1.Research progress of T cell lymphoma: reports from 2014 international conference on T cell lymphoma in clinical treatment
Jun MA ; Jun ZHU ; Yuankai SHI ; Wenqi JIANG ; Huiqiang HUANG ; Lin QIU
Journal of Leukemia & Lymphoma 2014;23(11):641-645,653
The treatment status and progress in T cell lymphoma including epigenetic involved mutations that control DNA and histone methylation were reported and intensively discussed in 2014 international T cell lymphoma forum.According to the theory,treatment with HDAC inhibitor belinostat and romidepsin for peripheral T cell lymphoma (PTCL) can achieve 29 %-38 % overall response rate (ORR) and 13.6 months median relief time.NK/T cell lymphoma in southeast asia is a common malignant lymphoma,15 %-28 % of the NHL accounted in China and Japan for,which is significantly higher than that in the European and American countries,mainly related to EB virus widespread infection.L-asparaginase enzymes,such as SMILE and AspMetDex,can make the early cases with more than 70 % long-term survival rate,advanced cases with 40 % response rate.Some new drugs,such as pralatrexate,combined with romidepsin can be used in PTCL cases to improve the complete remission rate.
2.Efficacy of 48-week tenofovir disoproxil fumarate therapy in patients who were unresponsive to nucleoside-analogue treatments.
Mingxing HUANG ; Xinhua LI ; Yuankai WU ; Ling TAO ; Yusheng JIE ; Xiangyong LI ; Hong SHI ; Guoli LIN ; Fangji YANG ; Yunlong AO ; Yihua PANG ; Min ZHANG ; Yutian CHONG
Chinese Journal of Hepatology 2014;22(4):266-271
OBJECTIVETo evaluate the efficacy and safety of tenofovir disoproxil fumarate (TDF) in patients with chronic hepatitis B (CHB) after failure of nucleoside-analogues (NAs).
METHODSA total of 30 CHB patients who had been previously treated with NAs and had subsequently completed a 48-week course of TDF were retrospectively investigated. Patients' data of HBV DNA level (log10 copies/ml) and rate of undetectable HBV DNA at treatment weeks 0 (baseline), 4, 12, 24, 36 and 48 were collected for evaluation. The lower limit of HBV DNA detection was 100 IU/ml. The serum alanine aminotransferase (ALT) normalization rate, hepatitis B e antigen (HBeAg) seroconversion rate, viral breakthrough (VBT) rate, viral response (VR) rate, and adverse events were determined upon treatment completion. Statistical analyses were carried out using the Student's t-test, the x² test or the Kaplan-Meier method.
RESULTSOver the 48-week treatment period, HBV DNA levels declined significantly from baseline (week 4:(2.11 ± 0.38) log10 IU/ml, t =5.582; week 12:(0.93 ± 0.31) log10 IU/ ml, t =9.303; week 24:(0.75 ± 0.20) log10 IU/ml, t =3.123; week 36:(0.16 ± 0.19) log10 IU/ml, t =10.759; week 48:(0.14 ± 0.25) log10 IU/ml, t =12.202) (all P less than 0.01). However, the rates of HBV DNA reduction and of cumulative reduction were comparable at weeks 24, 36 and 48 (all P more than 0.05). The most robust decline in HBV DNA levels was observed at week 4 ((2.11 ± 0.38) log10 IU/ml) and the highest cumulative HBV DNA reduction was observed at week 24 ((3.79 ± 0.37) log10 IU/ml). The rate of undetectable HBV DNA at week 4 (26.7%) was significantly lower than that at weeks 24 (87.5%, P less than 0.01), 36 (80.0%, P=0.007), and 48 (88.9%, P=0.001). The median time to achieving undetectable HBV DNA was 10.4 weeks (range:3.43-34.0 weeks). At week 48, the rates of VR, HBeAg seroconversion, and VBT were 88.9% ,6.7%, and 0% respectively. During treatment, the levels of creatine kinase were more than two times the upper limit normal in 9.2% of the patients, and were comparable at each time point examined (all P more than 0.05). All patients showed a normal level of serum creatinine throughout the treatment period.
CONCLUSIONFor CHB patients with non-response to NAs, TDF can suppress HBV DNA replication very quickly and achieve a high rate of ALT normalization with a low rate of adverse events.
