今日の臨床サポート

眼瞼けいれん

著者: 若倉雅登 井上眼科病院

監修: 沖波聡 倉敷中央病院眼科

著者校正/監修レビュー済:2022/08/31
参考ガイドライン:
  1. 日本神経眼科学会:眼瞼けいれん診療ガイドラインVer.2(2022,in press)
患者向け説明資料

概要・推奨   

  1. 眼瞼けいれんは、神経学的には局所ジストニアに属し、臨床的説明としては「眼輪筋のれん縮による不随意的閉瞼」がその本質である。
  1. 症状としては3つの柱からなり、①運動異常としての開瞼困難、瞬目異常、②感覚異常(感覚過敏)としての羞明、眼不快感、乾燥感など、さらに、③精神神経異常として抑うつ、焦燥、不安、不眠が症例により種々の程度で出現する。
  1. 従来の疾患概念としては①は必須と考えられていたが、①が目立たないまたは欠く例で②、③が全面に出る例がある。これを本症として考えるか、別に分類するかは議論がある。
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
若倉雅登 : 特に申告事項無し[2022年]
監修:沖波聡 : 特に申告事項無し[2022年]

改訂のポイント:
  1. 眼瞼けいれん診療ガイドラインVer.2(2022)に基づいてアップデートした。

病態・疫学・診察

疫学情報・病態・注意事項  
  1. 眼瞼けいれんは、神経学的には局所ジストニアに属し、臨床的説明としては「眼輪筋のれん縮による不随意的閉瞼」がその本質である。症状としては3つの柱からなり、①運動異常としての開瞼困難、瞬目異常、②感覚異常(感覚過敏)としての羞明、眼不快感、乾燥感など、さらに、③精神神経異常として抑うつ、焦燥、不安、不眠が症例により種々の程度で出現する。
  1. 従来の疾患概念としては①は必須と考えられていたが、①が目立たないまたは欠く例で②、③が前面に出る例がある。これを本症として考えるか、別に分類するかは議論がある[1]
  1. 本症は、本態性、薬物性、症候性に分けられ、男女比はおよそ1:2~2.5、40~50歳以上に多く、軽症例に対する理解が深まり、決してまれな疾患でないことが認識されてきている[2]
  1. 重症例では、眼周囲、口輪筋など口の開閉に関わる筋や、笑筋、舌、咽頭、頚部筋にまで及ぶ不随意運動、つまりジストニアがみられ、Meige症候群と呼ぶことがある。
 
  1. 発症のメカニズム
  1. 眼瞼ジストニアでは特に視床において有意な糖代謝亢進がみられたとする研究[3][4]があり、特に本症の愁訴として非常に高頻度である羞明の原因は視床にある可能性があり、中枢性羞明と考えられる。本症の機能画像研究からは、視床のみならず、広義の基底核(尾状核、被殻、淡蒼球、黒質、視床下核)複合体と補足運動野、視覚野、前部帯状回など大脳皮質とで形成されるサーキットの異常が報告されている[5]
 
  1. 薬物性とは(参考文献:[6]
  1. 遅発性ジスキネジアと同じスペクトラムの局所型と位置づけられるが[7]、遅発性ジストニアでは主として抗精神病薬の長期投与が原因であるのに対して、薬物性眼瞼けいれんでは、そうした薬物[8]に加え、特に日本では、抗不安薬、睡眠導入薬での報告が多くなっている[9][10]。しかも、その減量、中止により改善する例も確実に存在する[11]。なお、薬物性では、発症年齢が10~40歳代の症例など若年発症も少なくない。
 
  1. 薬物以外の危険因子について
  1. 実証的研究はあまり進んでいないが、家族性[12]や、環境化学物質[13]、また精神的ストレスの存在[14]を指摘するものもある。
  1. また、日常においても精神状態と症状との関係は深く、ガイドラインでも、「特に好ましくないことを想起したり、好ましくない人と接すると悪化することが多い」と指摘している。
問診・診察のポイント  
  1. 表情は、重症例では眼周囲、眉間、鼻根に皺を寄せて、まぶしそうな「しかめ面」をしている(<図表>)。開瞼しようとしても開瞼できないか、眼周囲の筋肉が不随意に動き(ジストニア)、開瞼が困難である。しかし、中等症以下では、このような表情が診察室でみられることは少ないので、表情からの診断は難しい。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

