| Background and Purpose:Lumbar disc herniation(LDH)is caused by degenerative changes of the lumbar spine or external forces that cause the contents of the disc to break through the annulus beyond the boundary of the normal disc,compressing nerve roots,blood vessels or spinal cord and other tissues,causing symptoms and signs such as pain,weakness,sarcomegaly or abnormal sensory distribution of the dermatomes.It is now generally believed that low back pain and sciatica have the origin of neuritis.Relieving mechanical compression is no longer the only controlling factor.The control of nerve root inflammation can also be used as an entry point for treatment.Low-temperature Pasma Ablation(LPA)is one of the minimally invasive procedures commonly used in the treatment of LDH in clinic.It has the characteristics of safe and effective,less invasive,and simple operation.However,LPA is mainly aimed at the decompression of the intervertebral disc,directly reducing the compression of the disc on the spinal cord and nerve roots,but it cannot completely solve the problem of lumbar nerve root inflammation.At the same time,in the North American Spine Surgery Society Guide for LDH,It is mentioned that there is insufficient clinical evidence to support and oppose the use of transforaminal dural hormone drugs for the treatment of lumbar disc herniation,and hormones have certain side effects.Therefore,it is imperative to look for drugs with small toxic and side effects.Related studies have found that the Chinese medicine Dan Shen Injection(DSI)has the effects of activating blood circulation,removing blood stasis,dilating blood vessels,and diminishing inflammation and analgesia.It has been reported that DSI has been injected into the muscles near the lumbar spine to treat LDH,and this method has achieved certain clinical efficacy.There is no study of direct injection of DSI into the nerve root of lumbar spine.Therefore,this study is guided by the theory of integrated Chinese and Western medicine,and it is planned to pass a basic test to observe whether the effect of DSI on the lumbar nerve root inflammation of LDH rat model can achieve the therapeutic effect through the intervention of related pain-causing substances.In clinical studies,Danshen injection was injected into the intervertebral foramen area to observe the clinical effect of Danshen injection on LDH with Blood Stasis and Qi Stagnation Type(BSQS).At the same time,we also need to observe and study the clinical efficacy of LPA combined with DSI in the treatment of LDH with QSBS and the reliability of this method in elderly LDH patients.This study evaluated the effectiveness and safety of DSI in the intervertebral foramen from the perspective of evidence-based medicine,so as to provide a strong scientific basis for its promotion.Methods:This study is divided into basic experiments and two groups of clinical experiments.Experiment 1:Basic experiment,60 Wistar rats were randomly divided into normal group,model group,DSI group and control group.After preparing a lumbar radiculitis model,the model group,DSI group,and control group were treated with normal saline,DSI,and cobalt adenosine for injection(1 time/d for 2 weeks),and the normal group did not intervene.The gait and tactile scores of rats were evaluated on days 1,7,14,and 30 after surgery,and electrophysiological measurements were performed on day 30.The content of β-endorphin(β-EP)and adrenocorticotropic hormone(ACTH)in the plasma of rats on days 7,14 and 30 was detected by ELISAExperiment2:Clinical experiment,70 patients with LDH were divided into the DSI group and the ozone group according to the random number table method.Each group of 35 people was injected DSI and ozone in the intervertebral foramen area.Visual pain scal(VAS),Oswestry dysfunction index(ODI)and number of straight leg elevations were observed before surgery,1 day,7 days,14 days and 3 months after surgery.The VAS score was used to assess the patient’s back and leg pain,the ODI score was used to assess the patient’s quality of life.Finally,we evaluate the clinical efficacy of patients based on their improvement in ODI scores.Experiment 3:A total of 140 patients were included in the clinical trial,105 of which were ordinary(<70 years old)LDH patients,and the other 35 patients were elderly(>70 years old)LDH patients.According to the random number table method,105 cases of ordinary LDH patients were randomly divided into Control Ⅰ(A)group,Control Ⅱ(B)group and Observer(C)Group,35 cases in each group.The C group was treated with LPA combined with DSI in the intervertebral foramen region.The other 30 patients were elderly LDH patients in group D,which was treated with lumbar low temperature plasma nucleus pulposus ablation alone,and control group Ⅱ(group B)was treated with with LPAcombined with DSI in the intervertebral foramen region.Visual pain scal(VAS),Japanese Orthopaedic Association Scores(JOA)and number of straight leg elevations were observed before surgery,1 day,7 days,14 days and 3 months after surgery.The VAS score was used to assess the patient’s back and leg pain,the JOA score was used to assess the patient’s quality of life.Finally,we evaluate the clinical efficacy of patients based on their improvement in JOA scores.Result:Experiment 1:In the basic experiment,the gait scores of the DSI group on days 7,14,and 30 were slightly better than those of the control group(P<0.05);the gait score on the 30th day was not statistically different from that of the normal group during the same period.The tactile scores on days 7,14 and 30 were slightly better than those in the control group(P<0.05);The tactile scores on day 30 were not statistically different from the normal group during the same period.The plasma β-EP content of the model group showed a gradual downward trend,while the plasma β-EP of the DSI group and the control group increased significantly,and the DSI group was slightly better than the control group(P<0.05);In the model group,the content of ACTH first increased and then decreased.The content of ACTH in the plasma of the DSI group and the control group was lower than that of the model group,and the DSI group was superior to the control group(P<0.05).Compared with the model group,the nerve conduction velocity of the DSI group and the control group had increased(P<0.05),the treatment effect of DSI group was slightly better than the control group(P<0.05).Experiment 2:In the clinical trial,all 70 patients successfully completed relevant treatment and follow-up.During the same period,the VAS score of the ozone group was significantly higher than that of the DSI group,and the ODI score of the ozone group was significantly higher than that of the DSI group.DSI group’s straight leg lift degree was significantly better than ozone group at 14 days and 3 months after treatment.After 3 months of treatment,the total effective number of DSI group was 29,with an effective rate of 82.86%;The total effective number of ozone group was 25,with an effective rate of 71.42%.Experiment 3:In the clinical trial,all 140 patients successfully completed the relevant treatment and follow-up.The VAS,JOA and ODI scores and straight leg lift degree of 105 patients with ordinary LDH were significantly improved after treatment,and the improvement of patients in the C group was better than that of B group,C group’s effective rate(91.42%)is also significantly better than B group(85.71%)and A group(74.28%).The VAS,JO A and ODI scores and straight leg lift degree of the D group were all significantly improved after treatment,and the effective rate was 82.85%.Conclusion:(1)DSI is safe and effective in the treatment of rat lumbar radiculitis,which may play a therapeutic role by regulating the expression of β-EP and ACTH.(2)DSI is safe and effective in the treatment of LDH with BSQS,which can be widely used in clinical practice.(3)The effect of LPA combined with DSI in the treatment of LDH with BSQS is very satisfactory.It can obviously relieve the pain of young and middle-aged patients and the elderly patients,improve the lumbar function,and improve the degree of straight leg lift.Thereby,we suppose that LPA combined with DSI in the treatment of of LDH with BSQS is worthy of clinical promotion and application. |
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