基于异病同治的双石通淋胶囊治疗下尿路刺激症状疾病的临床研究OA

Objective To observe the efficacy and safety of Shuangshi Tonglin Capsules in treating chronic prostatitis and acute lower urinary tract infection,both presenting with lower urinary tract symptoms.Methods Fifty-four patients with lower urinary tract symptoms and the traditional Chinese medicine(TCM)syndrome type of dampness-heat obstruction,who visited the Urology Outpatient Clinic of Guangdong Second Hospital of Traditional Chinese Medicine from December 2023 to July 2024 were selected.These patients included 24 cases of chronic prostatitis and 30 cases of acute lower urinary tract infection.Based on whether Shuangshi Tonglin Capsules were used,they were further divided into exposed and non-exposed groups.The chronic prostatitis group comprised 18 exposed and 6 non-exposed cases;the acute lower urinary tract infection group comprised 20 exposed and 10 non-exposed cases.The chronic prostatitis exposed group received oral use of Shuangshi Tonglin Capsules,while the non-exposed group received oral use of Serenoa repens fruit extract(Sabarte).The observation period was up to 8 weeks,with a treatment course not shorter than 4 weeks.The acute lower urinary tract infection exposed group received oral Shuangshi Tonglin Capsules,while the non-exposed group received oral quinolone antibiotics,with an observation period up to 2 weeks.Changes in lower urinary tract irritation symptom scores were observed before and after treatment in both the exposed and non-exposed groups for each disease.The time for disappearance of individual lower urinary tract symptoms(frequent urination,urgent urination,dysuria,urethral burning),TCM syndrome efficacy at different time points,and the incidence of adverse reactions were compared between the exposed and non-exposed groups for each disease.Changes in the National Institutes of Health Chronic Prostatitis Symptom Index(NIH-CPSI)scores were analyzed before and after treatment for the chronic prostatitis exposed and non-exposed groups.Results(1)Regarding study attrition,in the chronic prostatitis group,6 cases dropped out from the exposed group and none from the non-exposed group,resulting in 18 cases completing clinical observation(12 exposed and 6 non-exposed).In the acute lower urinary tract infection group,3 cases dropped out from the exposed group and one from the non-exposed group,resulting in 26 cases completing clinical observation(17 exposed and 9 non-exposed).(2)Regarding TCM syndrome efficacy,for chronic prostatitis patients,the effective rates in the exposed group were higher than those in the non-exposed group at 2,4,and 8 post-treatment weeks,but the differences were not statistically significant(P＞0.05).For acute lower urinary tract infection patients,the effective rates in the exposed group were lower than those in the non-exposed group at one and 2 post-treatment week(s),but the differences were not statistically significant(P＞0.05).(3)Regarding lower urinary tract irritation symptom scores,after treatment,scores were significantly decreased compared to before treatment in both the exposed and non-exposed groups for chronic prostatitis and acute lower urinary tract infection(P＜0.01).However,no statistically significant differences were found between the groups after treatment for either condition(P＞0.05).(4)Regarding the disappearance time of individual lower urinary tract irritation symptoms,in the chronic prostatitis group,the disappearance time for frequent urination and urgent urinetion was significantly shorter in the non-exposed group than in the exposed group(P＜0.05).The disappearance time for dysuria was slightly shorter in the non-exposed group,but there was no statistically significant difference(P＞0.05).The disappearance time for urethral burning was shorter in the exposed group,but there was no statistically significant(P＞0.05).In the acute lower urinary tract infection group,the disappearance times for urinary frequency and dysuria were significantly shorter in the non-exposed group(P＜0.05).No statistically significant differences were found between groups for urgent urination and urethral burning(P＞0.05).(5)Regarding adverse reactions,the incidence in the chronic prostatitis and acute lower urinary tract infection exposed groups was 33.33%(4/12)and 17.65%(3/17),respectively.Compared to the non-exposed groups[16.67%(1/6)and 0.00%(0/9)],the differences were not statistically significant(P＞0.05).(6)Regarding NIH-CPSI scores,after 2,4,and 8 weeks of treatment,the scores were significantly decreased compared to before treatment in both the exposed and non-exposed chronic prostatitis groups(P＜0.01).However,no statistically significant differences were found between the groups at any post-treatment observation time point(P＞0.05).Conclusion The overall efficacy of Shuangshi Tonglin Capsules in treating diseases with lower urinary tract symptoms is comparable to conventional western medicine treatments.However,it presents unique advantages in reducing antibiotic use and for long-term symptom management.