＜6 mm者可达到90%。
2.4 PLDD的有效率与术后病程的关系:术后第2天的有效率最高为86%,术后1周有效率最低为79%,术后3个月以后有效率基本稳定。
2.5并发症情况本组病例PLDD术后均未应用抗生素,无一例感染。Nd:YAG激光的高温,特别是当激光总能量超过1000J时,可使椎间盘组织产生反应性无菌性炎症,造成腰痛,本组病例发生率约1%,发生的概率随激光治疗时能量的增加而增高。患者出现腰痛,一般卧床休息,症状重者口服非甾体抗炎药,经过3～5天症状可以消失。
2.6 PLDD有效率单点和多点气化减压之间无显著性差异(P＞0.5)。
LDH is a common and frequently-occurring disease.Among 100 people, there will be 15 people suffer from it.Doctors often use traditional methods such as traction,massage,surgery or minimally insasive methods such as CCNL,APLD,PLDD to cure it.Compared with the traditional ones, PLDD has advantages of simplicity,convenience,minimal trauma and without serious complications.
Research target
object:
To research the experimental animals and patients in the hospital and statistically analyze the pressure,cubage and temperature obtained from PLDD operation,we can estimate the curative effect of PLDD according to the MacNab and JOA criterion.
Material and method
Method
1 Grouping Method
According to the differences between animal models,we can divide them into two groups---experiment group(group A)and contrast group(group B).Group A:Measuring the pressure of disc by the single-point PLDD;Group B:Measuring the pressure of disc by the multi-point PLDD.Apply stochastic method to establish the curative scheme---group A first,then the group B,or on the contrary.
2.Reserch method
①Lying down on one side with sick limb up;②Puncture point: puncture needle and the body sagittal section are at an angle of 45°～60°.Local anaesthesia:Take 5ml～10ml 0.5ml～1.0ml lidocaine to do the local infiltration anaesthesia through derma,hypoderm,muscle and vertebra joint.No anaesthesia the nerve root.
Treatment Method
1.Animal reserch:
If the needle meets the bony resister,pull it back a little to the outer part,then the needle will slide to the disc,when the needle insert the disc velamen and A.F,the patient will feel a slight pain,and then the resister disappears,the pain will fade away when the needle gets to the marrow core.To locate the position of the needle by X-Ray from the normotopia and lateral position of lumber respectively.Normotopia is in the center of disc.Fiber optic laser inserts the lumbar 5mm deeper than the puncture needle,6mm deeper than the top of fibrin,therefore,the centre position of cauterization is in the 10mm front of the centre of the puncture needle.If we pull the needle 10mm back,the marrow core will be cauterized and boiled away.To insert the needle in the symmetric part of uninjured part and injured part,and connect the pressure pickup to check the pressure,and then we can compare the differences of the pressures in the disc before and after PLDD(See the profile).
2.Clinical Reserch:
Laser irradiation:the laser irradiation happens once every two seconds,if the patient' hurt in waist and legs,it is because of the heat of vaporization,then we pull out the fiber optic laser,wait for a few seconds to fade away the heat,thereafter we continue to operate by delivering the power in 1000J.The target of laser cutoff:①patient feels hurt,overheating;②the top of the laser fiber adhering carbonization;③the smell of burnt protein;④the top of the fiber optic laser appears matchstick like changes.
The treatment after laser irradiation:to pull out the fiber optic laser to control the traumatic inflammation in the disc,and inject glucocorticoid into disc.To pull out the puncture needle,and cover it with the pledget.The patient lies on his back to accept the SLR examination,toe myodynamic examination and sense examination.70%of the patients improved obviously after the operation,patients are asked to wear the soft kummerbund for 3 weeks,be in hospital for 3 days.
Stat.methods and data process
To adopt SPSS10.0 software,all the data is checked by bilateral statistic method.If P≤0.05,the checked differences are significative.
Conclusion
1 Conclusion of animal research
1.1 The relationship between the efficiency of PLDD and the patients' age:the younger the patient is,more effective of the PLDD,especially for patients under 40 years old,which can reach 93%.
