转腰汤对退行性腰椎管狭窄症VAS评分及炎症因子的影响

【作者】 李磊；

【导师】 高景华；

【作者基本信息】 北京中医药大学 ， 中医骨伤科学（专业学位）， 2023， 硕士

【摘要】 背景:随着我国步入老龄化社会,退行性腰椎管狭窄症在我国50岁人群中发病率约为1.7%～8%,逐渐成为影响我国老年人生活质量的疾病之一,目前口服药物治疗DLSS腰腿痛包括非甾体抗炎药、营养神经药、肌松剂等,但均存在一定副作用与临床局限,而中医药治疗DLSS在长期临床中疗效确切且副作用低等优势,目前中药治疗DLSS多从肾虚、痰瘀、外邪等论治,确立补益肾气、化痰祛瘀、扶正祛邪等治法。由于脾肾具有后天与先天相互滋养、共同参与机体水液代谢的功能,临床上从肾虚、痰瘀、外感邪气而忽略脾肾在DLSS致病过程中的作用,对于指导DLSS的临床治疗不太全面。目的:探究转腰汤对退行性腰椎管狭窄症腰腿痛VAS评分及炎症因子的影响及影响疗效的相关因素分析,为转腰汤治疗退行性腰椎管狭窄症(脾肾阳虚、痰瘀互结证)的临床运用提供参考。方法:通过双盲双模拟的随机对照试验研究方法,在门诊招募患者,纳入满足退行性腰椎管狭窄症脾肾阳虚、痰瘀互结证诊断的患者,通过随机分组,分为治疗组与对照组,治疗组予转腰汤+塞来昔布胶囊模拟剂+甲钴胺片模拟剂;对照组予塞来昔布胶囊+甲钴胺片+转腰汤模拟剂。入组时记录患者性别、年龄、身高、体重、BMI、临床兼症(下肢发凉、下肢疼痛分级、下肢抽筋、大便稀溏)、影像学资料(腰椎管狭窄程度、椎管狭窄节段数量)等资料。分别在患者入组时、治疗1周、治疗2周、治疗3周、治疗后1个月5个时间点记录患者VAS评分观察指标,于入组时,治疗3周后抽血记录患者血液炎症指标(白介素6、降钙素原)、血液安全性指标(肝肾功能、血常规)并进行分析。分析影响退行性腰椎管狭窄症VAS评分疗效的相关因素。结果:本研究从2022年1月-2022年10月共纳入104例患者,治疗组4例失访,2例疗效不满意换药,1例自愿退出。对照组3例失访,2例自愿退出,1例疗效不满意换药。最终91例完成研究,其中治疗组45例,对照组46例。1.VAS评分:两组患者腰腿痛VAS评分符合正态分布,治疗组5个观测时间点VAS评分均值分别为6.11±0.88分、5.31±1.06分、3.95±1.08分、3.11±0.98分、2.42±0.83分,对照组均值为5.97±0.90分、4.84±1.01 分、3.54±0.86分、3.15±1.03分、2.84±0.86分。两组患者组内VAS评分比较采取配对样本T检验,治疗组治疗前后VAS评分差异具有统计学意义(P<0.05)。对照组治疗前后VAS评分差异具有统计学意义(P<0.05)。两组患者组间比较采取独立样本T检验,治疗组与对照组在入组时差异无统计学意义(P>0.05),治疗后两组VAS评分差异无统计学意义(P>0.05)。两组患者不同时间点VAS评分分析采用重复测量方差分析,治疗组入组时与其他4个观测时间点对比差异均具有统计学意义(P<0.05),对照组入组时与其他4个观测时间点对比差异均具有统计学意义(P<0.05)。两组患者5个时间点分别比较后显示,入组时、治疗3周两组VAS评分差异无统计学意义(P>0.05),治疗1周、治疗2周、治疗后1个月两组VAS评分差异具有统计学意义(P<0.05)。2.白介素6:白介素6组内比较采用Wilcoxon符号秩检验,治疗组治疗前后差异具有统计学意义(P<0.05)。对照组治疗前后差异具有统计学意义(P<0.05)。治疗组与对照组组间比较采用曼惠特尼U检验,两组患者入组时差异无统计学意义(P>0.05),两组患者在治疗3周后白介素6差异具有统计学意义(P<0.05)。3.降钙素原:降钙素原组内比较采用Wilcoxon符号秩检验,治疗组治疗前后差异具有统计学意义(P<0.05),对照组治疗前后差异具有统计学意义(P<0.05),两组患者降钙素原组间对比采用曼惠特尼U检验,两组患者入组时降钙素原差异无统计学意义(P>0.05),两组患者治疗后降钙素原差异无统计学意义(P>0.05)。4.相关因素分析:治疗组Sperman相关性分析结果提示;患者下肢发凉症状、下肢疼痛分级、大便稀溏症状、椎管狭窄程度与治疗组治疗后VAS评分改善率相关(P<0.1),治疗组多元线性回归结果表明下肢发凉症状、下肢疼痛分级是影响转腰汤改善DLSS腰腿痛VAS评分影响因素(P<0.05),有下肢发凉症状、下肢中度疼痛患者服用转腰汤V AS评分改善率更好。对照组Sperman分析结果提示;患者病程、下肢疼痛分级、狭窄程度分级与对照组患者治疗后VAS评分改善率相关(P<0.1),对照组多元线性回归结果表明下肢疼痛分级是影响VAS评分的影响因素(P<0.05),下肢重度疼痛患者服用塞来昔布胶囊联合甲钴胺片VAS评分改善率更高。结论:1.对于改善DLSS腰腿痛VAS评分方面;转腰汤通过补益脾肾、祛痰逐瘀治疗退行性腰椎管狭窄症(脾肾阳虚、痰瘀互结证),可以有效改善患者的腰腿痛VAS评分并且疗效稳定持久。2.改善炎症因子方面;转腰汤可以降低DLSS患者血液中IL-6、PCT含量,改善DLS S炎症反应,与塞来昔布胶囊联合甲钴胺片相比,在治疗结束时转腰汤对IL-6的改善更好,而对PCT的改善两者无区别。3.在疗效影响相关因素方面;有下肢发凉、中度疼痛的患者服用转腰汤后对腰腿痛VAS评分改善更明显。重度疼痛的患者服用塞来昔布胶囊联合甲钴胺片后对腰腿痛VAS评分改善更明显。更多还原