Adenine ; administration & dosage ; analogs & derivatives ; therapeutic use ; Adult ; Antiviral Agents ; administration & dosage ; therapeutic use ; DNA, Viral ; blood ; Female ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; drug therapy ; Humans ; Male ; Middle Aged ; Organophosphonates ; administration & dosage ; therapeutic use ; Retrospective Studies ; Tenofovir ; Young Adult
3.The features of MRI in spectrum of fetal cloaca malformation
Bin AI ; Hongsheng LIU ; Li HUANG ; Yuankai CHEN ; Ren YAN ; Qianqian WU
Chinese Journal of Radiology 2022;56(5):498-502
Objective:To explore the features and application value of MRI in the spectrum of fetal cloaca malformation.Methods:The clinical, MRI and ultrasound data of 6 fetuses with spectrum of cloaca malformation were retrospectively analyzed in Guangzhou Women and Children′s Medical Center Affiliated to Guangzhou Medical University from January 2017 to February 2021, and the MRI features of each subtype were analyzed.Results:Among the 6 fetuses of spectrum of the cloaca malformation, 5 were confirmed by postnatal imaging and surgery, and 1 was confirmed by induced labor autopsy, including 3 persistent cloaca, 1 posterior cloaca, 1 cloaca variant, and 1 urogenital sinus. The high signal on T 1WI of the rectal meconium disappeared or became weaker, and the signal on T 2WI of meconium of the dilated colon increased in the 3 cases of persistent cloaca and 1 case of posterior cloaca. All 6 cases showed colonic dilatation. All cases except 1 persistent cloaca showed vaginal and/or uterine effusion. Two cases of persistent cloaca, 1 case of posterior cloaca and 1 case of cloaca variant showed duplicated genital tract. Two cases of persistent cloaca showed only 1 perineal opening, which opened at the urethral orifice. One case of cloaca variant showed 2 openings, which opened at the urethral orifice and in front of the normal anus, respectively. Conclusion:Prenatal MRI can help to clarify the diagnosis of cloacal malformation spectrum and to determine its specific classification.
4. Immunocheckpoint inhibition in head and neck squamous cell carcinoma: the current status and progress
Chinese Journal of Oncology 2019;41(9):641-647
Over the past decades, although the clinical efficacy of advanced head and neck squamous cell carcinoma (HNSCC) has been moderately improved by the combination of cetuximab and chemotherapy, no remarkable treatment has emerged. The prognosis of HNSCC is still unsatisfied. With the deeper exploration of tumor immunological therapy, immunocheckpoint inhibitors such as monoclonal antibodies targeting on programmed cell death protein 1 (PD-1)/ cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) have shown appreciable anti-tumor effect on cancers such as melanoma and non-small cell lung cancer. Some successful clinical studies on HNSCC have also been reported, which provide a new opportunity for the improvement of HNSCC prognosis.Here we systemically review the progress of checkpoint inhibitors and its combination therapy in HNSCC, some immunotherapy efficacy-related biomarkers are also discussed.
