唾液腺灌洗缓解干燥综合征患者口干:随访40周的单盲随机对照临床试验

doi:10.13591/j.cnki.kqyx.2023.11.006

摘要/Abstract

摘要：

目的验证曲安奈德(TA)和生理盐水(NS)灌洗唾液腺长期缓解干燥综合征(SS)患者口干症的效果。方法将纳入的49例SS患者随机分为对照组(不灌洗,n=16)、NS组(NS灌洗,n=17)和TA组(TA灌洗,n=16)。在灌洗前1周(0W)和灌洗后8周(8W)、16周(16W)、32周(32W)和40周(40W)检查未刺激的全唾液流(unstimulated whole salivary flow, UWS)、咀嚼刺激的全唾液流(chewing-stimulated whole saliva flow,SWS)、柠檬酸刺激的腮腺流(citric acid-stimulated parotid flow,SPF)、临床口腔干燥评分(CODS)、口干量表(XI)和 EULAR SS 患者报告指数(ESSPRI)。结果每组14例患者完成随访。与0W相比,经TA 和NS灌洗后8W、16W、24W和32W的SWS和SPF增高(P<0.05),而40W无显著差异(P>0.05)。与0W相比,TA 和NS组8W、16W、24W 和32W的ESSPRI(口干症状)降低(P<0.05)。TA组16W、24W和32W的SWS和SPF均高于对照组(P<0.05)。TA组8W、24W和32W的CODS低于对照组(P<0.05)。结论 TA和NS灌洗大唾液腺可以持续32周缓解SS患者口干。

关键词: 灌洗, 唾液, 唾液腺, 干燥综合征, 口干症

Abstract:

Objective To verify the effect of triamcinolone acetonide(TA) and normal saline(NS) irrigating salivary glands on long-term relief of xerostomia in patients with Sjögren’s syndrome(SS). Methods A total of 49 SS patients were randomly divided into control group (no irrigation, n=16), NS group(NS irrigation, n=17) and TA group(TA irrigation, n=16). The examinations of the unstimulated whole salivary flow(UWS), chewing-stimulated total salivary flow(SWS), citric acid-stimulated parotid flow(SPF), clinical xerostomia score(CODS), xerostomia scale(XI) and EULAR SS patient-reported index(ESSPRI) were conductedat 1 week before irrigation(0W) and 8 weeks(8W), 16 weeks(16W), 32 weeks(32W) and 40 weeks(40W) after irrigation. Results The follow-up of 14 cases in each group was completed. Compared with 0W, the SWS and SPF of 8W, 16W, 24W and 32W were increased after TA and NS irrigation(P<0.05), but there was no significant difference at 40W(P>0.05). Compared with 0W, ESSPRI(oral dryness domain) was decreased in TA and NS groups at 8W, 16W and 24W and 32W(P<0.05). The SWS and SPF of the TA group at 16W, 24W and 32W were higher than those of the control group(P<0.05). The CDOS in the NS group at 8W, 24W, and 32W were lower than those of the control group(P<0.05). Conclusion TA and NS irrigation of the major salivary glands can continuously relieve xerostomia in SS patients for 32 weeks.

Key words: irrigation, saliva, salivary glands, Sjögren’s syndrome, xerostomia

中图分类号:

R781.71

杜洪明, 朱晓东, 赵静, 肖珊珊, 傅振. 唾液腺灌洗缓解干燥综合征患者口干:随访40周的单盲随机对照临床试验[J]. 口腔医学, 2023, 43(11): 996-1001.

DU Hongming, ZHU Xiaodong, ZHAO Jing, XIAO Shanshan, FU Zhen. Salivary gland irrigation relieves xerostomia in patients with Sjögren’s syndrome:A single-blind randomized controlled clinical trial with 40-week follow-up[J]. Stomatology, 2023, 43(11): 996-1001.

