Grigor'ev P Ia, Iakovenko A V, Iakovenko E P, Vasil'ev I V, Komleva Iu V, Oprishchenko I V, Aldiiarova M A
Eksp Klin Gastroenterol. 2004(5):31-8, 148.
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.
该研究是一项动态比较疗效调查，对马斯特里赫特共识推荐的标准三联和四联疗法作为根除幽门螺杆菌感染的一线疗法进行了为期5年的研究。该研究纳入了199例胃溃疡Hp阳性患者；其中101例于1997年接受检查，98例于2002年接受检查。根据治疗类型，患者被分为两组：OCM/A组（1997年和2002年分别有48例和53例患者）接受奥美拉唑、克拉霉素和甲硝唑治疗7天，ODTM组（1997年和2002年分别有46例和52例患者）接受奥美拉唑、铋剂、四环素和甲硝唑治疗。为了发现并确认Hp根除情况，采用了细胞学、组织学和快速尿素酶试验。当所有试验均为阴性时，Hp根除被视为成功。根除频率通过意向性分析（ITT）和符合方案分析（PP）进行评估。在OCM/A组中，1997年和2002年采用意向性分析时，分别有81.3%和62.3%（p<0.05）的患者Hp被根除，采用符合方案分析时，分别有88.6%和66.0%（p<0.01）的患者Hp被根除。在ODTM组中，1997年和2002年采用意向性分析时，分别有89.1%和88.5%（p<0.05）的患者幽门螺杆菌被根除，采用符合方案分析时，分别有95.3%和93.9%（p<0.05）的患者幽门螺杆菌被根除。溃疡愈合和糜烂表皮化的频率与治疗类型无关。三联和四联疗法的依从性和副作用之间没有显著差异。考虑到三联抗Hp疗法疗效的下降，使用四联疗法作为根除Hp感染的一线疗法的必要性得到了证实。
