[논문]HIV 감염 환자에서 고활성 항레트로바이러스 요법을 포함한 신기능 장애 위험인자 연구

여지영; 신형식; 진범식; 이유정

HIV 감염 환자에서 고활성 항레트로바이러스 요법을 포함한 신기능 장애 위험인자 연구
Factors Associated with Renal Dysfunction, Including Highly Active Antiretroviral Therapy in Korean HIV-Infected Patients 원문보기

한국임상약학회지 = Korean journal of clinical pharmacy, v.22 no.2, 2012년, pp.95 - 102

여지영 (국립중앙의료원 약제과) , 신형식 (국립중앙의료원 감염내과) , 진범식 (국립중앙의료원 감염내과) , 이유정 (숙명여자대학교 임상약학대학원)

초록
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HIV 치료를 위한 강력한 항바이러스 약물요법이 널리 사용됨에 따라 HIV에 감염된 상태에서 신장질환 발생 위험성을 지닌 채 오랜 기간 생존하는 환자들이 증가하고 있다. 본 연구는 국립중앙의료원 감염병 센터를 내원한 만18세 이상의 HIV 감염 환자를 대상으로 HIV 감염 환자에게 신기능 장애를 유발하는 위험인자를 평가하고자 환자군 대조군 연구를 후향적으로 실시하였다. 2006년 1월부터 2011년 3월까지 5년 3개월 동안 신기능이 저하된 모든 HIV 감염 환자를 환자군으로 하며, 정상 신기능을 가진 HIV 감염 환자들 중 대조군을 무작위로 선정하여 환자군과 대조군을 1:2의 비율로 하였다. 환자군과 대조군을 비교해 만성신질환을 유발하는 위험인자를 평가하기 위한 분석변수로 성별, 연령, CD4+ 세포수, 혈중 바이러스 수, HAART 56일 이상 여부, 당뇨병과 C형 간염을 선정하였다. 또한 추가적으로 개별 antiretroviral 약물들 사용과 신기능이 얼마나 관련되어 있는지 알아보기 위해 각각의 약물과 eGFR의 상관관계를 분석하였다. 환자군은 CD4+ 세포수가 < $200{\times}10^6$ cells/l 인 군이 7.7배(OR: 7.7; 95% CI, 1.8-32.9) 단백뇨가 있는 환자의 경우 7.8배(OR: 7.8; 95% CI, 1.6-37.8) 더 유의하게 만성신질환 발생위험이 높았다. 개별 antiretroviral 약물들과 eGFR의 상관관계를 분석한 결과, lamivudine 이 eGFR 과 약한 음적 상관관계를 보이는 것으로 나타났으며(r = -.211, p < .05), 다른 약물들의 경우 통계적으로 유의한 값을 보이지 않았다. 이번 환자군-대조군 연구는 HIV 감염 환자들이 만성 신질환으로 발전하는데 여러 인자들의 역할에 대해 평가하고자 하였다. 여러 변수들을 평가해 본 결과, 만성 신질환 환자들의 경우 CD4+ 세포수가 < $200{\times}10^6$ cells/l 이거나 단백뇨를 동반한 경우가 통계적으로 유의하게 많았다.

주제어

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문제 정의

³⁾ Because many studies have shown racial differences in HIV-infected patients’ renal function, the risk factors associated with CKD in Korean HIVinfected patients must be identified to better understand HIV-infected patients in Korea. The objective of this study was to identify risk factors, particularly in the context of HAART, for CKD in patients with HIV in Korea.
This case-control study aimed to identify the risk factors that cause CKD in HIV-infected patients. Logistic regression analyses of all the risk factors in the study revealed that the risk of developing CKD was significantly greater for patients with CD4+ cell counts of <200×10⁶cells/l and for patients with proteinuria.

제안 방법

Additionally, to determine whether individual drugs influence renal function, this study analyzed the correlation between each drug and the eGFR, but it did not attempt to evaluate whether each of the individual drugs is a risk factor with a direct effect on CKD or the extent of its effects. A recent study of antiretroviral drugs has reported that age, atazanavir treatment, and tenofovir treatment are each significantly related to distal tubular dysfunction.
After which, only those variables with p < 0.05 were retained for multivariate comparisons by using backward stepwise logistic regression to identify risk factors that might be associated with CKD in patients who were HIV positive.
All patients are entered into the Order Communication System (OCS) of the NMC, which is an electronic database with pertinent laboratory, diagnostic, procedural, pharmaceutical, vital sign, and demographic data. We used the OCS data for this study, and the most recent data were selected.
An additional limitation of this study is that it was conducted retroactively and consisted of selecting a specific study period and reviewing target patient information and medical records, unlike the approaches used in previous studies. In addition, because the number of target patients was small, it was difficult to draw a statistically significant conclusion when analyzing the differences in the characteristics between the patient group and the control group or when analyzing the risk factors.
The estimates of the relative risk of CKD are expressed as odds ratios (ORs) and 95% confidence intervals (CIs). In addition, bivariate correlation testing was performed to assess the strength of associations between individual antiretroviral agents and eGFR. A p-value of less than 0.
In this study, the correlation between each of the drugs and the eGFR was analyzed to identify the relationships between individual drugs (abacavir sulfate, lamivudine, lamivudine/zidovudine complex, lopinavir/ritonavir complex, atazanavir, efavirenz, ritonavir, raltegravir, and didanosine) and renal function.
We used the OCS data for this study, and the most recent data were selected. The following data were included in this study: age, gender, CD4+ cell count, HIV RNA level, antiretroviral therapy, presence of proteinuria, presence of diabetes, presence of hypertension, and hepatitis C infection status. This study was carried out in accordance with the principles enunciated in the Declaration of Helsinki, and approval to conduct this study was obtained from the NMC institutional review board.

데이터처리

Student’s t-test was used to compare continuous variables.
The data were analyzed using Fisher’s exact test or the chi-squared test for categorical variables.

성능/효과

7-fold) greater risk of developing CKD. However, when only the risk factors that gave significant results in the logistic regression analysis were analyzed, there was an increase in the risk of developing CKD, but it was not statistically significant (OR: 3.2; 95% CI, 1.0-10.3, p = 0.05). For patients with proteinuria, the risk of developing CKD was 4.
01). Patients with a history of hypertension had a higher probability of developing kidney disease regardless of the medication taken, but this result was not statistically significant (patients using ACEI or ARB; OR, 5.2; 95% CI, 1.0- 26.4, p = 0.05; patients using non-ACEI or ARB: OR, 2.7; 95% CI, 0.2-35.0, p = 0.45). Having received more than 56 days of HAART and the highest plasma viral load category were found to be unrelated to the risk of developing CKD.

후속연구

²⁴⁾ Thus, risk factor analyses of drugs vary slightly depending on the race and the characteristics of the patient group in each study. Because the drugs that are known to reduce renal function, such as tenofovir and indinavir, have not yet been used in NMC, there has not yet been an opportunity to evaluate them, and additional studies will be necessary after tenofovir and indinavir are introduced in NMC.
This study is significant despite its limitations in its use of Koreans as subjects; there has not been sufficient research that targets Asians on the risk factors for developing CKD or the drugs used for HIV-infected patients, and no such study has ever used Koreans as subjects. The results of this study are expected to contribute to the prevention and management of CKD in HIV-infected patients. To validate these results and make them applicable, prospective studies on a larger number of target patients should be undertaken in the future.

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