兰索拉唑三联疗法用于幽门螺杆菌相关性胃溃疡的临床观察

Clinical Observation of Lansoprazole Triple Therapy in the Treatment of Hp Associated Gastric Ulcer

目的:观察兰索拉唑三联疗法用于幽门螺杆菌(Hp)相关性胃溃疡的疗效和安全性。方法:80例Hp相关性胃溃疡患者随机分为对照组(40例)和联合组(40例)。对照组患者口服兰索拉唑胶囊30 mg,晨起或睡前服用1次,连用6周。联合组患者口服兰索拉唑胶囊(用法用量同对照组)+克拉霉素片0.5 g,每日2次+阿莫西林分散片1 g,每日2次,连用1周后,仅服用兰索拉唑胶囊30 mg,晨起或睡前服用1次,连用5周;阿莫西林过敏者则改用甲硝唑片0.4 g,口服,每日2次。观察两组患者Hp根除率,治疗6、12个月后Hp阴性患者复燃率及治疗总有效患者的复发情况,治疗前后Th1型细胞因子[干扰素-γ(IFN-γ)、白细胞介素2(IL-2)、IL-12]、Th2型细胞因子(IL-4、IL-6、IL-10)水平,并记录不良反应发生情况。结果:两组患者溃疡愈合总有效率、Hp根除率、不良反应发生率比较,差异均无统计学意义(P>0.05)。治疗6个月后,两组患者复发率比较,差异无统计学意义(P>0.05)。治疗12个月后联合组患者复发率和治疗6、12个月后联合组患者复燃率均显著低于对照组,差异均有统计学意义(P<0.05)。治疗前,两组患者Th1型、Th2型细胞因子水平比较,差异均无统计学意义(P>0.05)。治疗1周及6、12个月后,两组患者INF-γ、IL-2、IL-12、IL-6水平均显著低于同组治疗前,且治疗12个月后联合组INF-γ、IL-2、IL-12水平显著低于对照组同期;治疗1周及6、12个月后,两组患者IL-4、IL-10水平均显著高于同组治疗前,且治疗12个月后联合组显著高于对照组同期,差异均有统计学意义(P<0.05);但两组间IL-6水平比较,差异均无统计学意义(P>0.05)。结论:兰索拉唑三联疗法用于Hp相关性胃溃疡的疗效显著,可改善细胞因子水平,降低复发率和复燃率,且未增加不良反应的发生。

OBJECTIVE： To observe therapeutic efficacy and safety of lansoprazole triple therapy in the treatment of Helico- bacter pylori （Hp） associated gastric ulcer. METHODS： A total of 80 patients with Hp associated gastric ulcer were randomly divid- ed into control group （40 cases） and combination group （40 cases）. Control group was given Lansoprazole capsules 30 mg once in the morning or before bedtime, for 6 weeks. Combination group was given Lansoprazole capsules （same usage and dosage as con- trol group）＋Clarithromycin tablets 0.5 g, twice a day＋Amoxicillin dispersible tablets 1 g, twice a day, for consecutive 1 week, and then given Lansoprazole capsules 30 mg once in the moming or before bedtime, for 5 weeks. Patients with amoxicillin allergy were switched to Metronidazole tablets 0.4 g, twice a day. Hp eradication rate of 2 groups were observed; recrudescence rate of Hp negative patients and the recurrence of effective patients were observed after 6, 12 months of treatment. The levels of Thl cyto- kines （IFN-y, IL-2, IL-12） and Th2 cytokines （IL-4, IL-6, IL-10） were observed before and after treatment, and the occurrence of ADR was recorded. RESULTS： There was no statistical significance in total response rate of ulcer healing, Hp eradication rate or the incidence of ADR between 2 groups （P〉0.05）. After 6 months of treatment, there was no statistical significance in recur- rence rate between 2 groups （P〉0.05）. The recurrence rate of combination group after 12 months of treatment and recrudescence rate of combination group after 6, 12 months of treatment were significantly lower than those of control group, with statistical sig- nificance （P〈0.05）. Before treatment, there was no statistical significance in Thl type cytokines and Th2 cytokines between 2 groups （P〉0.05）. After 1 week and 6, 12 months of treatment, the levels of INF-y, IL-2, IL-12 and IL-6 in 2 groups were signifi- cantly lower than before; the levels of INF-y, IL-2 and IL-12 in combination group were significantly lower than control group af- ter 12 months of treatment. After 1 week and 6, 12 months of treatment, the levels of IL-4 and IL-10 in 2 groups were significant- ly higher than before; those indexes of combination group were significantly higher than those of control group after 12 months of treatment, with statistical significance （P〈0.05） ; but there was no statistical significance in the level of IL-6 between 2 groups （P〉 0.05）. CONCLUSIONS： Lansoprazole triple therapy shows significant therapeutic efficacy for Hp associated gastric ulcer, im- prove cytokines level and reduces recurrence rate and recrudescence rate without increasing the incidence of ADR.