Objective To evaluate the clinical efficacy and safety of pazufloxacin for the treatment of moderate and severe acute bacterial respiratory infections.Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin (500 mg twice daily for 7 to 10 days), and patients in the levofloxacin group were treated with levofloxacin (300 mg twice daily for 7 to 10 days). Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS). At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.
Objective To evaluate and select essential medicine for children with fever and adult gastrointestinal flu caused by common cold using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 12 guidelines were included, 11 of which were evidence-based or based on expert consensus. We offered a recommendation for medicines used in the treatment including analgesics and antipyretics, decongestants, antihistamines, cough-relieving drug, phlegm-removing drug and drug for gastrointestinal symptoms. (2) A result of four RCTs (very low quality) indicated that in the treatment of children with cold, ibuprofen suspension had an antipyretic effect similar to paracetamol solution (for oral use) with a pooled result of 6-hour efficiency in relieving fever (RR 1.48, 95%CI 0.66 to 3.30, P=0.34). The major adverse effects of ibuprofen suspension included gastrointestinal reaction and profuse sweats (RR=1.23, 95%CI 0.72 to 2.11, P=0.45). With good applicability, ibuprofen suspension (for oral use with no need to be supervised) cost 1.93 yuan daily. (3) A result of three RCTs (low quality) indicated that after given for 30 minutes and one hour, paracetamol solution (suppository) was fairly superior to ibuprofen suspension in lowering the high temperature caused by fever (given for 30 min: MD= –0.16°C, 95%CI –0.21 to –0.11, Plt;0.01; given for one hour: MD= –0.19°C, 95%CI –0.28 to 0.10, Plt;0.01). As to adverse reaction, paracetamol solution (suppository) mainly included anal irritation, skin rashes and profuse sweats, which had a comparative result of incidence with ibuprofen suspension (RR=1.84, 95%CI 0.62 to 5.44, P=0.27). For children with fever, paracetamol solution (suppository) cost 0.90 yuan daily. With good applicability, paracetamol solution (suppository) was administered via the anus. Conclusion (1) We offer a b recommendation for ibuprofen suspension (2 g/100 mL) or acetaminophen (0.1 g/suppository) as symptomatic treatment used in children with fever, pain and discomfort caused by common cold, and for Huo Xiang Zheng Qi Jiao Nang (0.3 g/ capsule) used in adults with gastrointestinal flu. We also offer a weak recommendation for acetylcysteine (injection, 300 mg/mL, 10 mL/ampoule) used in patients with paracetamol poisoning. (2) In order to produce high-quality local evidence, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on ibuprofen suspension and acetaminophen suppository in the treatment of children with fever, pain and discomfort caused by common cold should be further carried out. Besides, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on Chinese patent drugs of Huo Xiang Zheng Qi used in chidren and Huo Xiang Zheng Qi Jiao Nang used in adults should further carried out. Moreover, we suggest that epidemiological investigation as well as clinical and pharmacoeconomic studies of acetylcysteine injection for paracetamol poisoning should be carried out and the instructions of acetylcysteine injection should be added in the guidelines of essential medicine in China. Finally, further studies on evidence of oxymetazoline, dextromethorphan and other Chinese patent drugs with the effect of relieving cough and treating cold should be carried out.