最新のエビデンスに基づいた二次文献データベース「今日の臨床サポート」。
常時アップデートされており、最新のエビデンスを各分野のエキスパートが豊富な図表や処方・検査例を交えて分かりやすく解説。日常臨床で遭遇するほぼ全ての症状・疾患から薬剤・検査情報まで瞬時に検索可能です。

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文献 

Yukihisa Suzuki, Shoichi Mizoguchi, Motohiro Kiyosawa, Manabu Mochizuki, Kiichi Ishiwata, Masato Wakakura, Kenji Ishii
Glucose hypermetabolism in the thalamus of patients with essential blepharospasm.
J Neurol. 2007 Jul;254(7):890-6. doi: 10.1007/s00415-006-0468-5. Epub 2007 Feb 26.
Abstract/Text Essential blepharospasm (EB) is classified as a form of focal dystonia characterized by involuntary spasms of the musculature of the upper face. The basic neurological process causing EB is not known. The purpose of this study was to investigate cerebral glucose metabolism in patients with EB whose symptoms were suppressed by an injection of botulinum-A toxin. Earlier studies were confounded by sensory feedback activities derived from dystonic symptom itself. Cerebral glucose metabolism was examined by positron emission tomography (PET) with (18)F-fluorodeoxyglucose (FDG) in 25 patients (8 men and 17 women; age 52.6 +/- 10.1 years) with EB. The patients were awake but with the spasms suppressed by an injection of botulinum-A toxin. Thirty-eight normal volunteers (14 men and 24 women; age 58.2 +/- 7.3 years) were examined as controls. The difference between the two groups was examined by statistical parametric mapping (SPM99). A significant increase in the glucose metabolism was detected in the thalamus and pons in the EB patients. Hyperactivity in the thalamus may be a key pathophysiological change common to EB and other types of focal dystonia. The activity of the striatum and cerebellum are likely to be sensory dependent.

PMID 17325818
Hirofumi Emoto, Yukihisa Suzuki, Masato Wakakura, Chiharu Horie, Motohiro Kiyosawa, Manabu Mochizuki, Keiichi Kawasaki, Keiichi Oda, Kiichi Ishiwata, Kenji Ishii
Photophobia in essential blepharospasm--a positron emission tomographic study.
Mov Disord. 2010 Mar 15;25(4):433-9. doi: 10.1002/mds.22916.
Abstract/Text To localize regional alterations in cerebral glucose metabolism in essential blepharospasm (EB) patients with photophobia. We have studied 22 EB patients by performing positron emission tomography and [(18)F]-fluorodeoxyglucose analysis. The patients were classified into two subgroups, namely, EB with photophobia (P group) and EB without photophobia (NP group), and compared with a healthy control group (n = 44). There were no significant differences between the two patient groups with respect to the severity of motor symptoms or the duration for which the condition persisted. The FDG-PET images were analyzed using the statistical parametric mapping software. As compared to the control group, the P group exhibited significant hypermetabolism in the thalamus (P = 0.002), while the NP group exhibited significant hypometabolism in the dorsal midbrain, especially, in the superior colliculus (P = 0.005). The P group exhibited significant hypermetabolism in the thalamus and the dorsal midbrain as compared to the NP group (P < 0.001). These findings suggest that photophobia in EB patients may be associated with abnormal hyperactivity in the thalamus. Either hyperactivity of the thalamus or hypoactivity of the superior colliculus, or both may be associated with excessive blinking in these patients.

PMID 20014062
M Wakakura, A Yamagami, M Iwasa
Blepharospasm in Japan: A Clinical Observational Study From a Large Referral Hospital in Tokyo.
Neuroophthalmology. 2018 Oct;42(5):275-283. doi: 10.1080/01658107.2017.1409770. Epub 2018 Jan 9.
Abstract/Text Focal dystonia is regarded as a characteristic feature of blepharospasm. However, patients do not always present with motor symptoms. To clarify the clinical features of blepharospasm in Japan, we conducted a retrospective observational study involving a large population of patients from a single institution. Common symptoms included difficulty opening the eyes, photophobia, and ocular pain/irritation. Initial symptoms often occurred following the long-term use of psychotropics such as etizoram, benzodiazepines, and zolpidem (32% of patients). Our findings demonstrated that the clinical presentation of blepharospasm is heterogenous, and that understanding regarding sensory-dominant forms of the disease may be poor among practitioners in Japan.

