Objective:To revise and enlarge the specification of pharmaceutical excipient sucrose palmitate.Methods:Reference to JP2018,USP-NF 2023,EP1 1.0,Chinese Pharmacopoeia 2020 edition of the four general rules and the first supplement of sucrose stearate pharmacopoeia standards and other relevant requirements for standard research.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient sucrose palmitate will be studied.At present,the quality standard of sucrose palmitate for pharmaceutical excipients has been disclosed.Conclusion:The established stand-ard will provide the quality guarantee for the application of sucrose palmitate in medicines.

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

Objective:To revise and enlarge the specification of pharmaceutical excipient sucrose palmitate.Methods:Reference to JP2018,USP-NF 2023,EP1 1.0,Chinese Pharmacopoeia 2020 edition of the four general rules and the first supplement of sucrose stearate pharmacopoeia standards and other relevant requirements for standard research.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient sucrose palmitate will be studied.At present,the quality standard of sucrose palmitate for pharmaceutical excipients has been disclosed.Conclusion:The established stand-ard will provide the quality guarantee for the application of sucrose palmitate in medicines.

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

OBJECTIVE: To compare the effectiveness of single-stage vascularized lymph node transfer (VLNT) combined with lymphaticovenular anastomosis (LVA) and liposuction (LS) (3L) versus LVA combined with LS (2L) for the treatment of moderate-to-late stage upper limb lymphedema following breast cancer surgery. METHODS: A retrospective analysis was conducted on the clinical data of 16 patients with moderate-to-late stage upper limb lymphedema after breast cancer surgery, treated between June 2022 and June 2024, who met the selection criteria. Patients were divided into 3L group (n=7) and 2L group (n=9) based on the surgical approach. There was no significant difference (P>0.05) in baseline data between the groups, including age, body mass index, duration of edema, volume of liposuction, International Society of Lymphology (ISL) stage, preoperative affected limb volume, preoperative circumferences of the affected limb at 12 levels (from 4 cm distal to the wrist to 42 cm proximal to the wrist), preoperative Lymphoedema Quality of Life (LYMQoL) score, and frequency of cellulitis episodes. The 2L group underwent LS on the upper arm and proximal forearm and LVA on the middle and distal forearm. The 3L group received additional VLNT in the axilla, with the groin serving as the donor site. Outcomes were assessed included the change in affected limb volume at 12 months postoperatively, and comparisons of limb circumferences, LYMQoL score, and frequency of cellulitis episodes between preoperative and 12-month postoperative. Ultrasound evaluation was performed at 12 months in the 3L group to assess lymph node viability. RESULTS: Both groups were followed up 12-20 months, with an average of 15.13 months. There was no significant difference in the follow-up time between the groups (t=-1.115, P=0.284). All surgical incisions healed by first intention. No adverse events, such as flap infection or necrosis, occurred in the 3L group. At 12 months after operation, ultrasound confirmed good viability of the transferred lymph nodes in the 3L group. Palpation revealed significant improvement in skin fibrosis and improved skin softness in both groups. Affected limb volume significantly decreased in both groups postoperatively (P<0.05). The reduction in limb volume significantly greater in the 3L group compared to the 2L group (P<0.05). Circumferences at all 12 measured levels significantly decreased in both groups compared to preoperative values (P<0.05). The reduction in circumference at all 12 levels was better in the 3L group than in the 2L group, with significant differences observed at 7 levels (8, 12, 16, 30, 34, 38, and 42 cm) proximal to the wrist (P<0.05). Both groups showed significant improvement in the frequency of cellulitis episodes and LYMQoL scores postoperatively (P<0.05). While the improvement in LYMQoL scores at 12 months did not differ significantly between groups (P>0.05), the reduction in cellulitis episodes was significantly greater in the 3L group compared to the 2L group (P<0.05). CONCLUSION The combination of VLNT+LVA+LS provides more durable and comprehensive outcomes for moderate-to-late stage upper limb lymphedema after breast cancer surgery compared to LVA+LS, offering an improved therapeutic solution for patients.
Humans ; Female ; Lipectomy/methods* ; Retrospective Studies ; Anastomosis, Surgical/methods* ; Lymphedema/etiology* ; Middle Aged ; Upper Extremity/surgery* ; Breast Neoplasms/surgery* ; Lymph Nodes/blood supply* ; Adult ; Lymphatic Vessels/surgery* ; Iliac Artery/surgery* ; Postoperative Complications/surgery* ; Perforator Flap/blood supply* ; Treatment Outcome ; Mastectomy/adverse effects* ; Quality of Life ; Aged

