独活寄生汤加减治疗腰椎骨性关节炎的临床研究
摘要
腰椎骨性关节炎(Lumbar Osteoarthritis,LOA)即腰椎关节突骨性关节炎(LumbarZygapophysial(Facet)Joint Osteoarthritis,LZ(F)OA),是骨科临床上的常见病和多发病。根据国内外文献报道,腰椎骨性关节炎的发病率为15%～40%,占骨性关节炎病人的16.5%以上,多发于中老年人,60岁以上占50%以上,症状多以腰痛伴活动受限为主,严重影响日常生活。目前,本病的发病机理仍不十分清楚,治疗方法虽然很多,但疗效不尽满意,且疗效评价缺乏统一量化标准,不能全面反映病情,仍值得探讨。
本研究以随机对照的方法,采用独活寄生汤加减治疗肝肾亏虚、风寒痹阻型腰椎骨性关节炎,并采用改良日本整形外科学会(Japanese Orthopedic Association,JOA)腰痛疾患疗效评定标准和Roland-Morris功能障碍调查表(Roland-Morris DisabilityQuestionnaire,RMDQ)、Oswestry功能障碍指数(Oswestry Disability Index,ODI)进行功能和疗效评价,以探讨独活寄生汤加减治疗肝肾亏虚、风寒痹阻型腰椎骨性关节炎的疗效;分析RMDQ、ODI评分与改良JOA评分的相关性,对腰椎骨性关节炎的疗效评价进行探索。
临床资料
1病例来源
选择符合本研究入选标准的腰椎骨性关节炎患者70例(剔除1例),均为2008年2月～2009年1月中国中医科学院望京医院门诊或住院病人。
2一般资料
共选择符合本研究入选标准的腰椎骨性关节炎患者70例,其中剔除1例,随机分为治疗组和对照组。治疗组34例,男18例,女16例;年龄40～69岁,平均53岁;病程2天～30年,平均48月。对照组35例,男12例,女23例;年龄40～70岁,平均54岁;病程7天～16年,平均38月。
3病例选择
3.1西医诊断标准
参考孙树椿等编著的《临床骨伤科学》腰椎骨性关节炎诊断标准制定。
3.2中医肝肾亏虚、风寒痹阻型(骨痹)辨证标准
参考陈百成、张静编著的《骨关节炎》、国家中医药管理局《中医病症诊断疗效标准》和《方剂学》制定。
3.3病例纳入标准
①符合中西医诊断标准;
②年龄40岁～70岁之间者;
③签署知情同意书,自愿作为受试对象接受治疗者;
④如果已经接受过其他治疗,经过7天以上的洗脱期者。
上述①～④项均为“是”,方可入选为本临床试验的合格受试者。
3.4病例排除标准
①年龄在40岁以下,70岁以上者;
②妊娠、哺乳期妇女;
③类风湿、肿瘤及脊柱结核患者等;
④腰椎间盘突出症、脊柱骨折脱位、腰椎椎弓峡部裂、腰椎管狭窄症以及强直性脊柱炎患者;
⑤合并有严重的心血管、肝、肾、造血系统、消化道溃疡等疾病者;
⑥精神疾病患者;
⑦不愿意接受研究者。
上述①～⑦项均为“否”的受试者,方可入选为本临床试验的合格受试者。
3.5剔除病例标准
①入选后未参加或未能完成治疗者;
②治疗后出现严重药物反应者;
③治疗后出现其他不可预测事件,影响试验进行者;
④症状明显加重而行其他方法治疗者。
试验过程中患者满足上述条件中任何一条即可剔除。
研究方法
1病例分组
选择符合本研究入选标准的腰椎骨性关节炎患者70例(剔除1例),应用随机数字表法随机分为治疗组(34例)与对照组(35例)。经统计学分析治疗组与对照组患者性别、年龄、病程、治疗前症状体征积分、腰椎X线测量、ALP、CRP、ESR、RMDQ、ODI等未见明显差异,具有可比性。
2治疗方法
治疗组患者给予独活寄生汤加减(独活、桑寄生、杜仲、牛膝、细辛、秦艽、茯苓、肉桂心、防风、川芎、人参、甘草、当归、芍药、干地黄等),由药剂科统一煎制,每日一剂,早晚分服,连服两周。对照组患者给予氨糖美辛肠溶片(江西制药有限责任公司,国药准字H36020727),每日2次,每次2粒(0.2g),连服两周。
3观察指标
3.1总体症状体征积分(依据日本整形外科学会(Japanese Orthopedic Association,JOA)腰痛疾患疗效评定标准)。
3.2腰痛的测定(采用疼痛视觉模拟标尺法(Visual analogue scales,VAS)
3.3腰椎X线的检查
3.4 ALP、CRP、ESR测定
3.5 RMDQ、ODI与改良JOA评分的相关性评定
3.6疗效评价标准(采用日本整形外科学会腰痛疾患疗效评定标准)
4统计方法
所得数据应用SPSS for Windows Release 13.0统计软件包分析处理。试验数据用均数±标准差(x±s)表示,P＜0.05被认为具有显著性统计学意义。计数资料应用x检验,计量资料应用t检验,等级资料应用秩和检验,相关性分析采用Pearson分析。
结果
1两组总体疗效评定
两组疗程结束后,治疗组总有效率是97.05%,对照组总有效率是88.57%,治疗组优良率是88.23%,对照组优良率是60.00%,其中治疗组临床控制4例、显效26例、有效3例、无效1例,对照组临床控制3例、显效18例、有效10例、无效4例。两组均未见不良反应。
2两组治疗前后症状体征积分比较
2.1两组治疗前后症状体征积分比较
治疗组治疗前、后症状体征积分比较,经t检验,t=-12.178,P＜0.01,差异具有统计学意义,说明治疗后患者症状体征改善;对照组治疗前、后症状体征积分比较,经t检验,t=-11.080,P＜0.01,差异具有统计学意义,说明治疗后患者症状体征改善;两组疗程结束后,治疗组与对照组治疗前、后症状体征积分差值比较,经t检验,t=1.403,P＞0.05,差异无统计学意义,说明治疗组与对照组的症状体征积分改善比较无差异性。
2.2两组治疗前后改良JOA各项评分比较
两组治疗前改良JOA各项评分自觉症状(腰痛)、睡觉翻身、起立动作、洗脸动作、欠身姿势和持续站立、长时间久坐、举重物并保持、步行、腰椎活动功能的评分例数比较,经秩和检验,Z值分别为-0.367、-0.351、-0.888、-1.485、-0.385、-0.367、-0.627、-0.751、-1.590,P值均大于0.05,差异无显著性意义,而且两组的平均等级相近,说明两组治疗前改良JOA各项评分的分布具有可比性;治疗后改良JOA各项评分,经秩和检验,Z值分别为-0.786,-1.450,-0.501,-1.147,-1.201,-0.557,-0.273,-0.451,-1.385,P值均大于0.05,显示两组差异无统计学意义,可以认为治疗后两组各项改良JOA评分没有区别,即两组治疗后改良JOA各项评分无差异性。
2.3两组改良JOA各项评分治疗前后比较
治疗组与对照组患者治疗后与治疗前改良JOA各项评分相比较,经秩和检验,P值均小于0.05,两组治疗后JOA各项评分与治疗前比较均有显著差异,说明两组治疗后改良JOA各项评分与治疗前比较均明显改善。
3两组治疗前后疼痛(VAS)评分比较
治疗组治疗前后VAS评分比较,经t检验,t=15.272,P＜0.01,差异具有统计学意义,说明治疗组药物具有明显镇痛作用;对照组治疗前后VAS评分比较,经t检验,t=14.482,P＜0.01,差异具有统计学意义,说明对照组药物具有明显镇痛作用;两组疗程结束后,治疗组、对照组治疗前后VAS评分差值比较,经t检验,t=-0.195,P＞0.05,差异无统计学意义,说明两组疼痛改善比较无差异性,进一步说明治疗组的镇痛作用与对照组无差异性。
