| Background: Primary trigeminal neuralgia is a neuropathological that has no definite cause in the dominant area of trigeminal nerve,it is the most common cranial nerve disease.The typical symptoms of PTN were paroxysmal,transient electric cauterization,acupuncture and tearing pain that attack time of duration several seconds to several minutes,and it is unbearable.The pain occurs in a single side and often have trigger points that washing face,brushing teeth,talking,shaving and others was induced,and in the interval is the same as normal.The etiology and pathogenminal of trigeminal neuralgia is not clear,and still belongs to the hypothesis stage.Drugs are available in the early stages of the disease,but almost all drugs are ineffective after disease progression.In the past one hundred years,modern medicine has invented a number of second-line treatment of intractable trigeminal neuralgia,including two categories: one is based on the microvascular compression hypothesis to try to relieve the oppression of the operation—microvascular compression(MVD),and the other is the partial destruction of the sensory afferent fibers of the trigeminal nerve—Gamma knife radiosurgery(GKS)is its representative.Due to the etiology of trigeminal neuralgia are still in the stage of hypothesis,two kinds of treatment of their supporters to each other,the final choice of treatment basically is according to the medical center’s medical condition,the doctor’s experience,or patients limited understanding of trigeminal neuralgia.Until now,there is no evidence of evidence-based medicine that has a better effect,because of the lack of high-level clinical evidence.In the past ten years,although there have been hundreds of technical documentation and efficacy analysis of various treatments in the SCI journal published,and these articles have two major flaws: first,almost all of the original papers are proponents of a certain class of therapy for the analysis and reporting of the study,and including the researcher’s bias.In addition,more than 95% of the articles are retrospective case report analysis,from the perspective of evidence based medicine demonstrated low strength,it is difficult to avoid selection bias.Based on the present research situation of the treatment of trigeminal neuralgia,we objectively analyzed the defects of the existing research on the therapy of trigeminal neuralgia,realize the importance of objective evaluation of comparative study of trigeminal neuralgia therapeutics,and on the basis of this,we designed a large-scale prospective randomized controlled study on evidence based medicine.Comparison of microvascular decompression surgery and gamma knife radiotherapy for the treatment of primary trigeminal neuralgia merits.Research objective: Through a prospective,large sample,multicenter randomized controlled clinical study of primary trigeminal neuralgia with MVD and treatment of GKS treatment,comparing the two kinds of therapy,at different time points of the complications and mortality,observe two treatment quality。 to provide a higher level of theoretical basis for the reasonable choice of clinical treatment plan,and to provide the basis for individual to evaluate the efficacy and risk.the basis for individual to evaluate the efficacy and risk.Research method: In this study,the selected cases were randomly divided into group MVD and group GKS by single and even number random grouping,and obtain the informed consent of patients.Cases of primary trigeminal neuralgia treated at Department of neurosurgery in West China Hospital from 1 April 2015 and 1 April 2016 were collected.According to the principle of random sampling,256 cases of MVD group and 257 cases of GKS group were included.Need to screen when incorporated:Secondary trigeminal neuralgia,With serious cases and other diseases can not tolerate surgery or gamma knife treatment,Or refuse surgery and gamma knife treatment,cases had been treated with other surgery or destruction,and bilateral primary trigeminal neuralgia.Under the condition of fully respecting patients’ right to know and choose,the patients were randomly assigned to two groups.The possible prognostic factors of all cases were recorded before treatment: age,sex,age of onset,history of illness,pain distribution and scope,Whether the use of the drug is effective,effective time,the type of drug use,dosage,the nature of pain,whether have atypical symptoms,Ultrathin layer(0.5mm)MRI scan showed positive findings of vascular compression,and BPI pain quality of life scale.Group MVD received simple microvascular decompression surgery,even if no vascular compression was found,we can not cut the feel root.Detailed record in the operation that pressure vessel type,combined venous compression,the distance between the compression point and the brain stem,nerve compression notch,nerve atrophy,Intra-operative bleeding and other accidents.Group GKS detailed record that radiation dose contour,total radiation dose,tolerance and discomfort in the course of treatment.The two groups of patients in the hospital during the treatment by the independent evaluation of the objective results of the treatment,complications,mortality,treatment costs,etc.Postoperative follow-up and evaluation of curative effect: Objective record the BPI efficacy quality of life scale of independent assessors outside the treatment group,and Patient’s satisfaction of treatment.And the incidence of complications,mortality and the total cost of treatment.Statistical analysis of these data.Research results: A total of 527 cases were collected,14 of which were in line with the study and were not included in the study because they did not consent to randomization,513 patients with primary trigeminal neuralgia met the inclusion and