Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity

OBJECTIVE: To examine the safety of botulinum toxin type A (BTX-A). DESIGN: Analysis of pooled data of 9 double-blind, placebo-controlled studies of patients with spasticity after stroke. SETTING: University hospitals and specialty rehabilitation centers in the United States. PARTICIPANTS: A total of 482 patients with upper-limb spasticity and 310 with lower-limb spasticity (overall mean age, 58y; 60% men). INTERVENTION: Treatment with BTX-A (n=534; 1-3 treatments; mean dose, 231U) or placebo (n=258). MAIN OUTCOME MEASURE: Adverse events. RESULTS: Most patients (69%) received only 1 treatment with BTX-A. Patients were followed for a mean of 17.8 weeks (range, 0.1-44.7wk) after each treatment. A total of 352 (65.9%) patients in the BTX-A group and 163 (63.2%) in the placebo group reported at least 1 adverse event (P=.475). The most frequent adverse events reported by patients (>5% but <10% in either group) were respiratory infection, seizures, incoordination, and injection site pain, none of which occurred at a significantly higher rate in the BTX-A group (all P>.05). The majority of adverse events were rated as mild or moderate in severity. Only nausea was reported at a significantly higher rate in the BTX-A group (12/534 [2.2%]) than the placebo group (0/258) (P=.011); in contrast, injection site pain, chest pain, and allergic reaction were reported significantly more frequently in the placebo group. CONCLUSIONS: BTX-A has an acceptable safety profile for treatment of patients with focal spasticity following stroke, a population in which adverse events and comorbidities are common.     

A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm

Myofascial pain syndrome (MPS) is a common illness, characterised by acute or chronic focal pain, muscle stiffness and fatigue. The pathophysiology of MPS remains unclear. Previous preliminary studies have demonstrated therapeutic efficacy of the muscle relaxant botulinum toxin type A (BTX-A) in the treatment of MPS. A single-centre, randomised trial compared the effects of BTX-A with the steroid methylprednisolone (both administered intramuscularly with 0.5% bupivacaine), in 40 patients suffering from chronic myofascial pain in the piriformis, iliopsoas or scalenus anterior muscles. Thirty days after receiving an injection of either BTX-A or steroid followed by post-injection physiotherapy, pain severity had decreased significantly from baseline in both treatment groups, with no significant difference between the two treatment groups. However, the baseline pain score was significantly higher in the BTX-A treatment group compared with the steroid group (7.9 vs. 7.3), and the reduction in pain score between baseline and 30 days post-injection was greater in the BTX-A group compared with the steroid group (-3.9 vs. -3.5; P=0.06). At 60 days post-injection, the pain severity score for the BTX-A-treated patients was statistically significantly lower than the pain score for the steroid-treated population (2.3 vs. 4.9). Furthermore, the reduction in pain score in the BTX-A group at 60 days post-injection was greater than at 30 days (-5.5 vs. -3.9), whereas the effect of the steroid had begun to wane. These results indicate the superior efficacy of BTX-A over conventional steroid treatment in patients suffering from MPS, when combined with appropriate physiotherapy.     

Managing spasticity in pediatric cerebral palsy using a very low dose of botulinum toxin type A: preliminary report

OBJECTIVE: To determine if very low doses of botulinum toxin type A (BTX-A) could reduce spasticity and improve gait in cerebral palsied children when combined with rehabilitation therapy. DESIGN: Ten trainable (IQ > 80), ambulatory, spastic diplegic or hemiplegic cerebral palsied children, with no fixed contractures in at least one limb, were selected for the study. Patients with a score of 3 on a modified Ashworth scale received 0.5 units of BTX-A/kg/muscle. Patients with an Ashworth score of 4 received 1.0 BTX-A/kg/muscle. After BTX-A injection, all patients received rehabilitation therapy and plastic ankle and foot orthoses for walking. RESULTS: Both groups exhibited improvement in Ashworth score and in gait within 72 hr of injection with botulinum toxin. Beneficial effects persisted for 10 to 12 mo in most patients, with three patients exhibiting benefits for at least 20 mo. CONCLUSIONS: The results of the present study indicate that a very low dose of botulinum toxin type A combined with'rehabilitation therapy resulted in a long-lasting decrease in spasticity and an improvement in gait in children with cerebral palsy.     

