Comparing the effectiveness of two-week and three-week treatment with prednisolone in immune thrombocytopenic purpura patients of Khansari Hospital

Dissertation:

Dissertation for receiving a specialized doctorate degree in internal medicine

Persian abstract

Title: Comparison of the effectiveness of two-week and three-week treatment with prednisolone in immune thrombocytopenic purpura patients of Khansari Hospital

Introduction: ITP is an acquired disorder characterized by immune-mediated destruction of platelets or inhibition of the release of platelets from megakaryocytes. The usual treatment for ITP includes prednisolone at a dose of 1 mg/kg/day. Usually, steroids are given to patients for about 3-6 weeks. Steroids have many side effects. Prednisolone increases platelets after 2-3 weeks, and considering that there is no need to taper after 2 weeks of prednisolone treatment, while after 3 weeks, tapering should be done, which increases the risk of complications. In this study, the effectiveness of two-week and three-week prednisolone treatment in ITP patients has been compared. Methodology: This study is a randomized clinical trial. 66 patients with ITP who visited the clinic of Khansari Hospital in Arak were randomly placed on a 2-week and 3-week treatment regimen of prednisolone (1 mg/kg/day) and the patients' platelet count and complications, especially hypertension (HTN) and diabetes (DM), were monitored and compared.

Results: At the end of the treatment period, the average platelet count in Two treatment groups (two-week treatment and three-week treatment), at the level of error a = 0.05, there was no statistically significant difference (P = 0.748).

Side effects were 15.2% in the two-week treatment protocol and 18.2% in the three-week treatment protocol, although statistically at the error level a = 0.05, the distribution of complications in the two treatment groups is the same. (P = 1.000).

In both treatment groups separately, there was no statistically significant difference between the average age in the two categories of response to treatment and non-response to treatment (P = 0.068 in two-week treatment and P = 0.789 in three-week treatment). Also, at the level of error a = 0.05, there was no statistically significant relationship between gender and response to treatment in two-week and three-week treatment (P = 0.673 and P = 1.000, respectively).

Conclusion: According to the results and findings of this study, especially considering the lack of significant difference in the average platelet count at the end of the 2-week and 3-week treatment and Considering the higher percentage of side effects in patients who received three-week treatment, it seems that the two-week treatment of ITP is as efficient and effective as the three-week treatment, while reducing the treatment period by one week and consequently reducing the side effects will not only bring the cooperation and better reception of the patient, but also reduce the waste of financial resources and imposing costs on him. However, in order to generalize these results to other patients with ITP, studies with a larger sample size are recommended.

Key words: prednisolone, immune thrombocytopenic purpura

Introduction

1-1- Statement of the problem

Immune thrombocytopenic purpura (its other name is idiopathic thrombocytopenic purpura) is an acquired disorder that only 2 criteria are needed to diagnose this disease:

only thrombocytopenia is present and other findings in the complete blood cell count (CBC) and The peripheral blood slide should be normal.

If there are no other clinical conditions with similar manifestations such as systemic lupus erythematosus (SLE), antiphospholipid syndrome, and chronic lymphoid leukemia (Cll), patients with the above conditions are considered to be suffering from secondary immune thrombocytopenia (6).

Etiology of ITP It is not clear, but it seems to be due to genetic and acquired factors (6, 7, and 8).

Some cases of ITP are related to previous viral infections, probably anti-viral antibodies.

Some cases of ITP are related to previous viral infections, it is possible that the produced anti-viral antibodies cross-react on platelet glycoprotein IIIa/IIb. Infection with HIV, HCV, CMV, and VZV may be associated with such antibodies and thus cause secondary ITP(9).

ITP is a common acquired bleeding disorder that is more common in children than adults(10).

The annual prevalence of ITP in adults is 22 cases per million people per year. (11).

The prevalence of ITP was 39 to 44 cases per million people per year in men and women, respectively (12).

The prevalence of ITP was mentioned in another article as 50-100 cases per million people per year (13). In many reports, it has been shown that about 70% of ITP patients are women and 72% of these women are under 40 years of age, but in the Danish study, the gender difference in the prevalence of ITP is only in people under 60 years of age (11).

There is no clear difference in the clinical symptoms of ITP between patients, although the onset of ITP may be acute and sudden, most cases have an insidious onset (14). Bleeding in symptomatic patients can range from petechiae and easy bruising to severe bleeding, and the symptoms of thrombocytopenia bleeding are mostly in the form of mucosal skin bleeding (14).

In patients with thrombocytopenia caused by ITP, petechiae, purpura, easy bruising, epistaxis, gum bleeding and menorrhagia are common, severe gastrointestinal bleeding and obvious hematuria are rare, and intracerebral hemorrhage (ICH) is common. It is very uncommon (14) Clinical manifestations of thrombocytopenia are very age-related, older patients may have severe bleeding symptoms such as gastrointestinal bleeding and ICH due to conditions such as HTN (15).

There is no gold standard test that can confirm the diagnosis of ITP, the diagnosis is by ruling out other causes of thrombocytopenia(16).

Only patients Patients with severe thrombocytopenia (platelets less than 20,000) should be treated due to the risk of bleeding (17). Treatment usually includes prednisolone at a dose of 1 mg/kg/day, the first step of treatment in ITP is prednisolone, and steroids help prevent bleeding and reduce platelet destruction (18). The duration of the initial treatment with prednisolone is determined by the platelet count response, if the platelet count normalizes quickly, prednisolone is tapered and stopped (17).

Usually, steroids are given to patients in about 3-6 weeks. Normally, with the administration of steroids, an increase in platelets occurs within 2-3 weeks(19).

In another article, it is mentioned that about 66% of patients respond partially or completely to steroids and most of these responses are seen at the end of the first week(20).

Glucocorticoid toxicity is one of the most common iatrogenic causes of diseases associated with It is a chronic inflammatory disease. Some of the side effects of glucocorticoids include:

Skin and soft tissue complications such as purpura, eye complications such as cataracts, cardiovascular complications such as hypertension (HTN), digestive complications such as gastritis, renal complications such as hypokalemia, urinary-genital complications (Gu) such as amenorrhea, bone complications such as osteonecrosis, muscle complications such as myopathy, neurological complications such as depression, endocrine complications such as diabetes and Infectious complications are like increasing the risk of typical infections (21).

The toxicity of glucocorticoids is related to the average dose and the duration of their use(22).

So considering the side effects of steroids and considering the effect of prednisolone in increasing platelets after 2-3 weeks of its administration and considering that after 2 weeks of treatment with prednisolone There is no need to taper, while tapering should be done after 3 weeks, which increases the risk of complications, we decided to do a comparison between 2-week and 3-week treatment of prednisolone in ITP.

Platelets are probably produced by the blood flow of the capillary sinuses from megakaryocytes.