| 摘要: | 隨著人口高齡化，慢性腎臟病在台灣的發生率及盛行率逐年上升，在醫療費用花費方面也是逐年增加，2021年台灣洗腎人數9.4萬人，在慢性腎病花費新台幣562億元，且腎功能下降常會伴隨著多項合併症，包括高血壓、貧血、營養不良、骨病變、神經病變並且降低生活品質，然而目前的西藥治療中，如類固醇可能造成肥胖、水腫、骨質疏鬆、消化性潰瘍、感染風險增加等；免疫抑制劑，如cyclophosphamide、mycophenolate mofetil可能使白血球低下，增加感染風險；血管張力素轉換?抑制劑(Angiotensin Converting Enzyme Inhibitor, ACEi)、第二型血管張力素受體拮抗劑(Angiotonin Receptor Blocker, ARB)可能造成高血鉀、血管神經性水腫，因此尋找替代療法對於治療慢性腎臟病是相當重要的。
本研究採用人體臨床試驗方式收案，屬開放性、單一中心、前瞻性、平行、有對照組之介入性試驗，將針對第三期至第四期慢性腎臟病的患者，以1:1比例隨機分成兩組，各30位受試者，實驗組為補陽還五湯組，使用中藥補陽還五湯3克，一天服用三次，及一般西藥治療持續12週；對照組為西藥組，接受一般西藥治療持續12週。追蹤項目包括腎絲球過濾率(Estimated glomerular filtration rate, eGFR)、糖化血色素(Glycated Hemoglobin, HbA1c)、低密度脂蛋白(Low Density Lipoprotein-Cholesterol, LDL)、收縮壓(Systolic blood pressure, SBP)、舒張壓(Diastolic blood pressure, DBP)、尿蛋白及尿液肌酸酐比值(Urine Protein to Urine Creatinine ratio, UPCR)、以及EQ-5D生活品質量表(European quality of life 5 dimensions index)。藉由追蹤丙胺酸轉胺?(Glutamic Pyruvic Transaminase, GPT)、糖化血色素以及鉀離子(Potassium, K)來進行安全性評估。
本研究截至2023年5月底共納入20位個案，其中16位受試者完成試驗，1位受試者失去追蹤(lost to follow-up)，3位受試者持續進行試驗。
試驗結果分析，補陽還五湯組加傳統西藥組與傳統西藥組組間之檢驗數據比較分析，兩組eGFR及EQ-5D-5治療前後具顯著差異；補陽還五湯組加傳統西藥組組內治療前後之檢驗數據比較分析，eGFR、LDL、EQ-5D-4、EQ-5D-5治療前後具顯著差異；傳統西藥組組內治療前後之檢驗數據比較分析，EQ-5D-4治療前後具顯著差異；補陽還五湯組加傳統西藥組且有高血壓共病，組內治療前後之檢驗數據比較分析，eGFR、LDL、EQ-5D-4、EQ-5D-5治療前後具顯著差異；傳統西藥組且有高血壓共病，組內治療前後之檢驗數據比較分析，EQ-5D-4治療前後具顯著差異。試驗過程並無不良反應發生。
從本試驗得知，使用補陽還五湯合併傳統西藥治療在12週內改善eGFR以及改善抑鬱及焦慮的生活品質比單純使用傳統西藥更有治療效果，但在改善UPCR、HbA1c、SBP、DBP則無顯著差異。
Population ageing caused high incidence and prevalence of chronic kidney disease. The medical expenses increased yearly. In 2021, the number of hemodialysis patients in Taiwan were 94 thousand and the medical expenses for chronic kidney disease caused 56.2 billion dollars. The decreased renal function usually accompanied with hypertension, anemia, malnutrition, renal osteodystrophy and neuropathy, which resulted in reducing quality of life. However, the clinical application of chronic kidney disease drugs may have some side effects. The steroid may lead to obesity, edema, osteoporosis, peptic ulcer, infection. The immunosuppressive agents such as azathioprine, cyclophosphamide, and mycophenolate mofetil may cause neutropenia and increase the infection risk. The angiotensin-converting enzyme inhibitor and angiotonin receptor blocker may cause hyperkalemia, and angioedema. Therefore, finding a complementary therapy for chronic kidney disease is very important.
This study was an open-label randomized controlled clinical trial containing two parallel groups and was conducted at a single medical institution. Sixty outpatients with stage three to stage four chronic kidney disease were randomly allocated to the Bu Yang Huan Wu Tang plus traditional western medicine group or traditional western medicine group. The Bu Yang Huan Wu Tang group received three grams Bu Yang Huan Wu Tang with traditional western medicine therapy for twelve weeks. The traditional western medicine group received traditional western medicine therapy for twelve weeks. The outcome measures were estimated glomerular filtration rate, glycated hemoglobin, low density lipoprotein-cholesterol, systolic blood pressure, diastolic blood pressure, urine protein and urine creatinine ratio and European quality of life-5 dimension. Adverse events were also recorded by glutamic pyruvic transaminase, glycated hemoglobin, and potassium.
This study conducted twenty participants until May, 2023. Sixteen participants complete the whole trial. One participant lost to follow-up. Three participants were under the trial.
Compared the data between the Bu Yang Huan Wu Tang plus traditional western medicine group and the traditional western medicine group, there were significant improvements in eGFR and EQ-5D-5, statistically. In the Bu Yang Huan Wu Tang plus traditional western medicine group, there were statistically improvements in eGFR, LDL, EQ-5D-4, and EQ-5D-5 before and after treatment. In the traditional western medicine group, there was a statistically significant improvements in EQ-5D-4 before and after treatment. In the subgroup analysis of the Bu Yang Huan Wu Tang plus traditional western medicine group with comorbid hypertension, there were significant improvements in eGFR, LDL, EQ-5D-4, and EQ-5D-5 before and after treatment, statistically. In the subgroup analysis of the traditional western medicine group with comorbid hypertension, there was a significant improvement in EQ-5D-4 before and after treatment, statistically. No adverse reactions occurred during the trial.
In this study, we could find out Bu Yang Huan Wu Tang combination with traditional western medicine showed better therapeutic effects within 12 weeks in improving eGFR and enhancing the quality of life in terms of depression and anxiety than taking traditional western medicine alone. However, there were no significant differences in improving UPCR, HbA1c, SBP, and DBP. |