1.2 The relationship between the efficiency of PLDD and the course of diseases:The shorter the course is,more effective the PLDD is, especially for the course which less than 2 years,reaching 88%.Of the 88%,there are 19%patients' discs recover to a certain extent in 3 moths.
1.3 The relationship between the efficiency of PLDD and severity of LDH: the less serious the disease is,the more effective the PLDD is.PID＜6mm,the efficiency can reach 90%.
1.4 The relationship between the efficiency of PLDD and the course of diseases after the operation,the second day after the operation,the efficiency will reach 86%,more than 79%after one week,the disease will be stable after three months.
2 Conclusion of clinical research
2.1 The relationship between the efficiency of PLDD and the patients' age:the younger the patient is,more effective of the PLDD,especially for patients under 40 years old,which can reach 93%.
2.2 The relationship between the efficiency of PLDD and the course of diseases:The shorter the course is,more effective the PLDD is, especially for the course which less than 2 years,reaching 88%.Of the 88%,there are 19%patients' discs recover to a certain extent in 3 moths.
2.3 The relationship between the efficiency of PLDD and severity of LDH: the less serious the disease is,the more effective the PLDD is.PID＜6mm,the efficiency can reach 90%.
2.4 The relationship between the efficiency of PLDD and the course of diseases after the operation,the second day after the operation,the efficiency will reach 86%,more than 79%after one week,the disease will be stable after three months.
2.5 complications
Patients in the group are not applied antibiotics after the PLDD operation, no infected was found.Nd:the heat of YAG laser,especially when the whole power exceeds 1000J,there will be reactive and non-bacterial phlogosis in the disc tissue and pain in the waist.The rate of the complication is about 1%,and it rises with the increase of the laser's power.The complication will fade away after 3 to 5 days if the patients have a good rest and take the NSAID.
2.6 There are no obvious differences of PLDD efficiency between the single-point and multi-point boiloff and decompression.
一、研究目的:
分别采用实验动物研究和临床研究分析说明PLDD术前、后腰椎间盘压力、气化腔横截面积、温度的变化,对所得数据进行统计学分析,并采用MacNab标准和JOA评分标准对临床疗效进行评价分析,从而说明PLDD为治疗腰椎间盘突出症安全有效的微创方法。
二、材料和研究方法:
1.一般资料
实验动物研究的对象为40只羊脊柱,而临床研究的病例为北京东直门医院骨科表现为腰背痛或和患侧及双侧下肢麻痛,直腿抬高及加强试验阳性,经CT或MRI检查证实为腰椎间盘突出症并进行PLDD术的40例患者。
2.研究方法
实验动物研究的动物模型随机分为A组和B组两组,每组各20例,其中A组为进行单点气化,B组为两点气化,从而分别比较A、B两组PLDD术前后椎间盘压力、温度、气化腔截面积的变化。
临床研究的40例病人也随机分为A组和B组两组,每组各20例,其中A组为进行单点气化,B组为两点气化,从而分别比较A、B两组PLDD术前术后椎间盘压力的变化。
三、治疗方法。