Use of botulinum toxin in the treatment of chronic myofascial pain

BACKGROUND: Myofascial pain syndrome (MPS) is defined as acute or chronic pain with sensory or motor autonomic symptoms, referred from active myofascial triggering points with associated dysfunction. Previous studies have suggested the usefulness of botulinum toxin A (BTX-A) in the treatment of MPS since it is capable of controlling muscular spasms, as well as other alternative mechanisms of action. OBJECTIVES: To analyze the efficacy of BTX-A treatment and its effect on daily life activities assessing pain reduction using a visual analogue scale (VAS); degree of improvement in physical impairment and disability scoring in the Oswestry low back pain questionnaire; and psychologic status using the Hospital Anxiety and Depression Scale (HAD), in patients suffering from MPS. METHOD: An open-label interventional prospective trial was conducted in 77 patients diagnosed of refractory MPS (defined as the presence of muscle spasm with pain on mobilization or stretching, plus the existence of trigger points with associated referred pain), resistant to both conservative management and to physical therapy. The BTX-A dosages for the different muscles were chosen according to a standardized protocol. Electromyographic guidance was used to localize the motor end plate prior to injection in superficial muscles; while fluoroscopic guidance was employed to evidence intramyofascial spread of the contrast solution within deep muscles. The assessment of treatment efficacy was based on a pain VAS applied before enrollment, at 15, 30, and 90 days and upon completion of the study; the Lattinen test to establish a relationship between pain intensity and its corresponding impact on daily living; and the HAD scale to assess psychologic stress, performed both before treatment and at the end of the study; and the Oswestry Questionnaire was used to evaluate patients' ability to carry out daily life activities according to their degree of physical impairment and disability scores. RESULTS: The global analysis revealed a positive correlation between the VAS score prior to treatment and the scoring at 15, 30, and 90 days. This correlation was maintained when analyzing independently for superficial or deep muscles. The correlation coefficients for HAD scores and the Lattinen test values showed a significant association between pre- and post-treatment findings. No adverse events were recorded for 83.1% of the cases. CONCLUSIONS: The results of this study are consistent with other studies showing the efficacy of BTX-A for treating pain in MPS. The evaluation of the psychologic dimension of this disorder and its associated disability can provide valuable information for the adequate management of these patients and for assessing treatment outcome.     

Physical Medicine and Rehabilitation (88)

Managing spasticity in pediatric cerebral palsy using a very low dose of botulinum toxin type A: preliminary report. (Chulalongkorn University Hospital, Bangkok, Thailand) Am J Phys Med Rehabil 2000;79:320–326.
This study was conducted to determine if very low doses of botulinum toxin type A (BTX-A) could reduce spasticity and improve gait in cerebral palsied children when combined with rehabilitation therapy. The trainable (IQ> 80), ambulatory, spastic diplegic or hemiplegic cerebral palsied children, with no fixed contractures in at least one limb, were selected for this study. Patients with a score of 3 on a modified Ashworth scale received 0.5 units of BTX-A/kg/muscle. Patients with an Ashworth score of 4 received 1.0 BTX-A/kg/muscle. After BTX-A injection, all patients received rehabilitation therapy and plastic ankle and foot orthoses for walking. Both groups exhibited improvement in Ashworth score and in gait within 72 h of injection with botulinum toxin. Beneficial effects persisted for 10 to 12 months in most patients, with 3 patients exhibiting benefits for at least 20 months. Conclude that a very low dose of BTX-A combined with rehabilitation therapy resulted in a long-lasting decrease in spasticity and an improvement in gait in children with cerebral palsy.     

