探讨草分枝杆菌R.U.36注射液(乌体林斯)预防咳嗽变异性哮喘(cough variant asthma，CVA)复发的疗效及其机制。

选取2008年1月至2010年10月于深圳儿童医院确诊的咳嗽变异性哮喘患儿49例为研究对象，将其随机分为治疗组(n＝25)和对照组(n＝24)。两组患儿性别、年龄及病程等比较，差异均无显著意义(P>0.05)(本研究遵循程序符合深圳儿童医院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象监护人的知情同意，并与其签署临床研究知情同意书)。对治疗组患儿采取孟鲁司特＋草分枝杆菌R.U.36注射液肌内注射治疗方式，对照组采取单纯孟鲁司特(剂量和用法与治疗组相同)治疗。观察两种治疗方法对预防咳嗽变异性哮喘的疗效及疗程结束1年内复发情况，同时测定嗜酸性粒细胞绝对值计数、总免疫球蛋白E(immunoglobulin E, IgE)，并行辅助性T淋巴细胞亚群(helper T lymphocyte，Th)1，Th2动态检测。

治疗组维持治疗过程中、疗程结束后1年内平均复发人次均低于对照组，两组比较(t＝3.98 vs. t＝3.63)，差异有显著意义(P<0.01)。两组患儿激素治疗前嗜酸性粒细胞绝对值计数，总IgE，Th1和Th2细胞百分率及Th1/Th2值比较，差异均无显著意义(P>0.05)。治疗组经草分枝杆菌R.U.36注射液治疗后，嗜酸性粒细胞绝对计数绝对值、总IgE均明显低于未经草分枝杆菌R.U.36注射液治疗的对照组，且差异有显著意义(t＝3.68 , t＝3.41；P<0.01)。治疗后，治疗组Th1细胞百分率和Th1/Th2值均明显高于对照组，且差异有显著性(t＝2.81，2.16；P<0.05)；而Th2细胞百分率低于对照组，但差异无显著性意义(P>0.05)。

草分枝杆菌R.U.36注射液肌内注射对预防咳嗽变异性哮喘复发有一定疗效，其机制可能与调节Th1/Th2功能平衡，抑制嗜酸性粒细胞和总IgE释放，促进咳嗽变异性哮喘免疫异常恢复和提高机体抗感染能力等有关。

To observe the effects of Mycobacterium phlei injection on antirelapse in cough variant asthma (CVA) and mechanism investigation.

From January 2008 to October 2010, 49 children with cough variant asthma were randomly divided into case group(n=25) and control group(n=24). Ages, sexes, course of disease between two groups had no significant differences(P>0.05). The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shenzhen Children's Hospital. Informed consent was obtained from the parents of each participating child. All children with cough variant asthma were all treated with montelukast. Mycobacterium phlei injection was given to case group(once a week for 12 weeks). The relapse rate during the treatment and within one year after course of treatment. A dynamic detection for absolute value of eosinophile count, total immunoglobubin(Ig) E, and helper T lymphocyte(Th) subsets was done in both groups.

The relapse rate in case group was lower than that of control group (t=3.98, 3.63; P<0.01). The absolute value of eosinophile count, total immunoglobubin E, the percentage of Th1 and Th2 and the ratio of Th1 and Th2(Th1/Th2) between two groups before treatment had no significant differences(P>0.05). After treatment by Mycobacterium phlei injection, the Th1/Th2 in case group were significantly higher than those of control group (t=2.81, 2.16; P<0.05), meanwhile the absolute value of eosinophile count and total immunoglobubin E in case group were significantly lower than those in control group (t=3.68, 3.41; P<0.01).

Mycobacterium phlei injection is effective for prevention of relapse of cough variant asthma.Its mechanism is related to adjusting Th1/Th2 function balance, lowering the eosinophile and total immunoglobubin E, accelerating the recovery of cough variant asthma immune abnormality and improving the capability of anti-infection.