1.Efficacy and safety of Regan Syrup in treatment of common cold (wind-heat syndrome):a multicenter, randomized, double-blind, double-dummy, placebo and positive drug-controlled, parallel, phase Ⅱb clinical trial.
Yi-Min HU ; Qing-Quan LIU ; Sheng CHEN ; Ye-Yang CHEN ; Lan WANG ; Nan LIU ; Ning CHEN ; You-Yu LONG ; Hui DONG
China Journal of Chinese Materia Medica 2023;48(8):2233-2240
Regan Syrup has the effect of clearing heat, releasing exterior, benefiting pharynx and relieving cough, and previous phase Ⅱ clinical trial showed that the efficacy of Regan Syrup high-dose and low-dose groups was better than that of the placebo group, and there was no statistically significant difference in the safety between the three groups. The present study was conducted to further investigate the efficacy and safety of the recommended dose(20 mL) of Regan Syrup in the treatment of common cold(wind-heat syndrome). Patients who met the inclusion and exclusion criteria were selected and divided into the test group(Regan Syrup+Shufeng Jiedu Capsules placebo), positive drug group(Regan Syrup placebo+Shufeng Jiedu Capsules) and placebo group(Regan Syrup placebo+Shufeng Jiedu Capsules placebo) at a 1∶1∶1 using a block randomization method. The course of treatment was 3 days. A total of 119 subjects were included from six study centers, 39 in the test group, 40 in the positive drug group and 40 in the placebo group. The onset time of antipyretic effect was shorter in the test group than in the placebo group(P≤0.01) and the positive drug group, but the difference between the test group and the positive drug group was not significant. The test group was superior to the positive drug group in terms of fever resolution(P<0.05), and had a shorter onset time of fever resolution than the placebo group, but without obvious difference between the two groups. Compared to the positive drug group, the test group had shortened disappearance time of all symptoms(P≤0.000 1). In addition, the test group was better than the positive drug group and the placebo group in relieving symptoms of sore throat and fever(P<0.05), and in terms of clinical efficacy, the recovery rate of common cold(wind-heat syndrome) was improved in the test group compared to that in the placebo group(P<0.05). On the fourth day after treatment, the total TCM syndrome score in both test group and positive drug group was lower than that in the placebo group(P<0.05). There was no significant difference in the incidence of adverse events between three groups and none of them experienced any serious adverse events related to the study drug. The results indicated that Regan Syrup could shorten the onset time of antipyretic effect, reduce the time of fever resolution, alleviate the symptoms such as sore throat and fever caused by wind-heat cold, reduce the total score of Chinese medicine symptoms, and improve the clinical recovery rate with good safety.
Humans
;
Antipyretics/therapeutic use*
;
Capsules
;
Common Cold/diagnosis*
;
Double-Blind Method
;
Fever/drug therapy*
;
Hot Temperature
;
Pharyngitis
;
Treatment Outcome
2.Clinical and imaging features of infective sacroiliitis in children.
