Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Salivary flow rate (Sauf)
研究概览
简要总结
To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.
详细描述
Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary Sjögren's syndrome
- •Must be able to receive acupuncture treatment and swallow tablets
排除标准
- •Patients with malignant tumors or severe organ function impairment
- •Patients who are lactating or pregnant.
- •Persons who are participating in clinical trials of other drugs.
研究组 & 干预措施
acupuncture combined with hydroxychloroquine sulfate tablets
Acupuncture combined with oral hydroxychloroquine sulfate tablets
干预措施: Acupuncture combined with oral hydroxychloroquine sulfate tablets (Other)
oral hydroxychloroquine sulfate tablets
Oral hydroxychloroquine sulfate tablets (Shanghai Shangyao Sino-Western Pharmaceutical Co., LTD., Fenle, Sinopyma approval number H19990263, 0.1g x 14 tablets) were treated with 0.2g each time, twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment.
结局指标
主要结局
Salivary flow rate (Sauf)
时间窗: 8 weeks
Used to evaluate the salivary flow rate of pSS patients before and after treatment. Before the start of the experiment, the patient gargled with water to keep the mouth clean and free of irritation. Saliva collected at the bottom of the mouth and spit it into the measuring cup every 1min. After collecting it for 10min, the value was recorded. The less the saliva flow rate within 10 minutes, the worse the symptoms, and less than 1ml is abnormal.
Schirmer test
时间窗: 8 weeks
Used to evaluate the degree of tear secretion in pSS patients before and after treatment. The 5mm×35mm filter paper was folded at a right Angle at 5mm from one end, and the end was placed in the conjunctival sac at 1/3 of the outer eyelid of the patient. The eyes were closed and the clamp was held for 5min, and the wet length of the filter paper was measured, and the filter paper was positive if it was less than 5mm/5min. The less tears are secreted within five minutes, the more severe the symptoms.
次要结局
- Sjögren's syndrome patient-reported index (ESSPRI)(8 weeks)
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score(8 weeks)
研究者
Senyue Zhang
Principal Investigator
Heilongjiang University of Chinese Medicine