Clinical evaluation of the efficacy against helicobacter pylori by amoxicillin from volume-based procurement and potassium amoxicillin clavulanate / 中国临床药理学与治疗学

AIM: To evaluate the clinical efficacy of amoxicillin from volume-based procurement (VBP) and potassium amoxicillin clavulanate in the eradication of helicobacter pylori (Hp) infection, providing basis for the selection of treatment programs. METHODS: Data from the patients who received Hp eradication therapy from May 2021 to May 2022 were recruited from the rational drug use management system. The data from the patients treated by amoxicillin (amoxicillin 1.0 g bid + bismuth potassium citrate 220 mg bid + esomeprazole 20 mg bid + clarithromycin 0.5 g bid, for 14 days) and potassium amoxicillin clavulanate (potassium amoxicillin clavulanate 0.914 g bid + bismuth potassium citrate 220 mg bid + esomeprazole 20 mg bid + clarithromycin 0.5 g bid, for 14 days) were selected and compared. RESULTS: A total of 171 cases were collected in the group treated by Amoxicillin program, and the eradication rate was 87.8% (150/171). A total of 69 cases were collected in the group of potassium amoxicillin clavulanate, and the eradication rate was 76.8% (53/69). There was no significant difference in baseline data between the two groups (P>0.05). There was a significant difference in clinical efficacy between the two groups (P< 0.05). In addition, the cost-effectiveness ratio (C/E) of the Amoxicillin treatment program was lower than that of the potassium amoxicillin clavulanate program CONCLUSION: The clinical efficacy of VBP Amoxicillin program in eradicating Hp infection is better than that of the potassium amoxicillin clavulanate program, which is worthy of clinical recommendation.

Phenotypic Characterization and Antibiotic Susceptibility Profile of Coagulase Positive Staphylococci from The External Surfaces of Hospital Cockroaches (Periplaneta americana)

A study to phenotypically characterize and determine the antibiogram of coagulase positive Staphylococci (CoPS) from the external surfaces of hospital cockroaches (Periplaneta americana) was conducted using standard microbiological methods. Out of the 50 cockroaches collected from various hospitals in Uyo, sixty-two percent (n = 31) had coagulase positive Staphylococci which consisted of Staphylococcus aureus (44.0 %; n = 22) and Staphylococcus intermedius (18.0 %; n = 9). The CoPS isolates showed 100% resistance to Penicillin, Tetracycline, Clindamycin and 80.6% sensitivity to Amoxicillin-clavulanate. The CoPS showed multiple antibiotic resistances to ≥ 3 antibiotics, with 60 % exhibiting resistance to 6 antibiotics. Out of the 80 % (n = 31) of the multidrug resistant CoPS that were sensitive to Amoxicillin-clavulanate, none of them showed production of beta lactamase. The cockroaches bore multiple antibiotic resistant CoPS on their external surfaces and their contact can initiate contamination of patients' food. Pest control measures in hospital are hereby recommended to minimize cockroach related infections

Activities of Biapenem against Mycobacterium tuberculosis in Macrophages and Mice / 生物医学与环境科学（英文）

OBJECTIVE@#To assess the activities of biapenem against multidrug-resistant and extensively drug-resistant Mycobacterium tuberculosis.@*METHODS@#Biapenem/clavulanate (BP/CL) was evaluated for in vitro activity against Mycobacterium tuberculosis (Mtb) multidrug-resistant (MDR) isolates, extensively drug-resistant (XDR) isolates, and the H37RV strain. BP/CL activity against the H37Rv strain was assessed in liquid cultures, in macrophages, and in mice..@*RESULTS@#BP/CL exhibited activity against MDR and XDR Mtb isolates in liquid cultures. BP/CL treatment significantly reduced the number of colony forming units (CFU) of Mtb within macrophages compared with control untreated infected macrophages. Notably, BP/CL synergized in pairwise combinations with protionamide, aminosalicylate, and capreomycin to achieve a fractional inhibitory concentration for each pairing of 0.375 in vitro. In a mouse tuberculosis infection model, the efficacy of a cocktail of levofloxacin + pyrazinamide + protionamide + aminosalicylate against Mtb increased when the cocktail was combined with BP/CL, achieving efficacy similar to that of the positive control treatment (isoniazid + rifampin + pyrazinamide) after 2 months of treatment.@*CONCLUSION@#BP/CL may provide a new option to clinically treat MDR tuberculosis.

