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Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.
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China has classified the Corona Virus Disease 2019(COVID-19) as a statutory category B infectious disease and managed it according to Category B since January 8, 2023.In view that Omicron variant is currently the main epidemic strain in China, in order to guide the treatment of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection in children with the times, refer to the Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial 10 th Edition), Expert Consensus on Diagnosis, Treatment and Prevention of Novel Coronavirus Infection in Children (Fourth Edition) and the Diagnosis and Treatment Strategy for Pediatric Related Viral Infections.The Expert Consensus on the Diagnosis, Treatment and Prevention of Novel Coronavirus Infection in Children (Fifth Edition) has been formulated and updated accordingly on related etiology, epidemiology, pathogenic mechanism, clinical manifestations, auxiliary examination, diagnosis and treatment, and added key points for the treatment of COVID-19 related encephalopathy, fulminating myocarditis and other serious complications for clinical reference.
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Objective:To investigate the clinical efficacy of Omalizumab in the treatment of moderate-to-severe allergic asthma with allergic comorbidities in children.Methods:The clinical data of 50 children with moderate-to-severe allergic asthma and allergic comorbidities, who were treated with Omalizumab and completed 12-month follow-up in the Department of Pediatrics of Peking University First Hospital from July 2018 to March 2022, were retrospectively analyzed.A comparison was performed on the scale scores of childhood allergic asthma and allergic comorbidities including allergic rhinitis (AR) and chronic spontaneous urticaria (CSU), pulmonary function test indices and fractional exhaled nitric oxide (FeNO) concentration before and after treating with Omalizumab.The data were compared by ANOVA, paired t-test, chi- square test and rank sum test. Results:(1)Improvement of clinical symptoms: after 12 months of Omalizumab treatment, the childhood asthma control test score of 42 children aged ≤11 years increased from (20.98±5.03) points to (26.95±0.22) points ( F=18.189, P<0.001). The asthma control questionnaire 7 score of 50 children decreased from (0.89±0.11) points to (0.10±0.02) points ( F=5.662, P=0.006). The score of visual analogue scale of 47 children with AR decreased from (11.00±1.65) points to (0.2±0.14) points ( F=14.901, P<0.001), and the urticaria control test score of 13 children with CSU decreased from (4.82±0.88) points to (1.87±0.61) points ( F=4.329, P=0.018). (2)Improvement of quality of life: compared with those before treatment, the pediatric asthma quality of life questionnaire score in 50 children increased from (124.50±32.13) points to (159.40±6.21) points ( F=12.052, P<0.001), and global evaluation of asthma treatment effectiveness decreased from (2.23±0.70) points to (1.07±0.26) points ( F=68.865, P<0.001) after Omalizumab treatment for 12 months.(3)Improvement of pulmonary function results: after 12 months of Omalizumab treatment, the number of children with forced expiratory volume in one second/forced vital capacity< 80% decreased from 13 cases (26%) to 1 case (2%), and the values increased from (91.39±12.88)% to (96.96±8.54)%( χ2=11.960; t=2.486, all P<0.05). The peak expiratory flow of predicted value increased from (86.73±16.05)% to (94.01±13.11)% ( t=2.445, P<0.05). The number of children with two indicators among the forced expiratory flow at 50% of forced vital capacity exhaled, forced expiratory flow at 75% of forced vital capacity exhaled and maximal mid-expiratory flow lower than 65% decreased from 31 cases (62%) to 7 cases (14%) ( χ2=24.450, P<0.001). There was no significant difference in FeNO concentration before and after treatment ( P>0.05). Safety of Omalizumab: no obvious adverse reactions were found during treatment and follow-up. Conclusions:Omalizumab can significantly improve the clinical symptoms, small airway function and quality of life of children with allergic asthma and concomitant AR or CSU.It is a potential targeted drug for treating a variety of allergic diseases in children.
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Since December 2019, severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infections have raged globally for more than 2 years.China has always adopted scientific and effective prevention and control measures to achieved some success.However, with the continuous variation of SARS-CoV-2 cases and imported cases from abroad, the prevention and control work has become more difficult and complex.With the variation of the mutant strain, the number of cases in children changed, and some new special symptoms and complications were found, which proposed a new topic for the prevention and treatment of SARS-CoV-2 infection in children in China.Based on the third edition, the present consensus according to the characteristics of the new strain, expounded the etiology, pathology, pathogenesis, and according to the clinical characteristics and experience of children′s cases, and puts forward recommendations on the diagnostic criteria, laboratory examination, treatment, prevention and control of children′s cases for providing reference for further guidance of effective prevention and treatment of SARS-CoV-2 infection in children in China.