1.实验动物研究的方法:在麻醉下切取羊脊柱充分切除附着在脊柱椎旁的骶棘肌等,保留前纵韧带、后纵韧带,在L4～5椎间盘前外侧中点水平面用直径为18G长度为18cm的穿刺针以45°角穿入至椎间盘髓核中央,将压力传感器与穿刺针相连接,再将压力传感器与压力表相连,将光导纤维与激光发射机相连接,开机后PPT 10次/秒,间隔时间为1秒进行操作。并进行数据记录(1)椎间盘气化腔截面积(2)激光气化中不同部位温度(3)椎间盘的组织形态学观察(4)椎间盘压力的变化。
2.临床研究的方法为:A、B组均采用患肢向上侧卧位,局麻下穿刺针与身体矢状面夹角约为45°～60°,穿刺部位在后正中线侧方8～12cm(约4横指),进行患侧椎间盘的穿刺,并在患侧相对称的健侧按同样的方法进行穿刺,连接测压仪,进行压力测定,A组进行单点气化,B组进行两点气化,采用统计分析的方法对结果进行比较分析。
四.统计方法与数据处理
实验和临床研究中的A、B组均采用SPSS11.5统计分析软件,所有数据均采用统计检验方法,P值小于或等于0.05被认为所检验差别有统计学意义。
五.结果
1实验动物的研究结果
1.1椎间盘气化腔截面积随能量的增加而增加,A、B两组间有非常显著性差异(P＜0.01)。
1.2激光气化椎间盘过程中,椎间盘前缘、后缘和椎间孔内壁温度变化不大,均在2℃以内,组内变化无显著性意义(P＞0.05),而不同能量组间变化也无显著性意义(P＞0.05)。
1.3在大体标本上,激光辐射后的椎间盘前缘表面及穿刺孔未见炭化痕迹,椎间盘中央可见空腔形成,空腔壁上有炭化组织,气化的空腔基本局限在髓核内,空腔与周边界限较清楚,其边缘纤维环、软骨终板未见明显破坏(见附图3),另可见进行多点气化后气化腔面积较单点面积大。
1.4椎间盘气化后随着能量的增加,椎间盘压力下降的幅度也随之增大,200J与500J有显著差异性(P＜0.01),但A组和B组之问压力变化的幅度无明显差异(P＞0.05)。
2.临床研究结果
2.1 PLDD的有效率与患者年龄的关系:患者年龄越小,有效率越高,尤其以＜40岁的有效率最高,达到93%。
2.2 PLDD的有效率与病程的关系:病程越短有效率越高,尤以＜2年为最高,达到88%,经MRI检查术后3个月椎间盘无明显回纳。
2.3 PLDD的有效率与椎间盘突出程度的关系:椎间盘突出程度越小有效率越高,＜6 mm者可达到90%。
2.4 PLDD的有效率与术后病程的关系:术后第2天的有效率最高为86%,术后1周有效率最低为79%,术后3个月以后有效率基本稳定。
2.5并发症情况本组病例PLDD术后均未应用抗生素,无一例感染。Nd:YAG激光的高温,特别是当激光总能量超过1000J时,可使椎间盘组织产生反应性无菌性炎症,造成腰痛,本组病例发生率约1%,发生的概率随激光治疗时能量的增加而增高。患者出现腰痛,一般卧床休息,症状重者口服非甾体抗炎药,经过3～5天症状可以消失。
2.6 PLDD有效率单点和多点气化减压之间无显著性差异(P＞0.5)。
LDH is a common and frequently-occurring disease.Among 100 people, there will be 15 people suffer from it.Doctors often use traditional methods such as traction,massage,surgery or minimally insasive methods such as CCNL,APLD,PLDD to cure it.Compared with the traditional ones, PLDD has advantages of simplicity,convenience,minimal trauma and without serious complications.
Research target
object:
To research the experimental animals and patients in the hospital and statistically analyze the pressure,cubage and temperature obtained from PLDD operation,we can estimate the curative effect of PLDD according to the MacNab and JOA criterion.
Material and method
Method
1 Grouping Method
According to the differences between animal models,we can divide them into two groups---experiment group(group A)and contrast group(group B).Group A:Measuring the pressure of disc by the single-point PLDD;Group B:Measuring the pressure of disc by the multi-point PLDD.Apply stochastic method to establish the curative scheme---group A first,then the group B,or on the contrary.
2.Reserch method
①Lying down on one side with sick limb up;②Puncture point: puncture needle and the body sagittal section are at an angle of 45°～60°.Local anaesthesia:Take 5ml～10ml 0.5ml～1.0ml lidocaine to do the local infiltration anaesthesia through derma,hypoderm,muscle and vertebra joint.No anaesthesia the nerve root.
