摘要
第一部分退变性下腰痛微创手术治疗随访评价系统的建立
1.退变性下腰痛手术治疗随访评价系统的建立
研究背景：退变性下腰痛是一种常见的脊柱疼痛综合征，当保守治疗无效时，往往需要手术治疗。传统手术治疗以开放手术为主，近年来越来越多的微创手术被应用于退变性下腰痛的治疗。微创与开放手术疗效的差异仍有争论。如何评价治疗疗效对于脊柱外科尤其是微创脊柱外科的发展显得至关重要。对于临床疗效的评价，随访是至关重要的。传统随访模式工作量大且无法快速查询，容易造成失访。目的：建立一套退变性下腰痛手术治疗随访评价系统，为后期评价退变性下腰痛微创治疗疗效及建立适合国人的评价方案打下基础。方法和结果：参考目前应用较为广泛的下腰痛评价方案，筛选疗效评定指标，建立随访表及随访流程。依托“军字一号”电子病例系统，将下腰痛患者的临床资料、卫生经济学指标及常用评价方案一并整合写入程序，设计建立退变性下腰痛手术治疗随访评价系统。结论：所建立的退变性下腰痛手术治疗随访评价系统录入快捷、安全可靠、查询方便，可以全面展示术前、术中和术后情况，为后期评价退变性下腰痛微创治疗疗效及建立适合国人的评价方案提供了数据平台。
2.退变性下腰痛疗效评分表的建立及初步评价
研究背景：目前国际上常用的下腰痛外科治疗疗效评定方案对于微创手术的短期疗效敏感性不高，并且部分评价项目并不适合国人。目前我国仍缺乏一种适合国人的、简洁实用的下腰痛疗效评价方法。目的：建立一种适合国人的下腰痛程度评定方法，用于进行外科手术尤其是微创手术的疗效评定。方法：通过临床资料随访进行数据统计，筛选出适合国人的评价指标，建立下腰痛疗效评分(low back pain outcome score，LBPOS)量表，将其运用于微创及开放手术的疗效评定，并与JOA下腰痛评分(Japaneseorthopaedic association low back pain score，JOA)、Oswestry功能障碍指数(Oswestrydisability index，ODI)等经典评价方法对比，验证其效度及信度。同时将其与其他常用评定方法整合建立退变性下腰痛微创手术治疗的随访评价系统。结果：LBPOS量表适合国人，依从性好，具有良好的内部一致性、分半信度，与JOA、ODI评分具有显著的相关性。结论：新建立的LBPOS量表具有良好的效度、信度和敏感度，适合国人进行下腰痛微创手术后短期的疗效评定，中长期的评定效果有待进一步验证。
第二部分腰椎盘突出症微创手术治疗评价的相关临床研究
1.两种微创手术治疗腰椎盘突出症的评价
研究背景：后路椎间盘镜下椎间盘切除术(microendoscopic discectomy，MED)与侧路经皮内窥镜下椎间盘切除术(percutaneous endoscopic lumbar discectomy，PELD)是目前最常采用的微创椎间盘手术，但是其临床效果的差别仍不明确。目前尚无严格的循证医学文献对两者的疗效进行对比研究。目的：前瞻性对比研究PELD和MED治疗腰椎间盘突出症的卫生经济学及临床效果差别，同时验证新建立的下腰痛疗效评分表的可行性及有效性。方法：通过建立的退变性下腰痛微创手术治疗随访评价系统，序贯抽取因腰椎间盘突出症行单节段MED及PELD手术的患者进行随访，统计比较其一般临床资料、卫生经济学指标，于术前、术后1周、术后2周、术后1月、术后2月、术后3月、术后6月、术后1年、术后2年各时间点进行疼痛程度及腰部功能评定(使用VAS、JOA、ODI、LBPOS评分)，末次随访时用改良Macnab标准评定临床效果。对比两种术式的疗效差别，验证LBPOS的依从性及及效度。结果：共有285例患者被纳入本研究。其中男性170例，女性115例，平均年龄46.2岁，平均病程2.1年，183例行MED，102例行PELD。两组病例的术前一般情况、疼痛与功能评分及住院费用均无统计学差异，PELD较MED手术时间长，但术中出血量少，住院时间短。MED并发症发生率低于PELD(1.6%vs.2.0%)，术后2年内复发率也低于PELD(4.4%vs.4.9%)，PELD术后优良率略低于MED(78.1%vs.80.9%)。术后3月内两组VAS、JOA、ODI、LBPOS评分均显著改善，MED术后1~2周腰部功能存在“反跳”现象，术后3月内各时间点PELD腰部功能评分多优于MED，但VAS评分两组无差别。术后6月至术后2年腰部疼痛程度及功能评分变化趋缓，两组各时间点VAS、ODI、LBPOS评分无差别。LBPOS具有良好的依从性和敏感度，与JOA、ODI评分具有显著的相关性。结论：PELD和MED治疗腰椎间盘突出症均安全、有效，PELD术后3月内的腰部功能恢复优于MED。LBPOS量表可以用于腰椎间盘突出症微创手术的疗效评定。
2.腰椎间盘突出症不同术式治疗的再手术分析
