與本協議作者的建議類似,我們采用多種方法調查抗逆轉錄病毒治療依從性的決定因素和患病率。然而,我們發現使用一些方法是具有挑戰性的。如果研究者提出他們的詳細計劃,說明如何處理每一種測量依從性的技術的缺點,那將是很有趣的。例如,該方案對擬議的藥片計數技術缺乏明確的規定。有兩種不同的藥片計數技術,即宣布和不宣布的藥片計數。然而,作者沒有具體說明在這項研究中使用哪種藥片計數技術。根據我們的經驗,在資源有限的情況下,使用公布的藥片數量(即,告知患者在預約日期攜帶藥物容器)可能具有挑戰性。其中一個挑戰是,該技術無法識別患者之間共用的藥物。在衛生保健可及性較好的發達國家進行的研究報告稱,家庭成員、朋友或熟人之間共用處方藥的流行率較高2-4;特別是對於使用同一類型藥物的艾滋病毒陽性伴侶來說,這可能是一個問題。 I could imagine that sharing medicine may be a common practice in Ethiopia where most of HIV patients are from lower socioeconomic background and might have difficulty to pay for transportation to collect their medicines from health care facilities.
致編輯,我們饒有興趣地閱讀了題為“心房顫動患者口服抗凝劑預防卒中患者的患者安全性和腎功能評估:(1)盡管這篇文章很好地展示了醫生在給老年人和/或腎功能下降的患者開新的口服抗凝劑達比加群和利伐沙班時遇到的困難,但我們想討論這些有問題的方法和對結果的解釋。首先,作者比較了用Cockcroft and Gault (CG)(2)公式計算的患者肌酐清除率(CrCl)與用縮寫或4變量MDRD方程(腎髒疾病飲食改變研究方程)計算的腎小球濾過率(eGFR)。然而,使用CG公式估算的CrCl以mL/min表示,而aMDRD公式計算的eGFR以mL/min/1.73 m2表示(3)。因此,計算的原始結果不能直接進行比較。這種比較需要轉換成相同的單位。如果患者的體表麵積(BSA)與1.73 m2沒有顯著差異,則後果有限。然而,沒有數據可以回答這個關鍵問題。其次,作者根據需要在aMDRD公式中使用了種族校正。然而,aMDRD方程中的校正因子已經在非裔美國人身上得到了驗證。其他研究表明,非裔歐洲人不需要相同的校正因子,甚至可能根本不需要校正因子(4)。在倫敦地區進行的研究中,患者最有可能是非裔歐洲人,而不是非裔美國人。 This point is of importance since it results in an overestimation of the eGFR of around 20% for Afro-Europeans. Thirdly, it is recommended that drug dosage adjustment must be performed according to the actual renal function of the patients, according to their actual BSA, thus in mL/min and not in mL/min/1.73 m2 (5). Indeed, in the study of MacCallum et al., the results obtained by the MDRD formula expressed in mL/min/1.73 m2 should thus not be used to determine the appropriate dosage adjustment of dabigatran and rivaroxaban. Finally, in the present study, 0.9% of the patients receiving dabigatran are considered misclassified by the aMDRD formula. Besides, the proportions of patients receiving rivaroxaban and considered misclassified or requiring a reduced dose according to the use of the MDRD formula were 0.1% and 4.5% respectively. How can the authors claim that the use of the MDRD formula gives a wrong classification? The authors outlined the fact that all biochemistry laboratories in UK provide an MDRD-derived eGFR (mL/min/1.73 m2) in keeping with national guidance. Indeed, the United- States National Kidney Foundation's Kidney Disease Outcomes Quality Initiative and the international group Kidney Disease: Improving Global Outcomes (KDOQI-KDIGO) emphasized that the CG formula was developed before the standardization of creatinine assays and cannot be re-expressed for use with standardized creatinine assays. Besides, they also reminded that the MDRD Study equation was developed in 1999 and is currently recommended for eGFR reporting in adults by the National Kidney Disease Education Program (NKDEP) and by the Department of Health in the United Kingdom (6). Therefore, considering the CG formula as a reference is not acceptable in 2013. Besides, it has been shown that, especially in the elderly (age over 65), the MDRD formula had a better accuracy and a better performance than the CG formula (7-9). In fact, 74% of the patients included in this study were older than 65, and thus the results of CG calculations are simply false. We agree however on the fact that dosing guidelines for these drugs are expressed according to the CG formula, as specified in the drugs' Summary of Product Characteristics (SmPC). It is of a major importance to keep in mind that drug dosage adjustment must be performed according to the patients' renal function, and that this latter must be estimated, if not measured, using the most appropriate method depending on the patient. In this study, given the age of the patients, the aMDRD equation is the method of choice to calculate the eGFR of the patients. Dosage adjustment must be determined according to the result of this calculation, once the result has been converted into ml/min, using the actual BSA of the patient. This is the official international recommendation from the KDIGO, publicly released 2 years ago (10). This study thus presents with several serious limitations and bias. We strongly disagree with its methodology and conclusions. It is of an utmost importance that the readers be aware of these limitations and do not take into account the conclusions of the authors, which lack robustness.
