中西醫合治腎病之臨床療效及安全性分析
林裕峯
行政院衛生署雙和醫院(委託臺北醫學大學興建經營)
隨著高齡化世紀的到來，尿毒症之盛行率及好發率亦逐年增加，在台灣僅就單純花費於尿毒症患者透析治療之健保費用每年即高達10億元新台幣以上，然而上述此種現象並不只侷限於台灣，在全世界其他先進國家亦如此；會有此種現象，皆因對於尿毒症相關之致病機轉不甚了解及無根本治療所致。在許多引發尿毒症病因中，以慢性腎絲球腎炎及糖尿病腎病變是最為常見的二種，各約莫佔了1/3。就目前所知，腎絲球腎炎大部分是因為免疫反應過度激活所引起，必須依賴抑制發炎反應之藥物來治療。這些藥物具有之副作用，且部分原發性腎絲球腎炎病患對這類治療效果不彰；至於糖尿病腎病變之致病機轉則牽涉到相當複雜的全身代謝反應，其治療上除了血糖及血壓的控制外，現今針對腎臟功能衰竭仍無有效之治療方法。因此，另尋具有治療腎絲球腎炎及糖尿病腎病變（以下合稱腎炎）之中、西藥物實為刻不容緩之事。
中藥是五千年來中國醫療文化之累積，在人體許多疾病上皆已被證實具有療效，然而中藥在腎臟疾病之使用上則仍處於渾沌未明時期，甚至許多文獻已證明中草藥是具腎毒性，更因為馬兜鈴酸（Aristolochilic acid）事件，因而有人提出中藥腎病變（Chinese Herb Nephropathy）之名稱，使得中藥幾乎與腎毒性劃上等號。截至目前為止，全世界在中藥與腎炎上之運用並未被提出具療效之藥劑，且二者間之關係及療效亦無被使用科學方法加以佐證。為了重新定位中藥在腎臟疾病之角色，本研究著重在中藥與腎臟疾病之探討。收集臨床慢性腎病變（Chronic Kidney Disease，簡稱CKD）之糖尿病及非糖尿病第一期～第五期個案，給予臨床使用之中藥複方治療，考證驗治中藥治療腎炎之療效，來證明中藥在腎炎治療之角色。希望藉由本臨床試驗之完成，開發臨床腎臟疾病之另一治療途徑，並推動中藥產業發展及維護國民健康。
先前本團隊結合了中、西醫師、統計及藥學專家，採跨院合作之研究模式，已利用個案報告表及問卷調查表，同時選擇中醫臨床上常用於改善腎臟發炎、調理腎臟之藥物-知柏地黃丸、濟生腎氣丸，成功建立中、西醫合併治療流程；初步結果證實上述中藥可能具調理腎臟之療效，但因治療期程較短，故再次結合本研究團隊，將臨床個案數增加、延長治療期程，並增加另一複方中藥人蔘養榮湯。本研究將使用上述三種複方中藥為主，合併西藥之治療，評估個案之療效及藥物安全性，期間針對個案作定期追蹤並收集其血液尿液，這些檢體除了接受臨床上常規性血液、尿液生化檢查外，亦將會利用相關之生物活性分析技術，來證明中藥在腎炎治療之角色，及評估其藥物安全性。綜合上述而言，本計畫之主旨及預期完成之目標如下述：
本計畫預期完成之總目標：
(1) 評估知柏地黃丸、濟生腎氣丸對慢性腎病未接受透析前之療效、安全性，並找出最適合之中西藥合併治療之比例。
(2) 評估人蔘養榮湯對慢性腎臟病以接受血液透析之療效、安全性，並找出最適合之中西藥合併治療之比例。
全面性分析CKD stage1～5個案，建立腎病之中西合治平台，提升中醫臨床服務品質並提升中醫與現代醫學互動及合作。
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With the arrival of aging century, the prevalence and incidence of uremia has increased year after year. In Taiwan, the dialysis treatment for uremic patients costs NT $300 billion dollars more per year; however, this problem not only happens to Taiwan but also to other developed countries in the world. The reason of such a phenomenon is because the less knowledge for the pathogenesis of uremia and the less effective treatment. Two of the most common causes of uremia, chronic glomerulonephritis (GN) and diabetic nephropathy (DN), have accounted for about two thirds of the disease. As known, the majority of glomerulonephritis is caused by hyperactive of immune reactions, which leads to the major treatment for GN relying on immunosuppressive agents. However, these drugs not only have side effects but are ineffective to some primary GN. As for DN, its pathogenesis involves a complex metabolic reaction of the body, and its treatment in addition to blood glucose and blood pressure control, there is no effective treatment to kidney failure. Therefore, it is urgency to find the new treatments for GN and DN (hereafter referred to chronic kidney diseases, CKD).
Chinese herbal medicine (CHM) is a medical culture in China for five thousand years. Up to present, a number of diseases in human beings have been confirmed with the effect on CHM. However, the role of CHM on CKD is still in the unknown period. Many of the literature of CHM has proved to be a renal toxicity, and furthermore because of aristolochic acid event, which was made of Chinese herbs nephropathy (CHN), making CHM almost equate nephrotoxicity. In order to re-define the role of CHM in CKD, the CHM which proved to have the therapeutic effect on human diseases were chosen to undergo clinical trials. The effective CHM on CKD will be determined.
For redefine the role of CHM on CKD, our study group integrates Chinese and Western doctors, statistics and pharmaceutical experts. In our previous study, we have suggested知柏地黃丸 and濟生腎氣丸showed the effect of anti-inflammation in kidney diseases, and also established the flow chart of combination therapy western and Chinese medicine. However, that study was short and limited cases. Here, we proposed this new study using the same research team to improve our previous results. This research will use the three main compound Chinese medicine, 知柏地黃丸、濟生腎氣丸and人蔘養榮湯. Those treatment combined Western medicine to assess the efficacy and drug safety one the CKD cases. Series of blood and urine were collected regularly during study. Basic biochemistry data and the markers referred to anti-inflammation were investigated to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety.
The final goals of the plan:
1. To determine the therapeutic effective of 知柏地黃丸 and濟生腎氣丸 on the cases of CKD before dialysis and establish the standard flow chart of combination therapy western and Chinese medicine.
2. To determine the therapeutic effective of 人蔘養榮湯 on the CKD under hemodialysis and establish the standard flow chart of combination therapy western and Chinese medicine.
3. To enhance the interaction and cooperation between Chinese and Western medicine.
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