HACCP体系在自行调节式口腔矫治器治疗OSAHS患者中的应用研究
【摘要】
目的：通过比较运用危害分析与关键控制点（hazard analysis critical control point，HACCP）体系与传统方式治疗阻塞性睡眠呼吸暂停低通气综合征（obstructive sleep apnea-hypopnea syndrome，OSAHS）患者使用自行调节式口腔矫治器（self-adjusting oral appliance，SOA）治疗在客观疗效、满意度、依从性以及不良事件发生方面的效果。
方法：研究纳入60例经PSG监测为轻、中度的OSAHS患者，随机分入实验组和对照组，两组患者均使用SOA治疗OSAHS。实验组的患者运用HACCP体系治疗，对照组的患者运用传统方式治疗。治疗前1周及治疗后1、6个月后，使用多导睡眠监测（Polysomnography，PSG）评价SOA的疗效，治疗后6个月填写自行设计的OSAHS患者满意度自制量表行满意度评价，治疗后1个月、3个月和6个月分别填写Morisky测量表自制量表和自行设计的OSAHS不良事件调查表行依从性和不良事件评价，获资料采用SPSS23.0进行统计学分析，以P<0.05差异有统计学意义。
结果：客观疗效方面，治疗前1周与治疗后1个月比较，PSG监测疗效指标AHI下降率为实验组（50.35±8.08）%，对照组（50.23±8.64）%，两组均有疗效且差异无统计学意义（P>0.05），LSaO2上升率为实验组（9.03±1.47）%，对照组（8.98±1.79）%，两组差异无统计学意义（P>0.05）；治疗前1周与治疗后6个月比较，PSG监测指标实验组AHI下降率（61.67±8.28）%，对照组AHI下降率（50.13±8.79）%，两组均有疗效，比较差异有统计学意义（P<0.05）；实验组LSaO2上升率（9.51±1.98）%，对照组LSaO2上升率（6.87±2.08）%，两组比较差异性有统计学意义（P<0.05）。满意度方面，治疗后6个月，实验组综合满意得分为6.07±0.87分，高于对照组为5.63±0.89分，满意度均较好，但两组综合满意度得分差异不明显（P>0.05），而两组在医患关系、医师处理和戴用时间三个方面的得分有显著差异（P<0.05）。依从性方面，治疗后1个月，实验组临床依从性良好率90.00%，对照组86.67%，差异无统计学意义（χ2=0.162，P>0.05）；治疗后3个月，实验组临床依从性良好率80.00%，对照组60.00%，差异无统计学意义（χ2=2.857，P>0.05）；治疗后6个月，实验组临床依从性良好率73.33%，对照组46.67%，差异有统计学意义（χ2=4.444，P<0.05）。不良事件发生方面，治疗后1、3个月，两组不良事件合计发生率比较，差异无统计学意义（P>0.05），治疗后6个月，两组不良事件合计发生率比较差异有统计学意义（P<0.05），并且在黏膜压痛、损伤和并发牙龈炎、牙周炎两种不良事件发生率比较，差异有统计学意义（P<0.05）。
结论：HACCP体系在SOA治疗OSAHS的满意度、依从性方面比传统治疗方式好。HACCP体系可以减少SOA矫治过程中不良事件的发生率。SOA在HACCP体系和传统方式中治疗OSAHS患者中都是有效的。
【关键词】HACCP；自行调节式口腔矫治器（SOA）；阻塞性睡眠呼吸暂停低通气综合征（OSAHS）
Study of HACCP system in the treatment of OSAHS patients with self-adjusting oral appliances(https://www.daowen.com)
ABSTRACT
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 LSaO2increase 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<0.05）.The increase rate of LSaO2in 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<0.05）.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 was 90.00%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 was 80.00%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，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：HACCP system is better than traditional treatment in the satisfaction and compliance of OSAHS treated by SOA.HACCP system can reduce the incidence of adverse events in the process of the treatment with SOA.SOA is effective in treating with OSAHS patients in HACCP system and traditional methods.
Key words：Hazard Analysis Critical Control Point；Self-adjusting Oral Appliance；Obstructive Sleep Apnea Hypopnea Syndrome