BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).
Identifieur interne : 004591 ( PubMed/Corpus ); précédent : 004590; suivant : 004592BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).
Auteurs : D D Truong ; P A Cullis ; C F O'Brien ; M. Koller ; T P Villegas ; J D WallaceSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 1997.
English descriptors
- KwdEn :
- Adult, Aged, Anti-Dyskinesia Agents (adverse effects), Anti-Dyskinesia Agents (immunology), Anti-Dyskinesia Agents (therapeutic use), Botulinum Toxins (adverse effects), Botulinum Toxins (immunology), Botulinum Toxins (therapeutic use), Botulinum Toxins, Type A (therapeutic use), Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Evaluation, Drug Resistance, Dystonia (drug therapy), Female, Humans, Injections, Intramuscular, Male, Middle Aged, Pain Measurement, Pilot Projects, Prospective Studies, Severity of Illness Index, Torticollis (drug therapy), Treatment Outcome.
- MESH :
- chemical , adverse effects : Anti-Dyskinesia Agents, Botulinum Toxins.
- chemical , immunology : Anti-Dyskinesia Agents, Botulinum Toxins.
- chemical , therapeutic use : Anti-Dyskinesia Agents, Botulinum Toxins, Botulinum Toxins, Type A.
- drug therapy : Dystonia, Torticollis.
- Adult, Aged, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Evaluation, Drug Resistance, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Pain Measurement, Pilot Projects, Prospective Studies, Severity of Illness Index, Treatment Outcome.
Abstract
Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open-label, dose-escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type-B treatment were reported. Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low-dose and high-dose groups, respectively. EFfectiveness was noted for the high-dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.
DOI: 10.1002/mds.870120526
PubMed: 9380065
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pubmed:9380065Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).</title><author><name sortKey="Truong, D D" sort="Truong, D D" uniqKey="Truong D" first="D D" last="Truong">D D Truong</name><affiliation><nlm:affiliation>Parkinson and Movement Disorders Program, Irvine, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cullis, P A" sort="Cullis, P A" uniqKey="Cullis P" first="P A" last="Cullis">P A Cullis</name></author><author><name sortKey="O Brien, C F" sort="O Brien, C F" uniqKey="O Brien C" first="C F" last="O'Brien">C F O'Brien</name></author><author><name sortKey="Koller, M" sort="Koller, M" uniqKey="Koller M" first="M" last="Koller">M. Koller</name></author><author><name sortKey="Villegas, T P" sort="Villegas, T P" uniqKey="Villegas T" first="T P" last="Villegas">T P Villegas</name></author><author><name sortKey="Wallace, J D" sort="Wallace, J D" uniqKey="Wallace J" first="J D" last="Wallace">J D Wallace</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1997">1997</date><idno type="RBID">pubmed:9380065</idno><idno type="pmid">9380065</idno><idno type="doi">10.1002/mds.870120526</idno><idno type="wicri:Area/PubMed/Corpus">004591</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).</title><author><name sortKey="Truong, D D" sort="Truong, D D" uniqKey="Truong D" first="D D" last="Truong">D D Truong</name><affiliation><nlm:affiliation>Parkinson and Movement Disorders Program, Irvine, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cullis, P A" sort="Cullis, P A" uniqKey="Cullis P" first="P A" last="Cullis">P A Cullis</name></author><author><name sortKey="O Brien, C F" sort="O Brien, C F" uniqKey="O Brien C" first="C F" last="O'Brien">C F O'Brien</name></author><author><name sortKey="Koller, M" sort="Koller, M" uniqKey="Koller M" first="M" last="Koller">M. Koller</name></author><author><name sortKey="Villegas, T P" sort="Villegas, T P" uniqKey="Villegas T" first="T P" last="Villegas">T P Villegas</name></author><author><name sortKey="Wallace, J D" sort="Wallace, J D" uniqKey="Wallace J" first="J D" last="Wallace">J D Wallace</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="1997" type="published">1997</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Anti-Dyskinesia Agents (adverse effects)</term><term>Anti-Dyskinesia Agents (immunology)</term><term>Anti-Dyskinesia Agents (therapeutic use)</term><term>Botulinum Toxins (adverse effects)</term><term>Botulinum Toxins (immunology)</term><term>Botulinum Toxins (therapeutic use)</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Evaluation</term><term>Drug Resistance</term><term>Dystonia (drug therapy)</term><term>Female</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Pilot Projects</term><term>Prospective Studies</term><term>Severity of Illness Index</term><term>Torticollis (drug therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term><term>Botulinum Toxins, Type A</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dystonia</term><term>Torticollis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Evaluation</term><term>Drug Resistance</term><term>Female</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Pilot Projects</term><term>Prospective Studies</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open-label, dose-escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type-B treatment were reported. Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low-dose and high-dose groups, respectively. EFfectiveness was noted for the high-dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">9380065</PMID><DateCreated><Year>1997</Year><Month>11</Month><Day>07</Day></DateCreated><DateCompleted><Year>1997</Year><Month>11</Month><Day>07</Day></DateCompleted><DateRevised><Year>2010</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>12</Volume><Issue>5</Issue><PubDate><Year>1997</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).</ArticleTitle><Pagination><MedlinePgn>772-5</MedlinePgn></Pagination><Abstract><AbstractText>Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open-label, dose-escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type-B treatment were reported. Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low-dose and high-dose groups, respectively. EFfectiveness was noted for the high-dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Truong</LastName><ForeName>D D</ForeName><Initials>DD</Initials><AffiliationInfo><Affiliation>Parkinson and Movement Disorders Program, Irvine, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cullis</LastName><ForeName>P A</ForeName><Initials>PA</Initials></Author><Author ValidYN="Y"><LastName>O'Brien</LastName><ForeName>C F</ForeName><Initials>CF</Initials></Author><Author ValidYN="Y"><LastName>Koller</LastName><ForeName>M</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Villegas</LastName><ForeName>T P</ForeName><Initials>TP</Initials></Author><Author ValidYN="Y"><LastName>Wallace</LastName><ForeName>J D</ForeName><Initials>JD</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>UNITED STATES</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018726">Anti-Dyskinesia Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D001905">Botulinum Toxins</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D019274">Botulinum Toxins, Type A</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018726">Anti-Dyskinesia Agents</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000276">immunology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001905">Botulinum Toxins</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000276">immunology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019274">Botulinum Toxins, Type A</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004334">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004341">Drug Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004351">Drug Resistance</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004421">Dystonia</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007273">Injections, Intramuscular</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010147">Pain Measurement</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010865">Pilot Projects</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011446">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D014103">Torticollis</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>1997</Year><Month>9</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1997</Year><Month>9</Month><Day>26</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1997</Year><Month>9</Month><Day>26</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">9380065</ArticleId><ArticleId IdType="doi">10.1002/mds.870120526</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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