OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment. METHODS The design， planning， and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） followed the WHO Handbook for Guideline Development （2nd edition）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

BACKGROUND: Clinical trial evidence is limited to identify better topical non-steroidal anti-inflammatory drugs (NSAIDs) for treating knee osteoarthritis (OA). We aimed to compare the clinical efficacy and safety of flurbiprofen cataplasms (FPC) with loxoprofen sodium cataplasms (LSC) in treating patients with knee OA. METHODS: This is an open-label, non-inferiority randomized controlled trial conducted at Peking University Shougang Hospital. Overall, 250 patients with knee OA admitted from October 2021 to April 2022 were randomly assigned to FPC and LSC treatment groups in a 1:1 ratio. Both medications were administered to patients for 28 days. The primary outcome was the change of pain measured by visual analog scale (VAS) score from baseline to day 28 (range, 0-10 points; higher score indicates worse pain; non-inferiority margin: 1 point; superiority margin: 0 point). There were four secondary outcomes, including the extent of pain relief, the change trends of VAS scores, joint function scores measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and adverse events. RESULTS: Among 250 randomized patients (One patient without complete baseline record in the flurbiprofen cataplasms was excluded; age, 62.8 ± 10.5 years; 61.4% [153/249] women), 234 (93.6%) finally completed the trial. In the intention-to-treat analysis, the decline of the VAS score for the 24-h most intense pain in the FPC group was non-inferior, and also superior to that in the LSC group (differences and 95% confidence interval, 0.414 (0.147-0.681); P <0.001 for non-inferiority; P = 0.001 for superiority). Similar results were observed of the VAS scores for the current pain and pain during exercise. WOMAC scores were also lower in the FPC group at week 4 (12.50 [8.00-22.50] vs . 16.00 [11.00-27.00], P = 0.010), mainly driven by the dimension of daily activity difficulty. In addition, the FPC group experienced a significantly lower incidence of adverse events (5.6% [7/124] vs . 33.6% [42/125], P <0.001), including irritation, rash and pain of the skin, and sticky hair uncovering pain. CONCLUSIONS This study suggested that FPC is superior to LSC for treating patients with knee OA in pain relief, joint function improvement, and safety profile.
Humans ; Female ; Middle Aged ; Aged ; Osteoarthritis, Knee/drug therapy* ; Flurbiprofen/therapeutic use* ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use* ; Pain/drug therapy* ; Treatment Outcome ; Double-Blind Method

OBJECTIVE To analyze the adverse drug reaction （ADR）signals of ado-trastuzumab emtansine and brentuximab vedotin，so as to provide reference for clinical medication safety. METHODS Using the FDA adverse drug event reporting system （FAERS）database and OpenVigil 2.1 data platform ，the ADR of the two drugs were collected from being approved by FDA to the Sep. 30th，2021. The ADR signals were detected by frequency method and sorted according to the occurrence frequency and signal strength respectively. RESULTS & CONCLUSIONS A total of 2 319 and 3 178 ADR reports related to ado-trastuzumab emtansine and brentuximab vedotin were collected ，215 and 329 ADR signals were detected respectively. According to the occurrence frequency，the most frequent ADR s of the two drugs were thrombocytopenia （109 cases）and febrile neutropenia （198 cases）， separately，which were consistent with the drug instructions. According to the signal strength ，the spider nevus of ado-trastuzumab emtansine（report odds ratio of 451.46）and the noninfectious endocarditis of brentuximab vedotin （report odds ratio of 304.35） ranked first ，both of which were not reported in the drug instructions. It is suggested that attention should be paid not only to the most common ADR s of blood and lymphatic system caused by both drugs ，but also to the ADRs not reported in the drug instructions such as spider nevus of ado-trastuzumab emtansine and noninfective endocarditis of brentuximab vedotin.

Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment ， Development，and Evaluation （GRADE）approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ，this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ，involving evaluation prior to administration （liver and renal function ，pleural effusion and ascites ， comedication，genetic testing ），pre-treatment and routine dosing regimen （pretreatment of hydration and alkalization ，urine alkalization，routine dosing regimen ），therapeutic drug monitoring （necessity，method，timing，target concentration ），leucovorin rescue（rescue timing ，rescue regimen ，rescue dose optimization ），and management of toxicities （liver and kidney function monitoring，supportive treatment ，blood purification treatment ）. This article aims to summarize and interpret the recommendations of this guideline ，so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.

