Assisted Therapeutic Effect Of Mycobacterium Vaccae On Asthma Patients

8Introduction:Bronchial asthma (asthma) is a chronic airway inflammatory disease of respiratory system characterized by eversible airway obstruction, airway hyper reactivity (AHR). Currently, it is defined as a chronic inflammatory disorder of the airways in which many cells (eosinophils, mast cells, T lymphocytes, neutrophils, epithelia cells) and cellular elements play a role. Asthma is characterized by chronic airway inflammation that is orchestrated by activated T-helper (Th) 2 cells producing interleukin (IL-4) and IL-5, which promote airways eosinophilia, Immunoglobulin (Ig) E syntheses , airway infiltration by inflammatory cells.Although glucocorticoids are the first line therapy for the control of asthma, it is effective and well tolerated in most patients, there are some limitations, and there is a clear medical need for the development of new therapies capable of changing or reprogramming the underlying immune processes to produce a long term, Ag-specific protective immune response.In the ovalbumin-sensitised mouse model, Mycobacterium vaccae (M.vaccae ) dramatically reduces serum IgE and IL-5 release from the spleen as well as blood and lung eosinophilia and bronchial hyper responsiveness. It is a fact that the clear efficacy of M.vaccae seen in animal models has not yet been reproduced in human asthma. So it is to be worth to investigate the Immunotherapeutic effect of Mycobacterium vaccae on asthma patients.Objective:1,Compare the levels of IFN-γ, IL-4, IL-5 and IgE in observation group with those in control group before and after the treatment course, to explore the immunotherapeutic effect of M.vaccae on the balance of Th1/Th2 of asthmatic patients.2,Compare the levels of FVC and FEV1 in observation group with those in control group before and after the treatment course, to explore the effect of M.vaccae on the lung function of asthmatic patients.3,To evaluate the affectivity and security of M.vaccae on asthmatic patients.Methods:34 asthmatics with mild to moderate disease were randomly enrolled into two groups: observation group (n=19) and control group (n=15). The patients in observation group inhaled salmeterol xinafoate and flulieasone propionate (50/250μg Bid) and intramuscularly injected with M.vaccae (22.5μg once 10 days). The patients in control group only used salmetrol xinafoate and flulieasone propionate. Each treatment course is 3months. The levels of IFN-γ,IL-4,IL-5,IgE in blood serum and the levels of lung function (FVC,FEV1 and FEV1/FVC) were determined before and after treatment course in all patients. Record the largest PEF everyday in the past 3 months. Results:1,The level of IL-4 in serum After 3months treatment, the level of IL-4 dropped from(231±87)ng·L-1 to (206±73)ng·L-1 in observation group, decreased(-23±83)ng·L-1; the level of IL-4 dropped from(232±78)ng·L-1 to(223±88)ng·L-1 In control group, decreased (-8±85)ng·L-1.The comparison of IL-4 between after treatment and before treatment showed no significant differences in each group (p>0.05).The comparison of the decreased values in the observation with those in control group showed no significant differences (p>0.05).2,The level of IL-5 in serum After 3months treatment, the level of IL-5 dropped from(96±14)ng·L-1 to(50±11)ng·L-1 in observation group, decreased(-46±13)ng·L-1; the level of IL-5 dropped from(98±15)ng·L-1 to (89±11)ng·L-1 In control group, decreased(-9±14)ng·L-1.The comparison of IL-5 between after treatment and before treatment showed significant differences in observation group(P<0.05), but showed no significant differences in control group (p>0.05).The comparison of the decreased values in the observation with those in control group showed significant differences(P <0.05).3,The level of IFN-γin serum After 3months treatment, the level of IFN-γupgraded from(247±45)ng·L-1 to (265±43)ng·L-1 in observation group, increased(18±44)ng·L-1; the level of IFN-γupgraded from (251±45)ng·L-1 to (257±54)ng·L-1 In control group, increased (6±49)ng·L-1.The comparison of IFN-γbetween after treatment and before treatment showed no significant differences in each group (p>0.05).The comparison of the increased values in the observation with those in control group showed no significant differences (p>0.05).4,The level of IgE in serum After 3months treatment, the level of IgE dropped from(152±44)IU·L-1 to (66±39)IU·L-1 in observation group, decreased(-86±43)IU·L-1; the level of IL-4 dropped from (150±33)IU·L-1 to (129±40)IU·L-1 In control group, decreased (-24±37)IU·L-1. The comparison of IgE between after treatment and before treatment showed significant differences in observation group(P <0.05), but showed no significant differences in control group (p>0.05). The comparison of the decreased values in the observation with those in control group showed significant differences (P <0.01).5,The level of FVC After 3months treatment, the level of FVC upgraded from(3.3±0.6)L to (3.5±0.5)L in observation group, increased(0.2±0.6)L; the level of FVC upgraded from (3.3±0.6)L to (3.5±0.8)L in control group, increased (0.2±0.7)L. The comparison of FVC between after treatment and before treatment showed no significant differences in each group (p>0.05).The comparison of the increased values in the observation with those in control group showed no significant differences (p>0.05).6,The level of FEV1 After 3months treatment, the level of FEV1 upgraded from(2.6±0.7)L to(2.9±0.7)L in observation group, increased(0.3±0.7)L; the level of FEV1 upgraded from(2.5±0.5)L to(2.7±0.7)L in control group, increased(0.2±0.7)L. The comparison of FEV1 between after treatment and before treatment showed no significant differences in each group (p>0.05).The comparison of the increased values in the observation with those in control group showed no significant differences (p>0.05).7,The level of PEF In observation group ,the 1st month PEF level reach at (3.28±0.23)L·S-1,the 2nd month reach a(t3.92±0.27)L·S-1,the 3rd month reach at (3.97±0.24)L·S-1. The comparison of the 2nd and the 3rd month with the 1st month showed significant differences respectively(each P <0.01),the comparison of the second month PEF with the third month ones showed no significant differences(P >0.05);In control group ,the 1st month PEF level reach at (3.34±0.27)L·S-1,the 2nd month reach at(3.52±0.23)L·S-1,the 3rd month reach at(3.56±0.25)L·S-1,the comparison of each other all showed on significant differences(each P>0.05);The comparison of the 2nd and 3rd month PEF in observation group with the identical month PEF in control group showed significant differences respectively(P <0.05).Conclusions:1,M.vaccae have immunotherapeutic effect on asthmatic patients, because it can contribute to the secretion of Th1 cytokines, restrain the secretion of Th2 cytokines significantly, regulate the balance of Th1/Th2 in asthmatic patients.2,To some extent, M.vaccae also may cut down airduct resistance of asthmatic patients.3,The authors believe that the clinic applications of M.vaccae are safety, but it needs further clinical trials to study the potential effect of M.vaccae as a treatment for chronic asthma.