Objective To evaluate the therapeutic effect, safty and tolerance of Gankeshuangqing Capsule in the treatment of patients suffering from wind-heat syndrome (acute upper respiratory infection or acute bronchitis). Methods The clinical trials were designed multicentered, double blind, double dummy, randomized and parallel positive drug controlled. A total of 289 patients participated in the trials. Those who suffered from acute upper respiratory infection were given throat virus-detection to make a definite diagnosis of the origins of disease. Results Among the 40 patients who were diagnosed with virus infection, 81.82% in Gankeshuangqing group were healed, but only 50.00% in control group, and significant differences were observed between the two groups (Plt;0.05). At the end of the third day of treatment, the rates of cure and excellence in patients suffering from acute upper respiratory infection were 80.00% in Gankeshuangqing group, and 68.57% in control group, and both groups showed good therapeutic effect，but there was no significant difference between the two groups (Pgt;0.05). At the end of the seventh day of treatment, the rates of cure and excellence in patients suffering from acute bronchitis were 82.35% in Gankeshuangqing group, and 63.77% in control group, and both groups showed good therapeutic effect, and there were significant differences between the two groups (Plt;0.05)；only one patient in Gankeshuangqing group had constipation during the treatment, but there was no evidence showing that it is caused by Gankeshuangqing. Conclusion The results show that Gankeshuangqing Capsule has a definite effect on wind-heat syndrome (acute upper respiratory infection or acute bronchitis) with good safety.
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 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.
【摘要】 目的 探讨左氧氟沙星联合阿奇霉素治疗老年难治性呼吸道感染的疗效及安全性。 方法 选择2005年2月-2010年9月收治的高龄难治性呼吸道细菌感染患者68例，随机分为治疗组和对照组。治疗组34例，给予左氧氟沙星联合阿奇霉素；对照组34例，给予左氧氟沙星，两组总疗程皆为15 d。观察两组患者的临床疗效、细菌清除率和不良反应。 结果 治疗组的总有效率为64.71%，对照组总有效率为32.35%，两组差异有统计学意义（Plt;0.05） 。治疗组细菌清除率为76.19%，对照组细菌清除率为36.36%，两组差异有统计学意义（Plt;0.05） 。治疗组和对照组的不良反应发生率分别为5.88%和8.82%，差异无统计学意义（Pgt;0.05）。结论 左氧氟沙星联合阿奇霉素治疗老年难治性呼吸道感染疗效高， 能有效清除细菌， 不良反应较少， 值得临床推广应用。【Abstract】 Objective To evaluate the efficacy and safety of levofloxacin combined with azithromycin on refractory respiratory infections in elder patients. Methods A total of 68 elder patients with refractory respiratory infections in our hospital from February 2005 to September 2010 were randomly divided into two groups: treatment group (n=34) and control group (n=34). The patients in treatment group were treated with levofloxacin combined with azithromycin; while the patients in the control group were treated with levofloxacin alone. The total treatment periods of both groups were 15 days. The therapeutic efficacy, eradication rate of pathogens and the rate of aelverse reactions were observed. Results The therapeutic effect rate was 64.71% in the treatment group and 32.35% in the control group, and the difference between the two groups was statistically significant (Plt;0.05). The eradication rate of pathogens was 76.19% in the treatment group and 36.36% in the control group, and the difference was significant (Plt;0.05). The rate of the adverse reaction was 5.88% in the treatment group and 8.82% in the control group, and there were no significant differences between the two groups (Pgt;0.05). Conclusion Levofloxacin combined with Azithromycin is effective on refractory respiratory tract infection in elder patients, which can effectively remove the bacteria with few adverse reaction.
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.
