| Objective: This study aims to investigate the clinical efficacy of Qi-supplementing Kidney-tonifying Recipe on patients with myasthenia gravis,and the influence of the Recipe on levels of cytokine interleukin-6(IL-6)and transforming growth factor-?(TGF-?),so as to verify the effectiveness and mechanism of the Recipe on myasthenia gravis,and to provide new methods and ideas for Chinese medicine when treating the myasthenia gravis.Methods: Observation was conducted for outpatient and ward patients in the First Affiliated Hospital of Henan College of Traditional Chinese Medicine from January 2015 to January 2016.Upon meeting the inclusion criteria,by treatment order,the 60 patients with myasthenia gravis(I-type,IIa-type,IIb-type)were randomly divided into two groups-the treatment group with 30 patients and the control group with the other 30 patients.Treatment group used the Recipe,combined with basic western medicines(prednisone and/or bromine pyridostigmine);control group used basic western medicines(prednisone and/or bromine pyridostigmine);both treatment periods were 4 weeks.In terms of clinical efficacy,before and after treatments,two groups of patients were measured by using the Myasthenia Gravis Score(QMG Standard Evaluation,the Scale for Busch Improved Quality of Life,and the Efficacy Assessment Form for TCM Syndrome.In terms of laboratory indicators,before treatment and after 4 weeks of treatment,5ml of fasting venous blood of the patients were collected into the vacuum blood-collecting tube.Then the collected blood was shook up gently and stored at room temperature for 20 minutes.Then the blood was put into a centrifuge for operation under 3,000 rpm for 20 min.Then the supernatant was stored in refrigerator at-20?.After entire collections of samples,by using enzyme-linked immunosorbent assay(ELISA),in accordance with its instructions,following steps were conducted in sequence: dilution,sample addition,incubation,liquid dispensing,washing,enzyme addition,incubation,washing,coloring,and termination.After these steps,within 15min,the OD value of each hole was measured by a microplate reader with wavelength of 450 nm,and the standard curve was drew.According to the standard curve,the levels of interleukin-6(IL-6)and transforming growth factor-?(TGF-?)were calculated.Meanwhile,observation was conducted to see if there would be adverse drug reactions,for safety evaluation.Results: In terms of clinical efficacy,after 4 weeks of treatment,upon efficacy in Myasthenia Gravis Score,the treatment group showed a total effective rate of 80.00%;the control group showed a total effective rate of69.57%;statistical analysis showed that there was a significant statistical difference(P <0.05)between the two groups.After 4 weeks of treatment,upon efficacy in TCM Symptom Score,the treatment group showed a total effective rate of 84.00% and the control group a total effective rate of56.52%;statistical analysis showed that there was a significant statistical difference(P <0.05)between the two groups.After 4 weeks of treatment,the myasthenia gravis score(QMG standard evaluation),the scale for Busch improved quality of life,and the TCM symptom efficacy scores were significantly lower than those before treatment,there was a statistically significant difference(P <0.01);moreover,after 4 weeks of treatment,the treatment group showed a more obvious decrease than that of the control group,and there was a significant difference(P <0.05)between the two groups.In terms of laboratory indicators,after 4 weeks of treatment,IL-6 level in serum of the two groups of patients was significantly lower than that before treatment,there was a statistically significant difference(P <0.01);and,after 4 weeks of treatment,the treatment group showed a more obvious decrease than that of the control group,and there was a statistically significant difference(P <0.01)between the two groups.After 4 weeks of treatment,TGF-?of the two groups were significantly higher than that before treatment,there was a statistically significant difference(P <0.01);and,after 4 weeks of treatment,the treatment group showed a more obvious increase than that of the control group,there was a statistically significant difference(P <0.01)between the two groups.Conclusion:(1)After 4 weeks of treatment,the efficacy in myasthenia gravis score and the efficacy in TCM symptom score showed statistically significant differences between the two groups,indicating that the clinical efficacy of the treatment group was better than that of the control group,which demonstrated the effectiveness of Qi-supplementing(2)Kidney-tonifying Recipe,and that the western medicine alone would not effectively improve the TCM symptoms.(3)Comparison between the two groups: in terms of improving the patients' myasthenia gravis,TCM symptoms and quality of life,the treatment group was significantly better than the control group,indicating that the Recipe is an effective method for treating myasthenia gravis,and worthy of clinical popularization and application.(4)After 4 weeks of treatment,the treatment group showed more obvious IL-6 decrease and TGF-?increase than those of the control group,indicating that the treatment group was better in immune regulation than the control group,which also verifies the immunomodulatory effects of the Recipe.(5)With level changes of IL-6 and TGF-?,the two groups of patients' myasthenia gravis,TCM symptoms and quality of life were significantly improved than that before treatment,and there was a significant statistical difference between the groups,indicating that the immune mechanism of the Recipe may be related to decrease of IL-6 and increase of TGF-?.(6)Clinical efficacy of the Recipe showed no significant side effects,giving preliminary affirmation for clinical application safety of the Recipe. |
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