Objective:To investigate the efficacy,safety,and prognostic factors associated with immune checkpoint inhibitors(ICIs)in pa-tients with non-small cell lung cancer(NSCLC)comorbid with chronic obstructive pulmonary disease(COPD).Methods:Clinical and patholo-gical data were collected from 100 patients with stage Ⅲ-Ⅳ NSCLC who received one or more cycles of ICI treatment at Peking University Shougang Hospital between January 2018 and October 2024 were collected.Based on COPD diagnosis,patients were assigned into the NSCLC with COPD(LC-COPD,n=52)and NSCLC without COPD(non-COPD,n=48)groups.The efficacy,safety,and prognostic factors of ICIs treatment were retrospectively analyzed in both groups.Survival analysis was performed using the Kaplan-Meier method,and survival rates were compared using the Log-rank test.Results:Among the patients who received ICIs treatment,median progression-free survival(PFS)in the LC-COPD group was longer than that in the non-COPD group(11.97 vs.7.83 months,P=0.022),but no significant difference was detec-ted in overall survival(OS)(22.37 vs.16.80 months,P=0.110).Compared with the LC-COPD group and patients with normal lung function,the preserved ratio impaired spirometry(PRISm)subgroup showed worse median PFS and OS following immunotherapy(all P<0.05).Multivari-ate analysis revealed that COPD comorbidity,programmed cell death-ligand 1(PD-L1)expression,treatment line,and neutrophil to lympho-cyte ratio(NLR)were independently associated with PFS(P<0.05).Additionally,PD-L1 expression,immunotherapy efficacy,NLR,and inhaled corticosteroids(ICS)use were significantly associated with OS(P<0.05).The incidence of immune-related adverse events was comparable between the two groups.Conclusions:ICI treatment demonstrated a greater positive impact on PFS in patients with NSCLC and COPD than in patients with NSCLC alone in a real-world study,with a good safety profile in both groups.NSCLC patients with PRISm showed poorer out-comes following ICI treatment.PD-L1 expression,FeNO,NLR,and ICS may serve as potential predictive biomarkers for immunotherapy effic-acy in NSCLC patients with COPD.

Objective:To investigate the efficacy,safety,and prognostic factors associated with immune checkpoint inhibitors(ICIs)in pa-tients with non-small cell lung cancer(NSCLC)comorbid with chronic obstructive pulmonary disease(COPD).Methods:Clinical and patholo-gical data were collected from 100 patients with stage Ⅲ-Ⅳ NSCLC who received one or more cycles of ICI treatment at Peking University Shougang Hospital between January 2018 and October 2024 were collected.Based on COPD diagnosis,patients were assigned into the NSCLC with COPD(LC-COPD,n=52)and NSCLC without COPD(non-COPD,n=48)groups.The efficacy,safety,and prognostic factors of ICIs treatment were retrospectively analyzed in both groups.Survival analysis was performed using the Kaplan-Meier method,and survival rates were compared using the Log-rank test.Results:Among the patients who received ICIs treatment,median progression-free survival(PFS)in the LC-COPD group was longer than that in the non-COPD group(11.97 vs.7.83 months,P=0.022),but no significant difference was detec-ted in overall survival(OS)(22.37 vs.16.80 months,P=0.110).Compared with the LC-COPD group and patients with normal lung function,the preserved ratio impaired spirometry(PRISm)subgroup showed worse median PFS and OS following immunotherapy(all P<0.05).Multivari-ate analysis revealed that COPD comorbidity,programmed cell death-ligand 1(PD-L1)expression,treatment line,and neutrophil to lympho-cyte ratio(NLR)were independently associated with PFS(P<0.05).Additionally,PD-L1 expression,immunotherapy efficacy,NLR,and inhaled corticosteroids(ICS)use were significantly associated with OS(P<0.05).The incidence of immune-related adverse events was comparable between the two groups.Conclusions:ICI treatment demonstrated a greater positive impact on PFS in patients with NSCLC and COPD than in patients with NSCLC alone in a real-world study,with a good safety profile in both groups.NSCLC patients with PRISm showed poorer out-comes following ICI treatment.PD-L1 expression,FeNO,NLR,and ICS may serve as potential predictive biomarkers for immunotherapy effic-acy in NSCLC patients with COPD.