Antibiotic sensitivity pattern of bacterial isolates in patients with chronic rhinosinusitis in Kaduna, Nigeria

Introduction: A common practice in the management of patients with chronic rhinosinusitis (CRS), the empirical use of antibiotics may contribute to treatment failure and to the development of antimicrobial resistance. Objective: To determine the antibiotic sensitivity pattern of aerobic and anaerobic bacteria associated with CRS. Methods: This was a prospective cross-sectional study in which endoscopically guided middlemeatal swabs (IBMSpss, version 16.0, Chicago, IL, USA) were aseptically taken from patients diagnosed with CRS after obtaining informed consent and ethical clearance. The samples were sent to the laboratory for qualitative and semiquantitative analysis via gram stain, aerobic, anaerobic cultures and antibacterial sensitivity tests. The collected data was analyzed using SPSS for Windows, version 16 (SPSS Inc, Chicago, IL, USA). Simple statistical parameters and paired sample t-test were used, as appropriate. Results: There were 74 (56.92%) bacterial growths, out of which 55 (74.32%) were aerobic and 19 (25.68%) were anaerobic isolates, from a total of 130 patients. About 13 (17.5%- 18%) of these bacterial growths yielded a mixed growth of aerobic and anaerobic isolates. Themost common bacterial isolates were 26 (35.14%) Staphylococcus aureus, Haemophilus influenzae 9 (12.16%), Streptococcus viridians 8 (10.81%), and Streptococcus pneumoniae 5 (6.76%). Augmentin, ciprofloxacin, and Peflacine were found to bemost effective, followed by levofloxacin, Rocephin, erythromycin and Zinat in that order (AU)

Intereactions between doripenem and clavulanate ­ Application of minimal inhibitory concentration analysis and cytometry flow for bactericidal studies

Background: In view of the current low efficacy of bacterial infection treatment the common trend towards searching for antibiotic systems exhibiting synergistic action is well justified. Among carbapenem analogues a particularly interesting option is provided by combinations of clavulanic acid with meropenem, which have proven to be especially effective. Results: Determination of the minimal inhibitory concentration (MIC) along with the method based on flow cytometry constitutes an important tool in the identification of bacterial sensitivity to active substances. Within this study the inhibitory effect of doripenem, clavulanic acid and the doripenem-clavulanate acid system was analyzed in relation to such bacteria as Salmonella enteritidis, Salmonella typhimurium, Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Proteus vulgaris, Clostridium butyricum and Clostridium pasteurianum, Acinetobacter baumannii, Enterobacter aerogenes. The lowest MIC, amounting to 0.03 µg/mL, was observed for the doripenem-clavulanate acid system in the case of E. coli ATCC 25922. In turn, the lowest MIC for doripenem applied alone was recorded for K. pneumoniae ATCC 31488, for which it was 0.1 µg/mL. The strain which proved to be most resistant both to doripenem and the doripenem-clavulanate acid system, was A. baumannii, with MIC of 32 µg/mL (clinical isolate) and 16 µg/mL (reference strain). Cytometric analysis for P. aeruginosa ATCC 27853 and S. aureus ATCC 25923 showed changes in cells following exposure to limiting concentrations of the active substance. Conclusions: Analysis of MIC supplies important information concerning microbial sensitivity to active substances, mainly in terms of limiting concentrations causing mortality or vitality of the tested species, which is essential when selecting appropriate antibiotic therapy.

Clinical effect observation of Bairui Granules combined with amoxicillin and clavulanate potassium tablets in treating acute tonsillitis / 中草药

Objective To observe the curative effect of Bairui Granules combined with amoxicillin and clavulanate potassium tablets in treating acute tonsillitis. Methods A total of 200 patients with acute tonsillitis treated in Dongfang Hospital from February to November in 2017 were randomly divided into the treatment group and the control group according to the random number table method. A total of 100 cases in the control group was treated with amoxicillin and clavulanate potassium tablets, 100 cases in the treatment group received Bairui Granules combined with amoxicillin and clavulanate potassium tablets, each group was treated for 5 d as one course. The clinical symptoms and signs improving time of two groups were observed and the therapeutic effects of the two groups were compared and analyzed. Result In the treatment group, the time of heat withdrawal and sore throat disappeared was significantly less than that of the control group (P < 0.01); After one course of treatment, the total effective rate of the treatment group was significantly higher than that of the control group (P < 0.05). In the two groups, there was no adverse reaction during the treatment. Conclusion Bairui Granules combined with amoxicillin and clavulanate potassium tablets had the advantages of short course and higher effect in the treatment of acute tonsillitis.