呼吸道感染在感染性疾病中占有重要地位，细菌性肺炎是呼吸道感染中的主要代表性疾病，最重要的治疗措施是抗菌治疗，用药选择及方法正确与否直接影响治疗的成败。同时如何降低医疗费用也是临床医生需要考虑的棘手问题。据国外文献报道在英国每年约有5亿张以上的抗微生物药物处方，其中住院处方中约40％为静脉制剂，而我国住院静脉制剂的处方比例则更高。医疗费用的增加部分与静脉用药过多有关。为寻求解决临床治疗与医疗费用之间的矛盾，选择高效、低毒、廉价的抗菌药物，1987年Quintiliani等[1]首先提出了抗生素序贯疗法（sequential therapy）的概念，即在经过相对短疗程（48～72 h）静脉抗菌药物治疗，临床症状基本稳定或改善后，改为口服抗菌药物治疗。口服的抗菌药物可以是与前者完全相同的口服剂型，也可以是同一类或抗菌谱相似的同一级药物，后也有人称之为"转换治疗"（switch therapy）、"降级治疗"（step-down therapy）。据国外文献报道，住院的社区获得性肺炎（CAP）应用序贯疗法者因早期出院每位患者节约费用293~1393美元[2-4]。
Objective To investigate nosocomial non-fermented bacterial infection in lower respiratory tract and the risk factors for multi-drug resistant bacterial infection. Methods 229 patients with nosocomial nonfermented bacterial infection in lower respiratory tract from January to December in 2007 in Xiangya Hospital were analyzed retrospectively. The distribution and drug sensitivity of pathogens were recorded. Of those 229 patients,183 cases were infected by non-fermented multi-drug resistant bacteria( MDRB) . The risk factors for non-fermented MDRB infection in lower respiratory tract were analyzed by multi-factor logistic multiple regression analysis.Results The top four non-fermented bacteria isolated were Pseudomonas aeruginosa( 47.6%) , Acinetobacter baumannii( 36. 3% ) , Acinetobacter spp( 8. 6% ) , and Stenotrophomonas maltophilia( 5. 1%) . Higher isolatated rate was found in neurosurgery ( 25. 7% ) and central ICU( 22. 9% ) . The isolated non-fermented bacteria except Stenotrophomonas maltophilia were resistant to all antibiotics except cefoperazone-sulbactam and meropenem. ICU stay( P lt; 0. 001) , tracheotomy or tracheal intubation( P = 0. 001) , and previous use of carbapenemantibiotics( P =0. 032) were independent risk factors for non-fermented MDRB infection. Conclusion Non-fermented bacillus were important pathogens of nosocomial infection in lower respiratory tract with high rates of antibiotic resistance. It is important to prevent non-fermented MDRB infection by strict limitation on the indication of ICU stay,tracheotomy and use of carbapenem.
Objective To study the concentration of neurotrophins( including NGF, BDNF, NT3 and NT4) in the lung of SD rats infected by respiratory syncytial virus( RSV) , and to explore the relationship between the concentration of the neurotrophins, airway hyperresponsiveness and airway neural plasticity.Methods Twenty SD newborn rats were randomly divided into a control group and a RSV-infected group with ten rats in each group. The RSV-infected group were infected with 5 ×104 TCID50/0. 1 mL RSV each week. After 8 weeks, the bronchial responsiveness of the SD rats was assessed. The bronchial inflammation was assessed by HE staining with left lung. Synaptophysin and neurofilament expressions in the lung of SD rats were assayed by the immunohistochemistry staining. In situ hybridization was used to detect the RSV RNA in the lung. The concentration of neurotrophins in the lung of SD rats were detected by ELISA. Results The RSV-infected group showed elevated airway hyperresponsiveness and more inflammatory cells infiltrated in the lung; In situ hybridization showed positive signal of RSV RNA in lung interstitium of the RSV-infected rats. Synaptophysin and neurofilame levels in the airway were increased in the RSV-infected group. Supernatant levels of NGF and BDNF were significantly increased compared with the control group ( P lt;0. 05) . The NT3 and NT4 levels had no significant difference in all groups. The expressions of NGF and BDNF were positively related to the expressions of synaptophysin( r1 = 0. 892, r2 = 0. 995, P lt; 0. 05) and neurofilament( r1 = 0. 949, r2 =0. 936, P lt;0. 05) , also positively related to the airway hyperresponsiveness ( r1 =0. 929, r2 = 0. 910, P lt; 0. 05) . Conclusion RSV infection results in increased expressions of NGF and BDNF in the lung, which are correlated to the change of airway neural plasticity and airway hyperresponsiveness.
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.