PMID 30258472
Pratibha G Aia, Gonzalo J Revuelta, Leslie J Cloud, Stewart A Factor
Tardive dyskinesia.
Curr Treat Options Neurol. 2011 Jun;13(3):231-41. doi: 10.1007/s11940-011-0117-x.
Abstract/Text OPINION STATEMENT: Tardive dyskinesia (TD) is iatrogenic (drug-induced); hence the best strategy is prevention. Try to limit exposure to any dopamine receptor blocking agents (DRBAs) if possible. These agents may be unavoidable in some psychiatric conditions such as schizophrenia, but alternative therapies can be used in many situations, such as in the treatment of depression, anxiety, gastrointestinal conditions, and other neurologic conditions, including migraines and sleep disorders. When DRBAs are necessary, physicians should prescribe the smallest possible dose and try to taper and stop the drug at the earliest signs of TD. Abrupt cessation should be avoided, as this can worsen symptoms of TD. Always discuss and document the possibility of TD as an adverse effect when starting patients on DRBAs. If TD is mild and tolerable, the withdrawal of the offending agent is possible, and exposure to DRBAs was short, physicians should consider avoiding treatment and waiting for spontaneous recovery. When treatment is necessary, tetrabenazine (TBZ) is considered a potential first-line agent and is known to be one of the most effective drugs in treating TD, but it is expensive and adverse effects such as depression, akathisia and parkinsonism frequently occur. Therefore, second-line agents with better tolerability profiles are often tried first in practice. These include amantadine, benzodiazepines, beta-blockers, and levetiracetam. When using TBZ, adverse effects should be aggressively monitored. (Depression often can be managed with antidepressants, for instance). In patients with psychosis, withdrawal of the antipsychotic may not be possible. Switching to clozapine or quetiapine is one option to minimize TD. When these agents are contraindicated and the patient must continue using other atypical antipsychotic drugs, try to add dopamine-depleting agents such as TBZ or reserpine, but watch for the development of parkinsonism. When the symptoms are focal, such as tongue protrusion or blepharospasm, botulinum toxin injections can be very effective if spontaneous recovery does not occur. As a last resort, when disabling, life-threatening symptoms of TD persist despite all of the above-mentioned methods, some advocate resuming treatment with the DRBA to suppress symptoms of TD. This has the potential to worsen TD in the long run.

PMID 21365202
J A Mauriello, P Carbonaro, S Dhillon, T Leone, M Franklin
Drug-associated facial dyskinesias--a study of 238 patients.
J Neuroophthalmol. 1998 Jun;18(2):153-7.
Abstract/Text UNLABELLED: The purpose of this study was to determine whether antidepressant, antimania, antipsychotic, antihistamine, or antiparkinsonian drugs are associated with eyelid and facial dyskinesias; whether discontinuing such drugs results in improvement in the facial dyskinesias; and whether response to botulinum toxin treatment is influenced by such medications.
METHODS: A retrospective review was performed on a population of 238 patients with presumed benign essential blepharospasm and Meige syndrome. Types of drugs taken before the development of disease and clinical response to botulinum toxin injections were studied.
RESULTS: Fourteen of 238 patients (5.9%) with facial dyskinesias had been prescribed a variety of antidepressants, antimania medications, antipsychotics, antihistamines, antiparkinsonian drugs, or a combination of these substances before their condition developed. The onset of blepharospasm varied from 2 months to 35 years after administration of the drug. Three of seven patients who discontinued the presumed responsible drug had improvement in their facial dyskinesias. Of the 11 patients who did not improve when their drugs were stopped or whose medication could not be stopped, all but one patient had a good response to treatment with botulinum toxin A.
CONCLUSIONS: Drug-induced blepharospasm should be considered in all patients who present with facial dyskinesias, and such patients should undergo withdrawal of the medication when possible. When withdrawal of medication is not possible or does not result in improvement in the facial dyskinesia, treatment with botulinum toxin injections should be initiated. The possible role in the production of facial dyskinesias of antidepressants that block reuptake of serotonin requires further evaluation.

