臺灣博碩士論文加值系統

前言：中國醫藥大學陳汶吉教授之研究證實，五苓散於體外實驗及動物試驗之中，的確有抑制草酸鈣結晶形成、凝集和成長之功效。本實驗之目的即為應用中藥五苓散，研究其對於復發型草酸鈣結石患者之結石促進及抑制因子之影響；以期找出ㄧ副作用低且有效之方法來預防結石之復發。
實驗方法： 實驗組一5人，五苓散2g每日三次飯後服用，共服用一個月，並多喝水維持每日尿量>2000cc。對照組5人，給予安慰劑2g每日三次飯後服用，共服用一個月，並多喝水維持每日尿量>2000cc。觀察其服藥前及服藥後一個月之血液檢查、尿液檢查、腹部X光及腎臟超音波檢查之變化，是否有新生成之結石及於血液與尿液中是否會產生變化。統計分析利用SPSS軟體進行t-test統計，p值<0.05認為於統計學上具有顯著之差異。
結果：10位病人中，男性7位(70%)，女性三位(30%)。平均年齡50.7歲(40至59歲) 。實驗組5人之尿量變化為，服用前2260±434毫升/天，服用後2580±526毫升/天(變化百分比14.1%)。對照組5人之尿量變化為，服用前2660±844毫升/天，服用後2660±850毫升/天(變化百分比-0.1%)。兩組比較發現中藥五苓散的確能增加結石病患之排尿量(t檢定，p值小於0.05)，而增加排尿量對結石之預防具有正面之助益。另ㄧ方面，中藥五苓散並無腸胃道刺激症狀或電解質失衡之情況發生；血清中電解質、肝及腎功能指數並無明顯之變化。
結論：中藥五苓散可能為ㄧ副作用低且有效之中藥可應用於預防結石之復發﹔與臨床上常應用於結石之檸檬酸鉀粉末比較發現，中藥五苓散並無腸胃道刺激症狀發生；與臨床上常應用於結石之利尿劑比較發現，中藥五苓散並無電解質失衡之情況發生。使用中藥五苓散可以使草酸鈣結石病患之尿量增加並鼓勵病人多喝水以增加尿量。所以對於需長期服用結石預防藥物的復發型草酸鈣結石患者而言，本方適合作為觀察長期服用預防效果的中藥方劑。

關鍵詞：草酸鈣；尿路結石；傳統中藥；五苓散；腎結石

Objectives: Wu-Ling-San formula has been proved to have a preventive effect on the treatment of calcium oxalate nephrolithiasis both in vitro and in vivo. In this study, we examined the efficacy of Wu-Ling-San formula prophylaxis for preventing recurrent calcium oxalate nephrolithiasis.
Methods: This was a prospective clinical study that evaluated the 24-hour urine parameters of 10 patients with kidney stones. All patients with a history of recurrent calcium oxalate nephrolithiasis who were aged 40 to 59 years old. The patients were asked to drink enough fluid to urinate at least 2 L daily during the study period. A 24-hour urine collection was performed to establish the baseline levels of multiple urinary parameters before taking the medicine. The patients were randomized divided into two groups. The medication group took 2 gm Wu-Ling-San formula three times daily for 1 month. The control group took 2 gm placebo formula three times daily for 1 month. All the patients received 24-hour urine collection was performed of multiple urinary parameters after complete the study. The serum liver, renal function and electrolyte was also collected.
Results: A total of 10 patients were enrolled, of whom 7 (70%) were men and 3 (30%) were women. All the patients completed of the study. The mean age was 50.7 years old (range 40 to 59). The patients reported a lifetime total of 3 to 6 (average 4.2) stone episodes. The patients had undergone 2 to 3 (average 2.5) stone procedures. The baseline urine output level was 2260±434 ml/day in Wu-Ling-San formula (WLS)group and 2660±844 ml/day in placebo group. After treatment with Wu-Ling-San formula group, the mean urine output level increased to 2580?b526ml/day (percentage of change, 14.1%). With placebo therapy, the mean decreased slightly to 2660.0?b850ml/day (percentage of change, -0.1%). Compare with both group, WLS group significantly increased the urine output. (student t-test, p<0.05). No patient complain of side effects, including fatigue, dizziness, impotence, musculoskeletal symptoms, or gastrointestinal disturbance. The serum liver function, renal function, electrolyte and urinary parameters were no significant change in both groups.
Conclusions: Wu-Ling-San formula is a promising adjunct to surgical and medical management of kidney stones. Compare with potassium citrate, they might be better accepted by patients than medications taken three times daily because of the lower gastrointestinal disturbance. Active therapy with Wu-Ling-San Formula did have a positive effect on the urine volume without electrolyte imbalance. Patients need ongoing education and encouragement to meet the goals of urinary output, and treatment with Wu-Ling-San Formula might help patients reach these goals.
Keywords: Calcium oxalate; Urinary Stone; Traditional Chinese medicine; Wu-Ling-San Formula; Nephrolithiasis

第一章 前言………………………………… 1
第二章 文獻探討……………………………..2
第三章 材料與方法…………………………..5
第四章 結果…………………………………..7
第五章 討論…………………………………..8
第六章 結論……………………………… 11
圖表…………………………………………….12
參考文獻……………………………………….14
英文摘要……………………………………….16
人體試驗計劃審核文件……………………….18
研究計畫審核文件…………………………….51
研究計畫期中報告…………………………….72
作者簡歷……………………………………….78
謝詞…………………………………………….80

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