5.Research on the Feasibility and Supervision Strategy of Using Intermediate Products to Prepare Children ’s Small- sized Preparations in Medical Institutions in China
Xiaoyu XI ; Mengqing LU ; Yuankai HUANG ; Rong SHAO
China Pharmacy 2020;31(20):2445-2451
OBJECTIVE:To provide reference for improving th e availability of clinical medication for children in China. METHODS:Based on the current laws and regulations of China ,referring to the relevant excellent experience and mode of foreign countries,the definition and regulatory attributes of intermediate products and final small-sized children ’s preparations were analyzed,and the feasible regulatory pathway of children ’s medicine preparedby intermediate products entering medical institutions were discussed. RESULTS & CONCLUSIONS :According to the clinical dosage and characteristics of medication ,small-sized preparations for children in medical institutions could be divided into preparations for children ’s medical institutions and personalized preparations for children. From the analysis of foreign experience ,legal policies and technical conditions ,it was feasible for medical institutions to use intermediate products to formulate children ’s small-sized preparations ,but they also faced certain difficulties as the difficulty to supervise ,unclear quality standards ,vague subject and scope of use ,etc. In terms of supervision,it wa s suggested that intermediate products should be taken as the main quality management object when children ’s small-sized preparations prepared by intermediate products entered medical institutions. Meanwhile ,quality risk management should be paid attention to it. In the management of small-sized preparations for children in medical institutions ,it is necessary to formulate the preparation specifications of small-sized preparations for children in medical institutions ,prepare guidelines for the use of excipients and improve the quality inspection standards of preparations ;in the aspect of preparation supervision ,the small-sized preparations for children in medical institutions with large clinical demand are strictly controlled ,and those with high personalized degree in medical institutions are under loose supervision ;in terms of registration and approval ,technical evaluation should be carried out at the same time as the implementation of registration/filing management ;in terms of price setting ,appropriate profit margins should be formulated according to the innovation degree ,clinical demand ,children’s family affordability and public opinion feedback of price of children ’s small-sized preparations in medical institutions. Indiviclualized preparations are forma- lated ased on the price of preparations inmedical institutions , with reference to the differential price comparice rules. Mean- while,pharmaceutical service fees are charged to compensate pharmacists’time and labor ;in terms of medical insurancepayment,the drugs are classified and managed according to whether they are included in the medical insurance list ,so as to ensure the same drug availability for children and adults .
6.Discussion on the concept of collaboration between clinical pharmacists and physicians in China
Chenyu WANG ; Yuankai HUANG ; Xiaoyu XI
China Pharmacy 2023;34(4):487-492
OBJECTIVE To make up the research gap of the concept of collaboration between clinical pharmacists and physicians in China, and to provide a theoretical basis for further improving the collaboration. METHODS Literature analysis was used to sort out the existing concepts of collaboration. Combined with the current practice and development trend of the collaboration between clinical pharmacists and physicians in China, the basic elements of the concept were deconstructed and the connotation of each component of the concept was explained in detail. RESULTS & CONCLUSIONS Based on the above theoretical research and practical analysis, the concept of collaboration between clinical pharmacists and physicians in the context of China was defined, that is, clinical pharmacists and physicians adhere to the patient-centered and rational drug use as the core in clinical drug therapy, and make joint decisions on drug management and drug therapy on the basis of communication, respect, trust and sharing, so as to ensure the effectiveness, safety and economy of clinical pharmaceutical care, and improve the coordination and cooperation process of comprehensive disease treatment system.
7.Exploration of influential factors for collaboration between clinical pharmacists and physicians in China based on literature review
Chenyu WANG ; Yuankai HUANG ; Xiaoyu XI
China Pharmacy 2022;33(22):2791-2796
OBJECTIVE To explore the influential factors for the collaboration between clinical pharmacists and physicians, and provide reference for improving the collaboration between clinical pharmacists and physicians in China. METHODS The published literature about influential factors for the collaboration between pharmacists and physicians from various countries was collected from Chinese and English databases; the division methods of influential factors for the collaboration were summarized; then the influential factors and possible mechanisms were summarized referring to the collaborative working relationship model, and the integrity and applicability of existing influential factors in Chinese health system were discussed. RESULTS & CONCLUSIONS Finally, a total of 27 pieces of literature were included and all in English. Different studies had different ways of classifying the influential factors. There were three main classifications: the perspective of the collaboration subject, the progress stage of collaboration/external and internal factors, existing collaboration conceptual model and measurement tool structure. By summarizing the existing literature, it can be obtained that there are influential factors and specific connotation for the collaboration between clinical pharmacists and physicians in China based on three dimensions of the characteristics of individual, context and exchange. In addition, the personnel situation and social publicity with Chinese characteristics can also be taken into consideration.
8.Discussion on Budget Impact Analysis Based on the Increment of Users
Jing ZHANG ; Yuankai HUANG ; Xiaoyu XI
China Pharmacy 2021;32(22):2790-2793
OBJECTIVE:To pr ovide reference for the development of pharmacoeconomic budget impact analysis and related decision-making. METHODS :Taking the incremental number of people using new intervention measures as the starting point ,a new algorithm was designed ,and the advantages and potential application scope of the new algorithm were compared with those of common algorithms. RESULTS & CONCLUSIONS :The new algorithm directly used the sales data from the real world to calculate the number of users and their increment of each intervention scheme. Compared with common algorithms ,the new algorithm did not consider the unchanged part of the number of users of each intervention scheme ,but focused on the changing part of the number of users ,avoided the estimation of the number of the target population and the users of some intervention schemes ,and could solve the problem of unreasonable or inaccurate prediction of the target population and market share by common algorithms to a certain extent ;moreover,it could be flexibly adjusted to adapt to different market conditions and medical insurance access conditions. However ,due to the strong subjectivity of key parameters (such as preemption rate )or inaccurate data sources ,the calculation results of the new algorithm are still uncertain.