Analgesic Effect of Botulinum Toxin A in Myofascial Pain Syndrome Patients Previously Treated with Local Infiltration of Anesthetic and Steroids

The purpose of this study was to evaluate the analgesic effect of botulinum toxin A (BoNTA) injections in patients with myofascial pain syndrome (MPS) who were previously treated with the local infiltration of anesthetic and steroids (LIAS). The study included a retrospective phase and a longitudinal open-label prospective phase, which were conducted on consecutive patients with MPS previously treated with the local infiltration of anesthetic (levobupivacaíne 0.25%) and steroids (triamcinolone 40 mg). Eligible patients were treated with a single intramuscular injection of BoNTA (Botox; Allergan, Inc., Irvine, CA). The treatment efficacy was determined according to the degree of pain relief obtained. Eighty-two patients met the inclusion/exclusion criteria and were included in the study. Successful results were obtained for 32 (39.0%) and 30 (36.6%) patients, during treatment with BoNTA and LIAS, respectively. The mean (standard deviation) length of the analgesic effect was significantly longer with BoNTA (29.6 [SD = 17.7] weeks) than with LIAS (8.5 [SD = 6.4] weeks), P <.0001. As regards the side effects, 19 (23.2%) patients reported transient soreness at the injection site for 2 to 3 days with BoNTA. The MPS patients previously treated with a local infiltration of anesthetic and steroids who then received a single injection of BoNTA experienced significantly reduced pain for a relatively long time.     

Randomized controlled trial of botulinum toxin A for chronic myogenous orofacial pain

The purpose of this study was to determine whether botulinum toxin A (BTX-A) was efficacious for the treatment of chronic moderate to severe jaw muscle pain in females. This was a randomized double-blind, placebo-controlled crossover trial of BTX-A. Twenty five units injected into each temporalis muscle and 50 U injected into each masseter muscle using three sites per muscle with 0.2 cm(3) per site. Data were collected at baseline, 8, 16, 24 weeks, with crossover occurring at 16 weeks. Primary outcome variables were pain intensity and unpleasantness, measured by horizontal visual analog scale (VAS). Secondary outcome variables were maximum interincisal opening without and irrespective of pain, muscle palpation tenderness (12 points), and four general questions. Fifteen female patients were enrolled (18-45 years), but only ten completed the trial. Of those who finished, no statistically significant difference was found in pain intensity (P=0.10), unpleasantness (P=0.40), palpation muscle tenderness (P=0.91), or the three general questions (P=0.64, P=0.66, P=0.67). Statistical significance was achieved for maximum opening without pain (P=0.02) and irrespective of pain (P=0.005) with the BTX-A arm having a relative decreased opening. No statistically significant difference was observed in any outcome measures except maximum opening, which showed BTX-A patient opening less wide than placebo. The results do not support the use of BTX-A in the treatment of moderate to severe jaw muscle pain in this patient population.     

Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: a randomized, controlled, double-blind multicenter study

Evidence of an effect by botulinum toxins is still lacking for most pain conditions. In the present randomized, placebo-controlled, crossover multicenter study, the efficacy of botulinum toxin type A (BTX-A) was investigated in patients with persistent myofascial temporomandibular disorders (TMD). Twenty-one patients with myofascial TMD without adequate pain relief after conventional treatment participated. A total of 50 U of BTX-A or isotonic saline (control) was randomly injected into 3 standardized sites of the painful masseter muscles. Follow-up was performed after 1 and 3 months, followed by a 1-month washout period, after which crossover occurred. Pain intensity at rest was the primary outcome measure, while physical and emotional function, global improvement, side effects, and clinical measures were additional outcome measures. There was no main difference between drugs (ANOVA; P = .163), but there was a significant time effect (P < .001), so BTX-A reduced mean (SD) percent change of pain intensity by 30 (33%) after 1 month and by 23 (30%) after 3 months compared to 11 (40%) and 4 (33%) for saline. The number of patients who received a 30% pain reduction was not significantly larger for BTX-A than after saline at any follow-up visit. The number needed to treat was 11 after 1 month and 7 after 3 months. There were no significant changes after treatment in any other outcome measures, with the exception of pain on palpation, which decreased 3 months after saline injection (P < .05). These results do not indicate a clinical relevant effect of BTX-A in patients with persistent myofascial TMD pain.     

