Objective: To explore the efficacy of Jinghuaweikang capsules combined with Quadruple therapy in the treatment of Helicobacter pylori (H.pylori)infection. Methods: Patients who were infected with H.pylori in 7 centers in Gansu Province were recruited in this prospective simple randomized study. All the patients are divided into four groups randomly: patients in Group A1 were treated with esomeprazole (20 mg, twice a day) + pectin bismuth (200 mg, three times a day) + amoxicillin (1 000 mg, twice a day) + clarithromycin (500 mg, twice a day), while Group A2 with Jinghuaweikang capsules(160 mg, three times a day) based on group A2, Group B1 with esomeprazole (20 mg, twice a day) + bismuth pectin (200 mg, three times a day) + amoxicillin (1 000 mg, twice a day) + furazolidone (100 mg, twice a day) and Group B2 with Jinghuaweikang capsules(160 mg, three times a day) based on group B2. The treatment time was 14 days for all 4 groups. In the course of treatment, abdominal pain, acid reflux, abdominal distension, belching, hiccups were observed at the time before treatment, 14 days and 30 days after treatment and were scored. Finally, all patients received (13)C or (14)C for H.pylori at the time of 30 days after the treatment. Result: A total of 455 patients were included in 7 hospitals from February 2016 to May 2017 in Gansu province, and there were 189 male patients. Group A1 included 129 cases, group A2 96 cases, group B1 112 cases and group B2 118 cases. The eradication rates that accorded with program data analysis (PP) were A1[46.9%(60/128)], A2[63.8%(60/94)], B1[60.7%(68/112)], B2[68.6%(81/118)] (P<0.004). Compared with group A1, the eradication rate of H.pylori in group B1 and group A2 increased (P<0.001, P=0.032), there was no statistical difference between group B2 and group A2, group B1 and group B2 (P=0.208, P=0.461). According to intentional analysis (ITT), the eradication rates of H.pylori in group A1 were 46.5% (60/129),group A2 were 62.5% (60/96),group B1 were 60.7% (68/112),and group B2 were 68.6% (81/118).The radical rate of A2 was higher than A1 (P=0.017), group B2 was not higher than group B1 (P=0.208), and there was no significant difference among the other groups. The symptoms of abdominal pain, abdominal distention, acid reflux, belching and hiccup in the group A2 and group B2 were improved than those in group A1 and group B1 (P<0.05). No serious adverse reactions occurred in all groups. Conclusion: Jinghuaweikang capsules can improve the eradication rate of Helicobacter pylori, and improve the symptoms of patients.
目的： 探讨甘肃地区荆花胃康胶丸联合四联疗法治疗幽门螺杆菌（H.pylori）感染的疗效。 方法： 采用前瞻性简单随机分组研究，对象为甘肃地区7个中心H.pylori感染患者，通过简单随机分组将其分为4组。A1组：埃索美拉唑（20 mg/次，2次/d）+果胶铋（200 mg/次，3次/d）+阿莫西林（1 000 mg/次，2次/d）+克拉霉素（500 mg/次，2次/d）；A2组：在A1组基础上加用荆花胃康胶丸（160 mg/次，3次/d）；B1组：埃索美拉唑（20 mg/次，2次/d）+果胶铋（200 mg/次，3次/d）+阿莫西林（1 000 mg/次，2次/d）+呋喃唑酮（100 mg/次，2次/d）；B2组：在B1组基础上加用荆花胃康胶丸（160 mg/次，3次/d）；疗程均为14 d。观察4组受试者治疗前、治疗14 d、治疗后30 d腹痛、反酸、腹胀、嗳气、呃逆等不适症状，同时在治疗结束后1个月所有受试者均接受(13)C或者(14)C检测H.pylori，判断根除结果。 结果： 纳入2016年2月至2017年5月甘肃地区7个中心符合入选标准的455例H.pylori感染受试者，其中男189例，A1、A2、B1、B2组分别入组129例、96例、112例、118例。A1、A2、B1、B2组H.pylori根除率符合方案数据分析（PP）分别为46.9%（60/128）、63.8%（60/94）、60.7%（68/112）、68.6%（81/118）（P=0.004）。各组根除率结果比较显示，B1组与A2组较A1组H.pylori根治率高，差异有统计学意义（P<0.001，P=0.032），而B2与A2组、B1与B2组之间差异无统计学意义（P=0.208，P=0.461）。A1、A2、B1、B2组H.pylori根除率意向性分析（ITT）为46.5%（60/129）、62.5%（60/96）、60.7%（68/112）、68.6%（81/118）。A2组较A1组根治率高，差异有统计学意义（P=0.017），B2组较B1组根治率高，但差异无统计学意义（P=0.208）；其余各组比较差异无统计学意义。在腹痛、腹胀、反酸、嗳气、呃逆的症状改善方面，含荆花胃康胶丸组较不含荆花胃康胶丸组效果好，差异有统计学意义（P<0.05）。各组均无严重不良反应发生。 结论： 联合荆花胃康胶丸可提高H.pylori的根除率，改善患者不适症状。.
Keywords: Chinese herb; Drug therapy,combination; Helicobacter pylori.