Tong YUE ; Jian Ming LAI ; Yang YANG ; Dan ZHANG ; Gai Xiu SU ; Jia ZHU ; Feng Qi WU
Chinese Journal of Pediatrics 2023;61(12):1092-1097
Objective: To summarize the clinical, radiological characteristics, and prognosis of infectious sacroiliitis in children. Methods: A case-control study was conducted, including 12 cases of infectious sacroiliitis diagnosed in the Rheumatology and Immunology Department of the Children's Hospital affiliated with the Capital Institute of Pediatrics from June 2018 to June 2023. These cases comprised the case group. Concurrently, 28 cases of pediatric idiopathic arthritis involving the sacroiliac joint in the same department served as the control group. Basic patient information, clinical features, laboratory parameters, and clinical treatment outcomes for both groups were collected and analyzed. Independent sample t-tests and chi-squared tests were used for inter-group comparisons. Results: Among the 12 cases in the case group, there were 5 males and 7 females, with a disease duration of 0.8 (0.5, 1.2) months. Nine patients presented with fever, and 1 patient had limping gait. Human leukocyte antigen (HLA)-B27 positivity was observed in 1 case, and there was no family history of ankylosing spondylitis. In the control group of 28 cases, there were 19 males and 9 females, with a disease duration of 7.0 (3.0, 17.0) months. One patient (4%) had fever, and 14 cases (50%) exhibited limping gait. HLA-B27 positivity was found in 18 cases (64%), and 18 cases (64%) had a family history of ankylosing spondylitis. The case group had higher white blood cell count (WBC), neutrophil ratio, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels, as well as a higher proportion of unilateral involvement on magnetic resonance imaging and bone destruction on CT compared to the control group ((11.1±6.2)×109 vs. (7.3±2.3)×109/L, 0.64±0.10 vs. 0.55±0.12, 72 (34, 86) vs. 18 (5, 41) mm/1 h, 24.6 (10.1, 67.3) mg/L vs. 3.6 (0.8, 15.0) mg/L, 11/12 vs. 36% (10/28), 9/12 vs. 11% (3/28), t=2.90, 3.07, Z=-2.94, -3.28, χ2=10.55, 16.53, all P<0.05). Conclusions: Pediatric infectious sacroiliitis often presents as unilateral involvement with a short disease history. Elevated WBC, CRP, and ESR, as well as a high rate of bone destruction, are also common characteristics.
Male
;
Female
;
Humans
;
Child
;
Sacroiliitis/diagnostic imaging*
;
Spondylitis, Ankylosing/diagnosis*
;
Case-Control Studies
;
Sacroiliac Joint/diagnostic imaging*
;
Radiography
;
Magnetic Resonance Imaging
;
Fever
3.Clinical analysis of 10 cases of multi-center tumor necrosis factor receptor-associated periodic syndrome.
Ming Sheng MA ; Zhi YANG ; Cai Hui ZHANG ; Yao Yao SHANGGUAN ; Yong Zhen LI ; Mei Fang ZHU ; Cui BAI ; Yu ZHOU ; Qiu Ye ZHANG ; Hai Guo YU ; Xiao Chuan WU ; Wen Jie ZHENG ; Jun YANG ; Hong Mei SONG
Chinese Journal of Pediatrics 2023;61(12):1098-1102
Objective: To summarize the clinical characteristics of tumour necrosis factor receptor-associated periodic syndrome (TRAPS) in children. Methods: The clinical manifestations, laboratory tests, genetic testing and follow-up of 10 children with TRAPS from May 2011 to May 2021 in 6 hospitals in China were retrospectively analyzed. Results: Among the 10 patients with TRAPS, including 8 boys and 2 girls. The age of onset was 2 (1, 5) years, the age of diagnosis was (8±4) years, and the time from onset to diagnosis was 3 (1, 7) years. A total of 7 types of TNFRSF1A gene variants were detected, including 5 paternal variations, 1 maternal variation and 4 de novo variations. Six children had a family history of related diseases. Clinical manifestations included recurrent fever in 10 cases, rash in 4 cases, abdominal pain in 6 cases, joint involvement in 6 cases, periorbital edema in 1 case, and myalgia in 4 cases. Two patients had hematological system involvement. The erythrocyte sedimentation rate and C-reactive protein were significantly increased in 10 cases. All patients were negative for autoantibodies. In the course of treatment, 5 cases were treated with glucocorticoids, 7 cases with immunosuppressants, and 7 cases with biological agents. Conclusions: TRAPS is clinically characterized by recurrent fever accompanied by joint, gastrointestinal, skin, and muscle involvement. Inflammatory markers are elevated, and autoantibodies are mostly negative. Treatment mainly involves glucocorticoids, immunosuppressants, and biological agents.
Male
;
Child
;
Female
;
Humans
;
Child, Preschool
;
Receptors, Tumor Necrosis Factor, Type I/genetics*
;
Retrospective Studies
;
Hereditary Autoinflammatory Diseases/drug therapy*
;
Glucocorticoids/therapeutic use*
;
Biological Factors/therapeutic use*
;
Immunosuppressive Agents/therapeutic use*
;
Autoantibodies
;
Familial Mediterranean Fever/diagnosis*
;
Mutation
4.Diagnostic strategies for diseases with fever in dental clinics.
