针药结合对原发性干燥综合征疾病相关指数影响的临床观察

Clinical observation on the effects of disease index linked to primary Sjögren syndrome by acupuncture combined with traditional Chinese medicine

关键词:  干燥综合征  针灸  解毒通络生津方  临床研究

Key words:  primary Sjögren syndrome  acupuncture  Jiedu Tongluo Shengjin prescription  clinical research

摘要:

[目的]研究针药结合治疗无内脏累及原发性干燥综合征（pSS）患者的临床疗效与安全性，寻求治疗pSS的新方法。[方法]对60例无内脏累及pSS患者进行随机分组，其中针药结合治疗组30例，西药对照组30例，针药结合治疗组所有患者采用针灸和解毒通络生津方中药内服治疗，西药对照组选用羟基氯喹片每次0.1 g，每日2次口服治疗。观察患者的欧洲抗风湿联盟干燥综合征患者报告指数（ESSPRI）、欧洲抗风湿联盟干燥综合征疾病活动指数（ESSDAI）评分，唾液流率、Schirmer's试验、血沉（ESR）、C-反应蛋白（CRP）、血清免疫球蛋白及补体，治疗过程中检查不良反应，1个月为1个疗程，治疗3个疗程后判定总体临床疗效。[结果]治疗组总有效率为83.33%，对照组总有效率为60.00%，治疗组优于对照组（P<0.05）。治疗组在ESSPRI评分、中医证候积分、唾液流率、ESR改善方面明显优于对照组，两组有显著差异（P<0.05）。在ESSDAI、Schirmer's试验、免疫球蛋白、补体、CRP指标治疗前后比较有显著性意义（P<0.05）。在改善CRP、血清免疫球蛋白G（immunoglobulin G，IgG）、补体等实验室指标方面两组疗效相当，无显著差异（P>0.05）。[结论]针药结合可以有效改善患者疾病相关指数，主观症状及客观指标，提高患者生活质量，且疗效明显优于对照组，是无内脏累及原发性干燥综合征患者安全有效的治疗方法。

Abstract:

[Objective] To observe clinical therapeutic effect and safety of acupuncture combined with traditional Chinese medicine (TCM) on primary Sjögren syndrome (pSS) patients without internal organs involvement, and seek a new method of treatment of primary Sjögren syndrome.[Methods] The 60 patients with pSS who have no internal organs involvement were randomly divided into two groups, the treatment group and the control group, with 30 cases in each group. Treatment group were treated with acupuncture combined with Jiedu Tongluo Shengjin granules, and the control group with 0.1 g hydroxychloroquine two times a day. The score of EULAR Sjögren's Syndrome Patient Reported Index(ESSPRI) and EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) were measured, the amount of tear secretion and saliva flow rate were recorded, and the level of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), immunoglobulin, and complement in blood serum were detected. After three months, therapeutic effects were compared.[Results] The total effective rate was 83.33% for treatment group and 60.00% for control group with a significant difference between two groups(P<0.05). Tear secretion, the level of ESR, TCM syndrome integral and ESSPRI before and after the treatment of treatment group was better than the control group (P<0.05). There were significant differences among the score of ESSDAI, the amount of saliva flow rate, the level of CRP, immunoglobulin, and complement in blood serum of two groups before and after the treatment (P<0.05). But there were no significant differences in level of CRP, immunoglobulin and complement in blood serum between two groups after treatment (P>0.05).[Conclusion] Combination of acupuncture with TCM shows good curative effect in improving the disease index, subjective symptoms and objective indicators of pSS. The method improved patients' quality of life, and the curative effect of treatment group was better than control group. It is a safe and effective treatment of the pSS patients without internal organs involvement.