1.Expert consensus of anti-tumor drugs prescription review: kidney cancer
Min LIU ; Wei MIAO ; Chao ZHANG ; Jie ZHANG ; Yuanyuan DAI ; Mei DONG ; Jiang LIU ; Hongbing HUANG ; Qing ZHAI ; Yuguo LIU ; Ting XU ; Ping HUANG ; Wenzhou ZHANG ; Gang JIANG ; Junling CAO ; Lixia WANG ; Yancai SUN ; Mingyan JIANG ; Yongning LYU ; Xiaoyang LU ; Maobai LIU ; Ningsheng LIANG ; Zhu DAI ; Yanqing SONG ; Pengmei LI ; Guangxuan LIU ; Zhiying HAO ; Dunwu YAO ; Guiru LI ; Shujia KONG ; Ruixiang XIE ; Jianhua WANG ; Qing WEI ; Lechuan JIA ; Mei LI ; Jun MENG ; Fang CAO ; Hongzhe SHI ; Dan YAN ; Zaixian BAI ; Chen WANG ; Guohui LI ; Jie HE
Adverse Drug Reactions Journal 2021;23(6):285-292
Kidney cancer usually requires multidisciplinary individualized treatments. No matter what kind of treatment, drugs are essential. According to the "six-step process" (prescription legitimacy review, patient basic information evaluation review, treatment protocol review, organ function and laboratory index review, pretreatment review, and unconventional prescription review) in prescription review proposed by the anti-tumor drug prescription review expert group and referring to domestic and foreign kidney cancer guidelines and drug instructions in recent years, this consensus selects 9 targeted drugs and 4 immunotherapeutic drugs that are currently commonly used in China and elaborates the key review points in patient basic information evaluation review, treatment protocol review, and organ function and laboratory index review of kidney cancer drug treatment, in order to provide reference for clinical front-line pharmacists to review prescriptions of kidney cancer patients and promote rational drug use in clinic.
2.Expert consensus of anti-tumor drugs prescription review: kidney cancer
Min LIU ; Wei MIAO ; Chao ZHANG ; Jie ZHANG ; Yuanyuan DAI ; Mei DONG ; Jiang LIU ; Hongbing HUANG ; Qing ZHAI ; Yuguo LIU ; Ting XU ; Ping HUANG ; Wenzhou ZHANG ; Gang JIANG ; Junling CAO ; Lixia WANG ; Yancai SUN ; Mingyan JIANG ; Yongning LYU ; Xiaoyang LU ; Maobai LIU ; Ningsheng LIANG ; Zhu DAI ; Yanqing SONG ; Pengmei LI ; Guangxuan LIU ; Zhiying HAO ; Dunwu YAO ; Guiru LI ; Shujia KONG ; Ruixiang XIE ; Jianhua WANG ; Qing WEI ; Lechuan JIA ; Mei LI ; Jun MENG ; Fang CAO ; Hongzhe SHI ; Dan YAN ; Zaixian BAI ; Chen WANG ; Guohui LI ; Jie HE
Adverse Drug Reactions Journal 2021;23(6):285-292
Kidney cancer usually requires multidisciplinary individualized treatments. No matter what kind of treatment, drugs are essential. According to the "six-step process" (prescription legitimacy review, patient basic information evaluation review, treatment protocol review, organ function and laboratory index review, pretreatment review, and unconventional prescription review) in prescription review proposed by the anti-tumor drug prescription review expert group and referring to domestic and foreign kidney cancer guidelines and drug instructions in recent years, this consensus selects 9 targeted drugs and 4 immunotherapeutic drugs that are currently commonly used in China and elaborates the key review points in patient basic information evaluation review, treatment protocol review, and organ function and laboratory index review of kidney cancer drug treatment, in order to provide reference for clinical front-line pharmacists to review prescriptions of kidney cancer patients and promote rational drug use in clinic.
3.Comparability of serum total prostate-specific antigen measurement by four domestic chemilumines-cence immunoassays and electrochemiluminescence immunoassay
Yancai WEI ; Jialing WEI ; Yan SHI ; Kexue YE ; Miaoli SONG ; Gengchao ZHU ; Chen YANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2018;38(11):745-748
Objective To study the comparability of total prostate specific antigen ( tPSA) meas-urement by four domestic chemiluminescence immunoassays ( DCI) and electrochemiluminescence immuno-assay ( ECI) . Methods A total of 45 serum samples that requested tPSA tests were selected. Four DCIs ( Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, HYBIOME AE180) and ECI ( Roche Cobas e601) were used to measure tPSA. The precisions of the methods were evaluated. The four DCIs were com-pared with Roche ECI respectively, and the comparability of the test results was analyzed. Wilcoxon signed rank test and Spearman correlation analysis were used to analyze the data. Results The precisions of five methods were good. The tPSA levels measured by Roche Cobas e601, Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, and HYBIOME AE180 were 14.11(9.92, 36.09), 12.00(8.56, 27.23), 12.10 (8. 60, 29.87), 13.35(9.51, 32.85) and 14.50(9.88, 40.06) μg/L, respectively. The correlation coeffi-cients of Roche with Snibe MAGLUMI 4000, Mindray CL-2000i, and Autobio A2000 were 0.992, 0.989, 0. 957 and 0.983, respectively (all P<0.001). Assuming the tPSA medical decision point for regression equation was 4.0μg/L, the proportional biases of Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, and HYBIOME AE180 compared with Roche were -10. 88%, -18. 07%, 0. 23% and 22. 31%, respectively. Conclusion The comparability of tPSA test results is different between 4 DCIs and Roche ECI, which pro-vides some references for clinical application and standardization of the DCI test results.
