1.Influence evaluation of pharmaceutical quality control on medication therapy management services by the ECHO model
Kun LIU ; Huanhuan JIANG ; Yushuang LI ; Yan HUANG ; Qianying ZHANG ; Dong CHEN ; Xiulin GU ; Jinhui FENG ; Zijian WANG ; Yunfei CHEN ; Yajuan QI ; Yanlei GE ; Aishuang FU
China Pharmacy 2025;36(9):1123-1128
OBJECTIVE To evaluate the influence of pharmaceutical quality control on the efficiency and outcomes of standardized medication therapy management (MTM) services for patients with coronary heart disease by using Economic, Clinical and Humanistic Outcomes (ECHO) model. METHODS This study collected case data of coronary heart disease patients who received MTM services during January-March 2023 (pre-quality control implementation group, n=96) and June-August 2023 (post-quality control implementation group, n=164). Using propensity score matching analysis, 80 patients were selected from each group. The study subsequently compared the economic, clinical, and humanistic outcome indicators of pharmaceutical services between the two matched groups. RESULTS There were no statistically significant differences in baseline data between the two groups after matching (P>0.05). Compared with pre-quality control implementation group, the daily treatment cost (16.26 yuan vs. 24.40 yuan, P<0.001), cost-effectiveness ratio [23.12 yuan/quality-adjusted life year (QALY) vs. 32.32 yuan/QALY, P<0.001], and the incidence of general adverse drug reactions (2.50% vs. 10.00%, P=0.049) of post-quality control implementation group were decreased significantly; the utility value of the EuroQol Five-Dimensional Questionnaire (0.74± 0.06 vs. 0.71±0.07, P=0.003), the reduction in the number of medication related problems (1.0 vs. 0.5, P<0.001), the medication adherence score ([ 6.32±0.48) points vs. (6.10±0.37) points, P=0.001], and the satisfaction score ([ 92.56±1.52) points vs. (91.95±1.56) points, P=0.013] all showed significant improvements. Neither group experienced serious adverse drug reactions. There was no statistically significant difference in the incidence of new adverse reactions between the two groups (1.25% vs. 3.75%, P=0.310). CONCLUSIONS Pharmaceutical quality control can improve the quality of pharmaceutical care, and the ECHO model can quantitatively evaluate the effect of MTM services, making pharmaceutical care better priced and more adaptable to social needs, thus being worthy of promotion.
2.Establishment and validation of the determination method for the related substances in carbetocin injection
Yimiao CHEN ; Xiang ZHANG ; Jinhui WU ; Yuye Huang
Journal of China Pharmaceutical University 2025;56(1):65-72
An HPLC analytical method was developed to determine the related substances in carbetocin injection. The method was performed on a Waters Xbridge C18 column (150 mm×3 mm, 3.5 μm) with 0.30 mg/mL ammonium acetate-19% acetonitrile aqueous solution as mobile phase A and mobile phase A-acetonitrile (1∶1) as mobile phase B. The detection wavelength was 220 nm. Gradient elution was performed at the flow rate of 0.8 mL/min and the column temperature of 60℃. The method was validated for system applicability, specificity, linearity and range, accuracy, with the results that the 9 impurities of carbetocin injection showed good linearity (R²>0.999) with peak area in their respective concentration range, and that the method had good precision (RSD<5%). This method is suitable for the simultaneous determination of carbetocin and its 9 impurities in carbetocin injection and can provide a theoretical basis for the quality control of the carbetocin injection.
3.Serological analysis of anti-K and anti-Wra detected in patient treated with daratumumab: a case report
Xian HUANG ; Ying ZHAO ; Tongtong LI ; Yang YANG ; Lei MA ; Jinhui JIE ; Jinghui ZHONG
Chinese Journal of Blood Transfusion 2024;37(4):466-470
【Objective】 To investigate the reasonable serological detection method by analyzing the characteristics of anti-K and anti-Wra from a patient who received treatment with daratumumab. 【Methods】 Unexpected antibody screening and identification were performed by saline method, polybrene, cardioagglutinin, dithiothreitol (DTT) treatment, trypsin treatment and papain treatment in the patient's plasma and acid elution solution. Heat elution test was detected after absorbing patient serum with K antigen negative red blood cells. The characteristics of antibodies were analyzed and their titer was continuously detected. Cross matching was performed after excluding interference of daratumumab. 【Results】 Anti-K and anti-Wra were detected in saline and polybrene in the patient's plasma. The patient's elution solution contained daratumumab. DTT or trypsin treatment excluded interference of daratumumab but papain treatment did not. DTT treatment destroyed K antigen and missed the detection of IgG antibodies in the Kell system. Trypsin treatment did not affect K antigen and can detect IgG antibodies of Kell system(anti-k)in the serum of the patient treated with daratumumab. Anti K was IgM and the titer was 4 by saline method and it decreased to no agglutination in room temperature after 39 days. Anti-Wra was IgG and the titer by polybrene method was 4, and it decreased to 1 after 39 days. After 76 days, neither anti-K nor anti-Wra could be detected. Transfusions of K and Wra antigen negative red blood cells were safe and effective. 【Conclusion】 DTT treatment can exclude interference of daratumumab, but attention should be paid to missed detection of anti-K. To avoid interference of daratumumab and identify unexpected antibody, multiple methods such as DTT treatment, polybrene and trypsin treatment in combination are recommended.