Botulinum toxin type A in prophylactic treatment of migraine

Current migraine preventive therapies are often unsatisfactory because of their limited efficacy, adverse effects, and drug interactions. An open-label, non-controlled study of botulinum toxin type A (BTX-A) suggested some benefits for patients with migraine. To assess the efficacy and safety of BTX-A, a randomized, double-blind, vehicle-controlled, parallel group study was conducted in 32 patients with a history of 2 to 8 migraine attacks per month, with or without aura. The patients were randomized to receive single administrations of 50-U BTX-A or vehicle injected into multiple sites of pericranial muscles at the same visit. Patients kept daily diaries in which they recorded outcome measures like migraine frequency, migraine severity, and the occurrence of migraine-associated symptoms. Patients graded symptoms on a 4-point scale ranging from grades 0 to 3 before and up to 3-months after treatment. The assessments were made at 0, 1, and 3 months. The primary efficacy parameters included number of headaches resolved (grade 3/2 to grade 0) and alleviation of other accompanying symptoms of migraine. The supplementary end point included improvement in quality of life (QOL). About 75% of patients reported complete relief to mild headache (grade 0-1) by BTX-A and none by placebo group. Patient' QOL parameters like energy/vitality and feelings and concerns about the treatment had shown considerable improvement. However, normal day-to-day work functioning and social interactions deteriorated. No adverse effects were reported in any of the patients in either of the groups during the study. It is evident from the study that pericranial injection of 50-U BTX-A showed good efficacy and tolerability as a prophylactic agent. However, this therapy will be expensive to the patients, but it is far superior in providing relief to the patients compared with existing therapies.     

Botulinum toxin type A in pregnancy

Question My patient received 62 units of botulinum toxin type A (BTX-A) for facial lines. Two weeks later, she found out that she was pregnant. Will this cause any harm to her fetus?Answer Botulinum toxin is not expected to be present in systemic circulation following proper intramuscular or intradermal injection. Moreover, BTX-A, which has a high molecular weight, does not appear to cross the placenta. From the 38 pregnancies reported in the literature, including women who had botulism poisoning during pregnancy, exposure to BTX-A does not appear to increase the risk of adverse outcome in the fetus.     

Physical therapy and adjunctive botulinum toxin type A in the treatment of cervical headache: a double-blind, randomised, placebo-controlled study

We examined the efficacy of physical therapy and adjunctive botulinum toxin type A (BTX-A) injections in the treatment of cervical headache. We performed a doubleblind, randomised, placebo-controlled study over a 12-week period in a university clinic outpatients department. A total of 33 patients with cervical headache, diagnosed according to International Headache Society classification were enrolled. All patients received standardized physical therapy over a three-week period. Patients were randomised to receive either BTX-A (Botox) or placebo. The BTX-A group received a total dose of 90 mouse units (mu) BTX-A at six trigger points while the placebo group received saline. Pain characteristics were reported in a headache diary. Tenderness in the neck muscles, the sagittal range of motion and biofeedback measurement were also documented. Both groups showed significant improvement in terms of headache severity (p<0.05), number of headache-free days (p=0.005) and number of headache hours per day (p<0.05). Trends towards an increase in the number of headache-free days and a decrease in headache hours per day were observed in the BTX-A group. No major side effects were observed. Physical measures and BTX-A injections are safe and effective in the treatment of cervical headache. Received: 12 July 2001, Accepted in revised form: 1 July 2002 Correspondence to P. Schnider     

Botulinum Toxin Type A for Painful Temporomandibular Disorders: Systematic Review and Meta-Analysis

This systematic review investigated the effectiveness and safety of botulinum toxin type A (BTX-A) for painful temporomandibular disorders. We searched for randomized controlled trials (RCTs) in 10 databases, from inception to February 12, 2019 (MEDLINE, EMBASE, CENTRAL, LILACS, BBO, Web of Science, Scopus, ClinicalTrials.gov, WHO and OpenGrey). We included 12 RCTs that compared BTX-A versus inactive or active interventions. BTX-A was slightly more effective than placebo for pain reduction at 1 month: mean difference −1.74 points (0–10 scale), 95% confidence interval −2.94 to −.54, 3 RCTs, 60 participants, I-square (I²) = 0%. However, there were no significant differences at 3 and 6 months. BTX-A was similar to no treatment for pain reduction at 3 and 6 months. BTX-A was more effective than conventional treatment and low-level laser therapy for pain reduction at 1, 6, and 12 months, but less effective than facial manipulation for pain reduction at 3 months. BTX-A was not associated with a significant increase in the risk of adverse events. The quality of the evidence was low, and results are insufficient to support the use of BTX-A for painful temporomandibular disorders. High-quality RCTs are needed to increase confidence in effect estimates.PerspectiveBTX-A for painful temporomandibular disorders appears to be well tolerated. For pain reduction, BTX-A is slightly more effective than placebo only at 1 month; conventional treatment and low-level laser at 1, 6, and 12 months. Low-quality evidence limits the applicability of these findings and precludes recommendations for practice.     

