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  • Xiao-yan ZHU, Qing-hua GUO, Tian ZHANG, Min YANG, Xu WANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3191-3199.
    Objective

    To observe the clinical efficacy and safety of retroauricular injection of dexamethasone sodium phosphate injection in the treatment of sudden deafness.

    Methods

    Patients with sudden deafness were divided into control group and treatment group according to actual treatment method. Both groups were given conventional treatment (neurotrophy and microcirculation improvement) according to guidelines. The control group received additional intravenous drip of methylprednisolone sodium succinate (80 mg once daily for 4 d, reduced to 40 mg for 4 d, then further reduced to 20 mg for 2 d). The treatment group was given retroauricular injection of dexamethasone (5 mg every other day) in addition to the control group’s regimen. Both groups were treated for 10 d. The efficacy, metabolomic differences, hearing recovery status, hemorheological indexes, and immune function indexes were compared between the two groups. Meanwhile, the safety was evaluated.

    Results

    38 cases and 42 cases were included in the control group and the treatment group, respectively. After treatment, the effective rates in the treatment group and the control group were 80.95% (34 cases/42 cases) and 57.89% (22 cases/38 cases), with statistically significant difference (P<0.05). There were significant increases in 11 metabolites and significant decreases in 18 metabolites before treatment for sudden deafness. The four metabolites showing the most significant increases were ascorbic acid, tauroursodeoxycholic acid, D-pantothenic acid, and glucaric acid. The most significantly decreased metabolites were lysophosphatidylethanolamine and vanillic acid. After treatment, patients with sudden deafness in the effective group showed significant increases in 37 metabolites and significant decreases in 8 metabolites compared to the ineffective group. The three metabolites showing the most significant increases were L-leucine, undecanoylcarnitine, and lauroylcarnitine, while the three with the most notable decreases were L-histidine, 2-pyridylacetic acid, and D-pantothenic acid. After treatment, hearing thresholds under 0.5, kHz in the control group and the treatment group were (49.82±7.03) and (43.69±5.38) dB, respectively; hearing thresholds under 1.0 kHz were (58.14±7.39) and (46.33±6.25) dB, respectively; hearing thresholds under 2.0 kHz were (60.05±8.23) and (49.51±5.30) dB, respectively; hearing thresholds under 4.0 kHz were (62.29±8.14) and (51.36±5.87) dB, respectively, with statistically significant differences between two groups (P<0.05). After treatment, superoxide dismutase (SOD) levels in the control group and the treatment group were (94.65±14.06) and (99.72±13.56) μg·L-1; malondialdehyde (MDA) levels were (4.36±0.51) and (3.94±0.40) μmol·L-1, with statistically significant differences between groups (P<0.05). After treatment, plasma viscosity in the control group and the treatment group was (2.12±0.30) and (1.55±0.26) mPa·s; erythrocyte aggregation index was 3.38±0.30 and 2.97±0.19; low-shear viscosity was (10.13±1.60) and (9.06±1.19) mPa·s; high-shear viscosity was (5.96±0.39) and (5.33±0.31) mPa·s, with statistically significant differences between groups (P<0.05). After treatment, CD3+ in the control group and the treatment group was 57.76±4.70 and 63.52±5.46; CD4+ was 33.29±3.38 and 37.42±3.68; CD4+/CD8+ was 1.43±0.22 and 1.70±0.30; immunoglobulin (Ig) G levels were (12.16±1.12) and (10.23±0.93) g·L-1; IgA levels were (2.36±0.23) and (2.11±0.15) g·L-1, with statistically significant differences between groups (all P<0.05). No significant adverse reactions occurred in either group during the treatment.

    Conclusion

    Retroauricular injection of dexamethasone sodium phosphate injection is markedly effective in the treatment of sudden deafness, and it has advantages in improving metabolomic differences, hemorheology and immune function.

  • Tian-tian WANG, Ran FU, De-qiang LI, Jing YU, Ting-ting ZHUO, Xiao-mei BAI, Peng DAI, Chun-hua ZHOU
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3228-3233.
    Objective

    To establish an ultra-high performance liquid chromatography-tandem mass spectrometry method (UPLC-MS/MS) for the determination of the contents of cholic acid, imperatorin, quercetin, isoquercetin, ferulic acid, chlorogenic acid, rutin, and cryptochlorogenic acid in the Huoxuexiaozhong capsule.

