【目的】 探讨活血解毒润燥方对原发性干燥综合征并发肺纤维化阴虚津亏证患者的临床疗效及对生物标志物的影响。 【方法】 前瞻性选取2021年1月至2024年1月在衡水市人民医院接受治疗的134例原发性干燥综合征并发肺纤维化阴虚津亏 证患者，采用随机数字表法将患者随机分为对照组和观察组，每组各67例。对照组给予口服硫酸氢氯喹治疗，观察组给予 口服硫酸氢氯喹联合活血解毒润燥方治疗，疗程为 12 周。观察 2 组患者治疗前后中医证候积分、血清炎症因子[白细胞介 素 4（IL-4）、白细胞介素6（IL-6）、C反应蛋白（CRP）]、免疫球蛋白（Ig）水平、肺功能指标[第1秒用力呼气量（FEV1）、用力 肺活量（FVC）、单次呼气一氧化碳扩散容量/气体肺泡通气量（DLco/VA）、总肺容积（TLC）]及干燥综合征患者报告指数 （ESSPRI）、干燥综合征疾病活动指数（ESSDAI）、改良版英国医学研究委员会呼吸困难问卷（mMRC）评分的变化情况，并评 价2组患者的临床疗效。【结果】（1）疗效方面，治疗12周后，观察组的总有效率为97.01%（65/67），对照组为83.58%（56/67）， 组间比较（χ2 检验），观察组的疗效明显优于对照组（P＜0.01）。（2）中医证候方面，治疗后，2组患者的五心烦热、口咽干燥、 大便干燥、舌干燥裂、双目干涩、腮腺肿痛、皮肤干裂、口眼黏腻、乏力倦怠、关节疼痛积分均较治疗前降低（P＜0.05）， 且观察组对除舌干燥裂外的各项中医证候积分的降低幅度均明显优于对照组（P＜0.05 或 P＜0.01）。（3）血清炎症因子方面， 治疗后，2 组患者的血清 IL-4、IL-6、CRP 水平均较治疗前降低（P＜0.05），且观察组的降低幅度均明显优于对照组（P＜ 0.01）。（4）肺功能指标方面，治疗后，2组患者的 FEV1、FVC、DLco/VA、TLC等肺功能指标均较治疗前升高（P＜0.05），且 观察组的升高幅度均明显优于对照组（P＜0.01）。（5）免疫球蛋白方面，治疗后，2组患者的血清IgA、IgG水平均较治疗前降 低（P＜0.05），且观察组的降低幅度均明显优于对照组（P＜0.01）。（6）量表评分方面，治疗后，2组患者的 ESSPRI、ESSDAI 和mMRC评分均较治疗前降低（P＜0.05），且观察组的降低幅度均明显优于对照组（P＜0.01）。【结论】 相较于单纯西药治疗， 活血解毒润燥方联合常规西药治疗原发性干燥综合征并发肺纤维化阴虚津亏证患者，能更有效地改善中医证候，降低血清 炎症因子及免疫球蛋白水平，提升肺功能，减轻干燥综合征症状及疾病活动度，并显著提高治疗总有效率，可为原发性干 燥综合征并发肺纤维化患者提供一种更为有效的治疗策略。

Objective To investigate the clinical efficacy of Huoxue Jiedu Runzao Formula （HJRF） and its impact on biomarkers in patients with primary Sjögren’s syndrome（pSS）complicated by pulmonary fibrosis （PF） presenting with yin deficiency and fluid depletion syndrome （YDFDS）. Methods A prospective study was conducted on 134 pSS-PF patients with YDFDS treated at Harrison International Peace Hospital from January 2021 to January 2024. Patients were randomly assigned to the control group （n=67） or the observation group （n=67）using a random number table. The control group received oral use of hydroxychloroquine sulfate， while the observation group received hydroxychloroquine sulfate combined with HJRF，both groups were treated for 12 weeks. Changes in traditional Chinese medicine （TCM） syndrome scores， serum inflammatory factors [interleukin-4 （IL-4），interleukin-6（IL-6），C-reactive protein （CRP）]，immunoglobulin （Ig） levels，pulmonary function parameters [forced expiratory volume in one second （FEV1），forced vital capacity （FVC），diffusing capacity of the lung for carbon monoxide per unit alveolar volume （DLco/VA），total lung capacity （TLC）]，EULAR Sjögren’s Syndrome Patient Reported Index （ESSPRI），EULAR Sjögren’s Syndrome Disease Activity Index （ESSDAI）， and modified Medical Research Council （mMRC） dyspnea scale scores were observed before and after treatment. The clinical efficacy was evaluated in both groups. Results （1） After 12 weeks of treatment，the overall response rate in the observation group was 97.01% （65/67）， while that in the control group was 83.58% （56/67）. The intergroup comparison （by chi-square test） revealed that the efficacy of the observation group was significantly superior to that of the control group （P＜0.01）.（2） After treatment， the TCM syndromes scores regarding to vexing heat in the chest，plams and soles，dryness of the mouth and throat，dry stools，dry and cracked tongue， dry and sore eyes，parotid swelling and pain，skin dryness and cracking，sticky mouth and eyes，fatigue and lassitude， and joint pain were all significantly reduced compared to those before treatment （P＜0.05）. Additionally， the reduction in scores for all TCM syndromes except dry and cracked tongue in the observation group was significantly greater than that in the control group （P＜0.05 or P＜0.01）.（3） After treatment，the serum IL-4，IL-6，and CRP levels in both groups decreased compared to those before treatment （P＜0.05），and the reduction in the observation group was significantly greater than that in the control group （P＜0.01）.（4） After treatment， the FEV1， FVC， DLco/VA， TLC， and other lung function indicators in both groups of patients increased compared to those before treatment （P＜0.05）， and the increase in the observation group was significantly greater than that in the control group （P＜0.01）.（5） After treatment，serum IgA and IgG levels in both groups decreased compared to those before treatment （P＜0.05），and the reduction in the observation group was significantly greater than that in the control group （P＜0.01）.（6） After treatment，the ESSPRI，ESSDAI， and mMRC scores in both groups decreased compared to those before treatment （P＜0.05），and the reduction in the observation group was significantly greater than that in the control group （P＜0.01）. Conclusion Compared to conventional western therapy alone，HJRF combined with hydroxychloroquine sulfate more effectively alleviates TCM syndromes，reduces inflammatory and immunoglobulin levels，improves pulmonary function，mitigates pSS symptoms and disease activity， and enhances overall treatment efficacy. This provides a superior therapeutic strategy for pSS-PF patients with YDFDS.

R275.9

国家自然科学基金资助项目（编号：81874438）