研究背景：近年来微创手术广泛应用于椎间盘突出症的治疗，但术后仍有2.8%到24%的患者进行了再次手术。不同的初次手术后的再手术率也不同，但再手术的原因和特点仍不明确。目的：对比研究椎间盘突出症不同术式后再手术的原因和特点，为后期制定随访计划、完善疗效随访评价系统提供参考。方法：调查我院2001至2012年10年间因腰椎间盘突出症入院行手术治疗的全部5280例患者，共有207例(232个椎间盘)进行了初次手术及再次手术，其中男性135例，女性72例，平均年龄47.7岁。统计、对比患者两次手术的术前一般情况、影像学检查结果、手术日期、手术方式、手术情况、手术时间间隔、再手术原因。结果：共有232个椎间盘进行了两次手术处理。其中119个椎间盘初次手术为MED(MED组)，68个椎间盘初次手术为PELD(PELD组)，45个椎间盘初次手术为开放手术(开放组)。再手术的部位与初次手术部位有较好的相关性(kappa系数=0.533)。再手术中有46.6%发生于术后半年内，35.3%发生于初次手术后1~5年之间。真性复发(同节段同侧再突出)是每种术式后再手术的主要原因，分别占据了PELD术后再手术总量的70.6%、MED术后再手术的47.1%及开放手术后再手术的37.8%。再手术与初次手术的时间间隔长短按以下顺序排列：PELD＜MED＜开放手术(8.1月vs.19.7月vs.33.1月，卡方检验p值均＜0.01)。结论：腰椎间盘突出症术后再手术的高发时间段，开放手术为术后1~5年；MED为术后0~0.5年及术后1~5年；PELD为术后0~0.5年。真性复发是腰椎间盘突出症术后再手术的主要原因，微创内窥镜手术术后由真性复发导致的再手术要多于开放手术术后。
第三部分椎间盘源性腰痛诊断方法与微创治疗的相关临床研究
1.椎间孔镜下椎间盘切除、纤维环热凝成形术治疗椎间盘源性腰痛的疗效评价
研究背景：椎间孔镜下椎间盘切除、纤维环热凝成形术(posterolateral transforaminalselective endoscopic discectomy and thermal annuloplasty，PEDTA)近年来开始用于椎间盘源性腰痛的治疗，但临床疗效有争议。对于椎间盘源性腰痛的手术治疗中，近期的少数研究发现单节段退变手术者疗效优于多节段退变者，但缺乏对照研究。目的：评价验证PEDTA治疗椎间盘源性腰痛的疗效，对比研究有无孤立退变椎间盘对手术疗效的影响，探讨椎间盘的“孤立退变”在微创手术病例选择及临床治疗中的意义。方法：101例经椎间盘造影确诊椎间盘源性腰痛并行PEDTA治疗的患者被纳入研究，其中男性47例，女性54例，平均年龄42.8岁，平均病程3.5年。根据改良Pfirrmann标准进行腰椎间盘退变程度分级，确定孤立退变椎间盘(比上下椎间盘退变分级均高出1级以上的椎间盘)。随访计算术前、术后的VAS、JOA、ODI评分，采用改良Macnab标准进行疗效评定。结果：101例患者均得到随访，平均随访时间2.5年。根据改良Macnab标准，101例患者术后疗效：优11例(10.9%)，良41例(40.6%)，可29例(28.7%)，差20例(19.8%)。术后患者VAS、JOA及ODI评分比术前有明显改善(p＜0.01)。共有49例患者存在孤立退变椎间盘(孤立退变组，n=49)，52例患者不存在孤立退变椎间盘(非孤立退变组，n=52)。两组术前的年龄、性别分布、病程及术前VAS、JOA与ODI评分均无差异。术后两组患者的VAS、JOA及ODI评分均与术前相比有明显改善(p＜0.01)，孤立退变组术后疼痛程度及腰部功能的改善优于非孤立退变组(p＜0.05)。孤立退变组疗效优良率为65.3%，，有效率87.8%；非孤立退变组优良率38.5%，有效率73.1%。结论：PEDTA治疗椎间盘源性腰痛安全、有效，有孤立退变椎间盘的患者疗效更好。
2.椎间盘内注射罗哌卡因对椎间盘源性腰痛的诊断与治疗作用
研究背景：椎间盘造影被认为是诊断DLBP的“金标准”，但一直备受争议。近年来椎间盘封闭开始用于诊断DLBP，我们初期的临床试验发现罗哌卡因椎间盘内注射对DLBP有治疗作用,目前尚未发现关于椎间盘封闭对于DLBP有长期疗效的报道。目的：观察用罗哌卡因进行椎间盘内注射封闭对于DLBP的诊断作用及治疗效果，探讨在DLBP的诊断阶段同时给予初期治疗的微创处理方案。方法：按照纳入、排除标准筛选14例慢性下腰痛患者进入研究。其中男性5例，女性9例，平均年龄46.0岁，平均病程4.8年。使用罗哌卡因对退变椎间盘进行封闭，观察封闭效果并进行疗效随访。使用VAS、ODI、LBPOS评分评定术前、术后1周、术后3月、术后6月、术后12月的疼痛及腰痛功能情况，末次随访采用改良Macnab标准进行疗效评定。结果：14例患者均操作顺利，无严重并发症，术后均得到随访。其中12例经椎间盘封闭诊断为DLBP，根据改良Macnab标准，12例DLBP患者治疗优良率46.7%，有效率75.0%。术后各随访时间点的VAS、ODI、LBPOS评分比术前均有明显改善(p＜0.05)。2例患者经椎间盘封闭诊断为非DLBP的患者术后各随访时间点的VAS、ODI、LBPOS评分均无明显改善，疗效均评定为“差”。结论：罗哌卡因椎间盘内注射是一种诊断同时初步治疗DLBP的经济、有效的微创方法，其治疗效果仍需大样本长期随访研究证实。