4.Analysis and evaluation of hepatitis B test results of blood nucleic acid testing under different screening modes
Yiqin HU ; Jihong HUANG ; Min WANG ; Fangjun FENG ; Jinhui LIU ; Jie DONG
Chinese Journal of Blood Transfusion 2024;37(9):1030-1035
【Objective】 To evaluate the effectiveness of Roche Cobas s 201 in detecting HBV by analyzing its blood nucleic acid testing (NAT) results. 【Methods】 The results were grouped according to the enzyme-linked immunosorbent assay (ELISA) and NAT minipool test (MP), NAT individual test (ID) and repeated NAT ID test (rID), and categorized into 4 groups as ELISA+ /NAT(ID)+ , ELISA+ /NAT(rID)+ , ELISA-/NAT(ID)+ and ELISA-/NAT(rID)+ . The data were statistically analyzed to explore whether there was a difference in the detection of reactive results by repeated NAT, and the correlation between cycle threshold (Ct) and nucleic acid detection rate for NAT-reactive samples with different ELISA results. The true infection status of blood donors was further analyzed by supplementary tests, including NAT systems and chemiluminescence serological marker assays using other methodologies. 【Results】 A total of 1 691 groups of 766 293 blood donor samples were HBV NAT(MP)+ , of which 1 418 groups(83.86%) were detected with reactive results (1 418 HBV NAT+ , 7 090 NAT-), and there were still 273 groups (16.14%) that remained undetected after repeated testing[a total of 1 638 NAT-, Ct(MP): 39.49±3.62]. Of the HBV NAT+ , 881(62.13%) were ELISA+ /NAT(ID)+ , 19(1.34%) were ELISA+ /NAT(rID)+ , 451(31.81%) were ELISA-/NAT(ID)+ , and 67(4.72%) were ELISA-/NAT(rID)+ . For samples with different ELISA results, difference was found in the detection of HBV by repeated NAT (P<0.05). There was no difference in Ct(ID) values between groups ELISA+ /NAT(rID)+ and ELISA-/ NAT(ID)+ , and groups ELISA+ /NAT(rID)+ and ELISA-/ NAT(rID)+ (P>0.05), but there were significant differences between other groups compared pairwise (P<0.05). Supplementary tests were performed on 228 ELISA-/ NAT(MP)+ (ID)- samples, 56 (24.56%) were reactive by chemiluminescent detection of HBsAg+ and 7 (3.07%) by other NAT systems. Among the remaining 221 NAT- samples/donors (96.93%), 53 (23.98%) HBsAg+ donors were likely to have chronic infection, 40 (18.10%) anti-HBe+ and/or anti-HBc+ donors might have previous infections, and the remaining 128 (57.92%) donors who were non-reactive were NAT (MP) pseudo-reactive, with significant differences in anti-HBs levels \'between groups (P<0.05). 【Conclusion】 Repeated NAT has differential detection of donor samples with different reactivity categories or different serologic results, especially within a certain interval, and repeated NAT for ELISA- samples can significantly improve the detection rate. Ct values can assist in assessing the stability and accuracy of the NAT system. For ELISA-/NAT(MP)+ (ID)- donors, the combination of other highly sensitive assays can reduce the risk of viral residuals and safeguard clinical blood safety.
