Influence of Methylprednisolone Pulse Therapy on Liver Function in Patients with Graves’ Orbitopathy

Table 4

Studies that evaluated the influence of IVMP on liver function in patients with moderate-to-severe Graves’ orbitopathy and DON.

Study	Scheme of treatment	Number of patients	ALI morbidity (%)	ALI mortality (%)	Comments
(1) Current study	GO: 6 × 0.5 g + 6 × 0.25 g of IVMP on a weekly schedule vs.	GO: 49	Mild: GO—2 (4%), DON—2 (11%)	GO: 0	ALI—ALT concentration > 300 U/L
			Moderate: GO—0, DON—4 (21%)		ALT increase—mild (40–100 U/L), moderate (100–300 U/L), severe (>300 U/L)
	DON: 3 × 1.0 g on consecutive days	DON: 19	Severe: ALI—0	DON: 0
(2) Le Moli et al. [28]	GO: 6 × 0.5 g + 6 × 0.25 g of IVMP on a weekly schedule vs.	GO: 14	0	0	Lack of ALI criterion. Patients with AST and/or ALT above the upper limit—40 U/L. Comparison of the effect of total GCs between the two groups of patients including those with prednisolone therapy.
	DON: 3 × 1.0 g of IVMP on consecutive days in the first week, repeated during the second week, followed by oral prednisolone in a tapering dose; CD of steroids 8.45 g	DON: 13	0	0
(3) Marino et al. [17]	GO: CD of IVMP 3.0–24 g	GO: 800	7 (0.8%)	3 (0.3%)	Lack of ALI criterion
(4) Wichary and Gasińska [30]	GO: CD of IVMP 8 g in 4 weeks	GO: 30	0	0	Lack of ALI criterion
(5) Bartalena et al. [14]	GO: CD of IVMP 2.25–7.47 g	GO: 159	0	0	ALI—4-fold increase of aminotransferases
(6) Curro et al. [27]	DON: CD of IVMP 3.0–10.5 g	DON: 24	0	0	ALI—4x the upper limit of normal
(7) Eguchi et al. [18]	GO and DON: 1 g/d of IVMP for 3 consecutive days/week, repeated for 3–6 cycles, followed by a tapering dose of oral prednisolone. The daily dose of MP was reduced to 0.5 g except in cases with DON	GO and DON: 175	Mild 62 (35%),	0	ALT increase—mild (40–100 U/L), moderate (100–300 U/L), severe (>300 U/L)
			Moderate 10 (6%),
			Severe 7 (4%)
(8) Sisti et al. [16]	GO 4 different treatment protocols; CD of IVMP 1.2–30 g	GO: 1076	14 (1.3%)	1 (0.09%)	ALI—ALT > 300 IU/L
(9) Sisti et al. [15]	GO 4 × 15 mg/kg for 4 weeks and 8 × 7.5 mg/kg for 8 weeks; CD 3.8–13.3 g	GO: 376	4 (1.06%)	0	ALI—ALT > 300 IU/L

GO—moderate-to-severe Graves’ orbitopathy; DON—dysthyroid optic neuropathy; ALI—acute liver injury; IVMP—intravenous methylprednisolone; CD—cumulative doses; ALT—alanine aminotransferase; AST—aspartate aminotransferase.