药物不良反应杂志
藥物不良反應雜誌
약물불량반응잡지
ADVERSE DRUG REACTIONS JOURNAL
2013年
4期
202-206
,共5页
刘琛%王育琴%沈芊%李晓玲%姜德春%李星炜
劉琛%王育琴%瀋芊%李曉玲%薑德春%李星煒
류침%왕육금%침천%리효령%강덕춘%리성위
顺铂%老年%肿瘤
順鉑%老年%腫瘤
순박%노년%종류
Cisplatin%Elderly%Neoplasms
目的 分析顺铂致癌症患者严重不良反应的临床表现并探讨其影响因素. 方法 收集国家药品不良反应监测中心2009年1月1日至2010年12月31日收到的顺铂致严重不良反应报告进行回顾性分析.将患者分为老年组(≥60岁)和非老年组(18 ～59岁),比较2组患者性别与年龄分布、肿瘤发生部位、用药后发生严重不良反应的时间、临床表现、顺铂剂型、剂量、合并用药情况及转归.将老年组患者进一步分为60 ～69岁组和70 ～79岁组,对有统计学意义的因素进行亚组分析. 结果 共收集到顺铂致严重不良反应报告228份,涉及228例患者.老年组103例,男性72例(69.9％),女性31例(30.1％),平均年龄(67±5)岁;非老年组125例,男性59例(47.2％),女性66例(52.8％),平均年龄(48±9)岁.老年组男性构成比高于非老年组(x2=11.907,P=0.001).2组患者均以呼吸系统肿瘤占比居首位,但老年组占比高于非老年组(x2 =8.512,P=0.004).老年组泌尿生殖系统肿瘤占比低于非老年组(x2=8.759,P=0.003).2组用药后出现严重不良反应时间的差异有统计学意义(x2=-2.545,P=0.011).2组患者使用顺铂粉针剂与注射剂的差异无统计学意义.老年组用药剂量为10 ～ 140 mg/d,非老年组为10 ～420 mg/d,差异有统计学意义(P=0.011).老年组多合并应用吉西他滨、依托泊苷、多西他赛等,合并用药种数的中位数为0种(四分位间距0～1);非老年组多合并应用紫杉醇、吉西他滨、多西他赛等,合并用药种数的中位数为1种(四分位间距1 ～1),差异有统计学意义(P =0.032).应用顺铂后出现的严重不良反应主要为骨髓抑制和白细胞减少.老年组出现骨髓抑制和白细胞计数减少者分别为50例(48.5％)和24例(23.3％);非老年组分别为69例(55.2％)和24例(19.2％),差异无统计学意义.老年组有2例患者出现肾功能损伤,非老年组有2例患者出现QT间期延长.经停药和对症治疗后,老年组严重不良反应治愈、好转、留有后遗症和死亡者分别为27例(26.2％)、72例(69.9％)、3例(2.9％)和1例(1.0％);非老年组分别为38例(30.4％)、83例(66.4％)、3例(2.4％)和1例(0.8％),差异无统计学意义.老年组70 ～ 79岁亚组男性构成比(87.1％)高于60 ～ 69岁亚组(62.5％),差异有统计学意义(x2 =6.232,P=0.013).2个亚组用药剂量和合并用药数量差异均无统计学意义. 结论 老年和非老年癌症患者使用顺铂所致严重不良反应相似.老年男性、特别是70 ～79岁老年男性癌症患者是应用顺铂后易出现严重不良反应的高危人群.