4两组治疗前后ALP、CRP、ESR比较
治疗组、对照组治疗前后ALP、CRP、ESR比较,经t检验,t值分别为1.096、1.188、1.643、1.329、1.705、1.940,P值均大于0.05,差异无统计学意义,说明两组治疗前后ALP、CRP、ESR改变比较无差异性;且治疗前、后两组指标(x±s)均在正常范围之内,因此,血清ALP、CRP、ESR指标可能并不是本病的特异性指标。
5两组治疗前后RMDQ、ODI比较
两组治疗前后RMDQ、ODI比较,经t检验,t值分别为11.396,10.198,11.276,9.359,P值均小于0.01;差异具有统计学意义,说明两组治疗前后RMDQ、ODI评分均明显改善。两组治疗前后RMDQ、ODI差值比较,t值分别为-0.403和-0.641,P值大于0.05,两组组间差值比较差异无统计学意义,说明两组间RMDQ、ODI的改善比较无差异性。
6 RMDQ与改良JOA评分的相关性分析
6.1治疗组RMDQ与改良JOA评分的相关性分析
治疗组治疗前RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.819,P＜0.001,差异具有统计学意义;治疗组治疗后RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.570,P＜0.001,差异具有统计学意义;治疗组治疗前后RMDQ差值与改良JOA评分的相关性,经Pearson分析,r=-0.597,P＜0.001,差异具有统计学意义;说明治疗组RMDQ与改良JOA评分存在负性相关关系。
6.2对照组RMDQ与改良JOA评分的相关性分析
对照组治疗前RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.876,P＜0.01,差异具有统计学意义;对照组治疗后RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.788,P＜0.01,差异具有统计学意义;对照组治疗前后RMDQ差值与改良JOA评分的相关性,经Pearson分析,r=-0.813,P＜0.01,差异具有统计学意义;说明对照组RMDQ与改良JOA评分存在负性相关关系。
6.3两组RMDQ与改良JOA评分的相关性分析
两组治疗前RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.841,P＜0.001,差异具有统计学意义;两组治疗后RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.721,P＜0.001,差异具有统计学意义;两组治疗前后RMDQ差值与改良JOA评分的相关性,经Pearson分析,r=-0.703,P＜0.001,差异具有统计学意义;说明两组RMDQ与改良JOA评分存在负性相关关系。
本研究中RMDQ与改良JOA评分存在负性相关关系,即RMDQ积分降低,改良JOA积分升高,患者病情缓解,而当RMDQ积分升高,改良JOA积分降低,患者病情加重;RMDQ可以在一定程度上作为腰椎骨性关节炎的疗效评定指标。
7 ODI与改良JOA评分的相关性分析
7.1治疗组ODI与改良JOA评分的相关性分析
治疗组治疗前ODI与改良JOA评分的相关性,经Pearson分析,r=-0.841,P＜0.001,差异具有统计学意义;治疗组治疗后ODI与改良JOA评分的相关性,经Pearson分析,r=-0.715,P＜0.001,差异具有统计学意义;治疗组治疗前后ODI差值与改良JOA评分的相关性,经Pearson分析,r=-0.785,P＜0.001,差异具有统计学意义;说明治疗组ODI与改良JOA评分存在负性相关关系。
7.2对照组ODI与改良JOA评分的相关性分析
对照组治疗前ODI与改良JOA评分的相关性,经Pearson分析,r=-0.807,P＜0.001,差异具有统计学意义;对照组治疗后ODI与改良JOA评分的相关性,经Pearson分析,r=-0.825,P＜0.001,差异具有统计学意义;对照组治疗前后ODI差值与改良JOA评分的相关性,经Pearson分析,r=-0.701,P＜0.001,差异具有统计学意义;说明对照组ODI与改良JOA评分存在负性相关关系。
7.3两组ODI与改良JOA评分的相关性分析
两组治疗前ODI与改良JOA评分的相关性,经Pearson分析,r=-0.824,P＜0.001,差异具有统计学意义;两组治疗后ODI与改良JOA评分的相关性,经Pearson分析,r=-0.766,P＜0.001,差异具有统计学意义;两组治疗前后ODI差值与改良JOA评分的相关性,经Pearson分析,r=-0.739,P＜0.001,差异具有统计学意义;说明两组ODI与改良JOA评分存在负性相关关系。
本研究中ODI与改良JOA评分存在负性相关关系,即ODI积分降低,改良JOA积分升高,患者病情缓解,而当ODI积分升高,改良JOA积分降低,患者病情加重;ODI可以在一定程度上作为腰椎骨性关节炎的疗效评定指标。
结论
1独活寄生汤加减治疗腰椎骨性关节炎取得较为显著的疗效(优良率为88.23%),独活寄生汤加减与氨糖美辛肠溶片均能有效改善患者腰痛等症状体征。
2 RMDQ、ODI可以作为腰椎骨性关节炎的疗效评定指标。
3本研究中ALP、CRP、ESR指标变化均不显著,可能不是腰椎骨性关节炎的特异性指标。
Lumbar Osteoarthritis(LOA),namely Lumbar Zygapophysial(Facet) Joint Osteoarthritis (LZ(F)OA),is a kind of common and frequently-occurring orthopedic disease.According to literature reports at home and abroad,the morbidity of LOA is 15%～40%,which accounted for more than 16.5%of Osteoarthritis patients,and it's up to 50%over the age of 60.It occurred mostly in the middle-aged and elderly people.Tts main symptom is low back pain with activity restricted,which has serious impact on daily life.However,its pathogenesis is still not very clear.A variety of treatments are used presently and their effects are still not satisfied.And there is lack of quantitative criteria of its unified evaluation.And it fails reflect the patient's overall conditions.