图/表 6

图1

表1

表2

表3

3组在不同时间点唾液流速的统计结果"

比较项目	对照组		NS组				TA组
	与0W相比		与0W相比		与对照组相比		与0W相比		与对照组相比		与NS组相比
	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P
UWS
0W					-0.001(-0.111,0.097)	0.888			0.010(-0.095,0.116)	0.844	-0.018(-0.120,0.084)	0.728
8W	-0.005(-0.023,0.014)	0.591	-0.047(-0.083,-0.011)	0.015^*	-0.049(-0.134,0.036)	0.248	-0.079(-0.134,-0.023)	0.009^*	-0.064(-0.150,0.023)	0.145	0.014(-0.069,0.098)	0.732
16W	0.004(-0.025,0.032)	0.773	-0.013(-0.045,0.018)	0.383	-0.024(-0.120,0.071)	0.609	-0.118(-0.147,-0.089)	<0.001^*	-0.111(-0.209,-0.014)	0.026^*	0.087(-0.007,0.181)	0.069
24W	0.009(-0.014,0.033)	0.406	<0.001(<0.001,<0.001)	1	-0.017(-0.111,0.078)	0.725	-0.031(-0.064,0.001)	0.059	-0.030(-0.126,0.066)	0.526	0.014(-0.079,0.106)	0.765
32W	0.003(-0.033,0.039)	0.856	-0.001(-0.022,0.019)	0.892	0.012(-0.064,0.088)	0.758	-0.031(-0.083,0.020)	0.207	0.024(-0.05,0.10)	0.532	0.012(-0.060,0.090)	0.738
40W	0.012(-0.011,0.036)	0.280	-0.001(-0.014,0.011)	0.820	0.021(-0.071,0.113)	0.649	0.006(-0.007,0.020)	0.316	-0.005(-0.098,0.089)	0.923	-0.025(-0.116,0.065)	0.573
SWS
0W					-0.027(-0.365,0.311)	0.873			-0.030(-0.374,0.313)	0.859	0.004(-0.328,0.335)	0.982
8W	-0.038(-0.089,0.012)	0.125	-0.102(0.194,0.010)	0.033^*	-0.090(-0.423,0.245)	0.589	-0.221(-0.334,-0.109)	0.001^*	-0.213(-0.555,0.128)	0.213	0.123(-0.206,0.452)	0.454
16W	-0.011(-0.191,0.170)	0.899	-0.136(-0.227,-0.045)	0.006^*	-0.152(-0.449,0.145)	0.307	-0.416(-0.566,-0.265)	<0.001^*	-0.435(-0.738,-0.133)	0.006^*	0.283(-0.008,0.575)	0.056
24W	0.014(-0.201,0.229)	0.891	-0.149(-0.215,-0.083)	<0.001^*	-0.189(-0.460,0.082)	0.166	-0.296(-0.440,-0.153)	0.001^*	-0.341(-0.616,-0.065)	0.017^*	0.151(-0.115,0.417)	0.256
32W	0.005(-0.206,0.216)	0.963	-0.144(-0.225,0.063)	0.002^*	0.175(-0.087,0.438)	0.185	-0.329(-0.490,0.167)	0.001^*	0.364(0.097,0.631)	0.009^*	0.188(-0.070,0.446)	0.148
40W	0.002(-0.010,0.013)	0.771	-0.001(-0.017,0.015)	0.930	0.029(-0.301,0.359)	0.860	0.011(-0.011,0.032)	0.305	0.021(-0.314,0.357)	0.899	-0.008(-0.331,0.316)	0.962
SPF
0W					0.014(-0.206,0.235)	0.897			-0.037(-0.262,0.187)	0.737	0.052(-0.165,0.268)	0.632
8W	-0.051(-0.103,0.001)	0.055	-0.087(-0.137,-0.036)	0.003^*	-0.022(-0.234,0.190)	0.837	-0.091(-0.171,-0.011)	0.029^*	-0.077(-0.293,0.138)	0.472	0.056(-0.152,0.264)	0.591
16W	-0.005(-0.132,0.122)	0.938	-0.090(-0.149,0.031)	0.005^*	-0.071(-0.261,0.119)	0.452	-0.268(-0.365,-0.171)	<0.001^*	-0.301(-0.494,-0.108)	0.003^*	0.229(0.043,0.416)	0.017^*
24W	0.021(-0.110,0.152)	0.736	-0.089(-0.165,-0.013)	0.025^*	-0.096(-0.264,0.072)	0.256	-0.209(-0.298,-0.121)	<0.001^*	-0.267(-0.439,-0.096)	0.003^*	0.172(0.006,0.337)	0.042^*
32W	0.017(-0.118,0.151)	0.789	-0.089(-0.173,-0.004)	0.041^*	0.091(-0.065,0.248)	0.244	-0.201(0.301,0.101)	0.001^*	0.256(0.097,0.415)	0.002^*	0.164(0.011,0.318)	0.036^*
40W	0.007(-0.015,0.029)	0.511	<0.001(-0.010,0.010)	1	-0.007(-0.217,0.202)	0.945	-0.003(-0.017,0.012)	0.679	0.047(-0.166,0.260)	0.656	0.054(-0.151,0.260)	0.595