5.Preparation and properties of selective laser melting of porous titanium at a low energy density
Jinhui CHENG ; Quan WU ; Min PENG ; Changli HUANG ; Huimin TIAN ; Yang LI
Chinese Journal of Tissue Engineering Research 2024;28(5):664-668
BACKGROUND:At present,the traditional powder sintering method is easy to introduce impurities in the process of preparing porous titanium,and the manufacturing of porous titanium still faces two major problems:impurity pollution and difficult control of the material forming process. OBJECTIVE:To prepare pure porous titanium with certain porosity,and analyze the microstructure evolution and properties of the porous titanium. METHODS:Porous titanium was prepared at a low energy density by selective laser melting technology.The parameter range of porous titanium with large porosity was obtained by measuring the porosity of the formed specimen,and the evolution of the microstructure and mechanical properties of the specimen in the range were analyzed. RESULTS AND CONCLUSION:(1)With the increase in energy density,the porosity of the porous titanium specimen decreased gradually.When the energy density was between 10.61 and 27.78 J/mm3,porous titanium with a porosity of 11.23%-33.67%could be formed.When the energy density was between 27.78-37.88 J/mm3,the forming parts were relatively dense.(2)The phase composition of porous titanium formed was mainly α titanium.With the increase in energy density,the porosity gradually decreased,and the pore morphology changed from irregularly connected pores to closed nearly spherical pores.The powder particles changed from a slightly sintered neck to a continuous fuse.The CT scan results revealed that there were a large number of connected pores in the forming specimen with a large specific surface area and the pore radius was roughly distributed between 2-6 μm at the energy density of 10.61 J/mm3.Simultaneously,porous titanium with compressive strength of 188-1 000 MPa could be obtained at the energy density of 10.61-27.78 J/mm3,which could meet the requirements of biomedical applications.(3)These results have confirmed that the selective laser melting technology can overcome the problems of impurity pollution and long manufacturing cycle caused by the traditional preparation process,and provide an effective solution for the preparation of porous titanium with excellent mechanical properties.
6.Impact of early and timely treatment and initial antiviral treatment regimen on antiviral treatment mortality and attrition among HIV-infected patients in Liuzhou, Guangxi
QIN Litai ; HUANG Jinghua ; CHEN Huanhuan ; LAN Guanghua ; FENG Yi ; XING Hui ; ZHU Jinhui ; CAI Wenlong ; RUAN Yuhua ; ZHU Qiuying ; XIE Yihong
China Tropical Medicine 2024;24(2):126-
Objective To understand the impact of early and timely treatment and initial antiviral treatment regimen on mortality and attrition of antiretroviral therapy. Methods A retrospective cohort study was conducted using download data on antiretroviral therapy for HIV-infected patients in Liuzhou City, Guangxi Province, from the database of the Basic Information System for AIDS Control and Prevention (BISAC) from 2010 to 2020. The Cox proportional risk regression model was used to analyze the influencing factors of mortality and attrition. Results A total of 15 713 infected patients were included, including 53.4% aged 18-<50 years, 69.4% male, 61.0% farmer, 75.1% CD4 count <350 cells /μL before initial antiviral treatment, the overall mortality rate was 4.30/100 person-years, and the overall attrition was 2.42/100 person-years. The results of Cox regression analysis showed that the influencing factors of mortality were pretreatment CD4 counts of 350-<500 cells/μL(AHR=0.72, 95%CI: 0.63-0.81) and ≥500 cells/μL (AHR= 0.64, 95%CI: 0.55-0.76); duration from diagnosis to initial antiviral treatment 91-180 days (AHR=1.25, 95%CI: 1.08-1.45), 181-365 days (AHR=1.26, 95%CI: 1.08-1.47), and ≥365 days (AHR=1.26, 95%CI: 1.11-1.44); initial antiviral treatment regimens of D4T+3TC+EFV/NVP (AHR=1.47, 95%CI: 1.32-1.63) and AZT/D4T/TDF+3TC+LPV/r (AHR=1.73, 95%CI: 1.50-1.99). Factors affecting attrition were pretreatment CD4 counts of 350-499 cells/μL (AHR=1.32, 95%CI: 1.16-1.50) and ≥500 cells/μL (AHR=1.28, 95%CI: 1.10-1.50); interval from HIV positivity confirmation to initial dosing ≥365 days (AHR=1.21, 95%CI: 1.04-1.40), initial antiviral treatment regimens of TDF+3TC+NVP (AHR=1.32, 95%CI: 1.13-1.55), AZT+3TC+EFV/NVP (AHR=1.43, 95%CI: 1.26-1.62) and AZT/D4T/TDF+3TC+LPV/r (AHR=1.33, 95CI%: 1.06-1.67). Conclusions Early and timely treatment and the initial antiviral treatment regimen of TDF+3TC+EFV have good efficacy, but attention should be paid to the high risk of attrition of HIV-infected people with high CD4 count before treatment.
