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Air Quality Criteria for Lead Volume II of II - (NEPIS)(EPA) - US ...

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AX6-115<br />

Table AX6-4.3 (cont’d). Renal Effects <strong>of</strong> <strong>Lead</strong> in the Patient Population<br />

Reference, Study<br />

Location, and<br />

Period Study Description Pb Measurement Findings, Interpretation<br />

Asia (cont’d)<br />

Lin et al. (2001b)<br />

Study location and<br />

date not provided;<br />

authors from Taiwan<br />

101 patients with CRI (defined as serum creatinine<br />

between 1.5 and 3.0 mg/dL).<br />

67 with CRI and gout.<br />

34 with CRI only.<br />

Eligibility criteria included no known history <strong>of</strong> Pb<br />

exposure, certain diagnoses, and medications. CRI must<br />

have preceded gout diagnosis.<br />

Randomized chelation trial<br />

30 participants with CRI, gout, and EDTA-chelatable Pb<br />

levels between 80.2 and 361 μg/72 hrs randomized to<br />

either a treatment group receiving 1 gram EDTA iv per wk<br />

<strong>for</strong> 4 wks (N = 20) or to a control group who received<br />

glucose in normal saline iv.<br />

Mean blood Pb<br />

5.4 µg/dL (CRI and gout)<br />

4.4 µg/dL (CRI only)<br />

Mean EDTA-chelatable Pb<br />

138.1 µg/72 hrs (CRI and<br />

gout)<br />

64.2 µg/72 hrs (CRI only)<br />

(p < 0.01)<br />

In 101, EDTA-chelatable Pb higher in patients with<br />

CRI and gout compared to those with CRI only.<br />

EDTA-chelatable Pb, but not blood Pb, was<br />

associated positively with serum urate and negatively<br />

with daily urate excretion, urate clearance, and<br />

fractional urate excretion.<br />

Randomized chelation trial<br />

The two groups had similar uric acid, renal function,<br />

and Pb measures pre-chelation. In the treated group,<br />

mean EDTA-chelatable Pb declined from 159.2 to<br />

41 μg/72 hrs; mean serum urate decreased from 10.2<br />

to 8.6 mg/dL (% change compared to the control<br />

group = !22.4 [95% CI: !46.0, !1.5]; p = 0.02), and<br />

mean urate clearance increased from 2.7 to<br />

4.2 mL/min (% change compared to the control group<br />

= 67.9 [95% CI: 12.2, 121.2]; p < 0.01). Daily and<br />

fractional urate excretion were also significantly<br />

different between the two groups. Mean measured<br />

creatinine clearance increased from 50.8 to<br />

54.2 mL/min (% change compared to the control<br />

group = 8.0 [95% CI: !0.4, 20.1]; p = 0.06).

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