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.

Ofloxacin in multidrug resistant tuberculosis.

Tuberculosis (TB) is the leading infectious cause of death today and 3.81 million cases occurred in 1997 and 1998. Even today in spite of having four drugs like isoniazid, rifampicin, streptomycin/pyrazinamide and ethambutol for the intensive phase, the total duration of treatment remains six months. Because of the global health problems of TB, the increasing rate of multidrug resistant TB (MDR-TB) and the high rate of co-infection with HIV, the need for effective non-toxic antituberculous agents is essential. Fluoroquinolones have been classified as drugs having low bactericidal activity by the WHO. To date, they have been used for preventive therapy, empirical treatment of patients with TB and retreatment of patients with relapsing TB. In-vitro and in-vivo clinical studies have identified ofloxacin as a promising new agent in the treatment of MDR-TB. Ofloxacin has been advocated by the WHO in case of MDR-TB, when susceptibility to test results are not available before starting the new treatment, in the continuation period (18 months) and if resistance is proven to at least isoniazid and rifampicin.

Open, prospective trial to evaluate the efficacy and safety of combination of metronidazole and povidone comparison to povidone iodine alone in pre-and postoperative sterilisation and surgical wound healing.

An open prospective trial was undertaken among 50 patients to evaluate the efficacy and safety of metronidazole and povidone iodine in comparison to povidone iodine alone in pre- and postoperative sterilisation and surgical wound healing. It was found that the combination of metronidazole and povidone iodine is superior to povidone iodine alone in respect to efficacy, in the study.

Accelerated atherosclerosis.

The process of accelerated atherosclerosis appears to share common pathophysiologic mechanisms, namely, endothelial injury with early platelet involvement and subsequent progressive smooth muscle cell proliferation and thrombosis leading to vascular occlusion. Understanding the mechanisms of this process has made it possible to include strategies to limit vascular injury and reduce subsequent thrombotic and proliferating cellular responses. In contrast to spontaneous atherosclerosis, a more significant denuding endothelial injury appears to be the critical initiating event, followed by intense platelet involvement and thrombus formation, leading to an initial predominant process of smooth muscle cell proliferation in accelerated atherosclerosis. Risk factors like cigarette smoking and hypertension play an important role in this process. This accelerated proliferative process appears to be the cause of premature coronary occlusion in patients undergoing heart and kidney transplantation, coronary vein graft bypass and percutaneous transluminal coronary angioplasty and diabetes. This accounts for significant morbidity and mortality in these patients. Prophylactic anticalcinotic vasoprotection by suitable calcium antagonists may offer a more appropriate way of anti-arteriosclerotic arterial protection than the other procedures hitherto used. Calcium channel blockers have positive effects on a number of processes that may be associated with restenosis, including reduction of platelet aggregation, minimisation of vasospasm and inhibition of mitogens. In this article the role of nifedipine in accelerated atherosclerosis has been reviewed.

Evaluation of anti-atherosclerotic and vasculoprotective effect of long acting nifedipine in patients after PTCA.

The anti-atherosclerotic and vasculoprotective effect of long acting nifedipine (nicardia retard 20) was evaluated on patients undergoing percutaneous transluminal coronary angioplasty (PTCA). This was a randomised, controlled, prospective clinical trial. A total of 30 patients fulfilling inclusion criteria were divided randomly in 2 groups of 15 each. One group was given long acting nifedipine while other group did not receive long acting nifedipine. The rest of the treatment was similar for both the groups. Clinical and angiographic parameters were evaluated regularly for a period of one year. The group receiving long acting nifedipine showed 20% restenosis as against 33% in group not receiving long acting nifedipine. Thus, from this trial, it can be concluded that long acting nifedipine can reduce the progress of reocclusion and thus demonstrates the anti-atherosclerotic and vasculoprotective action.