Randomized and controlled method is used in this study,treating LOA with Du Huo Ji Sheng Tang,and Japanese Orthopedic Association(JOA) assessment criteria for low back pain (LBP),Roland-Morris Disability Questionnaire(RMDQ) and Oswestry Disability Index(ODI) are used to evaluate the functionality and the efficacy of treating LOA(the type of liver and kidney deficiency,obstruction of wind and cold) with Du Huo Ji Sheng Tang by addition and subtraction;and analyse the correlation of RMDQ,ODI and the modified JOA score,to probe new idea of assessing the effectiveness of LOA.
Clinical data
1 Case Source
Seventy(one was eliminated) in-patients or out-patients of LOA who were all consistent with entry criteria were enrolled in the study in Wang Jing Hospital of China Academy Of Medical Sciences from February 2008 to January 2009.
2 General information
Seventy patients of LOA who were all consistent with entry criteria enrolled were divided into two groups(the testing group and the control grouop),with one eliminated.Among 34 patients of the testing group,18 cases were male and 16 cases were female;average age was 53, ranging from 40 to 69;average course of disease was 48 months,ranging from 2 days to 30 years.Among 35 patients of the control group,12 cases were male and 23 cases were female; average age was 54,ranging from 40 to 70;average course of disease was 38 months,ranging from 7 days to 16 years.
3 Case selections
3.1 Diagnostic criteria of western medicine
Drafting it with reference to the diagnostic criteria of LOA of "Clinic Orthopaedics and Traumatology" of Shuchun Sun's.
3.2 Differentiation standard of the type of liver and kidney deficiency,obstruction of wind and cold(syndrome of bone obstruction) of Traditional Chinese Medicine
Drafting it with reference to "Osteoarthritis" edited by Baicheng Chen and Jing Zhang,"Traditional Chinese medicinal diagnosis,symptoms and efficacy standards" of State Administration of Traditional Chinese Medicine and "Pharmacology of traditional Chinese medical formulae".
3.3 Case inclusion criteria
①Meeting the diagnostic criteria of Chinese and Western medicine;
②Ranging from 40 to 70 years old;
③Signed the informed consent,receiving treatments voluntarily as subjects;
④Once received other treatments;it needs elution stage for more than seven days.
3.4 Case exclusion criteria
①Less than 40 years old and more than 70 years old;
②Pregnant or breast-feeding women;
③Rheumatoid,tumors and spinal tuberculosis patients and et al;
④Lumbar disc herniation,spinal fracture and dislocation,lumbar isthmic spondylolysis, lumbar spinal stenosis patients,as well as ankylosing spondylitis patients;
⑤Having serious cardiovascular,liver,kidney,hematopoietic system,or peptic ulcer diseases;
⑥Patients with mental illness;
⑦Patients who are unwilling to accept the study.
①～⑦of the above are all "no" were eligibly capable of being selected of this clinical trial.
3.5 Excluding standards of cases
①Selected cases who did not take part in or failed to complete the treatment;
②Occuring serious drug reactions after treatment;
③Other unpredictable events after treatment,which impacted the treatment;
④Trying other treatments while symptoms exacerbate.
Satisfy the item of the experiment of patients with any of the above conditions can be eliminated.
Methods
1 Case grouping
Seventy patients(one was eliminated) of LOA who were all consistent with entry criteria, were divided into two groups through random number table method:the testing group(34 cases) and the control group(35 cases).There are no apparently statistical differences among sex,age, course of disease,scores of signs and symptoms pretherapy,X-ray measurements of lumbar spine,Alkaline phosphatase(ALP),C-reactive protein(CRP),Erythrocyte sedimentation rate (ESR),Roland-Morris Disability Questionnaire(RMDQ) and Oswestry Disability Index(ODI) score,that means that the two groups are comparable.
2 Treatments
Patients of the testing group take Du Huo Ji Sheng Tang addition and subtraction(Duhuo, Jisheng,Duzhong,Bidentata,Breviscapus,Qinjiao,Poria cocos,Cinnamon,Fangfeng, Chuanxiong,Ginseng,Glycyrrhiza,Chinese Angelica,Chinese herbaceous peony,Radix Rehmanniae,etc.),which were decocted and made by the department of pharmacy of the hospital,and take one dose which was separated into halves in the morning and at night once a day for two weeks as a session.Patients of the control group take Glucosamine Indomethacin Entric-coated tablets(State authorized title H36020727,Jiangxi Pharmaceutical Co.,Ltd) two pills twice a day for two weeks as a session.
3 Outcome measures
3.1 Overall scores of symptoms and signs(Developed according to the Japanese Orthopedic Association(JOA) score for efficacy criteria of disorders of low back pain)
3.2 Determination of low back pain(Using Visual analogue scales(VAS))
3.3 Inspection lumbar spine X-ray
3.4 Determination of ALP,CRP,ESR
3.5 Assessment of correlations of RMDQ,ODI and the modified JOA score
3.6 Evaluation criteria(Using the evaluation criteria according to JOA)
3.7 Statistical methods
The obtained data was processed through the application of SPSS for Windows Release 13.0 statistical analysis package.Experimental data was demonstrated with mean±standard deviation((?)±s),P＜0.05 was considered significant statistical difference.Analyze count data through Chi-square test,measurement data through t test,level data through rank-sum test,and illustrate the correlation through Pearson analysis.
Results
1 Assessment of the overall efficacy of the two groups
After treatment the total efficiency of the testing group is 97.05%while the control group is 88.57%.And the total fine rate is 88.23%while the control group's is 60.00%.And in the testing group there are four of clinical control,twenty-six of excellence,three in effect and one of inefficacy,while there are three of clinical control,eithteen of excellence,ten in effect and four of inefficacy in the control group.There were no adverse reactions occurred in both the two groups.
2 Signs and symptoms compared before and after treatment
2.1 Signs and symptoms compared before and after treatment
By t test(t=-12.178,P＜0.01),there's significant difference of improvement of the comparison of signs and symptoms in the testing group before and after treatment.Through t test(t=-11.080,P＜0.01),there's significant difference of improvement of the comparison of signs and symptoms in the control group before and after treatment.The comparison of differences of signs and symptoms in the testing and the control group before and after treatment shows little statistical significance through t test(t=1.403,P＞0.05),which means there's no apparent differences of improvements between the two groups.