Part Ⅰ Establishment of Cases Follow-up and Evaluation System for MinimallyInvasive Surgical Treatment of Degenerative Low Back Pain
Section A Establishment of Cases Follow-up and Evaluation System for SurgicalTreatment of Degenerative Low Back Pain
Backgroud Chronic degenerative low back pain (LBP) is a common disorder of thelumbar spine and and it is occasionally treated surgically when conservative treatment isinvalid. Traditional surgical therapies are often open surgeries. Recently, minimal invasivetechniques were also widely used in this field. However, there were contentious controversiesin clinical efficacy of these techniques. How to evaluate the efficacy of these techniques isvery important for the development of minimally invasive spine surgery. Follow-up isessential for the evaluation of clinical efficacy. Using traditional follow-up model, we can notsearch quickly and the cases always lost to follow-up easily. Objective To establish a casesfollow-up and evaluation system for surgical treatment of degenerative LBP. Methods andResults Reference to widely used rating scales for LBP, the evaluation indicators wereselected out. The follow-up questionnaire and follow-up process were also established.Through the medical record system "No.1Military" project, we put clinical data and healtheconomics indicators of patients together with the rating scales for LBP, established the casesfollow-up and evaluation system for surgical treatment of degenerative LBP. Conclusion Thecases follow-up and evaluation system is safe and reliable. It provides fast entry andconvenient query. It can fully demonstrate the preoperative, intraoperative and postoperativeconditions. The system also provides a data platform to evaluate the minimally invasivesurgical treatment for degenerative LBP and to establish the LBP scoring system for Chinese.