參考文獻:(1)MacCallum PK, Mathur R, Hull SA, Saja K, Green L, Morris JK, Ashman N.服用新型口服抗凝劑預防房顫卒中患者的患者安全性和腎功能評估:一項斷麵研究。beplay体育官方手机版2013年BMJ公開賽;3 (9): e003343。(2) Cockcroft DW, Gault MH.血清肌酐清除率預測。腎元。1976;16(1):31-41。(3)李建軍,李建軍,李建軍,李建軍。基於血清肌酐的腎小球濾過率預測方法研究進展。腎病研究組飲食的改變。Ann Intern Med 1999;130(6): 461 - 470。(4)王曉明,王曉明,王曉明,等。血漿肌酐、Cockcroft和MDRD在慢性腎病患者腎功能評估中的應用[j]。 Presse Med 2010; 39(3): 303-11. (5) Stevens LA, Levey AS. Use of the MDRD study equation to estimate kidney function for drug dosing. Clin Pharmacol Ther 2009; 86(5): 465-7. (6) Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med 2013; 158(11): 825-30. (7) Cirillo M, Anastasio P, De Santo NG. Relationship of gender, age, and body mass index to errors in predicted kidney function. Nephrol Dial Transplant 2005; 20(9): 1791-8. (8) Michels WM, Grootendorst DC, Verduijn M, Elliott EG, Dekker FW, Krediet RT. Performance of the Cockcroft-Gault, MDRD, and new CKD-EPI formulas in relation to GFR, age, and body size. Clin J Am Soc Nephrol. 2010; 5(6): 1003-9. (9) Froissart M, Rossert J, Jacquot C, Paillard M, Houillier P. Predictive performance of the modification of diet in renal disease and Cockcroft- Gault equations for estimating renal function. J Am Soc Nephrol 2005; 16(3): 763-73. (10) Matzke GR, Aronoff GR, Atkinson AJ Jr, Bennett WM, Decker BS, Eckardt KU, Golper T, Grabe DW, Kasiske B, Keller F, Kielstein JT, Mehta R, Mueller BA, Pasko DA, Schaefer F, Sica DA, Inker LA, Umans JG, Murray P. Drug dosing consideration in patients with acute and chronic kidney disease-a clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int 2011; 80(11): 1122-37.
引用1。馬歇爾VL, Reininger CB, Marquardt M.帕金森病在診斷不確定病例的基線臨床過度診斷:一項為期3年的歐洲多中心重複FP-CIT SPECT研究[123]。醫學雜誌2009;24:50 -8。2.[12]張建軍,張建軍,張建軍,張建軍,張建軍。基於ct的帕金森病早期診斷研究進展。中華神經科雜誌2004;61:1224-9。3.Vlaar AM, van Kroonenburgh MJ, Kessels AG,等。SPECT診斷帕金森綜合征準確性文獻薈萃分析。中國生物醫學工程學報(英文版);2007;27 - 27。 Vlaar A, Tromp SC, Weber WE, Hustinx RM, Mess WH. The reliability of transcranial duplex scanning in parkinsonian patients: comparison of different observers and ultrasound systems. Ultraschall Med. 2011 Jan;32 Suppl 1:S83-8. 5. Vlaar AM, de Nijs T, van Kroonenburgh MJ et al. The predictive value of transcranial duplex sonography for the clinical diagnosis in undiagnosed parkinsonian syndromes: comparison with SPECT scans. BMC Neurol 2008;8:42. 6. Berardelli A, Wenning GK, Antonini A, et al. EFNS/MDS-ES/ENS [corrected] recommendations for the diagnosis of Parkinson's disease. Eur J Neurol 2013;20:16-34. 7. Suchowersky O, Reich S, Perlmutter J, Zesiewicz T, Gronseth G, Weiner WJ. Practice parameter: diagnosis and prognosis of new onset Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2006;66:968- 75. 8. Holloway RG, Mooney CJ, Getchius TS, Edlund WS, Miyasaki JO. Invited Article: Conflicts of interest for authors of American Academy of Neurology clinical practice guidelines. Neurology. 2008 Jul 1;71(1):57-63. 9. Vlaar AM, Bouwmans A, Mess WH, Tromp SC, Weber WE. Transcranial duplex in the differential diagnosis of parkinsonian syndromes: a systematic review. J Neurol. 2009 Apr;256(4):530-8.