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Monkeypox is a zoonotic disease.Previous studies have shown that children are vulnerable to monkeypox and are also at high risk for severe disease or complications.In order to improve pediatricians′ understanding of monkeypox and achieve early detection, early diagnosis, early treatment and early disposal, the committee composed of more than 40 experts in the related fields of infectious diseases, pediatrics, infection control and public health formulate this expert consensus, on the basis of the latest clinical management and infection prevention and control for monkeypox released by the World Health Organization (WHO), the guidelines for diagnosis and treatment of monkeypox (version 2022) issued by National Health Commission of the People′s Republic of China and other relevant documents.During the development of this consensus, multidisciplinary experts have repeatedly demonstrated the etiology, epidemiology, transmission, clinical manifestations, laboratory examinations, diagnosis and differential diagnosis, treatment, discharge criteria, prevention, case management process and key points of prevention and control about monkeypox.
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Objective:To investigate drug resistance gene in Mycoplasma pneumoniae(MP) and the distribution of 13 respiratory pathogens in bronchoalveolar lavage fluid(BALF) of children with Mycoplasma pneumoniae pneumonia(MPP).Methods:A total of 100 BALF of children with MPP in Peking University Third Hospital and Peking University First Hospital from January 2018 to January 2019 were collected.Fluorogenic quantitative PCR was used to detect nucleic acid and it′s drug resistance gene of MP and multiple PCR method was adopted to detect influenza A virus, influenza A virus-H 1N 1, influenza A virus-H 3N 2, influenza B, human parainfluenza virus, adenovirus, human bocavirus, human rhinovirus, Chlamydia pneumoniae, human metapneumovirus, MP, human coronavirus, and respi-ratory syncytial virus gene, and the results were compared by using Chi square test. Results:In 100 BALF samples, MP and drug resistance gene were detected by fluorogenic quantitative PCR.Totally, 83 cases (83.00%) were MP positive and 78 cases (93.98%) were drug resistant.All of them had the point mutations A2063G in V region of 23S rRNA domain.A total of 13 kinds of respiratory pathogens were detected by multiplex PCR method, and 89 cases (89.00%) were positive.Totally, 79 cases (79.00%) were MP positive, of which 74 cases (74.00%) detected only MP, and 5 cases (5.00%) detected MP combined with other pathogens.Other pathogens were detected in 10 cases (10.00%). The virus detection rate of 0-4 years old group was higher than that of >4-6 years old group ( P=0.042) and >6 years old group ( P=0.002), and the differences were statistically significant. Conclusions:MP can be detected in most BALF samples of MPP children, the drug resistance phenomenon is serious, and the main point mutation is A2063G.There were other respiratory pathogens and 2 or 3 pathogens were detected in a small number of BALF samples.
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Severe acute respiratory syndrome coronavirus-2(SARS-CoV-2)infection is still worldwide.As a vulnerable group, severe and dead pediatric cases are also reported.Under this severe epidemic situation, children should be well protected.With the widespread vaccination of SARS-CoV-2 vaccine in adults, the infection rate have decreased.Therefore, SARS-CoV-2 vaccine inoculation for children groups step by step is of great significance to the protection of children and the prevention and control of corona virus disease 2019(COVID-19) as a whole.But the safety of children vaccinated with SARS-CoV-2 vaccine is a main concern of parents.Therefore, in order to ensure the safety of vaccination and the implementation of vaccination work, National Clinical Research Center for Respiratory Diseases, National Center for Children′s Health and the Society of Pediatrics, Chinese Medical Association organized experts to interpret the main issue of parents about SARS-CoV-2 vaccine for children, in order to answer the doubts of parents.