Jian YUAN ; Chuanxia LIU ; Zaiye LI ; Qianming CHEN
Journal of Zhejiang University. Science. B 2023;24(4):352-358
Fever is an increase in body temperature beyond the normal range, acting as a protective inflammatory mechanism. This article summarizes diseases with fever encountered in dental clinics, including what is known about pyrexia in coronavirus infection, and further proposes a "six steps in one" identification and analysis strategy to guide the clinical work of stomatology.
Humans
;
Dental Clinics
;
Fever/diagnosis*
;
Coronavirus Infections
5.Analysis of clinical features and poor prognostic factors of acute hematogenous osteomyelitis in children.
Yue CHANG ; Tian Ming CHEN ; Ling Yun GUO ; Zhuang Zhuang WANG ; Shu Ping LIU ; Bing HU ; Qiang WANG ; Wei FENG ; Gang LIU
Chinese Journal of Pediatrics 2022;60(8):756-761
Objective: To analyze the clinical characteristics, pathogenic bacteria, complications and risk factors of prognosis of acute hematogenous osteomyelitis in children. Methods: The clinical manifestations, laboratorg tests, etiological charateristics and clinical data of 107 patients with acute hematogenous osteomyelitis admitted to Beijing Children's Hospital from January 2017 to December 2020 were retrospectively analyzed. According to the drug sensitivity results of Staphylococcus aureus, the group was divided into methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible Staphylococcus aureus (MSSA) group; according to the presence or absence of complications, the group was divided into the group with and without complications; according to the prognosis of the follow-up children, the group was divided into good prognosis and poor prognosis. The χ2 test or Mann-Whitney U test used for comparison between groups, and Logistic regression was used to analyze the risk factors for complications and prognosis. Results: Of the 107 patients, 62 were males and 45 were females. The age of presentation was 5.6 (1.7, 10.0) years, including 5 patients (4.7%) age from >28 days to 3 months, 46 patients (43.0%) age from >3 months to 5 years, 43 patients (40.2%)>5-12 years of age, and 13 patients (12.1%)>12-18 years of age. The first symptoms were acute fever in 35 patients (32.7%), limb pain in 24 patients (22.4%), and fever with limb pain in 23 patients (21.5%). Pathogen culture was positive in 75 patients (70.1%), Streptococcus pyogenes, Salmonella enterica and Escherichia coli in 1 case (1.4%) each, and Staphylococcus aureus in 72 cases (96.0%), among them, 47 cases were MSSA, 22 cases were MRSA, and 3 cases had positive reports of Staphylococcus aureus from other hospitals without drug-sensitive tests. The proportion of infected children living in rural areas and receiving surgical treatment was higher in the MRSA group than in the MSSA group (14 cases (63.6%) vs. 18 cases (38.3%) and 21 cases (95.5%) vs. 33 cases (70.2%), χ2=3.87, 4.23, both P<0.05). Sixty-five children had no complications while 42 children (39.3%) suffered from complications. Common complications consisted of 19 cases (17.8%) of sepsis, 17 cases (15.9%) of septic arthritis, and 12 cases (11.2%) of venous thrombosis. The group with complications showed higher mental changes, decreased appetite and (or) weakness, positive pathogenic cultures, and time from admission to surgery than the group without complications (18 cases (42.9%) vs. 9 cases (13.8%), 20 cases (47.6%) vs. 12 cases (18.5%), 34 cases (81.0%) vs. 41 cases (63.1%), 3.5 (2.0, 6.0) vs. 2.0 (1.0, 4.0) d,χ2=11.38, 10.35, 3.89, Z=2.21, all P<0.05). The poor prognosis group had more comorbidities, combined local complications, and positive aureus than the good prognosis group (10/15 vs. 34.9% (30/86), 7/15 vs. 17.4% (15/86), 14/15 vs. 61.6% (53/86), χ2=5.39, 6.40, 4.42, all P<0.05). Multifactorial Logistic regression analysis showed that acute phase C-reactive protein (CRP) was both an independent risk factor for complications (OR=1.01, 95%CI 1.01-1.02) and an independent risk factor for poor prognosis (OR=1.01, 95%CI 1.00-1.02). Conclusions: The first symptoms of acute hematogenous osteomyelitis are acute fever, limb pain, and fever with limb pain are most common. Staphylococcus aureus is the most common pathogenic organism. Those with loss of appetite and (or) weakness, mental changes, positive pathogenic cultures, and longer time between admission and surgery are prone to complications. Those with complications, combined local complications, and positive for Staphylococcus aureus had a poor prognosis. Elevated CRP is an independent risk factor not only for complications but for poor prognosis as well.
