Abstract: Objective: To investigate the efficacy and safety of the α-adrenergic receptor (α2AR) blocker terazosin combined with chlormethadione in the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). METHODS: One hundred and sixty-eight patients with CP/CPPS were randomly divided into 3 groups: 58 patients in the terazosin group, 38 patients in the chlormethadone group, and 72 patients in the terazosin+chlormethadone group, and each group received drug treatment for 4 weeks. The National Institutes of Health Chronic Prostatitis Symptom Index (N IH2CPSI) score was used as the efficacy index to evaluate the efficacy and adverse drug reactions in each group. Results: 159 patients completed 4 weeks of treatment and received final evaluation, including 55 patients in the terazosin group, 35 patients in the clomazepam group, and 69 patients in the terazosin+clomazepam group. the total N IH2CPSI scores of the three groups decreased by 7. 90, 5. 92, and 8. 92 points before and after treatment, respectively, with significant differences compared with those before treatment (P < 0. 05). There was a significant difference (P < 0. 05) in the total score decrease in the terazosin+chlormethadone group compared with the terazosin and chlormethadone groups. Adverse drug reactions included postural hypotension (17.1% in the terazosin group and 15.4% in the terazosin+chlormethadone group), ejaculatory disorders (3.4% in the terazosin group only), and lethargy, fatigue, and anorexia (18.5% in the chlormethadone group and 12.6% in the terazosin+chlormethadone group). A total of 9 cases were discontinued due to adverse events, including 3 cases in the terazosin group (5.2%), 3 cases in the chlormethadone group (7.9%), and 3 cases in the terazosin+chlormethadone group (4.2%). Conclusion: Both terazosin and chlormethiazide can effectively relieve the symptoms and improve the quality of life of patients with CP/CPPS, and their combined treatment is more effective than single treatment. The pathogenesis of CP/CPPS is still not clear, and the treatment lacks specificity, and the effect is often short-lived[ 2 ], and the prolonged disease causes anxiety, depression and other psychological changes, The prolonged disease may lead to anxiety, depression and other psychological changes, which may further aggravate the disease. Therefore, it has become a hot topic of research to explore specific treatment methods with definite efficacy. In this study, we investigated the efficacy and safety of trazodiazepine, chlormethiazide and their combination in the treatment of CP/CPPS using a randomized controlled approach. 1. Data and methods 1. 1 Clinical data The subjects were patients with CP/CPPS who visited our urological male clinic from March 2008 to September 2008. Inclusion criteria: ① Age 20-50 years; ② National institutes of health2chronic p rostatitis symp tom index (N IH2CPSI) scores ≥1 for the first and second items; ③ Duration of disease ≥3 months and actively seeking (3) Those who have been actively seeking treatment for more than 3 months; (4) Those who have not been treated previously and have not taken α2-adrenergic receptor (α2AR) blockers and sedative-hypnotic drugs; (5) Those whose chronic bacterial prostatitis has been ruled out by urine routine, urine culture, prostate massage fluid routine and four-cup method. The exclusion criteria were: ① those who had used α2AR blockers and sedative-hypnotic drugs in the past 2 weeks, history of acute urinary tract infection, serious cardiovascular disease, history of allergy to α2AR blockers and sedative-hypnotic drugs; ② those who did not accept the grouping scheme. According to the above criteria, 168 patients were enrolled. 1. 2 Methods 168 patients were divided into 3 groups according to the randomization scheme (grouped according to the order of consultation 1, 2 and 3), namely, the terazosin group (58 patients), the chlormezanone group (38 patients) and the combined treatment group (72 patients), which were treated with terazosin, chlormezanone and terazosin + chlormezanone, respectively. Ltd. (lot no. 0804009), 1 mg orally once a night, and if there was no significant adverse reaction after 2 d, it was changed to 2 mg orally once a night; clomazone (trade name: Fenaluron) was manufactured by Dandong Medical Creation Pharmaceutical Co, Patients in all three groups were also given phytochemical preparation Pulsatilla (Sernitone) 0. 375 mg orally, 2 times/d, as the basic medication. The N IH2CPSI scores were assessed before and after treatment. The pain score of N IH2CPSI was used as the main index, the quality of life score of N IH2CPSI was used as the secondary index, and the other indexes included the total score of N IH2CPSI, urinary symptoms and adverse drug reactions. 1. 4 Statistical analysis The database was established and statistical analysis was performed with SPSS11. 5 software package, and the whole process was completed by a uniform professional to ensure the quality of data processing. The t-test for paired measures of total N IH2CPSI scores and pain scores, and the χ2 test for paired counts of voiding symptoms and quality of life scores were performed before and after treatment in each group; ANOVA with a completely randomized design was performed on the total N IH2CPSI scores and pain scores after treatment in the three groups, followed by two-by-two multiple comparisons of multiple sample means; the scores of voiding symptoms and quality of life scores after treatment in the three groups were The rank sum test for multiple sample comparisons was performed on the urinary symptom scores and quality of life scores in the 3 groups after treatment. A two-sided test was performed, and P < 0. 05 was considered statistically different. 2. Results: 168 patients were unbalanced due to untimely follow-up and missed visits. 7 patients dropped out for various reasons (including missed visits), and 159 patients completed 4 weeks of treatment and received final evaluation. The mean age, total N IH2CPSI score, and pain score before treatment in the three groups enrolled in the study were analyzed by ANOVA in a completely randomized design, and the χ2 test for the duration of disease and the rank sum test for multiple sample comparisons of voiding symptoms and quality of life scores were not significantly different (P > 0. 05), indicating that the baseline conditions of patients in the three groups were basically the same and there was no statistical difference overall. The ages of patients in the terazosin, clomazepam group, and combination therapy groups were ( 32. 8 ± 6. 9), ( 33. 2 ± 6. 9), and (32. 9 ± 6. 1) years, respectively, and the total N IH2CPSI scores were ( 24. 05 ± 3. 02), (23. 43 ± 3. 58), and (23. 93 ± 3. 30), respectively, and the pain scores were (12. 18 ± 1. 71 ), (12. 14 ±1. 68), (12. 16 ±2. 06), median urinary symptom scores of 5, 4 and 5, and median quality of life scores of 7, 7 and 7, respectively. The results are detailed in Table 1. 2. 1 Comparison of the efficacy of the terazosin group, the clomazepam group and the combination treatment group Compared with the pre and post treatment, the total N IH 2CPSI score decreased from (24. 05 ± 3. 02) to ( 16. 15 ± 3. 25) in the terazosin group.
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