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  • Jing-hao ZHANG, Rui-qi HE, Su-jun XIAO, Xue-kang ZHANG
    Chinese Journal of New Drugs. 2026, 35(13): 1389-1395.
    Objective:

    To investigate the impact of distal forearm peripheral nerve block (DPNB) with liposomal bupivacaine on rebound pain (RP) after peripheral nerve block and postoperative rehabilitation in patients with hand trauma.

    Methods:

    Patients with hand trauma, aged 18~65 years, body mass index (BMI) 18~30 kg·m-2, and American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ, whose surgical area involved the innervation of the radial nerve, median nerve, and/or ulnar nerve, were selected. They were randomly divided into a liposomal bupivacaine group (group L) and a control group (group C) using a random number table, with 40 patients in each group. Both groups initially received an interscalene brachial plexus block (ISBPB) with 20 mL of a mixture of 0.375% ropivacaine and 0.5% lidocaine. In group L, the ulnar nerve, radial nerve or median nerve in the forearm were selected under ultrasound guidance according to the innervation of the surgical area, and 3 mL of 0.665% liposomal bupivacaine was injected perineurally around each selected nerve. Group C received no intervention. After surgery, all patients in both groups were equipped with patient-controlled intravenous analgesia (PCIA) pumps. The incidence of RP within 24 h postoperatively was recorded. Numerical rating scale (NRS) scores at rest and during movement were recorded before surgery, immediately upon leaving the operating room, and at 6, 12, 24, 48 and 72 h postoperatively. The resting NRS score upon leaving the operating room, the modified rebound pain score (MRPS), and the cumulative opioid consumption within 72 h postoperatively were recorded. The durations of sensory and motor blockade were recorded. Muscle strength grades and modified Bromage scores were recorded before surgery and at 6, 12, 24, 48 and 72 h postoperatively. The 15-item Quality of Recovery (QoR-15) scores were recorded before surgery and at 24, 48 and 72 h postoperatively. Adverse reactions such as chest tightness, dizziness, nausea and vomiting were recorded after surgery.

    Results:

    Compared with group C, the incidence of RP within 24 h postoperatively was lower in group L (P<0.05). Compared with group C, the resting NRS scores at 6 and 12 h postoperatively were also lower (P<0.05), and the NRS scores during movement at 6 and 12 h postoperatively were also lower (P<0.05). Compared with group C, the MRPS and the cumulative opioid consumption within 72 h postoperatively were lower in group L (P<0.05). Compared with group C, the duration of sensory block was significantly prolonged in group L (P<0.05), while the duration of motor block, and the modified Bromage scores and muscle strength grades at 6, 12, 24, 48 and 72 h postoperatively were not significantly different (all P>0.05). Compared with group C, the QoR-15 scores at 24, 48 and 72 h postoperatively were higher in group L (P<0.05). There were no statistically significant differences in the incidence of postoperative adverse reactions between the two groups (P>0.05).

    Conclusion:

    Distal forearm peripheral nerve block with liposomal bupivacaine effectively reduces the incidence of RP in hand trauma patients, provides analgesia for up to 12 h postoperatively, and promotes postoperative rehabilitation.

  • Jian WANG, Xing-he WANG, Bin-yan LIU
    Chinese Journal of New Drugs. 2026, 35(13): 1396-1402.
    Objective:

    To explore the effects of sintilimab combined with chemotherapy on postoperative peripheral blood immune cell counts, inflammatory markers, and prognosis in patients with stage Ⅱ~Ⅲ colorectal cancer.

    Methods:

    A retrospective analysis was conducted on 35 patients with stage Ⅱ~Ⅲ colorectal cancer admitted to the Department of Gastrointestinal Surgery, Beijing Shijitan Hospital, Capital Medical University, between January 2021 and December 2023. According to postoperative adjuvant treatment regimens, patients were divided into the observation group (n=17, sintilimab combined with XELOX/FOLFOX regimen) and the control group (n=18, XELOX/FOLFOX chemotherapy alone). Changes in neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), lymphocyte-to-monocyte ratio (LMR), and leukocyte subset counts were compared between the two groups before and after treatment. Kaplan-Meier method and Cox proportional hazards regression model were used to analyze progression-free survival (PFS) and prognostic factors in both groups.