至2002年6月,有关上呼吸道感染治疗的临床证据如下:①止痛剂/抗炎药用于缓解症状:1个系统评价发现与安慰剂比较止痛剂或抗炎药在1～5 d时显著减轻咽喉炎症状;1个RCT发现在服用抗生素的急性鼻窦炎患者,激素鼻喷剂较安慰剂明显改善症状,持续21 d.②抗生素用于预防β溶血链球菌咽炎的少见并发症:1个系统评价发现抗生素可预防β溶血链球菌咽炎的非化脓性并发症,但在工业化国家该并发症少见.③抗生素能缩短流感嗜血杆菌、卡他莫拉菌或肺炎链球菌感染的康复时间,在少部分患者中其上呼吸道感染由流感嗜血杆菌,卡他莫拉菌或肺炎链球菌引起.1个RCT发现抗生素较安慰剂明显增加这些患者在5 d时的康复.但目前尚无简捷的方法将此亚组患者从众多鼻咽培养阴性的患者中甄别出来.④抗生素缩短急性支气管炎、咽喉炎和鼻窦炎的康复时间:系统评价发现抗生素能轻度改善症状.与安慰剂比较,使用抗生素常出现副作用(恶心、呕吐、头痛、皮疹、阴道炎).⑤抗生素在感冒患者中的作用:2个系统评价发现,在患感冒6～14 d时使用抗生素在治愈率或全身改善方面与安慰剂没有差异.⑥抗组胺药用于流涕和喷嚏:1个系统评价发现,使用抗组胺药2 d后流涕和喷嚏明显减轻,但临床获益较小.⑦β受体激动剂缩短成人支气管高反应性、喘息或气流受限患者咳嗽的持续时间:1个系统评价发现,与安慰剂或红霉素比较,在7 d时β受体激动剂可减轻成人咳嗽症状,但亚组分析表明此种获益仅限于伴有支气管高反应性、喘息或气流受限者.β受体激动剂明显增加手抖、震颤和神经过敏的发生比例.儿童中进行的2个小样本RCTs发现在7 d时咳嗽症状在β受体激动剂和安慰剂间没有显著差异.但是,这些RCTs规模太小,故不能检出临床上重要的差异.⑧减充血剂用于充血症状的长期缓解:1个系统评价发现,无证据支持数天中反复使用减充血剂.1个病例对照研究发现,有微弱证据支持去甲麻黄碱可能增加出血性中风的风险.⑨减充血剂用于充血症状的短期缓解:1个系统评价发现,与安慰剂比较单剂减充血剂显著减轻鼻充血,持续3～10h.⑩紫锥花属用于预防:1个系统评价发现与不干预比较,紫锥花属显著减少一次感染发作的人数,但与安慰剂比较,无有效证据支持紫锥花属的作用.(11)紫锥花属制剂:2个系统评价发现有限证据支持紫锥花属的某些制剂在改善症状方面优于安慰剂,但我们未发现有效证据支持任何特定产品的疗效.(12)蒸汽吸入:1个系统评价发现,无证据支持蒸汽吸入的作用.(13)维生素C:1个系统评价发现与安慰剂比较维生素C可轻度缩短感冒症状持续时间,但该作用较小且可能是发表偏倚.(14)锌(鼻内锌胶或锭剂):2个RCTs发现,与安慰剂比较鼻内锌胶缩短感冒症状的平均持续时间,但仅有1个RCT发现差异有显著性.2个系统评价发现,与安慰剂比较葡萄糖酸锌或醋酸盐锌锭剂在7d时减轻症状的持续.
Objective To understand the changing patterns and characteristics of the number of patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) before, during, and in the post-epidemic period of the COVID-19 pandemic and the Association between acute respiratory infections and hospitalization of patients with AECOPD. Methods A retrospective analysis was conducted to count the patients hospitalized for AECOPD in the Department of Respiratory Medicine of the Third Affiliated Hospital of Chongqing Medical University from July 2017 to June 2024. The pattern of change in the number of AECOPD hospitalizations and the associations with patients with respiratory tract infections in outpatient emergency departments were analyzed. Results During the COVID-19 epidemic, the number of hospitalizations of patients with AECOPD did not increase compared with the pre-epidemic period. Instead, it significantly decreased, especially in the winter and spring peaks (P<0.05). The only exception was a peak AECOPD hospitalization in the summer of 2022. COPD inpatient mortality and non-medical discharge rates tended to increase during the epidemic compared with the pre-epidemic period. Analysis of the curve of change in the number of patients with respiratory infections in our outpatient emergency departments during the same period revealed a downward trend in the number of patients with respiratory infections during the epidemic and an explosive increase in the number of patients with respiratory infections in the post epidemic period, whose average monthly number was more than twice as high as that during the epidemic. Correlation analysis of the number of patients with respiratory infections between AECOPD hospitalizations and outpatient emergency departments showed that there was a good correlation between the two in the pre-epidemic and post-epidemic periods, and the correlation between the two in the post-epidemic period was more significant in particular (r=0.84-0.91, P<0.001).In contrast, there was no significant correlation in 2021 and 2022 during the epidemic (r=0.24 and 0.50, P>0.05 ). The most common respiratory infection pathogens among AECOPD hospitalized patients during the post-epidemic period were influenza virus, COVID-19 virus, and human rhinovirus, respectively. Conclusions The pandemic period of COVID-19 infection did not show an increase in the number of AECOPD hospitalizations but rather a trend towards fewer hospitalizations. Respiratory infections were strongly associated with the number of AECOPD hospitalizations in the pre- and post-pandemic periods, while the correlation between the two was poorer during the pandemic period. Influenza virus was the most important respiratory infection pathogen for AECOPD during the post-epidemic period.