A clinical trial to study the failure of treating initial Helicobacter pylori eradication with the doxycycline,amoxicillin and clavulanate potassium containing rescue quadruple regimen / 实用医学杂志

Objectives To investigate the efficacy and safety of quadruple regimen containing doxycy-cline,amoxicillin and clavulanate potassium in the treatment of Helicobacter pylori(Hp)after the failed initial eradication. Methods A total of 136 patients who had a failed course of initial eradication therapy were randomly divided into four groups. The 46 patients in group A were given rabeprazole,colloidal bismuth tartrate,doxycy-cline,amoxicillin and clavulanate potassium for 14 days). The 45 cases in group B were treated with rabeprazole, colloidal bismuth tartrate,doxycycline,amoxicillin and clavulanate potassium for 10 days. The 45 cases in control group received rabeprazole,colloidal bismuth tartrate,levofloxacin,amoxicillin for 14 days. After 4 weeks of treat-ment,the 13C-urea breath test was performed. The Hp eradication rates,adverse reactions,treatment compliance and cost-effectiveness ratio of the three groups were evaluated. Results A total of 130 patients completed the study. The intention to treat(ITT)and Per-protocol(PP)analyses revealed that the eradication rates of the three groups were 71.74% and 76.74%(group A),71.11% and 72.72%(group B),51.11% and 53.49%(control group),respectively. The ITT and PP of group were significantly higher than those of control group(P < 0.05). But there was no significant difference between group B and control group(P > 0.05). The rates of adverse reac-tions in each group were not statistically significant(P > 0.05),and the patient compliance of three groups was more than 80%. The cost and cost-effectiveness ratio showed that group B < control group < group A. Conclu-sions The quadruple therapy containing doxycycline,amoxicillin and clavulanate potassium as a rescue regimen given for 14 days is safe,effective and with high patient compliance,which is of high clinical significance.

Treatment progress and prognosis of protracted bacterial bronchitis / 中华实用儿科临床杂志

Protracted bacterial bronchitis (PBB) is an important cause of chronic wet cough.Bacterial infection is the main pathogen of PBB,so antibacterial infection is the main treatment.As the main antibiotic of experiential treatment,Amoxicillin-clavulanate is recommended to be used for at least 2 weeks,usually 4 weeks,and 6 to 8 weeks in part.If the sputum culture or bronchoalveolar lavage fluid is positive,the selection of antibiotic therapy can be according to drug sensitivity test.

Optimization of Dosage Regimen of Amoxicillin and Clavulanate Potassium Extended Release Tablets Based on PK/PD Parameters / 中国药师

Objective:To optimize the clinical dosage regimen of amoxicillin and clavulanate potassium extended release ( ER) tablets based on the PK/PD parameters. Methods:Totally 30 healthy subjects ( half male and half female) were randomly divided into three groups, and orally administered the ER tablets respectively under fasting condition, before the meal and after the meal, and the optimal administration time was determined by comparing the pharmacokinetic characteristics. The subjects in the three groups were ad-ministered the ER tablets respectively at low, medium and high dosage, and the optimal dosage and dosing interval were determined based on the PK/PD parameters. Results:Under fasting condition, the AUC of amoxicillin [(32.2 ±15.0) μg·h·ml-1] was sig-nificantly lower than that before the meal [(41.7 ±1.92) μg·h·ml-1] and that after the meal [(42.6 ±17.7) μg·h·ml-1]. In contrast, the AUC of clavulanate acid after the meal [(1.89 ±0.54) μg·h·ml-1] was significantly lower than that under fasting condition [(2.55 ±0.76) μg·h·ml-1] and that before the meal [(2.58 ±0.76) μg·h·ml-1] (P MIC) in 12 h was 5. 5, 7 and 10 h, and the percentage was 46%, 58% and 83%, respectively, and T> MIC in 12 h was 4. 5, 6 and 8 h, and the percentage was 38%, 50% and 67%, re-spectively when MIC was 4. 0μg·ml-1 . Conclusion:It is suggested that amoxicillin and clavulanate potassium ER tablets be taken at the start of a standard meal, 2 tablets per time, twice daily, which is sufficient to achieve T> MIC of 40% -50%.

