| Background: The first-line treatment of the chronic airway diseases is the inhalation therapy,and the level of inhalation technique of this kind of patients is an important factor affecting the efficacy of it.At present,the Digital Assessment of inhalation technique is limited at home and abroad,which is the main technical bottleneck restricting the clinical guidance of patients.In this study,we want to explore the influencing factors of the inhalation technique of patients with chronic airway disease in the real world by investigating their level of inhalation technique of them.A new type of digital intelligent assessment technology was used to evaluate the inhalation pattern of patients quantitatively and explore the evaluation parameters and standards which reflect the characteristics of inhalation ability.Not only providdes a new strategy for the selection and application of different inhalers correctly for clinical patients,but also provides a scientific basis for the quantitative evaluation of the of quality of inhalation therapy for chronic airway diseases.Method:1.A questionnaire was used to investigate the inhalation technique of chronic airway disease patients who used the inhalers.2.A standard flow/volume simulator(Model 1120,Hans Rudolph Inc.,USA)was used to evaluate the quality of flow,volume and impedance of the new inhalation technique assessment device(PF810,UBREATH(?),Zhejiang)under the condition of adding different inhaler built-in resistance(R0 ~ R5 levels).3.Normal people,patients with bronchial asthma and patients with chronic obstructive pulmonary disease were subjected to inhalation tests at least 5 times under different resistance gears with PF810 respectively.After testing the optimal curve and the results of the inhalation index were selected for analysis.The inhalation index included peak inspiratory flow(PIF),effective inspiratory volume(EIV),effective inspiratory time(EIT),breath-hold time after inspiratory(BHT),time to reach the minimum effective inspiratory flow rate(Tmin),time to reach the peak inspiratory flow(Tpf).The inhalation technique of the patients with chronic airway disease was trained by PF810 and the inhalation technical indicators were reviewed to compare the changes before and after training.SPSS V25.0 statistical software was used for statistical analysis.T-test was used to analyze the normally distributed data and the Kruskal-wallis H test was used to analyze the skewed distributions.A nomogram was used to establish the risk prediction model.P<0.05 was defined as a statistically significant difference.3.Normal people,patients with bronchial asthma and patients with chronic obstructive pulmonary disease were subjected to inhalation tests at least 5 times under different resistance gears with PF810 respectively.After testing the optimal curve and the results of the inhalation index were selected for analysis.The inhalation index included peak inspiratory flow(PIF),effective inspiratory volume(EIV),effective inspiratory time(EIT),breath-hold time after inspiratory(BHT),time to reach the minimum effective inspiratory flow rate(Tmin),time to reach the peak inspiratory flow(Tpf).The inhalation technique of the patients with chronic airway disease was trained by PF810 and the inhalation technical indicators were reviewed to compare the changes before and after training.SPSS V25.0 statistical software was used for statistical analysis.T-test was used to analyze the normally distributed data and the Kruskal-wallis H test was used to analyze the skewed distributions.A nomogram was used to establish the risk prediction model.P<0.05 was defined as a statistically significant difference.Results:1.A total of 206 patients were included in the analysis of the inhalation technique survey.The median score of medication compliance was 6.00(4.19,7.00),which indicates moderate compliance.The median score of mastery of the inhalation technique was 8.00(7.00,9.00),indicating good mastery of the inhalation technique.Among them,the scores of the COPD group and asthma group were 7.00(6.00,9.00)and 9.00(7.00,10.00),respectively.Chi-square test results showed that the proportion of the asthma group with good inhalation technique was significantly higher than that of the COPD group(χ2=11.57,P=0.001).Seven risk factors were included in the nomogram prediction model for incorrect inhalation techniques,including age,education,drug recognition,efficacy evaluation,pre-inhalation guidance,postguidance assessment,and follow-up assessment.The ROC curve obtained by this model showed that the AUC was 0.814,the sensitivity was 0.78,and the specificity was 0.75.The model had good discriminability,correctability and clinical validity.The C-index was 0.814(Z=10.31,P < 0.001)and it was confirmed to be 0.783 by bootstrapping validation.2.The quality control pass rate of the flow test repeatability,accuracy and linearity of the PF810 was 100.00%(48/48),95.83%(46/48)and 95.24%(40/42).The pass rate of repeatability,accuracy and linearity of the volume test was 100.00%.The relative errors of resistance between the inhalers and the corresponding simulated built-in resistance of PF810 were all < 5%.3.A total of 217 subjects were included in the assessment of inhalation administration quantitatively.51 healthy subjects,75 patients with asthma,91 patients with COPD were included.A total of 4559 inhalation tests were performed.The pass rate of R0 ~ R5 resistance gears from low to high was R1(3.38%),R0(8.42%),R2(15.31%),R3(16.71%),R4(20.27%)and R5(46.91%).Among all resistance gear,the highest percentage in excessive PIF was R0(23.08%)and the highest percentage in insufficient PIF was R1(11.86%).The highest percentage in insufficient EIT was R0(83.78%)and the highest and lowest percentage in BHT less than 5 s was R0(73.80%)and R5(18.40%)respectively.149 subjects who had used the inhalation device were trained in the inhalation technique.Compared with the evaluation indexes of inhalation administration before and after training,it was found that the EIV and EIT at R0 were increased significantly compared with that before training(Z values were-5.651 and-5.646,P < 0.001),and the excessive PIF was decreased compared with that before training(Z =-4.484,P < 0.001).P < 0.001)which was closer to the optimal PIF.The EIV(Z values were-2.521,-4.724,-5.258,-2.847,all P < 0.05)and EIT(Z values were-2.366,-4.590,-5.160,-2.934,all P < 0.05)under R1,R2,R3 and R5 resistance was increased significantly after training.Simple linear regression between EIV and demographic data and clinical characteristics showed that EIV had positive linear relationships with height,weight,FVC%pred,and negative linear relationships with age.Conclusions:1.Further training is needed to improve the mastery of inhalation techniques in patients with chronic airway diseases,especially COPD patients.Age,education level,drug cognition,self-evaluation of curative effect,inhalation device use instruction before treatment,and post-instruction evaluation at return visit were risk factors for incorrect inhalation techniques in patients with chronic airway disease.2.A standard flow/volume simulator can be used to test the quality of the inhalation assessment device under additional resistance objectively and scientifically.The new intelligent assessment device for the effectiveness of inhalation drug delivery used in this study has good detection performance.3.Patients with chronic airway diseases have poor inhalation techniques when using inhaler devices.The assessment of inhalation techniques of patients with chronic airway diseases scientifically and objectively can guide the clinical to select suitable inhalers.Training in inhalation techniques visually and precisely can improve the inhalation pattern of patients with chronic airway diseases. |
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