Section B Establishment and Preliminary Evaluation of Low Back Pain Outcome Score Scale
Backgroud Current common rating scales for LBP are not very suitable for the short-term efficacy assessment of minimally invasive surgery. Some of items in these ratingscales are not very suitable for Chinese. At present, we are still far from a simple and practicalevaluation method for LBP which is fit for Chinese people. Objective To establish a LBPoutcome score scale which is suitable for Chinese and can be used to make the assessment forminimally invasive surgical treatment of degenerative LBP. Methods Using the follow-upquestionnaire, the follow up for LBP were proceeded and the items fit for Chinese wereselected out to construct the low back pain outcome score (LBPOS) scale. Minimally invasiveand open surgical treatments for degenerative LBP were evaluated by Japanese orthopaedicassociation low back pain score (JOA), Oswestry Disability Index (ODI) and LBPOS scale.The validity and reliability of LBPOS scale are verified. Results LBPOS scale is suitable forChinese. With good compliance, internal consistency and split-half reliability, LBPOS scorehas a significant correlation with JOA score and ODI. Conclusion With good validity,reliability and sensitivity, LBPOS scale can be used to make the assessment for minimallyinvasive surgical treatment of degenerative LBP.
Part Ⅱ Related Clinical Research About Evaluation for Minimally InvasiveSurgical Treatment of Lumbar Disc Herniation
Section A Evaluation for Minimally Invasive Surgical Treatment of Lumbar DiscHerniation
Backgroud Microendoscopic discectomy (MED) and percutaneous endoscopic lumbardiscectomy (PELD) are the most commonly used minimally invasive surgeries for lumbardisc herniation (LDH). With no strict evidence-based control research, the difference ofclinical outcomes between them remains unclear. Objective To prospectively compare theclinical results and cost utility of PELD with MED, and to verify the feasibility andeffectiveness of LBPOS scale. Methods Through cases follow-up and evaluation system weestablished, a series of LDH patients underwent single level endoscopic discectomy werefollowed up for2years. In addition to general and cost utility parameters, the followingmeasuring instruments were used: VAS, JOA, ODI, LBPOS, and modified MacNab criteria.The compliance and validity of LBPOS scale were also verified. Results285patients wereincluded in,170men and115women with a mean age of46.2years. One hundredeighty-three patients underwent PELD and102underwent MED. General preoperative data included VAS score, JOA score, ODI and LBPOS score, showed no statistical differencebetween the2groups (p>0.05). There were no serious complications observed duringfollow-up. The hospitalization costs in2groups are similar. The time of operation in PELDgroup is longer than that in MED group, but the blood loss was less and the hospital stay wasshorter than that in MED group. The success rate (excellent and good) in PELD group was alittle lower than that in MED group (78.1%vs.80.9%). Within3months after surgery, theimprovements in pain and functional disability were rapidly, and improvements of JOA score,ODI and LBPOS were significantly better in PELD group than in MED group (p＜0.01).From6months to2years after surgery, the improvements in pain and functional disabilitybecame slowly, and improvements of VAS score, ODI and LBPOS were similiar in PELDgroup than in MED group (p＞0.05). With good compliance and sensitivity, LBPOS score hasa significant correlation with JOA score and ODI. Conclusion PELD presents a safe andeffective treatment for LDH as well as MED. The improvements in functional disability weresignificantly better within3months after PELD than that after MED. LBPOS scale can beused to make the assessment for minimally invasive surgical treatment of LDH.
