中藥複方治療乾燥症候群之隨機雙盲安慰劑對照式臨床試驗

中山醫學大學機構典藏 CSMUIR > 醫學院 > 醫學研究所 > 博碩士論文 > Item 310902500/19654

Please use this identifier to cite or link to this item: https://ir.csmu.edu.tw:8080/ir/handle/310902500/19654

Title:	中藥複方治療乾燥症候群之隨機雙盲安慰劑對照式臨床試驗 A randomized, double-blinded, placebo-controlled clinical trial of Traditional Chinese Medicine in patients with Sjogren’s syndrome
Authors:	陳皇希 Chen, HuangHsi
Contributors:	中山醫學大學:醫學研究所;魏正宗
Keywords:	乾燥症;甘露飲;味逍遙散;機雙盲的臨床試驗 Gan Lu Yin;Jia Wei Xiao Yao San;double-blinded, randomized,placebo-controlled clinical trial
Date:	2018
Issue Date:	2019-01-04T04:43:37Z (UTC)
Abstract:	研究目的：因為目前臨床對乾燥症候群（Sjogren’s syndrome）的治療效果有限，本試驗的目的利用中藥複方甘露飲、加味逍遙散加上夜交藤及酸棗仁複方治療乾燥症病人，並追蹤觀察其治療效果。研究方法：本試驗採用一個隨機、雙盲、安慰劑為對照組的臨床試驗。試驗納入45位病人，年紀分布在20到40歲之間，以2:1的比例分別分派到治療組及安慰劑組。治療組病人每天早上服用甘露飲6克，晚餐後服用加味逍遙散6克及夜交藤1克、酸棗仁1克共8克。試驗進行12週，受試者必須在第0、4、8、12週回診，接受相關的評估。本試驗所選用的主要療效指標為「乾燥症候群患者疾病活性指數」(Sjogren’s Syndrome Patient-reported Index, ESSPRI )，次要指標為「乾燥症候群患者疾病活性指數」(Sjogren’s Syndrome Disease Activity Index, ESSDAI)、病人整體評估（PGA）、疼痛指數（VAS）、健康生活品質量表（SF-36）、匹茲堡睡眠品質量表（PSOI）、多軸向疲倦測量表（MFI-20）、中醫體質評估（BCQ）及安全性評估。試驗結果：經過篩選，最後共有42位病人進入隨機分派的試驗。其中14人被分派到安慰劑組（A組），服用劑量僅有治療組十分之一的安慰劑。另外28人被分派到治療組（B組）。總體來說，在基線時治療組受試者的健康狀況比安慰劑組差。第12週時主要療效指標（ESSPRI）安慰劑組和治療組都有改善的趨勢，但是安慰劑組-0.91±1.26 比治療組的-0.62±1.57（p=0.557）改善較多。次要療效指標ESSDAI兩組都有改善，安慰劑組-0.91±1.26比治療組的-0.62±1.57（p=0.703）降低較多。匹茲堡睡眠品質（PSQI）的睡眠時間（Sleep Duration）治療組-0.61±0.99較安慰劑組-0.21±0.7（p=0.914）下降，顯示治療組病人的平均睡眠時間有延長。結論：試驗結果顯示甘露飲與加味加遙散、夜交藤、酸棗仁複方使用12週的安性良好。全由主要療效指標ESSPRI之比較來看，本試驗用藥對乾燥症症狀改善是無效的，但於試驗中發現藥物對延長乾燥症患者總睡眠時間，增加患者睡眠品質可能有其效果。試驗也意外發現中藥複方似乎有降低患者血壓的效果。 Objective Sjogren’s syndrome (SS) is a chronic inflammatory autoimmune disease mainly characterized by dryness, fatigue, and pain. The current regular therapies for SS in Western Medicine have limited effects on patients. The purpose of this study is to observe the clinical effects and safety of a traditional Chinese medicine (TCM) formula on SS patients. Methods We performed a 12 week, randomized, double-blinded, placebo-controlled clinical trial at Chung Shan Medical University Hospital. We included patients who aged between 20 and 80 years and met the criteria of American and European Consensus Group (AECG). Patients who had other severe systemic manifestations or diseases were excluded from this trial. After screening, patients were randomized assigned to controlled group and treatment group. During the test, patients in treatment group were treated with 6 grams of Gan Lu Yin after breakfast in the morning, and 6 grams of Jia Wei Xiao Yao San combined with 1 gram of Suan Zao Ren and Ye Jiao Teng after dinner in the evening every day. Patients in the controlled group were taken placebo with the same appearance, flavor, but only one tenth of dosage of that of the treatment group. Patients must return to clinic and receive assessments every 4 weeks. The Sjogren’s syndrome Patient-reported Index (ESSPRI) was used to evaluate the patients’ main symptoms. Sjogren’s Syndrome Disease Activity Index (ESSDAI) was used to assess patients’ systemic manifestations. We also conducted Physician Global Assessment (PGA), Visual Analogue Scale (VAS), SF-36, MFI-20, Pittsburgh Sleep Quality Score (PSQI) to measure other domains of disease activity of patients. To assess the safety of this TCM formula, serum and biochemistry tests were carried out at each time of patients’ return visit. Adverse events were recorded case by case. Results Finally, 42 patients were included in this trial after screening. 28 patients were assigned to the treatment group and 14 patients were assigned to the controlled group. In treatment group, 7 patients were withdrawn from this trial during test; in controlled group, 5 patients were withdrawn from this study during test. At week 12, the ESSPRI scores of both groups were improved. However, the ESSPRI score of the treatment group decreased by -0.62 (p=0.557) and that of the placebo group decreased by -0.91 (p=0.557). The primary endpoint (ESSPRI) of the treatment group was higher than it of the controlled group. The domain of sleep duration in PSQI was -0.61 which was improved more than the -0.21 of the placebo group (p=0.914). Other secondary endpoints of the two groups didn’t reveal any efficacy of this TCM formula. There was one severe adverse event which was caused by hydronephrosis, but it was related to the TCM formula. Conclusion At week 12, the ESSPRI scores didn’t reveal that the TCM formula had efficacy on SS patients. But the PSQI showed that this formula could prolong the patients’ sleep duration. We also found that this formula had function to decrease the patients’ blood pressure.
URI:	https://ir.csmu.edu.tw:8080/ir/handle/310902500/19654
Appears in Collections:	[醫學研究所] 博碩士論文

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