Objective:To explore the feasibility of high-flow nasal cannula(HFNC)therapy for respiratory failure in elderly patients.Methods:A total of 300 patients with respiratory failure admitted to Peking University Shougang Hospital from December 2016 to March 2019 were enrolled in this prospective study.Patients were divided into three groups: the HFNC group, the conventional oxygen therapy(COT)group and the non-invasive positive pressure ventilation(NPPV)group(n=100 in each group). Arterial oxygen saturation(SPO 2), oxygen index(OI), heart rate(HR), respiratory rate(RR), mean arterial pressure(MAP), comfort level, discharge rate, tracheal intubation rate, rate of referral to ICU, mortality and rate of referral to another group after therapy were compared between the HFNC and COT groups and between the HFNC and NPPV groups. Results:SPO 2 after oxygen therapy for 30 minutes( t=-2.992, P=0.003), 1 hour( t=-2.884, P=0.005)and 6 hours( t=-3.196, P=0.002)and OI before discharge( t=-2.060, P=0.048)were higher in the HFNC group than in the COT group.The HR in the above two groups was lower before discharge than before therapy, and the HR in the COT group was even lower(73.1±25.1 beat per minute vs.75.1±25.9 beat per minute), but both were within the normal range.The discharge rate was higher( χ2=-1.969, P=0.049), while the rate of referral to another group was lower in the HFNC group than in the COT group( χ2=-3.115, P=0.002). There was no significant difference in the tracheal intubation rate, ICU transfer rate and mortality between the HFNC and COT groups.SPO 2 after oxygen therapy for 30 minutes( t=-2.026, P=0.046)and 6 hours( t=-2.101, P=0.040)were higher in the HFNC group than in the NPPV group, but there was no significant difference in OI and SPO 2 between the two groups before discharge.The HR in both HFNC and NPPV groups was lower before discharge than before therapy, and there was no statistical difference between the two groups.The mortality, discharge rate, tracheal intubation rate, ICU transfer rate and rate of referral to another group had no significant difference between the HFNC and NPPV groups.The comfort level was higher in the HFNC group than in the COT and NPPV groups( t=-3.758 and -19.180, both P=0.000). Conclusions:HFNC is a new type of oxygen therapy equipment introduced after COT and NPPV, and possesses more advantages for elderly patients with respiratory failure.

OBJECTIVE:To explore the effects of PDCA method in the new specialties accreditation of drug clinical trial institution. METHODS:PDCA method was used for drug clinical trial institution office and 9 newly applied majors in our hospital. Total score of each major were compared before and after intervention,in order to make the newly applied major meet the standard of specialties accreditation of drug clinical trial. RESULTS:After conducting PDCA related training,establishing new specialties accreditation work group,formulating work goals and plans,9 new majors of our hospital were all approved by CFDA for new specialties accreditation;after intervention total score of each accreditation item for newly applied major were all higher than before intervention,with statistical significance(P<0.05),improved by more than 45.57%. CONCLUSIONS:It is feasible to adopt PDCA method in the preparation of new specialty accreditation of drug clinical trials. It is of significance to guarantee scientific and reliable drug clinical trial results and protect the rights and interests of the subjects.