Acute Disease
;
Adolescent
;
Anti-Bacterial Agents/therapeutic use*
;
Child
;
Female
;
Fever/etiology*
;
Humans
;
Male
;
Methicillin-Resistant Staphylococcus aureus
;
Osteomyelitis/microbiology*
;
Pain/drug therapy*
;
Prognosis
;
Retrospective Studies
;
Staphylococcal Infections/diagnosis*
;
Staphylococcus aureus
6.A case of neonatal complete Kawasaki disease.
Lei XIANG ; Xiao Yu WANG ; Xu Xu NIU ; Li ZHANG ; Jin Zhen GUO ; Shan ZHU ; Li ZHANG
Chinese Journal of Pediatrics 2022;60(4):353-355
7.Application value of metagenomic next-generation sequencing for pathogen detection in childhood agranulocytosis with fever.
Shan ZHU ; Ying LIU ; Hai-Yan LUO ; Ming-Hua YANG ; Liang-Chun YANG ; Wen-Jun DENG
Chinese Journal of Contemporary Pediatrics 2022;24(7):753-758
OBJECTIVES:
To study the application value of metagenomic next-generation sequencing (mNGS) for pathogen detection in childhood agranulocytosis with fever.
METHODS:
A retrospective analysis was performed on the mNGS results of pathogen detection of 116 children with agranulocytosis with fever who were treated from January 2020 to December 2021. Among these children, 38 children with negative mNGS results were enrolled as the negative group, and 78 children with positive results were divided into a bacteria group (n=22), a fungal group (n=23), and a viral group (n=31). Clinical data were compared between groups.
RESULTS:
For the 116 children with agranulocytosis and fever, the median age was 8 years at diagnosis, the median turnaround time of mNGS results was 2 days, and the positive rate of mNGS testing was 67.2% (78/116). Compared with the negative group, the bacterial group had a higher procalcitonin level (P<0.05), the fungal group had higher level of C-reactive protein and positive rate of (1,3)-β-D glucan test/galactomannan test (P<0.05), and the fungal group had a longer duration of fever (P<0.05). Among the 22 positive microbial culture specimens, 9 (41%) were consistent with the mNGS results. Among the 17 positive blood culture specimens, 8 (47%) were consistent with the mNGS results. Treatment was adjusted for 28 children (36%) with the mNGS results, among whom 26 were cured and discharged.
CONCLUSIONS
The mNGS technique has a shorter turnaround time and a higher sensitivity for pathogen detection and can provide evidence for the pathogenic diagnosis of children with agranulocytosis and fever.
Agranulocytosis/diagnosis*
;
Bacteria
;
Child
;
Fever/diagnosis*
;
High-Throughput Nucleotide Sequencing/methods*
;
Humans
;
Metagenomics/methods*
;
Retrospective Studies
;
Sensitivity and Specificity
8.Kawasaki disease complicated with mild encephalitis/encephalopathy with a reversible splenial lesion: A case report and literature review.
