| Abstract: | The study involved a dynamic comparative efficacy survey of the standard triple and quadruple therapies recommended by the Maastricht Consensus as first line therapies for eradication of Helicobacter pylori infection with the time period of 5 years. The study included 199 Hp-positive patients with stomach ulcer; 101 of them were under examination in 1997 and 98 in 2002. Depending on the therapy type, patients were assigned to one of two groups: the OCM/A group (48 and 53 patients in 1997 and 2002, respectively) was treated with Omeprazole, Clarithromycin and Metronidazole for 7 days and ODTM group (46 and 52 patients in 1997 and 2002, correspondingly) was treated with Omeprazole, De-Nol, Tetracycline and Metronidazole. To discover and confirm Hp eradication, cytological, histological and rapid urease tests were used. Hp eradication was considered as successful when all the tests were negative. The eradication frequency was assessed with the help of ITT and PP analyses. In the OCM/A group Hp was eradicated in 81.3% and 62.3% (p<0.05) of patients when analyzed by the intention-to-treat and in 88.6% and 66.0% (p<0.01) of patients when analyzed by per-protocol in 1997 and 2002, respectively. In the ODTM group Helicobacter pylori was eradicated in 89.1% and 88.5% (p<0.05) of patients when analyzed by intention-to-treat and 95.3% and 93.9% (p<0.05) when analyzed by per-protocol in 1997 and 2002, respectively. The frequency of ulcer cicatrisation and cuticularization of erosions did not depend on the type of the treatment. There was no significant difference between the compliance and side effects of the triple and quadruple therapies. Taking into account the decrease in the efficacy of the triple anti-Hp therapy, the need to use the quadruple therapy as a first line therapy for Hp infection eradication was substantiated. |