【Abstract】 Background:As China has entered an aging society,the incidence rate of degenerative lumbar spinal stenosis among 50 year olds in China is about 1.7%-8%,and it has gradually become one of the diseases that affect the quality of life of the elderly in China.At present,oral medication for DLSS low back and leg pain includes Nonsteroidal anti-inflammatory drug,neurotrophic drugs,muscle relaxants,etc.,but there are certain side effects and clinical limitations.However,traditional Chinese medicine has the advantages of definite efficacy and low side effects in long-term clinical treatment of DLSS,At present,the treatment of DLSS with traditional Chinese medicine mainly focuses on kidney deficiency,phlegm and blood stasis,and external pathogenic factors,establishing treatment methods such as tonifying kidney qi,resolving phlegm and blood stasis,and supporting the right and eliminating pathogenic factors.Due to the fact that the spleen and kidney have the function of nourishing each other and participating in the body’s water metabolism,the role of the spleen and kidney in the pathogenesis of DLSS is not comprehensive in guiding the clinical treatment of DLSS from the perspectives of kidney deficiency,phlegm and blood stasis,and external pathogenic factors.Objective:To explore the influence of Zhuanyao Decoction on the VAS score and inflammatory factors of degenerative lumbar spinal stenosis and the analysis of related factors affecting the efficacy,so as to provide reference for the clinical application of Zhuanyao Decoction in treating degenerative lumbar spinal stenosis(spleen and kidney yang deficiency,phlegm and blood stasis syndrome).Method:A double blind and double simulated randomized controlled trial was conducted to recruit patients from outpatient clinics.Patients who met the diagnosis of degenerative lumbar spinal stenosis with spleen kidney yang deficiency and phlegm stasis syndrome were randomly divided into a treatment group and a control group.The treatment group was treated with Zhuanyao Tang,celecoxib capsule simulant,and mecobalamin tablet simulant;The control group was treated with celecoxib capsules,mecobalamin tablets,and Zhuanyao Tang simulant.At the time of enrollment,record the patient’s gender,age,height,weight,BMI,clinical symptoms(lower limb chills,lower limb pain grading,lower limb cramps,loose stools),imaging data(degree of lumbar spinal stenosis,number of spinal stenosis segments),and other data.The VAS score observation indicators of patients with low back and leg pain were recorded at five time points when the patients were enrolled,one week after treatment,two weeks after treatment,three weeks after treatment,and one month after treatment.At the time of enrollment,blood samples were drawn after three weeks of treatment to record the patients’ blood inflammation indicators(interleukin 6,pro Calcitonin),blood safety indicators(liver and kidney function,blood routine)and analyze them.Analyze the relevant factors that affect the efficacy of VAS score for degenerative lumbar spinal stenosis with low back and leg pain.3.Result:A total of 104 patients were included in this study from January 2022 to October 2022.In the treatment group,4 patients were lost to follow-up,2 patients were dissatisfied with the treatment effect and changed dressing,and 1 patient voluntarily withdrew.In the control group,3 cases were lost to follow-up,2 cases voluntarily withdrew,and 1 case was dissatisfied with the efficacy and changed dressing.The final 91 cases completed the study,including 45 cases in the treatment group and 46 cases in the control group.1.VAS score:The VAS score of low back and leg pain in the two groups conforms to the Normal distribution.The average VAS score at five observation time poin ts in the treatment group is 6.11 ± 0.88 points,5.31 ± 1.06 points,3.95 ± 1.08 points,3.11 ± 0.98 points,2.42 ± 0.83 points,and the average in the control group is 5.97±0.90 points,4.84±1.01 points,3.54±0.86 points,3.15 ± 1.03 points,2.84 ± 0.86 points.Paired sample T-test was used to compare the VAS scores with in the two groups of patients.The difference in VAS scores between the treatment group before and after treatment was statistically significant(P<0.05).The difference in VAS scores between the control group before and after treatment was statistically significant(P<0.05).The independent sample T-test was used to compare the two groups of patients.There was no statistically significant difference