Amyotrophic Lateral Sclerosis, Respiratory Function, Scopolamine
Conditions
Brief summary
Thirty cases of amyotrophic lateral sclerosis patients were recruited from the neurology department of Ruijin Hospital, the pain department and the encephalopathy center of Luwan Branch of Ruijin Hospital. After the informed consent was signed, they were divided into a trial group and a control group. Each group contains 15 cases. The patients in the control group was treated with edaravone dissolved in saline during hospitalization, while the patients in the trial group was treated with edaravone, scopolamine, atropine and dexmedetomidine. Both groups of subjects were treated for 7 days within 3 weeks, followed by a buffer period of 3 weeks for observation, which was one treatment course. The total treatment protocol contains 3 treatment courses (or 18 weeks). Patients with amyotrophic lateral sclerosis were evaluated before treatment and 6, 12, 18, 24, 36, 48 weeks after treatment. The observations include whether the functional scores of patients with amyotrophic lateral sclerosis, Norris amyotrophic lateral sclerosis score, amyotrophic lateral sclerosis self-score, forced expiratory volume in one second, partial pressure of oxygen and maximum displacement of the hyoid were superior to those before treatment, and whether the partial pressure of carbon dioxide was inferior to those before treatment. Study hypothesis: Cholinergic receptor blocking therapy for amyotrophic lateral sclerosis is safe and effective in improving motor function and delaying disease progression in patients with amyotrophic lateral sclerosis.
Interventions
DRUGScopolamine, atropine, edaravone and dexmedetomidine
The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.
DRUGEdaravone
The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients should voluntarily participate in the experiment by signing an informed consent form. 2. Patients should comply with the research process and cooperate with the interventions applied throughout the experiment. 3. Patients should be between 30 and 65 years of age, and both sexes are acceptable. 4. Patients should comply with the diagnostic criteria and
Exclusion criteria
for amyotrophic lateral sclerosis in the Chinese Guidelines for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis developed by the Chinese Society of Neurology of the Chinese Medical Association in 2012. 5. Patient's amyotrophic lateral sclerosis history must not exceed 5 years. 6. ALS functional scale score (ALSFRS-R) should be ≥ 2 points for each patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ineffective | 48 weeks | Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was decreased or remained unchanged. |
| Effective | 48 weeks | Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was elevated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective | 48 weeks | Partial pressure of oxygen (PO2), maximum displacement of the hyoid or the modified Norris scale score (minimum score: 0, maximum score: 100, higher score is related to a better outcome) was elevated or partial pressure of carbon dioxide (PCO2) was decreased or remained unchanged. |
| Ineffective | 48 weeks | Partial pressure of carbon dioxide (PCO2) was elevated, or partial pressure of oxygen (PO2), maximum displacement of the hyoid or the modified Norris scale score (minimum score: 0, maximum score: 100, higher score is related to a better outcome) was decreased or remained unchanged. |
Countries
China
Contacts
Primary ContactJun Liu, Professor
Outcome results
None listed