Objective:To explore the clinical effect of thin superficial circumflex iliac artery perforator flap with venous superdrainage in treatment of wound in extremities.Methods:Clinical data of 20 patients who were treated from January 2018 to January 2024 in the Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University were retrospectively analysed. The soft tissue defects in extremity were reconstructed with thin perforator flaps of superficial iliac circumflex artery with venous superdrainage. There were 13 patients with upper limb defects and 7 with ankle defects. Of the defects, 12 were of trauma, 2 of tumour resection, 3 of scar release surgery and 3 of donor flat harvesting. The defects ranged from 5.0 cm×4.0 cm to 18.0 cm×7.0 cm in size. During the surgery, portable Doppler was used to detect the perforating branches of the superficial rotational iliac artery and design flaps. The flaps were 5.0 cm×5.0 cm to 20.0 cm×7.0 cm in size, including 16 single-lobed flaps, 3 double-lobed flaps and 1 triple-lobed flaps. The flaps were 2-7 mm in thickness, with an average of 4 mm. Based on the distribution of perforators, the flaps carried the superficial helioiliac artery and the accompanying vein, as well as the superficial helioiliac vein. The superficial helioiliac artery and the accompanying vein were anastomosed during the surgery, and the superficial helioiliac vein was anastomosed to the superficial or deep vein of the recipient site for superreflux. The donor sites were all directly sutured and closed. Postoperative follow-up was conducted by visits of outpatient clinic, and via telephone and WeChat interviews. The survival and appearance of the flaps and complications were observed.Results:A total of 22 arteries and 42 veins of the 20 flaps were anastomosed in surgery. All flaps survived. The donor sites were closed in the first stage. No vascular compromise occurred. One patient had early exudate under the flap on the exposed wound of interphalangeal joint, which healed after routine dressing change and drainage. All patients were included in the postoperative follow-up, with a peroid over 5 to 40 months, at 10.8 months in average. The flaps were thin and soft, with good wear resistance and without pigmentation. The healing of donor sites was good except 1 donore site that had early lymphatic leakage, which was cured after compression and drainage. A linear scar left at the donor sites and it was acceptable to the patients.Conclusion:The treatment of defective soft tissue wounds in extremities using thin perforator flap with venous superdrainage of the superficial circumflex iliac artery is safe and feasible. No further flap thinning surgery is required, and there is a reliable clinical effect.

BackgroundThe adolescent mood disorders become more prevalent， imposing progressively greater perceived and actual caregiving burdens on caregivers， while the current health education resources， delivery formats and training programs remain insufficient in addressing their needs. ObjectiveTo evaluate the effect of structured health education on the caregiver burden associated with adolescent mood disorders， thereby informing evidence-based strategies for alleviating the burden. MethodsA total of 195 caregivers of adolescent inpatients with mood disorders admitted to a tertiary general hospital in Mianyang from June 1， 2020 to July 31， 2022 were consecutively enrolled and randomly assigned to either the research group （n=99） or the control group （n=96） using random number table method. Both groups received routine health education. In addition， the research group participated in a structured health education program comprising three modules covering disease knowledge， medication management， coping with family stress， and guidance for daily living. Upon admission， baseline information regarding both caregivers and adolescent inpatients was collected though a self-administered questionnaire. Caregiver Strain Index （CSI） was administered to assess caregiver burden at admission， discharge， and 1， 3 and 6 months post-discharge. A self-designed health education feedback questionnaire was administered on the day of discharge to evaluate caregivers' feedback on the health education. At 6 months post-discharge， data on any hospital readmission were collected. ResultsUltimately， 85 caregivers （85.86%） in the research group and 84 caregivers （87.50%） in the control group completed the study. Generalized estimating equation analysis revealed significant time effects and group-by-time interaction effects on CSI scores between the two groups （Wald χ²=790.347， 10.047， P<0.05 or 0.01）. There was no statistically significant difference between the two groups in terms of access to disease information， trust preference and core information needs （P>0.05）. Additionally， caregivers in the research group reported significantly better understanding of the disease-related knowledge and higher ratings on the effectiveness of health education when compared to the control group， with statistically significant differences （P<0.01）. ConclusionIn contrast to routine health education， structured health education may help alleviate caregiving burden among caregivers of adolescents with mood disorders.［Funded by Sichuan Medical Association Project （number， Q190004）］