2.2 The comparison of each item of the modified JOA score before and after treatment in the two groups
By rank-sum test(Z values are -0.367,-0.351,-0.888,-1.485,-0.385,-0.367,-0.627, -0.751,-1.590,and P value are all above 0.05),the comparisons of cases of each item of the modified JOA score(symptom(low back pain),sleeping and moving over,standing up, washing face,rasing oneself slishtly and standing continuous,sedentariness,heavy-lifting and maintaining,walking,functional activities of lumbar spine) show ittle statistical difference,and the average level is similar in the two groups,which demonstrates the distribution of the items of the modified JOA score is comparable in the two groups pre-therapy.Through rank-sum test (Z values are -0.786,-1.450,-0.501,-1.147,-1.201,-0.557,-0.273,-0.451,-1.385,and P value are all above 0.05),they show there is no difference of each item of the modified JOA score in the two groups after treatment,that is to say there's no difference of the modified JOA score after treatment in the two groups.
2.3 The comparison of each item the modified JOA score in the testing group and the control group before and after treatment
By rank-sum test,P value are all less than 0.05,the comparison of each item of the modified JOA score before and after treatment shows significant difference in the testing group and the control group,that is to say each item of the modified JOA score in both the testing group and the control group improves greatly through treatments.
3 The VAS score comparison of two groups before and after treatment
By t test(t=15.272,P＜0.01),there's significant difference of improvement of the comparison of VAS score in the testing group before and after treatment.Through t test (t=14.482,P＜0.01),there's significant difference of improvement of the comparison of VAS score in the control group before and after treatment.The comparison of differences of VAS score in the testing and the control group before and after treatment shows little statistical significance through t test(t=-0.195,P＞0.05),which means there's no differences between the two groups,further it means the analgesic effect of the testing group is equal to the control group's.
4 The comparison of ALP,CRP,ESR of two groups before and after treatment
By t test,t values of ALP,CRP,ESR were 1.096,1.188,1.643,1.329,1.705,1.940,P values were greater than 0.05,there're no statistical differences of the two groups post-treatment and pre-therapy,which means there're no differences of the two groups before and after treatment.And the indicators((?)±s) were within normal range,so the serum ALP,CRP,ESR might not be the specific indicators of therapeutic efficacy.
5 The RMDQ,ODI comparison of two groups before and after treatment
By t test,t values of RMDQ,ODI are 11.396,10.198,11.276,9.359,P values are less than 0.01,there's statistical difference,which means both RMDQ and ODI scores were improved after treatment.The comparisons of differences of RMDQ and ODI in the testing and the control group before and after treatment show little statistical significance through t test (t=-0.403,P＞0.05;t=-0.641,P＞0.05),which means there're no differences of the comparison of RMDQ and ODI in the two groups.
6 Relevance analyses of RMDQ and the modified JOA score
6.1 Relevance analysis of RMDQ and the modified JOA in the testing group
By Pearson analysis(r=-0.819,P＜0.001),there is significant difference between RMDQ and the modified JOA score in the testing group pre-therapy.Through Pearson analysis (r=-0.570,P＜0.001),there is significant difference between RMDQ and the modified JOA score post-treatment in the testing group.The comparison of difference in the testing group of RMDQ and the modified JOA score shows great significance through Pearson analysis (r=-0.597,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of RMDQ and the modified JOA score in the testing group.
6.2 Relevance analysis of RMDQ and the modified JOA in the control group
By Pearson analysis(r=-0.876,P＜0.001),there is significant difference between RMDQ and the modified JOA score in the control group pre-therapy.Through Pearson analysis (r=-0.788,P＜0.001),there is significant difference between RMDQ and the modified JOA score post-treatment in the control group.The comparison of difference in the control group of RMDQ and the modified JOA score shows great significance through Pearson analysis (r=-0.813,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of RMDQ and the modified JOA score in the control group.
6.3 Relevance analysis of RMDQ and the modified JOA in the two groups
By Pearson analysis(r=-0.841,P＜0.001),there is significant difference between RMDQ and the modified JOA score in the two groups pre-therapy.Through Pearson analysis(r=-0.721, P＜0.001),there is significant difference between RMDQ and the modified JOA score post-treatment in the two groups.The comparison of difference in the two groups of RMDQ and the modified JOA score shows great significance through Pearson analysis(r=-0.703,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of RMDQ and the modified JOA score in the two groups.
There're existences negative correlation of RMDQ and the modified JOA score,that is to say that the RMDQ score reduces when the modified JOA score increases,the disease relieves, and when RMDQ score increases,the modified JOA score decreases,and the disease aggravates.So RMDQ could be used to evaluate LOA to some extent.
7 Relevance analyses of ODI and the modified JOA score
7.1 Relevance analysis of ODI and the modified JOA in the testing group
By Pearson analysis(r=-0.841,P＜0.001),there is significant difference between ODI and the modified JOA score in the testing group pre-therapy.Through Pearson analysis(r=-0.715, P＜0.001),there is significant difference between ODI and the modified JOA score post-treatment in the testing group.The comparison of difference in the testing group of ODI and the modified JOA score shows great significance through Pearson analysis(r=-0.785, P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of ODI and the modified JOA score in the testing group.
7.2 Relevance analysis of ODI and the modified JOA score in the control group
By Pearson analysis(r=-0.807,P＜0.001),there is significant difference between ODI and the modified JOA score in the control group pre-therapy.Through Pearson analysis(r=-0.825, P＜0.001),there is significant difference between ODI and the modified JOA score post-treatment in the control group.The comparison of difference in control group of ODI and the modified JOA score shows great significance through Pearson analysis(r=-0.701,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of ODI and the modified JOA score in the control group.
7.3 Relevance analysis of ODI and the modified JOA in the two groups
By Pearson analysis(r=-0.824,P＜0.001),there is significant difference between ODI and the modified JOA score in the two groups pre-therapy.Through Pearson analysis(r=-0.766, P＜0.001),there is significant difference between ODI and the modified JOA score post-treatment in the two groups.The comparison of difference in the two groups of ODI and the modified JOA score shows great significance through Pearson analysis(r=-0.739,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of ODI and the modified JOA score in the two groups.
There're existences of negative correlation of ODI and the modified JOA score,that is to say that the ODI score reduces when the modified JOA score increases,the disease relieves,and when ODI score increases,the modified JOA score decreases,and the disease aggravates.So ODI could be used to evaluate LOA to some extent.
