Research Methods

(1)

Misdiagnosis Association & Society, Seattle, WA, USA

Keywords

PemphigusTherapy-resistantRituximabWhite blood cell (WBC)Hemoglobin (Hgb)Platelet (Plt)Aspartate aminotransferase (AST)Alanine aminotransferase (ALT)UreaCreatinine (Cr)AgeGenderInvolved sitesPrevious therapiesUnderlying diseaseDisease duration

Investigation Method

Thirty-nine therapy-resistant pemphigus patients in Razi Hospital in Tehran, Iran, who had received rituximab from 2008 to 2012, were considered for inclusion in this retrospective cohort study. Data was collected before and after rituximab treatment. The variables included lab indices—white blood cell (WBC) , hemoglobin (Hgb) , platelet (Plt) , aspartate aminotransferase (AST) , alanine aminotransferase (ALT) , urea , creatinine (Cr)—and age, gender , involved sites , previous therapies, underlying disease, and disease duration . Test sheets associated to before and after rituximab application, containing WBC, Hgb, Plt, AST, ALT, urea, and Cr, were compared.

Type of Study

This study is a retrospective cohort study conducted on the pemphigus patients resistant to therapies who had received rituximab in 2008–2012.

Studied Population

The study included 39 therapy-resistant pemphigus patients who were treated with rituximab in Razi Hospital, Tehran, Iran, in 2008–2012.

Inclusion Criteria

Pemphigus patients who did not respond to the initial therapies (therapy-resistant pemphigus) were then treated with rituximab.

Exclusion Criteria

The following types of patients were excluded from the study:

1.

Patients with no required tests before application of rituximab in their file
2.

Patients with no follow-up after receiving rituximab
3.

Patients whose first follow-up, after the last dosage of rituximab, was greater than 1 month.

Sampling Method

According to the available files, files of all the patients who had received rituximab from 2008 to 2012 were considered for inclusion.

Data Collection

The data collection tool included a checklist divided into two parts: one for the data before and one for the data collection after rituximab treatment. The variables included WBC , Hgb, Plt, AST, ALT , urea , and Cr, as well as age, gender, involved sites , previous therapies, underlying disease, and disease duration.

Project Implementation

After studying the files of therapy-resistant pemphigus patients, the patients who had the required data in their files were entered into the research. Rituximab treatment was defined as receiving four doses of 500 mg for 4 weeks, along with normal saline. Test sheets associated to before and after rituximab application, containing WBC, Hgb, Plt, AST, ALT, urea, and Cr, were compared. (The maximum time interval between the second test sheet and the last dosage of rituximab could be 1 month.)

Data Analysis

Finally, the finalized cases that had the inclusion criteria were analyzed in Stata statistical software (StataCorp, Texas, USA) in terms of variations in WBC, Hgb , Plt, AST, ALT, urea , and Cr after application of rituximab as the major variable and investigation of minor variables.

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