    Results:

    In the observation group, lymphocyte count (1.40±0.63 vs 1.38±0.52, P=0.007) and eosinophil count (0.34±0.40 vs 0.16±0.18, P=0.004) were significantly increased after treatment compared with baseline. In the control group, monocyte count increased (0.36±0.13 vs 0.35±0.09, P=0.011), while eosinophil count decreased (0.12±0.07 vs 0.13±0.11, P=0.031) after treatment. Intergroup comparison showed that post-treatment monocyte count (0.49±0.22 vs 0.35±0.12, P=0.039) and eosinophil count (0.33±0.39 vs 0.12±0.06, P=0.030) in the observation group were significantly higher than those in the control group. Survival analysis showed that the 3-year PFS rate was significantly higher in the observation group than in the control group (88.2% vs 44.4%, P<0.05). Multivariate Cox proportional hazards regression analysis indicated that treatment regimen was an independent protective factor for prognosis (HR=0.038, 95%CI: 0.003~0.444, P=0.009), and sintilimab combined with chemotherapy significantly reduced the risk of disease progression.

    Conclusion:

    Sintilimab combined with chemotherapy significantly improved postoperative peripheral blood lymphocyte and eosinophil levels, modulated tumor microenvironment immune status, and markedly increased 3-year progression-free survival. Peripheral blood immune cell counts represent potential biomarkers for monitoring immunotherapy response, though their long-term clinical implications and optimal patient selection warrant further investigation in prospective, large-scale studies.

  • Xue MEI, Xing TANG, Xing-pei XU, Ding-shan DUAN, Cong-cong YU
    Chinese Journal of New Drugs. 2026, 35(13): 1403-1408.
    Objective:

    To evaluate the consistency of clinical efficacy and safety between Chaihu Shugan San formula granules and traditional decoction pieces in the treatment of chronic hepatitis B (CHB) in the immune clearance phase with liver depression and qi stagnation syndrome, and to provide an evidence-based basis for clinical dosage form selection.

    Methods:

    A multicenter, randomized, single-blind, positive-controlled clinical trial design was adopted. A total of 133 patients with CHB in the immune clearance phase with liver depression and qi stagnation syndrome were enrolled and randomly divided into a test group (formula granules) and a control group (traditional decoction pieces) using a random number table. Both groups received oral administration before meals, three times a day, with 14 days as one course of treatment, an interval of 1 day between courses, and a total of 2 consecutive courses. The treatment response rate, hepatitis B virus DNA (HBV-DNA) quantification, liver function indexes [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], TCM syndrome score and adverse reactions were used as evaluation indicators, and a consistency test was employed to analyze the consistency of efficacy and safety between the two groups.

    Results:

    The consistency of treatment response rate between the two groups was strong (κ=0.645); the complete response rate in the test group (8.0%) was higher than that in the control group. The consistency of improvement of AST and ALT between the two groups was strong [intraclass correlation coefficient (ICC)=0.689, 0.791], and the mean AST and ALT after treatment in the test group were lower than those in the control group. The consistency of the improvement in TCM syndrome scores between the two groups was strong (ICC=0.637), and the post treatment syndrome score in the test group was lower than that in the control group. The consistency of HBV-DNA negative conversion rate between the two groups was moderate (κ=0.332), and the negative conversion rate in the test group (42.7%) was higher than that in the control group (30.0%). The incidence of adverse reactions in the test group was 5.0%, and no adverse reactions occurred in the control group.

    Conclusion:

    Chaihu Shugan San formula granules and traditional decoction pieces show strong consistency in overall response rate and liver function improvement. Formula granules demonstrate advantages in TCM syndrome improvement, HBV-DNA negative conversion rate, and complete response rate; however, they are associated with a higher incidence of adverse reactions. Therefore, the benefits and risks should be carefully weighed when selecting the dosage form in clinical practice.