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

Objective:To explore the clinical effect of thin superficial circumflex iliac artery perforator flap with venous superdrainage in treatment of wound in extremities.Methods:Clinical data of 20 patients who were treated from January 2018 to January 2024 in the Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University were retrospectively analysed. The soft tissue defects in extremity were reconstructed with thin perforator flaps of superficial iliac circumflex artery with venous superdrainage. There were 13 patients with upper limb defects and 7 with ankle defects. Of the defects, 12 were of trauma, 2 of tumour resection, 3 of scar release surgery and 3 of donor flat harvesting. The defects ranged from 5.0 cm×4.0 cm to 18.0 cm×7.0 cm in size. During the surgery, portable Doppler was used to detect the perforating branches of the superficial rotational iliac artery and design flaps. The flaps were 5.0 cm×5.0 cm to 20.0 cm×7.0 cm in size, including 16 single-lobed flaps, 3 double-lobed flaps and 1 triple-lobed flaps. The flaps were 2-7 mm in thickness, with an average of 4 mm. Based on the distribution of perforators, the flaps carried the superficial helioiliac artery and the accompanying vein, as well as the superficial helioiliac vein. The superficial helioiliac artery and the accompanying vein were anastomosed during the surgery, and the superficial helioiliac vein was anastomosed to the superficial or deep vein of the recipient site for superreflux. The donor sites were all directly sutured and closed. Postoperative follow-up was conducted by visits of outpatient clinic, and via telephone and WeChat interviews. The survival and appearance of the flaps and complications were observed.Results:A total of 22 arteries and 42 veins of the 20 flaps were anastomosed in surgery. All flaps survived. The donor sites were closed in the first stage. No vascular compromise occurred. One patient had early exudate under the flap on the exposed wound of interphalangeal joint, which healed after routine dressing change and drainage. All patients were included in the postoperative follow-up, with a peroid over 5 to 40 months, at 10.8 months in average. The flaps were thin and soft, with good wear resistance and without pigmentation. The healing of donor sites was good except 1 donore site that had early lymphatic leakage, which was cured after compression and drainage. A linear scar left at the donor sites and it was acceptable to the patients.Conclusion:The treatment of defective soft tissue wounds in extremities using thin perforator flap with venous superdrainage of the superficial circumflex iliac artery is safe and feasible. No further flap thinning surgery is required, and there is a reliable clinical effect.

Objective:To revise and enlarge the specification of pharmaceutical excipient denatonium benzoate in the Chinese Pharmacopoeia 2025.Methods:At present,only USP-NF 2023 in domestic and foreign pharmacopoe-ias includes denatonium benzoate.This quality standard is subject to standard research in accordance with USP-NF 2023,the fourth general rules of the Chinese Pharmacopoeia 2020 edition,and other relevant requirements.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient denatonium benzoate will be studied.At present,the quality standard of denatoni-um benzoate for pharmaceutical excipients has been disclosed.Conclusion:The established standard will fill the domestic gap and provide the quality guarantee for the application of denatonium benzoate in medicines.