Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction

* Project Title**: Clinical Study on the Role of Inflammatory Markers in Patients with Erectile Dysfunction * Research Objective**:

To explore the changes in the levels of inflammatory markers in patients with erectile dysfunction (ED), providing scientific evidence for the diagnosis and treatment of ED.

**Study Design**: Retrospective controlled study

* Total Sample Size**:

150 cases * Case Selection**: * Inclusion Criteria for Case Group**:

1. Males with regular sexual activity; 2. Age between 18 and 55 years; 3. Complete medical records; 4. Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score < 22. Cases with an IIEF-5 score < 22 are diagnosed with ED, while the rest are diagnosed as non-ED. * Inclusion Criteria for Control Group**:

1. Males with regular sexual activity; 2. Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected; 3. Complete medical records; 4. Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22. * Exclusion Criteria**:

1. Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis; 2. Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i); 3. Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections; 4. Patients with poor rapid eye movement (REM) sleep quality. * Efficacy Assessment**: * Observational Indicators**:

Peripheral blood count, including monocyte count, neutrophil count, lymphocyte count, and biochemical markers such as C-reactive protein.

**Safety Evaluation Indicators**: Reproductive system damage.

**Statistical Methods**: Data analysis will be performed using R software (version 4.1.6). All statistical tests will be two-sided, with P values < 0.05 considered significant. Normality of data will be assessed using the Shapiro-Wilk test. Data with normal distribution will be presented as mean ± standard deviation, and data with non-normal distribution will be presented as median [interquartile range]. Baseline characteristics will be compared using independent sample t-tests, Mann-Whitney U tests, or chi-square/Fisher's exact tests. Multivariate analysis will be conducted using logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI). Missing data will be handled using appropriate methods based on the data missing mechanism. To control Type I errors, Bonferroni correction will be applied during multiple comparisons. All analysis procedures and code will be documented in detail to ensure the reproducibility of the analysis.