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*Only for medical professionals to read and reference, take you to understand the latest trends in the international narcolepsy guidelines and new breakthrough treatment plans September 24-25, the 24th National Neurology Conference of the Chinese Medical Association (NCN 2021) went smoothly in Zhuhai Convened
.
Narcolepsy is an internationally recognized rare disease [1], and we found that most clinical experts and doctors are not familiar with it
.
With the deepening of clinical research in this field internationally, the international guidelines have been revised and updated accordingly.
In 2021, the European Society of Neurology (EAN), the European Society for Sleep Research (ESRS) and the European Narcolepsy Collaborative Group (EU-NN) ) Jointly issued the European Narcolepsy Guidelines, providing the latest clinical recommendations based on evidence-based medicine for the treatment of the disease
.
Domestic related research is also increasing year by year.
During this annual neurological conference, many experts presented special reports and paper exchanges on narcolepsy
.
Among them, Professor Wu Huijuan from Shanghai Changzheng Hospital gave a lecture on "The overall regulation of narcolepsy sleep-wake rhythm", and Professor Wang Zan from the First Hospital of Jilin University gave a lecture on "Night sleep quality and daytime functional status assessment of narcolepsy patients" Etc.
caused a enthusiastic response
.
In the academic topic on September 25, Professor Wang Yuping from Xuanwu Hospital of Capital Medical University served as the chair, and Professor Yu Huan from Huashan Hospital Affiliated to Fudan University as the speaker, interpreted in detail the "2021 European Adult and Child Narcolepsy Treatment Guidelines and Experts" Consensus (hereinafter referred to as the "2021 European Guidelines")
.
Narcolepsy is a serious and rare sleep disease.
Professor Yu Huan pointed out that narcolepsy is an internationally recognized rare disease [1].
Because of its extremely low incidence, insidious disease and atypical symptoms, The lack of understanding by clinicians in Shanghai can easily lead to missed diagnosis and misdiagnosis [2-3]
.
In addition, narcolepsy has a higher risk of co-existing other diseases.
The possibility of comorbid mental illness, digestive system disease, and nervous system disease is 3.
8 times, 2.
7 times, and 3.
7 times that of the normal population, respectively [4-5], of which about 29.
4%-51.
4% of narcolepsy patients have obstructive sleep apnea (OSA), which affects the normal life of patients [6]
.
Narcolepsy can significantly reduce the health-related quality of life (HRQL) of patients [7-8].
At the same time, the risk of hospitalization for accidental motor vehicle injuries in patients with narcolepsy is still 6.
725 times that of the general population [8]
.
Narcolepsy seriously affects the quality of life of patients and brings a heavy burden of disease to individuals and society.
In view of this, domestic and foreign guidelines are constantly being introduced to provide guidance for standardized treatment of narcolepsy
.
Narcolepsy Guidelines Update Background The Narcolepsy Treatment Guidelines were originally published in Europe in 2006 and in the United States in 2007
.
In 2014, when the American Academy of Sleep Medicine updated the International Classification of Sleep Disorders (ICSD-3 in 2014), the diagnostic criteria for narcolepsy were revised and they are still in use today
.
Some researchers have pointed out that the current diagnostic criteria have certain difficulties in clinical implementation, resulting in differences between clinical and pathological classifications
.
"European Guidelines 2021" put forward some suggestions on the operation of clinical diagnosis of narcolepsy
.
The 2021 European guidelines highlights and the formation of treatment.
The 2021 European narcolepsy guidelines point out that the treatment methods for narcolepsy mainly include non-drug treatment and drug treatment
.
In terms of non-drug treatment, the guidelines recommend regular naps during the day to help improve the symptoms of narcolepsy patients
.
In terms of drug treatment, a variety of drugs are recommended to treat different symptoms and groups of people [9]
.
Figure 1: 2021 European Narcolepsy Guidelines ■ Daytime excessive sleepiness guidelines recommend modafinil, tilorizine, sodium oxybate, Solriamfetol, methylphenidate, etc.
for adult narcolepsy excessive daytime thinking Treatment of sleep (EDS) symptoms
.
