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  • Title: [Randomized control multi-center clinical study of mycophenolate mofetil and cyclophosphamide in the treatment of connective tissue disease related interstitial lung disease].
    Author: Zhang G, Xu T, Zhang H, Ye S, Wang Q, Zhang L, Lei Y, Luo R, Zhang X.
    Journal: Zhonghua Yi Xue Za Zhi; 2015 Dec 01; 95(45):3641-5. PubMed ID: 26849923.
    Abstract:
    OBJECTIVE: To investigate the efficacy and safety of mycophenolate mofetil (MMF) in the treatment of connective tissue disease-related interstitial lung disease (CTD-ILD). METHODS: A total of 60 patients with CTD-ILD, confirmed by high resolution computer tomography (HRCT), were enrolled from five clinical centers from July 2010 to July 2014. In addition to the basic glucocorticoid treatment, patients received intravenous cyclophosphamide (Group A) or oral MMF (Group B) for one year. Pulmonary function was assessed at the 3, 6, 12 months. All adverse events were recorded and efficacy and safety were evaluated at the end of this trial. RESULTS: Total 60 patients were enrolled, each group had 30 patients. 5 patients withdrew voluntarily from each group, 2 and 3 patients died in group A and B, respectively. Total 45 patients completed this trial. Neither lung function, HRCT nor adverse events had differences between the two groups or within group (P>0.05). When the analysis was done among patients with forced vital capacity (FVC) ≤ 75% and forced expiratory volume in one second (FEV1)% ≤ 75%, there were significantly statistical differences in FVC and FEV1 at 6th month compared with prior treatment in group A (both P<0.05). And there were significant increase in FVC and FEV1 at 12 months in group B (both P<0.05). But there was no statistical difference between the two groups. For the patients with diffusion capacity for carbon monoxide (DLco) ≤ 65%, there were significant increase in group A at 3, 6 and 12 months (P<0.01, P<0.05, P<0.05, respectively). but no significant increase was found in patients on MMF. And there was no difference between the two groups. No statistical difference existed in survival rate between these two groups (P>0.05). CONCLUSIONS: MMF has comparative effect as cyclophosphamide in the remission or stability of lung function and HRCT manifestations of CTD-ILD patients. MMF is generally well-tolerated, but its efficacy in maintenance therapy and long-term safety remains to be clarified.
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