Objective To evaluate the clinical efficacy and safety of sparfioxacin in treatment of the acute respiratory tract infections. Methods A randomized-controlled clinical trial was carried out. Sparfloxaein 200 mg once daily and ofioxacin, as a control drug, 200 mg twice a day, both drugs were given by infusion for 7-14 days. There were 30 cases in each group. Results The clinical cure rates and the clinical efficacy rates of the two groups were 33.33%, 26.67%, and 80.00%, 76.67 % respectively. The bacterial clearance rates were 89.66% and 89.29% respectively. The adverse drug reaction rates were 13.33% and 16.67% respectively. There were no statistical differences between the two groups (Pgt;0.05). Photosensitive reaction was not observed in this study. Conclusion Sparfloxacin was effective in the treatment of the respiratory infections.
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.
Objective To investigate the relations between the human beta defensin-2 (HBD-2) and systemic inflammatory responses in patients with lower respiratory tract infection（LRTI）. Methods Eighty-one patients with confirmed LRTI including community-acquired pneumonia，acute exacerbation of chronic obstructive pulmonary disease or concurrent lung infection，and bronchiectasis concurrent infection were enrolled，and twenty healthy volunteers were included as control. Plasma concentrations of HBD-2，IL-1β，and IL-8 were assayed with ELISA method in all patients and controls. Furthermore the patients were divided into three groups according to the onset of disease:,ie.group A （shorter than 7 days），group B （7 to 14 days），and group C （more than 14 days）. The differences between these groups were compared. Correlation between HBD-2 and IL-1β or IL-8 concentrations was analyzed. Results HBD-2，IL-1β，white blood cell （WBC） of the peripheral blood in the patients with LRTI were all significantly higher than those in the healthy controls. HBD-2 and IL-1β increased in group A and group B，and decreased in group C comparing to the control group （Plt;0.05 respectively）. There was no significant difference of IL-8 in group A，B and C. HBD-2 showed a positive linear correlation with IL-1β （r=0.313，P=0.030） and no correlation with IL-8（Pgt;0.05）. Conclusions The plasma HBD-2 concentration is increased in LRTI patients，which may be a biomarker of systemic inflammation in the early or relative early course of LRTI.
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 explore the application value of Mycoplasma pneumoniae （MP） rapid culture technique for diagnosis of lower respiratory tract infections （LRTIs ） inpatients. Methods 120 LRTIs inpatients in respiratory ward，Anzhen hospital from January 1，2010 to December 31，2010，were recruited in this study. Their pharynx swabs were obtained for rapid MP culture and the serum antibody detection of MP was performed by Gelatin particle agglutination method. Results There were 33 positive yields in 120 LRTIs patients by rapid culture method and 24 positive yields by serological assay. The positive rates were 27.5% and 20.0% respectively. There was no significant difference in the two detecting methods （Pgt;0.05）. Conclusions MP rapid culture method is a better early diagnostic method at the present. MP rapid culture method combined with serological detection can improve the positive yield and avoid missed diagnosis.
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.
Objective To evaluate the efficacy and safety of domestic ambroxol hydrochloride injection in the treatment of lower respiratory tract infection. Methods A total of 120 patients with respiratory tract infections were included and randomized into the treatment group (ambroxol hydrochloride injection 30mg, iv, q12h) and the control group (mucosolvan ampoule 30mg, iv, q12h). The duration of treatment was 6 days. Results 118 patients completed the trial, 59 in each group. From Day 1 to Day 6, the severity scores of cough, sputum amount, difficulty in expectoration and rales were similar between the two groups (Pgt;0.05), but a significant difference was observed in the nature of sputum (Plt;0.05). The total effective rates of the treatment group and the control group were 96.6% (FAS analysis and PP analysis) or 93.3% (FAS analysis), and 94.9% (PP analysis), respectively. There was no significant difference between the two groups (Pgt;0.05). The incidence of adverse effects was comparable between the two groups (1.7% vs. 0%, Pgt;0.05), and no severe adverse effect was observed. Conclusion The efficacy of domestic ambroxol hydrochloride injection in the treatment of lower respiratory infection was equal to that of mucosolvan ampoule, and it can even further improve the nature of sputum. Ambroxol hydrochloride was as safe as mucosolvan ampoule.
Objective To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection. Methods The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days. Results Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (Plt;0.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (Plt;0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation.Conclusion Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.
Objective To investigate the differences in bacteria distribution and drug resistance of pathogens in patients with lower respiratory tract infection between respiratory general wards and respiratory intensive care unit ( RICU) .Methods All the clinical isolates fromsputumor secretion of lower respiratory tract from2007. 1-2010. 10 were analyzed retrospectively. Antibiotic susceptibility was tested by Kirby-Bauer method. Results The total number of isolated strains was 3202. Among 1254 strains isolated from respiratory general wards, Gram-positive bacteria accounted for 2. 63% , Gram-positive bacteria accounted for 42. 42% , and fungi accounted for 54. 95% . Streptococcus pneumoniae ranked first place among Gram-positive bacteria, accounting for 51. 52% . Haemophilus parainfluenzae bacillus ranked first place among Gramnegative bacteria, accounting for 21. 99% . Both were sensitive to the most commonly used antibiotics. Among 1948 strains isolated from RICU ward, Gram-positive bacteria accounted for 4. 52% , Gram-positive bacteria accounted for 37.73% , and fungi accounted for 57. 75% . Staphylococcus aureus ranked first place among Gram-positive bacteria, accounting for 52. 27% . Acinetobacter baumannii ranked first place in Gramnegative bacteria, accounting for 27. 35% . Both were resistant to most commonly used antibiotics. Pseudomonas aeruginosa had a higher rate of infection both in the general wards and RICU, and was resistant to most commonly used antibiotics.Conclusions In lower respiratory tract infection of respiratory general ward, Gram-positive bacteria with Streptococcus pneumoniae mainly and Gram-negative bacteria with Haemophilus parainfluenzae mainly are both sensitive to the most commonly used antibiotics. While in the RICU ward, Gram-positive bacteria infections with Staphylococcus aureus mainly and Gram-negative bacteria infections with Acinetobacter baumannii mainly are both resistant to most commonly used antibiotics.