The clinical practice guideline on traditional Chinese medicine alone or combined with antibiotics for patients with acute upper respiratory infection in children was issued by China Association of Chinese Medicine in June 2017. Base on the evidence, consensus and experience, five manage groups, steering committee, consensus expert group, systematic review group, drafting group and secretary group, have promoted the project. The main work process refers to up-to-date clinical practice guideline definitions of institute of medicine and quick recommendations guide of guidelines international network and WHO. In order to provide readers with a better understanding of the guideline, the drafting process of guideline principle, main work process, and basis policy were described in detail in this paper. The guidelines’ scientific characteristics, accuracy and practicability were better exhibited in attempt to enhance its promotion and application.
Objective To study the incidence and etiological distribution of lower respiratory tract infection (LRTI) after airway metal stent implantation in patients with malignant central airway obstruction (MCAO). Methods The clinical data of 149 patients with MCAO who underwent airway metal stent implantation in Department of Pulmonary and Critical Care Medicine of Hunan Provincial People's Hospital from April 2014 to April 2021 were selected for a retrospective study. The incidence of LRTI after treatment was counted. According to whether LRTI occurred after operation, they were divided into infected group and uninfected group. The clinical data of the two groups were compared and the influencing factors of LRTI were analyzed. Sputum samples and/or bronchoalveolar lavage fluid samples from patients infected with LRTI were collected for pathogen detection and drug susceptibility test, and the distribution and drug resistance of main pathogens were analyzed. Results A total of 149 patients who met the criteria were included in this study and the incidence of LRTI was 21.48%. People in the infected group was older than that in the uninfected one, and the proportion of people with a history of smoking, chemoradiotherapy, covered metal stents, and stent-related granulation tissue proliferation was higher, and the proportion of people with postoperative standardized aerosol inhalation was lower (P<0.05). Age, smoking history, chemoradiotherapy, covered metal stents, stent-related granulation tissue hyperplasia and postoperative standardized aerosol inhalation were all influencing factors of LRTI in these patients (P<0.05). A total of 38 pathogens were detected in 32 patients with LRTI. Gram negative bacteria, gram positive bacteria and fungi accounted for 68.42% (26/38), 21.05% (8/38) and 10.53% (4/38) respectively. Pseudomonas aeruginosa, the main Gram-negative bacteria, had no resistance to tobramycin, gentamicin and amikacin, but had high resistance to compound sulfamethoxazole, tigecycline and ampicillin; Klebsiella pneumoniae had low resistance to tobramycin, amikacin and tigecycline, and high resistance to cefotaxime, ciprofloxacin and cefepime; the main Gram-positive Staphylococcus aureus had no drug resistance to vancomycin, linezolid, compound sulfamethoxazole and quinuptin/dafuptin, but had high drug resistance to tetracycline, penicillin G, levofloxacin, oxacillin and ciprofloxacin; the main fungi Candida albicans showed no resistance to fluconazole, itraconazole, voriconazole, 5-fluorocytosine and amphotericin B. These results of pathogenic detection and drug susceptibility test contributed to the improvement of the rational application rate of antibiotics. Conclusions LRTI occurs in about a quarter of patients with MCAO after airway metal stent implantation. The pathogens are mainly Pseudomonas aeruginosa and Staphylococcus aureus. Antimicrobial treatment should be based on the results of etiological detection and drug susceptibility test.