Simultaneous Determination of 2 Main Components in Ticarcillin Disodium and Potassium Clavulanate for Injection by Improved HPLC / 中国药房

OBJECTIVE:To improve the method for the determination of 2 main components in Ticarcillin disodium and potas-sium clavulanate for injection. METHODS:HPLC was performed on the column of Waters XBridgeTM C18 with mobile phase of 0.01 mol/L ammonium dibasic phosphate solution(pH 7.0)-menthol(80:20,V/V)at a flow rate of 1.0 mL/min,the detection wave-length was 220 nm, column temperature was 30 ℃, and injection volume was 20 μL. RESULTS:The linear range was 1.95-195.22 μg/mL for ticarcillin (r=0.9999) and 0.12-12.18 μg/mL for clavulanate(r=0.9999);RSDs of precision,stability (under 4 ℃) and reproducibility tests were lower than 1.0%;recoveries were 99.3%-100.5%(RSD=0.4%,n=9) and 99.2%-101.0%(RSD=0.7%,n=9). CONCLUSIONS:The method is rapid,accurate and reliable,and can be used for the determination of 2 main components in Ticarcillin disodium and potassium clavulanate for injection.

Analysis of Impurity Profile of Amoxicillin and Clavulanate Potassium Tablets / 中国药学杂志

OBJECTIVE: To establish an HPLC-UV-ESI-MSn method for the study of impurity profile of amoxicillin and clavulanate potassium tablets. METHODS: Agilent 1100 LC/MSD Trap liquid chromatography-mass spectrometry was used, and the column was Shim pack CLC-ODS RP18(4.6 mm×250 mm, 5 μm). The mobile phase A was 20 mmol·L-1 ammonium acetate (pH adjusted to 6.0), and the mobile phase B was 20 mmol·L-1 ammonium acetate-acetonitrile (20∶80) (pH adjusted to 6.0). Gradient elution was performed at a flow rate of 1.0 mL·min-1. ESI source was used. Positive and negative ion scan was conducted with a scanning range of m/z 100-1 500. The nebulizing pressure was 275.8 kPa, dry gas flow was 9 L·min-1, and post-column diversion ratio was 1∶5. Some related substances were identified by comparing the retention time in the chromatography, [M+H]+ spectrum and MS2 spectrum with those of the reference substances, while the others which do not have reference substances were deduced or speculated by analyzing the MS2 or MSn fragmentation with the help of a rule summarized from the MS2 fragmentation of amoxicillin, clavulanic acid and system suitability impurity reference substances. RESULTS: A total of 15 related substances were separated and characterized including nine known impurities like amoxicilloic acid, amoxicillin dimer, etc. and six unknown impurities. CONCLUSION: The method can be applied in the identification and qualitative analysis of the related substances in amoxicillin and clavulanate potassium tablets and is helpful for the quality control and optimization of the synthetic process.

Efficacy of amoxicillin, clavulanate potassium and cefotaxime in the treatment of neonatal pneumonia and its influence on intestinal microflora / 中国基层医药

