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(Improvement in therapeutic pressure parameters and symptoms in patients with obstructive sleep apnea hypopnea syndrome after intervention with two types of devices for automatic and continuous regulation of the positive airways pressure) [Chinese - simplified characters]
Liu J-X, Zhu Y
Zhongguo Zuzhi Gongcheng yu Linchuang Kangfu [Journal of Clinical Rehabilitative Tissue Engineering Research] 2007 Mar 4;11(9):1675-1678
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: to compare the clinical efficacy of two types device regulating automatic continuous positive airways pressure (auto-CPAP) in treating obstructive sleep apnea syndrome, so as to provide references for clinical selection of auto-CPAP. METHODS: Thirty-two inpatients with obstructive sleep apnea hypopnea syndrome treated in Fifth People's Hospital of Shangqiu and Sleep Disorders Center, Third People's Hospital of Shangqiu between April 2004 and April 2005 were selected. All the patients received twice treatments, in which they were given auto-CPAP: autoSet Spirit (ResMeD, Australia), and Puritan Bennett 420E (Puritan Bennett, USA) therapy in randomized order, every treatment lasted for the sleep parameters such as airflow of mouth and nose, respiratory movement of chest, snore, saturation of arterial blood oxygen (SAO2) and so on were measured. With random single blind design, the sleep parameter and therapeutic pressure during two types auto-CPAP therapy were compared among the 32 patients with obstructive sleep apnea hypopnea syndrome. The Chi-square test was adopted for count data, and t-test was used to compare the count data before and after treatment. The comparison of the count data between the two types device treated the same patient was analyzed with t-test. RESULTS: Thirty patients involved in the result analysis, and 2 were lost. (1) After 420E therapy for the 32 patients, 84.5% showed significant improvement in drowsiness in daytime; the apnea-hypopnea index (AHI) of 86.7% was decreased AAHI < 5 times per hour after treatment), and the lowest SAO2 reached 90%. (2) No significant difference was found in AHI, lowest SAO2 and average apnea time. (3) Spirit was more efficacious in shortening the longest apnea time and lowering the apnea events (percentage of hypopnea and apnea time) compared with 420E (longest apnea time: 26.23 +/- 9.81, 34.15 +/- 15.23 s; percentage of time: 0.87 +/- 0.72, 1.47 +/- 1.10, p < 0.05). (4) The mean pressure of Spirit was larger than that of 420E (mean difference values: 102.90 +/- 117.60 Pa, p > 0.05). (5) There was no significant difference in the maximum pressure and 95% confidence interval pressure. CONCLUSION: AutoSet Spirit is equally as effective as Puritan Bennett 420E in treating medium and severe obstructive sleep apnea hypopnea syndrome. But there are some differences in improving certain single parameter between the two types device, and their average therapeutic pressures are also different.

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