PMID 9621275
M Wakakura, T Tsubouchi, J Inouye
Etizolam and benzodiazepine induced blepharospasm.
J Neurol Neurosurg Psychiatry. 2004 Mar;75(3):506-7. doi: 10.1136/jnnp.2003.019869.
Abstract/Text
PMID 14966178
Yuko Emoto, Hirofumi Emoto, Eriko Oishi, Syunichi Hikita, Masato Wakakura
Twelve cases of drug-induced blepharospasm improved within 2 months of psychotropic cessation.
Drug Healthc Patient Saf. 2011;3:9-14. doi: 10.2147/DHPS.S20691. Epub 2011 Jun 3.
Abstract/Text BACKGROUND: To determine whether psychotropic cessation in patients with drug-induced blepharospasm improves motor symptoms.
METHODS: In patients with drug-induced blepharospasm, we withdrew part or all of their psychotropic medication and assessed motor symptoms using the Jankovic rating scale (0 = none, 1 = noticeable, 2 = mild, 3 = moderate, 4 = severe) at first presentation and after cessation.
RESULTS: Twelve patients (eleven women and one man, mean age 60.4 years) were enrolled. Psychotropics were administered before the onset of blepharospasm in all patients. The mean duration of treatment with psychotropic medication was 47.3 (range 3-120) months. Jankovic rating scale at initial presentation was 3 in eleven patients and 2 in one patient. After cessation, blepharospasm started to improve in all cases within 2 months (average 3.9 weeks). While the effect of psychotropic cessation was variable, the symptoms eventually improved to more than 2 on the rating scale. Three of the twelve patients underwent a single botulinum neurotoxin injection and were withdrawn from therapy after cessation.
CONCLUSION: Psychotropic drugs can cause blepharospasm in some cases. Clinicians should consider reducing psychotropic medication as far as possible in patients with blepharospasm taking these agents.

PMID 21753898
G Defazio, D Martino, M S Aniello, G Masi, G Abbruzzese, S Lamberti, E M Valente, F Brancati, P Livrea, A Berardelli
A family study on primary blepharospasm.
J Neurol Neurosurg Psychiatry. 2006 Feb;77(2):252-4. doi: 10.1136/jnnp.2005.068007.
Abstract/Text BACKGROUND: Previous family studies provided evidence that blepharospasm (BSP) can aggregate in families but did not give accurate and reliable information on the characteristics and degree of familial clustering.
AIM: To evaluate the proportion of familial and non-familial BSP cases, the clinical expression of dystonia within families, the inheritance pattern, and the extent of penetrance.
METHODS: The study was based on the examination of the first degree relatives of 56 probands with primary BSP.
RESULTS: The 56 families produced a potential population of 436 first degree relatives of whom 296 were alive and 233 were examined. The proportion of index patients with at least one first degree relative affected by BSP, or adult onset dystonia other than BSP, was 27%. There was a remarkable degree of phenotypic variability of dystonia within families. Similar segregation ratios were calculated for probands' siblings and children. Under the assumption of autosomal dominant transmission of adult onset dystonia, penetrance was about 20%.
CONCLUSIONS: The findings of this family study are relevant for accurately counselling the families of patients with BSP and may help identify the most appropriate study design to explore genetic susceptibility in BSP.

PMID 16421132
Lenworth N Johnson, Ryan W Lapour, Gabriella M Johnson, Patricia J Johnson, Richard W Madsen, Steven A Hackley
Closely spaced stressful life events precede the onset of benign essential blepharospasm and hemifacial spasm.
J Neuroophthalmol. 2007 Dec;27(4):275-80. doi: 10.1097/WNO.0b013e31815c4233.
Abstract/Text BACKGROUND: The purpose of this study was to assess the possible role of major stressful life events, complicated grief, and depression in the pathogenesis of benign essential blepharospasm (BEB) and hemifacial spasm (HFS).
METHODS: This was a case-control study involving 23 participants with BEB/HFS and 23 control subjects, comparing the frequency of major stressful life events, depression on the Beck Depression Inventory-II, and complicated grief on the Inventory of Complicated Grief.
RESULTS: There was no difference in the rate of depression or complicated grief between participants with BEB/HFS (57%) and control subjects (48%). Participants with BEB/HFS experienced a significantly (P = 0.0048) shorter time interval between two major stressful life events (median, 0.3 year) than did the control group (median, 3.0 years). The proportion of participants who had suffered two major stressful lifetime events separated by 1 year or less was significantly greater for participants with BEB/HFS than for control subjects (P = 0.0007).
CONCLUSIONS: The onset of BEB and HFS was often preceded by a major lifetime stressor. The development of these conditions was significantly related to the number of stressful life events occurring within the preceding year rather than to the total number of stressful life events. Subjects who sustain closely spaced stressful life events may be at increased risk of developing BEB and HFS.

