Acute prostatitis after prostate biopsy under ciprofloxacin prophylaxis with or without ornidazole and pre-biopsy enema: analysis of 3. 479 prostate biopsy cases

ABSTRACT Objectives: To investigate the characteristics of cases of NIH category I acute prostatitis developed after transrectal prostate biopsy and clarifiy the risk factors and preventive factors. Materials and Methods: We retrospectively reviewed the medical records of 3.479 cases of transrectal ultrasound-guided needle biopsies performed with different prophylactic antibiotherapy regimens at two different institutions between January 2011 and February 2016. The patients of Group I have received ciprofl oxacin (n=1.523, 500mg twice daily) and the patients of Group II have received ciprofl oxacin plus ornidazole (n=1.956, 500mg twice daily) and cleansing enema combination as prophylactic antibiotherapy. The incidence, clinical features and other related microbiological and clinical data, were evaluated. Results: Mean age was 62.38±7.30 (47-75), and the mean prostate volume was 43.17±15.20 (21-100) mL. Of the 3.479 patients, 39 (1.1%) developed acute prostatitis after the prostate biopsy procedure. Of the 39 cases of acute prostatitis, 28/3.042 occurred after the first biopsy and 11/437 occurred after repeat biopsy (p=0.038). In Group I, 22 of 1.523 (1.4%) patients developed acute prostatitis. In Group II, 17 of 1.959 (0.8%) patients developed acute prostatitis. There was no statistical difference between the two groups according to acute prostatitis rates (X2=2.56, P=0.11). Further, hypertension or DM were not related to the development of acute prostatitis (P=0.76, X2=0.096 and P=0.83, X2=0.046, respectively). Conclusions: Repeat biopsy seems to increase the risk of acute prostatitis, while the use of antibiotics effective for anaerobic pathogens seems not to be essential yet.

An Open, Comparative, Randomized, Parallel, Post Marketing, Multicentric Trial to Compare the Safety and Efficacy of Formula A (Ofloxacin + Ornidazole + Terbinafine Hydrochloride + Clobetasol Propionate) versus Formula B (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate), Formula C (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) and Formula D (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) in the Treatment of Patients with Vaginitis.

Vaginitis is among the most common conditions for which women seek medical care, with vaginal discharge accounting for approximately 10 million office visits each year. Since there are no published studies till date that evaluated the Clinical Effectiveness and Safety of Topical Cream of Formula A [Ofloxacin (0.75 % w/w) + Ornidazole (2% w/w) + Terbinafine Hydrochloride (1% w/w) + Clobetasol Propionate (0.05% w/w)] compared to Formula B [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], Formula C [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], and Formula D [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], in mild to moderate vaginitis, hence we undertook this randomized controlled Post Marketing Multicentric trial. Materials and methods: Female subjects diagnosed with mild to moderate symptoms of Vaginitis were eligible and those fulfilling the subject selection criteria were randomized to receive either Formula A, Formula B, Formula C or Formula D for 14 days. The Primary efficacy measures were assessment of symptoms of Vaginitis i.e. vaginal pruritis, vaginal irritation, vaginal soreness or pain, dyspareunia, vaginal erosion and vaginal inflammation and Secondary efficacy measures were assessment of Physical characteristics of vaginal discharge, assessment of pH of vaginal discharge and Microbiological evaluation. Assessment of Safety was done by recording the occurrence of adverse drug reactions. Results: The clinical success rates were comparable and even far better in case of Formula A group (in vaginal pain, Dyspareunia and vaginal erosion it was 100 %, in case of vaginal inflammation it was 92.655 % while in case of vaginal irritation, it was 94.767 % and vaginal pruritus, it was 87.096 %). Adverse events were mild and self limiting while it was totally absent in case of Formula A group. Conclusion: Topical Cream of Formula A is safe and effective for the treatment of mild to moderate vaginitis.

A Comparative Study for Efficacy and Tolerability of Satranidazole Plus Ofloxacin Versus Ornidazole Plus Ofloxacin in Periodontal Infections.

