The efficacy of vonoprazan fumarate in the treatment of laryngopharyngeal reflux disease evaluated by the Chinese version of the RSS-12 scale
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摘要: 目的 探讨中文版RSS-12量表评价富马酸伏诺拉生治疗喉咽反流性疾病(LPRD)的疗效。方法 纳入100例喉咽反流性疾病患者为研究对象，随机分为2组(各50例)，观察组富马酸伏诺拉生(20 mg、qd)治疗，对照组艾司奥美拉唑肠溶胶囊(20 mg、bid)治疗，持续12周。本次研究中选取的观察指标包括治疗前后RSI、中文版RSS-12及RFS评分。结果 治疗前，2组中文版RSS-12、RSI、RFS比较差异无统计学意义(P>0.05)。2组抗酸治疗后8周、12周中文版RSS-12、RSI均显著下降且差异有统计学意义(P < 0.05)，在治疗0~8周，中文版RSS-12、RSI对症状的变化尤其明显。治疗后12周RFS评分较治疗前均下降，差异有统计学意义(P < 0.05)。抗酸治疗12周后，根据中文版RSS-12，观察组80%的患者有良好的治疗效果，对照组64%的患者有良好的治疗效果；而根据RSI，观察组90%的患者有良好的治疗效果，对照组84%的患者有良好的治疗效果，2组治疗后12周治疗效果比较，差异无统计学意义(P>0.05)。结论 富马酸伏诺拉生可明显改善喉咽反流的症状和体征，其治疗效果不劣于质子泵抑制剂。与RSI比较，中文版RSS-12可作为我国LPRD的临床诊断的新的筛查工具。Abstract: Objective To explore the efficacy of vonoprazan fumarate in the treatment of laryngopharyngeal reflux disease(LPRD) evaluated by the Chinese version of the RSS-12 scale.Methods A total of 100 LPRD patients treated in the otolaryngology-head and neck surgery outpatient clinic of our hospital were randomly divided into two groups(50 cases each). The observation group was treated with vonoprazan fumarate(20 mg, once daily), and the control group was treated with esomeprazole enteric-coated capsules(20 mg, twice daily) for 12 weeks. The selected observation indicators in this study included RSI, the Chinese version of RSS-12, and RFS scores before and after treatment.Results Prior to treatment, there was no statistically significant difference in the Chinese version of RSS-12, RSI, and RFS between the two groups(P>0.05). After 8 and 12 weeks of antacid treatment, both the Chinese version of RSS-12 and RSI significantly decreased in both group (P < 0.05). The changes in symptoms were particularly noticeable between 0-8 weeks of treatment according to the Chinese version of RSS-12 and RSI. After 12 weeks of treatment, the RFS scores significantly decreased compared to pretreatment levels (P < 0.05). After 12 weeks of antacid treatment, according to the Chinese version of RSS-12, 80% of patients in the observation group showed a good therapeutic response, compared to 64% in the control group; according to RSI, 90% of patients in the observation group showed a good therapeutic response, compared to 84% in the control group. There was no statistically significant difference in the treatment effect between the two groups after 12 weeks of treatment(P>0.05).Conclusion Vonoprazan fumarate can significantly improve the symptoms and signs of laryngopharyngeal reflux, and their treatment effect is not inferior to proton pump inhibitors. Compared with RSI, the Chinese version of RSS-12 can serve as a new screening tool for clinical diagnosis of LPRD in China.