表3

表4

表5

3组在不同时间点SS相关指数的统计结果"

比较项目	对照组		NS组				TA组
	与0W相比		与0W相比		与对照组相比		与0W相比		与对照组相比		与NS组相比
	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P	差值(95%CI)	P
XI
0W					1.385(-3.763,6.532)	0.589			0.242(-4.990,5.474)	0.926	1.143(-3.905,6.191)	0.650
8W	0.462(-0.342,1.265)	0.235	2.200(0.484,3.916)	0.016^*	3.123(-2.131,8.377)	0.236	4.500(1.719,7.281)	0.004^*	4.280(-1.060,9.621)	0.113	-1.157(-6.310,3.995)	0.652
16W	0.692(-0.243,1.628)	0.133	2.200(0.190,4.210)	0.034^*	2.892(-1.726,7.511)	0.213	6.214(3.591,8.838)	<0.001^*	5.764(1.070,10.458)	0.017^*	-2.871(-7.401,1.658)	0.207
24W	0.692(-0.210,1.595)	0.121	2.133(0.298,3.968)	0.026^*	2.826(-1.920,7.572)	0.236	4.857(2.420,7.295)	0.001^*	4.407(-0.418,9.231)	0.072	-1.581(-6.235,3.073)	0.496
32W	1.462(0.315,2.609)	0.017	2.733(1.322,4.145)	0.001^*	-2.656(-7.005,1.693)	0.224	5.286(2.564,8.007)	0.001^*	-4.066(-8.486,0.355)	0.070	-1.410(-5.674,2.855)	0.508
40W	0.308(-0.265,0.880)	0.264	0.133(-0.328,0.595)	0.546	-1.210(-6.464,4.044)	0.644	0.143(-0.568,0.854)	0.671	-0.077(-5.417,5.264)	0.977	1.133(-4.019,6.286)	0.659
CODS
0W					0.221(-0.526,0.967)	0.554			0.368(-0.391,1.127)	0.332	-0.148(-0.880)	0.686
8W	0.077(-0.382,0.536)	0.721	0.333(-0.008,0.675)	0.055	0.477(-0.035,0.989)	0.067	0.500(0.124,0.876)	0.013^*	0.791(0.271,1.311)	0.004^*	-0.314(-0.816,0.188)	0.213
16W	0.385(-0.008,0.778)	0.054	0.733(0.244,1.223)	0.006^*	0.569(-0.369,1.507)	0.227	0.643(0.213,1.073)	0.007^*	0.626(-0.327,1.580)	0.192	-0.057(-0.977,0.863)	0.901
24W	0.231(-0.272,0.734)	0.337	0.267(-0.062,0.595)	0.104	0.256(-0.301,0.814)	0.358	0.571(0.198,0.945)	0.006^*	0.709(0.142,1.275)	0.016^*	-0.452(-0.999,0.094)	0.102
32W	0.231(-0.207,0.669)	0.273	0.067(-0.187,0.320)	0.582	-0.056(-0.670,0.557)	0.853	0.571(0.198,0.945)	0.006^*	-0.709(-1.333,-0.085)	0.027^*	-0.652(-1.254,-0.050)	0.034^*
40W	-0.077(-0.245,0.091)	0.337	-0.067(-0.210,0.076)	0.334	-0.231(-0.980,0.518)	0.537	-0.143(-0.353,0.067)	0.165	-0.302(-1.063,0.459)	0.427	-0.071(-0.806,0.663)	0.845
