| Objective:To compare the effects of self-adjusting oral appliance on objective effects,satisfaction,compliance and adverse events in patients with obstructive sleep apnea-hypopnea syndrome treated by HACCP system and traditional methods.Methods:Sixty patients with mild and moderate OSAHS monitored by PSG were randomly divided into experimental group and control group.Both groups were treated with SOA.Patients in the experimental group were treated with HACCP system,while patients in the control group were treated with traditional methods.One week before treatment,one months and six months after treatment,the objective effects of SOA was evaluated by Polysomnography.Six months after treatment,the self-designed OSAHS patient satisfaction scale was filled in to evaluate the satisfaction.One month,three months and six months after treatment,the self-made Morisky scale and the self-designed OSAHS adverse events questionnaire were filled in to evaluate the compliance and adverse events.SPSS23.0 was used for statistical analysis,and p < 0.05 was considered to be statistically significant.Results::In terms of objective effect,1 week before treatment and 1 month after treatment,the AHI decrease rate of PSG monitoring efficacy index was(50.35±8.08)% in the experimental group and(50.23±8.64%)in the control group.There was no significant difference between the two groups(p> 0.05).The LSa O2 increase rate was(9.03±1.47)% in the experimental group and(8.98±1.79)% in the control group.There was no significant difference between the two groups(p > 0.05).1 week before treatment and 6 month after treatment,the decrease rate of AHI in the experimental group was(61.67±8.28)% and that in the control group was(50.13 ±8.79)%.There were significant differences between the two groups(p< 0.001).The increase rate of LSa O2 in the experimental group was(9.51 ±1.98)% and that in the control group was(6.87 ±2.08)%.There was significant difference between the two groups(p < 0.001).In terms of satisfaction,6 months after treatment,the comprehensive satisfaction score of the experimental group was(6.07±0.87),higher than that of the control group was(5.63±0.89).However,there was no significant difference in the comprehensive satisfaction score between the two groups(p > 0.05),while there were significant differences in the three aspects of doctor-patient relationship,doctor treatment and wearing time between the two groups(p < 0.05).In terms of compliance,the good rate of clinical compliance was90.00% in the experimental group and 86.67% in the control group at 1 month after treatment,with no significant difference(χ2= 0.162,p > 0.05);the good rate of clinical compliance was80.00% in the experimental group and 60.00% in the control group at 3 months after treatment,with no significant difference(χ2 =2.857,p > 0.05);and the good rate of clinical compliance was 73.33% in the experimental group and the control group at 6 months after treatment.The difference was statistically significant(χ2= 4.444,p < 0.05).In terms of adverse events,there was no significant difference in the total incidence of adverse events between the two groups at 1 and 3 months after treatment(p> 0.05).At 6 months after treatment,there was significant difference in the total incidence of adverse events between the two groups(p < 0.05),and there was significant difference in the incidence of the tenderness and injury at mucous membrane,and complications of gingivitis and periodontitis(p < 0.05).Conclusions::Under the HACCP system or traditional management,SOA treatment OSAHS can both achieve better objective efficacy,but the application of HACCP system for management can improve patient satisfaction and compliance to a certain extent,and reduce the incidence of adverse events in the process of SOA correction. |