中国骨质疏松杂志
中國骨質疏鬆雜誌
중국골질소송잡지
CHINESE JOURNAL OF OSTEOPOROSIS
2015年
7期
870-874
,共5页
谢炜星%马辉%晋大祥%丁金勇%徐继禧%梁德
謝煒星%馬輝%晉大祥%丁金勇%徐繼禧%樑德
사위성%마휘%진대상%정금용%서계희%량덕
唑来膦酸%首次%急性期反应%用药安全%预测
唑來膦痠%首次%急性期反應%用藥安全%預測
서래련산%수차%급성기반응%용약안전%예측
Zoledronic acid%First dose%Acute phase response%Drug safety%Predictive factor
目的:观察首次使用唑来膦酸的急性期反应( Acute Phase Response,APR)对血细胞计数及对肝肾功能指标变化的影响,以分析常规实验室检查是否存在APR的预测因子及评估临床用药的安全性。方法对2013年1月-2014年6月于我院首次使用唑来膦酸治疗的66例绝经后老年女性骨质疏松症患者进行回顾性研究,按是否出现APR分为反应组和无反应组。记录发生APR情况,注射前后行血液分析、生化等实验室检查,记录相关数据,统计分析使用前后数据是否存在差异,并对相关因素行多因素回归分析,试图找出APR预测因子,对比肝肾功能指标,评估用药安全性。结果66例骨质疏松症患者出现APR共42人,APR发生率为63.6%,其中最常见为发热34例(51.5%),骨关节肌肉疼痛18例(27.2%),四肢乏力12例(18.1%),呕吐5例(7.5%),头痛4例(6.0%)。注射后反应组中心粒细胞(P=0.009)、嗜酸性粒细胞(P=0.005)、碱性磷酸酶(P=0.005)较无反应组显著升高,淋巴细胞(P=0.002)及单核细胞(P=0.042)显著降低。肝肾功能指标中仅碱性磷酸酶( P=0.005)显著升高。多因素回归分析显示,较小年龄及单核细胞基线水平较高的患者更容易出现APR。结论注射唑来膦酸后APR发生率较高,但多为一过性反应,程度较轻,注射前后预防和干预能有效缓解,注射后对肝肾功能无明显影响,用药安全性较高。较小年龄及更高基线值的单核细胞与APR显著相关,但二者目前不能作为APR的准确预测因子。
目的:觀察首次使用唑來膦痠的急性期反應( Acute Phase Response,APR)對血細胞計數及對肝腎功能指標變化的影響,以分析常規實驗室檢查是否存在APR的預測因子及評估臨床用藥的安全性。方法對2013年1月-2014年6月于我院首次使用唑來膦痠治療的66例絕經後老年女性骨質疏鬆癥患者進行迴顧性研究,按是否齣現APR分為反應組和無反應組。記錄髮生APR情況,註射前後行血液分析、生化等實驗室檢查,記錄相關數據,統計分析使用前後數據是否存在差異,併對相關因素行多因素迴歸分析,試圖找齣APR預測因子,對比肝腎功能指標,評估用藥安全性。結果66例骨質疏鬆癥患者齣現APR共42人,APR髮生率為63.6%,其中最常見為髮熱34例(51.5%),骨關節肌肉疼痛18例(27.2%),四肢乏力12例(18.1%),嘔吐5例(7.5%),頭痛4例(6.0%)。註射後反應組中心粒細胞(P=0.009)、嗜痠性粒細胞(P=0.005)、堿性燐痠酶(P=0.005)較無反應組顯著升高,淋巴細胞(P=0.002)及單覈細胞(P=0.042)顯著降低。肝腎功能指標中僅堿性燐痠酶( P=0.005)顯著升高。多因素迴歸分析顯示,較小年齡及單覈細胞基線水平較高的患者更容易齣現APR。結論註射唑來膦痠後APR髮生率較高,但多為一過性反應,程度較輕,註射前後預防和榦預能有效緩解,註射後對肝腎功能無明顯影響,用藥安全性較高。較小年齡及更高基線值的單覈細胞與APR顯著相關,但二者目前不能作為APR的準確預測因子。
목적:관찰수차사용서래련산적급성기반응( Acute Phase Response,APR)대혈세포계수급대간신공능지표변화적영향,이분석상규실험실검사시부존재APR적예측인자급평고림상용약적안전성。방법대2013년1월-2014년6월우아원수차사용서래련산치료적66례절경후노년녀성골질소송증환자진행회고성연구,안시부출현APR분위반응조화무반응조。기록발생APR정황,주사전후행혈액분석、생화등실험실검사,기록상관수거,통계분석사용전후수거시부존재차이,병대상관인소행다인소회귀분석,시도조출APR예측인자,대비간신공능지표,평고용약안전성。결과66례골질소송증환자출현APR공42인,APR발생솔위63.6%,기중최상견위발열34례(51.5%),골관절기육동통18례(27.2%),사지핍력12례(18.1%),구토5례(7.5%),두통4례(6.0%)。주사후반응조중심립세포(P=0.009)、기산성립세포(P=0.005)、감성린산매(P=0.005)교무반응조현저승고,림파세포(P=0.002)급단핵세포(P=0.042)현저강저。간신공능지표중부감성린산매( P=0.005)현저승고。다인소회귀분석현시,교소년령급단핵세포기선수평교고적환자경용역출현APR。결론주사서래련산후APR발생솔교고,단다위일과성반응,정도교경,주사전후예방화간예능유효완해,주사후대간신공능무명현영향,용약안전성교고。교소년령급경고기선치적단핵세포여APR현저상관,단이자목전불능작위APR적준학예측인자。
Objective To observe the acute phase response ( APR) after the first use of zoledronic acid and its effect on whole blood cell count and the parameters of hepatorenal function before and after the use, and to analysis if the clinical and laboratory parameters can predict zoledronic acid-induced APR and the safety of the drug.Methods Sixty-six postmenopausal elderly women with osteoporosis, who were treated with intravenous zoledronic acid for the first time in our hospital from January 2013 to June 2014, were retrospectively studied.They were divided into APR group ( APR+) and no APR group ( APR-) according to their response after the infusion.The APR situation was recorded.Blood analysis, laboratory parameters, and related data before and after the injection were recorded.Data were compared and analyzed to look for the predictive factors.The hepatorenal function was compared and evaluated for the drug safety.Results Forty-three patients experienced APR ( 63.6%) .Among those, 34 had fever (51.5%), 18 had musculoskeletal pain(27.2%), 12 had limb weakness (18.1%), 5 had vomiting (7.5%), and 4 had headache ( 6.0%) .Compare to those in the APR-group, the neutrophils, eosinophilic granulocytes, and alkaline phosphatase increased significantly in the APR +group, but the lymphocytes and monocytes decreased significantly.Multifactor regression analysis showed that the patients with younger age and high level of baseline monocytes were highly correlated with APR. Conclusion The incidence of APR induced by the first use of zoledronic acid is high.Intravenous zoledronic acid is quite safe for the liver and kidney function.Our data suggest that pretreatment higher monocyte number and younger age increases the risk of APR, but both of them can not be the predictive factor of APR.