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Objective To evaluate the safety and efficacy of botulinum toxin type A for injection in the treatment of post-stroke upper limb spasticity (dosage was 200 U,or 240 U if combined with thumb spasticity).Methods The study was a multi-center,stratified block randomized,double-blind,placebocontrolled trial.All the qualificd subjects were from 15 clinical centers from September 2014 to February 2016.They were randomized (2∶1) to injections of botulinum toxin type A made in China (200-240 U;n =118) or placebo (n =60) in pivotal phase after informed consent signed.The study was divided into two stages.The pivotal trial phase included a one-week screening,12-week double-blind treatment,followed by an expanded phase which included six-week open-label treatment.The tone of the wrist,finger,thumb flexors was assessed at baseline and at weeks 0,1,4,6,8,12,16 and 18 using Modified Ashworth Scale (MAS),disability in activities of daily living was rated using the Disability Assessment Scale and impaction on pain,muscle tone and deformity was assessed using the Global Assessment Scale.The primary endpoint was the score difference between botulinum toxin type A and placebo groups in the tone of the wrist flexor using MAS at six weeks compared to baseline.Results Muscle tone MAS score in the wrist flexor of botulinum toxin type A and placebo groups at six weeks changed-1.00 (-2.00,-1.00) and 0.00 (-0.50,0.00) respectively from baseline.Botulinum toxin type A was significantly superior to placebo for the primary endpoint (Z =6.618,P ＜ 0.01).The safety measurement showed 10 subjects who received botulinum toxin type A had 13 adverse reactions,with an incidence of 8.47％ (10/118),and three subjects who received placebo had three adverse reactions,with an incidence of 5.00％ (3/60) during the pivotal trial phase.All adverse reactions were mild to moderate,none serious.There was no significant difference in adverse reactions incidence between the botulinum toxin type A and the placebo groups.During the expanded phase three subjects had four adverse reactions and the incidence was 1.95％.All adverse reactions were mild,none serious.Conclusion Botulinum toxin type A was found to be safe and efficacious for the treatment of post-stroke upper limb spasticity.Clinical Trial Registration:China Drug Trials,CTR20131191
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Objective To investigate the expression of bone marrow γ-H2AX in the patients with multiple myeloma(MM) and its correlation with the prognosis.Methods The patients with newly diagnosed MM in this hospital were selected as the case group,and the patients with non-hemopoietic system tumor without obvious morphological abnormalities by bone marrow smear and biopsy served as the control group.The immunohistochemistry was adopted to detect the expression level of bone marrow γ-H2AX in the cases group and control group,the image-Pro Plus(IPP) semiquantitative analysis was performed.The expression differences were compared between the two groups,moreover the case group was re-divided into the strong expression group and weak expression group according to γ-H2AX expression level.Then the relation ship between γ-H2AX expression level and the prognosis in the patients with MM.Results The bone marrow γ-H2AX expression level in the case group was significantly higher than that in the control group (P＜0.05);the level of γ-H2AX expression in the strong expression group was significantly stronger than that in the weak expression group (P＜0.05).Conclusion The level of γ-H2AX expression was higher among MM patients,and the over expression of γ-H2AX predicts the shorter survival time.
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Objective To explore anxiety and depression status in patients with hemifacial spasm (HFS) and benign essential blepharospasm (BEB), and the change after botulinum toxin type A (BTX-A) therapy. Methods Ninety idiopathic HFS patients and 90 BEB patients. The anxiety and depression statud was evaluated by using SAS and SDS before and after the injection of BTX-A. Results Before treatment, the SAS and SDS standard scores of the HFS patients were 41.25 ±6.35and 42.25 ±7.57, respectively. The SAS scores were 40.17 ± 8.36 in the male and 43.56 ± 6.10in female(P=0.031). The SDS scores were 40.25 ± 6.46 in the male and 45.48 ± 7.31 in the female(P=0.008). After treatment, the SAS and SDS standard scores were 30.12 ± 4.35(P=0.000)and 30.58 ± 4.89(P=0.000)respectively. There was significant difference inbetween before and after treatment. In BEB patients, before treatment, The SAS standard scores were 58.90±10.61, 58.78±9.89. The SAS of the male and female patients scored 56.45 ± 8.75, 60.89 ± 9.11 (P=0.017), The SDS of the male and female patients scored 57.90 ± 7.93, 60.12 ± 8.35 (P=0.011)respectively. After treatment, the SAS standard score were 38.17 ± 3.67 (P=0.000), and the SDS standard score were 38.12 ± 4.15 (P=0.001)respectively. these two scores were significantly different between before and after treatment. Conclusion HFS and BEB patients, especially female patients are associated with anxiety and depression. BTX-A can improve the symptoms of anxiety and depression.
