中华核医学与分子影像杂志
中華覈醫學與分子影像雜誌
중화핵의학여분자영상잡지
Chinese Journal of Nuclear Medicine and Molecular Imaging
2014年
5期
366-369
,共4页
陈永辉%罗亚平%靳晓娜%马艳茹%王志强%郭宁%王俊清%李方%邱艳丽
陳永輝%囉亞平%靳曉娜%馬豔茹%王誌彊%郭寧%王俊清%李方%邱豔麗
진영휘%라아평%근효나%마염여%왕지강%곽저%왕준청%리방%구염려
格雷夫斯病%放射疗法%碘放射性同位素%药代动力学
格雷伕斯病%放射療法%碘放射性同位素%藥代動力學
격뢰부사병%방사요법%전방사성동위소%약대동역학
Graves disease%Radiotherapy%Iodine radioisotopes%Pharmacokinetics
目的 比较诊断期及治疗期碘[131I]化钠胶囊与口服液在格雷夫斯病(GD)患者体内的血液药代动力学及患者甲状腺摄碘率的差异,评价两者治疗GD的疗效及安全性.方法 采用开放、平行、随机、对照的前瞻性临床研究.纳入44例GD患者[男14例,女30例,年龄(33.84±4.96)岁].其中试验组(A组,22例)诊断期口服碘[131I]化钠口服液,治疗期口服碘[131I]化钠胶囊;对照组(B组,22例)反之.测定2组诊断期及治疗期服药后0、5、10、20、40和80 min血放射性计数,以及2、4、6和24 h甲状腺摄碘率,采用梯形法计算两者时间曲线的AUC、峰浓度(cmax)及达峰时间(tmax).观察3、6个月疗效及不良反应.采用SAS 9.3软件对试验数据进行多因素方差分析、t检验及x2检验.结果 每组各有1例失访,有效病例每组各21例.诊断期A组血放射性计数占给药放射性计数百分比(OD％)的时间曲线AUC0→t[(450.70±258.00)％·min]小于B组[(684.45±237.00)％·min],cmax[(8.43±4.00)％]低于B组[(13.28±4.20)％],Z=2.640 7、t=3.923 0,均P＜0.01;2组tmax分别为(37.27±23.10)和(34.55±21.30) min,Z=-0.335 9,P＞0.05.治疗期A、B组tmax分别为(46.36±24.98)和(28.64±19.35) min,Z=-2.681 8,P＜0.01;而2组AUC0→t和cmax差异均无统计学意义(t=1.707 4、1.357 4,均P＞0.05).诊断期及治疗期2组摄碘率AUC0→t、cmax及tmax差异均没有统计学意义(t=0.420 8、1.596 8、0.797 8、1.688 0,Z=0.556 4、-0.013 8,均P＞0.05).治疗后3个月A组甲状腺功能亢进症(简称甲亢)缓解者占66.7％(14/21),B组相应比例为61.9％(13/21),x2=0.104,P＞0.05;2组发生甲状腺功能减退症(简称甲减)比例分别为23.8％(5/21)和28.6％(6/21),x2=0.123,P＞0.05.治疗后6个月2组甲亢和甲减发生比例差异也均无统计学意义(x2=1.118、1.714,均P＞0.05).无一例出现不良反应.结论 诊断期和治疗期2种剂型碘[131I]化钠的血液药代动力学存在一些差异,但并不影响甲状腺24h摄碘率.两者治疗GD的疗效相同,且无不良反应.
目的 比較診斷期及治療期碘[131I]化鈉膠囊與口服液在格雷伕斯病(GD)患者體內的血液藥代動力學及患者甲狀腺攝碘率的差異,評價兩者治療GD的療效及安全性.方法 採用開放、平行、隨機、對照的前瞻性臨床研究.納入44例GD患者[男14例,女30例,年齡(33.84±4.96)歲].其中試驗組(A組,22例)診斷期口服碘[131I]化鈉口服液,治療期口服碘[131I]化鈉膠囊;對照組(B組,22例)反之.測定2組診斷期及治療期服藥後0、5、10、20、40和80 min血放射性計數,以及2、4、6和24 h甲狀腺攝碘率,採用梯形法計算兩者時間麯線的AUC、峰濃度(cmax)及達峰時間(tmax).觀察3、6箇月療效及不良反應.採用SAS 9.3軟件對試驗數據進行多因素方差分析、t檢驗及x2檢驗.結果 每組各有1例失訪,有效病例每組各21例.診斷期A組血放射性計數佔給藥放射性計數百分比(OD％)的時間麯線AUC0→t[(450.70±258.00)％·min]小于B組[(684.45±237.00)％·min],cmax[(8.43±4.00)％]低于B組[(13.28±4.20)％],Z=2.640 7、t=3.923 0,均P＜0.01;2組tmax分彆為(37.27±23.10)和(34.55±21.30) min,Z=-0.335 9,P＞0.05.治療期A、B組tmax分彆為(46.36±24.98)和(28.64±19.35) min,Z=-2.681 8,P＜0.01;而2組AUC0→t和cmax差異均無統計學意義(t=1.707 4、1.357 4,均P＞0.05).診斷期及治療期2組攝碘率AUC0→t、cmax及tmax差異均沒有統計學意義(t=0.420 8、1.596 8、0.797 8、1.688 0,Z=0.556 4、-0.013 8,均P＞0.05).治療後3箇月A組甲狀腺功能亢進癥(簡稱甲亢)緩解者佔66.7％(14/21),B組相應比例為61.9％(13/21),x2=0.104,P＞0.05;2組髮生甲狀腺功能減退癥(簡稱甲減)比例分彆為23.8％(5/21)和28.6％(6/21),x2=0.123,P＞0.05.治療後6箇月2組甲亢和甲減髮生比例差異也均無統計學意義(x2=1.118、1.714,均P＞0.05).無一例齣現不良反應.結論 診斷期和治療期2種劑型碘[131I]化鈉的血液藥代動力學存在一些差異,但併不影響甲狀腺24h攝碘率.兩者治療GD的療效相同,且無不良反應.
