[Objective] To investigate effects of LTC4, IL-8, TNF-a, ET ofinflammation in stable patients with moderate to severe chronic obstructive pulmonary disease (COPD )And observe the influence of LTA or ICS on clinic symptom, quality of life, pulmonary function test, airway inflammation patients in stable patients with moderate to severe COPD. At the same time, we can evaluate the of airway inflammation in stable phase of COPD in order to find the theoretical basement for the LTA or ICS treatment in stable patients with COPD.[Metheods] 80 in-patients with COPD diagnosed and followed up inout-patients department of Shandong provincial hospital were enrolled in the study between Mar. 2005 and Dec. 2006. All patients were defined by the guideline of diagnosis and therapy for COPD and they were randomized to divide into therapy group(C, n:30, D,n:30) and control group(B, n: 20).The patients of C received conventional therapy and montelukast 10 mg qn, The patients of D received conventional therapy and Pulmicort Turbuhaler 400 ug bid, and single conventional therapy in B for 6 months. The conventional therapy included oxygen inhalation therapy, expectorant and Salmeterol inhalation used as rescue medicaton. 15 healthy subjects were obversed in this study. Record the following data at the beginning and end of the study.1. The genereal status, including age, gender, smoking index, exacerbation number every year and the grade and duration of disease.2. All man were draw blood 2 ml and stored at -70°C for future measurements the concentrations of LTC4, IL-8, TNF-a, ET.3. Pulmonary function tests(PFT),including bronchodilatation test, forced vital capacity(FVC), forced the first second of expiratory volume (FEV1) and FEV1/FVC.4. 6-MWT: The distance of Six minutes walk.5. The score of health-related quality of life (HRQoL) (the St.George's respiratory questionnaire ),including symptom score, impact score ,activity score and total score.6. The score of dyspnea.7. The percentage of neutrophils and eosinophils in the sputum samples.[Results]1 .There were no significant difference in common data including sex, age, smoking history in B, C and D groups at baseline (P>0.05 ) And 4 patients were exited this experiment for hoarse voice.2. LTC4 There was a significant difference in LTC4 in A 92.98±14.41 pg/ml and B1002.161±71.02 pg/ml (P < 0.01), and no significant difference in B,C,D at the first month.3Month(3M): There was a significant decrease in C,D (P < 0.05) , but no difference in C and D( P > 0.05).6 Month(6M): There also was a significant decrease in C,D (P < 0.05), but no difference in C and D( P > 0.05).3. IL-8 There was a significant difference in IL8 in A149.47±25.23pg/ml and B806.33±142.9 pg/ml (P < 0.01) and no significant difference in B,C,D at the first month . 3M: B were deteriorated (P < 0.05). 6M: There was a significant decrease in C,D (P < 0.05) , but no difference in C and D( P > 0.05)4.TNF - a There was a significant difference in TNF - a in A0.12±0.16ng/ml and B 0.22±0.02 ng/m1.3M: There was a significant decrease in C,D (P< 0.05) , but no difference in C and D( P > 0.05) 6M There also was a significant decrease in C,D (P < 0.05), but no difference in C and D( P > 0.05).5. ET 3M: There was a significant decrease in C87.64±8.34 pg/ml, (P < 0.05) , 6M There also was a significant decrease in C,D (P < 0.05), and have difference in C84.21±10.06pg/ml and D88.97±9.67pg/ml ( P < 0.05).6. FEV1 There was a significant difference in FEV1 , in A2.84±0.78L and B1.35±0.38L(P < 0.01) and no significant in B,C and D at the first P >0.05;3M: There was significant decrease in C,DandB(P < 0.05), 6M There was significant difference in C,DandB(P < 0.05), but no difference in C and D ( P> 0.05) ;7. The score of dyspnea There was a significant difference in The score of dyspnea in A1.8±0.4B3.4±0.7(P < 0.01); There was significant decrease in C,Din first month; 3M C and D wre continued improve(P < 0.01).6M Also have improved in CandD,but have no significant difference with 3M (P >0.05);8. 6-MWT There was a significant difference in A538.33±51.84m and B361.40±64.61m(P < 0.01); After one month a significant increase in C and D3M There were significant increase in Cand D(P< 0.05).6M There were significant increase in Cand D(P < 0.05) but have no significant difference with 3M(P>0.05);9. SGRQ There was a significant difference in A25.89±5.21 B65.78±4.11 (P < 0.01), 3M There was significant decrease in C and D(P < 0.01). 6M There was significant decrease in C and D(P< 0.01), but no difference in C and D (P> 0.05);10. There was a significant difference in the change of neutrophilic percentage in sputum samples in A18.12±10.05 and B48.76±11.64 , a significant decrease after the study3 month and 6 month in C and D (P <0.05 );11. Correlation The level of LTC4 was positively correlated with The level of IL-8,ET in blood (r=0.543, 0.642 P=0.037, 0.010) ,The level of LTC4 was negatively correlated with FEV1 (r= - 0.578 P=0.024) ; The level of IL-8 was positively correlated with The level of TNF-a in blood (r=0.534 P=0.040) The level of IL-8 was negatively correlated with FEV1 (r= - 0.566 P=0.028) ; 6-MWT was positively correlated with FEV1 (r=5.74 P=0.025) ;SGRQ was negatively correlated with FEV, (r=-5.65 P=0.026)[Conclusions]1. LTC4, IL-8, TNF-a and ET may play an important role in inflammation of COPD.2. 6-MWT and the score of SGRQ may also as a item of lung function .3. LTA- montelukastis used additionally in routine treatment protocol can improve the HRQoL, 6-MWT, PFT and decrease the neutrophilic percentage in sputum. LTA may be taken into account when there is need for additional anti-inflammatory treatment in COPD patients.4. ICS- Pulmicort Turbuhaler also can used can improve the HRQoL, PFT, 6-MWT in routine treatment COPD patients.5. Although two drugs may have a similar roule in COPD, LTA- montelukastis was easy to received by takeing once one day. |