Yan Yan DU ; Jian WANG ; Lan HE ; Li Na JI ; Xi Wei XU
Journal of Peking University(Health Sciences) 2022;54(4):756-761
We reported a pediatric case of Kawasaki disease complicated with mild encephalitis/encephalopathy with a reversible splenial lesion (MERS) from Beijing Tsinghua Changgung Hospital. The clinical data were retrospectively analyzed and the related literature was reviewed. The clinical features, treatment and prognosis of the disease were summarized to improve recognition of Kawasaki disease complicated with MERS. A 7-year-old boy was diagnosed with Kawasaki disease due to continuous high fever for 6 d, accompanied by strawberry tongue, conjunctival congestion, erythema-like hyperemia rash, and cervical enlarged lymph nodes. And treatment was started with intravenous immunoglobulin (IVIG: 2 g/kg) and oral aspirin [40 mg/(kg·d)]. Twenty-four hours after the treatment of IVIG, the patient' s fever persisted and in addition he developed headache and drowsiness. His cranial magnetic resonance imaging (MRI) demonstrated a localized lesion in the splenium of the corpus callosum with high intensity signal on diffusion-weighted images (DWI) and T2-weighted, and low intensity signal on apparent diffusion coefficient (ADC) and T1-weighted. Based on these findings, he was diagnosed with MERS-complicated Kawasaki disease. Methylprednisolone [2 mg/(kg·d)] treatment was started intravenously, and within several hours he was afebrile and the neurological symptoms disappeared. A follow-up MRI was conducted after 1 week was normal. He was discharged without any neurological sequelae and coronary artery lesions. A total of 12 qualified foreign literature were retrieved, with no Chinese literature searched. Seventeen children were reported, the median age was 6.5 years (range: 1-14 years), among them 11 cases were children over 5 years old, and 4 cases were complicated with coronary artery lesions. All children had neurological symptoms, such as consciousness disorder, visual hallucination or convulsion. MRI conformed to MERS imaging changes. After active treatment, the neurological manifestations and radiological abnormalities completely disappeared, leaving no neurological sequelae. Kawasaki disease complicated with MERS had not been reported in China by now. Literature that identified Kawasaki disease complicated with MERS mostly occurred in children over 5 years old. Cranial MRI examination is helpful for early diagnosis. Timely treatment can reverse MERS in a short time, without neurological sequelae left.
Brain Diseases/diagnosis*
;
Child
;
Child, Preschool
;
Encephalitis/pathology*
;
Fever
;
Humans
;
Hyperplasia/complications*
;
Immunoglobulins, Intravenous/therapeutic use*
;
Magnetic Resonance Imaging
;
Male
;
Mucocutaneous Lymph Node Syndrome/diagnosis*
;
Retrospective Studies
9.Hemophagocytic lymphohistiocytosis caused by hematogenous disseminated pulmonary tuberculosis: A case report.
Qiu Yu LI ; Ying LIANG ; Ni Ni DAI ; Yu Xiang WANG ; Bo Tao ZHU ; Rui WU ; Hong ZHU ; Yong Chang SUN
Journal of Peking University(Health Sciences) 2022;54(6):1219-1223
Hemophagocytic lymphohistiocytosis (HLH) was a life-threatening syndrome due to the uncontrolled immune activation of cytotoxic T lymphocytes, natural killer (NK) cells, and macrophages. HLH is characterized by primary and secondary causes, the early diagnosis and treatment of patients are closely related to the prognosis and clinical outcome of patients. The clinical presentation is variable but mostly includes prolonged fever, splenomegaly, coagulopathy, hypertriglyceridemia, and hemophagocytosis, none of them is specific and particular for HLH. Tuberculosis (TB) infection is one of the causes of HLH. HLH caused by TB is very rare clinically, but it has a high mortality. For patients with fever of unknown origin, HLH-related clinical manifestations sometimes present before the final diagnosis of TB, and HLH is associated with the most significant mortality rate. This article is mainly about a 28-year-old patient with HLH who suffered from severe TB infection. The patient attended a hospital with a history of 2 months of prolonged fever, 10 days booger and subcutaneous hemorrhage in lower limbs. Before this, he was in good health and denied any history of tuberculosis exposure. Combined with relevant laboratory test results (such as splenomegaly, hemoglobin, platelet count, and hypertriglyceridemia) and clinical manifestations (e.g. fever), the patient was diagnosed with hemophagocytic lymphohistiocytosis, but the etiology of HLH remained to be determined. To confirm the etiology, the patient was asked about the relevant medical history (intermittent low back pain) and was performed chest CT scan, bone marrow biopsy, and fundus photography. Finally, he was diagnosed with hemophagocytic lymphohistiocytosis caused by hematogenous disseminated pulmonary tuberculosis. In response to this, intravenous methylprednisolone and anti-tuberculosis treatment (isoniazid, pyrazinamide, moxifloxacin, and amikacin) were administered to the patient. After more than a month of treatment, the patient recovered from HLH caused by severe TB infection. Therefore, this case suggests that we should be vigilant to the patient who admitted to the hospital with fever for unknown reasons, to diagnose HLH as early as possible and clarify its cause, then perform interventions and treatment, especially HLH secondary to tuberculosis. Also, cases of atypical TB and severe TB should be carefully monitored to achieve early diagnosis and early intervention.