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At present, severe acute respiratory syndrome coronavirus-2(SARS-CoV-2)infection is still rampant worldwide.As of September 10, 2021, there were about 222 million confirmed cases of corona virus disease 2019(COVID-19)and more than 4.6 million deaths worldwide.With the development of COVID-19 vaccines and the gradual vaccination worldwide, the increasing number of cases in children and unvaccinated young people has drawn attention.According to World Health Organization surveillance data, the proportion of COVID-19 infection cases in children gradually increased, and the proportion of cases in the age groups of under 5 years and 5-14 years increased from 1.0% and 2.5% in January 2020 to 2.0% and 8.7% in July 2021, respectively.At present, billions of adults have been vaccinated with various COVID-19 vaccines worldwide, and their protective effects including reducing infection and transmission, reducing severe disease and hospitalization, and reducing death, as well as high safety have been confirmed.Canada, the United States, Europe and other countries have approved the emergency COVID-19 vaccination in children and adolescents aged 12 to 17 years, and China has also approved the phased vaccination of COVID-19 vaccination in children and adolescents aged 3 to 17 years. For smooth advancement and implementation of COVID-19 vaccination in children, academic institutions, including National Clinical Research Center for Respiratory Diseases, National Center for Children′s Health, and The Society of Pediatrics, Chinese Medical Association organized relevant experts to reach this consensus on COVID-19 vaccination in children.
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2019 novel coronavirus(2019-nCoV) outbreak is one of the public health emergency of international concern.Since the 2019-nCoV outbreak, China has been adopting strict prevention and control measures, and has achieved remarkable results in the initial stage of prevention and control.However, some imported cases and sporadic regional cases have been found, and even short-term regional epidemics have occurred, indicating that the preventing and control against the epidemic remains grim.With the change of the incidence proportion and the number of cases in children under 18 years old, some new special symptoms and complications have appeared in children patients.In addition, with the occurrence of virus mutation, it has not only attracted attention from all parties, but also proposed a new topic for the prevention and treatment of 2019-nCoV infection in children of China.Based on the second edition, the present consensus further summarizes the clinical characteristics and experience of children′s cases, and puts forward recommendations on the diagnostic criteria, laboratory examination, treatment, prevention and control of children′s cases for providing reference for further guidance of treatment of 2019-nCoV infection in children.
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The clinical manifestations of inherited metabolic diseases are diverse.If not treated in time, they often cause damage to multiple systems and multiple organs, including the lung, which is one of the common target organs of inherited metabolic diseases.Some patients present with recurrent respiratory infections and/or dyspnea and respiratory failure, and long-term lung damage, which increase the rate of hospitalization and mortality of inherited metabolic diseases.Because patients lack specific symptoms and signs, early identification is difficult, and they are easily misdiagnosed as children′s respiratory diseases.Therefore, now, the lung involvement of inherited metabolic diseases was explored, and the symptoms, signs, chest imaging manifestations, biochemical and genetic analysis, etc., were differentiated in order to help clinicians to increase vigilance and conduct timely intervention to improve lung function and the quality of life of the patients.
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Objective:To explore the clinical efficacy and safety of the new targeted anti-immunoglobulin E (IgE) drug Omalizumab in the treatment of children with moderate and severe allergic bronchial asthma in China.Methods:The clinical data of children with moderate and severe allergic asthma who were treated in the Department of Pediatrics of Peking University First Hospital from July 2018 to January 2020 and treated with Omalizumab were retrospectively analyzed.A comparison was performed on the changes of questionnaires, including childhood asthma control test (C-ACT), pediatric asthma quality of life questionnaire (PAQLQ), mini-asthma quality of life questionnaire (Mini-AQLQ) and global evaluation of asthma treatment effectiveness (GETE), pulmonary function test, including forced expiratory volume in the first second (FEV 1), percentage to predicted value (FEV 1% pred) and small airway function, fractional concentration of exhaled nitric oxide (FeNO) and so on, before and after treating with Omalizumab. Results:A total of 15 pediatric patients completed 16 weeks of treatment follow-up.After 16 weeks of Omazumab treatment, the score of C-ACT increased from (16.001.66) scores to (25.38±0.64) scores ( F=11.969, P<0.001), PAQLQ increased from (118.08 ± 23.78) scores to (141.00 ± 11.91) scores ( F=9.289, P=0.001), Mini-AQLQ increased from (78.93±7.43) scores to (97.92±3.12) scores ( F=4.145, P=0.042), and GETE decreased from (2.47±0.27) scores to (1.60±0.19) scores ( t=2.982, P=0.010). The actual value of FEV 1, FEV 1% pred, the maximum expiratory flow percentage of the predicted value (PEF% pred), forced expiratory flow at 25% (MEF 75), forced expiratory flow at 50% (MEF 50) and maximum midexpiratory flow (MMEF 75/25), increased from (1.96±0.12) L to (2.17±0.21) L ( F=0.425, P=0.789), (81.46±2.85)% to (82.64±1.55)% ( F=0.926, P=0.465), (82.05±3.58)% to (91.10±4.67)% ( F=1.909, P=0.128), (60.36±7.43)% to (76.94±4.65)% ( F=2.120, P=0.096), (52.72±3.75)% to (73.80±8.34)% ( F=3.140, P=0.047) and (60.05±8.47)% to (74.86±10.85)% ( F=7.860, P=0.010), respectively.FeNO decreased from 25.0 (14.5, 35.5) μg/L to 20.0 (18.5, 30.0) μg/L ( Z=-0.206, P=0.840). Transient headache was observed in 1 case and evanescent eruption in 2 cases during the treatment, respectively. Conclusions:Omalizumab can significantly improve the clinical manifestations, lung function indicators and quality of life of children with moderate and severe allergic asthma, and has good safety.Thus, it is expected to play an important role in the treatment of children with moderate-to-severe allergic asthma.