目的 分析順鉑緻癌癥患者嚴重不良反應的臨床錶現併探討其影響因素. 方法 收集國傢藥品不良反應鑑測中心2009年1月1日至2010年12月31日收到的順鉑緻嚴重不良反應報告進行迴顧性分析.將患者分為老年組(≥60歲)和非老年組(18 ～59歲),比較2組患者性彆與年齡分佈、腫瘤髮生部位、用藥後髮生嚴重不良反應的時間、臨床錶現、順鉑劑型、劑量、閤併用藥情況及轉歸.將老年組患者進一步分為60 ～69歲組和70 ～79歲組,對有統計學意義的因素進行亞組分析. 結果 共收集到順鉑緻嚴重不良反應報告228份,涉及228例患者.老年組103例,男性72例(69.9％),女性31例(30.1％),平均年齡(67±5)歲;非老年組125例,男性59例(47.2％),女性66例(52.8％),平均年齡(48±9)歲.老年組男性構成比高于非老年組(x2=11.907,P=0.001).2組患者均以呼吸繫統腫瘤佔比居首位,但老年組佔比高于非老年組(x2 =8.512,P=0.004).老年組泌尿生殖繫統腫瘤佔比低于非老年組(x2=8.759,P=0.003).2組用藥後齣現嚴重不良反應時間的差異有統計學意義(x2=-2.545,P=0.011).2組患者使用順鉑粉針劑與註射劑的差異無統計學意義.老年組用藥劑量為10 ～ 140 mg/d,非老年組為10 ～420 mg/d,差異有統計學意義(P=0.011).老年組多閤併應用吉西他濱、依託泊苷、多西他賽等,閤併用藥種數的中位數為0種(四分位間距0～1);非老年組多閤併應用紫杉醇、吉西他濱、多西他賽等,閤併用藥種數的中位數為1種(四分位間距1 ～1),差異有統計學意義(P =0.032).應用順鉑後齣現的嚴重不良反應主要為骨髓抑製和白細胞減少.老年組齣現骨髓抑製和白細胞計數減少者分彆為50例(48.5％)和24例(23.3％);非老年組分彆為69例(55.2％)和24例(19.2％),差異無統計學意義.老年組有2例患者齣現腎功能損傷,非老年組有2例患者齣現QT間期延長.經停藥和對癥治療後,老年組嚴重不良反應治愈、好轉、留有後遺癥和死亡者分彆為27例(26.2％)、72例(69.9％)、3例(2.9％)和1例(1.0％);非老年組分彆為38例(30.4％)、83例(66.4％)、3例(2.4％)和1例(0.8％),差異無統計學意義.老年組70 ～ 79歲亞組男性構成比(87.1％)高于60 ～ 69歲亞組(62.5％),差異有統計學意義(x2 =6.232,P=0.013).2箇亞組用藥劑量和閤併用藥數量差異均無統計學意義. 結論 老年和非老年癌癥患者使用順鉑所緻嚴重不良反應相似.老年男性、特彆是70 ～79歲老年男性癌癥患者是應用順鉑後易齣現嚴重不良反應的高危人群.
목적 분석순박치암증환자엄중불량반응적림상표현병탐토기영향인소. 방법 수집국가약품불량반응감측중심2009년1월1일지2010년12월31일수도적순박치엄중불량반응보고진행회고성분석.장환자분위노년조(≥60세)화비노년조(18 ～59세),비교2조환자성별여년령분포、종류발생부위、용약후발생엄중불량반응적시간、림상표현、순박제형、제량、합병용약정황급전귀.장노년조환자진일보분위60 ～69세조화70 ～79세조,대유통계학의의적인소진행아조분석. 결과 공수집도순박치엄중불량반응보고228빈,섭급228례환자.노년조103례,남성72례(69.9％),녀성31례(30.1％),평균년령(67±5)세;비노년조125례,남성59례(47.2％),녀성66례(52.8％),평균년령(48±9)세.노년조남성구성비고우비노년조(x2=11.907,P=0.001).2조환자균이호흡계통종류점비거수위,단노년조점비고우비노년조(x2 =8.512,P=0.004).노년조비뇨생식계통종류점비저우비노년조(x2=8.759,P=0.003).2조용약후출현엄중불량반응시간적차이유통계학의의(x2=-2.545,P=0.011).2조환자사용순박분침제여주사제적차이무통계학의의.노년조용약제량위10 ～ 140 mg/d,비노년조위10 ～420 mg/d,차이유통계학의의(P=0.011).노년조다합병응용길서타빈、의탁박감、다서타새등,합병용약충수적중위수위0충(사분위간거0～1);비노년조다합병응용자삼순、길서타빈、다서타새등,합병용약충수적중위수위1충(사분위간거1 ～1),차이유통계학의의(P =0.032).응용순박후출현적엄중불량반응주요위골수억제화백세포감소.노년조출현골수억제화백세포계수감소자분별위50례(48.5％)화24례(23.3％);비노년조분별위69례(55.2％)화24례(19.2％),차이무통계학의의.노년조유2례환자출현신공능손상,비노년조유2례환자출현QT간기연장.경정약화대증치료후,노년조엄중불량반응치유、호전、류유후유증화사망자분별위27례(26.2％)、72례(69.9％)、3례(2.9％)화1례(1.0％);비노년조분별위38례(30.4％)、83례(66.4％)、3례(2.4％)화1례(0.8％),차이무통계학의의.노년조70 ～ 79세아조남성구성비(87.1％)고우60 ～ 69세아조(62.5％),차이유통계학의의(x2 =6.232,P=0.013).2개아조용약제량화합병용약수량차이균무통계학의의. 결론 노년화비노년암증환자사용순박소치엄중불량반응상사.노년남성、특별시70 ～79세노년남성암증환자시응용순박후역출현엄중불량반응적고위인군.