Treatment Method
1.Animal reserch:
If the needle meets the bony resister,pull it back a little to the outer part,then the needle will slide to the disc,when the needle insert the disc velamen and A.F,the patient will feel a slight pain,and then the resister disappears,the pain will fade away when the needle gets to the marrow core.To locate the position of the needle by X-Ray from the normotopia and lateral position of lumber respectively.Normotopia is in the center of disc.Fiber optic laser inserts the lumbar 5mm deeper than the puncture needle,6mm deeper than the top of fibrin,therefore,the centre position of cauterization is in the 10mm front of the centre of the puncture needle.If we pull the needle 10mm back,the marrow core will be cauterized and boiled away.To insert the needle in the symmetric part of uninjured part and injured part,and connect the pressure pickup to check the pressure,and then we can compare the differences of the pressures in the disc before and after PLDD(See the profile).
2.Clinical Reserch:
Laser irradiation:the laser irradiation happens once every two seconds,if the patient' hurt in waist and legs,it is because of the heat of vaporization,then we pull out the fiber optic laser,wait for a few seconds to fade away the heat,thereafter we continue to operate by delivering the power in 1000J.The target of laser cutoff:①patient feels hurt,overheating;②the top of the laser fiber adhering carbonization;③the smell of burnt protein;④the top of the fiber optic laser appears matchstick like changes.
The treatment after laser irradiation:to pull out the fiber optic laser to control the traumatic inflammation in the disc,and inject glucocorticoid into disc.To pull out the puncture needle,and cover it with the pledget.The patient lies on his back to accept the SLR examination,toe myodynamic examination and sense examination.70%of the patients improved obviously after the operation,patients are asked to wear the soft kummerbund for 3 weeks,be in hospital for 3 days.
Stat.methods and data process
To adopt SPSS10.0 software,all the data is checked by bilateral statistic method.If P≤0.05,the checked differences are significative.
Conclusion
1 Conclusion of animal research
1.1 The relationship between the efficiency of PLDD and the patients' age:the younger the patient is,more effective of the PLDD,especially for patients under 40 years old,which can reach 93%.
1.2 The relationship between the efficiency of PLDD and the course of diseases:The shorter the course is,more effective the PLDD is, especially for the course which less than 2 years,reaching 88%.Of the 88%,there are 19%patients' discs recover to a certain extent in 3 moths.
1.3 The relationship between the efficiency of PLDD and severity of LDH: the less serious the disease is,the more effective the PLDD is.PID＜6mm,the efficiency can reach 90%.
1.4 The relationship between the efficiency of PLDD and the course of diseases after the operation,the second day after the operation,the efficiency will reach 86%,more than 79%after one week,the disease will be stable after three months.
2 Conclusion of clinical research
2.1 The relationship between the efficiency of PLDD and the patients' age:the younger the patient is,more effective of the PLDD,especially for patients under 40 years old,which can reach 93%.
2.2 The relationship between the efficiency of PLDD and the course of diseases:The shorter the course is,more effective the PLDD is, especially for the course which less than 2 years,reaching 88%.Of the 88%,there are 19%patients' discs recover to a certain extent in 3 moths.
2.3 The relationship between the efficiency of PLDD and severity of LDH: the less serious the disease is,the more effective the PLDD is.PID＜6mm,the efficiency can reach 90%.
2.4 The relationship between the efficiency of PLDD and the course of diseases after the operation,the second day after the operation,the efficiency will reach 86%,more than 79%after one week,the disease will be stable after three months.
2.5 complications
Patients in the group are not applied antibiotics after the PLDD operation, no infected was found.Nd:the heat of YAG laser,especially when the whole power exceeds 1000J,there will be reactive and non-bacterial phlogosis in the disc tissue and pain in the waist.The rate of the complication is about 1%,and it rises with the increase of the laser's power.The complication will fade away after 3 to 5 days if the patients have a good rest and take the NSAID.
2.6 There are no obvious differences of PLDD efficiency between the single-point and multi-point boiloff and decompression.
引文
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