4.Performance verification and evaluation of 4 domestic chemiluminescence systems on 8 tumor mark-ers
Yan SHI ; Yancai WEI ; Weiling ZHENG ; Jialing WEI ; Miaoli SONG ; Gengchao ZHU ; Xun LU ; Chen YANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2018;38(12):801-804
Objective To validate the performance of 4 domestic chemiluminescence immunoassay (CLIA) systems on 8 tumor markers quantitative assay kits. Methods Four domestic CLIA systems were randomly marked as A, B, C, D and 8 tumor markers, including carbohydrate antigen (CA)125, CA15-3, CA19-9, ferritin (Fer), alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), prostate-specific an-tigen (PSA) and free PSA (fPSA) were determined. According to the standard of Clinical and Laboratory Standards Institute (CLSI), the precision, methodological comparison and analytical measure range of 4 systems were validated. Clinical serum samples were obtained from patients in Suzhou Hospital. According to the CLSI EP9-A3 protocol, imported equipment was used as the reference system. The biases of medical de-cision points were assumed, and Pearson correlation analysis and Spearman correlation analysis were used to analyze the data. Results The precision verification of CA125 and PSA on A, CA125 and AFP on B, CA125, CEA, AFP and PSA on C, and all 8 tumor markers on D could meet the laboratory quality control requirements. The correlations of the test results between A-D and the imported equipment were significant (all P<0.05) with the correlation coefficients 0.79-0.99, 0.47-0.99, 0.90-0.98 and 0.78-1.00, respec-tively, and the number of acceptable tests at the level of medical decision was 5, 2, 5, 4. All tests were certified to meet the analytical measure range validation. Conclusions The detection performance of 4 do-mestic CLIA systems for all 8 tumor markers are different. The performance of domestic CLIA systems should be tested when choosing one that can meet laboratory quality control requirements.
5.Composing and evaluating the measurement uncertainty of two kinds of chemiluminescence detection system
Yancai WEI ; Yan SHI ; Shuxiang LI ; Chenlu ZHU ; Gengchao ZHU ; Chen YANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2016;36(2):171-174
Objective To compose and evaluate the measurement uncertainty of two kinds of chemiluminescence detection system using different methods.Methods The measurement uncertainty was composed by 4 different methods:(1) U 1% was composed of within-run CV(CVw %),between-run CV(CVB %)and bias (CVBias %);(2) U2% was composed of CVB % and uncertainty of calibration (CVcal %);(3) U3% was composed of CVW%,CVs% and CVcal%;(4) U4% was composed of CVW%,CVB%,CVBias% and CVcal%.The measurement uncertainty of Architect i2000SR system (Abbott,USA) and DXI800 system (Beckman,USA) was assessed.Pearson correlation analysis,Spearman correlation analysis,Paried t test and Mann-Whitney u test were performed to analyze the data.Results For Architect i2000SR system,U1%,U2%,U3% and U4% were significantly correlated (r=0.727-0.988,all P<0.05),U3% and U2% were significantly different (t =6.88,P<0.05),U4% and U1% were significantly different (t =6.21,P<0.05).For DXI800 system,U1%,U2%,U3% and U4% were also significantly correlated (r =0.608-0.975,all P<0.05),no significant difference was found between U3% and U2% (z=-1.33,P>0.05),or between U4% and U 1% (z =-1.04,P> 0.05);the expanded measurement uncertainty was correlated with CVW%,CVB%,CVBias%(rs=0.653-0.912,all P<0.05),but not with CVcal%(rs=0.548,P>0.05).Conclusions For Architect i2000SR system,the fourth method is more proper to compose the measurement uncertainty (U4%).For DXI800 system,the first method is more appropriate (U1%).According to the contribution of different components to the measurement uncertainty,the measurement quality could be improved by reducing the imprecision and bias.
6.Determination of paeonol in the bulk drug and injection by RP-HPLC
Yancai SUN ; Yuxian SHEN ; Guoping SUN ; Liming CHEN ; Jian QU ; Wei WEI
Chinese Pharmacological Bulletin 1986;0(05):-
AIM To determine the concentration of paeonol in the bulk drug and injection, a method of reversed-phase high performance liquid chromatography (RP-HPLC) was developed. METHODS Lichrospher C_ 18 column(4.6 mm?250 mm, 5 ?m)was used with methanol-acetonitrile-water(30∶40∶30)as mobile phase at a flow rate of 0.8 ml?min -1 . 20 ?l of sample was injected into the C_ 18 column where the temperature was 25℃. The detection wavelength was 274 nm. RESULTS The linear regression equation for paeonol was = 3 772.525 8 X- 0.747 4 (r = 1.000 0, n =5) under the linearity range from 0.02 mg?L -1 to 25.60 mg?L -1 . The average recovery was 99.87%. The relative standard deviations of the intra-day and inter-day were less than 4%. CONCLUSION The method is simple and rapid, which may be used for the determination of paeonol and its preparation for different purpose.

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