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Hawking’s gradual freezing disease, whose scientific name is "Amyotrophic Lateral Sclerosis" (ALS), is a progressive neurodegenerative disease related to motor neurons.
The upper and lower motor neurons are affected in patients with this disease.
Causes the muscles innervated by neurons to appear muscle weakness, muscle atrophy, tremor, spasm and other related clinical symptoms.
The course of the disease is mostly progressive, and eventually death is often due to respiratory paralysis
.
.
In patients with this disease, upper and lower motor neurons are affected, leading to muscle weakness, muscle atrophy, tremor, spasm and other related clinical symptoms in the muscles innervated by neurons
ALS is considered to be one of the top five terminal illnesses in the world
The REFALS study is a randomized, double-blind, placebo-controlled phase 3 trial conducted in 99 ALS specialty centers in 14 countries around the world
.
Included ALS patients aged> 18 years old, the slow vitality (SVC) in the sitting position was 60-90%
Between June 21, 2018 and June 28, 2019, 871 people were screened to participate in the study, and 496 of them were randomly assigned to levosimendan (n=329) or placebo (n=167)
.
Participants were followed up from June 27, 2018 to June 26, 2020, with a median time of 50.
At 12 weeks, the SVC in the supine position of levosimendan was -6.
Differences in the changes of SVC and CAFS between the two groups of patients during the follow-up period
Similarly, at week 48, there was no difference in CAFS between treatment groups (the least squares average change from baseline 10.
69 to 37.
12)
.
The most common adverse events were increased heart rate (levosimendan [33%] vs placebo [7%]), falls ([26%] vs [29%]), headache ([29%] vs [22%] ) And dyspnea ([18%] vs [19%])
Similarly, at week 48, there was no difference in CAFS between treatment groups (the least squares average change from baseline 10.
In patients with extensive amyotrophic lateral sclerosis, levosimendan is not superior to placebo in maintaining respiratory function
references:
Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial.
Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial.
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