感謝您的工作,這對臨床試驗選址非常有幫助。我們想告知自2002年以來在法國完成的一項關於臨床研究吸引力的工作,並於2013年初發表在Therapie Journal上(Therapie 2013 janvier - fever;68(1):1-18)。一項新的調查正在進行中,結果將於2014年底公布。最近一次出版物的摘要是:自2002年以來,……
在2013年8月1日的回信中,作者將2012年的一項薈萃分析(1)的結論描述為誤解,該分析使用了許多相同的數據庫,並與即時研究的一位共同作者進行了研究,即隻有非常規的床上共享與SIDS風險增加有關。這樣一來,他們就忽略了自己研究的一個關鍵局限,這個局限從根本上質疑了……
應包括下列更正:
表1:平均年齡為29.8歲。應該在括號中給出SD 4.5,而不是4到5。
表3:年齡應該是25-30歲,而不是5-30歲。
此外,在摘要第8行結果部分,受過高等教育的婦女沒有在括號中給出CMV-IgG血清陽性率。應該是52.0%。
衝突啊……
我對Callander等人最近發表的題為《慢性健康狀況與貧困:使用多維貧困指標的橫斷麵研究》的文章很感興趣。雖然這項研究的質量很高,但我認為,作者們忽視了這樣一種可能性,即貧困也可能影響健康,而不僅僅是健康狀況不佳導致貧困加劇。鑒於Surv…
關於Hozumi et. al.(1)的文章,我對通過無效的數據分析得出的結論感到擔憂。在Hozumi等人提供的信息中,風險比(HR)並不是衡量關聯強度的合適指標。首先,似乎患者在隨訪期間接受了不同的治療,為了正確使用Cox回歸分析獲得HR,患者必須有r…
在他們提出的關於埃塞俄比亞西北部HIV陽性患者堅持抗逆轉錄病毒藥物治療的研究方案中,Bezabhe等人恰當地指出了埃塞俄比亞情況下長期堅持抗逆轉錄病毒藥物治療的決定因素的信息缺乏。鑒於堅持長期治療結果的重要性,了解其決定因素有助於提高向患者和醫生提供的醫療保健質量。
我們感謝Sarah Rapuch及其同事對我們的文章感興趣。
我們同意估算肌酐清除率(基於Cockcroft-Gault方程的eCrCl)和估算腎小球濾過率(基於4變量MDRD方程的eGFR)的表達單位不同,但不同意他們由此得出的結論。關於第1、2和4點,無論有利還是不利……
對於編輯,我們饒有興趣地閱讀了MacCallum等人發表的題為“在房顫患者中使用新型口服抗凝劑預防卒中的患者的安全性和腎功能評估:一項斷麵研究”的文章。(1)盡管這篇文章很好地展示了醫生在老年人和/或部分老年人中使用新型口服抗凝劑達比加群和利伐沙班時遇到的困難。
我們要感謝Mahlknecht、Seppi和Berg博士對這項設計和執行良好的研究的讚揚。
然而,它們確實對我們的研究提出了兩個主要和一個次要的批評。
首先,我們研究中的DAT-SPECT數據與臨床數據不一致,提示“患者臨床分型不理想”。其次,TCS數據令人失望,因為,在…
我們每天在一個低收入國家(馬拉維)最大的醫院的手術室工作,很高興地讀到Aveling和同事b[1]的研究。他們以一種清晰、全麵和關鍵的方式展示了在資源匱乏的情況下手術安全清單所麵臨的挑戰。
不斷經曆非洲的現實生活,我們確實認為有一個重要的……
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