Objective To investigate the viral etiology of acute lower respiratory tract infection in adult inpatients. Methods 192 adult inpatients suffering from community-acquired pneumonia, acute bronchitis, or acute exacerbation of chronic obstructive pulmonary disease, admitted from October 2007 to October 2008, were enrolled in the study. Swabs from the nasopharynxes were collected. Multiple polymerase chain reaction was employed to identify the 7 common species of respiratory virus ( including 11subspecies) . Serumspecific IgM against several viruses were detected by indirect immunofluorescence. 106 healthy volunteers were enrolled as control. Results Only 4 cases were found to be infected with virus in 106 healthy volunteers. Viruses were identified in 80 ( 41. 6% ) cases of 192 inpatients and 99 ( 51. 5% )viral strains were detected. The most common viruses identified in the inpatients were influenza virus A ( FluA) , rhinovirus ( RhV) , and parainfluenza virus 1 ( PIV1) . The ratio of the 3 virus strains to the all strains identified was 81. 8% ( 81/99) . Serumspecific IgM was positive in 61 ( 31. 7% ) inpatients and 73 ( 38. 0% ) viral strains were detected. The most common viruses identified in the inpatients were FluA, PIV1,and respiratory syncytial virus ( RSV) . When summing up the data from the swabs and serum, 91 ( 47. 3% )cases had viral infection in 192 inpatients and 110 ( 57. 2% ) viral strains were detected. Conclusion The rate of viral infection is relatively high in the adult inpatients with acute lower respiratory tract infection, and the most common species are FluA, RhV, and PIV1.
Objective To investigate the clinical features of lower respiratory tract infection caused by hypermastigote. Methods The clinical manifestations, chest imaging characteristics, fiber bronchoscopic and etiological test results were analyzed in 16 patients with hypermastigote infection in lower respiratory tract. Results In 16 patients with hypermastigote infection in lower respiratory tract, fever were present in all the cases, cough in 15 cases, night sweat in 12 cases, wheezing in 3 cases, and eosinophilia in 3 cases.Alive hypermastigotes were found in respiratory tract secretion in all the 16 cases. Bacterial culture of respiratory tract secretion yielded positive results in 8 of 16 cases. Chest imaging showed infiltrations in several lobes and segments or a large opacity with fuzzy patches. Bronchoscopy showed an acute inflammation in the respiratory tract lumen. Prognosis was good with the therapy of Metronidazole. Conclusions Detection of hypermastigote infection in lower respiratory tract have a definite clinical significance in Shenzhen area. Mixed infection is common in hypermastigote infection of lower respiratory tract.
Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were 1g for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable (15 in the triagroup and 15 in the control group). No significant differences were observed between the trial group and the control group with respect to the cure rate (40% vs. 27%), the effective rate (80% vs. 87%), the bacterial clearance rate (92% vs. 100%), and the incidence of adverse drug reactions (12.5% vs. 13%) (Pgt;0.05). Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.
Objective To explore the distribution of bacteria among community acquired lower respiratory tract infection (LRTI) inpatients with underlying chronic respiratory tract diseases.Methods The clinical data，sputum culture and drug susceptibility results of 212 community acquired LRTI patients who were hospitalized during the period 2001-2005 were retrospectively analyzed.All patients had various underlying chronic respiratory tract diseases.Results A total of 229 strains of pathogens were detected，with the majority being gram negative bacteria.In pathogens of acute exacerbation of chronic obstructive pulmonary disease，gram negative bacteria occupied 73.9%.And Pseudomonas aeruginosa and Klebsiella pneumoniae were the most common pathogens，with each occupying 18.2% and 13.6% respectively.Gram positive bacteria occupied 23.8%，mainly Staphylococcus aureus (10.2%) and Streptococcus pneumoniae (9.1%).In patients with bronchiectasis exacerbated by bacterial infection，86.2% were caused by gram negative bacteria，the top three being，in descending order，Pseudomonas aeruginosa (27.5%)，Haemophilus parainfluenzae (13.7%)，and Haemophilus influenzae (11.8%).Bronchiectasis was the major risk factor of getting Pseudomonas aeruginosa infection (OR=5.590，95%CI 2.792~11.192).The risk factors of getting Acinetobacter baumanii infection were antacid usage within 1 month (OR=9.652，95%CI 2.792~11.192) and hypoalbuminemia (OR=2.679，95%CI 1.108~6.476).For enterobacters infections，including Klebsiella pneumoniae，Enterobacter cloacae and Escherichia coli，the risk factors were antibiotic usage within 1 month (OR=4.236，95%CI 1.982~9.057)，having renal diseases (OR=4.305，95%CI 1.090~17.008) and diabetes mellitus (OR=2.836，95%CI 1.339~6.009).Conclusions Gram negative bacteria were the main pathogens of community acquired LRTI in hospitalized patients with underlying chronic respiratory tract diseases.The pathogens were influenced by underlying diseases，severity of diseases and drug usage history of patients.