目的 系統評價癃閉舒膠囊聯合化學藥治療良性前列腺增生（BPH）的臨床療效和安全性。方法 檢索中國學術期刊全文數據庫（CNKI）、萬方數據庫（Wanfang Data）、中國生物醫(yī)學文獻數據庫（CBM）、維普中文科技期刊數據庫（VIP）、Cochrane Library、Embase、PubMed，檢索時限為建庫至2023年4月30日癃閉舒膠囊聯合化學藥治療BPH臨床隨機對照試驗（RCT），篩選文獻后，應用RevMan 5.4軟件進行Meta分析。結果 共納入17項RCTs，涉及患者1 997例，其中治療組1 015例、對照組982例。Meta分析結果顯示，與對照組比較，治療組可提高總有效率［RR＝1.22，95% CI（1.16，1.29），P<0.000 01］，降低國際前列腺癥狀評分［MD＝-4.27，95% CI（-4.58，-3.95），P<0.000 01］，減少膀胱殘余尿量［MD＝-8.02，95% CI（-9.58，-6.06），P<0.000 01］，縮小前列腺體積［MD＝-2.52，95% CI（-4.79，-0.25），P=0.03］，提高最大尿流率［MD＝3.15，95% CI （2.24，4.07），P<0.000 01］，降低生活質量評分［MD＝ - 0.80，95% CI（-1.35，-0.25），P=0.004］，降低中醫(yī)癥狀評分［MD＝-2.58，95% CI（-4.88，-0.29），P<0.03］，減少不良反應發(fā)生率［MD＝0.66，95% CI（0.51，0.86），P=0.002］。結論 癃閉舒膠囊聯合化學藥治療BPH療效優(yōu)異、安全性高，應用前景廣泛，但仍需高質量、大樣本、多中心RCT驗證。

Objective To systematically evaluate the clinical efficacy and safety of Longbishu Capsules combined with chemical drug for the treatment of benign prostatic hyperplasia (BPH). Methods The databases of CNKI, Wanfang Data, CBM, VIP, Cochrane Library, Embase and PubMed were searched for the randomized controlled trial (RCT) of Longbishu Capsules combined with chemical drug for the treatment of BPH from the database established to April 30, 2023. After screening the literature, RevMan 5.4 software was used to Meta-analyis. Results A total of 17 RCTs involving 1 997 patients were included, including 1 015 cases in the treatment group and 982 cases in the control group. The results of Meta-analysis showed that compared with the control group, the treatment group could improve the overall effective rate [RR = 1.22, 95%CI (1.16, 1.29), P< 0.000 01], reduce international prostate symptom score [MD = -4.27, 95%CI (-4.58, -3.95), P< 0.000 01], decrease the residual bladder urine volume [MD = -8.02, 95%CI (-9.58, -6.06), P< 0.000 01], reduced prostate volume [MD = -2.52, 95%CI (-4.79, -0.25), P= 0.03], increased maximum urinary flow rate [MD = 3.15, 95%CI (2.24, 4.07), P< 0.000 01], and decreased quality of life scores [MD = - 0.80, 95%CI ( - 1.35, - 0.25), P= 0.004], reduced TCM symptom scores [MD = - 2.58, 95%CI (- 4.88, - 0.29), P< 0.03], and reduced the incidence of adverse events [MD = 0.66, 95%CI (0.51, 0.86), P= 0.002]. Conclusion The combination of Longbishu Capsules with chemical medicine for BPH has excellent efficacy, high safety and wide application prospects, but high-quality, large sample and multicentre RCT validation is still needed.

R287.3

中國中醫(yī)科學院科技創(chuàng)新工程重大攻關項目（CI2021A02205）