台灣醫療政策還是民粹式--政府官員無權對醫療專業任意論斷

[李誠民]

美國是HIV感染極高的國家,社會也普遍接受這群人,所以長期透析患者也相當普遍;
反觀台灣,對HIV感染仍存有相當大歧見,就以血液透析中心而言,VDRL B C肝都會檢查,但HIV就不一定了,因為不論是台灣腎臟醫學會年度報告或政府官方的長期透析患者的Survy都缺少這一塊,;
而衛生署醫政處官員,在發生台大器官捐贈者為HIV感染事件中,卻輕易說出:,台灣器官捐贈法修法時,可考慮將HIV-infected recipients納入,;至少目前腎臟移植上,在世界先進國家是有爭議的議題,台灣卻毫無經驗與實例,這不同於器官移植者捐贈者,目前是絕對排除在外的,很奇怪的是衛生署是否清楚事實,確任意發言,台灣的醫療政策不就是民粹式的制定?!提供以下四篇文獻供參考:(都是台大發生器官捐贈者為HIV-infected的事件時,已出刊的 文獻)

1.Outcomes of Kidney Transplantation in HIV-Infected Recipients
Peter G. Stock, M.D., Ph.D.(UC San Francisco), Burc Barin, M.S., Barbara Murphy, M.D., Douglas Hanto, M.D., Ph.D., Jorge M. Diego, M.D., Jimmy Light, M.D., Charles Davis, M.D., Emily Blumberg, M.D., David Simon, M.D., Ph.D., Aruna Subramanian, M.D., J. Michael Millis, M.D., G. Marshall Lyon, M.D., Kenneth Brayman, M.D., Doug Slakey, M.D., Ron Shapiro, M.D., Joseph Melancon, M.D., Jeffrey M. Jacobson, M.D., Valentina Stosor, M.D., Jean L. Olson, M.D., Donald M. Stablein, Ph.D., and Michelle E. Roland, M.D. for the HIV-TR Investigators
N Engl J Med 2010; 363:2004-2014November 18, 2010

2.Outcomes of Kidney Transplantation in HIV-Infected Recipients
Michelle M. Estrella, MD, MHS
Mohamed G. Atta, MD, MPH
Hamid Rabb, MD⁎
________________________________________
Johns Hopkins University School of Medicine, Baltimore, Maryland


American Journal of Kidney Diseases - Volume 58, Issue 1 (July 2011)

“This trial had several limitations. Follow-up was short, with only a minority of patients having reached 3 years posttransplant. This hampers the ability to (1) evaluate the impact of higher acute rejection rates on longitudinal kidney function, (2) assess the long-term cancer risk associated with prolonged immunosuppression and exposure to antirejection medications, (3) determine the risk of cardiovascular disease in patients already at risk because of HIV-related endothelial dysfunction and metabolic derangements from immunosuppressive and antiretroviral medications, and (4) examine the clinical implications of transient HIV-1 viremia. The investigators did not report on additional factors that may influence allograft survival (eg, delayed graft function, cold ischemia time, and panel-reactive antibody titer). Although this study represents the largest prospective study to date, its overall small sample size limits interpretation of subgroup comparisons (eg, hepatitis C serostatus groups). With the uncertainty of actual CNI exposure due to the complex pharmacokinetic interactions of these drugs with antiretroviral medications, data for pathologic findings consistent with CNI nephrotoxicity were lacking. Although sirolimus was substituted in those with CNI nephrotoxicity, the number of affected participants was not reported.”價格?--cost-effective?台灣衛生署有沒搞清楚現況?卻任意發言
Ps:CNI:Calcineurin inhibitors

Outcomes of Kidney Transplantation in HIV-Infected Recipients--Reply
N Engl J Med 2011; 364:683-684February 17, 2011

3. Lode J. Swinnen, M.D.
Johns Hopkins University School of Medicine, Baltimore, MD Erik M. van Maarseveen, Pharm
" Many physicians treating patients with HIV and advanced chronic kidney disease initially favored recruitment of only patients with an overall poor prognosis for studies on the feasibility of kidney transplantation. Stock et al. focused on patients with optimal immunologic factors and good HIV control, both to reduce individual risk and to increase the likelihood of an interpretable study result. That approach required courage, and the authors are to be commended for having pursued it. However, it is important to recognize that those stringent eligibility criteria also limit the generalizability of the study results".

4.Arjan D. van Zuilen, M.D.
Tania Mudrikova, M.D., Ph.D.
University Medical Center Utrecht, Utrecht,
" the NetherlandsDosing of tacrolimus in transplant recipients is ideally based on a 12-hour area under the curve (AUC). In clinical practice, trough levels are usually monitored, assuming a correlation with AUCs.1 However, the pharmacokinetic curve of tacrolimus in HIV patients receiving protease inhibitors does not show the normal peak-and-trough pattern but rather resembles a flat line with a half-life of up to 20 days as a result of extremely strong inhibition of CYP3A.2 Therefore, and based on our findings, trough levels of tacrolimus in patients receiving protease inhibitors should be higher (17.5 ng per milliliter at 1 month and 10 ng per milliliter at 1 year after transplantation) than the trough levels reported by Stock et al"

Author/Editor Response
We concur with the comments by Swinnen that expansion of the eligibility criteria required for kidney transplantation in HIV-infected recipients in our study (CD4 counts ≥200 per milliliter, undetectable HIV RNA, and a history of only treatable opportunistic infections) may have resulted in poorer outcomes than we have reported. However, substantial numbers of HIV-infected patients meet these criteria and continue to be denied access to transplantation. These conservative criteria should serve as a starting point, with further expansion dependent on refining both immunosuppressive regimens to minimize the high rejection rates observed in this trial as well as strategies for controlling HIV viremia.
With regard to improvements in immunosuppressive regimens, the observations by van Maarseveen et al. are important. We have previously noted the difficulties in dosing cyclosporine, tacrolimus, and sirolimus in patients receiving protease inhibitor−based antiretroviral regimens.1,2 However, attempts to escalate doses of calcineurin inhibitors have resulted in frequent drug toxicities related to nephrotoxicity from calcineurin inhibitors, neurotoxicity (predominantly tremors) from calcineurin inhibitors, and the diabetogenic toxic effects of both the calcineurin inhibitors and protease inhibitors. In addition, analyses have not shown an association between transplant rejection and use of protease inhibitors (hazard ratio, 1.33; 95% confidence interval, 0.76 to 2.35; P=0.32), although these analyses are limited in power and such associations may be seen with larger sample sizes. During the development of this protocol, health care providers with HIV-infected patients who were transplant recipients were hesitant to switch antiretroviral drugs that resulted in the excellent control of HIV required for this study. Antiretroviral options that were not based on protease inhibitors, especially the use of integrase inhibitors, chemokine receptor 5 inhibitors, or both, may facilitate more optimal dosing of calcineurin inhibitors. Indeed, a recent early study suggested that the use of integrase inhibitor−based antiretroviral drugs with avoidance of protease inhibitors greatly facilitated the ability to reach appropriate levels of calcineurin inhibitors after kidney transplantation in five HIV-infected recipients.3 Moving forward, selection of antiretroviral agents should be individualized and take into account drug resistance, drug interactions, and tolerability.卻不提CNI Nepgrotoxicity?