DataSheet_1_A randomized controlled trial to verify the irrigation of salivary glands in relieving xerostomia in patients with Sjögren’s syndrome.doc

ObjectiveTo verify the effect of triamcinolone acetonide (TA) and major salivary glands saline irrigation on relieving xerostomia in Sjögren’s syndrome (SS) patients.
MethodsThe enrolled 49 SS patients were randomly assigned to the control group (no irrigation, n=16), saline group (irrigation with saline, n=17) and TA group (irrigation with TA, n=16). Fourteen cases of each group were treated differently but received the same examinations. The examinations include unstimulated whole saliva flow (UWS), chewing-stimulated whole saliva flow (SWS), citric acid-stimulated parotid flow (SPF), Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient Reported Index (ESSPRI) of 1 week before irrigation (T0) and 1 week(T1), 8 weeks (T8), 16 weeks (T16) and 24 weeks (T24) after major salivary irrigation.
ResultsEach group had 14 cases with completed follow-ups. Both TA and saline irrigation of major salivary glands resulted in higher SWS and SPF of T8, T16 and than those at T0. ESSPRI (oral dryness domain) of T8, T16 and T24 were significantly lower than that at T0, respectively (P < 0.05). SWS and SPF of T8, T16 and T24 in the saline group were significantly higher than in the control group (P< 0.05). XI and ESSPRI (oral dress domain) of T8, T16 and T24 in the saline group were significantly lower than those in the control group, respectively (P< 0.05). SWS and SPF of T16 and T24 in the TA group were significantly higher than in the control group (P< 0.05). All cases with completed follow-up in TA and saline groups were divided into responders and non-responders. Compared with responders, the UWS, SWS, SPF and CODS of T0 in non-responders were significantly increased (P<0.05). Compared with responders, the XI and ESSPRI of T0 in non-responders were significantly decreased (P<0.05).
ConclusionThe irrigation of major salivary glands by TA and saline relieve xerostomia in SS patients. Patients with non-severe xerostomia (responders) have better relief after irrigation than patients with severe xerostomia (non-responders).
Clinical Trial Registrationwww.chictr.org.cn, identifier (ChiCTR210052314).

研究目的：验证曲安奈德（triamcinolone acetonide, TA）与大唾液腺生理盐水灌洗对干燥综合征（Sjögren’s syndrome, SS）患者口干症状的缓解效果。
研究方法：纳入的49例SS患者被随机分为三组：对照组（不予灌洗，n=16）、生理盐水组（采用生理盐水灌洗，n=17）及TA组（采用TA灌洗，n=16）。每组各14例患者接受差异化治疗，并完成统一的检查流程。分别于大唾液腺灌洗前1周（T0）、灌洗后1周（T1）、8周（T8）、16周（T16）及24周（T24）进行检测，检测指标包括未刺激全唾液流量（unstimulated whole saliva flow, UWS）、咀嚼刺激全唾液流量（chewing-stimulated whole saliva flow, SWS）、柠檬酸刺激腮腺流量（citric acid-stimulated parotid flow, SPF）、临床口腔干燥评分（Clinical Oral Dryness Score, CODS）、口干量表（Xerostomia Inventory, XI）及欧洲抗风湿病联盟干燥综合征患者报告指数（EULAR SS Patient Reported Index, ESSPRI）。
研究结果：三组各有14例患者完成随访。与T0时相比，TA组与生理盐水组灌洗后T8、T16的SWS与SPF水平均显著升高；T8、T16及T24的ESSPRI（口腔干燥维度）均显著低于T0时（P<0.05）。生理盐水组T8、T16及T24的SWS与SPF水平均显著高于对照组（P<0.05），同期XI及ESSPRI（口腔干燥维度）均显著低于对照组（P<0.05）。TA组T16、T24的SWS与SPF水平均显著高于对照组（P<0.05）。将完成随访的TA组与生理盐水组患者分为应答者与非应答者，与应答者相比，非应答者T0时的UWS、SWS、SPF及CODS均显著升高（P<0.05），而T0时的XI及ESSPRI均显著降低（P<0.05）。
研究结论：大唾液腺TA灌洗与生理盐水灌洗均可缓解SS患者的口干症状，其中轻度口干患者（应答者）较重度口干患者（非应答者）可获得更显著的症状缓解。
临床试验注册：www.chictr.org.cn，注册号（ChiCTR210052314）。