| Objective: To assess the effects of Shenzhe Jiangqi Powder on improving the clinical symptoms of amyotrophic lateral sclerosis and enhancing the quality of life of patients by comparing its clinical efficacy for Chong meridian qi adversely ascending type ALS with Rilutek Tablets, and to explore its therapeutic mechanism.Methods: 80 patients who were admitted in our hospital’s Amyotrophy Deparment between December 2013 and December 2014 being diagnosed as ALS with adversely ascending qi of Chong meridian are selected for the clinical trial. Test drug is Shenzhe Jiangqi Powder, and control drug is Rilutek Tablets. Since the appearance and odor of the two drugs are not the same and unchangable, a randomized, double-blind, double-dummy, placebo-controlled, parallel group trial is designed. Shenzhe Jiangqi Powder simulants manufactured by Yiling Pharmaceuticals and Rilutek simulants are used. and random number table for random drug blinding is generated using SAS statistical software. The drugs are assigned and packaged according to codes. and the blind codes are preserved in the Science and Education Department. Drugs are blinded randomly in the Science and Education Department based on the random number table, so that each patient has an equal opportunity to be assigned to the treatment or control group. Treatment group uses Shenzhe Jiangqi Powder + Rilutek placebo, whereas control group uses Shenzhe Jiangqi Powder placebo + Rilutek, and then the blinding records are saved. Next, the drugs are assigned and encoded by the Science and Education Department based on the random number table. In this trial, the number of cases is 80, with 40 cases for treatment group and 40 cases for control group, and drug codes range 01-80. After printing drug codes, packing and labeling,the two groups of drugs are placed in the same large box, and sequenced. The patients included in the trial take the drugs numbered in an ascending order according to their admission time. Patients in the treatment group take 5 g of Shenzhe Jiangqi Powder orally 3 times a day, and 50 mg of Rilutek placebo orally 3 times a day. Patients in the control group take 5 g of Shenzhe Jiangqi Powder placebo orally 3 times a day,and 50 mg of Rilutek orally 3 times a day. Observation period is 90 days for both the treatment and control groups. Patients in the two groups are checked for body temperature,respiration, pulse and blood pressure for a total of four times: before treatment,30 days after treatment,60 days after treatment and 90 days after treatment. They also undergo blood,urine and stool routine examination, liver and kidney function tests and ECG twice: before treatment and 90 days after treatment. ALS functional rating scale(ALSFRS), modified Norris scale,40-item ALS Assessment Questionnaire(ALSAQ-40) scores and motor unit number estimates(MUNE)of each patient are recorded and observed before treatment and 90 days after treatment. Finally, data are timely,completely,accurately and clearly input in the case report form based on the original observation records of subjects. All the case report forms are reviewed for accuracy,completeness,as well as consistency with the original data. The first unblinding is done based on blind cones,group A and group B are identified according to the codes,then analysis is performed using SPSS17.0 statistical software. All measurement data are expressed as mean ± standard deviation( X ± s). After samples are checked for conformity to normal distribution by comparison between groups and between before and after treatment, homogeneity of variance test is performed. afterwards, t test,calibration t test or paired t test is applied based on the homogeneity of variance. X2 test is used for count data, while Ridit test is used for ranked data. After data analysis, the second unblinding is done, which identifies group A as the treatment group and group B as the control group. and final conclusions are drawn.Results: After treatment, the results are as follows.1A total of 80 patients enter the study, after unblinding, treatment group consists of 40 cases, 2 cases are removed due to failure to take drugs as prescribed,so the remaining is 38 cases. control group consists of 40 cases, 2 patients withdraw from the trial, so the remaining is 38 cases. There are 26 males and 12 females in the treatment group, and 25 males and 13 females in the control group. Average age is 49.38 ± 8.96 years for treatment group, and 50.05 ± 8.10 years for control group. Average course of disease is 13.90 ± 8.37 months in the treatment group,and 13.05 ± 8.26 months in the control group. Differences in gender, age and course of disease between two groups are comparable but not statistically significant(P>0.05).2 Comparison of ALSFRS scores between the two groupsBefore treatment, no significant difference is found in ALSFRS scores between the two groups(P>0.05). After treatment,ALSRFS scores of the treatment group increase significantly, before and after treatment showing significant difference(P<0.01). for control group, no significant difference is seen in ALSRFS scores between before and after treatment(P>0.05). ALSRFS scores of the treatment group differ significantly from the control group after treatment(P<0.01).3Comparison of modified Norris scores between the two groupsBefore treatment,modified Norris scores between the two groups is not significantly different(P>0.05). After treatment, modified Norris scores of the treatment group increase significantly, before and after treatment showing significant difference(P<0.01). for control group, no significant difference is seen in modified Norris scores between before and after treatment(P>0.05). Modified Norris scores of the treatment group differ significantly from the control group after treatment(P<0.01).4 Comparison of ALSAQ-40 scores between the two groupsBefore treatment, no significant difference is found in ALSAQ-40 scores between the two groups(P>0.05). After treatment,ALSAQ-40 scores of the treatment group increase significantly, before and after treatment showing significant difference(P<0.01). for control group,no significant difference is seen in ALSAQ-40 scores between before and after treatment(P>0.05). ALSAQ-40 scores of the treatment group differ significantly from the control group after treatment(P<0.01).5 Comparison of therapeutic efficacy between the two groups before and after treatmentAmong the 38 cases in the treatment group, clinical control is found in 4 cases are led, remarkable effectiveness is found in 9 cases, effectiveness is found in 19 cases, and ineffectiveness in 6 cases, with an overall effectiveness of 84.2%. Among 30 cases in the control group, clinical control is found in 1 case,remarkable effectiveness is found in 6 cases, effectiveness is found in 16 cases, and ineffectiveness in 15 cases, with an overall effectiveness of 60.5%. There is a significant difference between the treatment and control groups(P<0.05).6 Comparison of MUNE between the two groupsBefore treatment, no significant difference is found in MUNE between the two groups(P>0.05). After treatment,for treatment group, no significant difference is seen in MUNE between before and after treatment(P>0.05). MUNE of the control group before and after treatment showing significant difference(P<0.05). MUNE of the treatment group differ significantly from the control group after treatment(P<0.01).7 No adverse reactions are observed in the treatment group after intake of Shenzhe Jiangqi Powder. For patients in the control group who take Rilutek, 13 have elevated transaminase, 5 have nausea, and 11 have drowsiness and fatigue.Conclusion: Shenzhe Jiangqi Powder is preliminarily considered to be able to be safely and effectively applied in the clinical practice for the treatment of Chong meridian qi adversely ascending type ALS. It exhibits better therapeutic efficacy than Rilutek,which is reflected mainly in the improvement of patients’ difficulty in chewing,drooling,unclear articulation,deglutition barrier and other bulbar paralysis symptoms, and enhancement of patients’ quality of life. |
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