treatment of UTI and newer quinolones are very much sensitive to these pathogenic organisms.

In the treatment of UTI, alkalinisation of urine is a common practice because this reduces the pain and burning sensation during voiding^1. Levofloxacin a well-known fluoroquinolone (Figure 1) often used for the treatment of UTI, is found to be effective in most of the cases of uncomplicated UTI.² However, when levofloxacin is combined with disodium hydrogen citrate, a urinary alkalinising solution, in treatment of UTI the outcome may change, but there is no clinical and pharmacokinetic data available regarding the outcome of this combination in our population.³ This present study was carried out to assess the effect of alkalinisation of urine on the efficacy of levofloxacin, a newer fluoroquinolone in the treatment of uncomplicated UTI. The clinical response was evaluated only in patients with symptoms and signs of lower urinary tract infections.⁴

MATERIALS AND METHODS

Patients were mostly recruited from the out-patient department (general screening OPD) of R. G. Kar Medical College, Kolkata. Permission from institutional ethics committee of R. G. Kar Medical College was taken prior to starting the study.

Patients with uncomplicated UTI aged between 15 to 45 years were included in the study. Exclusion criteria were pregnant and lactating mothers, any haematological diseases, diabetes mellitus (Type 1 & 2), malignancy, any urinary tract abnormality, known liver/kidney/cardiac disorders, known allergy to fluoroquinolones and history of any other antibiotic intake within 2 weeks prior to study and also during study period.

Methods

After recruitment, a detailed medical history was taken followed by thorough clinical examinations which include both general and systemic examination. These were followed by examination of urine i.e. routine urine examination (pH, pus cells, RBC, epithelial cells, albumin, sugar, casts) with culture and sensitivity test. Common laboratory investigations (Hb%, TC, DC, ESR, FBS, urea, creatinine, Liver function test) and imaging (Straight x-ray abdomen/KUB, Ultrasonography) were done mainly in selected cases.

The patients with UTI were screened from OPD with one or more of the following criteria: dysuria, increased frequency of urination, decreased amount of urine passed, high coloured or red urine, fever, suprapubic tenderness. Following the above inclusion and exclusion criteria, 80 patients were included in the study in a randomised way among the patients of UTI found during the study periods.

The study is a randomised and assessor blind study. Randomisation were done using randomisation table. After screening, the patients fulfilling the selection criteria except the culture sensitivity report (Which will be available after 72 hours) were randomised and first dose of study medication were given orally on this 1^st day of visit. A mid-stream urine specimen was obtained at baseline for routine analysis and for culture & sensitivity testing before ingestion of the drug. On next visit, at 3^rd day of treatment, clinical evaluation was done as well as bacteriological tests were repeated in all patients. Those with persistence of symptoms, another course of levofloxacin 250 mg once daily for another 3 days were given. Bacteriological and clinical effectiveness reassessed on 7^th day.

Treatment Modality

The patients were put into the following two groups on the basis of treatment pattern irrespective of types of uropathogen detected. First group consisted of 40 patients who were treated with levofloxacin in doses of 250 mg once daily for 3 days. The second group of 40 patients were treated with levofloxacin in doses of 250 mg OD and alkali solution (disodium hydrogen citrate 1.4 g/5 mL) 10 mL thrice daily for 3 days.⁵ Patients were evaluated bacteriologically and clinically accordingly and statistical analysis by chi square test.

RESULTS

Among the 80 patients in the study, 76 were female and 4 were male. Their mean age was 32 years and average body weight was 56 kg. The commonest symptom was dysuria followed by increased frequency. Many clinically diagnosed cases of UTI were excluded from our study when results of urinalysis were negative for microscopical as well as culture.

Analysis of the clinical and bacteriological findings of these cases who had urinary symptoms were done. The results were shown in table 1.

Result of Culture of Urine

All the 80 cases were diagnosed as cases of UTI on the basis of culture, Pus cells and Bacteria obtained from urine of the patients. The various organisms isolated from the urine culture were as follows: Escherichia coli 73 cases, Klebsiella 3 cases, Pseudomonas 3 cases and Proteus 1 case given in the following table 2.

This table shows that Escherichia coli was the most common organism isolated from urine samples and Proteus is the least one.

Result of Treatment

All our study population received levofloxacin empirically. Clinical and bacteriological evaluations were done after 3 days of therapy. It is seen that the 40 cases treated with Levofloxacin alone, 37 were clinically cured (93%) and in the other group of 40 patients treated with Levofloxacin and alkali solution cure rate was (70%) 28 cases.

Cases were designated bacteriologically as eradicated, when urine samples were found to be sterile and persistent when the urine specimens showed bacteria microscopically or growth on culture or both. This is shown in table 3.

It was seen that after 3 days of therapy, eradication is 93% with Levofloxacin alone and only 70% with Levofloxacin+ alkali solution.

Result of Retreatment

Those 12 cases which were not eradicated by Levofloxacin plus alkali solution treatment for 3 days were again subjected to another 3 days’ therapy with levofloxacin 250 mg alone. It is seen that out of 12 patients, 10 cases who failed to show eradication by treatment with levofloxacin with alkali solution could be eradicated by another 3 days’ therapy with levofloxacin alone. It is also seen that three (03) cases in group A and two (02) patients in group B failed to another 3 days’ therapy with 250 mg levofloxacin and they were prescribed another antibiotic.

Bacteriological Outcome in Vitro

All the microorganisms isolated in Macon key’s culture medium were moderate to highly sensitive to levofloxacin              5 mcg /bio-disc.

Statistical Analysis

Finding the p-value with Pearson’s two-sided Chi-square comparison, we found the significance of difference of clinical outcome results between levofloxacin (Group A) and levofloxacin+alkali solution (Group B). The p value was                   p <0.001 which denotes that the observation is statistically significant.

P= PUS Cells, B= Bacteria, C= Culture