1.Clinical practice guidelines for intraoperative cell salvage in patients with malignant tumors
Changtai ZHU ; Ling LI ; Zhiqiang LI ; Xinjian WAN ; Shiyao CHEN ; Jian PAN ; Yi ZHANG ; Xiang REN ; Kun HAN ; Feng ZOU ; Aiqing WEN ; Ruiming RONG ; Rong XIA ; Baohua QIAN ; Xin MA
Chinese Journal of Blood Transfusion 2025;38(2):149-167
Intraoperative cell salvage (IOCS) has been widely applied as an important blood conservation measure in surgical operations. However, there is currently a lack of clinical practice guidelines for the implementation of IOCS in patients with malignant tumors. This report aims to provide clinicians with recommendations on the use of IOCS in patients with malignant tumors based on the review and assessment of the existed evidence. Data were derived from databases such as PubMed, Embase, the Cochrane Library and Wanfang. The guideline development team formulated recommendations based on the quality of evidence, balance of benefits and harms, patient preferences, and health economic assessments. This study constructed seven major clinical questions. The main conclusions of this guideline are as follows: 1) Compared with no perioperative allogeneic blood transfusion (NPABT), perioperative allogeneic blood transfusion (PABT) leads to a more unfavorable prognosis in cancer patients (Recommended); 2) Compared with the transfusion of allogeneic blood or no transfusion, IOCS does not lead to a more unfavorable prognosis in cancer patients (Recommended); 3) The implementation of IOCS in cancer patients is economically feasible (Recommended); 4) Leukocyte depletion filters (LDF) should be used when implementing IOCS in cancer patients (Strongly Recommended); 5) Irradiation treatment of autologous blood to be reinfused can be used when implementing IOCS in cancer patients (Recommended); 6) A careful assessment of the condition of cancer patients (meeting indications and excluding contraindications) should be conducted before implementing IOCS (Strongly Recommended); 7) Informed consent from cancer patients should be obtained when implementing IOCS, with a thorough pre-assessment of the patient's condition and the likelihood of blood loss, adherence to standardized internally audited management procedures, meeting corresponding conditions, and obtaining corresponding qualifications (Recommended). In brief, current evidence indicates that IOCS can be implemented for some malignant tumor patients who need allogeneic blood transfusion after physician full evaluation, and LDF or irradiation should be used during the implementation process.
2.Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain:a rapid health technology assessment
Ning GAO ; Bing FENG ; Shengnan GAO ; Ranran ZHANG ; Yuxi ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(8):1001-1007
OBJECTIVE To evaluate the efficacy, safety and economics of calcium channel modulators in the treatment of diabetic peripheral neuropathic pain (DPNP), and provide evidence-based evidence for clinical drug selection and decision-making. METHODS PubMed, Embase, Cochrane Library, CNKI, Wanfang data, VIP net, CBM and official websites of foreign health technology assessment (HTA) institutions were systematically searched to collect HTA reports, systematic review/meta-analyses, and pharmacoeconomic studies of pregabalin, gabapentin, crisugabalin, and mirogabalin for the treatment of DPNP. The timeframe for all searches was from the inception to June 2024. After data extraction and quality assessment, the results of the included studies were analyzed descriptively. RESULTS A total of 16 articles were included, involving 1 HTA report, 7 systematic reviews/meta- analyses, and 8 pharmacoeconomic studies. No studies on crisugabalin were retrieved. Compared with placebo, both pregabalin and mirogabalin reduced end point pain scores and increased the proportion of patients with ≥30% and/or ≥50% reduction in pain scores. Pregabalin also improved patient global impression of change (PGIC). Gabapentin was similar to placebo in reducing end point pain scores and increasing the proportion of patients with ≥30% and/or ≥50% reduction in pain scores, but gabapentin improved PGIC of patients. Compared with pregabalin, mirogabalin was more effective in the treatment of pain. The safety of pregabalin and mirogabalin was similar, and compared with placebo, both pregabalin and mirogabalin increased the risk of common adverse reactions such as dizziness and somnolence. The safety of gabapentin was similar to placebo and duloxetine. Compared with duloxetine, pregabalin and gabapentin were not cost-effective. Compared with gabapentin, pregabalin was cost-effective. Mirogabalin was cost-effective, as compared with placebo and pregabalin. CONCLUSIONS Pregabalin and mirogabalin are effective in the treatment of DPNP, the efficacy of mirogabalin is better than pregabalin, and the safety is similar between them. The economic conclusions vary from country to country, pending a pharmacoeconomic study based on our population.