However, it is worth noting that methylphenidate, modafinil, amphetamine, and Solriamfetol have the risk of increasing heart rate and blood pressure.
Follow-up monitoring of cardiovascular risk factors and corresponding treatment are required [9]
.
Figure 2.
Drug treatment recommendation for adult narcolepsy EDS.
Tilolisen is recommended by the guidelines (strong recommendation and medium quality of evidence), which is mainly based on the Harmony Phase III study.
At 12 months of treatment, regardless of tilorizine The Epwoth Sleepiness Scale (ESS) scores of the patients can be reduced by single agent or in combination with other drugs
.
When Tilolisheng was used as a single agent to treat newly-onset patients, the ESS score decreased the most (a decrease of 6.
5±1.
4) [10]
.
■ Cataplexy 60%-70% of narcolepsy patients present with cataplexy.
The guide recommends sodium oxybate, SSRI-NSRI-other antidepressants, tricyclic antidepressants, and tilorizine for adult seizures.
Treatment of cataplexy episodes of narcolepsy [9]
.
Among them, Tilorisen was approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of cataplexy in narcolepsy in 2020, and was granted breakthrough therapy qualification at the same time
.
■ Sleep paralysis, hallucinations before going to bed/awake About 50% of narcolepsy patients present with sleep paralysis (SP), hallucinations before going to bed/awake (HH)
.
The guidelines recommend sodium oxybate, tilorizine and antidepressants for the treatment of sleep paralysis and pre-sleep/waking hallucinations in narcolepsy [9]
.
■ More than 50% of children with narcolepsy have their initial symptoms before the age of 18
.
The symptoms of narcolepsy in children and adolescents are different from adults, and the treatment strategies for the disease are also different from adults
.
Recommended Guidelines for the treatment of seizures in children narcolepsy drugs: sodium oxybate, methylphenidate, modafinil, antidepressants, and the like for Luoli Sheng
.
Children need to pay special attention to factors such as safety and risk-benefit ratio during treatment [9]
.
Summary At the end of the interpretation of the guide, Professor Yu Huan concluded that narcolepsy seriously affects the quality of life of patients, and has caused a lot of burden on individuals, society and the economy
.
Narcolepsy has a variety of clinical manifestations, and individual differences in patients are also very obvious
.
Therefore, clinicians need to give each patient a personalized treatment plan
.
At the same time, Professor Wang Yuping also summarized this academic topic, and pointed out that Tilorisen is a new attempt in the history of narcolepsy drug treatment.
It has a broad spectrum of action.
It not only has the effect of improving wakefulness, but also can prevent cataplexy.
To improve the symptoms of night sleep disorders in patients, and provide a new hope for patients with narcolepsy
.
As an innovative treatment drug for narcolepsy, tilorizine can effectively improve the four symptoms of patients with EDS, cataplexy, hallucinations and sleep paralysis.
Tilolisheng is safe and easily tolerated by patients
.
Therefore, the 2021 European Narcolepsy Guidelines recommended for the first time tilorisen as the first-line monotherapy for adult narcolepsy EDS and cataplexy, as well as the first-line monotherapy for childhood narcolepsy EDS [9]
.
Looking forward to the near future, more innovative treatments in the field of narcolepsy will enter China, so that clinicians will have medicines available within the scope of the indications and benefit more Chinese patients
.
References: [1] Khatami R, Luca G, Baumann CR, et al.
The European Narcolepsy Network (EU-NN) database.
J Sleep Res.
2016;25(3):356-364.
[2] Zhang Ruirui, Zhang Hongju .
Research progress of narcolepsy[J].
Journal of Apoplexy and Nervous Diseases,2019,36(7):594-596.
[3]Xu Qinglin, Lou Guodong, Wang Tiantian, et al.
Advances in drug treatment of narcolepsy[ J].
Journal of Zhejiang University (Medical Edition), 2020,49(4):419-424.
[4]Black J, Reaven NL, Funk SE, et al.
Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease ( BOND) study.
Sleep Med.
2017;33:13-18.
[5]Sansa G, Iranzo A, Santamaria J.
Obstructive sleep apnea in narcolepsy.
Sleep Med.
2010;11(1):93-95.
[6] Cohen A, Mandrekar J, St Louis EK, Silber MH, Kotagal S.
Comorbidities in a community sample of narcolepsy.
Sleep Med.
2018;43:14-18.
[7]Dodel R, Peter H, Spottke A, et al.
Health-related quality of life in patients with narcolepsy.
Sleep Med.
2007;8(7-8):733-741.
[8]Tzeng NS, Hsing SC, Chung CH, et al.
The Risk of Hospitalization for Motor Vehicle Accident Injury in Narcolepsy and the Benefits of Stimulant Use: A Nationwide Cohort Study in Taiwan.
J Clin Sleep Med.
2019;15(6):881-889.
[9]Bassetti CLA, Kallweit U, Vignatelli L, et al.
European guideline and expert statements on the management of narcolepsy in adults and children [published online ahead of print, 2021 Jun 25].
J Sleep Res.
2021;e13387.
[10]Dauvilliers Y, Arnulf I, Szakacs Z, et al.
Long-term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Sleep.
2019;42(11):zsz174.
*This article is only used to provide scientific information to medical and health professionals and does not represent a platform ViewEuropean guideline and expert statements on the management of narcolepsy in adults and children [published online ahead of print, 2021 Jun 25].
J Sleep Res.
2021;e13387.
[10]Dauvilliers Y, Arnulf I, Szakacs Z, et al.
Long -term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Sleep.
2019;42(11):zsz174.
*This article is only used to provide scientific information to medical and health professionals and does not represent platform viewsEuropean guideline and expert statements on the management of narcolepsy in adults and children [published online ahead of print, 2021 Jun 25].
J Sleep Res.
2021;e13387.
[10]Dauvilliers Y, Arnulf I, Szakacs Z, et al.
Long -term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Sleep.
2019;42(11):zsz174.
*This article is only used to provide scientific information to medical and health professionals and does not represent platform views
.
Narcolepsy is an internationally recognized rare disease [1], and we found that most clinical experts and doctors are not familiar with it
.
With the deepening of clinical research in this field internationally, the international guidelines have been revised and updated accordingly.
In 2021, the European Society of Neurology (EAN), the European Society for Sleep Research (ESRS) and the European Narcolepsy Collaborative Group (EU-NN) ) Jointly issued the European Narcolepsy Guidelines, providing the latest clinical recommendations based on evidence-based medicine for the treatment of the disease
.
Domestic related research is also increasing year by year.
During this annual neurological conference, many experts presented special reports and paper exchanges on narcolepsy
.
Among them, Professor Wu Huijuan from Shanghai Changzheng Hospital gave a lecture on "The overall regulation of narcolepsy sleep-wake rhythm", and Professor Wang Zan from the First Hospital of Jilin University gave a lecture on "Night sleep quality and daytime functional status assessment of narcolepsy patients" Etc.
caused a enthusiastic response
.
In the academic topic on September 25, Professor Wang Yuping from Xuanwu Hospital of Capital Medical University served as the chair, and Professor Yu Huan from Huashan Hospital Affiliated to Fudan University as the speaker, interpreted in detail the "2021 European Adult and Child Narcolepsy Treatment Guidelines and Experts" Consensus (hereinafter referred to as the "2021 European Guidelines")
.
Narcolepsy is a serious and rare sleep disease.
Professor Yu Huan pointed out that narcolepsy is an internationally recognized rare disease [1].
Because of its extremely low incidence, insidious disease and atypical symptoms, The lack of understanding by clinicians in Shanghai can easily lead to missed diagnosis and misdiagnosis [2-3]
.
In addition, narcolepsy has a higher risk of co-existing other diseases.
The possibility of comorbid mental illness, digestive system disease, and nervous system disease is 3.
8 times, 2.
7 times, and 3.
