Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study

被引：15

作者：

Patti, Francesco ^{[1
]}

Chisari, Clara Grazia ^{[1
]}

Solaro, Claudio ^{[2
,3
]}

Benedetti, Maria Donata ^{[4
]}

Berra, Eliana ^{[5
]}

Bianco, Assunta ^{[6
]}

Bossio, Roberto Bruno ^{[7
,8
]}

Buttari, Fabio ^{[9
]}

Castelli, Letizia ^{[10
]}

Cavalla, Paola ^{[11
]}

Cerqua, Raffaella ^{[12
]}

Costantino, Gianfranco ^{[13
]}

Gasperini, Claudio ^{[14
]}

Guareschi, Angelica ^{[15
]}

Ippolito, Domenico ^{[16
]}

Lanzillo, Roberta ^{[17
]}

Maniscalco, Giorgia Teresa ^{[18
]}

Matta, Manuela ^{[19
,20
]}

Paolicelli, Damiano ^{[21
]}

Petrucci, Loredana ^{[22
]}

Pontecorvo, Simona ^{[23
]}

Righini, Isabella ^{[24
]}

Russo, Margherita ^{[25
]}

Sacca, Francesco ^{[17
]}

Salamone, Giovanna ^{[26
]}

Signoriello, Elisabetta ^{[27
]}

Spinicci, Gabriella ^{[28
]}

Spitaleri, Daniele ^{[29
]}

Tavazzi, Eleonora ^{[30
]}

Trotta, Maria ^{[31
]}

Zaffaroni, Mauro ^{[32
]}

Zappia, Mario ^{[1
]}

机构：

[1] Univ Catania, Dept GF Ingrassia, Sect Neurosci, Catania, Italy

[2] ML Novarese Hosp Moncrivello, Dept Neurol, ASL3 Genovese, Genoa, Italy

[3] ML Novarese Hosp Moncrivello, Dept Rehabil, Genoa, Italy

[4] Univ Verona, Dept Neurosci Biomed & Movement Sci, Sect Neurol, Verona, Italy

[5] Neurol Inst C Mondino, Neurorehabil Unit, Dept Neurol, Pavia, Italy

[6] Fdn Policlin Univ A Gemelli IRCCS, Multiple Sclerosis Unit, Rome, Italy

[7] Prov Hlth Author Cosenza, Neurol Operating Unit, Cosenza, Italy

[8] Prov Hlth Author Cosenza, Multiple Sclerosis Ctr, Cosenza, Italy

[9] Tor Vergata Univ, Dept Syst Med, Synapt Immunopathol Lab, Rome, Italy

[10] IRCCS Fdn Don Carlo Gnocchi, Neurol Unit, Milan, Italy

[11] Hlth & Sci City Univ Hosp Turin, Multiple Sclerosis Ctr, Dept Neurosci & Mental Hlth, Turin, Italy

[12] Marche Polytech Univ, Dept Expt & Clin Med, Neurol Clin, Ancona, Italy

[13] Foggia Hosp, Demyelinating Dis Ctr, Foggia, Italy

[14] San Camillo Forlanini Hosp, Multiple Sclerosis Ctr, Rome, Italy

[15] Fidenza Hosp, Multiple Sclerosis Ctr, Med Dept, Fidenza, PR, Italy

[16] Univ Campania Luigi Vanvitelli, Dept Adv Med & Surg Sci, Naples, Italy

[17] Univ Federico II, Dept Neurosci Reprod & Odontostomatol Sci, Naples, Italy

[18] Osped Cardarelli, Dept Neurol, Naples, Italy

[19] San Luigi Gonzaga Univ Hosp, CReSM Reg Referring Ctr Multiple Sclerosis, Neurobiol Unit, Neurol 2, Orbassano, TO, Italy

[20] NICO, Orbassano, TO, Italy

[21] Univ Bari Aldo Moro, Dept Basic Med Sci Neurosci & Sense Organs, Bari, Italy

[22] Univ Hosp Pisa, Multiple Sclerosis Ctr, Pisa, Italy

[23] Univ Rome, Multiple Sclerosis Ctr, Dept Neurol & Psychiat Sapienza, Rome, Italy

[24] Univ Florence, Dept NEUROFARBA, Florence, Italy

[25] IRCCS Bonino Pulejo Ctr, Multiple Sclerosis Ctr, Messina, Italy

[26] Villa Sofia Cervello Hosp, Neuroimmunol Unit, Palermo, Italy

[27] Univ Campania Luigi Vanvitelli, Multiple Sclerosis Ctr, Dept Clin & Expt Med, Div Neurol 2, Naples, Italy

[28] Univ Cagliari, Multiple Sclerosis Ctr, Dept Med Sci & Publ Hlth, Cagliari, Italy

[29] Azienda Osped Rilievo Nazl San Giuseppe Moscati, Avellino, Italy

[30] Fdn Don C Gnocchi, Multiple Sclerosis Ctr, Unit Motor Neurorehabil, IRCCS Santa Maria Nascente, Milan, Italy

[31] Magna Graecia Univ Catanzaro, Inst Neurol, Catanzaro, Italy

[32] Gallarate Hosp, Multiple Sclerosis Ctr, ASST Valle Olona, Gallarate, VA, Italy

来源：

NEUROLOGICAL SCIENCES | 2020年 / 41卷 / 10期

关键词：

Multiple sclerosis; Clinical practice; Spasticity-related symptoms; THC; CBD; QUALITY-OF-LIFE; DOUBLE-BLIND; NEUROPATHIC PAIN; SATIVEX(R); NABIXIMOLS; CANNABINOIDS; MANAGEMENT; BLADDER; PATIENT; TRIAL;

D O I：

10.1007/s10072-020-04413-6

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Introduction The approval of 9-delta-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex (R)) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice. Materials and methods MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: >= 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score >= 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms. Results Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a >= 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group. Conclusion Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.