    Methods

    The analysis was performed by UPLC-MS/MS. Chromatographic conditions: separation was achieved on an Agilent Poroshell 120 EC-C18 column (2.1×150 mm, 1.9 μm). The mobile phase consisted of acetonitrile (A) and 0.1% formic acid in water (B) with gradient elution, at a flow rate of 0.3 mL·min-1 and a column temperature of 35 ℃. Mass spectrometry conditions: multiple reaction monitoring (MRM) with positive/negative ion switching mode was used electrospray ionization source. The ion source voltage was set at +5.5 kV and -4.5 kV, with the ion source temperature maintained at 550 ℃. The gas settings were as follows: GS1 344.74 kPa, GS2 344.74 kPa, and CUR 241.32 kPa. The specificity, standard curves and limits of detection and quantification, precision and recovery, and stability were investigated.

    Results

    The analytical method demonstrated good linearities for cholic acid, quercetin, isoquercitrin, ferulic acid, chlorogenic acid, cryptochlorogenic acid, rutin and imperatorin over the concentration ranges of (0.26-25.70), (0.03-1.68), (0.03-1.51), (0.03-1.47), (0.40-10.34), (0.56-27.05), (0.03-1.37), and (2.50-759.65) μg·mL-1, respectively (R2 ≥ 0.9911). The relative standard deviations (RSD) of peak areas for reference standards and test samples were ≤ 2.44% and ≤ 2.87%, respectively. Recoveries for all components ranged from 96.54% to 107.86%, with RSD values between 0.47% and 5.41%, indicating good precision and accuracy. The stability of the method showed an RSD of ≤ 2.77%.

    Conclusion

    The UPLC-MS/MS method was established to determine the concentration of eight components in Huoxuexiaozhong capsule simultaneously. This method has high sensitivity, specificity and stability, which can be used as a reliable reference for the quality control of the capsule.

  • Man-jiao YAO
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3171-3177.
    Objective

    To investigate the changes of intestinal flora in patients with Helicobacter pylori (HP) positive gastric ulcer treated with rabeprazole capsule combined with aluminum phosphate gel based on metagenomics.

    Methods

    Patients with HP-positive gastric ulcers were selected who were admitted from January 2022 to December 2024. They were randomly divided into the combined group and the control group. The control group only received rabeprazole treatment, while the combined group received combined treatment with rabeprazole and aluminum phosphate gel. The model efficacy and key biomarkers for distinguishing patients in different treatment groups were detected using a linear kernel-based support vector classification (SVC) model and recursive feature elimination (RFE). The association between microbial abundance and clinical continuous indicators was detected using a support vector regression factor model (SVR). The Kyoto Encyclopedia of Genes and Genomes (KEGG) functional enrichment analysis was used to detect the metabolic and signaling pathways enriched by the differentially expressed genes in the intestinal microbiota. The clinical efficacy of the two groups was compared, and the safety was evaluated.

    Results

    A total of 130 patients were enrolled in the study, with 65 patients in each of the combined group and the control group. The intestinal microbial diversity in the combined group was significantly higher than that in the control group (P<0.05). Using RFE to further distinguish between the two groups, the area under the curve (AUC) was 0.80. Among the patients in the combined group, the levels of 10 metabolites were elevated. Through multi-omics integrated analysis of the fecal samples of the two groups of patients, it was found that the AUC of combining specific microbial communities and fecal metabolites analysis was 0.85, with higher accuracy than using microbial community or metabolite analysis alone, and the statistical difference was statistically significant (P<0.05). SVC and SVR analysis showed that the intestinal inflammation of patients was related to the composition of specific microbial communities. A metabolic reaction network diagram was constructed based on KEGG. The results showed that the levels of arginase, protein phosphatase, and tyrosine phosphatase were higher in patients with positive HP gastric ulcers. The ulcer healing rates in the combined group and the control group were 95.38% (62 cases/65 cases) and 83.08% (54 cases/65 cases), respectively. There was statistically significant difference between the two groups (P<0.05). The incidence of adverse drug reactions was 10.77% (7 cases/65 cases) in the combined group and 16.92% (11 cases/65 cases) in the control group. There was no statistically significant difference between the two groups (P>0.05).

    Conclusion

    The treatment plan of rabeprazole combined with aluminum phosphate gel can enhance the diversity of intestinal microorganisms, promote the secretion of microbial metabolites, effectively improve the intestinal flora, and facilitate the recovery of patients.