Conclusion
1 This Clinical study proves that Du Huo Ji Sheng Tang in treating LOA has significant effectiveness and its total fine rate is 88.23%.
2 RMDQ and ODI scores could be used to evaluate LOA.
3 Serum ALP,CRP and ESR might not be the specific indicators to LOA.
本研究以随机对照的方法,采用独活寄生汤加减治疗肝肾亏虚、风寒痹阻型腰椎骨性关节炎,并采用改良日本整形外科学会(Japanese Orthopedic Association,JOA)腰痛疾患疗效评定标准和Roland-Morris功能障碍调查表(Roland-Morris DisabilityQuestionnaire,RMDQ)、Oswestry功能障碍指数(Oswestry Disability Index,ODI)进行功能和疗效评价,以探讨独活寄生汤加减治疗肝肾亏虚、风寒痹阻型腰椎骨性关节炎的疗效;分析RMDQ、ODI评分与改良JOA评分的相关性,对腰椎骨性关节炎的疗效评价进行探索。
临床资料
1病例来源
选择符合本研究入选标准的腰椎骨性关节炎患者70例(剔除1例),均为2008年2月～2009年1月中国中医科学院望京医院门诊或住院病人。
2一般资料
共选择符合本研究入选标准的腰椎骨性关节炎患者70例,其中剔除1例,随机分为治疗组和对照组。治疗组34例,男18例,女16例;年龄40～69岁,平均53岁;病程2天～30年,平均48月。对照组35例,男12例,女23例;年龄40～70岁,平均54岁;病程7天～16年,平均38月。
3病例选择
3.1西医诊断标准
参考孙树椿等编著的《临床骨伤科学》腰椎骨性关节炎诊断标准制定。
3.2中医肝肾亏虚、风寒痹阻型(骨痹)辨证标准
参考陈百成、张静编著的《骨关节炎》、国家中医药管理局《中医病症诊断疗效标准》和《方剂学》制定。
3.3病例纳入标准
①符合中西医诊断标准;
②年龄40岁～70岁之间者;
③签署知情同意书,自愿作为受试对象接受治疗者;
④如果已经接受过其他治疗,经过7天以上的洗脱期者。
上述①～④项均为“是”,方可入选为本临床试验的合格受试者。
3.4病例排除标准
①年龄在40岁以下,70岁以上者;
②妊娠、哺乳期妇女;
③类风湿、肿瘤及脊柱结核患者等;
④腰椎间盘突出症、脊柱骨折脱位、腰椎椎弓峡部裂、腰椎管狭窄症以及强直性脊柱炎患者;
⑤合并有严重的心血管、肝、肾、造血系统、消化道溃疡等疾病者;
⑥精神疾病患者;
⑦不愿意接受研究者。
上述①～⑦项均为“否”的受试者,方可入选为本临床试验的合格受试者。
3.5剔除病例标准
①入选后未参加或未能完成治疗者;
②治疗后出现严重药物反应者;
③治疗后出现其他不可预测事件,影响试验进行者;
④症状明显加重而行其他方法治疗者。
试验过程中患者满足上述条件中任何一条即可剔除。
研究方法
1病例分组
选择符合本研究入选标准的腰椎骨性关节炎患者70例(剔除1例),应用随机数字表法随机分为治疗组(34例)与对照组(35例)。经统计学分析治疗组与对照组患者性别、年龄、病程、治疗前症状体征积分、腰椎X线测量、ALP、CRP、ESR、RMDQ、ODI等未见明显差异,具有可比性。
2治疗方法
治疗组患者给予独活寄生汤加减(独活、桑寄生、杜仲、牛膝、细辛、秦艽、茯苓、肉桂心、防风、川芎、人参、甘草、当归、芍药、干地黄等),由药剂科统一煎制,每日一剂,早晚分服,连服两周。对照组患者给予氨糖美辛肠溶片(江西制药有限责任公司,国药准字H36020727),每日2次,每次2粒(0.2g),连服两周。
3观察指标
3.1总体症状体征积分(依据日本整形外科学会(Japanese Orthopedic Association,JOA)腰痛疾患疗效评定标准)。
3.2腰痛的测定(采用疼痛视觉模拟标尺法(Visual analogue scales,VAS)
3.3腰椎X线的检查
3.4 ALP、CRP、ESR测定
3.5 RMDQ、ODI与改良JOA评分的相关性评定
3.6疗效评价标准(采用日本整形外科学会腰痛疾患疗效评定标准)
4统计方法
所得数据应用SPSS for Windows Release 13.0统计软件包分析处理。试验数据用均数±标准差(x±s)表示,P＜0.05被认为具有显著性统计学意义。计数资料应用x检验,计量资料应用t检验,等级资料应用秩和检验,相关性分析采用Pearson分析。
结果
1两组总体疗效评定
两组疗程结束后,治疗组总有效率是97.05%,对照组总有效率是88.57%,治疗组优良率是88.23%,对照组优良率是60.00%,其中治疗组临床控制4例、显效26例、有效3例、无效1例,对照组临床控制3例、显效18例、有效10例、无效4例。两组均未见不良反应。
2两组治疗前后症状体征积分比较
2.1两组治疗前后症状体征积分比较
治疗组治疗前、后症状体征积分比较,经t检验,t=-12.178,P＜0.01,差异具有统计学意义,说明治疗后患者症状体征改善;对照组治疗前、后症状体征积分比较,经t检验,t=-11.080,P＜0.01,差异具有统计学意义,说明治疗后患者症状体征改善;两组疗程结束后,治疗组与对照组治疗前、后症状体征积分差值比较,经t检验,t=1.403,P＞0.05,差异无统计学意义,说明治疗组与对照组的症状体征积分改善比较无差异性。
2.2两组治疗前后改良JOA各项评分比较
两组治疗前改良JOA各项评分自觉症状(腰痛)、睡觉翻身、起立动作、洗脸动作、欠身姿势和持续站立、长时间久坐、举重物并保持、步行、腰椎活动功能的评分例数比较,经秩和检验,Z值分别为-0.367、-0.351、-0.888、-1.485、-0.385、-0.367、-0.627、-0.751、-1.590,P值均大于0.05,差异无显著性意义,而且两组的平均等级相近,说明两组治疗前改良JOA各项评分的分布具有可比性;治疗后改良JOA各项评分,经秩和检验,Z值分别为-0.786,-1.450,-0.501,-1.147,-1.201,-0.557,-0.273,-0.451,-1.385,P值均大于0.05,显示两组差异无统计学意义,可以认为治疗后两组各项改良JOA评分没有区别,即两组治疗后改良JOA各项评分无差异性。
2.3两组改良JOA各项评分治疗前后比较
治疗组与对照组患者治疗后与治疗前改良JOA各项评分相比较,经秩和检验,P值均小于0.05,两组治疗后JOA各项评分与治疗前比较均有显著差异,说明两组治疗后改良JOA各项评分与治疗前比较均明显改善。
3两组治疗前后疼痛(VAS)评分比较
治疗组治疗前后VAS评分比较,经t检验,t=15.272,P＜0.01,差异具有统计学意义,说明治疗组药物具有明显镇痛作用;对照组治疗前后VAS评分比较,经t检验,t=14.482,P＜0.01,差异具有统计学意义,说明对照组药物具有明显镇痛作用;两组疗程结束后,治疗组、对照组治疗前后VAS评分差值比较,经t检验,t=-0.195,P＞0.05,差异无统计学意义,说明两组疼痛改善比较无差异性,进一步说明治疗组的镇痛作用与对照组无差异性。