ESSPRI (总分)
0W					0.221(-3.046,3.487)	0.892			-0.703(-4.024,2.627)	0.671	0.924(-2.280,4.127)	0.563
8W	-0.231(-1.540,1.078)	0.708	1.667(-0.236,3.570)	0.081	2.118(-1.719,5.955)	0.271	3.214(1.547,4.881)	0.001^*	2.742(-1.158,6.642)	0.163	-0.624(-4.386,3.139)	0.739
16W	0.769(-0.813,2.352)	0.310	3.000(0.577,5.423)	0.019^*	2.451(-1.405,6.308)	0.206	8.214(6.251,10.178)	<0.001^*	6.742(2.822,10.661)	0.001^*	-4.290(-8.072,-0.509)	0.027^*
24W	0.846(-0.104,1.797)	0.076	1.800(-0.533,4.133)	0.120	1.174(-2.683,5.032)	0.542	4.500(2.609,6.391)	<0.001^*	2.951(-0.970,6.871)	0.136	-1.776(-5.558,2.007)	0.348
32W	0.692(-0.575,1.960)	0.257	2.067(0.201,3.933)	0.032	-1.595(-5.082,1.892)	0.361	4.643(2.713,6.573)	<0.001^*	-3.247(-6.792,0.297)	0.071	-1.652(-5.072,1.768)	0.334
40W	-0.615(-1.377,0.147)	0.104	<0.001(-0.694,0.694)	1	-0.836(-4.176,2.504)	0.616	0.286(-0.446,1.017)	0.414	-0.198(-3.593,3.197)	0.907	0.638(-2.638,3.914)	0.696
ESSPRI (口干症状)
0W					-0.800(-2.052,0.452)	0.204			-0.857(-2.130,0.416)	0.181	0.057(-1.171,1.285)	0.926
8W	-0.077(-0.598,0.444)	0.753	0.600(0.192,1.008)	0.007^*	-0.123(-1.214,0.968)	0.821	0.714(0.140,1.288)	0.019^*	-0.066(-1.175,1.043)	0.905	-0.057(-1.127,1.013)	0.915
16W	-0.077(-0.653,0.500)	0.776	0.533(0.179,0.888)	0.006^*	-0.190(-1.162,0.782)	0.695	1.571(0.903,2.240)	<0.001^*	0.791(-0.197,1.779)	0.113	-0.981(-1.934,-0.028)	0.044^*
24W	0.077(-0.500,0.653)	0.776	0.600(0.250,0.950)	0.003^*	-0.277(-1.218,0.664)	0.555	1.357(0.821,1.893)	<0.001^*	0.423(-0.534,1.380)	0.377	-0.700(-1.623,0.223)	0.133
32W	-0.385(-1.223,0.453)	0.337	0.467(-0.040,0.974)	0.068^*	-0.051(-1.030,0.928)	0.916	1.500(0.830,2.170)	<0.001^*	-1.027(-2.023,-0.032)	0.043	-0.976(-1.936,-0.016)	0.046^*
40W	-0.154(-0.489,0.181)	0.337	0.267(0.013,0.520)	0.041^*	0.379(-0.796,1.555)	0.518	0.071(-0.203,0.345)	0.583	0.632(-0.563,1.827)	0.291	0.252(-0.901,1.406)	0.660