  • Wen-zhang LIANG, Jing-he HUANG, Yan-fang WANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3185-3190.
    Objective

    To analyze the effect of conbercept ophthalmic injection on aqueous humor glucose (AHG) and vascular endothelial growth factor (VEGF) in elderly patients with diabetes retinopathy (DR) and vitreous hemorrhage, and the correlation with blood glucose.

    Methods

    A total of 80 elderly patients with DR and vitreous hemorrhage were selected as the study subjects. All of them received intravitreal injection of 0.05 mL of conbercept ophthalmic injection for 7 consecutive days, and then underwent vitrectomy. They were divided into the standard reaching group and the non-standard reaching group according to whether blood glucose control met the standard. The changes in ocular signs and visual recovery indicators [central macular thickness (CMT), hemorrhagic spot area and best corrected visual acuity (BCVA)], aqueous humor AHG, VEGF, inflammatory factors [interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α)] and blood glucose before and after conbercept ophthalmic injection treatment were compared between groups. Pearson method was used to analyze the correlation between AHG, VEGF and blood glucose level. Logistic regression method was used to identify the independent influencing factors of inadequate blood glucose control.

    Results

    49 patients were included in the standard reaching group, and 31 patients were included in the non-standard reaching group. After treatment, the CMT values of standard reaching and the non-standard reaching groups were (215.63±22.45) and (254.68±26.73) μm, respectively; the bleeding spot areas were (1.18±0.14) and (1.46±0.17) mm2, respectively; the BCVA values were 0.85±0.07 and 0.71±0.08, respectively; the AHG values for aqueous humor were (4.68±0.54) and (6.27±0.65) mmol·L-1, respectively; VEGF levels were (121.46±13.65) and (158.72±16.39) pg·mL-1, respectively; IL-6 levels were (18.13±1.89) and (19.44±2.31) pg·mL-1, respectively; TNF-α levels were (6.73±0.75) and (7.16±0.73) pg·mL-1, respectively; the blood glucose levels were (5.16±0.57) and (7.22±0.78) mmol·L-1, respectively; the above indicators of standard reaching group were compared with those of the non-standard reaching group, and the differences were statistically significant (all P<0.05). Correlation analysis found that the levels of aqueous humor AHG, VEGF, IL-6 and TNF-α were positively correlated with blood glucose levels in elderly patients with DR and vitreous hemorrhage (P<0.05). Logistic regression analysis showed that aqueous humor AHG, VEGF, and IL-6 were independent risk factors for inadequate blood glucose control in elderly patients with DR and vitreous hemorrhage (P<0.05).

    Conclusion

    After conbercept ophthalmic injection treatment, there are significant differences in the levels of AHG and VEGF in elderly patients with DR and vitreous hemorrhage, and visual acuity is restored. Moreover, AHG and VEGF are positively correlated with blood glucose. Monitoring them can assist in efficacy evaluation.

  • Qin-qin MA, Rui ZHANG, Luo-bu GESANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3262-3269.

    The high-altitude environment is characterized by hypoxia, low temperatures, strong radiation, and low humidity, with hypoxia exerting profound effects on human physiological functions. Cardiovascular disease, a prevalent chronic condition in plateau regions, poses a serious threat to health. While pharmacotherapy is the primary intervention, the hypoxic environment significantly alters the pharmacokinetic processes of cardiovascular drugs in vivo, thereby compromising their safety and efficacy. Consequently, investigating the pharmacokinetic characteristics of cardiovascular drugs under high-altitude hypoxia is crucial. Given the current scarcity of research in this area, this review summarizes the impact of high-altitude hypoxia on key pharmacokinetic parameters of cardiovascular drugs and explores potential mechanisms of action, aiming to provide a theoretical basis for the rational clinical use of these drugs in plateau areas.

  • Bao-ping JIANG, Fang-fang MA
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3156-3163.
    Objective

    To compare the efficacy and safety of ticagrelor combined with nicorandil versus clopidogrel combined with nicorandil in elderly coronary heart disease (CHD) patients experiencing angina pectoris following percutaneous coronary intervention (PCI).