exclusion criteria and completed the treatment,including 256 cases in group MVD and 257 cases in group GKS..A total of441 patients were followed up for a one years,including MVD group220 cases,and GKS group 221 cases.72 patients was not completed follow-up,the miss rate is 14.04%.1.Group MVD: 93 cases of male,female,male and female ratio 1:1.36,the average age was 56.03 years,the right side in 116 cases,the left side in 104 cases.The average duration of 5.47 years,the duration of more than 5 years in 96 cases,124 patients <5 years duration,pain regional single in 137 cases,two of 69 cases,14 cases of multi branch.Group GKS: 93 cases of male,female,,male and female ratio 1:1.38,the average age was 60.98 years old,right side in the case of the other,the left side in 98 cases.The average duration of 4.96 years,the duration of more than 5 years in 84 cases,137 cases of history less than 5 years,one in 150 cases,two of 60 cases,11 cases of multi branch.MVD group and GKS group of two cases,gender,age,course of disease,and patients with ipsilateral total not significant(P>0.05),it was no statistical significance.2.In the MVD patients,no obvious vascular compression was found in 15 cases,including venous compression in 26 cases,arteriovenous compression in the artery in 3 cases,and arterial pressure in the other in 176 cases.During the operation,191 cases were found to be oppressed by different degrees of blood vessels,and there were no obvious vascular compression in 29 cases.In the 10 cases of invalid MVD,2cases were artery compression,and the other one was non arterial compression in 8 cases,The difference was significant(P< 0.05).And in the 10 cases of invalid MVD,No obvious vascular compression and mild vascular compression(grade 0 and grade I)accounted for 9 cases,and grade II and III degree of compression after MVD only 1 cases invalid,the difference is significant(P<0.05).3.In group GKS,105 cases were found to have obvious blood vessels in the affected side,and 116 cases no obvious vessel was found in the patients.The treatment measure of trigeminal nerve root exposed length is larger than 7mm 153 cases,exposure length was less than 7mm in 68 cases.After 1 years of follow-up,the results showed that there were no effective treatment in 17 cases,trigeminal nerve root exposure length of less than 7mm in 12 cases,5 cases of more than 7mm,the difference is significant(P<0.05).4.38 cases of primary trigeminal neuralgia were complicated with hypertension,and the symptoms of hypertension disappeared in MVD group after treatment with MVD.53 cases of primary trigeminal neuralgia were complicated with hypertension,and the symptoms of hypertension disappeared in GKS group after GKS treatment.There was no significant difference between the two groups(P>0.05),it was no statistical significance.5.The main complications after MVD treatment were chemical meningitis,cerebrospinal fluid leakage,facial numbness,facial paralysis and corneal reflex.The common complications of GKS were facial numbness and decreased corneal reflex.There was no difference of postoperative outcome between the two groups in the incidence of complications(P>0.05).6.MVD group and GKS group after the treatment effect comparison: there was significant difference between the two groups before and after operation,however,there was no significant difference between the two groups in the follow-up period of 1 years.After 1 years of follow-up,the cure rate of MVD group was significantly higher than that of GKS group,the difference was significant(P<0.05),but the remission rate was no significant difference between the two groups(P>0.05),it was no statistical significance.7.Two groups of patients were followed up for 1 years,Group MVD was ineffective in the treatment of 10 cases,recurrence of 1 cases.Group GKS was ineffective in 17 cases,recurrence in 2 cases.There was no significant difference in recurrence rate between the two groups(P >0.05).There was no significant difference between the two groups in sex,age,incidence,risk factors and complications(P>0.05),The duration of more than 5 year recurrence rate was significantly higher than that in less than 5 years duration of patients,with significant difference(P<0.05).8.Kaplan-Meier survival analysis showed that time related pain relief rate of MVD were higher than GKS(P<0.05)。9.MVD average treatment costs $6586.31,GKS $2327.44,significantly higher than that of GKS,which is 2.8 times of GKS,significant difference(P<0.05),and MVD each of the per patient was cured of the average cost to $7639.17,and GKS was cost to $9117.24,MVD less than GKS,with significant difference(P<0.05).Conclusions:1.MVD and GKS are safe and effective in the treatment of Primary trigeminal neuralgia.The immediate effect of MVD group was significantly higher than that of grou P GKS,and the cure rate of MVD was 1 higher than that of GKS,however,there was no significant difference in remission rate.2.There was no significant difference between the two grouPs in gender,age,risk factors,risk factors and com Plications,negatively correlated with course of disease.The Prognosis of MVD in treatment of PTN non arterial com Pression was worse than that of arterial com Pression,the vascular com Pression of the lower level,the worse the surgical effect.The trigeminal root ex Posed,the more obvious effect.3.In Patients with Primary trigeminal neuralgia com Plicated with hy Pertension,MVD and GKS treatment of PTN,but also can be used to treat vascular hy Pertension.4.The average cost of MVD treatment was significantly higher than that of GKS,while the average cost of MVD for each Per Patient cured was less than GKS,and the cost-effectiveness of MVD was better than that of GKS. |
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