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<p><b>BACKGROUND</b>Hemifacial spasm (HFS) is a facial nerve disorder characterized by episodic involuntary ipsilateral facial muscle contraction. Information on Chinese patients with HFS has not been well-characterized. This study aimed to evaluate the clinical feature and the treatment status of HFS across China.</p><p><b>METHODS</b>A cross-sectional study including 1003 primary HFS patients had been carried out in 15 movement disorder clinics in China in 2012. The investigated information was acquired from questionnaires and medical records including demographic data, site of onset, aggravating and relieving factors, treatments prior to the investigation, etc.</p><p><b>RESULTS</b>In this study, the ratio of male to female was 1.0:1.8, the mean age at onset was (46.6 ± 11.5) years. About 1.0% patients were bilaterally affected. The most often site of initial onset was the orbicularis oculi muscle. The most often affected sites were orbicularis oculi, zygomatic, and orbicularis oris muscles. Stress/anxiety and relaxation were most often aggravating and relieving factors, respectively; 2.3% patients had family history, 28.4% cases were combined with hypertension, and 1.4% patients were with trigeminal neuralgia. Botulinum toxin type A (BTX-A) injection was the most commonly used treatment, followed by acupuncture and oral medication. BTX-A maintained the highest repeat treatment ratio (68.7%), while 98.4% patients gave up acupuncture. The mean latency of BTX-A effect was (5.0 ± 4.7) days, the mean total duration of the effect was (19.5 ± 11.7) weeks, and 95.9% patients developed improvements no worse than moderate in both severity and function. The most common side effect was droopy mouth.</p><p><b>CONCLUSIONS</b>The onset age of HFS in China is earlier than that in western countries. The most often used two treatments are BTX-A injection and acupuncture, while the latter kept the poor repeat treatment ratio because of dissatisfactory therapeutic effect.</p>
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Adult , Female , Humans , Male , Middle Aged , Botulinum Toxins, Type A , Therapeutic Uses , China , Cross-Sectional Studies , Hemifacial Spasm , Diagnosis , Drug Therapy , Neuromuscular Agents , Therapeutic UsesABSTRACT
Objective To investigate prospectively the diagnostic significance of ulnar/median nerve amplitude ratio in motor neuron disorders.Methods Patients referral to our department between May 2009 and February 2012,due to muscle weakness,inflexible,cramps and atrophy,were consecutively enrolled.Conventional nerve conduction studies of 4 extremities (using surface electrodes) and needle electromyography were performed in all patients with fixed examiner.The compound muscle action potentials (CMAP) were recorded from abductor digiti minimi (ADM) and abductor pollicis brevis (APB) with stimulation of ulnar and median nerve at wrist,respectively.Moreover,the ratio of CMAP amplitude between ADM and APB (ADM/APB) was calculated in the patients who met the diagnostic criteria for definite amyotrophic lateral sclerosis (ALS) and Hirayama disease (HD).The patients with Guillain-Barré syndrome (GBS) and other popyneuropathies (PN) were served as case-controls,and 34 healthy volunteers (aged (45.7 ± 16.3) years) as normal-controls.Results (1) There were 78 cases with ALS,25 HD,51 GBS and 140 other PN,with the mean age(years) of 54.7 ± 11.6,17.6 ± 2.2,41.3 ± 18.4 and 57.1 ± 14.3,respectively.(2) ADM/APB in the ALS subgroup was 2.28 ±2.87 (0.12-22.38),HD0.66±0.36 (0.05-1.34),GBS 1.42 ± 1.33 (0.25-9.85),other PN 1.36 ± 1.48 (0.08-14.44) and normal-controls 1.07 ± 0.28 (0.61-1.64,F =6.872,P =0.000),respectively.(3) The areas under receiver operator characteristic curve in patients with ALS was 0.830 (s-x =0.039) and HD 0.691 (sx =0.039,P =0.000) ; the diagnostic sensitivity and specificity for ALS patients were 36.7％ and 93.3％,respectively,with cutoff value of ADM/APB =2; and the diagnostic sensitivity and specificity for HD patients were 53.6％ and 89.0％,respectively,with cutoff value of ADM/APB =0.7.Conclusions The ulnar/median CMAP amplitude ratio increases in ALS,but decreases in HD,which may be served as a relatively specific electrophysiological index.ADM/APB amplitude ratio ＞ 2.0 is suggested to be a diagnostic parameter for ALS and ＜ 0.7 for HD.