목적 비교진단기급치료기전[131I]화납효낭여구복액재격뢰부사병(GD)환자체내적혈액약대동역학급환자갑상선섭전솔적차이,평개량자치료GD적료효급안전성.방법 채용개방、평행、수궤、대조적전첨성림상연구.납입44례GD환자[남14례,녀30례,년령(33.84±4.96)세].기중시험조(A조,22례)진단기구복전[131I]화납구복액,치료기구복전[131I]화납효낭;대조조(B조,22례)반지.측정2조진단기급치료기복약후0、5、10、20、40화80 min혈방사성계수,이급2、4、6화24 h갑상선섭전솔,채용제형법계산량자시간곡선적AUC、봉농도(cmax)급체봉시간(tmax).관찰3、6개월료효급불량반응.채용SAS 9.3연건대시험수거진행다인소방차분석、t검험급x2검험.결과 매조각유1례실방,유효병례매조각21례.진단기A조혈방사성계수점급약방사성계수백분비(OD％)적시간곡선AUC0→t[(450.70±258.00)％·min]소우B조[(684.45±237.00)％·min],cmax[(8.43±4.00)％]저우B조[(13.28±4.20)％],Z=2.640 7、t=3.923 0,균P＜0.01;2조tmax분별위(37.27±23.10)화(34.55±21.30) min,Z=-0.335 9,P＞0.05.치료기A、B조tmax분별위(46.36±24.98)화(28.64±19.35) min,Z=-2.681 8,P＜0.01;이2조AUC0→t화cmax차이균무통계학의의(t=1.707 4、1.357 4,균P＞0.05).진단기급치료기2조섭전솔AUC0→t、cmax급tmax차이균몰유통계학의의(t=0.420 8、1.596 8、0.797 8、1.688 0,Z=0.556 4、-0.013 8,균P＞0.05).치료후3개월A조갑상선공능항진증(간칭갑항)완해자점66.7％(14/21),B조상응비례위61.9％(13/21),x2=0.104,P＞0.05;2조발생갑상선공능감퇴증(간칭갑감)비례분별위23.8％(5/21)화28.6％(6/21),x2=0.123,P＞0.05.치료후6개월2조갑항화갑감발생비례차이야균무통계학의의(x2=1.118、1.714,균P＞0.05).무일례출현불량반응.결론 진단기화치료기2충제형전[131I]화납적혈액약대동역학존재일사차이,단병불영향갑상선24h섭전솔.량자치료GD적료효상동,차무불량반응.
Objective To determine the serum pharmacokinetics and radioiodine uptake of sodium iodide (131 I) liquid and capsule in patients with Graves disease(GD),and to evaluate the effectiveness and safety of these two dosage forms in treating GD.Methods An open,randomized,parallel controlled prospective clinical study was designed.Forty-four patients (14 males,30 females,(33.84±4.96) years) with GD were recruited.The experimental group (group A,n=22) received sodium iodide (131I) liquid in diagnostic period and sodium iodide (131I) capsule in therapeutic period and vice versa (capsule vs liquid) for control group (group B,n=22).Serum radioactivity (0,5,10,20,40,80 min) and radioiodine uptake (2,4,6,24 h) were measured both in the diagnostic and therapeutic periods.The values of AUC (AUC0→t),maximum concentration (cmax) and maximum time (tmax) were calculated by trapezium method.Effectiveness and adverse events were evaluated in 3 and 6 months.Analysis of variance,t test and x2 test were performed by SAS 9.3.Results There were 21 valid cases in both groups (1 patient was lost in each group).In diagnostic period,AUC0→t and cmax of percentage of oral dose (OD％) in group A were significantly lower than those in group B:(450.70 ± 258.00) ％ · min vs (684.45 ± 237.00) ％ · min,(8.43 ±4.00)％ vs (13.28±4.20)％(Z=2.6 407,t=3.9 230,both P＜0.01).There was no significant difference of tmax between the 2 groups:(37.27±23.10) vs (34.55±21.30) min,Z=-0.335 9,P＞0.05.In therapeutic period,tmax in group A was significantly longer than that in group B:(46.36±24.98) vs (28.64±19.35) min,Z=-2.681 8,P＜0.01.There was no significant difference in neither AUC0→t nor cmax between the 2 groups (t=1.7 074,1.3 574,both P＞0.05).No significant difference was shown in AUC0→t,cmax and tmax between the 2 groups in both diagnostic period and therapeutic period(t=0.420 8,1.596 8,0.797 8,1.688 0,Z=0.556 4,-0.013 8,all P＞0.05).Three months after treatment,14 out of 21 cases (66.7％) remitted in group A while 13 patients (61.9％) remitted in group B(x2=0.104,P＞0.05).Five patients(23.8％) developed hypothyroidism in group A while 6 patients (28.6％) in group B (x2=0.123,P＞0.05).Six months after treatment,the percent of hypothyroidism and remission were not significantly different between group A and B (x2=1.118,1.714,both P＞0.05).No adverse event occurred in both groups.Conclusions Though pharmacokinetics between the two dosage forms showed significantly difference,outcomes were similar.Besides,no severe adverse event was observed in both groups.
