McGlashan Julian A, Johnstone Lesley M, Sykes John, Strugala Vicki, Dettmar Peter W
Department of Otorhinolaryngology Head and Neck Surgery, Queen's Medical Centre, Nottingham University Hospital, Nottingham NG7 2UH, UK.
Eur Arch Otorhinolaryngol. 2009 Feb;266(2):243-51. doi: 10.1007/s00405-008-0708-7. Epub 2008 May 28.
Laryngopharyngeal reflux (LPR) refers to the backflow of stomach contents into the laryngopharynx. Increasing evidence has demonstrated that LPR is a contributing factor in some cases of hoarseness, vocal fatigue, voice breaks, cough and globus and chronic throat clearing. However, several randomised placebo-controlled trials of proton pump inhibitors in the treatment of LPR have been reported with the majority showing no significant benefit in patient symptom scores over placebo. The aim of this pilot clinical study was to investigate whether any improvement in LPR-related symptoms, using the Reflux Symptom Index (RSI), and clinical findings, using the Reflux Finding Score (RFS), could be achieved with treatment with a liquid alginate suspension compared to control (no treatment). Patients presenting with the symptoms of LPR to the Otorhinolaryngology Outpatient Department at the Queen's Medical Centre, Nottingham, UK were considered eligible if they had an RSI of greater than 10 and an RFS greater than 5 based on a fibreoptic examination of the larynx. A total of 49 patients were randomised into the open, parallel group study; 24 patients were randomised to receive 10 ml liquid alginate suspension (Gaviscon Advance) four times daily after meals and at bedtime, and 25 patients into the control group (no treatment). Patients were assessed pre-treatment and at 2, 4 and 6 months post treatment. Mean (SD) RSI and RFS pre-treatment scores were 23.9 (7.0) and 10.4 (3.6) for the treatment group and 24.6 (7.4) and 10.3 (3.3) for the control group, respectively. Significant differences between treatment and control were observed for RSI at the 2-month (11.2 (7.0) vs. 16.8 (6.4), P=0.005) and 6-month (11.2 (8.1) vs. 18.3 (9.4), P=0.008) assessments and for RFS at the 6-month (7.1 (2.8) vs. 9.5 (3.4), P=0.005) assessment. Significant improvement in symptom scores and clinical findings were achieved with liquid alginate suspension (Gaviscon Advance) compared to control and further evaluation for the management of patients presenting with LPR is warranted.
喉咽反流（LPR）是指胃内容物反流至喉咽。越来越多的证据表明，LPR在某些声音嘶哑、声带疲劳、声音中断、咳嗽、咽部异物感和慢性清嗓病例中是一个促成因素。然而，已有多项关于质子泵抑制剂治疗LPR的随机安慰剂对照试验报告，大多数试验显示，与安慰剂相比，患者症状评分无显著改善。这项初步临床研究的目的是调查与对照组（不治疗）相比，使用藻酸盐液体混悬液治疗是否能改善LPR相关症状（使用反流症状指数（RSI））和临床检查结果（使用反流发现评分（RFS））。在英国诺丁汉女王医疗中心耳鼻喉科门诊出现LPR症状的患者，如果根据喉镜纤维检查RSI大于10且RFS大于5，则被认为符合条件。共有49例患者被随机纳入开放、平行组研究；24例患者被随机分配接受10 ml藻酸盐液体混悬液（Gaviscon Advance），每天饭后及睡前服用4次，25例患者被纳入对照组（不治疗）。在治疗前以及治疗后2、4和6个月对患者进行评估。治疗组治疗前RSI和RFS的平均（标准差）评分分别为23.9（7.0）和10.4（3.6），对照组分别为24.6（7.4）和10.3（3.3）。在2个月（11.2（7.0）对16.8（6.4），P = 0.005）和6个月（11.2（8.1）对18.3（9.4），P = 0.008）评估时，治疗组和对照组的RSI存在显著差异；在6个月评估时（7.1（2.8）对9.5（3.4），P = 0.005），治疗组和对照组的RFS存在显著差异。与对照组相比，藻酸盐液体混悬液（Gaviscon Advance）使症状评分和临床检查结果得到显著改善，因此有必要对LPR患者的治疗进行进一步评估。