7 times that of the normal population, respectively [4-5], of which about 29.
4%-51.
4% of narcolepsy patients have obstructive sleep apnea (OSA), which affects the normal life of patients [6]
.
Narcolepsy can significantly reduce the health-related quality of life (HRQL) of patients [7-8].
At the same time, the risk of hospitalization for accidental motor vehicle injuries in patients with narcolepsy is still 6.
725 times that of the general population [8]
.
Narcolepsy seriously affects the quality of life of patients and brings a heavy burden of disease to individuals and society.
In view of this, domestic and foreign guidelines are constantly being introduced to provide guidance for standardized treatment of narcolepsy
.
Narcolepsy Guidelines Update Background The Narcolepsy Treatment Guidelines were originally published in Europe in 2006 and in the United States in 2007
.
In 2014, when the American Academy of Sleep Medicine updated the International Classification of Sleep Disorders (ICSD-3 in 2014), the diagnostic criteria for narcolepsy were revised and they are still in use today
.
Some researchers have pointed out that the current diagnostic criteria have certain difficulties in clinical implementation, resulting in differences between clinical and pathological classifications
.
"European Guidelines 2021" put forward some suggestions on the operation of clinical diagnosis of narcolepsy
.
The 2021 European guidelines highlights and the formation of treatment.
The 2021 European narcolepsy guidelines point out that the treatment methods for narcolepsy mainly include non-drug treatment and drug treatment
.
In terms of non-drug treatment, the guidelines recommend regular naps during the day to help improve the symptoms of narcolepsy patients
.
In terms of drug treatment, a variety of drugs are recommended to treat different symptoms and groups of people [9]
.
Figure 1: 2021 European Narcolepsy Guidelines ■ Daytime excessive sleepiness guidelines recommend modafinil, tilorizine, sodium oxybate, Solriamfetol, methylphenidate, etc.
for adult narcolepsy excessive daytime thinking Treatment of sleep (EDS) symptoms
.
However, it is worth noting that methylphenidate, modafinil, amphetamine, and Solriamfetol have the risk of increasing heart rate and blood pressure.
Follow-up monitoring of cardiovascular risk factors and corresponding treatment are required [9]
.
Figure 2.
Drug treatment recommendation for adult narcolepsy EDS.
Tilolisen is recommended by the guidelines (strong recommendation and medium quality of evidence), which is mainly based on the Harmony Phase III study.
At 12 months of treatment, regardless of tilorizine The Epwoth Sleepiness Scale (ESS) scores of the patients can be reduced by single agent or in combination with other drugs
.
When Tilolisheng was used as a single agent to treat newly-onset patients, the ESS score decreased the most (a decrease of 6.
5±1.
4) [10]
.
■ Cataplexy 60%-70% of narcolepsy patients present with cataplexy.
The guide recommends sodium oxybate, SSRI-NSRI-other antidepressants, tricyclic antidepressants, and tilorizine for adult seizures.
Treatment of cataplexy episodes of narcolepsy [9]
.
Among them, Tilorisen was approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of cataplexy in narcolepsy in 2020, and was granted breakthrough therapy qualification at the same time
.
■ Sleep paralysis, hallucinations before going to bed/awake About 50% of narcolepsy patients present with sleep paralysis (SP), hallucinations before going to bed/awake (HH)
.
The guidelines recommend sodium oxybate, tilorizine and antidepressants for the treatment of sleep paralysis and pre-sleep/waking hallucinations in narcolepsy [9]
.
■ More than 50% of children with narcolepsy have their initial symptoms before the age of 18
.
The symptoms of narcolepsy in children and adolescents are different from adults, and the treatment strategies for the disease are also different from adults
.
Recommended Guidelines for the treatment of seizures in children narcolepsy drugs: sodium oxybate, methylphenidate, modafinil, antidepressants, and the like for Luoli Sheng
.
Children need to pay special attention to factors such as safety and risk-benefit ratio during treatment [9]
.
