摘要
目的 通过多中心随机对照临床研究,评估注射用间苯三酚对肾绞痛的治疗效果和安全性.方法 选取2013年6月至2014年7月在5家医疗机构就诊的肾绞痛患者作为研究对象.纳入标准：年龄18～70岁;临床确诊为泌尿系结石引起的肾绞痛患者;无相关药物过敏史;无严重肝、肾、心脏及造血系统疾病.排除标准：严重感染患者;妊娠期及哺乳期妇女;伴有无法控制的高血压、心肌梗死、心律失常,需药物治疗者;消化道溃疡、酗酒、药物滥用或其他可能影响研究进行者.采用随机数字表法将受试患者按1∶1比例纳入研究组或对照组,所有患者均给予解痉药联合非甾体类镇痛药物治疗.解痉药研究组给予间苯三酚120 mg静脉滴注,对照组给予山莨菪碱注射液20 mg静脉滴注.镇痛药物统一采用双氯芬酸钠栓50 mg.观察并记录72 h内患者肾绞痛的疼痛程度、缓解时间、发作次数、结石排出情况及不良反应.结果 200例肾绞痛患者参加并完成本试验,研究组和对照组各100例.两组患者性别、年龄、结石位置、结石大小和肾积水程度比较差异均无统计学意义（P＞0.05）.对照组患者肾绞痛发作次数为（4.2±2.5）次,疼痛指数为7.8±1.1,疼痛缓解时间（21.7±8.2） min;研究组肾绞痛发作次数为（4.0±2.2）次,疼痛指数为7.7±1.3,疼痛缓解时间（19.3±7.6） min;组间比较差异均无统计学意义（P＞0.05）.对照组结石排出率为3％（3/100）,研究组为11％（11/100） （P＜0.05）.对照组总的不良反应发生率为71％（71/100）,其中口干发生率高达67％（67/100）,头晕发生率15％（15/100）,皮肤潮红发生率22％ （22/100）,排尿困难发生率8％（8/100）,尿潴留发生率6％（6/100）.间苯三酚治疗组不良反应发生率为4％（4/100）,显著低于对照组,组间比较差异有统计学意义（P＜0.01）.结论 注射用间苯三酚治疗肾绞痛安全有效.间苯三酚在治疗肾绞痛的同时有助于结石排出.
Objective To evaluate the efficacy and safety of phloroglucinol injection in the treatment of renal colic by a multicentre,prospective,randomized trial.Methods From June 2013 to July 2014,a total of 200 patients with renal colic were enrolled from 5 medical centers as subjects for the study.The patients who met the following inclusion criteria were consecutively enrolled：age range of 18-70 years,emergency admission for renal colic,and a radiopaque or radiolucent urinary stone diagnosed with plain abdominal radiography,urinary system ultrasonography or non-contrast CT.Exclusion criteria included urinary tract infection,confirmed or suspected pregnancy,uncontrollable hypotension,cardiac insufficiency,arrhythmias,presence of fever,gastric ulcer and alcoholism.According to a computer-generated randomization table,patients were randomized 1 ∶ 1 assigned to phloroglucinol group （receive intravenous phloroglucinol 120 mg plus diclofenac sodium suppositories 50 mg once daily） or anisodamine group （intravenous anisodamine hydrochloride 20 mg plus diclofenac sodium suppositories 50 mg once daily）.After 72 h,patients were asked about the number of colic episodes and lasting time of each episode.Pain intensity was recorded using a visual analog scale before drug administration and after treatment.Overall analgesics consumption,stone-expulsion rate and the side-effects of the drugs were also recorded.Results Among 200 patients enrolled in the study,100 patients received intravenous phloroglucinol 120 mg plus diclofenac sodium supposit＆243;ries 50 mg once daily and 100 patients received intravenous anisodamine hydrochloride 20 mg plus diclofenac sodium suppositories 50 mg once daily.There were no significant differences between the 2 groups for age,gender,stone size and stone location （P〉0.05）.There were no differences in the pain intensity and the drug effectiveness between the 2 groups （P〉0.05）.During the 72 h,there was spontaneous stone expulsion in 11 cases from phloroglucinol group and 3 cases from anisodamine group.The stone-expulsion rate was 11% and 3%,respectively.The phloroglucinol group had a significantly higher stone expulsion rate when compared with that of anisodamine group （P〈0.05）.Side-effect incidences of phloroglucinol group and anisodamine group were 4% and 71%,respectively.The adverse events,including dry mouth,dizziness,nausea,erubescence,dysuria and uroschesis,were significantly more frequent in patients who received anisodamine （P〈0.01）.None of the patients withdrew from the study because of side-effects caused by the medications.Conclusion Phloroglucinol could be a safe and effective medication in relieving renal colic and facilitating stone expulsion.
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2015年第4期257-260,共4页
Chinese Journal of Urology
关键词
间苯三酚
肾绞痛
多中心研究
随机对照试验
Phloroglucinol
Renal colic
Multicenter studies
Randomized controlled trials