OBJECTIVE：To evaluate th e effectiveness ，safety and economy of albu min-bound paclitaxel （nab-PTX）in the treatment of breast cancer by using rapid health technology assessment （HTA），and to provide evidence-based reference for drug selection. METHODS ：Retrieved from PubMed ，the Cochrane Library ，CNKI，Wangfang database and other databases ，systematic evaluation/Meta-analysis，HTA and pharmacoeconomic studies about nab-PTX in the treatment of breast cancer were included ；the conclusions were classified and analyzed by using descriptive analysis. RESULTS ：A total of 5 systematic reviews/Meta-analysis ， 8 pharmacoeconomic studies were included in this study. Compared with conventional taxanes ，nab-PTX increased pathological complete response （pCR）rate [OR ＝1.39，95％CI（1.16，1.67），P＜0.001] and event-free survival （EFS）[HR＝0.69，95％CI（0.57， 0.85），P＜0.001] in neoadjuvant chemotherapy （NAC）-treated breast cancer patients. However ，there were no significant differences in overall survival （OS），progression-free survival （PFS），objective response rate （ORR）and disease control rate （DCR）in metastatic breast cancer （MBC）patients between 2 groups. In the terms of safety ，nab-PTX increased the incidence of grade 3-4 sensory neuropathy [OR ＝1.89，95％CI（1.36，2.61），P＜0.001] in MBC patients ，and increased the incidence of neutropenia [OR ＝ 1.52，95％CI（1.23，1.88，P＜0.001]，sensory neuropathy [OR ＝ 2.17，95％CI（1.38，3.40），P＜0.001]，rash [OR ＝1.46，95％CI mei1213@163.com （1.18，1.80），P＜0.001] and fatigue [OR ＝1.28，95％CI（1.04， 1.56）， P＝0.02] in NAC -treated breast cancer patients.Pharmacoeconomic studies showed that nab-PTX could improve the quality adjusted lif e years of MBC patients compared with traditional taxanes ，and it was a economical option. CONCLUSIONS：Nab-PTX enhances pCR in NAC-treated breast cancer patients ，but has no significant advantage in the effectiveness of MBC patients ，and increases the occurrence of ADR. Nab-PTX may have a cost-utility advantage over conventional taxanes for MBC.

OBJECTIVE：To evaluate the benefit and risk of tirofiban in the treatment of acute coronary syndrome （ACS），and to provide evidence-based reference for clinical drug selection and decision. METHODS ：Retrieved from domestic and foreign database as PubMed ，the Cochrane Library ，CNKI and Wanfang database ，during the establishment of database to Apr. 2020，two researcher independently screened the literature based on inclusion and exclusion criteria and extracted the data. After the quality evaluation of the included literatures ，based on rapid health technology assessment ，the extracted results were classifiedly evaluated and comprehensively analyzed. RESULTS ：A total of 13 researches of systematic review/Meta-analysis and 1 research of pharmacoeconomics were included. Compared with placebo ，tirofiban could significantly reduce all-cause mortality [OR ＝0.68， 95％CI（0.54，0.86），P＝0.000 1] and the incidence of major adverse cardiac events （MACE）in patients with ACS [RR ＝0.24， 95％CI（0.14，0.40），P＜0.01]，and increased the incidence of TIMI 3 [OR＝5.73，95％CI（2.99.10.97），P＜0.01]. Tirofiban and eptifibatide had similar therapeutic efficacy in the treatment of ACS ，but tirofiban significantly increased the risk of TIMI small bleeding in patients with ACS [RR ＝0.61，95％CI（0.38，0.98），P＝0.04]. For ACS patients with non-ST elevation （NSTE-ACS）， compared with placbo ，tirofiban significantly reduced the incidence of MACE [RR ＝0.76，95％ CI（0.61，0.96），P＝0.018]，but significantly increased the risk of bleeding [OR ＝1.49，95％CI（1.12，1.98），P＝0.006]，while there was no significant difference in its effects on the all-cause mortality of NSTE-ACS patients （P＞0.05）. For STEMI patients ，compared with placebo ，tirofiban significantly reduced the all-cause mortality [RR＝0.61，95％CI（0.35，1.05），P＝0.007] and the incidence of MACE [RR ＝0.63，95％ CI（0.44，0.90），P＝0.007]. When combined with liposuction ，tirofiban also significantly reduced the incidence of MACE [RR ＝ 2.05，95％CI（1.71，2.46），P＜0.01]，and significantly increased the incidence of TIMI 3 [OR＝3.18，95％ CI（2.4，4.22），P＜ 0.01]，but there was no significant difference in its effects on bleeding risk （P＞0.05）. The included pharmacoeconomic study showed that patients treated with bivalutine could get 10.07 QALYs，patients treated with heparin combined with tirofiban could get 9.98 QALYs，and the incremental cost-effectiveness ratio bivalutine compared to the latter one was 28 575.77 yuan/QALYs，which was lower than 3 times of the per capita GDP of some cities. CONCLUSIONS ：Tirofiban has good efficacy in the treatment of ACS，but it can increase the risk of bleeding than eptifibatide and placebo. Domestic bivalirudin treating for ACS has a cost-effectiveness advantage over tirofiban combined with heparin.