9.Calculation Method of Medical Insurance Fund Expenditure of Intervention Scheme for Cross-year Survival Patients Based on Survival Data of Cohort Model
Yuankai HUANG ; Lei CHEN ; Ying LI ; Xiaoyu XI
China Pharmacy 2021;32(17):2097-2102
OBJECTIVE:To construct a calculation method which can accurately reflect the medical insurance fund expenditure of intervention scheme for cross-year survival patients ,and to provide reference for the research of medical insurance budget impact analysis(BIA). METHODS :Based on survival data of cohort model ,taking the patients diagnosed in each cycle in each year as a cohort,the number of per capita survival cycle of cohort patients in each state in the study year was calculated ,i.e. the average survival time ;on this basis ,the total cost of patients in all cohorts in the study year was calculated according to the number of people in each cohort and the per capita cost each cycle in each state. Taking the intervention scheme of a cancer as an example , the calculation was carried out by the established algorithm ,and the calculation results were compared with the results of several common algorithms ;at the same time ,the application suggestions were put forward for the expansion of the constructed algorithm in special cases. RESULTS & CONCLUSIONS :Compared with the several common algorithms ,the calculation process of the constructed algorithm is more in line with the process of medical insurance fund expenditure related to drug intervention scheme in the real world ,and it can flexibly adapt to the calculation needs in a variety of special situations. This algorithm can more accurately calculate the medical insurance fund expenditure of a intervention scheme in a specific year ,and to a certain extent solve the problem of inaccurate prediction of medical insurance fund expenditure due to insufficient consideration of cross-year survival patients or simple and rough calculation process. It can provide a more accurate method choice for the research of medical insurance BIA in China.
10.Analysis of Output Related Researches on Collaboration Between Clinical Pharmacists and Physicians in China
Lu XIA ; Yuankai HUANG ; Xiaoyu XI
China Pharmacy 2021;32(18):2277-2286
OBJECTIVE:To summarize the current output research status of collaboration between clinical pharmacists and physicians in China ,and to provide reference for comprehensively understanding the development trend of relevant research and the collaborative value of clinical pharmacists and physicians. METHODS :Literature analysis was used to sort out the general characteristics,the indexes and results of output related researches ,and investigate the focuses and results of collaboration output indexes from 3 dimensions,such as time ,hospital level and disease type /situation. RESULTS & CONCLUSIONS :In the aspect of focuses,the number of output related researches in China had decreased in recent years ,among which tertiary hospitals conducted more related researches ;secondary hospitals had few related researches and a limited perspective on evaluating outputs. On the whole,the current researches paid more attention to t he use of antibiotics in bacterial in fection. Most of the research sites were inpatient departments ,and most of the research designs were historical controlled parallel trials and single arm trials. In addition,the three output measurement indexes of safety , cpulucyxia@163.com effectiveness and economy develop diversely , scientifically and comprehensively. Ho wever,at the present ,little attention was paid to complex and dif ficult measurement indexes ,such as“cognitive level of patients ”“recurrence rate ”improvement in “quality of life ”“cost-effectiveness/benefit analysis of clinical pharmaceutical care ”. In aspect of research result ,most of the existing researches could prove that the collaboration can significantly improve medication safety ,effectiveness and economy ;the proportion of “significantly improved ”results of most indicators had been stable or had increased stage by stage. However ,there were still a small number of researches that had not carried out statistical test on the results before and after collaboration. In the future ,relevant researchers still need to strengthen the research on outpatient pharmaceutical care ,randomized controlled trials and multi disease and multi situation ,and should scientifically and reasonably select output measurement indicators and pay attention to the application of statistical methods ,so as to further expand the focus of research and comprehensively explore the value of collaboration between clinical pharmacists and physicians.