| Part 1:Clinical Study and Mechanism Reseach of Yaobi grain in Treating Degenerative Lumbar Spinal StenosisLumbar Spinal Stenosis(LSS) is a kind of common and frequently-occuring orthopedic disease. According to literature reports at home and aboard, the morbidity of Degenerative Lumbar Spinal Stenosis (DLSS) is 1.7%-10% from the age of 50 to 70, which accounted for more than 95% of LSS. Its main sympton is low back pain and intermittent claudication with lumbar activity restricted, which has serious impact on daily life. However, its pathogenesis is still not sheerly clear. An increasing number of treatments are used presently but their effects are still not satisfied. And there is lack of quantitative criteria of its functional and effective evaluation. What’s more, it fails reflect the patinet’s overall conditions.Based on the clinical experience of treating DLSS with Yaobi grain (a Chinese medicine prescription), JOA (Japandese Orthopedic Association) and VAS (Visual analogue scales) are used to study the effectiveness of Yaobi grain on treating DLSS and to analyse the relevance of JOA score and intermittent claudication, to provide a new idea of assessing the effectiveness of DLSS.Clinical data1 Case SourceSixty out-patients of DLSS who were all consistent with entry criteria were enrolled in the study in Wangjing Hospital of China Academy of Chinese Medical Sciences from February 2010 to February 2012.2 General imformationEighty patients of DLSS who were all consistent with entry criteria were entolled. Among 30 patients of testing group,14 cases were male and 16 cases were female. Their average age was 53, ranging from 45 to 70 and thier average cource of disease was 40 months, ranging from 4 days to 10 years. Among 30 patients of testing group,14 cases were male and 16 cases were female. Their average age was 54, ranging from 48 to 70 and their average cource of disease was 34 months, ranging from 1 month to 16 years.3 Case selection3 Case selection3.1 Diagnostic criteria of western medicineDrafting it with reference to Lianshun Jia’s diagnostic criteria of "Modern Lumbar Surgery".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 "Traditional Chinese Medicine diagnosis, symptoms and efficacy standards" of State Administration of Traditional Chinese Medicine.13 Case inclusion criteria①Satisfying the diagnostic criteria of Chinese and Western medicine;②Ranging from 40 to 70 years old;③Signed the informed consent, receiving treatments voluntarily;④Once received other treatments, an elution stage of seven days is needed.3.4 Case exclusion criteria①Less than 40 years old and more than 70 years old; Pregnant or breast-feeding women;②Have paralysis of the lower limps or gatism results in bedridden. ③Rheumatism, tumors and spinal tuberculosis patients and et al;④Patients with congenital lumbar spinal srenosis; Vasogenic limp or Spinal source limp results of lower limbs vascular disease and spinal cord COMPression.⑤Have serious cardiovascular, liver, kidney, hemaropoietic diseases or peptic ulcer;⑥Parients with mental illness;⑦Patients who are unwilling to accept the study.3.5 Excluding standards of cases①Selected cases who did not take part in or failed to COMPlete the treatment;②Having serious drug reactions after treatment;③Other unpredictable events after treatment, which impacted the treatment;④Trying other treatments while symptoms exacerbate.Method1 Case groupingSixty patients of DLSS who were all consistent with entry criteria, were divided into two groups through central clinical random system:testing group (30 cases) and control group (30 cases). There are no apparantly statistical differences among sex, age, course of disease, scores of signs and symptoms pretherapy.2 TreatmentsPatients of testing group take Yaobi grain (Chuanxiong, Gouji, Duhuo, Danggui, Duzhong, Niuxi, Mugua, Shudi, Baishao, Guiban, Biejia), which were decocted and made by the Department of Pharmacy of the hospital. Taking one dose which was separated into two parts in morning and evening once a day for two weeks as a session. Patients of 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 measures3.1 Overall scores of symptoms and signs (modified accoeding to the Japanese Orthopedic Association score for efficacy criteria of disordens of low back pain).3.2 Evaluation of low back pain and leg pain:Using visual analogue scales (VAS).3.3 Measure the intermittent claudication:According to walking distance.3.4 Evaluation criteria (Developed from the evaluation criteria according to modified JOA score).Results1 Assessment of the overall efficacy of the two groupsAfter treatment the total effciency of testing group is 87.67% while the control group is 73.33%. And the total fine rate is 46.67% while the control group is 40%. No adverse reactions occurred in any group.2 Signs and symptoms COMPared before and after treatmentBy t-test, there is significant difference of improvement of the COMParison of signs and symptoms in the testing group before and after treatment (t=-6.441, p<0.01). There is significant difference of the COMParison of signs and symptoms in the control group before and after treatment (t=-3.946, p<0.01). 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=1.348, p>0.05), which means there is no apparent diffetences of improvemen between the two groups.3 The VAS score COMParison of two groups before and after treatmentBy t test (t=6.842, p<0.01), there’s significant difference of improvement of the COMParison of VAS score in the testing group before and after treatment. Though test (t=7.768, p<0.01), there is 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 significant through t test (t=-1.06, p>0.05), further it means that the analygesic effect of the testing group is equal to the control group’s.4 Relevance analyses of walking distance and modified JOA score4.1 Relevance analyses of walking distance and modified JOA of the testing groupBy Pearson analysis(r=0.514, p<0.05), there is significant difference between walking distance and modified JOA score in the testing group pre-therapy.Through Pearson analysis (r=0.625, p<0.01), there is significant difference between walking distance and modified JOA score in the testing group pre-therapy.The COMParison of defference in the testing group of walking distance and modified JOA score show s great significance through Pearson