OBJECTIVE：To provid e reference for pharmaceutical workers to better understand Novel Coronavirus Infection ： Expert Consensus on Guidance and Prevention Strategies for Hospital Pharmacists and the Pharmacy Workforce （hereinafter referred to as “expert consensus ”），and to apply and practice in specific work ，so as to give full play to the role of pharmacists to help fight the epidemic.METHODS ：The background of the formulation and revision of the expert consensus were introduced ，and its main contents and viewpoints were interpreted. RESULTS & CONCLUSIONS ：The text of expert consensus is divided into 8 parts，mainly including disease diagnosis and treatment [SARS-CoV- 2 infection related background ，clinical manifestations and diagnosis， treatment]，hospital pharmacy （prevention and control strategy ，work guidance ），drug and facility support management（key drug/facility/equipment support ，management and use of the drug in special circumstances ），information sources and related resources ，etc.，which comprehensively and detailedly provide information ，guidance and strategies for coronavirus SARS-CoV-2 infection prevention and control to play the role of pharmacists in hospital pharmacy well ，do well in the protection of staff in different pharmaceutical posts ，drug security work in response to epidemic situation ，and develop pharmaceutical care. So far，the understanding of SARS-CoV- 2 in the pharmaceutical industry is relatively limited. Based on the accumulated experience and progress in epidemic prevention and control ，the expert consensus will be updated and improved continuously ，so as to provide guidance and help for hospital pharmaceutical personnel.

OBJECTIVE：To provide drug ，material supp ly and emergency management reference for novel coronavirus （SARS-CoV-2）infection in pharmacy staff in hospital. METHODS ：The method of 5M1E was used to analyze the six main factors，including man ，machine，material，method，environment and measurement of drug ，material supply and emergency management. The relevant prevention and control strategies were put forward. RESULTS & CONCLUSIONS ：In the drug ，material supply and emergency management of epidemic prevention and control ，the man factors were involved ，such as mainly pharmacists from pharmacy departments of medical institutions. At the same time ，the management also involved machine factors such as drug storage，cleaning and disinfection ；material factors such as emergency drugs ，disinfection products ，in vitro diagnostic reagents ， the guarantee of medicine materials for medical team ，investigational products ；methods factors such as relevant management measures；environmental factors such as storage environment and facilities ；measurement factors such as drug use ，drug and substance reserve. In view of the above factors ，it is suggested to strengthen the professional knowledge and communication skills training of pharmacists ，and strengthen humanistic care ，so as to improve their post competency ，communication in emergency response and psychological tolerance. Equipment and materials management shall be strengthened ，and equipment maintenance and disinfection shall be done well to ensure normal use of equipment. According to the evidence-based method ，the emergency drug list should be established. According to the disinfection protection requirements ，the disinfection products should be reasonably selected and their quality and sufficient inventory should be ensured. The qualified in vitro diagnostic reagents should be purchased in time. The investigational products should be managed reasonably according to the relevant requirements of clinical trials ，to ensure the drug and material supply of medical team members. Emergency plans and standard operating procedures shall be formulated，the principle of sympathetic drug use shall be followed ，and the management of off-label drug use and early warning of drug and material shortage shall be done well. Reasonable storage space should be reserved to strengthen environmental monitoring and disinfection. We should strengthen the monitoring and reporting of daily data ，strengthen the quality monitoring ， and accept the independent audit of the third party. Above strategies are helpful to improve the ability of drug supply risk identification and response ability ，and cooperate with the medical team to timely rescue patients.

OBJECTIVE：To pro vide reference for exposure protection countermeasures for Novel coronavirus （SARS-CoV-2） infection in hospital pharmaceutical staff. METHODS ：According to the recommendations of related medical staff protection guideline，combined with the characteristics and prevention and control requirements of novel coronavirus pneumonia （COVID- 19），based on the basic principle of exposure protection ，actual exposure risk of infections for hospital pharmaceutical staff were evaluated，and the countermeasures for exposure protection were constructed under the epidemic condition of COVID- 19. RESULTS：According to the standard prevention principle and the risk evaluation of infection exposure ，most of the pharmaceutical posts in the hospital belonged to low-risk exposure posts ，and only a few posts belonged to medium-and high-risk exposure posts. Personal protective equipment should be provided according to the exposure risk level of different pharmaceutical posts and work demand. At the same time ，infection protection training should be strengthened ；environment and facilities in pharmacy should be cleaned and disinfected. CONCLUSIONS ：Standard prevention principle should be followed by hospital pharmaceutical staff during epidemic period. Based on the characteristics and exposure risks of pharmacy posts ，and according to the regulations of the hospital，personal protection for hospital pharmaceutical staff should be conducted according to the exposure risk level determined by the pharmaceutical department and relevant management regulations to avoid over-protection or inadequate protection ，so as to ensure the smooth and safe development of pharmaceutical care.