To observe the efficacy of a pharmaceutical composition for promoting nerve repair in patients with motor neuron disease (MND).

A prospective, self-controlled study of 60 patients with MND admitted to Wujin Hospital affiliated to Jiangsu University, the People’s Hospital of SND and Changzhou Huasen Rehabilitation Hospital from September 2016 to April 2018 was conducted, including 39 males and 21 females, aged from 26 to 73 years, with the average age(52.87 ± 9.78)years. On the basis of conventional comprehensive treatment, the above pharmaceutical composition [main components: arginine 1.5-5 g, isoleucine 1.5-5 g, lysine 2.5-7.5 g, methionine 0.5-1.5 g, phenylalanine 0.5-5 g, tryptophan 0.5-1.5 g, valine 2.5-7.5 g, histidine 1.5-4 g, glycine 1.5-4 g, alanine 1.5-5 g, proline 1.5-4 g, asparagine 0.05-1.5 g, cysteine 0.05-1.5 g, cysteine 1.5-5 g, serine 0.25-2.5 g, tyrosine 0.05-1.5 g, L-ornithine 0.25-4 g, aspartic acid 0.5-2.5 g and vitamins (vitamin B₁ 1-2 mg, vitamin B₂ 1-2 mg, vitamin B₆ 3-10 g, vitamin C 1-3 g)] was prepared in a three-liter infusion bag for intravenous infusion, once a day, 28 days for 1 course of treatment. After a 2-week interval, the next course of treatment was repeated. And the continuous treatment lasted at least for 4 courses (or 6 months). The changes of amyotrophic lateral sclerosis modified functional rating scale-revised (ALSFRS-R), disease progression rate and clinical manifestation were observed in all patients pre- and post-treatment to evaluate the therapeutic effect. The adverse reactions during the treatment were also recorded to evaluate the safety of the new therapy.

Three patients (5.00%) died of the advanced respiratory failure. Symptoms of muscle atrophy and muscle strength were improved in 6 cases (10.00%), tongue muscle atrophy and dysarthria were improved in 1 case (1.67%), salivation were improved in 2 cases (3.33%), the swallowing function was improved in 1 case (1.67%), and limb activity were improved 4 cases (6.67%). 1 patient (1.67%) who could not walk independently could squat and stand up with other’s assistance and walked slowly and independently. For the outpatients (n=60), ALSFRS-R scores ranged from 15.0 to 48.0, with an average of (32.21 ± 8.70) points. After 4 courses (or 6 months) (n=60), the score was 3.0~45.0 points, with an average of (28.32 ± 9.56) points. The score after final treatment (n = 59) was 3.0~48.0 points, with an average of (28.36 ± 9.50) points. Compared with the result before treatment, the ALSFRS-R scores were both decreased after the 4 courses (or 6 months) (n=60, t=-3.950, P<0.05) and the last treatment (n=59, t=3.845, P<0.05). However, after the 6-month treatment, 19 patients (31.67%) had an increase in ALSFRS-R score, 2 patients (3.33%) had the same score, and 61.67% (37/60) had a lower disease progression rate. After a prolonged treatment, the proportion of patients with decreased scores went down to 57.63% (34/59). A follow-up of 2 to 12 months in 28 patients showed that after a certain course of treatment was completed, a long-term sustained effect was observed even if the patient stopped taking the drug; the ALSFRS-R score increased in 25.93% (7/28) compared with that before treatment. And the disease progression rate at the last follow-up was still lower than that before treatment [0.50 (0.42) points/month to 0.56 (0.60) points/month, Z=-2.691, P<0.05). ], and the disease progression rate of 74.07% (20/27) discontinued patients was slower than that before treatment. However, because the effect was difficult to maintain a good level for a long time after stopping treatment [74.07% (20/27) patients with the last follow-up ALSFRS-R was lower than that of the last treatment], a continuous consolidation treatment was necessary.

Clinically, the pharmaceutical composition for promoting nerve damage repair can provide the substrate, coenzyme and strong kinetic energy for MND patients, thus delaying the development of the disease and improving the condition and clinical symptoms. The new treatment is indeed non-toxic, harmless, less side effects and reproducible.