Section B Reoperation after Different Surgical Treatments for Lumbar Disc Herniation
Backgroud Despite the development of surgical techniques,2.8%to24%of patientsunderwent reoperations after their primary surgeries for LDH. The rates of reoperation afterdifferent primary surgical methods were reported to be different, but the comparative studyabout the causes and characteristics among different surgical methods have not been reported.Objective To compare the causes and characteristics of reoperations after different primarysurgeries for LDH. Methods Out of a series of5280patients who underwent surgeries forLDH between2001and2012,207patients (135male and72female, mean age47.7years)underwent primary and revision operations, which were included in this study. The followingclinical parameters were retrospectively assessed: the primary surgical methods, the intervalsbetween primary and revision surgeries, and surgical findings in reoperations. Results In total,232lumbar discs underwent reoperations. One hundred and nineteen reoperations wereperformed after microendoscopic discectomy (MED group),68after percutaneous endoscopiclumbar discectomy (PELD group) and45after open disc surgery (open group). The locationsof revision surgeries had priority over those of primary surgeries, with a moderate correlation (kappa coefficient=0.533).46.6%of reoperations were performed within0.5years afterprimary surgery, and35.3%were performed in1-5years. Real recurrent herniation(homolateral herniations at the same level) was significantly more common than otherreoperative surgical findings (70.6%in PELD group,47.1%in MED group,37.8%in opengroup). The overall mean interval until revision surgery was18.9months (8.1months inPELD group vs.19.7months in MED group vs.33.1months in open group, p <0.01).Conclusion For LDH, different reoperation peak occurred after different primary operation.Real recurrent herniation was the most common cause of reoperations, and more reoperationsfor real recurrent herniations and shorter intervals were found after minimally invasiveendoscopic discectomy than after open disc surgery.
Part Ⅲ Related Clinical Research About Diagnosis and Minimally InvasiveSurgical Treatment for Discogenic Low Back Pain
Section A Posterolateral Transforaminal Selective Endoscopic Discectomy withThermal Annuloplasty for Discogenic Low Back Pain
Backgroud recent years posterolateral transforaminal selective endoscopic discectomyand thermal annuloplasty (PEDTA) is reported to be used in treatment for discogenic lowback pain (DLBP) with contentious controversies in clinical efficacy. A small number ofrecent studies focusing on invasive treatments for DLBP noted that single-level degenerationmight respond better to invasive treatment than multi-level degeneration, but no comparativestudies. Objective To evaluate the clinical results of therapy for DLBP with PEDTA，and tocompare the clinical results between DLBP with isolated and consecutive disc degeneration.Methods One hundred and one consecutive DLBP patients with positive concordant pain indiscography underwent PEDTA. These patients included47men and54women with a meanage of42.8years. Based on modified Pfirrmann criteria, the preoperative disc degenerationgrade was evaluated, and Patients were divided into2groups. Patients with isolated discdegeneration constituted Group1(49cases). Patients with consecutive degeneration made upGroup2(52cases). Clinical results of2groups were evaluated by Visual analog scale (VAS)score, JOA score, ODI and modified MacNab criteria. Results101cases were followed upfor a mean period of2.5years. The percentages of excellent, good, fair and poor were10.9%,40.6%,28.7%and19.8%overall. General preoperative data included age, sex, duration of pain, VAS score, JOA score and ODI, showed no statistical difference between the twogroups (p>0.05). After surgery, both groups show significant reliefs in pain and functionaldisability. Improvements of VAS score, JOA score and ODI were significantly better in group1than in group2(p<0.05). The success rate (excellent and good) was65.3%in group1and38.5%in group2. Conclusion PEDTA presents a safe and effective treatment for carefullyselected DLBP patient. Better clinical results occurred in patients with isolated discdegeneration.
Section B Diagnosis and Treatment for Discogenic Low Back Pain with IntradiscInjection of Ropivacaine
Backgroud Provocative discography is considered as the gold standard for diagnosingDLBP with controversy. Recently discoblock is reported to be used in diagnosis for DLBP. Atherapeutic effect for DLBP was found in our initial clinical trial on discoblock withropivacaine, but no public report. Objective To evaluate the diagnosis and clinical therapyresults of DLBP with intradisc injection of ropivacaine. Methods Fourteen patients (5maleand9female, mean age46.0years) patients with chronic degenerative LBP were evaluated bydiscoblock (intradisc injection of2mL of0.2%ropivacaine). The VAS score, ODI andLBPOS score were recorded before and after discoblock. Clinical results were evaluated bymodified MacNab criteria. Results The discoblock were carried out successfully with noserious complications. The patients were followed up for12months. Twelve patients whoexperienced pain relief with discoblock were evaluated. The percentages of excellent, good,fair and poor were25.0%,16.7%,33.3%and25.0%. Twelve DLBP patients show significantimprovements in VAS score, ODI and LBPOS score at each follow-up point after discoblock.Two patients with no pain relief after discoblock showed poor results at each follow-up.Conclusion Intradisc injection of ropivacaine was a useful tool for the diagnosis of DLBP aswell as an economical and effective treatment for carefully selected DLBP patient.
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