预防硬膜外瘢痕粘连的不同方法对MED疗效影响的临床研究
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摘要
目的:
     通过比较预防腰椎间盘镜下髓核摘除术(MED)术后硬膜外可能发生的粘连的不同方法对临床疗效的影响,评价各种方法的有效性,以期寻找到对腰椎间盘突出症术后患者症状改善有积极影响的术中干预因素,以指导进一步的临床实践。
     方法:
     筛选2005年3月至2005年12月住院的腰椎间盘突出症病例,对纳入研究范围的MED手术病例进行随机化分组,分别是:A组——常规MED组;B组——常规MED+几丁糖组;C组——保留黄韧带组。各组分别施行相应的术中干预手段并进行术前一天在院评定及术后三周、术后三月及术后一年的随访,通过数据统计分析各组病例1)疼痛强度;2)下腰痛相关性功能障碍指数;3)体征的变化情况,另将各随访时段功能障碍指数依其改善率域段划分为代表临床疗效的四个等级(>75%为优,50%~74%为良,25%~49%为可,<24%为差),结合患者对治疗的主观满意度(以术后一年随访获得的数据进入统计)进行统计分析,对不同预防MED术后硬膜外瘢痕粘连方法临床疗效的差异进行综合评估。术后一年的门诊随诊中对患者病变椎间盘的脊柱节段进行CT扫描,根据CT显示的手术节段椎管内粘连程度的不同进行分级,对各组间不同分级的人数构成进行对比分析,并将各病例CT显示的粘连等级与相应的临床疗效改善率进行相关性分析。
     结果:
     1、所有计量资料数值均符合正态分布,各组数值方差齐。
     2、术前1天各组间VAS、ODI均数均无显著性差异,F值分别为0.050、0.116,P值分别为0.951、0.890。
     3、A、B、C三组腰椎间盘突出症病例经过MED治疗,临床症状总体上较术前均有显著改善(P<0.001)。各个时间段相应的VAS、ODI数值之间均存在显著的相关性(P<0.01)。
     4、术后3周A、C组间VAS、ODI均数无显著性差异(P>0.05),但与B组比较均存在显著性差异(P<0.001)。与之相应,这个时间段VAS、ODI变化情况(以术前1天为参照)A、C组间无显著差异,但与B组比较均有显著性差异(P<0.001)。各组均数比较B<A,B<C。
     5、术后3月B、C组间VAS、ODI均数无显著性差异(P>0.05),但与A组比较均存在显著性差异(P<0.001)。与之相应,这个时间段VAS、ODI变化情况(以术前1天为参照)B、C组间无显著差异,但与A组比较均有显著性差异(P<0.001)。各组均数比较B<A,C<A。
     6、术后1年,A、B、C三组VAS、ODI均数比较两两之间均有显著性差异。与之相应,这个时间段VAS变化情况(以术前1天为参照)三组两两之间均有显著性差异(P<0.001)。ODI变化情况A、B组之间差异不显著(P>0.05),B、C组(P<0.05)及A、C组(P<0.01)之间存在显著性差异。各组均数比较C<B<A。
     7、根据术后各随访时段的ODI数值分别计算相应的改善率并进行各项统计,结果与VAS、ODI的统计结果相符。通过对优良率的计算,发现各组疗效优良率差别不大,随着时间变化,优良率波动范围也不大。这与各组例数有限及部分病例失随访有关。
     8、术后1年门诊随访,各组患者主诉临床症状与体征均较术前有不同程度的改善,但各组间改善程度看不出明显差异,体征与临床症状之间亦没有明显的关联。
     9、术后1年的随访,A、B、C三组自觉疗效好的各占85.71%、95.45%、95.45%。不同得分的人数构成三组间差别均无统计学意义(P>0.05)。但自觉完全康复的病例以C组最多(9例),B组次之(6例),A组最少(4例)。所有病例中,没有患者认为症状较术前加重。
     10、术后1年随访椎管内粘连程度CT分级,三组不同分级的人数构成两两之间差异均有统计学意义。对所有患者的CT分级及其术后1年ODI数值对应的临床症状改善率进行相关性分析,结果显示存在极其显著的差异(P<0.01)。
     结论:
     1、常规MED及术中使用几丁糖或保留黄韧带的MED,经过临床检验,均为有效的术式。而术中使用几丁糖的MED和保留黄韧带的MED手术均能获得比常规MED更为良好的临床疗效。
     2、使用几丁糖的MED能够获得较好的近期疗效,但术后1年的随访结果显示,以保留黄韧带的MED手术疗效最优。
     3、从术后1年随访手术节段CT显示的结果看,术后椎管内粘连的程度差异与术中不同干预手段及临床疗效均存在一定程度的关联。
     4、本课题随访的最长时间为1年,对MED术中加用几丁糖、保留黄韧带的干预手段的近期疗效有大致的直观印象,但其远期疗效有待于长期随访后总结。
     5、根据MED术中保留黄韧带的操作体会,认为保留黄韧带的操作方式并非拘泥于一种,根据具体情况操作稍有不同,需要在今后的临床应用中总结。
Purpose:
     Through comparison with different methods for preventing post-operative epiduralfibrosis formation and their effects on microendoscopic discectomy, appraise the validity ofthese methods and expect to looking for intervening factors during operation which positivelyimproved patients' symptoms of lumbar disc herniation, give instructions to further clinicatpractices.