4两组治疗前后ALP、CRP、ESR比较
治疗组、对照组治疗前后ALP、CRP、ESR比较,经t检验,t值分别为1.096、1.188、1.643、1.329、1.705、1.940,P值均大于0.05,差异无统计学意义,说明两组治疗前后ALP、CRP、ESR改变比较无差异性;且治疗前、后两组指标(x±s)均在正常范围之内,因此,血清ALP、CRP、ESR指标可能并不是本病的特异性指标。
5两组治疗前后RMDQ、ODI比较
两组治疗前后RMDQ、ODI比较,经t检验,t值分别为11.396,10.198,11.276,9.359,P值均小于0.01;差异具有统计学意义,说明两组治疗前后RMDQ、ODI评分均明显改善。两组治疗前后RMDQ、ODI差值比较,t值分别为-0.403和-0.641,P值大于0.05,两组组间差值比较差异无统计学意义,说明两组间RMDQ、ODI的改善比较无差异性。
6 RMDQ与改良JOA评分的相关性分析
6.1治疗组RMDQ与改良JOA评分的相关性分析
治疗组治疗前RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.819,P＜0.001,差异具有统计学意义;治疗组治疗后RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.570,P＜0.001,差异具有统计学意义;治疗组治疗前后RMDQ差值与改良JOA评分的相关性,经Pearson分析,r=-0.597,P＜0.001,差异具有统计学意义;说明治疗组RMDQ与改良JOA评分存在负性相关关系。
6.2对照组RMDQ与改良JOA评分的相关性分析
对照组治疗前RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.876,P＜0.01,差异具有统计学意义;对照组治疗后RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.788,P＜0.01,差异具有统计学意义;对照组治疗前后RMDQ差值与改良JOA评分的相关性,经Pearson分析,r=-0.813,P＜0.01,差异具有统计学意义;说明对照组RMDQ与改良JOA评分存在负性相关关系。
6.3两组RMDQ与改良JOA评分的相关性分析
两组治疗前RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.841,P＜0.001,差异具有统计学意义;两组治疗后RMDQ与改良JOA评分的相关性,经Pearson分析,r=-0.721,P＜0.001,差异具有统计学意义;两组治疗前后RMDQ差值与改良JOA评分的相关性,经Pearson分析,r=-0.703,P＜0.001,差异具有统计学意义;说明两组RMDQ与改良JOA评分存在负性相关关系。
本研究中RMDQ与改良JOA评分存在负性相关关系,即RMDQ积分降低,改良JOA积分升高,患者病情缓解,而当RMDQ积分升高,改良JOA积分降低,患者病情加重;RMDQ可以在一定程度上作为腰椎骨性关节炎的疗效评定指标。
7 ODI与改良JOA评分的相关性分析
7.1治疗组ODI与改良JOA评分的相关性分析
治疗组治疗前ODI与改良JOA评分的相关性,经Pearson分析,r=-0.841,P＜0.001,差异具有统计学意义;治疗组治疗后ODI与改良JOA评分的相关性,经Pearson分析,r=-0.715,P＜0.001,差异具有统计学意义;治疗组治疗前后ODI差值与改良JOA评分的相关性,经Pearson分析,r=-0.785,P＜0.001,差异具有统计学意义;说明治疗组ODI与改良JOA评分存在负性相关关系。
7.2对照组ODI与改良JOA评分的相关性分析
对照组治疗前ODI与改良JOA评分的相关性,经Pearson分析,r=-0.807,P＜0.001,差异具有统计学意义;对照组治疗后ODI与改良JOA评分的相关性,经Pearson分析,r=-0.825,P＜0.001,差异具有统计学意义;对照组治疗前后ODI差值与改良JOA评分的相关性,经Pearson分析,r=-0.701,P＜0.001,差异具有统计学意义;说明对照组ODI与改良JOA评分存在负性相关关系。
7.3两组ODI与改良JOA评分的相关性分析
两组治疗前ODI与改良JOA评分的相关性,经Pearson分析,r=-0.824,P＜0.001,差异具有统计学意义;两组治疗后ODI与改良JOA评分的相关性,经Pearson分析,r=-0.766,P＜0.001,差异具有统计学意义;两组治疗前后ODI差值与改良JOA评分的相关性,经Pearson分析,r=-0.739,P＜0.001,差异具有统计学意义;说明两组ODI与改良JOA评分存在负性相关关系。
本研究中ODI与改良JOA评分存在负性相关关系,即ODI积分降低,改良JOA积分升高,患者病情缓解,而当ODI积分升高,改良JOA积分降低,患者病情加重;ODI可以在一定程度上作为腰椎骨性关节炎的疗效评定指标。
结论
1独活寄生汤加减治疗腰椎骨性关节炎取得较为显著的疗效(优良率为88.23%),独活寄生汤加减与氨糖美辛肠溶片均能有效改善患者腰痛等症状体征。
2 RMDQ、ODI可以作为腰椎骨性关节炎的疗效评定指标。
3本研究中ALP、CRP、ESR指标变化均不显著,可能不是腰椎骨性关节炎的特异性指标。
Lumbar Osteoarthritis(LOA),namely Lumbar Zygapophysial(Facet) Joint Osteoarthritis (LZ(F)OA),is a kind of common and frequently-occurring orthopedic disease.According to literature reports at home and abroad,the morbidity of LOA is 15%～40%,which accounted for more than 16.5%of Osteoarthritis patients,and it's up to 50%over the age of 60.It occurred mostly in the middle-aged and elderly people.Tts main symptom is low back pain with activity restricted,which has serious impact on daily life.However,its pathogenesis is still not very clear.A variety of treatments are used presently and their effects are still not satisfied.And there is lack of quantitative criteria of its unified evaluation.And it fails reflect the patient's overall conditions.