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Objective To investigate the involvement of posterior auricular muscle (PAM) and the effect of botulinum toxin type A (BTX-A) injection into PAM in patients with hemifacial spasm (HFS)complicated by auricular symptoms.Methods Sixty-three consecutive HFS patients with auricular symptoms such as tinnitus or murmur,"ticking" or a "clicking" sound and discomfort on the same side,referred to our department between July,2009 and January,2010,were enrolled,and the diagnosis of idiopathic HFS was clinically made.The patients were largely randomized into two groups according to the order of referral.One was regular group including 33 cases whose injection sites were routinely at the frontal,orbicularis oculi,zygomaticus and buccinator muscles while another was PAM group including 30 cases,in which 4 units of BTX-A was additionally injected to the PAM.Before and after injection,the test of blink reflex was performed and lateral spread of blink reflex to orbicularis oris(OO)and PAM,I.e.Abnormal muscle response(AMR),were recorded,and the peak-peak amplitude of AMR was measured.The patients were followed up clinically and electrophysiologically at least 4 weeks((29.5±2.5)days) later.Results(1)The patients reported that their auricular symptoms subsided after injection in both groups.The remission rate was 45.5%(15/33)in the regular group and 76.7%(23/30)in the PAM group,respectively,with a higher rate in the PAM group(x2=6.40,P=0.011).(2)In both groups the AMR amplitude decreased significantly after injection.In the regular group,the OO amplitudes (μV) before and after injection were 304.0±30.3 and 129.3±9.6(t =5.820,P =0.000),and PAM amplitudes,298.0±33.3 and 184.7±20.2(t=2.818,P=0.014),respectively.In the PAM group,OO amplitudes were 405.3±66.7 and 116.0±10.0(t=4.214,P=0.001),PAM amplitudes,390.0±53.6 and 72.0±9.7(t=6.011,P=0.000),respectively.(3)The decrease of PAM amplitudes in the PAM group was more significant compared with those in the regular group (t=4.237,P=0.001).Conclusions In HFS patients with auricular symptoms,the electrophysiological studies are helpful for the guidance of treatment;and the auricular symptoms could be better improved after BTX-A injection into PAM in addition to those regular injection sites.
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Objective To investigate the diagnostic significance of sensory nerve action protential (SNAP) on diabetic neuropathy (DN), through measuring amplitude and amplitude ratio. Methods There were 91 patients with type 2 diabetes involing 51 cases without neurologic symptom/sign as subgroup Ⅰ, 30 cases with mild neuropathy as subgroup Ⅱ and 10 cases with severe neuropathy as subgroup Ⅲ, according to Toronto clinical scoring system (TCSS). Thirty-nine healthy volunteers with age- and gender-matched were served as controls. SNAP were antidromically recorded using surface electrodes. The observed parameters were as follows: conduction velocity and amplitude of median, radial and sural nerve, shorten for Vine, Vra and Vsu and Ame, Ara and Asu, respectively; sural/radial nerve amplitude ratio (SRAR) and median/ radial nerve amplitude ratio (MRAR). Results (1) As compared with the controls (P<0.05),conduction velocity (m/s, Vine : 46. 2 ±7.3, Vra: 45.8±6. 9, Vsu: 30. 3±9. 5) and amplitude (μV, Am: 15.4±10.5, Ar: 16.6±9.8, As: 5.9±6. 3)decreased significantly in subgroup Ⅲ; Vsu (46.2± 4. 7) significantly slowed in subgroup Ⅱ (P = 0. 002) ; both Ame (34. 5 ± 10. 2, 33. 0 ± 14. 6) and Asu (13.8± 5.6, 10.7 ± 5.5) decreased significantly in both subgroup Ⅰ and Ⅱ respectively, with Asu decreasing more significantly in subgroup Ⅱ (Z=- 3.22, P = 0. 001) ; SRAR (0. 432±: 0. 112) was significantly smaller only in subgroup Ⅰ , both SRAR (0. 330 ±0. 102) and MRAR (1. 008 ± 0. 225) were significantly smaller in subgroup Ⅱ. SRAR decreased more significantly in subgroup Ⅱ (t = - 3. 86, P = 0. 003). (2) The abnormal rate of Ame was the highest in subgroup Ⅰ (26. 0%), and Asu in subgroup Ⅱ (41.4%) ; while that of combination of Asu and SRAR (68.9%) was significantly higher than that of Asu alone (x2 = 9. 212, P = 0. 003). (3) TCSS scores were negatively related to Van (r = - 0. 583), Ame (r=-0. 406), Asu (r=-0.620) and SRAR (r=-0.527, all P<0.05), and there was no significant correlation of TCSS scores with MRAR in subgroup Ⅱ; both SRAR (r = -0.435) and MRAR (r = - 0. 319) were negatively related to the diabetic duration (both P < 0. 05). Conclusions In mild or early DN, SNAP amplitude is more sensitive than conduction velocity, combination of SRAR and Vsu may be serve as a useful indication for early diagnosis. In the DN patient, diabetic duration has more influence on the measurement of sensory NCS, and SRAR is related to the severity of neuropathy.