Objective To observe the clinical efficacy ofTiaozhong YifeiPrescription combined with Western therapy for treatment of cough variant asthma (CVA) remission. Methods Totally 90 patients with CVA remission were randomly divided into TCM group, Western therapy group and TCM and Western therapy group, 30 cases in each group. TCM group was givenTiaozhong YifeiPrescription, 1 dose per day, morning and evening; Western therapy group was given salmeterol xinafoate and fluticasone propionate powder for inhalation, each 1 suction, 2 times a day, inhalation; a mixture ofTiaozhong YifeiPrescription and xinafoate and fluticasone propionate powder for inhalation was given to TCM and Western therapy group, the same as above, continuous treatment for 12 weeks. TCM syndrome score, EOS, IgE, pulmonary function and safety index were observed in the three groups before and after treatment. The recurrence rate and the number of colds after three-month treatment were observed.Results TCM syndrome scores in the three groups decreased after treatment (P<0.05). There was statistical significance between TCM group and TCM and Western therapy group after treatment (P<0.05). The total effective rate of TCM group was 96.67% (29/30), 100.00% (30/30) of Western therapy group, 76.67% (23/30) of TCM and Western therapy group, with statistical significance (P<0.05). After three-month treatment, 1, 0 and 11 cases relapsed in TCM group, TCM and Western therapy group and Western therapy group, respectively, with statistical significance (P<0.001). Compared with the Western therapy group, the number of colds in the TCM group and TCM and Western therapy group significantly decreased (P<0.05). Compared with before treatment, IgE decreased significantly (P<0.05). There was no significant difference in EOS among the three groups before and after treatment (P>0.05). After treatment, the maximum expiratory flow in TCM and Western therapy groupwas higher than that before treatment and lower than that in the Western therapy group (P<0.01), and the other lung function indexes were not statistically significant (P>0.05). 1 mild adverse reaction was found in the TCM and Western therapy, and no obvious adverse reactions were found in other groups (P<0.05).ConclusionTiaozhong Yifei Prescription has good clinical efficacy for CVA.

Objective To explore the effects of tiotropium combined with seretide inhalation therapy on pulmonary function and prognosis of patients with moderate and severe chronic obstructive pulmonary disease(COPD).Methods A total of 91 patients with moderate and severe COPD were divided into observation group(n=48)and control group(n=43).The control group was only given seretide inhalation,while the observation group was given additional tiotropium bromide inhalation therapy on the basis of the control group.The pulmonary function and prognosis before and after treatment were compared between the two groups.Results After treatment,the levels of FEV1,FVC,FEV1/FVC/％and FEV1％pre in the observation group were significantly higher than those in the control group(P<0.05).In the observation group,the p(O2),p(CO2)after treatment were significantly better than the control group(P<0.05).The levels of hs-CRP,IL-6 and PCT were significantly lower in the observation group than the control group(P<0.05).The dyspnea score,CAT score and SGRQ score of the observation group after treatment were significantly lower than those of the control group,and the 6 min walking test was significantly higher than the control group(P<0.05).Conclusion For patients with moderate and severe COPD,tiotropium combined with seretide inhalation therapy can significantly improve their pulmonary functions and arterial blood gas status,alleviate inflammatory response,so it is worthy of popularization.

Objective To explore the effects of tiotropium combined with seretide inhalation therapy on pulmonary function and prognosis of patients with moderate and severe chronic obstructive pulmonary disease(COPD).Methods A total of 91 patients with moderate and severe COPD were divided into observation group(n=48)and control group(n=43).The control group was only given seretide inhalation,while the observation group was given additional tiotropium bromide inhalation therapy on the basis of the control group.The pulmonary function and prognosis before and after treatment were compared between the two groups.Results After treatment,the levels of FEV1,FVC,FEV1/FVC/％and FEV1％pre in the observation group were significantly higher than those in the control group(P<0.05).In the observation group,the p(O2),p(CO2)after treatment were significantly better than the control group(P<0.05).The levels of hs-CRP,IL-6 and PCT were significantly lower in the observation group than the control group(P<0.05).The dyspnea score,CAT score and SGRQ score of the observation group after treatment were significantly lower than those of the control group,and the 6 min walking test was significantly higher than the control group(P<0.05).Conclusion For patients with moderate and severe COPD,tiotropium combined with seretide inhalation therapy can significantly improve their pulmonary functions and arterial blood gas status,alleviate inflammatory response,so it is worthy of popularization.

Objective To evaluate the preventive effect of BCG-PSN on respiratory infection of patients with chronic obstructive pulmonary disease.Methods 48 cases with COPD were randomly divided into two groups:the BCG-PSN group and the control group.The BCG-PSN group received BCG-PSN,0 5mg,im,twice a week for 18 times injection in addition to the routine therapy,and the control group only received routine therapy.Both groups were followed up every two weeks for six months.The serum IgA,IgG,IgM levels were determined before and 4,24 weeks after the treatment.Results Cases of infection and their lasting days,infective rate in the BCG-PSN group were significantly lower than that of the control group(P