ABSTRACT
Objective To observe the clinical effect of Sangpa Zhike decoction in the treatment of acute exacerbations of chronic bronchitis. Methods 180 patients with acute exacerbation of chronic bronchitis admitted to Autonomous Prefecture Hospital of traditional Chinese medicine(TCM)in Changji,Xinjiang,from August 2012 to August 2013 were enrolled. They were divided into Sangpa Zhike decoction treatment group and western medicine treatment control group by random number table,90 cases in each group. General treatments were given to the two groups. In the Sangpa Zhike decoction treatment group,additionally only oral Sangpa Zhike decoction was given(composition:Morus alba 10 g,loquat leaf 10 g,Houttuynia 10 g,honey aster 15 g,honey coltsfoot flower 6 g,Zhejiang Fritillaria 12 g,perilla 10 g,white mustard seed 6 g,Platycodon grandiflorum 10 g,Rhizoma Cynanchi Stauntonii 12 g,tangerine peel 6 g,Stemona 6 g). The ingredients were mixed in water and boiled to form a decoction,one dose daily,divided into two parts to be taken twice a day. In the western medicine treatment group,the infection was controlled by western medicine and the drugs to eliminate cough and phlegm,etc were used. The therapeutic course in both groups was 7 days. The therapeutic effect for treatment of TCM syndromes and the cough quantized integration score in the two groups were observed after treatment. Results The cure rate of Sangpa Zhike decoction treatment group was significantly higher than that of western medicine treatment control group〔70.00%(63/90)vs. 33.33%(30/90),P<0.01〕. Before treatment,the cough symptom quantization integral scores in the two groups had no statistically significance, but after treatment,the scores in the two groups were significantly lower than those before treatment. And the score in Sangpa Zhike decoction treatment group was decreased more significantly (1.66±1.12 vs. 4.36±2.32, P<0.01). Conclusion Sangpa Zhike Decoction has obvious curative effect in the treatment of acute attack of chronic bronchitis.
ABSTRACT
BACKGROUND: LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. METHODS: This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. RESULTS: The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(< or = 0.03 ug/mL) than those for other quinolones, beta-lactams and acrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. CONCLUSION: The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.
Subject(s)
Adult , Humans , beta-Lactams , Bronchitis, Chronic , Double-Blind Method , Follow-Up Studies , Mesylates , Pneumonia , Quinolones , Research PersonnelABSTRACT
BACKGROUND: Moxifloxacin is a newly developed drug which is more potent and safe compared to previous fluoroquinolones. This drug effectively eradicates organisms such as beta-lactamase-producing or other resistant bacteria. Moxifloxacin is known to be effective in treating respiratory infections such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella spp. and Mycoplasma pneumoniae. METHODS: In a multicenter, randomized, open, comparative study, the efficacy and safety of oral moxifloxacin taken 400 mg once a day and clarithromycin taken 500 mg twice daily for 7 days were compared for the treatment of Korean patients with acute exacerbations of chronic bronchitis. RESULTS: A total of 170 patients were enrolled, and they were divided into two groups:87 in the moxifloxacin group and 83 in the clarithromycin group. Of those enrolled, 76 (35 for bacteriologic efficacy) in the moxifloxacin group and 77 (31 for bacteriologic efficacy) in the clarithromycin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 70 (92.1%) of 76 moxifloxacin-treated patients and 71 (92.2%) of 77 clarithromycin-treated patients. Bacteriologic success rate seemed to be higher in moxifloxacin group (73.5%) than in clarithromycin group (54.8%), but statistically insignificant (p=0.098). Drug susceptibility among organisms initially isolated was higher in moxifloxacin group on Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae(p<0.001). Adverse events were reported by 12.8% of 86 patients receiving moxifloxacin and 21.7% of 83 patients receiveing clarithromycin. Headache (4.7% vs 4.8%, moxiflosacin group vs clarithromycin group, respectively) and indigestion (2.3% vs 6.0%, moxifloxacin group vs clarithromycin group, respectively) were the most frequent side effects in the two groups. CONCLUSION: This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 7-days course of moxifloxacin 400 mg od was clinically equivalent and microbiologically superior to clarithromycin 500 mg bid.