引用

页码：2905 / 2913

页数：9

共 37 条

[21] Neuropathic orofacial pain: Cannabinoids as a therapeutic avenue [J].

McDonough, Patrick ;

McKenna, Joseph P. ;

McCreary, Christine ;

Downer, Eric J. .

INTERNATIONAL JOURNAL OF BIOCHEMISTRY & CELL BIOLOGY, 2014, 55 :72-78

[22] Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study) [J].

Messina, Silvia ;

Solaro, Claudio ;

Righini, Isabella ;

Bergamaschi, Roberto ;

Bonavita, Simona ;

Bossio, Roberto Bruno ;

Morra, Vincenzo Brescia ;

Costantino, Gianfranco ;

Cavalla, Paola ;

Centonze, Diego ;

Comi, Giancarlo ;

Cottone, Salvatore ;

Danni, Maura Chiara ;

Francia, Ada ;

Gajofatto, Alberto ;

Gasperini, Claudio ;

Zaffaroni, Mauro ;

Petrucci, Loredana ;

Signoriello, Elisabetta ;

Maniscalco, Giorgia Teresa ;

Spinicci, Gabriella ;

Matta, Manuela ;

Mirabella, Massimiliano ;

Peda, Graziella ;

Castelli, Letizia ;

Rovaris, Marco ;

Sessa, Edoardo ;

Spitaleri, Daniele ;

Paolicelli, Damiano ;

Granata, Alfredo ;

Zappia, Mario ;

Patti, Francesco .

PLOS ONE, 2017, 12 (08)

[23] Effect of Sativex on spasticity-associated symptoms in patients with multiple sclerosis [J].

Meuth, Sven G. ;

Vila, Carlos ;

Dechant, Kerry L. .

EXPERT REVIEW OF NEUROTHERAPEUTICS, 2015, 15 (08) :909-918

[24] Cholecystokinin Exerts an Effect via the Endocannabinoid System to Inhibit GABAergic Transmission in Midbrain Periaqueductal Gray [J].

Mitchell, Vanessa A. ;

Jeong, Hyo-Jin ;

Drew, Geoffrey M. ;

Vaughan, Christopher W. .

NEUROPSYCHOPHARMACOLOGY, 2011, 36 (09) :1801-1810

[25] A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis [J].

Novotna, A. ;

Mares, J. ;

Ratcliffe, S. ;

Novakova, I. ;

Vachova, M. ;

Zapletalova, O. ;

Gasperini, C. ;

Pozzilli, C. ;

Cefaro, L. ;

Comi, G. ;

Rossi, P. ;

Ambler, Z. ;

Stelmasiak, Z. ;

Erdmann, A. ;

Montalban, X. ;

Klimek, A. ;

Davies, P. .

EUROPEAN JOURNAL OF NEUROLOGY, 2011, 18 (09) :1122-1131

[26] Spasticity in multiple sclerosis: results of a patient survey [J].

Oreja-Guevara, C. ;

Gonzalez-Segura, D. ;

Vila, C. .

INTERNATIONAL JOURNAL OF NEUROSCIENCE, 2013, 123 (06) :400-408

[27]

Oreja-Guevara Celia, 2012, Expert Rev Neurother, V12, P3, DOI 10.1586/ern.12.11

[28] Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity [J].

Patti, F. ;

Messina, S. ;

Solaro, C. ;

Amato, M. P. ;

Bergamaschi, R. ;

Bonavita, S. ;

Bossio, R. Bruno ;

Morra, V. Brescia ;

Costantino, G. F. ;

Cavalla, P. ;

Centonze, D. ;

Comi, G. ;

Cottone, S. ;

Danni, M. ;

Francia, A. ;

Gajofatto, A. ;

Gasperini, C. ;

Ghezzi, A. ;

Iudice, A. ;

Lus, G. ;

Maniscalco, G. T. ;

Marrosu, M. G. ;

Matta, M. ;

Mirabella, M. ;

Montanari, E. ;

Pozzilli, C. ;

Rovaris, M. ;

Sessa, E. ;

Spitaleri, D. ;

Trojano, M. ;

Valentino, P. ;

Zappia, M. .

JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, 2016, 87 (09) :944-951

[29] Managing neuropathic pain with Sativex®:: a review of its pros and cons [J].

Perez, Jordi ;

Ribera, Maria Victoria .

EXPERT OPINION ON PHARMACOTHERAPY, 2008, 9 (07) :1189-1195

[30] Combined cannabinoid therapy via an oromucosal spray [J].

Perez, Jordi .

DRUGS OF TODAY, 2006, 42 (08) :495-503

← 1 2 3 4 →