Periodontal infections and related conditions like Chronic Gingivitis, Chronic Periodontitis, Pericoronitis, Peridontal & Periapical Abscess are common clinical problems, but sometimes Gingivitis and Periodontitis can be acute also. These all are generally treated by scaling and root planning, but studies have reported that despite conventional periodontal therapy certain sites continue to show periodontal tissue destruction. These periodontal infections can be controlled by antibiotics which are effective against Gram-negative aerobic and anaerobic bacteria and has good penetration in periodontal tissues. Objective: The purpose of the present study was to compare the efficacy and tolerability of a fixed dose combination of Satranidazole (300 mg) plus Ofloxacin (200 mg) versus fixed dose combination of Ornidazole (500 mg) plus Ofloxacin (200 mg) for the treatment of periodontal infections. Methods : One hundred and twelve adult patients (59 females and 53 males) with moderate to advanced periodontitis were enrolled and given fixed dose combination of Satranidazole (300 mg) plus Ofloxacin (200 mg) or Ornidazole (500 mg) plus Ofloxacin (200 mg) orally two times daily. Clinical assessment like Gingival Index, Periodontal Index, Mobility Index and VAS Score were done before and after the treatment. Clinical evaluation was performed on 3rd and 5th day after treatment. Results : At the baseline the values for Gingival Index, Periodontal Index, Mobility Index and VAS Score were comparable in both the groups. Both the treatment group have shown attenuation of Gingival Index, Periodontal Index, Mobility Index and VAS Score. However, treatment with Satranidazole plus Ofloxacin showed significantly (p< 0.05) better improvement in all clinical parameters compared to Ornidazole plus Ofloxacin treatment. Treatment with Satranidazole plus Ofloxacin was well tolerated and no serious adverse event was observed. 6 patients (15%) with Ornidazole plus Ofloxacin have shown side effects, which resulted in discontinuation of therapy. These side effects include allergy, nausea, vomiting & acidity. Conclusion : This study concludes that efficacy and tolerability of fixed dose combination of Satranidazole (300 mg) plus Ofloxacin (200 mg) is better than fixed dose combination of Ornidazole (500 mg) plus Ofloxacin (200 mg) in treatment of periodontal infections.

Clinical Trial Comparing Efficacy and Safety of Ornidazole 1% and Povidone Iodine 5% Fixed Dose Combination Ointment with Povidone Iodine 5% Formulation and Ornidazole 1% Formulation for Prevention or Treatment of Surgical Wounds.

Aim: This trial is undertaken to evaluate the efficacy and safety of this FDC ointment for post-surgical patient management. This multi-centre, prospective, randomized, comparative, open-labeled, three-arm parallel group study involving 180 patients was conducted in patients with surgical wound. The trial was conducted at 2 centres and had 90 patients completed at each center. Methods: Patients were in randomized in three groups, to receive either the study formulation of Ornidazole 1% - Povidone iodine 5% FDC ointment (Group I ) or Povidone iodine 5% Ointment (Group II) or Ornidazole 1% Ointment (Group III). These ointments were applied for post surgical wound care. Dressing was done twice daily till the discharge of patients (Day 5-7). Patients were asked to use respective ointment for wound dressings after discharge. The patients were assessed for clinical wound improvement by using the Bates Jensen Wound Assessment Tool (BWATS). General and systemic examination was done at every visit of the patient. Results: Reduction in wound size was significant in all three groups from day 1 onwards. In group I exudates amount improved significantly from day 5 as compared to day 3, in Group II and Group III the improvement was from Day 8 onwards as compared to day 5. Peripheral tissue edema and Peripheral Tissue Induration improved in Group I and as compared to baseline. Epithelialization was statistically better in Group I and Group II from day 1 compared to baseline and in Group III it improved from day 5. No adverse event were seen in any of the groups. Conclusion: We concluded that the combination was better as compared to each individual drug in prevention of wound infection and promoting wound healing.

Single-day treatment of trichomonas vaginitis with low dose of ornidazole.

A total of 107 cases of trichomonas vaginitis were treated with different regimens of ornidazole. The overall success rate of the treatment assessed by wet smear and clinical signs after three days in 68 cases was 98.5%. The side effects were mild and of short duration. These were noted in 14.7% of the assessable cases. No significant differences were seen in the success rate between the three drug regimens and the preliminary conclusions of the trial are that ornidazole is safe and effective in the treatment of trichomonas vaginitis in Korean women with an oral dose of 1.0 gm, 1.0 gm plus 0.5 gm intravaginally or 2.0 gm given in a single day.