between the treatment group and the control group at the time of enrollment(P>0.05),and there was no statistically significant difference in VAS scores between the two groups after treatment(P>0.05).The VAS scores of two groups of patients at different time points were analyzedusing repeated measurement analysis of variance.The difference between the treatment group and the other four observation time points was statistically significant(P<0.05),while the difference between the control group and the other four observation time points was statistically significant(P<0.05).After comparing the two groups of patients at five time points,it was found that there was no statistically significant difference in VAS scores between the two groups at enrollment and 3 weeks of treatment(P>0.05).However,there was a statistically significant difference in VAS scores between the two groups at 1 week,2 weeks,and 1 month after treatment(P<0.05).2.Interleukin 6:The Wilcoxon sign rank test was used for comparison within the IL-6 group,and the difference between the treatment group before and after treatment was statistically significant(P<0.05).The difference between the control group before and after treatment was statistically significant(P<0.05).The comparison between the treatment group and the control group was conducted using Mann Whitney U-test,and there was no statistically significant difference in the time of enrollment between the two groups of patients(P>0.05).The difference in interleukin-6 between the two groups of patients after 3 weeks of treatment was statistically significant(P<0.05).3.Calcitonin:Wilcoxon sign rank test was used for comparison within the original Calcitonin group.The difference between the treatment group and the control group before and after treatment was statistically significant(P<0.05).Mann Whitney U test was used for comparison between the two groups of patients with Calcitonin.There was no statistically significant difference between the two groups of patients with Calcitonin when they entered the group(P>0.05),There was no significant difference in procalcitonin between the two groups after treatment(P>0.05).4.Analysis of related factors:Sperman correlation analysis results in the treatment group suggest;The lower limb cooling symptoms,lower limb pain grades,loose stool symptoms,and the degree of Spinal stenosis of the patients were correlated with the VAS score improvement rate after treatment in the treatment group(P<0.1).The multiple linear regression results of the treatment group showed that the lower limb cooling symptoms and lower limb pain grades were the influencing factors of Zhuanyao Decoction in improving the VAS score of DLSS lumbar and leg pain(P<0.05).The VAS score improvement rate of patients with lower limb cooling symptoms and lower limb moderate pain who took Zhuanyao Decoction was better.The results of Sperman analysis in the control group indicate that;The course of disease,pain grade and stenosis grade of lower limbs were correlated with the improvement rate of VAS score after treatment in the control group(P<0.1).The results of multiple linear regression in the control group showed that the pain grade of lower limbs was the influencing factor of VAS score(P<0.05).The improvement rate of VAS score in patients with severe lower limb pain who took Celecoxib capsule combined with mecobalamin tablets was higher.Conclusion:1.For improving the VAS score of DLSS low back and leg pain;Zhuanyao Decoction can effectively improve the VAS score of patients with lumbar and leg pain and has a stable and lasting effect by treating degenerative lumbar spinal stenosis(spleen and kidney yang deficiency,phlegm and blood stasis syndrome)through tonifying the spleen and kidney,removing phlegm and blood stasis.2.Improve inflammatory factors;Zhuanyao Decoction can reduce the content of IL-6 and PCT in the blood of patients with DLSS,and improve the inflammatory reaction of DLSS.Compared with Celecoxib capsules combined with mecobalamin tablets,Zhuanyao Decoction can improve IL-6 better at the end of treatment,but it has no difference in improving PCT.3.In terms of influencing factors related to efficacy;Patients with lower limb cooling and moderate pain who take Zhuanyao Tang have a more significant improvement in the VAS score of lower limb pain.After taking Celecoxib capsules and mecobalamin tablets,patients with severe pain improved their VAS scores of low back and leg pain more significantly.更多还原