Randomized and controlled method is used in this study,treating LOA with Du Huo Ji Sheng Tang,and Japanese Orthopedic Association(JOA) assessment criteria for low back pain (LBP),Roland-Morris Disability Questionnaire(RMDQ) and Oswestry Disability Index(ODI) are used to evaluate the functionality and the efficacy of treating LOA(the type of liver and kidney deficiency,obstruction of wind and cold) with Du Huo Ji Sheng Tang by addition and subtraction;and analyse the correlation of RMDQ,ODI and the modified JOA score,to probe new idea of assessing the effectiveness of LOA.
Clinical data
1 Case Source
Seventy(one was eliminated) in-patients or out-patients of LOA who were all consistent with entry criteria were enrolled in the study in Wang Jing Hospital of China Academy Of Medical Sciences from February 2008 to January 2009.
2 General information
Seventy patients of LOA who were all consistent with entry criteria enrolled were divided into two groups(the testing group and the control grouop),with one eliminated.Among 34 patients of the testing group,18 cases were male and 16 cases were female;average age was 53, ranging from 40 to 69;average course of disease was 48 months,ranging from 2 days to 30 years.Among 35 patients of the control group,12 cases were male and 23 cases were female; average age was 54,ranging from 40 to 70;average course of disease was 38 months,ranging from 7 days to 16 years.
3 Case selections
3.1 Diagnostic criteria of western medicine
Drafting it with reference to the diagnostic criteria of LOA of "Clinic Orthopaedics and Traumatology" of Shuchun Sun's.
3.2 Differentiation standard of the type of liver and kidney deficiency,obstruction of wind and cold(syndrome of bone obstruction) of Traditional Chinese Medicine
Drafting it with reference to "Osteoarthritis" edited by Baicheng Chen and Jing Zhang,"Traditional Chinese medicinal diagnosis,symptoms and efficacy standards" of State Administration of Traditional Chinese Medicine and "Pharmacology of traditional Chinese medical formulae".
3.3 Case inclusion criteria
①Meeting the diagnostic criteria of Chinese and Western medicine;
②Ranging from 40 to 70 years old;
③Signed the informed consent,receiving treatments voluntarily as subjects;
④Once received other treatments;it needs elution stage for more than seven days.
3.4 Case exclusion criteria
①Less than 40 years old and more than 70 years old;
②Pregnant or breast-feeding women;
③Rheumatoid,tumors and spinal tuberculosis patients and et al;
④Lumbar disc herniation,spinal fracture and dislocation,lumbar isthmic spondylolysis, lumbar spinal stenosis patients,as well as ankylosing spondylitis patients;
⑤Having serious cardiovascular,liver,kidney,hematopoietic system,or peptic ulcer diseases;
⑥Patients with mental illness;
⑦Patients who are unwilling to accept the study.
①～⑦of the above are all "no" were eligibly capable of being selected of this clinical trial.
3.5 Excluding standards of cases
①Selected cases who did not take part in or failed to complete the treatment;
②Occuring serious drug reactions after treatment;
③Other unpredictable events after treatment,which impacted the treatment;
④Trying other treatments while symptoms exacerbate.
Satisfy the item of the experiment of patients with any of the above conditions can be eliminated.
Methods
1 Case grouping
Seventy patients(one was eliminated) of LOA who were all consistent with entry criteria, were divided into two groups through random number table method:the testing group(34 cases) and the control group(35 cases).There are no apparently statistical differences among sex,age, course of disease,scores of signs and symptoms pretherapy,X-ray measurements of lumbar spine,Alkaline phosphatase(ALP),C-reactive protein(CRP),Erythrocyte sedimentation rate (ESR),Roland-Morris Disability Questionnaire(RMDQ) and Oswestry Disability Index(ODI) score,that means that the two groups are comparable.
2 Treatments
Patients of the testing group take Du Huo Ji Sheng Tang addition and subtraction(Duhuo, Jisheng,Duzhong,Bidentata,Breviscapus,Qinjiao,Poria cocos,Cinnamon,Fangfeng, Chuanxiong,Ginseng,Glycyrrhiza,Chinese Angelica,Chinese herbaceous peony,Radix Rehmanniae,etc.),which were decocted and made by the department of pharmacy of the hospital,and take one dose which was separated into halves in the morning and at night once a day for two weeks as a session.Patients of the control group take Glucosamine Indomethacin Entric-coated tablets(State authorized title H36020727,Jiangxi Pharmaceutical Co.,Ltd) two pills twice a day for two weeks as a session.
3 Outcome measures
3.1 Overall scores of symptoms and signs(Developed according to the Japanese Orthopedic Association(JOA) score for efficacy criteria of disorders of low back pain)
3.2 Determination of low back pain(Using Visual analogue scales(VAS))
3.3 Inspection lumbar spine X-ray
3.4 Determination of ALP,CRP,ESR
3.5 Assessment of correlations of RMDQ,ODI and the modified JOA score
3.6 Evaluation criteria(Using the evaluation criteria according to JOA)
3.7 Statistical methods
The obtained data was processed through the application of SPSS for Windows Release 13.0 statistical analysis package.Experimental data was demonstrated with mean±standard deviation((?)±s),P＜0.05 was considered significant statistical difference.Analyze count data through Chi-square test,measurement data through t test,level data through rank-sum test,and illustrate the correlation through Pearson analysis.
Results
1 Assessment of the overall efficacy of the two groups
After treatment the total efficiency of the testing group is 97.05%while the control group is 88.57%.And the total fine rate is 88.23%while the control group's is 60.00%.And in the testing group there are four of clinical control,twenty-six of excellence,three in effect and one of inefficacy,while there are three of clinical control,eithteen of excellence,ten in effect and four of inefficacy in the control group.There were no adverse reactions occurred in both the two groups.
2 Signs and symptoms compared before and after treatment
2.1 Signs and symptoms compared before and after treatment
By t test(t=-12.178,P＜0.01),there's significant difference of improvement of the comparison of signs and symptoms in the testing group before and after treatment.Through t test(t=-11.080,P＜0.01),there's significant difference of improvement of the comparison of signs and symptoms in the control group before and after treatment.The comparison of differences of signs and symptoms in the testing and the control group before and after treatment shows little statistical significance through t test(t=1.403,P＞0.05),which means there's no apparent differences of improvements between the two groups.
