2. Materials and Methods
2.1 Inclusion and exclusion criteria
We screened a total of 378children (6–12 years-of-age) with M.
pneumoniae pneumonia who had been hospitalized at Beijing Friendship
Hospital affiliated toCapital Medical University between February 2017
and December 2018.Of these, 130 were not eligible, as determined by our
inclusion criteria, and 91 declined to take
part. Consequently, our final
analysis featured 157 children; these children were randomly allocated
into a control group (82 patients) and an HFCWO group (75 patients).
The inclusion criteria were as follows:1) clinical manifestations of
pneumonia, such as fever and cough;2) radiological changes associated
with pneumonia; 3) an antibody titer ≥1:160 in the gelatin particle
agglutination assay;4) no treatment prior to admission; and 5) no
requirement for immediate oxygen therapy. Patients were excluded if
pathogen detection tests suggested
that the patient had a combination
of infections, if chest radiography showed obvious pulmonary
consolidation, if the patient suffered from congenital respiratory
problems, or if the patient was unable to complete the lung function
test.
The study was approved by the medical ethics committee of Beijing
Friendship Hospital affiliated toCapital Medical University (Reference
Number: 2017-239) and the parents/guardians of all included subjects
provided informed and signed consent.
2.2 Treatment
The control group were administered
with azithromycin (Pfizer Ireland
Pharmaceuticals, NY, USA) via an intravenous drip (10 mg/kg, once
daily),Budesonide Suspension for
Inhalation (AstraZeneca Pty Ltd., North Ryde, Australia) by
atomization inhalation (2 mg, twice
daily), and Compound Ipratropium Bromide Solution for Inhalation
(Laboratoire Unither, Espace
Industriel Nord, France) by atomization inhalation (1.25–2.5 mL, twice
daily). All drugs were administered for 7 days. In addition to the
treatment provided for the control group,the HFCWO group also underwent
sputum clearance using HFCWO (20
min, twice daily for 7 days, 10 Hz, at a pressure setting of 4) (Talent
Medical Electronics Co., Ltd, Zibo, China). In the event of fever,
subjects in either group were given ibuprofen (Shanghai Johnson &
Johnson Co., Shanghai, China). If
children developed expiratory dyspnea and transcutaneous oxygen
saturation SO2<90%, they were given
persistent low flow oxygen therapy (1–3L/min).
2.3 Clinical data collection
Upon recruitment, we acquired a range of clinical information from all
patients, including gender, age, clinical data related to illness, time
of symptom onset, time of symptom
remission,respiratory rate and
oxygen supplementation. We then calculated the duration of symptomsas
the time from the onset of symptoms to remission. The length of
stay(LOS) was determined for all patients, as well as the costs
involved.
2.4 Lung function testing
Prior to treatment, and after 7 days of treatment, we tested the
pulmonary function of each child using a lung function measurement
system (AS-507; MINATO Medical Science Co.,LTD.,Osaka,Japan).We recorded
a range of parameters, including
theforced expiratory volume in 1 s
(FEV1)/predicted value, forced vital capacity (FVC)/predicted value, and
peak expiratory flow (PEF)/predicted value. All patients were of Chinese
ancestry. The predicted values were calculated by using the published
predicted valuesfor children’s lung function in Beijing,China(11).
2.5 Imaging and laboratory tests
Chest X-rays,routine blood tests, and C-reactive protein (CRP) tests,
were performed immediately on the day of admission and 7 days after
treatment. Chest X-rays were compared by a radiologist, who was blinded
to the experimental grouping, based on the electronic images of two
images taken before and after treatment so as to identify changes in
chest abnormalities and create a formal report.
2.6 Therapeutic effects
After 7 days of treatment, we evaluated the efficacy of our treatment
plan. The treatment was considered
as
“effective”
if fever, convulsive cough, and other symptoms of the upper respiratory
tract,had disappeared. The treatment was considered as “ineffective”
if obvious clinical symptoms remained after the treatment had finished,
and the chest X-ray suggested no
improvement or aggravation (12).
2.7 Data analysis
SPSS 21.0(IBMCorp.,Armonk,NY,USA) was used for all statistical
analyses.The Shapiro-Wilk test was
used to determine whether data were normally distributed.Normally
distributedcontinuous data are expressed as mean ± standard deviation,
whilecategorical data are expressed as frequency and percentage.
Chi-square tests and independent-sample t-testswere used to compare data
between the two groups.
3. Results
3.1 Side effects arising from vibration therapy
Ten children described transient dizziness caused by vibration during
HFCWO treatment, although this was well tolerated and disappeared when
the treatment had been completed. None of the children experienced side
effects, such as an abnormally fast heart rate, shortness of breath,
chest distress, or other problems caused by hammer dynamic changes.
3.2 Comparison of baseline data between the HFCWO and control groups
There were 75 patients in the HFCWO group; 53 males (79.7%) males and
22 females (20.3%) with a mean age of 8.01±1.37 years. There were 82
patients in the control group; 62 males (75.6%) and 20 females (24.4%)
with a mean age of 7.96±1.37 years. There were no significant
differences between the two groups with regards to age, gender, white
blood cell count(WBC), respiratory rate or CRP level
(P>0.05). Prior to treatment, there were no significant
differences between the two groups with respect to FEV1 (79.2±2.51%vs 79±2.48%), FVC (83.1±2.74% vs 83.4±2.69%), or PEF
(82±0.86% vs 82±0.85%) (Table 1).
3.3 Comparison of the treatment effects,cost, and length of staybetween
the HFCWO and control groups
Following treatment, there were no significant differences in WBC and
respiratory ratewhen compared between the two groups. However, the CRP
levels of patients in the HFCWO group were significantly lower than
those in the control
group(7.13±4.39vs 9.53±1.51
mg/L; P<0.05).Although there was no difference inrespiratory rate,but
high respiration rate matched for age and gender in the HWCO group had
significantly less than the contrcol group(10.1%vs 23.2%;
P<0.05)Five children required oxygen in theHFCWO group; this was
significantly fewer than the 14 patients in the control group that
required oxygen (6.67% vs 17.07%; P<0.05). The total effective
rate in the HFCWO group (88%) was significantly higher than that in the
control group (75.6%; P<0.05). The duration ofcough in the
HFCWO group (5.2±1.2 days) was significantly shorter than that in the
control group (5.8±1.5 days; P<0.001). Furthermore, the
duration of fever in the HFCWO group (3.6±0.93 days) was significantly
shorter than that in the control group (5.1±1.08 days;
P<0.001). Following treatment, FEV1
(81.5±1.67% vs 80.3±2.19%;
P<0.001), FVC (85.3±2.49% vs 84.2±2.67%; P = 0.007),
and PEF (85.5±1.34% vs 84.0±1.05%; P<0.001), were all
significantly higher in the HFCWO group than in the control group (Table
2). The proportion of chest X-raysindicating no improvement or
aggravation in the HFCWO group(27,36%) was lower than that in the
control group(35,42.7%),but the difference showed no statistically
significant(P=0.392).The LOS in the HFCWO group was significantly
shorter than that in the control
group(9.03±1.81vs10.78±2.49 days; P<0.001). Finally, the treatment costs in the HFCWO
group were significantly lower than the control
group(6263.29±1727.7vs7769.82±2118.65 yuan; P<0.001).