Catarrhalis obtained from upper respiratory tract are susceptible to amoxicillin-clavulanate potassium 3-5. Hoberman A et al., reported that 10 days treatment with amoxicillin-clavulanate potassium in children between 6 to 23 months of age with AOM showed resolution of signs and symptoms and decreased overall symptoms burden . American association of paediatrics also recommends amoxicillin-clavulanate potassium as the first line drug in treatment of AOM . To compare the efficacy and safety of cefpodoxime and amoxicillin-clavulanate potassium for the treatment of PAOM in children below two years. Out of 40 children screened, 36 fulfilled the selection criteria and included in the study.
Thus, it can be suggested that both cefpodoxime and amoxicillin-clavulanate potassium are effective in treatment of PAOM. Inter group analysis of the AOM-SOS scores showed that there was no statistically significant difference in the baseline, day 5 and day 10 AOM-SOS scores. So, it can be suggested that both cefpodoxime and amoxicillin-clavulanate potassium are equally effective in treatment of PAOM. Suspected bacteria and their antibiotic susceptibility pattern guide the choice of antimicrobial agents for treatment of AOM. Common bacteria known to cause AOM in children are Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis . However, there is relative paucity of data on middle ear pathogens as tympanocentesis is not routinely performed in children with AOM.
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Few mild and self-limiting AEs were observed and both the drugs were well tolerated.
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- Inter group comparisons showed that the decrease in most of the symptoms was significantly higher in cefaclor arm as compared to amoxicillin-clavulanate potassium arm.
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- The perspective of management of AOM has been changing continuously.
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Acute Otitis Media (AOM) is one of the frequently diagnosed diseases in children below two years. Amoxicillin-clavulanate potassium is the first line drug in treatment of Paediatric AOM (PAOM). Cefpodoxime has amxoline good antimicrobial activity against various types of microorganisms that include causative microorganisms of PAOM.
The study conducted by Hoberman A et al., evaluated children between 6 to 23 months of age with AOM. They reported that treatment with amoxicillin-clavulanate potassium for 10 days resulted in quick recovery and decreased signs and symptoms of AOM on otoscopic examination . The result proved that amoxicillin-clavulanate potassium is the first line drug for the treatment of PAOM in children below two years. Few studies have evaluated efficacy of oral cephalosporins in treatment of PAOM 14-17.
One multi-centric prospective clinical trial compared the efficacy and safety of cefaclor and amoxicillin-clavulanate potassium in children with AOM. Both cefaclor and amoxicillin-clavulanate potassium caused a significant improvement in all the signs and symptoms after 10 days of treatment period. Inter group comparisons showed that the decrease in most of the symptoms was significantly higher in cefaclor arm as compared to amoxicillin-clavulanate potassium arm. The study showed cefaclor is well tolerated and effective treatment option for AOM in children and it is superior to the combination of amoxicillin-clavulanate potassium in efficacy and tolerability in AOM. However, the children included in the study by Agarwal M et al., were above two years of age.
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Future trials are required to assess relapse rates and bacteriological cure to provide more scientific insight into the study. Children fulfilling the selection criteria, were randomly divided into two treatment groups. Children in Group A received amoxicillin-clavulanate potassium 30 mg/kg/day (amoxicillin base) in two divided doses for 10 days.
These non-serious AEs did not require dose modification or withdrawal of drug therapy. Several published studies 6,11-14 show the efficacy of amoxicillin-clavulanate potassium for the treatment of PAOM. Few studies have also proved the efficacy of ceftriaxone, cefaclor and cefuroxime axetil in children with PAOM . But no published data are available that compared amoxicillin-clavulanate potassium with an oral third-generation cephalosporin like cefpodoxime in PAOM. Our study shows that efficacy and safety of 10 days therapy with cefpodoxime is comparable to that of amoxicillin-clavulanate potassium in PAOM in children below two years.
- To compare the efficacy and safety of cefpodoxime and amoxicillin-clavulanate potassium for the treatment of PAOM in children below two years.
- The four children, who were excluded from the study, were given adequate treatment accordingly.
- One multi-centric prospective clinical trial compared the efficacy and safety of cefaclor and amoxicillin-clavulanate potassium in children with AOM.
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Guidelines of American associations of paediatrics suggests that ceftriaxone, cefprozil and cefuroxime axetil can be used as alternative options for treatment of PAOM in under two years as well as over two years of age . Against this backdrop, the present study was conducted to compare the efficacy and safety of cefpodoxime with amoxicillin-clavulanate potassium in PAOM in children below two years. A randomized double blind clinical trial could not be conducted due to lack of resources. Secondly, the sample sized of our study was relatively small. We conducted this study to provide information to paediatricians on the comparative efficacy of these two antibiotics as initial antibiotics for children with PAOM below two years of age based on clinical assessment scores. Intra group analysis of AOM-SOS score at baseline (day 0) against day 5 and day 10 scores showed a highly significant decrease in both groups and clinically significant improvement in the signs and symptoms of the PAOM.
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Our study showed that cefpodoxime and amoxicillin-clavulanate potassium are equally effective in clinically diagnosed cases of PAOM, both in terms of efficacy and safety. After treatment with a 10-day course, the clinical success rates were comparable i.e., 88.2% in the cefpodoxime group and 93.8% in the amoxicillin-clavulanate potassium group. The incidence of AEs was also minimal i.e., two in the amoxicillin-clavulanate potassium group.
एमोक्सिसिलिन कैप्सूल के उपयोग – (Uses of Amoxicillin Capsules in Hindi)
Linking your external account can take up to two days. These were mild AEs and did not require modification of drug therapy. Over all safety profile of both the study drugs was good. The perspective of management of AOM has been changing continuously.