Objective To investigate the efficacy of amoxicillin,clavulanate potassium and cefotaxime in the treatment of neonatal pneumonia and its influence on intestinal microflora.Methods 310 cases of neonatal pneumonia diagnosed in the hospital from June 2014 to June 2016 were selected as the subjects.They were divided into three groups according to random number table.The group A (100 cases) was treated with amoxicillin and clavulanate potassium,group B(105 cases) was treated with cefotaxime,group C(105 cases) was treated with amoxicillin,clavulanate potassium and cefotaxime.The effect and the difference of intestinal microecology were compared among the three groups.Results There were no statistically significant differences among the three groups in effect and the cure time [(5.2 ± 1.3) d vs.(5.4 ± 1.5) d vs.(5.3 ± 1.4) d] (P ＞ 0.05).There were statistically significant differences in intestinal microecology among the group A,group B,group C and control group (x2 =11.741,7.066,6.163,8.752,22.851,all P ＜ 0.05).The lactobacillus,Bifidobacterium,Enterococcus and true Bacillus of group A,group B,group C were less than those of the control group,which in group C were significantly less than group A and group B,there were statistically significant differences (t =10.453,6.843,5.974,17.654,all P ＜ 0.05).The Enterobacteriaceae of group A,group B and group C was significantly more than that of the control group,and the Enterobacteriaceae of group C was significantly more than that in group A and group B,there were statistically significant differences (t =6.574,4.634,3.968,9.893,all P ＜ 0.05).Conclusion Amoxicillin,clavulanate potassium and cefotaxime are effective in the treatment of neonatal pneumonia,the combined use of drugs has great influence on intestinal microflora.

Effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia / 药物评价研究

Objective To discuss the effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia.Methods Totally 1 00 infants with pneumonia were selected.They were randomly divided into two groups,the observation group (52 cases) were given Yanhuning Injection combined with amoxicillin and clavulanate potassium.The control group (48 cases) were given Yanhuning Injection.The effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia was evaluated using efficacy,cough,pulmonary rales disappeared time,pyretolysis time,pulmonary function indexes and adverse reaction during treatment as indexes.Results The effective rate was 92.3％ in the observation group and 75.0％ in the control group.The effective rate in the observation group was higher than that of the control group (P ＜ 0.05).The cough,pulmonary rales disappeared time of the observation group was shorter than that of the control group (P ＜ 0.05).There was no statistical significance on pyretolysis time between two groups.Before treatment,there was no statistical significance on FVC,FEV1 and FEV1/FVC％ between two groups.After treatment,the FVC,FEV1 and FEV1/FVC％ were increased and higher in the observation group (P ＜ 0.05).During treatment,there was no statistical significance on adverse reaction between two group.Conclusion Yanhuning Injection combined with amoxicillin and clavulanate potassium has a good effective on infantile pneumonia.It could improve the symptoms of pneumonia and lung function while inhibiting inflammation with good safety.It was worthy of clinical application.

Effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia / 药物评价研究

Objective To discuss the effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia.Methods Totally 1 00 infants with pneumonia were selected.They were randomly divided into two groups,the observation group (52 cases) were given Yanhuning Injection combined with amoxicillin and clavulanate potassium.The control group (48 cases) were given Yanhuning Injection.The effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia was evaluated using efficacy,cough,pulmonary rales disappeared time,pyretolysis time,pulmonary function indexes and adverse reaction during treatment as indexes.Results The effective rate was 92.3％ in the observation group and 75.0％ in the control group.The effective rate in the observation group was higher than that of the control group (P ＜ 0.05).The cough,pulmonary rales disappeared time of the observation group was shorter than that of the control group (P ＜ 0.05).There was no statistical significance on pyretolysis time between two groups.Before treatment,there was no statistical significance on FVC,FEV1 and FEV1/FVC％ between two groups.After treatment,the FVC,FEV1 and FEV1/FVC％ were increased and higher in the observation group (P ＜ 0.05).During treatment,there was no statistical significance on adverse reaction between two group.Conclusion Yanhuning Injection combined with amoxicillin and clavulanate potassium has a good effective on infantile pneumonia.It could improve the symptoms of pneumonia and lung function while inhibiting inflammation with good safety.It was worthy of clinical application.