    Methods

    Patients with post-PCI angina admitted to our hospital were divided into treatment group and control group based on treatment protocols. The control group received clopidogrel bisulfate tablets (75 mg, qd), and nicotardil tablets (5 mg, tid) based on standard post-PCI therapy including aspirin enteric-coated tablets (100 mg, qd), atorvastatin calcium tablets (20 mg, qd). The treatment group received ticagrelor tablets (90 mg, bid), and nicotardil tablets (5 mg, tid) based on the same standard post-PCI therapy. Both groups underwent continuous treatment for 24 weeks. Sublingual nitroglycerin tablets were allowed for acute angina attacks. Primary outcomes included therapeutic efficacy, cardiac function indices, lipid profiles, lipoprotein-associated phospholipase A2 (Lp-PLA2) levels, antiplatelet reactivity and coagulation parameters, Seattle angina questionnaire (SAQ) scores, and incidence of major adverse cardiovascular events (MACE) were compared between the two groups.

    Results

    A total of 123 patients were enrolled with 59 patients in treatment group and 64 patients in control group. After treatment, the overall response rates in treatment group and control group were 91.53% (54 cases /59 cases) and 78.12% (50 cases/64 cases), respectively. Left ventricular end-diastolic diameter (LVEDD) in treatment group and control group were (44.76±4.23) mm and (46.63±4.13) mm, respectively; left ventricular end-systolic diameter (LVESD) were (30.16±4.22) and (32.57±5.13) mm, respectively; left ventricular ejection fraction (LVEF) were (61.49±6.24)% and (58.49±6.13)%, respectively; cardiac index (CI) were (2.80±0.29) and (2.67±0.27) L·min-1·m-2, respectively; triglycerides (TG) were (1.70±0.21) and (1.82±0.35) mmol·L-1, respectively; total cholesterol (TC) were (5.12±0.56) and (5.41±0.60) mmol·L-1, respectively; low-density lipoprotein cholesterol (LDL-C) were (3.28±0.64) and (3.57±0.58) mmol·L-1, respectively; high-density lipoprotein cholesterol (HDL-C) were (2.74±0.54) and (2.53±0.51) mmol·L-1, respectively; Lp-PLA2 were (231.63±32.47) and (244.89±35.62) ng·mL-1, respectively. Regarding antiplatelet and coagulation parameters, the arachidonic acid inhibition rate (AA-IR) in treatment group and control group were (81.26±15.11)% and (74.52±15.13)%, respectively; adenosine diphosphate inhibition rate (ADP-IR) were (78.56±15.96)% and (70.95±14.57)%, respectively; lower maximum platelet aggregation rate (MPAR) were (26.78±4.82)% and (28.52±4.18)%, respectively; coagulation rate (CR) were (18.04±2.04) and (19.28±2.71) sig·min-1, respectively; SAQ scores were significantly higher in the treatment group across all dimensions: angina stability were (82.80±9.10) and (78.53±8.91) points, respectively; attack frequency were (80.17±12.24) and (75.63±10.22) points, respectively; physical activity limitation were (82.10±10.26) and (77.77±9.99) points, respectively; disease awareness were (74.49±11.25) and (69.13±10.96) points, respectively; and satisfaction were (83.41±10.35) and (78.56±11.49) points, respectively; the difference of the above indexes were all statistically significant (all P<0.05). The total incidence rates of MACE in treatment group and control group were 6.78% (4 cases/59 cases) and 20.31% (13 cases /64 cases), respectively, with statistically significant difference (P<0.05).

    Conclusion

    Compared with clopidogrel combined with nicorandil, ticagrelor combined with nicorandil exhibits superior efficacy in treating angina pectoris after CHD-PCI in elderly patients, with significant improvements in cardiac function and angina symptoms, as well as favorable safety profiles.

  • Hui-jie MA, Min LI, Gui-zhi WANG, Yin-gui SUN
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3164-3170.
    Objective

    To explore the clinical efficacy and safety of thoracolumbar fascia plane block with ropivacaine hydrochloride injection combined with compound betamethasone injection in elderly patients undergoing lumbar spine surgery during the perioperative period.

    Methods

    The elderly patients admitted to our hospital who underwent posterolateral approach lumbar fusion (PLIF) under general anesthesia due to lumbar degenerative diseases were divided into control group and treatment group according to different anesthesia methods. Both groups of patients received thoracolumbar fascia plane (TLIP) block. Control group was injected with a single dose of 20 mL of 0.375% ropivacaine hydrochloride injection, while treatment group was injected with a single dose of a mixture of 20 mL of 0.375% ropivacaine hydrochloride injection and 5 mg of compound betamethasone injection for TLIP block. The remaining operations were same. The hemodynamic indicators, rehabilitation process indicators, opioid dosage and remedial analgesia conditions, visual analogue scale (VAS) scores at rest and turning over at different time points, stress and immune indicators of the two groups of patients were compared, and safety evaluations were conducted.

