中华泌尿外科杂志
中華泌尿外科雜誌
중화비뇨외과잡지
CHINESE JOURNAL OF UROLOGY
2015年
4期
257-260
,共4页
章传华%刘双林%陈志强%王珅%高文喜%周洁%郭永连%李国灏%张景宇
章傳華%劉雙林%陳誌彊%王珅%高文喜%週潔%郭永連%李國灝%張景宇
장전화%류쌍림%진지강%왕신%고문희%주길%곽영련%리국호%장경우
间苯三酚%肾绞痛%多中心研究%随机对照试验
間苯三酚%腎絞痛%多中心研究%隨機對照試驗
간분삼분%신교통%다중심연구%수궤대조시험
Phloroglucinol%Renal colic%Multicenter studies%Randomized controlled trials
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.
目的 通過多中心隨機對照臨床研究,評估註射用間苯三酚對腎絞痛的治療效果和安全性.方法 選取2013年6月至2014年7月在5傢醫療機構就診的腎絞痛患者作為研究對象.納入標準:年齡18～70歲;臨床確診為泌尿繫結石引起的腎絞痛患者;無相關藥物過敏史;無嚴重肝、腎、心髒及造血繫統疾病.排除標準:嚴重感染患者;妊娠期及哺乳期婦女;伴有無法控製的高血壓、心肌梗死、心律失常,需藥物治療者;消化道潰瘍、酗酒、藥物濫用或其他可能影響研究進行者.採用隨機數字錶法將受試患者按1∶1比例納入研究組或對照組,所有患者均給予解痙藥聯閤非甾體類鎮痛藥物治療.解痙藥研究組給予間苯三酚120 mg靜脈滴註,對照組給予山莨菪堿註射液20 mg靜脈滴註.鎮痛藥物統一採用雙氯芬痠鈉栓50 mg.觀察併記錄72 h內患者腎絞痛的疼痛程度、緩解時間、髮作次數、結石排齣情況及不良反應.結果 200例腎絞痛患者參加併完成本試驗,研究組和對照組各100例.兩組患者性彆、年齡、結石位置、結石大小和腎積水程度比較差異均無統計學意義(P＞0.05).對照組患者腎絞痛髮作次數為(4.2±2.5)次,疼痛指數為7.8±1.1,疼痛緩解時間(21.7±8.2) min;研究組腎絞痛髮作次數為(4.0±2.2)次,疼痛指數為7.7±1.3,疼痛緩解時間(19.3±7.6) min;組間比較差異均無統計學意義(P＞0.05).對照組結石排齣率為3％(3/100),研究組為11％(11/100) (P＜0.05).對照組總的不良反應髮生率為71％(71/100),其中口榦髮生率高達67％(67/100),頭暈髮生率15％(15/100),皮膚潮紅髮生率22％ (22/100),排尿睏難髮生率8％(8/100),尿潴留髮生率6％(6/100).間苯三酚治療組不良反應髮生率為4％(4/100),顯著低于對照組,組間比較差異有統計學意義(P＜0.01).結論 註射用間苯三酚治療腎絞痛安全有效.間苯三酚在治療腎絞痛的同時有助于結石排齣.
목적 통과다중심수궤대조림상연구,평고주사용간분삼분대신교통적치료효과화안전성.방법 선취2013년6월지2014년7월재5가의료궤구취진적신교통환자작위연구대상.납입표준:년령18～70세;림상학진위비뇨계결석인기적신교통환자;무상관약물과민사;무엄중간、신、심장급조혈계통질병.배제표준:엄중감염환자;임신기급포유기부녀;반유무법공제적고혈압、심기경사、심률실상,수약물치료자;소화도궤양、후주、약물람용혹기타가능영향연구진행자.채용수궤수자표법장수시환자안1∶1비례납입연구조혹대조조,소유환자균급여해경약연합비치체류진통약물치료.해경약연구조급여간분삼분120 mg정맥적주,대조조급여산랑탕감주사액20 mg정맥적주.진통약물통일채용쌍록분산납전50 mg.관찰병기록72 h내환자신교통적동통정도、완해시간、발작차수、결석배출정황급불량반응.결과 200례신교통환자삼가병완성본시험,연구조화대조조각100례.량조환자성별、년령、결석위치、결석대소화신적수정도비교차이균무통계학의의(P＞0.05).대조조환자신교통발작차수위(4.2±2.5)차,동통지수위7.8±1.1,동통완해시간(21.7±8.2) min;연구조신교통발작차수위(4.0±2.2)차,동통지수위7.7±1.3,동통완해시간(19.3±7.6) min;조간비교차이균무통계학의의(P＞0.05).대조조결석배출솔위3％(3/100),연구조위11％(11/100) (P＜0.05).대조조총적불량반응발생솔위71％(71/100),기중구간발생솔고체67％(67/100),두훈발생솔15％(15/100),피부조홍발생솔22％ (22/100),배뇨곤난발생솔8％(8/100),뇨저류발생솔6％(6/100).간분삼분치료조불량반응발생솔위4％(4/100),현저저우대조조,조간비교차이유통계학의의(P＜0.01).결론 주사용간분삼분치료신교통안전유효.간분삼분재치료신교통적동시유조우결석배출.
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 suppositóries 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.