A one-year retrospective economic evaluation of botulinum toxin type A treatment of chronic tension headache

Abstract The objective was to measure the impact of botulinum toxin type A (BTX-A) treatment on symptoms and medication utilisation patterns in patients with chronic tension-type headache. A retrospective chart analysis was completed in the Day Hospital of the Regional Referral Headache Centre at SantAndrea Hospital in Rome. Clinical charts were randomly selected for 100 patients treated from February 2002 to January 2003. Patients were treated with 100 U of BTX-A every three months for one year by using the Fixed Doses Fixed Sites procedure. Treatment outcome ranged from complete resolution of headache symptoms to a worsening of symptoms resulting in discontinuation. Headache medication use before and after treatment was analysed. After BTX-A treatment, 85% of patients experienced at least some degree of pain relief and reduced their use of analgesics. The reduced percentages of patients using a variety of headache medications after BTX-A treatment results from a reduction in their headache symptoms.     

Duration of effect of botulinum toxin type A in adult patients with cervical dystonia: a retrospective chart review

BACKGROUND: Clinical trials have established the efficacy and safety of botulinum toxin type A (BTX-A) in patients with cervical dystonia. To maintain the clinical benefits of BTX-A, injections need to be repeated whenever patients' symptoms begin to recur. OBJECTIVE: The purpose of this study was to determine, in clinical practice settings, the mean duration of effect of BTX-A in the treatment of adult patients with cervical dystonia. METHODS: A retrospective chart review was undertaken at an academic center and a private neurology practice. At each site, > or =50 patients being treated for cervical dystonia were identified and randomized for chart review. Patients had to have received the first assessable injection of BTX-A between January 1, 1998, and March 31, 1998, to coincide with the clinical availability of the most current formulation of the neurotoxin. A chart was eligible for review if the patient was aged > or =18 years, had a documented diagnosis of idiopathic cervical dystonia, was being treated with BTX-A, and had been under the continuous care of investigators from January 1, 1998, to August 31, 1999. Of the 102 patients initially identified, the first 30 from each site who met the study inclusion criteria were assessed for (1) age and sex; (2) severity of dystonia; (3) years of BTX-A use; (4) dates of first, second, third, and fourth BTX-A injections; (5) drug dose; (6) use of electromyography; (7) use of other prescribed therapies; (8) laboratory tests; and (9) adverse events. The mean interval between each visit and mean per-patient duration of effect were calculated and stratified by patient characteristics. RESULTS: The mean age of the patients was 56.4 years. Two thirds of the patients were women. Forty-one of the 60 patients (68.3%) had either moderate or severe disease, and 48 (80.0%) had experienced cervical dystonia for >5 years. The mean per-patient duration of effect across the 4 visits was 15.5 weeks (range, 12.2-24.3 weeks). The duration of effect did not differ significantly between study sites despite the differences in disease severity, drug dose, and use of adjunctive therapy. CONCLUSION: BTX-A the controls symptoms of cervical dystonia for 12 to 24 weeks, with a mean duration of effect per patient of 15.5 weeks.     

Severity and impact of xerostomia in patients treated with botulinum toxin type b for cervical dystonia: Observations on the quality of life of patients with xerostomia

