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Chelation Therapy for Patients with Elevated Body Lead Burden and Progressive Renal Insufficiency: A Randomized, Controlled Trial

Ja-Liang Lin, MD; Huei-Huang Ho, MD; and Chun-Chen Yu, MD
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From Chang Gung Memorial Hospital, Taipei, Taiwan, Republic of China.


Ann Intern Med. 1999;130(1):7-13. doi:10.7326/0003-4819-130-1-199901050-00003
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Background: Nephropathy is known to occur in persons exposed to high levels of lead, but the question of whether long-term exposure to low levels of environmental lead is associated with impaired renal function remains controversial.

Objective: To examine whether chelation therapy slows the progression of renal insufficiency in patients with mildly elevated body lead burden.

Design: Randomized, controlled trial.

Setting: Academic medical center in Taiwan.

Patients: 32 patients with chronic renal insufficiency (serum creatinine level > 132.6 µmol/L [1.5 mg/dL] and < 353.8 µmol/L [4.0 mg/dL]), mildly elevated body lead burden (>0.72 µmol [150 µg] of lead per 72-hour urine collection and < 2.90 µmol [600 µg] of lead per 72-hour urine collection [EDTA mobilization tests]), and no history of heavy lead exposure.

Intervention: The treatment group received 2 months of chelation therapy; the control group received no therapy.

Measurements: The reciprocal of serum creatinine (1/Cr) was used as an index of progressive renal insufficiency.

Results: Rates of progression of renal insufficiency were similar in the treatment group and the control group during a 12-month baseline observation period (1/Cr, 0.000054 L/µmol per month compared with 0.000046 L/µmol per month; P > 0.2). After the 2-month treatment period, improvement in renal function was greater in the treatment group than in the control group. In the 12 months after the treatment period, renal insufficiency progressed more slowly in the treatment group than in the control group (1/Cr, 0.000033 ± 0.00038 L/µmol per month compared with 0.000045 ± 0.000038 L/µmol per month; P = 0.0030).

Conclusion: Chelation therapy seems to slow the progression of renal insufficiency in patients with mildly elevated body lead burden. This implies that long-term exposure to low levels of environmental lead may be associated with impaired renal function in patients with chronic renal disease.

Figures

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Figure 1.
Flow diagram of patient recruitment and follow-up.

To convert serum creatinine level from µmol/L to mg/dL, divide by 88.40; to convert body lead burden from µmol/L to mg/dL, divide by 48.26. BP = blood pressure; CGN = chronic glomerulonephritis; DN = diabetic nephropathy; NSAID = nonsteroidal anti-inflammatory drug; SLE = systemic lupus erythematosus.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Plots of the reciprocal of serum creatinine (mean2 SEs) versus time in the treatment group (n=14) (triangles) and the control group (n=15) (circles) during the study.

± The patients in the treatment group received EDTA chelation therapy from month 12 to month 14.

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