临床药师对消化性溃疡伴幽门螺杆菌感染患者药学干预效果的随机对照研究

A Randomized Controlled Study of Pharmaceutical Intervention on Patients with Peptic Ulcer and Helicobacter Pylori Infection by Clinical Pharmacists

目的:探讨临床药师对消化性溃疡伴幽门螺杆菌感染患者的药学干预效果。方法:选取2018年7月至2020年6月于喀什地区第二人民医院就诊的符合纳入、排除标准的消化道溃疡伴幽门螺杆菌感染患者86例,采用随机数字表法分为干预组和对照组,每组43例。两组患者均采用四联疗法治疗10 d,根除治疗结束后继续服用质子泵抑制剂和铋剂治疗,其中,胃溃疡用药时间6~8周,十二指肠球部溃疡用药时间4~6周。对照组患者接受医师常规诊疗流程;在对照组的治疗基础上,临床药师在住院期间对干预组患者通过药学查房进行用药干预,在出院后发放服药日志卡,并进行定期随访。两组患者在出院时接受调查问卷评估,治疗结束时评估用药依从性和不良反应发生情况;停药后30 d接受14C尿素呼气试验评价幽门螺杆菌根除率;在治疗结束时、治疗结束后30 d和治疗结束后6个月时接受电话随访消化性溃疡症状缓解情况。结果:临床药师对干预组患者住院期间的药学干预成功率为100%。出院时,干预组患者在用药正确患者占比、疗程知晓患者占比、不良反应了解程度评分和满意度等方面明显优于对照组,差异均有统计学意义(P <0.05)。干预组、对照组患者的幽门螺杆菌根除率分别为81.40%(35/43)、74.42%(32/43),组间比较,差异无统计学意义(P> 0.05)。在治疗结束时、治疗结束后30 d和治疗结束后6个月时进行电话随访,两组患者胃肠道症状分级评分的差异均无统计学意义(P> 0.05)。干预组、对照组无漏服患者占比分别为90.70%(39/43)、41.86%(18/43),组间比较,差异有统计学意义(P <0.001)。干预组患者的不良反应发生率为37.21%(16/43),明显低于对照组的62.79%(27/43),差异有统计学意义(P <0.05)。结论:临床药师的药学干预可以改善消化性溃疡伴幽门螺杆菌感染患者的用药准确性、依从性及对药学服务的满意度。

OBJECTIVE: To probe into the pharmaceutical intervention on patients with peptic ulcer and Helicobacter pylori( H. pylori) infection by clinical pharmacists. METHODS: A total of 86 patients with peptic ulcer and H. pylori infection met the inclusion and exclusion criteria from Kashgar District Second People’s Hospital from Jul.2018 to Jun. 2020 were extracted to be divided into the intervention group and the control group via the random number table,with 43 cases in each group. Both groups were treated with quadruple therapy for 10 d. Treatment with proton pump inhibitors and bismuth was continued after the end of eradication therapy,with 6 to 8 weeks for gastric ulcers and4 to 6 weeks for duodenal bulb ulcers. The control group received the routine diagnosis and treatment procedure,while the intervention group was treated with the pharmaceutical intervention through the pharmaceutic ward round model in hospital,the intervention group were provided with diary card after discharge and were routinely telephone followed-up by pharmacists at home besides the routine procedure. Both groups were surveyed before discharge and were assessed the medication compliance and the incidence of adverse drug reactions when the treatment was finished,the eradication rate of H. pylori was evaluated by14 C urea breath test after drug withdrawal of 30 d. Telephone follow-up was performed at the end of treatment,30 d after treatment and 6 months after treatment for remission of peptic ulcer disease symptoms. RESULTS: The success rate of pharmaceutical interventions by clinical pharmacists for patients in the intervention group during the hospitalization was 100%. At the time of discharge,the questionnaire evaluation of patients in the intervention group was significantly better than the control group in proportion of patients with correct medication,proportion of patients with knowledge of course of treatment,score of understanding of adverse reactions and satisfaction,with statistical significant differences( P < 0. 05). The eradication rates of H. pylori in the intervention group and the control group were respectively 81. 40%( 35/43) and 74. 42%( 32/43),the difference was not statistically significant( P > 0. 05). There was no significant difference in gastrointestinal symptom rating scale scores between two groups in telephone follow-up at the end of treatment,30 d after treatment and 6 months after treatment( P > 0. 05). The proportion of patients without missed medication in the intervention group and control group were respectively 90. 70%( 39/43) and 41. 86%( 18/43),the difference was statistically significant( P < 0. 001).The incidence of adverse drug reactions in the intervention group was 37. 21%( 16/43),significantly lower than that in the control group 62. 79%( 27/43),the difference was statistically significant( P < 0. 05). CONCLUSIONS:Pharmaceutical intervention by clinical pharmacists can improve the medication accuracy,compliance and satisfaction of pharmaceutical care in patients with peptic ulcer and H. pylori infection.