7.Value of serum Lp-PLA2 in the diagnostic grading and prognostic assessment of pneumonia-related acute respiratory distress syndrome
Yujia YANG ; Baojun DONG ; Jinhui QU ; Jin HUANG ; Xue BAI ; Hongwei YANG
Chinese Journal of Clinical Laboratory Science 2024;42(8):580-585
Objective To explore the value of lipoprotein-associated phospholipase A2(Lp-PLA2)in the diagnostic grading and prog-nostic assessment of pneumonia-associated acute respiratory distress syndrome(p-ARDS).Methods The study was a prospective ob-servational study.Fifty-seven patients with p-ARDS admitted to the ICU ward of Tianjin Hospital from January 2022 to August 2023 were included as the research subjects.Twenty-six pneumonia patients admitted to the general respiratory ward during the same period and 10 healthy individuals undergoing medical examinations were selected as the control group.Their serum samples were collected,and the samples from p-ARDS and pneumonia patients were obtained within 24 hours of admission.The levels of serum Lp-PLA2,in-terleukin 6(IL-6),and IL-8 were detected using the Luminex? multiplex test kit.The baseline data and laboratory test results,inclu-ding routine blood parameters,biochemical markers,C-reactive protein(CRP),procalcitonin(PCT),and D-dimer at admission,were collected from the patients with p-ARDS or pneumonia.The levels of serum Lp-PLA2 were compared by grouping based on clinical diagnosis,severity of ARDS,and clinical outcomes on day 28 after admission.The diagnostic and prognostic value of serum Lp-PLA2 in p-ARDS was evaluated by plotting the receiver operating characteristic(ROC)curve,Spearman correlation analysis,and Logistic regression analysis.Results The levels of serum Lp-PLA2 in the p-ARDS group([233.67±83.49]ng/mL)were significantly higher than that in the pneumonia group([150.86±39.48]ng/mL,P<0.05),while those in the pneumonia group were significantly higher than that in the healthy control group([150.86±39.48]ng/mL vs[92.07±12.89]ng/mL,P<0.05).The analysis results of the ROC curve showed that serum Lp-PLA2 had a better ability to distinguish p-ARDS from pneumonia than indicators such as IL-6,IL-8,CRP,and PCT,with an area under the ROC curve(AUCROC)of 0.781(95%CI:0.685-0.878).The diagnostic value of serum Lp-PLA2 combined with D-dimer was higher,with an AUCROC of 0.897(95%CI:0.832-0.963).Subgroup analysis found that as lung inju-ry worsened,the levels of serum Lp-PLA2 increased,and that serum Lp-PLA2 levels were negatively correlated with the PaO2/FiO2 ra-tio in p-ARDS patients(r=-0.549)and positively correlated with the sequential organ failure assessment(SOFA)scores at admission(r=0.412).The levels of serum Lp-PLA2 in the death group of p-ARDS were significantly higher than that in the survival group([314.5±43.1]ng/mL vs[174.9±48.9]ng/mL,P<0.001).Logistic regression analysis showed that after adjusting for the SOFA score,serum Lp-PLA2 was independently associated with the mortality risk on day 28 after admission(OR=1.099,95%CI:1.026-1.178,P=0.007).Similar results were obtained after adjusting for IL-8 or the PaO2/FiO2 ratio.Conclusion Serum Lp-PLA2 may be used as a biomarker to aid in the diagnostic grading and prognostic assessment of p-ARDS.
8.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
9.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
10.Analysis of ABO allelic enhancement phenomenon in 20 cases with ABO*AW.37 allele
Xian HUANG ; Shuangyu LI ; Tongtong LI ; Lina WU ; Jinhui XIE ; Lei MA ; Jinghui CHONG ; Shiping AN
Chinese Journal of Blood Transfusion 2024;37(8):886-889
Objective To investigate the serological and molecular characteristics of twenty blood samples carrying ABO?AW.37 allele and to analyze ABO allelic enhancement.Methods The ABO phenotype of the twenty samples was de-termined by serological methods and the genotype of 1-7 ABO exons was analyzed by Sanger sequencing.Results Sequen-cing analysis showed that all twenty samples contained a c.940A>G(p.Lys314Glu)mutation of A allele,which was defined as ABO?AW.37.When ABO?AW.37 and B alleles were inherited simultaneously in 9 cases,in forward typing anti-A anti-bodies all agglutinated and the serological phenotype was Aw B.Among the 11 cases with ABO?AW.37 and O alleles inherited simultaneously,there was no agglutination of anti-A in forward typing.For absorption and elution tests,5 cases were weakly positive and the serological phenotype was Ael,while 6 cases were negative for absorption and elution tests and the serologi-cal phenotype was O type.Conclusion Allelic enhancement occured when both ABO?AW.37 allele and B allele were in-herited simultaneously.When ABO? AW.37 was inherited simultaneously with O allele,the serological phenotype was Aelor O type and attention should be paid to blood type identification.

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