Summary At the end of the interpretation of the guide, Professor Yu Huan concluded that narcolepsy seriously affects the quality of life of patients, and has caused a lot of burden on individuals, society and the economy
.
Narcolepsy has a variety of clinical manifestations, and individual differences in patients are also very obvious
.
Therefore, clinicians need to give each patient a personalized treatment plan
.
At the same time, Professor Wang Yuping also summarized this academic topic, and pointed out that Tilorisen is a new attempt in the history of narcolepsy drug treatment.
It has a broad spectrum of action.
It not only has the effect of improving wakefulness, but also can prevent cataplexy.
To improve the symptoms of night sleep disorders in patients, and provide a new hope for patients with narcolepsy
.
As an innovative treatment drug for narcolepsy, tilorizine can effectively improve the four symptoms of patients with EDS, cataplexy, hallucinations and sleep paralysis.
Tilolisheng is safe and easily tolerated by patients
.
Therefore, the 2021 European Narcolepsy Guidelines recommended for the first time tilorisen as the first-line monotherapy for adult narcolepsy EDS and cataplexy, as well as the first-line monotherapy for childhood narcolepsy EDS [9]
.
Looking forward to the near future, more innovative treatments in the field of narcolepsy will enter China, so that clinicians will have medicines available within the scope of the indications and benefit more Chinese patients
.
References: [1] Khatami R, Luca G, Baumann CR, et al.
The European Narcolepsy Network (EU-NN) database.
J Sleep Res.
2016;25(3):356-364.
[2] Zhang Ruirui, Zhang Hongju .
Research progress of narcolepsy[J].
Journal of Apoplexy and Nervous Diseases,2019,36(7):594-596.
[3]Xu Qinglin, Lou Guodong, Wang Tiantian, et al.
Advances in drug treatment of narcolepsy[ J].
Journal of Zhejiang University (Medical Edition), 2020,49(4):419-424.
[4]Black J, Reaven NL, Funk SE, et al.
Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease ( BOND) study.
Sleep Med.
2017;33:13-18.
[5]Sansa G, Iranzo A, Santamaria J.
Obstructive sleep apnea in narcolepsy.
Sleep Med.
2010;11(1):93-95.
[6] Cohen A, Mandrekar J, St Louis EK, Silber MH, Kotagal S.
Comorbidities in a community sample of narcolepsy.
Sleep Med.
2018;43:14-18.
[7]Dodel R, Peter H, Spottke A, et al.
Health-related quality of life in patients with narcolepsy.
Sleep Med.
2007;8(7-8):733-741.
[8]Tzeng NS, Hsing SC, Chung CH, et al.
The Risk of Hospitalization for Motor Vehicle Accident Injury in Narcolepsy and the Benefits of Stimulant Use: A Nationwide Cohort Study in Taiwan.
J Clin Sleep Med.
2019;15(6):881-889.
[9]Bassetti CLA, Kallweit U, Vignatelli L, et al.
European guideline and expert statements on the management of narcolepsy in adults and children [published online ahead of print, 2021 Jun 25].
J Sleep Res.
2021;e13387.
[10]Dauvilliers Y, Arnulf I, Szakacs Z, et al.
Long-term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Sleep.
2019;42(11):zsz174.
*This article is only used to provide scientific information to medical and health professionals and does not represent a platform ViewEuropean guideline and expert statements on the management of narcolepsy in adults and children [published online ahead of print, 2021 Jun 25].
J Sleep Res.
2021;e13387.
[10]Dauvilliers Y, Arnulf I, Szakacs Z, et al.
Long -term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Sleep.
2019;42(11):zsz174.
*This article is only used to provide scientific information to medical and health professionals and does not represent platform viewsEuropean guideline and expert statements on the management of narcolepsy in adults and children [published online ahead of print, 2021 Jun 25].
J Sleep Res.
2021;e13387.
[10]Dauvilliers Y, Arnulf I, Szakacs Z, et al.
Long -term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Sleep.
2019;42(11):zsz174.
*This article is only used to provide scientific information to medical and health professionals and does not represent platform views