3.Literature Review on Adverse Events and Introduction of "Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy"
Masaaki SUGAWARA ; Taro MIYAWAKI ; Yasufumi FUKUYO
Journal of the Japan Society of Acupuncture and Moxibustion 2025;75(1):67-74
The Safety Committee, Clinical Information Department, Japan Society of Acupuncture and Moxibustion (JSAM) held a workshop at its 73rd Annual Meeting in Miyagi titled "Literature Review on Adverse Events and Introduction of the Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy." The following topics were presented, followed by a question-and-answer session: 1. Literature Review on Adverse Events Associated with Moxibustion 2. Literature Review on Adverse Events Associated with Acupuncture 3. Introduction of the "Practical Manual for Safety Management of Acupuncture and Moxibustion Therapy" The manual was published in July 2024, and members are encouraged to read it and use it as a safety reference for daily practice settings.
4.CARE guidelines for case reports
Yuse OKAWA ; Sumire ISHIYAMA ; Yuto MATSUURA ; Hitoshi YAMASHITA
Journal of the Japan Society of Acupuncture and Moxibustion 2025;75(1):93-102
Case reports are an indispensable research format in the advancement of medicine. They play a significant role in accumulating medical knowledge on new or rare diseases and evaluating the efficacy and safety of therapeutic interventions. Furthermore, case reports provide a critical opportunity for generating new research hypotheses and are widely recognized for their value as essential educational tools for healthcare professionals. However, some case reports fail to include sufficient essential information, and their incompleteness or lack of transparency may lead to misinterpretation by readers. To address these issues, the CARE (CAse REport) guidelines were established in 2013, providing standards to improve the completeness and transparency of case reports. The CARE guidelines comprehensively cover essential reporting items for case reports in various fields. By adhering to these guidelines, authors can ensure the completeness of information and achieve transparent reporting. However, there still does not seem to be sufficient recognition and dissemination of the CARE guidelines in Japan. Therefore, this article introduces the key components of the CARE guidelines and discusses their application, particularly in the field of acupuncture practice. It is hoped that the wider use of the CARE guidelines in case reports related to acupuncture will enhance reporting quality and facilitate the provision of more reliable and credible information.
6.Cost-utility analysis of capecitabine metronomic chemotherapy combined with aromatase inhibitor as first-line treatment for HR+/HER2- metastatic breast cancer
Ranran ZHANG ; Guoqiang LIU ; Yuxi ZHANG ; Shengnan GAO ; Ning GAO ; Bing FENG ; Ran LIU ; Qian LI
China Pharmacy 2025;36(15):1893-1898
OBJECTIVE To evaluate the cost-effectiveness of capecitabine metronomic chemotherapy combined with aromatase inhibitor (AI) versus AI monotherapy as first-line treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, thereby providing evidence-based support for clinical therapeutic decision- making and healthcare policy formulation. METHODS Based on the MECCA trial, a partitioned survival model was constructed using a 4-week cycle length to simulate outcomes over patients’ lifetime. The model outputs included total costs, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed to validate the robustness of base-case results, while scenario analyses examined the cost-effectiveness of both treatment strategies under 10-year, 20-year, and lifetime time horizons. RESULTS With the willingness-to-pay (WTP) threshold set at 1 times China’s 2024 per capita gross domestic product (GDP) (95 749 yuan/QALY), patients receiving capecitabine metronomic chemotherapy combined with AI regimen gained incremental utility (0.66 QALYs) while incurring higher costs, with ICER of 27 684.85 yuan/QALY. Results of the one-way sensitivity analysis showed that factors with significant impacts on ICER included the cost discount rate, drug costs of the capecitabine metronomic chemotherapy combined with AI group, utility value in the progression-free survival state, follow-up costs, and treatment costs in the subsequent stablephase. Probabilistic sensitivity analysis indicated that when the WTP threshold ≥49 250 yuan/QALY, the capecitabine metronomic chemotherapy combined with AI regimen had a 100% probability of being cost-effective. Scenario analysis results demonstrated that capecitabine metronomic chemotherapy combined with AI regimen was more cost-effective than the AI alone regimen across 10-year, 20-year, and lifetime study horizons. CONCLUSIONS Under the premise that the WTP threshold is set at 1 times China’s per capita GDP in 2024, capecitabine metronomic chemotherapy combined with AI regimen is more cost-effective than the AI alone regimen as the first-line treatment for HR+/HER2- metastatic breast cancer.