    Results

    A total of 115 cases were screened in this study, with 102 cases enrolled. Among them, 50 cases were enrolled in control group and 52 cases in treatment group. The heart rate (HR) of the control group and the treatment group at T4 were (82.13±10.68) and (74.81±10.19) times·min-1, respectively; and the mean arterial pressure (MAP) were (92.33±9.87) and (88.27±8.92) mmHg, respectively; the recovery time were (36.41±6.97) and (31.87±6.53) min, respectively; and the resting VAS scores at 48 hours after the operation were (2.71±0.88) and (2.56±0.82) points, respectively; the VAS scores at turning over 48 hours after the operation were (3.42±0.97) and (2.88±0.84) points, respectively; the first PCIA time were (20.04±5.67) and (16.79±4.32) hours, respectively; the effective compression times of PCIA were (14.19±4.36) and (11.64±3.52) times, respectively; and the β-Endorphin (β -endorphin) 24 hours after the operation were (160.31±19.68) and (146.83±18.49) pg·mL-1, respectively; CC Chemokine ligand 2 (CCL2) were (109.39±19.78) and (97.86±17.88) pg·mL-1, respectively; angiotensin Ⅱ (Ang Ⅱ) were (79.14±12.53) and (70.65±11.71) pg·mL-1, respectively. The above indicators of treatment group were compared with those of control group, and the differences were all statistically significant (all P<0.05). The incidence rates of adverse reactions to anesthetic drugs during the perioperative period in the two groups of patients were 9.62%(5 cases/52 cases) and 16.00%(8 cases/50 cases), respectively, and there was no statistically significant difference (P>0.05).

    Conclusion

    The TLIP block with ropivacaine combined with betamethasone can enhance the analgesic effect during the perioperative period of patients undergoing PLIF, reduce the dosage of opioid drugs, alleviate early pain symptoms and the level of postoperative stress responses, and has a relatively high level of safety.

  • Zhen-wei QIN, Xin-meng WANG, Yin SUN, Jing ZHONG
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3206-3213.
    Objective

    To investigate the effects of lycorine (LYC) on the proliferation and apoptosis of acute promyelocytic leukemia (APL) cells by regulating the phosphatase and tensin homolog deleted on chromosome ten (PTEN)/phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT) signaling pathway.

    Methods

    Human APL cells (NB4) were treated with 1.0-32.0 μmol·L-1 LYC, the cell viability was detected, and the LYC experimental concentration was screened. NB4 cells were divided into group A (control group), group B, group C, group D (lycorine low concentration group, medium concentration group, high concentration group), group E (high concentration lycorine+PI3K activator 740 Y-P group). Except for the control group, groups B, C, and D were treated with 4.0, 8.0 and 16.0 μmol·L-1 lycorine, respectively, for 24 hours. Group E was treated with 16.0 μmol·L-1 lycorine combined with 25.0 μmol·L-1 740 Y-P for 24 hours. Cell proliferation, apoptosis, invasion, migration, and cell cycle status were detected, and the expression of related proteins was detected.