Susceptibilidad antimicrobiana de dos periodontopatógenos a moxifloxacina y amoxicilina ácido clavulánico / Antimicrobial susceptibility of moxifloxacin and amoxicillin clavulanic acid against two periodontopathogens

Fundamento: se ha documentado un aumento importante de la resistencia de algunos perio-dontopatógenos a los antimicrobianos usados de forma tradicional como coadyuvantes en la terapia periodontal. Objetivo: evaluar la susceptibilidad de Aggregatibacter actinomycetemcomitans y Porphyromonas gingivalis a la moxifloxacina y amoxicilina ácido clavulánico en pacientes con periodontitis crónica. Métodos: se realizó un estudio observacional de corte transversal el universo estuvo constitui-do por 30 pacientes con periodontitis crónica. La toma y procesamiento de las muestras microbiológicas se realizaron mediante protocolos descritos de forma previa. Para evaluar la susceptibilidad de A. actinomycetemcomitans y P. gingivalis frente a la moxifloxacina y amoxicilina ácido clavulánico, se usaron pruebas de difusión en disco. Resultados: P. gingivalis fue el microorganismo más prevalente en la población estudiada. Los dos periodontopatógenos cultivados fueron muy sensibles a los dos antimicrobianos evaluados. Conclusiones: A. actinomycetemcomitans y P. gingivalis son muy susceptibles a la moxifloxacina y la amoxicilina ácido clavulánico en la población estudiada, donde se convierte de esta manera en una alternativa coadyuvante para el tratamiento de la periodontitis.

Background: a significant increase in the resistance of some antimicrobial periodontopathogens traditionally used as adjuncts in periodontal therapy has been reported. Objective: to assess the susceptibility of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis to moxifloxacin and amoxicillin clavulanic acid in patients with chronic periodontitis. Methods: an observational cross-sectional study of the universe composed of 30 patients with chronic periodontitis was conducted. Microbiological samples processing were performed following protocols described previously. Disk diffusion tests were used to assess the susceptibility of A. actinomycetemcomitans and P. gingivalis against moxifloxacin and amoxicillin clavulanic acid. Results: P. gingivalis was the most prevalent microorganism in the population studied. The two periodontopathogens grown were highly sensitive to both antimicrobials tested. Conclusions: A. actinomycetemcomitans and P. gingivalis are highly susceptible to moxifloxacin and amoxicillin clavulanic acid in this population, therefore it is an alternative adjuvant for the treatment of periodontitis.

Resistance to amoxicillin‑clavulanate and its relation to virulence‑related factors in Yersinia enterocolitica biovar 1A.

Recent studies have reported that the virulence factors (VFs) were detected more frequently in amoxicillin‑clavulanate (AMC) susceptible clinical isolates of Escherichia coli. Here, we have evaluated the relationship between VFs and AMC‑resistance phenotype in clinical isolates of Y. enterocolitica biovar 1A. The presence/absence of VFs was compared with their minimum inhibitory concentrations for AMC in strains of two serovars. We observed that the strains of the serovar O: 6, 30‑6, 31 showed a similar relationship between the number of VFs and resistance to clavulanic acid as in E. coli but not of serovar O: 6, 30. Variations in the promoters/complete coding sequences (CCDSs) of β‑lactamase gene (blaA) or the serological characteristics could not account for unusual susceptibility to AMC displayed by the strains of the serovar O: 6, 30. Therefore, we speculate that since the clinical strains of serovar O: 6, 30‑6, 31 originated from the environment they were less exposed to antibiotics compared to clinical strains of serovar O: 6, 30. Thus, AMC susceptibility seems to be influenced by factors other than serotypes or promoters/CCDS of β‑lactamase genes.

The control of the critical quality attributes of amoxicillin and clavulanate potassium tablet / 药学学报

The critical attribute was analyzed in clavulanate potassium tablet of amoxicillin according to the principle QbD. By investigation of the drug impurity profile, the cycle-closed dimer and penicilloic acid of amoxicillin were considered to be the critical impurities, and the sources and the degradation pathways of these two impurities were discussed. The research confirmed that crystal form was the critical attribute of drug substance. The drying process in the tablet granulation was regarded as the critical process parameter. The tablet formulation was also another factor in the impurity generation. This study provides a new idea for the evaluation of drug quality.