analysis(r=0.566, p<0.01), before and after treatment. They demonstrate that there is existence of negative correlation of walking distance and JOA score in the testing group.4.2 Relevance analyses of walking distance and modified JOA of the control groupBy Pearson analysis(r=0.188, p<0.05), there is significant difference between walking distance and modified JOA score in the control group pre-therapy.Through Pearson analysis (r=0.519, p<0.05), there is significant difference between walking distance and modified JOA score in the control group pre-therapy.The COMParison of defference in the testing group of walking distance and modified JOA score show s great significance through Pearson analysis(r=0.362, p<0.05), before and after treatment. They demonstrate that there is existence of negative correlation of walking distance and JOA score in the control group.There’re existence of negative correlation of walking distance and modified JOA score, that is to say that the walking distance reduces when the modified JOA score increases, the disease relieves, and when walking distance increases, the modified JOA score decreases, and the disease aggravates. So walking distance could be used to evaluate DLSS.5 Conclusion1.The clinical study proves that Yaobi grain in treating DLSS has significant effectiveness and the effective rate is 86.67%.2. The intermittent claudication associate with the effectiveness of DLSS. Key word:Yaobi Grain; Intermittent Claudication; DLSSPart2:The establishment of Degeneration Lumbar Spinal Stenosis model to evaluate the effect of the Yaobi grain on inhibiting the Inflammatory painBackgroundLumbar Spinal Stenosis(LSS) is a kind of common and frequently-occuring orthopedic disease. According to literature reports at home and aboard, the morbidity of Degenerative Lumbar Spinal Stenosis (DLSS) is 1.7%～10% from the age of 50 to 70, which accounted for more than 95% of LSS. Its main sympton is low back pain and intermittent claudication with lumbar activity restricted, which has serious impact on daily life. However, its pathogenesis is still not sheerly clear. An increasing number of treatments are used presently but their effects are still not satisfied. And there is lack of quantitative criteria of its functional and effective evaluation. Recently, a number of studies by the revelation LEK, SP protein, GFAP, C-FOS, PGE-2 and other cytokines may inhibit the onset of pain DLSS plays a major role in the waist Bi Tang, and may reflect the severity, activity and efficacy an important indicator. Through animal experiments, observations LEK, SP protein, GFAP, c-fos, PGE-2 changes, maybe for DLSS pathogenesis and analgesic mechanism YaoBi Grain particles are important.ObjectiveTo explore the effect of and resolving hard lump method on Inflammatory pain and intermittent claudication response caused of rabbits, in order to provide the basis for the treatment of Degeneration Lumbar Spinal Stenosis with Chinese medical immunotherapy.MethodsSixty New Zealand rabbits were devided into 4 groups randomly according to body weight layer:sham operation group(group A), model contrast group(group B), Yaobi grain group(group C), modified Danlutongdu tablet group (group D). There were 15 rabbits in each group. Bite bone particle shearing and re implantation defects by operation in group B, C, D, which can lead to intermittent claudication and immuno-inflammatory response of rabbits; the group A were only treated with sham operation. At the 8th week after operation, the rabbits were fed through intragastric administration, the group A and B with distilled water(10ml/kg), the group C and D respectively with suspension of Yaobi grain (10ml/kg, 0.78g/ml) and water-decocted liquid of modified Danlutongdu tabl- et(10ml/kg,0.054g/ml), once a day and continuous medication for 4 weeks. All rabbits were killed at 12th weeks after operation. The Leu-enkephalin(LEK), Cellular oncogene fos(c-fos) and Glial fibrillary acidic protein(GFAP), P Substance(SP protein) and Postsynaptically synthesized prostaglandin E2 (PGE2) level in serum of different groups were detected with ELISA method. At the same time, surrounding tissues of the transplanted Lamina and Cauda equina were observed by pathological section.Result1 Determination of BBB FormComParison between 4 groups, the number of BBB Form in serum were significantly different (P<0.01). The number of BBB Form in serum of group B was significantly lower than that of group A (P<0.01); the number of BBB Form in serum of group C, D was significantly lower than that of group B(P<0.01); the number of BBB Form in serum between group C and D had no obvious difference(P<0.05).2 Determination of LEK/C-fos/SP/GFAP/PGE-2COMParison between 4 groups, the level of LEK/c-fos/SP/GFAP/PGE-2 in serum were significantly different (P<0.01). The level of LEK/c-fos/SP/GFAP/PGE-2in serum of group B was significantly higher than that of group A (P<0.01); the level of LEK/c-fos /SP/ GFAP/PGE-2 in serum of group C, D was significantly lower than that of group B(P<0.05 or P<0.01); the level of LEK/SP/GFAP/PGE-2 in serum between group C and D had no obvious difference (P>0.05), while the level of c-fos in serum of group D was significantly lower than that of group C(P<0.01). The statistics showed that both modified Yaobi grain and Danlutongdu tablets could inhibit the inhibiting level of c-fos/SP/GFAP/PGE-2 in serum of model rabbits, and modified Yaobi grain had a better effect increasing on LEK than Danlutongdu tablets.Conclusion1 The bite laminectomy and spinous backfill cover ways to build models of degenerative lumbar spinal stenosis is a safe and operable high success rate method.2 Resolving hard lump method could inhibit the increasing level of C-FOS/SP/GFAP/PGE-2 and increace the LEK in serum of model rabbits and improve the immune inflammation damage of surrounding tissue of nucleus pulposus. Consequently, it is likely that the method could inhibit inflammatory response and Improve the symptoms of intermittent claudication, which may be one of mechanisms of this method treating DLSS.3 activating blood circulation and resolving hard lump method could inhibit immuno-inflammatory response and release the intermittent claudication, which may provide a new clue for immune treatment of LDH by Chinese medicines. |
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