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表 1 观察组治疗前后中文版RSS-12评分比较
X±S 栏目 治疗前 治疗后8周 治疗后12周 P 1.声嘶或发音有问题 4.64±4.96 2.16±2.53 1.82±2.18 < 0.001 2.咽喉痛或吞咽痛 4.26±3.83 2.20±2.00 1.84±1.78 < 0.001 3.吞咽不顺(药片，液体，固体食物) 3.78±4.17 1.92±2.39 1.74±2.04 < 0.001 4.清嗓子(不是咳嗽) 9.50±3.93 4.24±2.36 3.56±1.96 < 0.001 5.感觉有东西堵在喉咙里 9.84±5.80 4.62±2.91 3.74±2.42 < 0.001 6.感觉到有过多黏液聚集在咽喉和(或)从鼻子后面滴下 6.50±5.68 3.56±3.04 3.08±2.68 < 0.001 7.口臭 2.18±2.95 1.18±1.80 1.04±1.62 < 0.001 8.胃烧灼感，胃酸反流，嗳气，打嗝或恶心 4.84±4.55 2.18±2.36 1.88±2.16 < 0.001 9.有腹痛或腹泻 1.54±1.61 0.84±1.06 0.66±1.00 < 0.001 10.消化不良，腹胀/肠胃气胀 2.38±2.32 1.46±1.64 1.22±1.53 < 0.001 11.咳嗽(不是清嗓子) 2.76±3.58 1.48±1.95 1.32±1.70 < 0.001 12.呼吸困难，呼吸急促，喘息 2.66±3.31 1.86±2.48 1.68±2.20 < 0.001 QoL 13.66±3.57 8.82±2.53 7.70±2.30 < 0.001 总RSS-12 54.88±11.20 27.70±6.73 23.58±6.07 < 0.001 
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表 2 对照组治疗前后中文版RSS-12评分比较
X±S 栏目 治疗前 治疗后8周 治疗后12周 P 1.声嘶或发音有问题 5.82±4.65 2.76±2.62 2.02±2.25 < 0.001 2.咽喉痛或吞咽痛 2.88±2.29 1.34±1.49 1.28±1.44 < 0.001 3.吞咽不顺(药片，液体，固体食物) 4.00±4.57 2.10±2.71 1.78±2.36 < 0.001 4.清嗓子(不是咳嗽) 9.84±4.84 5.54±3.07 4.50±2.74 < 0.001 5.感觉有东西堵在喉咙里 10.22±4.94 5.50±3.19 4.48±2.83 < 0.001 6.感觉到有过多黏液聚集在咽喉和(或)从鼻子后面滴下 7.12±5.33 3.94±3.17 3.40±2.76 < 0.001 7.口臭 1.90±2.36 1.02±1.36 0.98±1.30 < 0.001 8.胃烧灼感，胃酸反流，嗳气，打嗝或恶心 5.44±5.29 3.08±3.40 2.82±3.04 < 0.001 9.有腹痛或腹泻 1.44±1.45 0.84±1.11 0.80±1.07 < 0.001 10.消化不良，腹胀/肠胃气胀 2.14±2.18 1.10±1.23 0.96±1.25 < 0.001 11.咳嗽(不是清嗓子) 3.88±4.45 2.36±2.60 2.14±2.42 < 0.001 12.呼吸困难，呼吸急促，喘息 2.10±2.66 1.50±1.62 1.24±1.61 < 0.001 QoL 14.49±2.63 10.35±1.91 8.96±1.79 < 0.001 总RSS-12 56.78±10.82 31.08±6.56 26.40±6.47 < 0.001
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表 3 治疗前后RSI量表评分比较
X±S 组别 治疗前 治疗后8周 治疗后12周 对照组 16.94±4.91 8.14±2.40 7.02±2.26 观察组 16.42±4.12 7.60±2.17 6.64±2.02
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表 4 治疗前后RFS量表评分比较
X±S 组别 治疗前 治疗后8周 治疗后12周 对照组 8.52±2.06 7.18±1.95 6.58±1.83 观察组 8.56±2.67 7.02±2.30 6.12±2.08
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表 5 2组治疗12周后治疗效果比较
例(%) 分组 组别 合计 观察组 对照组 RSS-12变化 < 50% 10(20.0) 18(36.0) 28 ≥50% 40(80.0) 32(64.0) 72 RSI变化 < 50% 5(10.0) 8(16.0) 13 ≥50% 45(90.0) 42(84.0) 87
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