不同体位物理振动排石机治疗输尿管结石性肾绞痛的前瞻性、多中心、随机对照临床研究

External physical vibration lithecbole in treatment of ureteral calculi with renal colic used different positions: a prospective multicenter randomized controlled clinical study

目的探讨不同体位物理振动排石对输尿管结石性肾绞痛的疗效和安全性。方法本研究为前瞻性、多中心、随机对照研究。临床研究注册号:ChiCTR1900025555。收集2018年6月至2019年8月浙江中医药大学附属第二医院、浙江省荣军医院、长兴县第二医院收治的输尿管结石性肾绞痛患者。纳入标准:患者自愿参与试验,并签署知情同意书;年龄18~65岁;输尿管结石性肾绞痛;结石直径<7 mm;患者发病至入院未使用镇痛、解痉类药物。排除标准:合并严重并发症(严重尿路感染、严重肾积水);泌尿系畸形;严重高血压病;脑血管疾病史;重要器官功能障碍;肥胖(体质指数>35 kg/m2);输尿管结石病史>2个月;凝血功能异常。采用随机数字表法将患者随机1∶1分为观察组和对照组。2组患者均采用物理振动排石机治疗,患者均先取仰卧位,观察组采用头低足高位,对照组采用头高足低位,倾斜角度均为24°。先采用副振子振动6 min,然后患者取俯卧位,同时打开主、副振子,振动6 min后治疗结束。观察两组的镇痛疗效、排石情况、不良反应。采用视觉模拟评分法(visual analogue scale,VAS)对治疗前后肾绞痛程度进行评估。疼痛缓解率=(治疗前VAS分值-治疗后VAS分值)/治疗前VAS分值×100%。疗效评价:显效为疼痛缓解率≥75%,有效为50%≤疼痛缓解率<75%,无效为疼痛缓解率<50%。总有效率=(显效+有效)/(显效+有效+无效)。结果本研究共纳入100例患者,观察组和对照组各50例。两组的年龄[(41.8±11.7)岁与(46.6±13.9)岁]、性别[男/女:37/13例与42/8例]、结石位置(输尿管上/中/下段结石:19/7/24例与12/3/35例)、结石侧别[右/左:21/29例与22/28例]、结石长径[(5.2±0.9)mm与(5.1±1.1)mm]、治疗前疼痛评分[(7.5±1.4)分与(7.6±1.5)分]、再入院率[22%(11/50)与18%(9/50)]、术后1周排石率[70%(35/50)与64%(32/50)]差异均无统计学意义(P>0.05)。观察组4例(8%)发生不良反应,分别为恶心3例,呕吐1例;对照组2例(4%)发生不良反应,均为恶心,两组不良反应发生率差异无统计学意义(P>0.05)。观察组后续治疗选择物理振动排石、体外冲击波碎石术、手术的例数分别为35、9、6例,对照组分别为35、10、5例,差异无统计学意义(P>0.05)。观察组治疗后VAS评分低于对照组[(2.4±1.3)分与(3.7±1.5)分,P<0.01],总有效率高于对照组[94%(47/50)与76%(38/50),P<0.01]。46例治疗后行泌尿系超声检查肾积水程度,观察组肾积水减轻率高于对照组[54.5%(18/33)与30.8%(4/13)],但差异无统计学意义(P=0.146)。观察组输尿管上段和下段结石治疗后VAS评分均低于对照组[(2.4±0.3)分与(3.9±0.4)分;(2.4±0.2)分与(3.5±0.2)分],差异均有统计学意义(P<0.01),总有效率差异均无统计学意义(P>0.05)。结论物理振动排石机采用头低足高位对输尿管结石性肾绞痛的缓解效果优于头高足低位,且安全性良好。

Objective To evaluate the efficacy and safety of different positions external physical vibration lithecbole(EPVL)therapy for ureteral calculi related renal colic.Methods This study was a prospective multicenter randomized controlled trial.The inclusion criteria was that patients volunteered to participate in the trial and signed informed consent,patients’age ranged from 18-65 years old,ureteral calculi related with renal colic,stone diameter was less than 7 mm,patients were not treated with analgesia,antispasmodic drugs.The exclusion criteria was that combination of severe urinary tract infection,severe hydronephrosis,urinary malformation,severe hypertension,history of cerebrovascular disease,vital organ dysfunction,obesity(BMI>35 kg/m^2),history of ureteral calculi exceeded 2 months,abnormal blood coagulation.Patients were randomized into observation group and control group using random number table method.The observation group and the control group were placed on the physical vibration stone arranging machine with head low foot high position and head high foot low position respectively.The inclination angle was 24°.The secondary vibrator vibrated for 6 minutes,then the patient took the prone position and opened the main,the secondary vibrator.The treatment is completed after 6 minutes of vibration.The analgesic effect,stone removal,follow-up effects and adverse reactions in the two groups was compared.We defined the pain relief rate as(VAS score before treatment-VAS score after treatment)/VAS score before treatment×100%.Results A total of 100 patients were included in the study,50 in the observation group and 50 in the control group.There were no statistical difference in the age of the two groups[(41.8±11.7)years and(46.6±13.9 years)],gender distribution[37(male)/13(female)and 42(male)/8(female)],location of stones(in the observation group,19 cases in upper ureter,7 cases in the middle ureter and 24 cases in the lower ureter;in the control group,12 cases in the upper ureter,3 cases in the middle ureter,and 35 in the lower ureter),left and right distribution of stones[21(right)/29(left)and 22(right)/28(left)],long diameter of stones[(5.2±0.9)mm and(5.1±1.1)mm],VAS scores before treatment(7.5±1.4 and 7.6±1.5),and readmission rate[22%(11/50)With 18%(9/50)],1 week stone removal rate[70%(35/50)and 64%(32/50)].The incidence of adverse reactions was 8%(4/50)in the observation group including 3 cases of nausea,1 case of vomiting.The incidence of adverse reactions was 4%in the control group(2/50),which 2 cases showed nausea.The number of patients who chose EPVL,ESWL or surgery for the subsequent treatment in observation group was 35 cases,9 cases,and 6 cases respectively.The number of patients who chose EPVL,ESWL or surgery for the subsequent treatment in the control group was 35 cases,10 cases and 5 cases respectively.There was no significant difference between the two groups(P>0.05).The VAS score after treatment of the observation group was lower than that of the control group(2.4±1.3 and 3.7±1.5,P<0.01).The total effective rate of the observation group was higher than that of the control group[94%(47/50)and 76%(38/50),P<0.01].46 patients underwent urinary ultrasonography to check the degree of hydronephrosis.The reduction rate of hydronephrosis was higher in the observation group than in the control group[54.5%(18/33)and 30.8%(4/13)],but there was no significant difference between the two groups(P=0.146).In the upper ureteral calculi,the VAS score of the observation group was lower than that of the control group(2.4±0.3 and 3.9±0.4,P<0.01).There was no significant difference in the total effective rate between the two groups.In the lower ureteral calculi,the observation group had low VAS score after treatment.In the control group(2.4±0.2 and 3.5±0.2,P<0.01),there was no significant difference in the total effective rate between the two groups;the middle segment stones were less included(10 in total)and were not discussed.Conclusions The external physical vibration lithecbole adopts"head high and low position"has better effect than"head low foot high position"in treatment of ureteral calculi with renal colic,and security is acceptable.