To observe the efficacy of a pharmaceutical composition for promoting nerve repair in patients with amyotrophic lateral sclerosis (ALS).

Twenty-two patients with ALS admitted to Affiliated Wujin Hospital of Jiangsu University and the People's Hospital of SND from April 2015 to September 2017 were enrolled in this study. The prospective self-controlled study included 10 males and 12 females, aged 34 to 68 years, with average age (51.64±9.28) years. On the basis of conventional comprehensive treatment, the pharmaceutical composition [The 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. Vitamins (vitamin B₁ 1-2 mg, vitamin B₂ 1-2 mg, vitamin B₆ 3-10 g, vitamin C 1-3 g)] were prepared in a three-liter infusion bag for intravenous infusion, once a day for 28 days for a course of treatment, the next course should be followed after a drug withdrawal for 2 weeks, and the continuous treatment lasted at least for 4 courses or 6 months. The changes of the amyotrophic lateral sclerosis modified functional rating scale-revised (ALSFRS-R), disease progression rate and symptoms and signs were observed in all patients pre- and post-treatment.

One of the 22 patients with ALS (4.55%) died from the advanced respiratory failure in the terminal phase of disease. Symptoms of muscle atrophy and muscle strength were improved in 3 cases (13.6%). Symptoms of atrophy of tongue muscle and dysarthria were improved in 1 case (4.5%). Symptoms of salivation were improved in 2 cases (9.1%). Swallowing function were improved in 1 case (4.5%). Limb activity were increased in 2 cases (9.1%). 1 patient (4.5%) who could not stand and walk restored the standing ability (under other’s support) after treatment. The fluctuation ranges of ALSFRS-R scores in each stage were 18.0~44.0 points for the first outpatient visit, 18.0~41.0 points for the 6 months of treatment, 12.0~39.0 points for the last treatment, and 6.0~38.0 points for the last follow-up. After 6 months of treatment, the ALSFRS-R score was not significantly different from that before treatment [24.50(12.3) points vs. 27.15(14.7)points, Z =-1.183, P>0.05], while 6 patients (27.3%) had an increased ALSFRS-R score, 4 patients (18.2%) remained the same, and 12 patients (54.5%) had a lower one. The ALSFRS-R score after the last treatment decreased compared with that before treatment [23.50 (6.0) points vs.27.15 (14.7) points, Z=-2.557, P>0.05]; however, 6 cases (27.3%) still had an increased score. Although the disease progression rate at neither 6 months of treatment nor the last treatment was statistically different from that before treatment [0.521 (0.563) points/month vs. 0.673 (0.716) points/month, Z=-1.834, P>0.05], they still got a lower rate of disease progression in 72.7% (16/22) and 54.5% (12/22) patients. All patients were followed up to more than 1 year since the first treatment, and the ALSFR-R score increased in 4 (18.2%), 1 (4.5%) remained unchanged, and 17 (77.3%) decreased, but the progression rate of the decline was still slower as compared with those before treatment [(0.584±0.372) points/month vs. (0.716±0.440) points/month, t = 2.706, P<0.05]. The last follow-up showed that 72.7% (16/22) of patients who had undergone a long-term standardized treatment still had a slower rate of disease progression even if they stopped the drug delivery for a while.

This pharmaceutical composition for promoting nerve repair can provide the ALS patients with metabolic substrate, coenzyme and energy as a whole, make the damage and degeneration of the nervous system repaired in a certain extent by promoting enzyme and amino acid metabolism and blood circulation, enhance the survival of neurons, to result in delaying the development of the disease and improving the condition and clinical symptoms. The new treatment is indeed non-toxic, harmless and reproducible with no side effects.