    Results

    After treatment with concentrations of 4.0, 8.0 and 16.0 μmol·L-1 of lycorine, the survival rate of NB4 cells prominently decreased, therefore, they were used for subsequent experiments. The colony formation numbers of NB4 cells in group A, group B, group C, group D and group E were 151.38±16.42, 117.15±12.78, 81.04±8.36, 56.17±6.05 and 105.02±10.64, respectively. The scratch healing rates were (89.62±9.15) %, (72.57±7.45)%, (55.34±5.83)%, (36.78±3.72)% and (65.59±6.58)%, respectively. The number of cell invasion was (168.27±17.82), (132.69±14.39), (90.58±9.25), (61.64±6.37) and (110.59±12.27), respectively. The proportion of cells in S phase was (46.17±4.71)%, (35.18±3.56)%, (28.20±3.13)%, (20.52±2.16)% and (32.01±3.32)%, respectively. The percentages of cells in G2/M phase were (24.68±2.56)%, (19.34±1.97)%, (15.62±1.55)%, (11.15±1.23)% and (17.03±1.89)%, respectively. The levels of cyclin dependent kinase 1 (CDK1) were 0.95±0.09, 0.74±0.07, 0.50±0.05, 0.32±0.03 and 0.63±0.06, respectively. The levels of matrix metalloproteinase 2 (MMP-2) were 1.14±0.11, 0.83±0.08, 0.56±0.05, 0.37±0.03 and 0.69±0.06, respectively. The levels of matrix metalloproteinase 9 (MMP-9) were 0.94±0.09, 0.70±0.07, 0.47±0.04, 0.26±0.02 and 0.55±0.05, respectively. The phosphorylated phosphatidylinositol 3-kinase (p-PI3K)/PI3K were 0.86±0.08, 0.71±0.07, 0.45±0.04, 0.26±0.02 and 0.55±0.05, respectively. The expression levels of phosphorylated protein kinase B (p-AKT)/AKT were 0.91±0.09, 0.78±0.07, 0.53±0.05, 0.31±0.03 and 0.69±0.06, respectively. The apoptosis rates were (2.23±0.26)%, (17.41±1.82)%, (26.34±2.75)%, (39.62±4.05)% and (21.58±2.27)%, respectively. The proportion of cells in G0/G1 phase was (29.15±3.06)%, (45.48±4.67)%, (56.18±5.73)%, (68.33±6.88)% and (50.96±5.01)%, respectively. The levels of Bcl-2 associated X protein (Bax) were 0.26±0.02, 0.41±0.04, 0.72±0.07, 0.98±0.09 and 0.66±0.06, respectively. The levels of PTEN were 0.32±0.03, 0.45±0.04, 0.74±0.07, 0.96±0.09 and 0.61±0.06, respectively. Group B, group C, group D compared with group A, group E compared with group D, the above indicators were statistically significant (P<0.05). After NK cells were co-cultured with NB4 cells, compared with the A group, the cell killing rate of B, C and D groups increased (P<0.001). Compared with the D group, the cell killing rate of E group decreased (P<0.001).

    Conclusion

    Lycorine inhibited APL cells with up-regulation of PTEN expression and inhibition of PI3K/AKT pathway, and its effect is dependent on PI3K/AKT pathway.

  • Xue-lan HE, Yi ZHAO, Yan LEI, Wei-tong LIN, Xu YANG, Kai-peng HUANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3296-3300.
    Objective

    To examine issues in sample management within drug clinical trials, their implications on subject rights, data integrity, and propose targeted enhancements.

    Methods

    A retrospective analysis was conducted on 69 clinical trial projects, encompassing bioequivalence and innovative drug phase I-IV trials, processed by the phase I clinical trial laboratory at our institution from April 2018 to December 2024. Problems in biological sample management were identified through monitoring records maintained by quality control professionals, institutional quality control personnel, and clinical research monitors. The distribution patterns of issues were analyzed, and non-standard problems were assessed and categorized using the protocol deviation (PD) evaluation system.

    Results

    A total of 68 issues were identified in biological sample management, primarily centered around sample collection (27.94%), processing (19.12%), and preservation (36.76%). PD evaluations indicated that deficiencies in operational processes (e.g., non-compliance with standard operating procedures), insufficient personnel training, and irregular documentation were the primary underlying causes.

    Conclusion

    Comprehensive standardized management strategies, including enhancing standardized procedures in critical stages, improving personnel training, quality control frameworks, and implementing intelligent information systems, are essential to ensure the provision of dependable sample support for high-caliber clinical research.

  • Chen-yang ZHAO, Shuang LU
    Chinese Journal of Clinical Pharmacology. 2025, 41(22): 3284-3289.

    Dystrophic epidermolysis bullosa (DEB) is a mechanobullous disorder caused by mutations in the COL7A1 gene encoding type VII collagen. It has been included in China’s Rare Disease List, with clinical management primarily focused on preventing mechanical trauma and infections. In recent years, significant progress has been made in the development of advanced therapy medicinal products (ATMPs) for DEB, with two products already approved for marketing and multiple others undergoing clinical trials. This article reviews the fundamental characteristics of both approved and investigational ATMPs for DEB and discusses key considerations in clinical trial design, aiming to provide valuable insights for the clinical development of advanced therapies for this condition.