7.Cost-effectiveness analysis of sacituzumab tirumotecan versus single-agent chemotherapy in second-line and later-line treatment for metastatic triple-negative breast cancer
Ranran ZHANG ; Yuxi ZHANG ; Shengnan GAO ; Bing FENG ; Ning GAO ; Guoqiang LIU
China Pharmacy 2025;36(16):2024-2029
OBJECTIVE To evaluate the cost-effectiveness of sacituzumab tirumotecan (ST) versus chemotherapy treatment physician’s choice (TPC) as second-line and later-line treatment for metastatic triple-negative breast cancer (mTNBC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was constructed based on the OptiTROP-Breast 01 trial, with a cycle length of 4 weeks and a time horizon of 10 years, applying a 5% discount rate. Quality adjusted life year (QALY) and costs were used as outcome measures, and the incremental cost-effectiveness ratio (ICER) of ST versus TPC for second-line and later-line treatment of mTNBC was calculated. Sensitivity analyses were conducted to validate the robustness of the base-case results. RESULTS At a willingness-to-pay threshold (WTP) of 3 times China’s 2024 per capita gross domestic product (GDP) (287 247 yuan/QALY), patients receiving ST gained incremental utility (0.42 QALY) at a higher cost, yielding an ICER of 205 562.07 yuan/QALY, which was lower than WTP, indicating that ST was more cost-effective compared to TPC. One-way sensitivity analysis revealed that key factors influencing the ICER included the utility value of progression-free survival and the price of ST. Probabilistic sensitivity analysis and scenario analysis showed that the base-case results were robust. CONCLUSIONS From the perspective of China’s healthcare system, at a WTP of 3 times China’s per capita GDP, ST is more cost-effective than TPC as second-line and later-line treatment for mTNBC.
8.International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025).
Sheng-Sheng ZHANG ; Lu-Qing ZHAO ; Xiao-Hua HOU ; Zhao-Xiang BIAN ; Jian-Hua ZHENG ; Hai-He TIAN ; Guan-Hu YANG ; Won-Sook HONG ; Yu-Ying HE ; Li LIU ; Hong SHEN ; Yan-Ping LI ; Sheng XIE ; Jin SHU ; Bin-Fang ZENG ; Jun-Xiang LI ; Zhen LIU ; Zheng-Hua XIAO ; Jing-Dong XIAO ; Pei-Yong ZHENG ; Shao-Gang HUANG ; Sheng-Liang CHEN ; Gui-Jun FEI
Journal of Integrative Medicine 2025;23(5):502-518
Functional dyspepsia (FD), characterized by persistent or recurrent dyspeptic symptoms without identifiable organic, systemic or metabolic causes, is an increasingly recognized global health issue. The objective of this guideline is to equip clinicians and nursing professionals with evidence-based strategies for the management and treatment of adult patients with FD using traditional Chinese medicine (TCM). The Guideline Development Group consulted existing TCM consensus documents on FD and convened a panel of 35 clinicians to generate initial clinical queries. To address these queries, a systematic literature search was conducted across PubMed, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, China Biology Medicine (SinoMed) Database, Wanfang Database, Traditional Medicine Research Data Expanded (TMRDE), and the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS). The evidence from the literature was critically appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The strength of the recommendations was ascertained through a consensus-building process involving TCM and allopathic medicine experts, methodologists, pharmacologists, nursing specialists, and health economists, leveraging their collective expertise and empirical knowledge. The guideline comprises a total of 43 evidence-informed recommendations that span a range of clinical aspects, including the pathogenesis according to TCM, diagnostic approaches, therapeutic interventions, efficacy assessments, and prognostic considerations. Please cite this article as: Zhang SS, Zhao LQ, Hou XH, Bian ZX, Zheng JH, Tian HH, Yang GH, Hong WS, He YY, Liu L, Shen H, Li YP, Xie S, Shu J, Zeng BF, Li JX, Liu Z, Xiao ZH, Xiao JD, Zheng PY, Huang SG, Chen SL, Fei GJ. International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025). J Integr Med. 2025; 23(5):502-518.
Dyspepsia/drug therapy*
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Humans
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Medicine, Chinese Traditional/methods*
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Practice Guidelines as Topic
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Drugs, Chinese Herbal/therapeutic use*
9.Expert consensuses on the application of nanopore sequencing technology in the detection of pathogenic micro-organisms
Shuyao ZHANG ; Tieying HOU ; Xiaoyan LI ; Shilong ZHONG ; Junyan WU ; Bin HUANG ; Society DIVISION ; Association EXPERT ; Microorganisms THE
China Pharmacy 2024;35(14):1673-1731
OBJECTIVE To improve the diagnosis and treatment level of critically ill infectious diseases, standardize the clinical application of nanopore sequencing and promote the sound development of the technology. METHODS Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society and Expert Committee of Precision Medicine for Clinical Treatment of Guangdong Pharmaceutical Association initiated and organized multidisciplinary experts to discuss and determine the consensus writing outline by using the nominal group method, forming a preliminary consensus draft; expert consultation was performed by using Delphi method, and then experts’ opinions were analyzed and revised to form consensus. RESULTS & CONCLUSIONS Consensuses of Experts on the Application of Nanopore Sequencing Technology in the Detection of Pathogenic Microorganisms covers targeted sequencing, metagenomic sequencing and whole genome sequencing, and is standardized in terms of sample collection and storage, detection process, bioinformatics analysis and report interpretation; the recommendations are provided for the key issues.
10.Evidence-based guideline for the management of clinical application of biosimilars in China (2024 edition)
Zaiwei SONG ; Yang HU ; Lingling YU ; Jun ZHU ; Lingli ZHANG ; Yu ZHANG ; Liyan MIAO ; Suodi ZHAI ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1933-1945
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.


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