PMID 18090560
K Tsubota, T Fujihara, M Kaido, A Mori, M Mimura, M Kato
Dry eye and Meige's syndrome.
Br J Ophthalmol. 1997 Jun;81(6):439-42. doi: 10.1136/bjo.81.6.439.
Abstract/Text AIMS: To determine the relation between dry eye and Meige's syndrome.
METHODS: 325 patients with dry eye were divided into those responsive to topical and other forms of treatment (n = 276) and those who were not (n = 49). A neuropsychiatric examination was performed to check for Meige's syndrome in the latter group.
RESULTS: Twenty eight (57%) of the treatment unresponsive patients were diagnosed with Meige's syndrome.
CONCLUSIONS: There is a subgroup of patients with dry eye who do not respond to simple therapy. More than half of these patients have Meige's syndrome and need psychiatric, as well as ophthalmic, care.

PMID 9274405
Susan Vitale, Neil R Miller, Luis J Mejico, Julian D Perry, Marianne Medura, Suzanne K Freitag, Christopher Girkin
A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome.
Am J Ophthalmol. 2004 Jul;138(1):18-32. doi: 10.1016/j.ajo.2004.02.062.
Abstract/Text PURPOSE: To evaluate the effectiveness of super blue-green algae (SBGA) supplements on the severity of essential blepharospasm treated with botulinum toxin A injections.
DESIGN: Double-masked, placebo-controlled, two-period, crossover randomized trial.
PATIENTS AND METHODS: The study was carried out in patients with essential blepharospasm or Meige syndrome undergoing routine treatment with botulinum toxin A injections.
INTERVENTION: Patients were randomly assigned to either SBGA capsules or placebo. After 6 months of treatment, patients underwent a 6-month washout period with no treatment, then were administered the alternate treatment for an additional 6 months, thus serving as their own controls.
MAIN OUTCOME MEASURES: Video documentation of blink rate and involuntary facial movements, time between botulinum toxin A injections, and patients' subjective assessment of the impact of blepharospasm on functioning were obtained at the beginning and end of the first and second (crossover) treatment periods.
RESULTS: A total of 24 patients (10 men, 14 women; aged 42 to 83 years) completed both treatment periods. Mean within-patient difference in blink rate between SBGA and placebo periods was -2.1 blinks per 2 minutes (95% confidence interval [CI]: -20.8-+31.9), not statistically different from zero (P =.83). Mean within-patient difference in time between injections between SBGA and placebo periods was 4.6 days (95% CI: -13.3-+22.5), not statistically different from zero (P =.62). The lack of statistical significance may have been because of small sample size. There were no significant differences in severity of involuntary movement between SBGA and placebo treatment periods. However, patients were more likely to report limitation in function during the period they took SBGA than during the period they took placebo (odds ratio, 0.2; P =.03).
CONCLUSION: Overall, we found no evidence of a beneficial effect of SBGA as an adjunct to botulinum toxin A injections; however, a few patients, all younger than 60 years, did appear to benefit from SBGA.