     Method:
     Filtrated the cases of lumbar disc herniation hospitalized during March 2005 toDecember 2005, grouped the absorbed MED surgical cases at random,respectively traditionalMED as group A, additional using Chitosan in traditional MED as group B,and sparing flavumligament in MED as group C. Each group were enforced with corresponding method duringoperation, assessed in hospital 1 day pre-operation, and took 3 weeks, 3 months and 1 yearfollow-up respectively. Analyse the cases in each group with the pain intensity, low-back-painspecific disability index and body drafts changements by data statistics. Extrally, divide theimprovement rates which related to disability index to 4 grades which denoted the clinicaleffect(>75% is excellent, 50%~74% is good,25%~49% is favorable,<24% is bad). Thencombine with patients' satisfaction degrees to treatment which acquired post 1 yearfoUow-up, statisticing and analyzing, synthetic appraising the difference of clinical effectsbetween diverse methods which used to prevent epidural fibrosis formation. During outpatientservice 1 year post-operation, each patient was enforced with computed tomography scan oninjuryed intervertebral disc corresponding spinal section, according to fibrosis levels insurgical section as CT films manifested, compare and statistic the constitution of different graded cases between 3 groups. Finally, make correlative analysis between each CT graded andits corresponding improvement rate derived from ODI value.
     Result:
     1. All numerical values of measurement data match to normal distribution, and all atequal variance.
     2. Both VAS and ODt means were have no significant difference between 3 groups 1 daypre-operation, the F values were 0.050,0.116 and P values were 0.951,0.890 respectively.
     3. All cases of lumbar disc herniation in group A,B,C were performed by MED therapyand the clinical symptoms were obvious improved compared to pre-operation as a whole (P<0.001). In each period of time, the VAS and related ODI values were all have significantdifferences (P<0.01).
     4. Both VAS and ODI means between group A,C were have no significant difference at 3weeks follow-up (P>0.05). However, when compared to group B,there were all observedsignificant differences (P<0.001).Accordingly, changements of VAS and ODI in this period oftime(comparatively to 1day pre-operation) had no significant difference in group A,C, andsignificant differences were observed when compared to group B (P<0.001).Meanscomparison between 3 groups is B<A, B<C.
     5. Both VAS and ODI means between group B,C were have no significant difference at 3months follow-up (P>0.05). However, when compared to group A, there were all observedsignificant differences (P<0.001).Accordingly, changements of VAS and ODI in this period oftime(comparatively to 1day pre-operation) had no significant difference in group B,C,andsignificant differences were observed when compared to group A (P<0.001).Meanscomparison between 3 groups is B<A,C<A.
     6. Pairwise comparison of VAS and ODI means between group A,B,C at 1 yearfollow-up were all observed significant differences. Accordingly, changements of VAS in thisperiod of time(comparatively to 1day pre-operation) were all have significant differences in 3groups by pairwise comparison (P<0.001).Changements of ODI were as follows: nosignificant difference between group A,B(P>0.05), group B,C (P<0.05) and group A,C(P<0.01) were all observed significant differences. Means comparison between 3 groups is C<B<A.
     7. Calculated the improvement rates according to ODI values acquired from each time offollow-up respectively, maked a series of statistics,concluded that result was consistent withforegoing statistics. Few difference between 3 groups was found via computing the excellentand good rate,and going with the time-lapse,the rate fluctuating range observed slight also.Itcould be concern with the result of finite cases in each group and absence of several cases infollow-up.
     8. During out-patient service at 1 year follow-up, patients in each group were all acquiredifferent improvement levels of clinical symptoms and body drafts.However, the extent ofimprovement was not obvious between 3 groups,no obvious relationship observed bebweenbody drafts and clinical symptoms also.
     9. Post 1 year follow-up, the percentage of serf-assessed as exellent result in each groupwas 85.71%,95.45% and 95.45% respectively. Compared with cases of different scores in eachgroup manifested no significant difference(P>0.05). However, in which the most cases offound completely cured was group C(9 cases),followed group B(6 cases), group A was theleast(4 cases).In all patients,none considered that clinical symptoms aggravated compare withpre-operation.
     10. Post 1 year follow-up, according to CT manifested fibrosis levels in surgicalvertebral canal,different graded cases in 3 group have pairwise significantdifference. Correlative analysis between each CT graded and corresponding improvement raterevealed that exists obvious difference(P<0.01).
     Conclusion:
     1. Traditional MED, MED with additional using chitosan and sparing flavumligamentum were all proved to be effective methods by clinical inspection. Both usingchitosan and sparing flavum ligamentum in MED have acquired better clinical curative effectsthan the traditional MED.
     2. MED in which chitosan is used has a better short-term clinical curative effects.However, post 1 year follow-up reveals that sparing flavum ligament during MED operationcan get the best curative effects.
     3. Concluded from post 1 year follow-up that CT films manifested of surgicalsection, there certainly to be somewhat correlative between post-operative fibrosis levels andintervening methods during operation and clinical effects.
     4. In this subject,the longest period of time for follow-up is 1 year.We can getapproximately direct impression about short-term clinical effects of methods that MEDoperation in which additional use of chitosan or sparing flavum ligament.However, theireffects of long-term remained to be summarized by further outcome.
     5. According to the experiences got from operation of sparing the flavum ligamentduring MED, we realized it is not only one operative technique for sparing the flavumligament. It should take somewhat modifications to suit for certain situations, and also needs tobe summarized in clinical applications in future.
引文
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