Table of Contents
According to the formula n = 2[(u1-α + u1-β) s/σ]2, α = 0.05, β = 0.01, n = 65 after calculating. Based on the provisions of the State Food and Drug Administration, 15% is the shedding release rate, so the sample size of the group is determined to be n = 65 × 1/(1-0.15) = 75.92 ≈ 76. Therefore, 76 children with RMPP admitted to our hospital from January 2020 to February 2021 were selected as the study subjects. According to the random number table method, they were divided into control group and study group, with 38 cases in each group. The study protocol was approved by the Ethics Committee of Wuhan Children’s Hospital, Tongji Medical College, Huazhong University of Science and Technology. The study protocol complies with the relevant requirements of the Declaration of Helsinki. All patients’ families were informed and signed the consents.
Inclusion and exclusion criteria
Inclusion criteria: (1) meet the diagnostic criteria for children with refractory Mycoplasma pneumoniae pneumonia in the Expert Consensus on the Diagnosis and Treatment of Mycoplasma pneumoniae Pneumonia in Children (2015 edition) : after regular treatment with macrolides for 1 week or more, the symptoms of the child did not significantly improve or worsen, the child still had a persistent fever, and the chest imaging findings were worse than before; MP-IgM titer greater than 1:160 or can detect a positive MP-DNA quantitation; (2) without previous history of recurrent respiratory tract infection or chronic pulmonary disease; (3) 5–12 years old; (4) body mass index of 19–23 kg/m2.
Exclusion criteria: Patients with (1) disease of immune system; (2) mixed infection with other pathogens; (3) respiratory distress syndrome; (4) other serious underlying diseases or complications; (5) ventilator-assisted ventilation; (6) consciousness disorder and intellectual disability.
The control group was given routine treatment, including 3-day continuous application of azithromycin (10 mg/kg, ivgtt, once a day), and then drug withdrawal for 4 days, as a course of treatment, continuous treatment for 2–3 courses. At the same time, according to the patient’s symptoms, corresponding treatment was given to relieve fever, cough, phlegm, and to protect organ function and maintain water and electrolyte balance .
The study group received interesting respiratory rehabilitation training on the basis of conventional treatment used in the children of the control group, specific contents are as follows: (1) Charge nurse and responsible physical therapist(more than N2 level) in respiratory ward were trained for specialized operation training by national rehabilitation specialist nurse, and after theory and skills examination, they could conduct clinical practice guided and supervised by junior nurses and the head nurse. At the same time, the children’s fun game venue was established, decorated with cartoon patterns, balloons, flowers, etc. in walls, and equipped with children’s books, tables and chairs, toys, etc., dressed by spliced foam floor on the ground (2). The physical therapists and responsible nurses will lead the children to the games venues, transfer the children’s interest to the game, and encourage them to pay attention to complete the respiratory training. The physical therapists helped responsible nurses to personalize training plan according to the actual circumstance of the child to, and regularly guided to adjust plans according to the needs of children. The children’s daily training was completed by the physical therapists who has been trained above (3). Before training, the inductive inquiry was performed to collect children’s interests and hobbies. Then the content of interaction was confirmed according to their interests. At the same time, some interesting cards which were popular in the children were taken as prizes for children to collect for every 10 cards for exchange of an interesting prize. If the children’s compliance was not good, the praise cards and prizes were prepared to encourage them to cooperate with the treatment bravely (4). The respiratory function training guidance included lip breathing, abdominal breathing, and three-ball breathing trainer with 8-level and 9-level expiratory conditioning. According to the situation of children, the level was adjusted gradually appropriately for increased resistance training for twice a day, 15–20 min every time. It was appropriate to ensure that children did not feel tired, and they could get a card for successfully completed a training. In addition, in order to improve the children’s training interest, children could blow confetti or newspaper, whistle or recorder, etc. in training spare time. In the interval of treatment, breath training gymnastics should be organized every day, which mainly included standing in place, upper arm lifting, chest expanding exercise, lower limb raising training, etc., with a rest (rest to attain mental composure in music) of 2–3 min per activity and a total time of less than 20 min. The training was performed continuously for one month.
The antipyretic time, disappearance time of pulmonary shadow and cough, length of hospital stay were observed and recorded.
Pulmonary function: The children were tested with Maibang MSA99 pulmonary function tester, including first second of expiratory volume (FEV1), forced vital capacity (FVC), FEV1/FVC at 1 day before and 1 day after intervention.
Serum levels of interleukin-6 (IL-6), C-reactive protein (CRP), tumor necrosis factor (TNF-α): 5mL of the venous blood was collected at 1 day before and after intervention and centrifuged for detection. The levels of IL-6 (anhui Joyee Biotechnics Co.,Ltd, JER-04), CRP, TNF-α (Wuhan MSK Biotechnology Co., LTD, kt25328、kt30278) were determined by enzyme-linked immunosorbent assay (ELISA), purchased from Shanghai enzyme-linked biotechnology co., LTD.
Quality of life: The PedsQL  (Pediatric Quality of Life Inventory) (Children’s Hospital and Health Center, San Diego, California) is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18. The health survey questionnaire was distributed at 1 day before and after intervention for evaluation. The scale includes 4 dimensions, consisting of 23 items, physiological function, emotional function, social function, and school function, for 100 points for each dimension. Higher score means higher quality of life.
SPSS 20.0 statistical software was used to analyze the data: the average ± standard deviation (mean ± SD) was used to describe measurement data such as antipyretic time, disappearance time of pulmonary shadow and cough, length of hospital stay. The T test was used for comparison between two groups. If the data did not conform to normal distribution, the median and interquartile M(Q1-Q3) were used for description, and the rank-sum test was used. The frequency (constituent ratio) was used to describe the equal count data like gender. The Wilcoxon test was used to compare the unidirectional ordered data, and the chi-square test was used to compare the disordered data. P < 0.05 indicates significant difference.