PMID 15234278
Marcus K Blackburn, Randy D Lamb, Kathleen B Digre, A Gordon Smith, Judith E A Warner, Robert W McClane, Sanjeev D Nandedkar, Wendy J Langeberg, Richard Holubkov, Bradley J Katz
FL-41 tint improves blink frequency, light sensitivity, and functional limitations in patients with benign essential blepharospasm.
Ophthalmology. 2009 May;116(5):997-1001. doi: 10.1016/j.ophtha.2008.12.031.
Abstract/Text OBJECTIVE: The objective of these 2 studies was to assess the efficacy of FL-41-tinted lenses in the treatment of benign essential blepharospasm (BEB).
DESIGN: A randomized crossover study and a randomized crossover case-control study.
PARTICIPANTS: The first study included 30 subjects with BEB. The second study included 26 subjects with BEB and 26 controls.
METHODS: For the first study, subjects were randomized to wear either FL-41 or gray-tinted lenses for 2 weeks. After a 2-week washout period, the other lens was worn for 2 weeks. Questionnaires were completed at baseline, after the first lens, and after the second lens. In the second study, surface electromyography (EMG) was used to measure blink frequency, duration, and force while subjects read and wore FL-41, rose, or gray-tinted lenses.
MAIN OUTCOME MEASURES: Questionnaires were used to assess perceptions of light sensitivity and the effect of light sensitivity on activities of daily living (ADL). EMG was used to measure blink frequency, duration, and force.
RESULTS: Most participants observed improvement while wearing both FL-41 and gray-tinted lenses. FL-41-tinted lenses provided superior improvement in the areas of reading, fluorescent light sensitivity, overall light sensitivity, blepharospasm frequency, and blepharospasm severity. FL-41 lenses reduced mean blink rate compared with both rose and gray-tinted lenses, and reduced eyelid contraction force compared with rose-tinted lenses.
CONCLUSIONS: FL-41 lenses provided both subjective and objective benefit to subjects with BEB. Physicians should consider recommending this noninvasive and inexpensive lens tint to patients with BEB.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

PMID 19410958
J A Mauriello, S Dhillon, T Leone, B Pakeman, R Mostafavi, M C Yepez
Treatment selections of 239 patients with blepharospasm and Meige syndrome over 11 years.
Br J Ophthalmol. 1996 Dec;80(12):1073-6.
Abstract/Text BACKGROUND: A retrospective review of 239 patients with benign essential blepharospasm and Meige syndrome was performed in order to determine patients' long term treatment preferences.
METHODS: Of 239 patients evaluated, 228 received local injections of botulinum toxin, type A, into the eyelid and facial musculature over 11 years.
RESULTS: Of 228 patients, 202 (72.1%) were still treated with botulinum toxin, type A. Eighteen patients (6.9%) no longer received botulinum toxin injections and sought no other treatment. Five patients (2.2%) had apparent remission of their disease after injection. Three patients (1.3%) ultimately obtained relief from orbicularis muscle extirpative surgery and required no additional treatment. Two of the 11 patients (4.6%) who chose not to receive botulinum toxin injections were successfully treated with other modalities: psychotherapy (one patient) and oral haloperidol (one patient).
CONCLUSION: While botulinum toxin is the most highly effective treatment for benign essential blepharospasm and Meige syndrome over a long period of time, adjunctive oral drug therapy, including minor tranquillisers as well as eyelid surgery, may augment its effectiveness.

PMID 9059273
Markus Naumann, Joseph Jankovic
Safety of botulinum toxin type A: a systematic review and meta-analysis.
Curr Med Res Opin. 2004 Jul;20(7):981-90. doi: 10.1185/030079904125003962.
Abstract/Text OBJECTIVE: To define quantitatively the safety and tolerability profile of botulinum toxin type A (BTX-A) across all common therapeutic indications. The review was limited to the evaluation of the safety profile of one preparation of BTX-A (BOTOX) because distinct formulations of BTX-A are associated with different clinical profiles, requiring separate consideration for an analysis of safety.
RESEARCH DESIGN AND METHODS: We identified randomized controlled trials of BTX-A through searches of the MEDLINE, EMBASE, and Cochrane Controlled Trial databases for the years 1966-2003. Studies were double-blind, randomized, crossover, or of parallel group design. The search strategy included the terms 'botulinum toxin', 'therapeutic use', 'randomized controlled trial', 'controlled clinical trial', 'randomized clinical trial', and 'placebo controlled trial'. Only randomized controlled trials of at least 7 days duration that reported adverse events were included in the analysis.
MAIN OUTCOME MEASURE: Safety was assessed by means of a meta-analysis of the number and frequency of adverse events.
RESULTS: Thirty-six studies involving 2309 subjects met the inclusion criteria. These reported on 1425 subjects receiving BTX-A treatment. No study reported any severe adverse events. The meta-analysis of any mild to moderate adverse events showed a rate of roughly 25% in the BTX-A-treated group (353/1425 patients) compared with 15% in the control group (133/884 patients, p < 0.001). Focal weakness was the only adverse event that occurred significantly more often with BTX-A treatment than control.
CONCLUSION: The results of this meta-analysis and experience from long-term, open-label investigations demonstrate that the formulation of BTX-A evaluated here has a favorable safety and tolerability profile across a broad spectrum of therapeutic uses.

PMID 15265242

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