Objective To analyze the clinical manifestations of severe adverse reactions induced by cisplatin in cancer patients and discuss the influencing factors.Methods The reports of severe adverse reactions induced by cisplatin in National Center for ADR Monitoring from January 1,2009 to December 31,2010 were collected and analyzed retrospectively.The patients were divided into two groups:elderly group (≥60 years old) and non-elderly group (18-59 years old).The gender and age distribution,tumor location,appearance time for severe adverse reactions after treatment,clinical manifestation,cisplatin's formulation and dosage,drug combination,and patients' outcome were compared between the two groups.The elderly group was further divided into two subgroups,60-69 years old and 70-79 years old.Subgroup analysis of statistically significant factors were conducted.Results A total of 228 reports of severe adverse reaction induced by cisplatin including 228 patients were collected.There were 103 patients in the elderly group comprising 72 (69.9％) males and 31 (30.1％) females with an average age of (67 ± 5) years.There were 125 patients in the non-elderly group comprising 59(47.2％) males and 66(52.8％) females with an average age of (48 ± 9) years.Percentage of male in the elderly group was higher than that in the non-elderly group (x2 =11.907,P =0.001).The proportion of respiratory system tumor was the leading ones in the list in both groups.The proportion of respiratory system tumor in the elderly group was higher than that in the non-elderly group (x2 =8.512,P =0.004).The proportion of urogenital tumor in the elderly group was lower than that in the non-elderly group (x2 =8.759,P =0.003).The difference of appearance time for serious adverse reactions after treatment between the 2 groups was statistically significant (x2 =-2.545,P =0.011).There was no statistically significant difference in applying cisplatin powder or cisplatin solution for injection between the 2 groups.The doses of cisplatin were 10-140 mg/d and 10-420 mg/d in the elderly group and the non-elderly group,respectively.The difference was statistically significant(P =0.011).In the elderly group cisplatin was combined with gemeitabine,etoposide,and docetaxel,the median number of drug combination was 0 (interquartile:0-1).In the non-elderly group cisplatin was combined with paclitaxel,gemcitabine,and docetaxel,the median number of drug combination was 1 (interquartile:1-1),the difference was statistically significant (P =0.032).The main severe adverse reactions induced by cisplatin were myelosuppression and leukopenia.The number of cases who developed myelosuppression and leucopenia was 50(48.5％) and 24(23.3％),69(55.2％) and 24(19.2％) in the elderly and nonelderly groups,respectively.The differences were no statistically significant.Two patients in the elderly group developed renal impairment.There was no report of renal impairment in the non-elderly group.Two patients in the non-elderly group developed QT prolongation.There was no report of QT prolongation in the elderly group.After discontinuation and symptomatic treatment,the number of cases with recovery,improvement,sequelae,and death in the elderly group were 27(26.2％),72(69.9％),3(2.9％),and 1 (1.0％),respectively,and in the non-elderly group were 38 (30.4％),83 (66.4％),3 (2.4％),and 1(0.8％),respectively.The differences were not statistically significant.Percentage of male in the subgroup of 70-79 years old (87.1％) was higher than that in the subgroup of 60-69 years old (62.5％)(x2 =6.232,P =0.013).Differences in dosage and number of drug combination were not statistically significant between the 2 subgroups.Conclusions The severe adverse reactions induced by cisplatin were similar in the elderly group and the non-elderly group.The elderly male,especially aged 70 to 79 years,were the high risk group of severe adverse reactions induced by cisplatin.