表5

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项目	基线情况
年龄/岁	46.07±7.13
女性/男性	13∶1
病程/年	3.48±1.47
对照组	3.33±0.89
NS组	3.93±1.83
TA组	3.14±1.46
原发SS	28(66.67%)
对照组	9(64.29%)
NS组	10(71.43%)
TA组	9(64.29%)
继发SS	14(33.33%)
对照组	5(35.71%)
NS组	4(28.57%)
TA组	5(35.71%)
血浆抗体阳性
anti-SSA	36(81.82%)
anti-SSB	34(80.95%)
RF	24(57.14%)
ANA	20(47.62%)
唇腺活检阳性	37(88.10%)
施墨试验阳性	36(85.71%)
基线UWS/(mL/min)
对照组	0.14±0.13
NS组	0.14±0.15
TA组	0.13±0.13
基线SWS/(mL/min)
对照组	0.34±0.43
NS组	0.37±0.40
TA组	0.37±0.38
基线SPF/(mL/min)
对照组	0.21±0.28
NS组	0.19±0.23
TA组	0.24±0.34
XI	42.81±6.59
ESSPRI(总分)	21.30±4.18
ESSPRI(口干症状)	6.57±1.64
CODS	4.95±0.96

各时间点	UWS			SWS			SPF
各时间点	对照组	NS组	TA组	对照组	NS组	TA组	对照组	NS组	TA组
0W	0.14±0.13	0.14±0.15	0.13±0.13	0.34±0.43	0.37±0.40	0.37±0.38	0.21±0.28	0.19±0.23	0.24±0.34
8W	0.14±0.11	0.19±0.11	0.20±0.10	0.38±0.44	0.47±0.40	0.60±0.47	0.26±0.32	0.28±0.24	0.33±0.26
16W	0.13±0.10	0.16±0.14	0.24±0.13	0.35±0.17	0.51±0.40	0.79±0.50	0.21±0.12	0.28±0.24	0.51±0.33
24W	0.13±0.11	0.14±0.15	0.16±0.10	0.33±0.12	0.52±0.40	0.67±0.44	0.19±0.09	0.28±0.19	0.45±0.31
32W	0.13±0.08	0.14±0.13	0.16±0.07	0.34±0.11	0.51±0.40	0.70±0.41	0.19±0.08	0.28±0.19	0.45±0.28
40W	0.12±0.11	0.14±0.14	0.12±0.11	0.34±0.44	0.37±0.39	0.36±0.46	0.20±0.27	0.19±0.22	0.25±0.32

各时间点	XI			CODS			ESSPRI(总分)			ESSPRI(口干症状)
各时间点	对照组	NS组	TA组	对照组	NS组	TA组	对照组	NS组	TA组	对照组	NS组	TA组
0W	43.38±5.9	42.00±7.12	43.14±7.00	5.15±0.90	4.93±1.03	4.79±0.97	21.15±4.54	20.93±4.83	21.86±3.21	6.00±1.68	6.80±1.61	6.86±1.61
8W	42.92±5.95	39.80±7.36	38.64±7.07	5.08±0.64	4.60±0.74	4.29±0.61	42.92±5.95	19.27±5.40	18.64±4.58	6.08±1.26	6.20±1.52	6.14±1.46
16W	42.69±5.64	39.80±5.83	36.93±6.55	4.77±1.09	4.20±1.52	4.14±0.95	20.38±3.20	17.93±6.18	13.64±5.03	6.08±1.12	6.27±1.44	5.29±1.20
24W	42.69±6.06	39.87±6.37	38.29±6.12	4.92±0.49	4.66±0.72	4.21±0.89	20.31±4.37	19.13±5.88	17.36±4.60	4.92±0.49	6.20±1.47	5.50±1.09
32W	41.92±4.73	39.27±6.15	37.86±5.93	4.92±0.64	4.87±0.92	4.21±0.80	20.46±4.54	18.87±4.60	17.21±4.51	6.38±1.50	6.33±1.35	5.36±0.93
40W	43.08±6.14	41.87±7.12	43.00±7.18	5.23±0.93	5.00±1.00	4.93±1.00	21.77±4.21	20.93±5.06	21.57±3.61	6.15±1.46	6.53±1.46	6.79±1.67