Male
;
Humans
;
Adult
;
Lymphohistiocytosis, Hemophagocytic/diagnosis*
;
Splenomegaly
;
Tuberculosis, Pulmonary/diagnosis*
;
Bone Marrow/pathology*
;
Fever/etiology*
;
Hypertriglyceridemia/complications*
10.Validation and comparison of the PECARN rule, Step-by-Step approach and Lab-score for predicting serious and invasive bacterial infections in young febrile infants.
Natalia SUTIMAN ; Zi Xean KHOO ; Gene Yong Kwang ONG ; Rupini PIRAGASAM ; Shu Ling CHONG
Annals of the Academy of Medicine, Singapore 2022;51(10):595-604
INTRODUCTION:
Differentiating infants with serious bacterial infections (SBIs) or invasive bacterial infections (IBIs) from those without remains a challenge. We sought to compare the diagnostic performances of single biomarkers (absolute neutrophil count [ANC], C-reactive protein [CRP] and procalcitonin [PCT]) and 4 diagnostic approaches comprising Lab-score, Step-by-Step approach (original and modified) and Pediatric Emergency Care Applied Research Network (PECARN) rule.
METHOD:
This is a prospective cohort study involving infants 0-90 days of age who presented to an emergency department from July 2020 to August 2021. SBIs were defined as bacterial meningitis, bacteraemia and/or urinary tract infections. IBIs were defined as bacteraemia and/or bacterial meningitis. We evaluated the performances of Lab-score, Step-by-Step (original and modified) and PECARN rule in predicting SBIs and IBIs.
RESULTS:
We analysed a total of 258 infants, among whom 86 (33.3%) had SBIs and 9 (3.5%) had IBIs. In predicting SBIs, ANC ≥4.09 had the highest sensitivity and negative predictive value (NPV), while PCT ≥1.7 had the highest specificity and positive predictive value (PPV). CRP ≥20 achieved the highest area under receiver operating characteristic curve (AUC) of 0.741 (95% confidence interval [CI] 0.672-0.810). The Step-by-Step (original) approach had the highest sensitivity (97.7%). Lab-score had the highest AUC of 0.695 (95% CI 0.621-0.768), compared to PECARN rule at 0.625 (95% CI 0.556-0.694) and Step-by-Step (original) at 0.573 (95% CI 0.502-0.644). In predicting IBIs, PCT ≥1.7 had the highest sensitivity, specificity, PPV and NPV. The Step-by-Step (original and modified) approach had the highest sensitivity of 100%. Lab-score had the highest AUC of 0.854 (95% CI 0.731-0.977) compared to PECARN rule at 0.589 (95% CI 0.420-0.758) and Step-by-Step at 0.562 (95% CI 0.392-0.732).
CONCLUSION
CRP strongly predicted SBIs, and PCT strongly predicted IBI. The Step-by-Step approach had the highest sensitivity and NPV, while Lab-score had the highest specificity and AUC in predicting SBIs and IBIs.
Infant
;
Humans
;
Child
;
Calcitonin
;
Prospective Studies
;
Emergency Service, Hospital
;
Bacterial Infections/diagnosis*
;
Fever/diagnosis*
;
C-Reactive Protein/analysis*
;
Meningitis, Bacterial/diagnosis*
;
Bacteremia
;
Biomarkers
;
Emergency Medical Services
;
Procalcitonin

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