前列泌尿栓治療慢性前列腺炎多中心雙盲陽性藥對照試驗研究

高筱松 高文喜 賀菊喬 段客杰 李蘭群 張亞強

【摘要】目的：評價前列泌尿栓治療慢性前列腺炎的有效性和安全性。方法：多中心、隨機、雙盲、陽性藥對照臨床試驗設(shè)計。480例濕熱瘀血蘊阻型慢性前列腺炎患者按3∶1的比例隨機分為治療組、陽性對照組。治療組360例，應(yīng)用前列泌尿栓，肛內(nèi)給藥，1粒/次，1次/d。安慰劑對照組120例，應(yīng)用前列安栓，肛內(nèi)給藥，1粒/次，1次/d。療程為4周。以美國國立衛(wèi)生院前列腺炎癥狀評分（NIH-CPSI）、慢性前列腺炎中醫(yī)證候評分作為主要療效評價指標。結(jié)果：（1）治療4周后，治療組和對照組CPSI評分分別為（11.88±5.28）分和（13.79±5.68）分，各組相對于基線的變化均有統(tǒng)計學意義（P<0.05）。治療組和對照組治療前后CPSI評分差值分別為（9.17±5.59）和（7.58±5.16），治療組降幅大于對照組（P<0.05）。治療組降低NIH-CPSI評分療效優(yōu)于對照組。（2）治療4周后，治療組和對照組中醫(yī)證候評分分別為（8.12±4.78）分和（9.04±4.52）分，治療組與對照組比較無統(tǒng)計學差異（P>0.05）；治療組和對照組治療前后差值分別為（9.32±5.12）和（8.93±5.23），治療組降幅與對照組比較無統(tǒng)計學差異（P>0.05）。（3）治療組愈顯率為49.17%，對照組為34.17%，扣除中心效應(yīng)，總愈顯率治療組療效優(yōu)于對照組（P<0.05）。結(jié)論：前列泌尿栓治療慢性前列腺炎安全、有效。

【關(guān)鍵詞】 前列泌尿栓；慢性前列腺炎；臨床療效評價；NIH-CPSI；中醫(yī)證候評分

The efficacy and safety of Qianlie Miniao suppository in the treatment of chronic prostatitis： a multi-center， randomized， double-blind， positive-controlled clinical trialGAO Xiaosong1，GAO Wenxi2， HE Juqiao3， DUAN Kejie4， LI Lanqun5， ZHANG Yaqiang1△. 1. Urology Department，Guanganmen Hospital of China Academy of Chinese Medical Sciences， Beijing 100053， China； 2.Urology Department， Hubei Traditional Chinese Medicine Hospital， Wuhan 430061， Hubei， China； 3. Department of Surgery of Traditional Chinese Medicine， The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine， Changsha 410007， Hunan， China； 4. Urology Department，The First Affiliated Hospital of Traditional Chinese Medicine， Tianjin 300052， China； 5. Andrology Department，China-Japan Friendship Hospital， Beijing 100029， China

【Abstract】Objectives： To evaluate the efficacy and safety of Qianlie Miniao suppository in the treatment of chronic prostatitis. Methods： A multi-central， randomized double-blind， positive-controlled clinical trial was conducted. A total of 480 patients diagnosed as chronic prostatitis with the type of damp-heat & blood stasis were divided into 2 groups with the ratio of 3/1： the trial group treated with Qianlie Miniao suppository for 4 weeks （anal，1 grains ， once a day） and the control group given Qianliean suppository in the same way. The efficacy was evaluated by the NIH chronic prostatitis symptom index （NIH-CPSI） and the syndrome index of Chinese medicine for prostatitis （SI-CM）. Results： ① After 4 weeks of treatment， the CPSI scores in treatment group and the control group were （11.88±5.28） and （13.79±5.68） respectively， which were significantly decreased compared to the baseline （P<0.05）. The difference in CPSI scores between post-treatment and baseline in treatment group and control group were （9.17±5.59） and （7.58±5.16）， more significant in the treatment group. ②=2＼*GB3 After 4 weeks of treatment， syndrome index of Chinese medicine in treatment group and the control group were （8.12±4.78） and （9.04±4.52） respectively. No significant difference was found between two groups （P>0.05）. The difference in syndrome index of Chinese medicine between post-treatment and baseline in treatment group and control group were （9.32±5.12） and （8.93±5.23） respectively， without significant difference between the two groups （P>0.05）. ③ The cured and significant improvement rate was 49.17% in treatment group， which was significant higher that the 34.17% in control group （P<0.05）. Conclusions： Qianlie Miniao suppository is effective and safe in the treatment of chronic prostatitis.

【Key words】Qianlie Miniao suppository； Chronic prostatitis； Clinical evaluation； NIH chronic prostatitis symptom index （NIH-CPSI）； The syndrome index of Chinese medical for prostatitis （SI-CM）

【中圖分類號】R697+.33【文獻標志碼】A

慢性前列腺炎是男性泌尿生殖系統(tǒng)的常見病，國外報道的發(fā)病率為2%～16%[1]，國內(nèi)約為6%～32%[2]，高于國外水平。這可能與人種、環(huán)境、教育程度等有關(guān)[3]。男性中約有50%的人在不同時期受到這種疾病的困擾[4]。由于本病發(fā)病率高，病因不明，癥狀多樣，病程遷延，給男性的身體及心理健康都帶來很大的危害，嚴重影響患者的生活質(zhì)量[5]。為使前列泌尿栓治療慢性前列腺炎的安全性和有效性得到進一步評價，我們在廣安門醫(yī)院、中日友好醫(yī)院、湖北中醫(yī)學院一附院、天津中醫(yī)學院一附院、湖南中醫(yī)學院一附院5所醫(yī)院同時進行了前列泌尿栓治療慢性前列腺炎的多中心、隨機、雙盲、與前列安栓對照的臨床研究，結(jié)果報告如下。