Background: Although dry mouth (xerostomia) has been reported with botulinum toxin type B used as treatment for cervical dystonia, the impact of this adverse effect (AE) on patients' activities of daily living (ADLs) has not been assessed.tObjective: The aim of this study was to examine the severity, duration, and impact of xerostomia in patients with cervical dystonia who reported this AE in routine clinical practice following treatment with botulinum toxin type B.Methods: In this uncontrolled study, investigators at 5 study centers across the United States retrospectively identified patients who were diagnosed with cervical dystonia and had received ≥ 1 treatment with botulinum toxin type B injection and who had reported xerostomia, based on patients' charts. These patients were mailed a survey that included questions about their treatment history, disease severity, and xerostomia (severity, onset, duration, change with subsequent injections, and effects on dental and oral health), as well as an 8-item Patient Benefit Questionnaire (PBQ), which was designed to assess the impact of xerostomia symptoms on patients' ADLs.Results: A total of 45 patients received a mean of 2.91 injections with botulinum toxin type B (mean dose per injection, 11,958 U), with a total of 131 injections. The mean severity of patient-rated xerostomia following the first injection of botulinum toxin type B was 3.88 on a scale of 1 (mild) to 5 (severe), and this rating did not change for patients who received subsequent injections (mean, 3.76). Following atypical injection of botulinum toxin type B, xerostomia began a mean (SD) of 4.82 (3.32) days later and persisted for a mean (SD) duration of 5.56 (3.57) weeks. The overall mean score on the 10-point PBQ prior to botulinum toxin treatment was 8.89, which decreased to 5.42 following botulinum toxin type B injection (lower scores indicate more severe xerostomia).Conclusions: This study of patients with cervical dystonia suggests that patients who experience xerostomia following treatment with botulinum toxin type B injection, on average, rate their symptoms as moderate to severe and exhibit reduced scores on the PBQ—a questionnaire on which lower scores indicate greater negative impact of xerostomia on patients' ADLs.     

剪切波速度提高肌筋膜疼痛综合征患者疗效的价值初探

目的 探索剪切波速度（shear wave velocity, SWV）提高肌筋膜疼痛综合征（myofascial pain syndrome, MPS）患者治疗疗效的价值。方法 选择我院收治的MPS患者80例并定义为MPS组,同期选择健康志愿者80例作为对照组。采用视觉模拟评分(visual analogue scale, VAS)、疼痛评定指数(values of pain rating index, PRI)、现时疼痛强度 (present pain intensity, PPI)评估患者疼痛程度。使用声辐射力脉冲（acoustic radiation force impulse, ARFI）弹性成像观察斜方肌组织弹性并记录SWV值。MPS患者均接受6个疗程的常规治疗,之后将疗效达到显效及以上的患者根据患者自愿原则进行分组,继续以SWV作为疗效观察指标并进行治疗的定义为继续治疗组,不继续治疗的患者定义为停止治疗组。所有患者进行为期1年的随访,比较继续治疗组与停止治疗组治疗后复发率的差异。结果 治疗过程中患者VAS值和SWV值均呈下降趋势,其差异有统计学意义（FVAS=3.649,PVAS=0.000;FVAS=2.631,PVAS=0.018）。MPS患者整体治疗的显效率为78.8%。治疗后MPS患者的VAS 、PRI、PPI均显著低于治疗前,差异均具有统计学意义（均P＜0.05）。MPS组治疗后平均SWV（2.63±1.09 m/）显著低于治疗前（4.35±1.56 m/s）,差异具有统计学意义（t=8.084,P=0.000）。继续治疗组累计无复发率（93.33%）显著高于停止治疗组（61.29%）,Logrank检验差异有统计学意义（X2=8.760,P=0.003）。结论 ARFI的SWV值可以客观反应MPS患者病情的严重程度,利用SWV值作为疗效的判定标准可能可以获得更好的疗效。     

Normal Saline Trigger Point Injections vs Conventional Active Drug Mix for Myofascial Pain Syndromes

BackgroundMyofascial pain syndrome (MPS) originates in the muscle and fascia. MPS presents with referred pain specific for each muscle and a trigger point that reproduces the symptoms. Trigger-point-injection (TPI) is an effective approach to treating MPS. Some TPI agents, however, are associated with systemic and local side effects.ObjectiveThe aim of this study was to evaluate the effectiveness of TPI with a conventional active drug mixture (CADM) vs. that with normal saline solution (NS) alone in patients with MPS presenting to the emergency department (ED).MethodsAdults with MPS diagnosed in the ED, participants were randomly assigned to receive TPI with NS or with CADM. Pain intensity was scored using a 0–10 numeric rating scale prior to and after TPI, before discharge and 2 weeks after TPI.ResultsAmong 48 patients analyzed, 23 received TPI with NS. The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM). At 2-week follow up, the mean pain scores were 4.29 (NS) and 4.14 (CADM). Pain was significantly reduced after TPI in both groups. At 2 weeks, the mean pain scores were similar between the groups. No adverse events were reported.ConclusionIn cases of MPS in the ED, pain can be controlled with TPI independent of the injectate. TPI with NS may be preferred over CADM because of its lower cost and more favorable side effect profile.     