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Nucleotide-binding oligomerization domain like receptors (NLRs) can recognize conserved sequences of microorganisms and initiate inflammation, nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing 3 (NLRP3) is one of the most representative members of the NLRs family.Activated by a variety of endogenous or exogenous dangerous signals, NLRP3 combines with apoptosis-associated speck-like protein(ASC) and caspase-1 to form inflammasome.And then it acts on downstream inflammatory factors such as inter-leukin-1β (IL-1β) and interleukin-18 (IL-18) to promote their maturation and secretion.At the same time, it can interact with gasdermin D(GSDMD)and eventually lead to pyroptosis.It was found that, NLRP3 was closely related to the occurrence and development of pulmonary diseases.Finding inhibitors of key proteins in NLRP3 inflammasome pathway may provide a new way to treat related diseases.This article reviews the composition of NLRP3 inflammasome, the relationship between NLRP3 inflammasome and the occurrence of pulmonary diseases, and the advances in intervention research.
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Nucleotide-binding oligomerization domain like receptors (NLRs) can recognize conserved sequences of microorganisms and initiate inflammation,nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing 3 (NLRP3) is one of the most representative members of the NLRs family.Activated by a variety of endogenous or exogenous dangerous signals,NLRP3 combines with apoptosis-associated speck-like protein (ASC) and caspase-1 to form inflammasome.And then it acts on downstream inflammatory factors such as interleukin-1β (IL-1β) and interleukin-18 (IL-18) to promote their maturation and secretion.At the same time,it can interact with gasdermin D(GSDMD) and eventually lead to pyroptosis.It was found that,NLRP3 was closely related to the occurrence and development of pulmonary diseases.Finding inhibitors of key proteins in NLRP3 inflammasome pathway may provide a new way to treat related diseases.This article reviews the composition of NLRP3 inflammasome,the relationship between NLRP3 inflammasome and the occurrence of pulmonary diseases,and the advances in intervention research.
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AIM: To investigate the effect of hypercapnia on hypoxia-induced pulmonary hypertension and the changes of lysyl oxidase (LOX) and extracellular matrix collagen cross-links in the rat.METHODS: Sprague-Dawley rats were randomly divided into 4 groups: normoxia group, hypoxia group, hypercapnia group and hypoxia+hypercapnia group.LOX activity was detected by fluorescence spectrophotometry.LOX protein expression was detected by immunohistochemistry and Western blot.The mRNA expression of LOX in the pulmonary artery was detected by real-time PCR.RESULTS: The levels of mean pulmonary artery pressure (mPAP), RV/(LV+S) and WA/TA in hypoxia group were significantly higher than those in normoxia group (P<0.01).Moreover, the levels of mPAP and RV/(LV+S) in hypoxia+hypercapnia group were significantly lower than those in hypoxia group (P<0.01).However, no significant difference of mPAP and RV/(LV+S) between hypercapnia group and normoxia group was observed.In hypoxia group, the collagen cross-links in the lung tissue was significantly higher than that in normoxia group and hypercapnia group (P<0.01).Importantly, collagen cross-links in the lung tissue of hypoxia+hypercapnia group was significantly lower than that in hypoxia group (P<0.01).There was no significant difference in collagen cross-links between hypercapnia group and normoxia group.The expression of LOX at mRNA and protein levels and its activity in the pulmonary arteries of hypoxia group were significantly increased as compared with normoxia group (P<0.01).Furthermore, the expression of LOX at mRNA and protein levels and its activity in the pulmonary arteries in hypoxia+hypercapnia group were lower than those in hypoxia group (P<0.01).CONCLUSION: Hypoxia not only up-regulates LOX but also promotes collagen cross-linking in the rat lung, which contributes to the development of pulmonary hypertension.Hypercapnia inhibits hypoxia-induced LOX expression and collagen cross-linking, therefore impairing the progress in hypoxia-induced pulmonary hypertension.