Pharmacoeconomics Evaluation of 5 Kinds of Antibiotics in the Treatment of Pediatric Bronchopneumonia / 中国药房

OBJECTIVE:To evaluate the pharmacoeconomics of cefathiamidine, ceftriaxone sodium, cefuroxime sodium, amoxicillin sodium/clavulanate potassium and cefoperazone sodium/sulbactam sodium in the treatment of pediatric bronchopneumo-nia,and to provide reference for rational drug use in the clinic. METHODS:By retrospective study,338 children with broncho-pneumonia were divided into groups A,B,C,D and E according to different therapy regimens. There were 75,65,76,66 and 56 cases in groups A,B,C,D and E,and they were given cefathiamidine,ceftriaxone sodium,cefuroxime sodium,amoxicillin sodium/clavulanate potassium and cefoperazone sodium/sulbactam sodium intravenously. The pharmacoeconomics of therapy regi-mens in group A,B,C,D and E were evaluated by cost-effectiveness analysis and decision tree analysis model. RESULTS:The effective rates of groups A,B,C,D and E were 93.33%,90.77%,96.05%,87.88% and 87.50%,respectively. The treatment cost of those groups were 1 929.09,2 173.73,1 611.91,1 661.42,1 801.32 yuan,respectively. The cost/effectiveness(C/E)ratio of those groups were 20.67,23.95,16.78,18.91,20.59,respectively. The treatment cost of group C was the smallest,so was the C/E. Results of cost-effectiveness analysis were supported by sensitivity analysis. CONCLUSIONS:Cefuroxime sodium is the best treatment for pediatric bronchopneumonia among 5 antibiotics in respect of cost-effectiveness.

Influence of moisture on stability of amoxicillin and potassium clavulanate granules / 中国药学杂志

OBJECTIVE: To investigate the influence of moisture including water content and water activity on the stability of amoxicillin and potassium clavulanate granules according to the characteristics of the granules, and reveal the key quality control property in the preparation process with stability as an indicator. METHODS: Under the condition of (25±2)℃ and (75±5)% RH, the water content, active ingredient contents, related substances and characteristics of crystal form of amoxicillin and potassium clavulanate granules were studied. RESULTS: The stability of amoxicillin and clavulante potassium granules was positively correlated with water activity in the samples, but was not related to water content closely. The sample with lower water activity was of higher stability. CONCLUSION: The key quality control property of amoxicillin and potassium clavulanate granules is the moisture, and the key process parameter in the preparation is the water activity.

Clinical Observation of Amoxicillin Sodium and Clavulanate Potassium Combined with Cranial Mild-mod-erate Hypothermia in the Treatment of Neonatal Hypoxic-ischemic Encephalopathy Complicating with Pul-monary Infection / 中国药房

OBJECTIVE:To investigate the clinical efficacy and safety of amoxicillin sodium and clavulanate potassium com-bined with cranial mild-moderate hypothermia in the treatment of neonatal hypoxic-ischemic encephalopathy (HIE) complicating with pulmonary infection. METHODS:80 children with HIE complicating with pulmonary infection were randomly divided into ob-servation group(42 cases)and control group(38 cases). Control group received routine treatment under normal body temperature as lowering intracranial pressure,correcting acid-base balance,giving nutritional support and anticonvulsive treatment,and then was given amoxicillin sodium and clavulanate potassium 30 mg/kg intravenously,tid,more than 30 min each time,for consecutive 3 d. On the basis of control group,observation group was additionally given cranial mild-moderate hypothermia therapy:wearing cooling cap,at 10 ℃;keeping pharynx nasalis temperature at 34 ℃;keeping rectal temperature at 33-37 ℃;decreasing at rate of 1 ℃/h. They continued treatment for 3 d till body temperature decreased to 34.5 ℃;and then cooling cap was taken off to recover normal body temperature. Therapeutic efficacy of HIE and pulmonary infection were observed in 2 groups. NBNA score of 2 groups were recorded 1st,2nd and 4th week after birth,and the occurrence of ADR was observed. RESULTS:Total effective rate of HIE therapy (95.24% vs. 78.95%),cure rate of pulmonary infection (52.38% vs. 26.32%) and total effective rate (85.71% vs. 65.79%) in observation group were significantly higher than control group,with statistical significance (P0.05). Compared to 1st week after birth,NBNA score were significantly improved 2nd and 4th week after birth,and the observation group were significantly higher than the control group,with statistical significance(P0.05). CONCLUSIONS:Amoxicillin sodium and clavulanate potassium combined with cranial mild-moderate hypothermia is effec-tive for HIE complicating with pulmonary infection,and can effectively improve the prognosis of children with good safety.