2.2 The comparison of each item of the modified JOA score before and after treatment in the two groups
By rank-sum test(Z values are -0.367,-0.351,-0.888,-1.485,-0.385,-0.367,-0.627, -0.751,-1.590,and P value are all above 0.05),the comparisons of cases of each item of the modified JOA score(symptom(low back pain),sleeping and moving over,standing up, washing face,rasing oneself slishtly and standing continuous,sedentariness,heavy-lifting and maintaining,walking,functional activities of lumbar spine) show ittle statistical difference,and the average level is similar in the two groups,which demonstrates the distribution of the items of the modified JOA score is comparable in the two groups pre-therapy.Through rank-sum test (Z values are -0.786,-1.450,-0.501,-1.147,-1.201,-0.557,-0.273,-0.451,-1.385,and P value are all above 0.05),they show there is no difference of each item of the modified JOA score in the two groups after treatment,that is to say there's no difference of the modified JOA score after treatment in the two groups.
2.3 The comparison of each item the modified JOA score in the testing group and the control group before and after treatment
By rank-sum test,P value are all less than 0.05,the comparison of each item of the modified JOA score before and after treatment shows significant difference in the testing group and the control group,that is to say each item of the modified JOA score in both the testing group and the control group improves greatly through treatments.
3 The VAS score comparison of two groups before and after treatment
By t test(t=15.272,P＜0.01),there's significant difference of improvement of the comparison of VAS score in the testing group before and after treatment.Through t test (t=14.482,P＜0.01),there's significant difference of improvement of the comparison of VAS score in the control group before and after treatment.The comparison of differences of VAS score in the testing and the control group before and after treatment shows little statistical significance through t test(t=-0.195,P＞0.05),which means there's no differences between the two groups,further it means the analgesic effect of the testing group is equal to the control group's.
4 The comparison of ALP,CRP,ESR of two groups before and after treatment
By t test,t values of ALP,CRP,ESR were 1.096,1.188,1.643,1.329,1.705,1.940,P values were greater than 0.05,there're no statistical differences of the two groups post-treatment and pre-therapy,which means there're no differences of the two groups before and after treatment.And the indicators((?)±s) were within normal range,so the serum ALP,CRP,ESR might not be the specific indicators of therapeutic efficacy.
5 The RMDQ,ODI comparison of two groups before and after treatment
By t test,t values of RMDQ,ODI are 11.396,10.198,11.276,9.359,P values are less than 0.01,there's statistical difference,which means both RMDQ and ODI scores were improved after treatment.The comparisons of differences of RMDQ and ODI in the testing and the control group before and after treatment show little statistical significance through t test (t=-0.403,P＞0.05;t=-0.641,P＞0.05),which means there're no differences of the comparison of RMDQ and ODI in the two groups.
6 Relevance analyses of RMDQ and the modified JOA score
6.1 Relevance analysis of RMDQ and the modified JOA in the testing group
By Pearson analysis(r=-0.819,P＜0.001),there is significant difference between RMDQ and the modified JOA score in the testing group pre-therapy.Through Pearson analysis (r=-0.570,P＜0.001),there is significant difference between RMDQ and the modified JOA score post-treatment in the testing group.The comparison of difference in the testing group of RMDQ and the modified JOA score shows great significance through Pearson analysis (r=-0.597,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of RMDQ and the modified JOA score in the testing group.
6.2 Relevance analysis of RMDQ and the modified JOA in the control group
By Pearson analysis(r=-0.876,P＜0.001),there is significant difference between RMDQ and the modified JOA score in the control group pre-therapy.Through Pearson analysis (r=-0.788,P＜0.001),there is significant difference between RMDQ and the modified JOA score post-treatment in the control group.The comparison of difference in the control group of RMDQ and the modified JOA score shows great significance through Pearson analysis (r=-0.813,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of RMDQ and the modified JOA score in the control group.
6.3 Relevance analysis of RMDQ and the modified JOA in the two groups
By Pearson analysis(r=-0.841,P＜0.001),there is significant difference between RMDQ and the modified JOA score in the two groups pre-therapy.Through Pearson analysis(r=-0.721, P＜0.001),there is significant difference between RMDQ and the modified JOA score post-treatment in the two groups.The comparison of difference in the two groups of RMDQ and the modified JOA score shows great significance through Pearson analysis(r=-0.703,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of RMDQ and the modified JOA score in the two groups.
There're existences negative correlation of RMDQ and the modified JOA score,that is to say that the RMDQ score reduces when the modified JOA score increases,the disease relieves, and when RMDQ score increases,the modified JOA score decreases,and the disease aggravates.So RMDQ could be used to evaluate LOA to some extent.
7 Relevance analyses of ODI and the modified JOA score
7.1 Relevance analysis of ODI and the modified JOA in the testing group
By Pearson analysis(r=-0.841,P＜0.001),there is significant difference between ODI and the modified JOA score in the testing group pre-therapy.Through Pearson analysis(r=-0.715, P＜0.001),there is significant difference between ODI and the modified JOA score post-treatment in the testing group.The comparison of difference in the testing group of ODI and the modified JOA score shows great significance through Pearson analysis(r=-0.785, P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of ODI and the modified JOA score in the testing group.
7.2 Relevance analysis of ODI and the modified JOA score in the control group
By Pearson analysis(r=-0.807,P＜0.001),there is significant difference between ODI and the modified JOA score in the control group pre-therapy.Through Pearson analysis(r=-0.825, P＜0.001),there is significant difference between ODI and the modified JOA score post-treatment in the control group.The comparison of difference in control group of ODI and the modified JOA score shows great significance through Pearson analysis(r=-0.701,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of ODI and the modified JOA score in the control group.
7.3 Relevance analysis of ODI and the modified JOA in the two groups
By Pearson analysis(r=-0.824,P＜0.001),there is significant difference between ODI and the modified JOA score in the two groups pre-therapy.Through Pearson analysis(r=-0.766, P＜0.001),there is significant difference between ODI and the modified JOA score post-treatment in the two groups.The comparison of difference in the two groups of ODI and the modified JOA score shows great significance through Pearson analysis(r=-0.739,P＜0.001) before and after treatment.They demonstrate that there is existence of negative correlation of ODI and the modified JOA score in the two groups.
There're existences of negative correlation of ODI and the modified JOA score,that is to say that the ODI score reduces when the modified JOA score increases,the disease relieves,and when ODI score increases,the modified JOA score decreases,and the disease aggravates.So ODI could be used to evaluate LOA to some extent.
Conclusion
1 This Clinical study proves that Du Huo Ji Sheng Tang in treating LOA has significant effectiveness and its total fine rate is 88.23%.
2 RMDQ and ODI scores could be used to evaluate LOA.
3 Serum ALP,CRP and ESR might not be the specific indicators to LOA.
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