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Objective To evaluate the clinical value of computed tomography (CT) examination in the etiologic diagnosis of small bowel obstruction.Methods From January 2010 to September 2013,a total of 237 patients with small bowel obstruction confirmed by operation were enrolled.The clinical data of all patients were collected.The diagnostic value of color Doppler ultrasound and abdominal CT examination were compared in estimating site of obstruction,etiology of obstruction and strangulation obstruction.Chi square test was performed for count data comparison.Results Among 237 patients with small bowel obstruction,there were 121 patients with data of both color Doppler ultrasound and abdominal CT examination.After operation,it was comfirmed that the accurate diagnosis rates of abdominal CT scan in the site of obstruction,the etiology of obstruction and strangulation obstruction were 75.2 ％ (91/121),66.1％ (80/121) and 87.2％ (41/47),respectively,and which were higher than those of abdominal color ultrasound (44.6％,54/121; 30.6％,37/121 and 42.6％,20/47).The differences were statistically significant (x2 =23.555,30.595 and 20.593,all P＜0.01).Conclusion The accurate diagnosis rates of abdominal CT scan in estimating the site of obstruction,the etiology of obstruction and strangulation obstruction were higher than those of color Doppler ultrasound,especially with obvious advantage in judging the etiology of obstruction.
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Objective To compare the efficacy of bowel-cleansing,patients′compliance, tolerability and side effects of different doses of polyethylene glycol(PEG)electrolyte solution for colonoscopy preparation.Methods Single-blind prospective randomized trial was performed.A total of 100 inpatients undergoing elective colonoscopy were randomized into three groups to receive 4 L PEG(n =35),2 L PEG (n =31)or 2 +1 L PEG(n =34),respectively,on the day of colonoscopy from May to July 2014.Bowel-cleansing efficacy was separately assessed with the Ottawa Scale for the right,middle,and left colon.Total score was obtained by adding the scores for individual evaluation of the three colon segments with the score of overall fluid in the entire colon.All patients filled in a questionnaire and were interviewed about their com-pliance to the assigned bowel preparation,tolerability,and side effects.Results Patients who did not complete the colonoscopy were excluded.A total of 91 patients were included in the last analysis:31 cases of 4 L group,30 cases of 2 L group and 30 cases of 2 +1 L group.The efficacy of bowel-cleansing of the three groups of patients according to the Ottawa Scale were similar(P >0.05),but the excellent and good rate of cleansing quality of the right colon was higher in 4 L group than in 2 L group(P <0.05).Compared with 4 L group and 2 +1 L group,patients in the 2 L group had higher compliance and tolerability,as well as lower rate of side effects(P <0.05 ).Conclusion The efficacy and safety of taking 2 L polyethylene glycol electrolyte solution in bowel-cleansing on the day of colonoscopy is good and suitable for use.Taking 4 L polyethylene glycol electrolyte solution for bowel preparation on the day of colonoscopy is more suitable for patients who are suspected highly with lesions of the right colon.
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AIM: To study the effect of signal transducer and activator of transcription 6 (STAT6) on airway inflammation of rats with asthma. METHODS: Male Sprague-Dawley rats were randomly divided into control group and asthma group. The lung tissue was sampled from the left lung. Bronchoalveolar lavage fluid (BALF) was collected from the right lung. The concentrations of IL-4 in serum and BALF were measured by sandwich ELISA. STAT6 protein and STAT6 mRNA were observed in the epithelial cells of bronchus by the technique of immunohistochemistry and in situ hybridization. RESULTS: (1) The concentrations of IL-4 in BALF and serum of asthma group were significantly higher than those in control group (P