Fluge & Mella Phase II cyclophosphamide study published

ljimbo423

ljimbo423

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Results: The overall response rate by Fatigue score was 55.0% (22 of 40 patients). Fatigue score and other outcome variables showed significant improvements compared to baseline.

The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders. Mean steps per 24 h increased from mean 3,199 at baseline to 4,347 at 18 months (all patients), and from 3,622 to 5,589 among responders.

At extended follow-up to 4 years 68% (15 of 22 responders) were still in remission. Patients positive for HLA-DQB1*03:03 and/or HLA-C*07:04 (n = 12) had significantly higher response rate compared to patients negative for these alleles (n = 28), 83 vs. 43%, respectively.

Nausea and constipation were common grade 1–2 adverse events. There were one suspected unexpected serious adverse reaction (aggravated POTS) and 11 serious adverse events in eight patients.


Conclusion: Intravenous cyclophosphamide treatment was feasible for ME/CFS patients and associated with an acceptable toxicity profile. More than half of the patients responded and with prolonged follow-up, a considerable proportion of patients reported ongoing remission.

Without a placebo group, clinical response data must be interpreted with caution. We nevertheless believe a future randomized trial is warranted.
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raghav

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Please dont mistake me. Can we take the side effects of cyclophosphamide
The most common side effects of this medicine include vomiting, nausea, hair loss, fever, and blood in urine. If they do not go away or get worse, tell your doctor. There may be ways of preventing or reducing these effects. It is very strong medicine and some people may develop serious side effects while taking it. This medicine may lower your ability to fight infections and lead to problems with your blood, liver or kidneys. Your doctor will advise you regular blood tests to check for these. It is advised that you drink extra fluids so that you pass more urine. This will help prevent bladder and kidney problems and keep your kidneys working well.
 
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