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BACKGROUND: After local injection of Botulinum toxin type-A (BoTX-A), not only the function of the neuromuscular conjunction was affected, but also the changes occurred remote from the injected site. F-waves result from the back fire of the motoneuron activation, which may indirectly reflect the functional state of the motoneurons.OBJECTIVE: To evaluate the remote effect of local BoTX-A injection by F-wave test.DESIGN: Self-control study based on patients with movement disorders.SETTING: Neruologic clinic in a university hospital.PARTICIPANTS: Twenty-six patients with movement disorders not received previous local BoTX-A were selected from Neurological Clinic in Renmin Hospital of Wuhan University between September 2002 and July 2003, including 19 cases with hemificiospasm, 5 Meige syndrome and 2 torticollis spasmodicus.INTERVENTIONS: F- and M-waves of ulnar and tibial nerves were recorded before 1, 12 - 24 weeks after local injection of BoTX-A in 26 patients.MAIN OUTCOME MEASURES: The following parameters were analyzed:latency(ML) and amplitude (Mamp) of M-wave, minimal (Fmin) and average latency (Fave), amplitude of negative peak(Famp), duration (Fdur), persistence (Fpcr) and chronodispersion (Fchr) of F-wave.RESULTS: No definite F-response of ulnar nerve stimulation was obtained 1 week after injection in 3 HFS patients (5 nerves) . Fave prolonged significantly on ulnar and tibal nerve and Fdur increased significantly on ulnar nerve 1 week after injection, but there was no significant difference 12 - 24 weeks later, compared with before injection. No significant correlation of the altered F-wave parameters was found with the dosage of BoTX-A.CONCLUSION: Fdur and Fave could sensitively assess the remote effect,which correlates with distance away from the injected muscle, rather than the dosage of BoTX-A.
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BACKGROUND: The minimal latency and conduction velocity of F-wave have been widely used for the detection of varied neurological disorders,whereas the significance and the diagnostic value for the other parameters of F wave are seldom reported. How sensitive are these parameters in the earlier evaluation of diabetic peripheral neuropathy (DPN) ?OBJECTIVE: To investigate the evaluating value of F-wave parameters for the earlier DPN, providing references for earlier clinical rehabilitative intervention.DESIGN: Case-control study with type 2 diabetic patients and health people as subjects.SETTING: The wards and outpatients in the Departments of Neurology and Endocrinology, Renmin Hospital of Wuhan University.PARTICIPANTS: Between January 1999 and December 2000, there were totally 106 patients with type 2 diabetic mellitus(DM) at the wards and outpatients in the department of neurology and endocrinology in Renmin Hospital of Wuhan University, including 64 males and 42 females, with the average age of (55 ± 13) years and the average DM course of (10.2 ± 4. 8)years. Meanwhile, 75 healthy volunteers were enrolled in the control group,including 45 males and 30 females, with the mean age of(54 ± 12) years.Two groups were matched in age and leg length( P ＞ 0. 05).INTERVENTIONS: Using Nicolet Viking-Ⅳ, F wave and M-wave parameters of tibial nerve stimulation were analyzed.MAIN OUTCOME MEASURES: The minimum latency (Fmin), duration (Fdur), amplitude(Famp) and area(Farca) of F wave; and the amplitude (Mamp)and aera(Marea) of M-wave.neuropathy( n = 30), there were 8 cases(the abnormal rate being 27% ) with increased Fdur, 4(13% ) with prolonged Fmin and 2(7% ) with increased F/Mamp and F/Marea increased significantly in the patients with DPN( n = 76).mality rate of Fdur was significantly higher (96% vs 21%, P ＜0.01), the abnormality rate of Fmin was significantly lower(51% vs 76%, P ＜ 0.05 ) and there were no significant difference of other parameters( P ＞ 0.05) in the patients with mild DPN subgroup ( n = 47).diagnostic parameter for earlier DPN, and therefore detect the sub-clinical DPN, and the proximal may be earlier involved than the distal.
