前列舒通胶囊联合坦索罗辛治疗慢性前列腺炎的Meta分析及GRADE质量评价

Meta-analysis and GRADE Quality Evaluation of Qianlie Shutong Capsules Combined with Tamsulosin in the Treatment of Chronic Prostatitis

目的系统评价前列舒通胶囊联合坦索罗辛治疗慢性前列腺炎(Chronic prostatitis,CP)的临床疗效。方法在线检索中国知识资源总库(CNKI)、万方数据、维普网、Sinomed、PubMed、Web of Science、Cochrane Library、Embase数据库建库至2023年4月1日期间前列舒通胶囊联合坦索罗辛治疗CP的随机对照研究,采用Cochrane风险偏倚评估工具对文献进行质量评价,运用RevMan 5.3软件进行Meta分析,并对结局指标进行GRADE质量分级。结果共纳入10篇RCT,涉及1013例受试者。Meta分析结果显示:相较于单用坦索罗辛,前列舒通胶囊联合坦索罗辛治疗CP能够显著提高临床有效率[RR=1.23,95%CI(1.16~1.30),P<0.00001],降低NIH-CPSI评分[MD=-5.09,95%CI(-6.84~-3.34),P<0.00001],降低NIH-CPSI疼痛症状评分[MD=-3.17,95%CI(-4.12~-2.23),P<0.00001]、NIH-CPSI排尿症状评分[MD=-2.11,95%CI(-2.55~-1.67),P<0.00001]、NIH-CPSI生活质量评分[MD=-1.79,95%CI(-1.87~-1.71),P<0.00001]、前列腺液白细胞计数[MD=-2.73,95%CI(-4.13~-1.34),P<0.00001],且联合用药不会增加不良反应发生。GRADE证据分级显示:前列舒通胶囊联合坦索罗辛质量在有效率和NIH-CPSI生活质量评分指标为中级,NIH-CPSI评分、NIH-CPSI疼痛症状评分、NIH-CPSI排尿症状评分和前列腺液白细胞计数指标为低级。结论与单用坦索罗辛治疗比较,前列舒通胶囊联合坦索罗辛可以显著改善CP患者临床疼痛、排尿不适等临床症状,且不增加不良反应的发生,但仍需更多高质量、大样本、多中心的RCT予以验证。

Objective To systematically evaluate the clinical efficacy of Qianlie Shutong capsules combined with tamsulosin in the treatment of chronic prostatitis(CP).Method Randomized Controlled Trials(RCTs)of Qianlie Shutong capsules combined with tamsulosin for the treatment of CP were searched in the databases of China Knowledge Infrastructure(CNKI),Wanfang Data,Wipu.com,Sinomed,PubMed,Web of Science,Cochrane Library,and Embase from the database establishment to April 1,2023.The Cochrane Risk of bias assessment tool was used to evaluate the quality of the literature,RevMan 5.3 software was used to perform Meta-analysis,and GRADE quality grading was performed for outcome indicators.Results A total of 10 RCTs involving 1013 subjects were included.The results of the Meta-analysis showed that compared with tamsulosin treatment alone,Qianlie Shutong capsules combined with tamsulosin for treating CP significantly improved the clinical efficiency[RR=1.23,95%CI(1.16~1.30),P<0.00001〗and reduced the NIH-CPSI score[MD=-5.09.95%CI(-6.84~-3.34),P<0.00001],NIH-CPSI pain symptom scores[MD=-3.17,95%CI(-4.12~-2.23),P<0.00001],NIH-CPSI voiding symptom scores[MD=-2.11,95%CI(-2.55~-1.67),P<0.00001],NIH-CPSI quality of life score[MD=-1.79,95%CI(-1.87~-1.71),P<0.00001]and prostate fluid white blood cell count[MD=-2.73,95%CI(-4.13~-1.34),P<0.00001].Moreover,the combination did not increase the incidence of adverse events.GRADE evidence grading showed that the combination of Qianlie Shutong capsules had an intermediate level of effectiveness and improvement in the quality of as assessed by NIH-CPSI score index.This combination demonstrated low levels in terms of NIH-CPSI score,NIH-CPSI pain symptom score,NIH-CPSI voiding symptom score,and prostate fluid leukocyte count index.Conclusion Compared with tamsulosin treatment alone,Qianlie Shutong capsules combined with tamsulosin can significantly improve clinical symptoms such as pain and urinary discomfort in CP patients,without increasing the occurrence of adverse effects.However,further validation through high-quality,large-sample and multicenter RCTs is still necessary.