Li Ben, Hou Jiaqi, Yang Yue, Piao Xuemei, Chen Yueying, Xue Luan, Wang Dan, Hu Jiandong, Li Guoling, Wu Xiangxiang, Sun Yu, Jin Runa
Department of Rheumatology and Immunology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
Evid Based Complement Alternat Med. 2017;2017:1315432. doi: 10.1155/2017/1315432. Epub 2017 Jul 10.
To evaluate the clinical therapeutic efficacy and safety of JieDuTongLuoShengJin granules + HCQ in patients with pSS.
40 patients with low-activity-level pSS and without visceral involvement participated in this study and were randomized to receive either JieDuTongLuoShengJin granules with HCQ or placebo with HCQ. Patients and investigators were blinded to treatment allocation. The primary endpoint was week 12 ESSPRI score, while secondary endpoints included ESSDAI, salivary and lacrimal gland function, and some laboratory variables. Safety-related data were also assessed.
Comparing with the placebo group, the treatment group experienced statistically significant improvement in the mean change from baseline for the primary endpoint of ESSPRI score and also in PGA. Moreover, in comparison with baseline values, the treatment group had significantly improved ESSDAI score, unstimulated saliva flow rate, and several laboratory variables. However, upon comparison of the two groups, there were no significant differences for them. The incidence of AEs was 10.0%, one in treatment group and three in placebo group.
Treatment with a combination of JieDuTongLuoShengJin granules with HCQ is effective in improving patients' subjective symptoms and some objective indicators of pSS. These results indicate that JieDuTongLuoShengJin is promising as a safe and effective treatment of pSS.
评估解毒通络生津颗粒联合羟氯喹治疗干燥综合征（pSS）患者的临床疗效及安全性。
40例低活动度且无内脏受累的pSS患者参与本研究，随机分为解毒通络生津颗粒联合羟氯喹组或安慰剂联合羟氯喹组。患者和研究者对治疗分配情况不知情。主要终点为第12周的欧洲干燥综合征患者报告指数（ESSPRI）评分，次要终点包括欧洲干燥综合征疾病活动指数（ESSDAI）、唾液腺和泪腺功能以及一些实验室指标。还评估了与安全性相关的数据。
与安慰剂组相比，治疗组在ESSPRI评分这一主要终点的平均基线变化及医师整体评估（PGA）方面有统计学意义的改善。此外，与基线值相比，治疗组的ESSDAI评分、非刺激性唾液流速及一些实验室指标有显著改善。然而，两组比较时，这些指标无显著差异。不良事件发生率为10.0%，治疗组1例，安慰剂组3例。
解毒通络生津颗粒联合羟氯喹治疗可有效改善pSS患者的主观症状及一些客观指标。这些结果表明解毒通络生津颗粒有望成为治疗pSS的安全有效药物。
