复方蓝棕果片治疗前列腺增生电切术术后膀胱刺激证患者的临床研究

Clinical trial of compound sabal berry tablet in the treatment of patients with bladder discomfort after electrocision of benign prostatic hyperplasia

目的观察复方蓝棕果片对前列腺增生(BPH)电切术术后膀胱刺激证(BD)的效果。方法将BPH经尿道前列腺电切术患者分为试验组和对照组。对照组术后当天给予盐酸坦索罗辛缓释胶囊,每次0.2mg,每天1次,口服;试验组在对照组的基础上给予复方蓝棕果片,每次0.5g,每天3次,口服。2组均治疗4周。比较2组患者的临床疗效、前列腺症状、膀胱过度活动症状、尿动力学变化[最大逼尿肌压力(MDP)、最大尿流率(Qmax)、膀胱最大容量(MCC)]、BD发生情况、炎症反应指标[白细胞介素-6(IL-6)、IL-17、肿瘤坏死因子-α(TNF-α)],并进行安全性评价。结果对照组入组45例,试验组入组49例。治疗后,试验组总有效率为95.92%(47例/49例),对照组为82.22%(37例/45例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组国际前列腺症状评分(IPSS)分别为(7.62±1.38)和(10.49±2.05)分,膀胱过度活动症评分(OABSS)分别为(2.78±0.64)和(3.92±0.72)分,MDP分别为(32.09±5.12)和(28.32±4.69)cmH2O,Qmax分别为(18.42±2.53)和(15.37±2.18)mL·s^(-1),MCC分别为(289.46±36.81)和(261.42±33.54)mL,BD发生率分别为18.37%(9例/49例)和37.78%(17例/45例),血清IL-6分别为(11.34±2.09)和(15.03±2.56)pg·mL^(-1),血清IL-17分别为(30.12±4.73)和(37.57±5.01)pg·mL^(-1),血清TNF-α分别为(82.06±12.95)和(98.63±15.70)pg·mL^(-1)。试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头晕、皮疹、恶心、腹泻,对照组的药物不良反应主要有头晕、皮疹、腹泻。对照组和试验组的总药物不良反应发生率分别为10.20%(5例/49例)和8.89%(4例/45例),在统计学上差异无统计学意义(P>0.05)。结论复方蓝棕果片治疗BPH经尿道前列腺电切术患者能减轻术后前列腺症及膀胱过度活动症状,改善尿动力学,减少BD发生,缓解炎症反应。

Objective To observe the effects of compound sabal berry tablet on bladder discomfort(BD)after electrocision of benign prostatic hyperplasia(BPH).Methods Patients with BPH undergoing transurethral resection of the prostate were divided into treatment group and control group.The control group was treated with tamsulosin hydrochloride sustained-release capsules(0.2 mg,qd)on the day after surgery,while treatment group was treated with compound sabal berry tablets(0.5 g,tid)on basis of control group.All patients were treated for 4 weeks.The clinical curative effect,prostate symptoms,overactive bladder symptoms,changes of urodynamics[maximum detrusor pressure(MDP),maximum urine flow rate(Qmax),maximum cystometric capacity(MCC)],occurrence of BD,inflammatory response indexes[interleukin-6(IL-6),IL-17,tumor necrosis factor-α(TNF-α)]and safety were compared between the two groups.Results There were 45 cases in control group and 49 cases in treatment group.After treatment,total response rate of treatment group was higher than that of control group[95.92%(47 cases/49 cases)vs 82.22%(37 cases/45 cases)],the differences were statistically significant(P<0.05).After treatment,international prostate symptom scores(IPSS)in treatment group and control group were(7.62±1.38)and(10.49±2.05)points;overactive bladder symptom scores(OABSS)were(2.78±0.64)and(3.92±0.72)points;MDP were(32.09±5.12)and(28.32±4.69)cmH_(2)O;Qmaxwere(18.42±2.53)and(15.37±2.18)mL·s-1;MCC were(289.46±36.81)and(261.42±33.54)mL;incidence of BD were 18.37%(9 cases/49 cases)and 37.78%(17 cases/45 cases);levels of serum IL-6 were(11.34±2.09)and(15.03±2.56)pg·mL^(-1);levels of serum IL-17 were(30.12±4.73)and(37.57±5.01)pg·mL^(-1);levels of serum TNF-αwere(82.06±12.95)and(98.63±15.70)pg·mL^(-1).The differences were statistically significant in the above indexes between the treatment group and control group(all P<0.05).The adverse drug reactions in treatment group were mainly on dizziness,rash,nausea and diarrhea,while adverse drug reactions in control group were mainly on dizziness,rash and diarrhea.There was no significant difference in the incidence of adverse reactions between the two groups[10.20%(5 cases/49 cases)vs 8.89%(4 cases/45 cases),P>0.05].Conclusion Compound sabal berry tablet can relieve prostate symptoms and overactive bladder symptoms,improve urodynamics,reduce BD and alleviate inflammatory response in BPH patients after transurethral resection of the prostate.