The Clinical Study Of JIWEILING Injection In Dealing With Amyotrophic Lateral Sclerosis Bulbar Paralysis

Objective: Approach the traditional Chinese medicine pathogenesis of amyotrophic lateral sclerosis(ALS) directed by Qi-jing and Collateral disease theory , observe and evaluate the clinical curative effect of JIWEILING injection (JWL) which is made directed by these theory in dealing with amyotrophic lateral sclerosis(ALS) bulbar paralysis.Methods: The JWL group took the basic treatment of inhaling oxygen and ejecting phlegm and administrated JIWEILING injection by intravenousdrip while the control group took the basic treatment of inhaling oxygen and ejecting phlegm and orally riluzole tablet. And 28days was a treatment course. We observed the clinical effect with the indexes such as the clinical symptoms and signs score, evaluation quality of life, motor unit number estimation(MUNE), respiratory function ,blood gas, NSE and detection of the contents of amino acid in cerebrospinal fluid(CSF) to observe the cure effect and security of JWL injection.Result: Statistic the ALS bulbar paralysis clinical symptoms scores and ALSFRS, there was no significant difference between the two groups before the treatment(p> 0.05). After the treatment the ALS bulbar paralysis clinical symptoms scores and ALSFRS increased and there was significant difference in the JWL group(p<0.05). The two groups had the significant difference after the treatment(p<0.01). It suggested that JWL injection could improve the clinical symptoms of patients. For the ALSAQ-40 scores there was no significant difference between the two groups before the treatmen(tp>0.05)and after the treatment the ALSAQ-40 score increased and there was significant difference in the JWL group(p<0.01), and the two groups had the significant difference after the treatment(p<0.01). It suggested that JWL injection could improve the patients'quality of life.For the MUNE, there was no significant difference between the two groups before the treatment(p >0.05). After the treatment the MUNE didn't decrease and there was no significant difference in the JWL group(p>0.05) while the MUNE decreased and there was significant difference in the control group(p<0.05). There was significant difference after the treatment in the two groups(p<0.01)and it suggested that the JWL group surpassed the control group of the protective effect on the motor neurons .For the resperatory function, there was no significant difference between the two groups before the treatment(p>0.05). After the treatment in the JWL group the VC, FVC, FEV1 and MVV of resperatory function all increased and there was significant difference comparing before the treatment(p< 0.01) and there was also significant difference in the control group(p<0.05). There was significant difference after the treatment in the two groups(p<0.01)and it suggested that the JWL group surpassed the control group of increasing the resperatory function,For blood gas analyse, there was no significant difference between the two groups before the treatmen(tp>0.05). Afterthe treatment in the JWL group the PaO2 and SaO2 were increased but PaCO2 was decreased and there was significant difference comparing before the treatment(p<0.01)while there was no significant difference in the control group(p>0.05). There was significant difference after the treatment in the two groups(p<0.01)and it suggested that the JWL group surpassed the control group of improving the resperatory function,For the NSE, there was no significant difference between the two groups before the treatment(p>0.05). After the treatment in the JWL group the NSE increased and there was significant difference comparing before the treatment(p<0.01) while there was no significant difference in the control group(p>0.05). There was significant difference after the treatment in the two groups(p<0.01).For the detection of amino acid in CSF, there was no significant difference between the two groups before the treatment(p>0.05).After treatment in the JWL group the contents of aspartic acid(Asp) and glutamic acid(Glu) were decreased significantly(p<0.01), yet apparent change in the contents of glycine (Gly)andγ-Aminobuyric acid(GABA) was not showed (p>0.05). After treatment in the control group the contents of aspartic acid(Asp) and glutamic acid(Glu) were decreased significantly(p<0.05)while the contents of Gly and GABA were not increased significantly(p>0.05). There was significant difference after the treatment in the contents of Asp and Glu in the two groups(p<0.01)while no significant difference in the contents of Gly and GABA. It suggested that the JWL group surpassed the control group of decreasing the toxicity of excitatory amino acid(EAA) in CSF.Of all the 30 JWL injection cases, 6 cases(20%) were markedly effective, 13 cases(43.3%) were effective 11 cases (36.7%) were failed.,the total effective rate is 63.3%. In the control group, the individual percents of above were 0 case (0.0%), 8cases(26.7%), 22 cases(73.3%), the total effective rate is 26.7%,the effect of the two groups showed significantly difference(P<0.01).There are liver dysfunction of the 13 cases in the control group(especially displayed aminopherase increasing). There was no side effect in the JWL group.Conclusion: The JWL injeciton has certain treating effect on the amyotrophic lateral sclerosis bulbar paralysis and is one kind of the safe and effective Chinese herb preparation.