柳栎浸膏胶囊治疗肾和输尿管结石的前瞻性、多中心、随机对照临床研究

Quercus salicina extract capsules in the management of kidney ureteral calculi： a prospective multicenter randomized controlled clinical study

目的 通过前瞻性、多中心、随机对照临床研究,比较柳栎浸膏胶囊与排石颗粒治疗肾输尿管结石的有效性和安全性.方法 选取2013年11月至2014年5月在7家研究中心就诊的、结石直径＜1 cm的肾、输尿管结石患者.共224例患者纳入研究,采用随机数字表法将患者分为试验组和对照组,各112例.两组患者的年龄、性别、病程、结石直径比较差异均无统计学意义（P＞0.05）.试验组1例、对照组2例因故退出研究.试验组肾结石、输尿管结石分别为23例、88例,对照组分别为26例、84例,差异无统计学意义（P＞0.05）.治疗前试验组腰痛和/或尿痛、尿频、尿急症状评分分别为3.0±0.7、7.6±1.7、0.8±0.6,对照组分别为3.0±0.8、7.9±1.4、0.7±0.6,差异无统计学意义（P＞0.05）.试验组口服柳栎浸膏胶囊,2粒/次,3次/d;对照组口服排石颗粒,1袋/次,3次/d;共治疗4周.观察两组的腰痛和/或尿痛、尿频、尿急症状评分的改善情况,比较两组的结石排出率、结石下移率、排石失败率、结石排出时间、每周累积排石率、不良反应发生率、腰痛缓解率等指标.结果 治疗4周后,试验组的腰痛和/或尿痛、尿频、尿急症状评分分别为1.4±0.6、6.3±1.0、0.2±0.4,对照组分别为1.7±0.7、6.9±1.2、0.2±0.4,与治疗前比较差异均有统计学意义（P＜0.01）.治疗后试验组和对照组的腰痛缓解率分别为64.9％（72/111）和36.4％（40/110）,差异有统计学意义（P＜0.01）.治疗后的结石排出率、结石下移率、排石失败率试验组分别为56.8％（63/111）、12.6％（14/111）、30.6％（34/111）,对照组分别为39.1％（43/110）、10.0％（11/110）、50.9％（56/110）,差异有统计学意义（P =0.003）.治疗后试验组和对照组的总有效率分别为69.4％（77/111）和49.1％（54/110）,差异有统计学意义（P=0.002）,且试验组的肾结石和输尿管结石的有效率分别为52.2％（12/23）、23.1％（6/26）,对照组分别为73.9％（65/88）、57.1％ （48/84）,差异有统计学意义（P＜0.05）.治疗1、2、3、4周的累积排石率试验组分别为23.4％（26/111）、41.4％（46/111）、50.5％（56/111）、56.8％（63/111）,对照组分别为10.9％（12/110）、18.2％ （20/110）、28.2％（31/110）、39.1％（43/110）,试验组的每周累积排石率均高于对照组（P＜0.05）.试验组和对照组分别有6例和7例出现恶心、呕吐、头晕、腹泻等不良反应,两组的不良反应发生率分别为5.4％（6/111）和6.4％ （7/110）,差异无统计学意义（P＞0.05）.结论 柳栎浸膏胶囊治疗直径＜1 cm的肾、输尿管结石安全、有效;与排石颗粒比较,能明显缓解腰痛症状,缩短结石排出时间,具有较高的治愈率.

Objective The objective of this prospective multicenter randomized controlled clinical study was to evaluate the efficacy and safety of urocalun in the management of patients with kidney ureteral calculi compared with lithagogue powder.Methods A total of 224 patients with kidney ureteral calculi less than 1 cm in diameter in seven research center from November 2013 to May 2014 were included in the study and randomly divided into 2 groups by random number table.The experiment group of 112 patients oral Quercus salicina extract capsules,2 pills every time,three times a day,and the control group of 112 patients oral lithagogue powder,1 bag every time,three times a day.All of patients were accepted 4 weeks treatment.There were no significant difference in ages,gender,duration and calculi diameter in two groups （P 〉 0.05）.Renal and ureteral calculi in two groups were 23,88 patients and 26,84 patients,separately （P 〉 0.05）.Low back pain or/and painful urination,urinary frequency,urgency symptom scores in experiment and control groups were 3.0 ± 0.7,7.6 ± 1.7,0.8 ± 0.6 and 3.0 ± 0.8,7.9 ± 1.4,0.7 ± 0.6,respectively （P 〉 0.05）.Low back pain or/and painful urination,urinary frequency,urgency symptom scores,stone discharge rate,stone down rate,stone expelling failure rate,stone discharge time,cumulative stone discharge rate per week,incidence of adverse effects and low back pain remission were evaluated after 4 weeks drug treatment.Results Low back pain or/and painful urination,urinary frequency,urgency symptom scores have significantly improved in the experiment and control groups after 4 weeks drug treatment were 1.4 ±0.6,6.3 ± 1.0,0.2 ±0.4 （P 〈0.01） and 1.7 ±0.7,6.9 ± 1.2,0.2 ± 0.4 （P 〈0.01）,respectively.Relieve efficient of low back pain in experiment group was obviously higher than control group which were 64.9% （72/111） and 36.4% （40/110）,respectively （P 〈 0.01）.Stone discharge rate,stone down rate and stone expelling failure rate in the experiment group were 56.8% （63/ 111）,12.6%（14/111）,30.6% （34/111）,the control group were 39.1% （43/110）,10.0% （11/ 110）,50.9% （56/110） （P =0.003）.Overall efficient in experiment group was significantly higher than control group which were 69.4% （77/111）,49.1% （54/110） （P =0.002）.The effective rate in the patients with kidney and ureteral calculi were 52.2% （12/23）,23.1% （6/26） and 73.9% （65/88）,57.1% （48/84） （P 〈 0.05）,respectively.The cumulative stone discharge rate per week in experiment group were significandy higher than control groups every week after 4 weeks,which were 23.4% （26/111）,41.4%（46/111）,50.5% （56/111）,56.8% （63/111） and 10.9% （12/110）,18.2% （20/110）,28.2% （31/110）,39.1% （43/110）,respectively （P 〈0.05）.There were no significant differences in incidence of adverse effects （P 〉 0.05）.Conclusions Quercus salicina extract capsules are safe and effective in the treatment of patients with the diameter of 1 cm below in kidney ureteral calculi.Compared with lithagogue powder,Quercus salicina extract capsules have higher cure rate and can obviously relieve back pain symptoms,shorten the calculi discharge time.