A型肉毒毒素治疗三叉神经痛和带状疱疹后神经痛的临床疗效

目的：观察A型肉毒毒素治疗三叉神经痛和带状疱疹后神经痛的临床效果。方法：选取33例三叉神经痛或带状疱疹后神经痛患者，进行疼痛区域A型肉毒毒素皮下或皮内注射治疗，评估患者治疗时、治疗2周后、治疗3个月后疼痛情况（NRS）、睡眠状况及生活质量（QOL），判断治疗效果，观察药物不良反应。结果：患者使用A型肉毒毒素治疗2周后、3个月后疼痛评分、睡眠评分显著低于治疗时（P<0.05），生活质量显著高于治疗时（P<0.05），治疗效果好，不良反应少。结论：A型肉毒毒素治疗三叉神经痛和带状疱疹后神经痛效果显著，可成为神经病理性疼痛治疗的一种新途径。     

Pain control in the week following laparoscopic surgery: A comparison of sustained-release ibuprofen and paracetamol

Summary. This study compared pain relief and adverse events from sustained-release ibuprofen and paracetamol administered for a week after laparoscopic cholecystectomy. Patients were randomly assigned to receive sustained-release ibuprofen (2 × 800 mg once daily) or paracetamol (2 × 500 mg PRN up to 4 hourly). Oxycodone tablets (5 mg) were available for rescue analgesia. Patients kept a pain diary for 1 week and were assessed by the investigators 24 h after surgery and at the surgical follow-up clinic. Patients receiving ibuprofen (n = 46) reported lower pain scores (scale 0–4, where 0 = no pain and 4 = unbearable pain) than those receiving paracetamol (n = 44) (mean 1.07 vs 1.35) and consumed less oxycodone (mean 0.83 vs 1.67 tablets). Although these differences were not statistically significant (P = 0.057 and P=0.12 respectively), the 95% confidence interval for the difference in mean pain scores was ?0.01 to +0.55 indicating that sustained-release ibuprofen was equivalent or superior to paracetamol. Nineteen patients who received ibuprofen reported a total of 33 adverse events compared to 13 patients receiving paracetamol who reported 18 adverse events (P=0.24). Sustained-release ibuprofen is as good as or better than paracetamol for the control of pain after laparoscopic surgery.     

Repeated treatments with botulinum toxin type a produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients

Elovic EP, Brashear A, Kaelin D, Liu J, Millis SR, Barron R, Turkel C. Repeated treatments with botulinum toxin type A produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients.

Objective

To assess the safety and evaluate the effects of repeated treatments with botulinum toxin type A (BTX-A) on functional disability, quality of life (QOL), and muscle tone of patients with upper-limb poststroke spasticity, as well as its effect on caregivers.

Design

Multicenter, open-label, repeated-dose study.

Setting

Thirty-five clinical sites in North America.

Participants

Patients (N=279) with upper-limb poststroke spasticity at 6 months or more poststroke.

Intervention

Up to 5 intramuscular injections of BTX-A (200-400U) divided among the wrist, finger, thumb, and elbow flexors, with at least 200U in the wrist and finger flexors. Retreatment was permitted at 12 weeks or more after the last treatment.

Main Outcome Measures

Investigators rated disability using the Disability Assessment Scale and muscle tone using the Ashworth Scale. Each patient's health-related QOL was assessed by using the Stroke Adapted Sickness Impact Profile and the visual analog scale of the European Quality of Life−5 Dimensions questionnaires.

Results

Patients treated with BTX-A reported improvements in muscle tone, disability, and ability to function that were statistically significant and clinically meaningful. Significant improvements were observed at week 30 and at subsequent time points in QOL in the overall group and the high-dose group.

Conclusions

Up to 5 treatments with BTX-A every 12 weeks for up to 56 weeks in patients with poststroke spasticity was well tolerated and significantly improved muscle tone, lessened disability, and improved patients' QOL. Further research is required to examine the effectiveness of repeated injections of BTX-A in patients with poststroke spasticity.