Zhou Liya, Zhang Jianzhong, Song Zhiqiang, He Lihua, Li Yanqing, Qian Jiaming, Bai Peng, Xue Yan, Wang Ye, Lin Sanren
Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
State Key Laboratory for Infectious Disease Prevention and Control, Chinese Center for Disease Control and Prevention, National Institute for Communicable Disease Control and Prevention, Beijing, China.
Helicobacter. 2016 Apr;21(2):91-9. doi: 10.1111/hel.12242. Epub 2015 Jun 23.
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of tailored therapy to those of triple therapy plus bismuth and concomitant therapy in the naïve patients with Helicobacter pylori infection.
Between September 2013 and April 2014, 1050 patients with H. pylori infection at three tertiary hospitals were randomly assigned to 10-day treatment with tailored, triple plus bismuth, or concomitant regimens. In tailored therapy, medications were adjusted according to clarithromycin sensitivity and cytochrome P450 isoenzyme 2C19 genotype. The antimicrobial susceptibility testing (E test) was performed. Eradication status was assessed 4-12 weeks after treatment.
The eradication rate was significantly higher in tailored group than in triple plus bismuth and concomitant groups in both intention-to-treat (88.7 vs 77.4 vs 78.3%, p < .001) and per-protocol (93.3 vs 87.0 vs 87.4%, p = .021) analyses in a setting with high antibiotic resistance (clarithromycin 48.8%, metronidazole 65.7%, and dual resistance 35.3%). Significantly, fewer adverse effects occurred in tailored group than in concomitant group (22.0 vs 31.7%, p = .018). The eradication rates of dual clarithromycin and metronidazole resistance, isolated clarithromycin resistance, isolated metronidazole resistance, and dual susceptible were 78.7, 82.4, 94.8, and 94.4% in triple therapy plus bismuth and 75.9, 87.2, 92.9, and 95.2% in concomitant therapy, respectively.
First-line tailored therapy achieves significantly higher eradication rates and fewer side effects, compared to triple therapy plus bismuth and concomitant therapy in a setting with high rates of clarithromycin and metronidazole resistance.
随着中国大陆抗生素耐药性显著增加以及常见经验性根除方案疗效不尽人意，个体化治疗可能是实现良好疗效的最佳选择。本研究比较了在初治幽门螺杆菌感染患者中，个体化治疗与三联疗法加铋剂及联合疗法的根除率、安全性和依从性。
2013年9月至2014年4月期间，三家三级医院的1050例幽门螺杆菌感染患者被随机分配接受个体化、三联加铋剂或联合方案的10天治疗。在个体化治疗中，根据克拉霉素敏感性和细胞色素P450同工酶2C19基因型调整用药。进行了抗菌药物敏感性试验（E试验）。治疗后4 - 12周评估根除情况。
在高抗生素耐药率（克拉霉素48.8%、甲硝唑65.7%、双重耐药35.3%）的情况下，在意向性分析（88.7%对77.4%对78.3%，p <.001）和符合方案分析（93.3%对87.0%对87.4%，p =.021）中，个体化治疗组的根除率显著高于三联加铋剂组和联合治疗组。值得注意的是，个体化治疗组的不良反应发生率显著低于联合治疗组（22.0%对31.7%，p =.018）。三联疗法加铋剂中克拉霉素和甲硝唑双重耐药、单独克拉霉素耐药、单独甲硝唑耐药以及双重敏感的根除率分别为78.7%、82.4%、94.8%和94.4%，联合疗法中分别为75.9%、87.2%、92.9%和95.2%。
在克拉霉素和甲硝唑耐药率较高的情况下，一线个体化治疗与三联疗法加铋剂及联合疗法相比，根除率显著更高且副作用更少。