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Objective To explore the association between the lung function and the related electroneurophysiological parameters in patients with chronic obstructive pulmonary disease (COPD). Methods Fifty COPD patients were studied. The lung function and the phrenic motor nerve conduction (PNC) were examined, respectively. Thirty cases of non respiratory disorders served as control. The lung function tests included maximal voluntary ventilation (MVV%), forced vital capacity (FVC), force expiratory volume (FEV 1) and RV/TLC% (residual volume, RV; total lung capacity, TLC). The phrenic nerve was stimulated electrically at the midpoint of the posterior border of the sternomastoid muscle, and the diaphragmatic compound muscle action potential (dCMAP) was recorded between the 7th and 8th intercostal space and xiphoid process. Results The relative values of MVV%, FVC 1/FVC 1% and RV/TLC% were 49.6?18.8, 62.5?16.4 and 54.1?8.0, respectively, which was significantly lower than that expected. There was no significant difference with regard to the PNC latency between the patients and the controls. The dCMAP amplitude ratio in the COPD patients was significantly lower than that of the controls, i.e., the dCMAP amplitude decreased in the COPD patients. Conclusion The decreased dCMAP might be associated with abnormal lung function. The PNC examination would provide valuable information for the evaluation of diaphragmatic dysfunction in those with abnormal lung function.
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Objective To study the relationship of lung function and the diaphragmatic nerve electrophysiological changes in elderly patients with chronic obstructive pulmonary disease(COPD).Methods The phrenic nerve motor conduction(PNC),diaphragmatic motor evoked potentials(dMEP)and diaphragmatic compound muscle action potentials(dCMAP)were detected in 50 COPD patients and 50 healthy controls aged 60 years and over,respectively. Results (1)The lung function of elderly COPD patients were significantly less than that of control group(P0.05),the lower amplitude of dCMAP than the control(P
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Objective To evaluate the remote effect of local injection of botulinum toxin by use of the F-wave measures. Methods The F-wave responses as well as M-waves were recorded before injection, and at 1 week,12 to 24 weeks after local injection of botulinum toxin type-A (BTX-A) in 26 patients, including 19 with hemi-facial spasm (HFS),5 Meige syndrome and 2 torticollis spasmodicus (TS).The following parameters were analyzed: M-wave latency (ML) and amplitude (Mamp), F-wave minimal latency(Fmin) and average latency(Fave),amplitude (Famp), duration (Fdur), persistence (Fper) and chronodispersion (Fchr). The above parameters were obtained through the electric stimulation of ulnar and tibial nerves, and recorded from the abductor digiti minimi and extensor digitorum brevis, respectively. Results No definite F-wave was obtained by electric stimulation of ulnar nerve at 1 week after injection in 3 HFS patients (5 nerves). The Fave recorded from electric stimulation of ulnar and tibial nerves prolonged significantlyand Fdur from ulnar nerve increased significantly at 1 week after injection, but were not significantly different from those of pre-injection when recorded at 12 to 24 weeks after injection. No significant correlation of the altered F-wave parameters was found with the dosage of BTX-A. Conclusion Fdur and Fave could sensitively assess the remote effect of the local injection of BTX-A, the remote effect might be correlated with the distance between injected muscle and tested muscle, rather than the dosage of BTX-A.
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Objective To investigate the effect of m il d hypothermia on the content of Ca 2+、Mg 2+、EAA in rat brain tissue and ET in plasma after acute cerebral infarction. Methods Forty-eight Sprague-Dawley rats were randomly assigned into trial group and control group. Using the method of reformed line-thrombosis,the cerebral in farction models were established. The rats in the trial-group were cooled by mi ld hypothermia for half an hour, while those in the control group were subjected to no disposal. Every group was divided into 4 sub-groups according to the pos t-infarction disposal time. Every sub-group was composed of 6 SD rats and kill ed at the time points of 1 hour,2 hour,4 hour and 8 hour after infarction, respe ctively. Then the content of Ca 2+、Mg 2+、EAA in rat brain tissue an d ET in plasma were measured. ResultsThe post-infar ction content of Ca 2+、EAA and ET of trial-group increased mildly and Mg 2+ reduced very little. There was a significant statistical difference bet ween the trial group and the control group. Conclusion Mild hypothermia may significantly reverse the increase of the content of Ca 2+ and EAA and the fall of Mg 2+ and the increment of ET in plasma as well after acute cerebral infarction in experimental animals. So as a result, m ild hypothermia possesses protective effect on brain.