云南白药胶囊减少经尿道前列腺电切术中出血的临床研究

The effect of Yunnan Baiyao on reduction of intra-operative bleeding of the patients undergoing transurethral resection of prostate

目的评价云南白药胶囊在减少经尿道前列腺电切术(TURP)术中出血的有效性和安全性。方法采用多中心、随机、双盲、安慰剂对照临床研究。符合人选标准的患者术前随机接受云南白药胶囊500 mg 或安慰剂治疗,每天4次,共3 d。比较两组患者的术中出血总量、出血指数(单位切除重量出血量)和出血强度(单位手术时间出血量),并对安全性进行评估。结果前列腺增生患者 TURP 手术前应用云南白药,可以减少患者手术中出血总量,降低出血指数和出血强度,其中出血总量在试验组和对照组分别为(147±144)ml 和(182±157)ml(P<0.05)。当切除腺体重量≥20g 时,术前应用云南白药,可以使出血指数、出血强度和出血总量均显著降低(P<0.05),出血总量在试验组和对照组分别为(146±116)ml 和(220±207)ml(P<0.05),出血强度分别为(2.4±1.8)ml/min 和(3.6±3.7)ml/min(P<0.01),出血指数分别为(4.7±4.6)ml/g 和(7.1±8.3ml/g(P<0.05)。在应用云南白药的患者中,围手术期没有出现血栓性疾病以及其他不良事件。结论术前口服云南白药胶囊可以明显减少 TURP 手术中的失血量,无明显副反应,患者耐受性好。

Objective To investigate the effect of Yunnan Baiyao on reduction of intra-operative bleeding of the patients undergoing transurethral resection of prostate （ TURP）. Methods A randomized placebo-control double-blind multi-center trial was conducted. 203 patients with benign prostate hyperplasia （BPH） , aged 50-80, who were to undergo TURP were randomly divided into 2 groups： Yunnan Baiyao group, given 500 mg Yunnan Baiyao four times daily since the third day before the operation for 3 days, and placebo group, given empty capsules for 3 days. The amount of intra-operative bleeding, bleeding index and bleeding intensity were compared. The side effect of Yunnan Baiyao was also evaluated. Results The amount of intra-operative bleeding of the Yunnan Baiyao group was 147 ml ± 144 ml, significantly less than that of the control group （ 182 ml ± 157 ml, P 〈 0. 05 ）. The amount of intra-operative bleeding of the per protocol （PP） population in the Yunnan Baiyao group （n =58） was 146 ml ± 116 ml, significantly less than the PP population in the control group （n = 66） （220 ml ± 207 ml, P = 0. 0361 ）. When the weight of the resected prostate tissue was more than 20 gram, the amount of intraoperative bleeding, bleeding index, and bleeding intensity of the ITT population in the Yunnan Baiyao group （ n = 60 ） were all significantly lower than those of the ITT population in the control group （ n = 68 ） （ all P 〈 0. 05 ） ; the bleeding intensity of the PP population in the Yunnan Baiyao group was 2. 4 ml/min ± 1.8 ml/min, significantly lower than that of the PP population in the control group （ 3.6 ml/min ± 3.7 ml/min, P = 0. 0072 ） ; the bleeding index of the PP population in the Yunnan Baiyao group was 4.7 ml/g ±4. 6 ml/g, significantly lower than that of the PP population in the control group （ 7. 1 ml/g ± 8. 3 ml/g, P = 0. 025 ）. No side effect was found in the 2 groups. Conclusion Yunnan Baiyao is effective on reducing the amount of intraoperative bleeding of TURP without side effect.