  • Juan ZHANG, Xue-yan LIU, Gui-sen YIN, Si-tong YANG
    Chinese Journal of New Drugs. 2026, 35(13): 1409-1416.
    Objective:

    To investigate the registration status of clinical trials on CDK4/6 inhibitors in ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR), analyze their registration characteristics and development trends, and provide a reference for clinical research.

    Methods:

    All clinical trials on CDK4/6 inhibitors registered in ClinicalTrials.gov and ChiCTR from the establishment of the database to April 17, 2025 were retrieved. Information including registration date, clinical phase, sample size, indication, registration status, country/region, and study type was extracted. Descriptive statistical analysis was performed using Excel.

    Results:

    A total of 765 clinical trials on CDK4/6 inhibitors were registered in the two databases, including 698 in ClinicalTrials.gov and 67 in ChiCTR. These trials involved more than 40 countries, with the top three being the United States (397 trials), China (69 trials), and France (22 trials). The number of registrations peaked in 2020. Most trials were interventional studies, with breast cancer as the primary indication. The main endpoints were core clinical indicators of efficacy and safety. However, there were significant differences between the two databases in terms of coverage breadth and research depth.

    Conclusion:

    This study is the first to summarize the registration status of CDK4/6 inhibitor clinical trials and analyze the registration characteristics in ClinicalTrials.gov and ChiCTR. Internationally, research and development started early with wide coverage, while domestic research mainly focuses on follow-up innovation and post-marketing studies, providing a reference for the direction of clinical research and resource allocation related to CDK4/6 inhibitors.

  • Jun-hao LIU, Ji-rong ZHAO, Yang ZHAN, Hong-nian YIN, Peng JIANG, Hua-sheng WANG, Dong MA, Rui ZHAO, Bo-qian MA
    Chinese Journal of New Drugs. 2026, 35(13): 1417-1425.
    Objective:

    To investigate the effect of Duzhong Yaotong Pill on spinal dorsal horn inflammation in rats with lumbar disc herniation (LDH) by regulating the c-Jun N-terminal kinase (c-JNK)/chemokine (C-X-C motif) ligand 1 (CXCL1) signaling pathway.

    Methods:

    Seventy-five rats were randomly divided into a sham operation group, a model group, and low-, medium-, and high-dose Duzhong Yaotong Pill groups. Two hours after model establishment, the Duzhong Yaotong Pill groups were gavaged with Duzhong Yaotong Pill solution, while the sham operation group and the model group were gavaged with normal saline. The general condition of the rats in each group was observed. The paw withdrawal mechanical threshold (PWMT) and paw withdrawal thermal latency (PWTL) were measured by hyperalgesia testing. The levels of interleukin-6 (IL-6) and interleukin-1β (IL-1β) in the spinal dorsal horn tissue were detected by ELISA. Histopathological changes in the dorsal root ganglion were observed by HE staining. Spinal cord cell apoptosis was detected by TUNEL staining. The mRNA expression of ionized calcium-binding adapter molecule 1 (Iba-1), c-JNK, p-c-JNK and CXCL1 was detected by qRT-PCR, and the protein expression of Iba-1, c-JNk, p-d-JNK and CXCL1 was detected by Westernblot.

    Results:

    Compared with the sham operation group, the model group showed neuronal atrophy, reduced nuclei and Nissl bodies, a significantly increased apoptosis rate, increased levels of IL-6, IL-β, Iba-1, p-c-JNK, and CXCL1, and decreased PWMT and PWTL (all P<0.05). Compared with the model group, the low-, medium-, and high-dose Duzhong Yaotong Pill groups showed recovery of neuronal morphology, distinct nucleoli, increased Nissl bodies, a significantly decreased apoptosis rate, decreased levels of IL-6, IL-β, decreased mRNA expression and protein expression of Iba-1, p-c-JNK, and CXCL1, and increased PWMT and PWTL (all P<0.05). There were no significant differences in the mRNA and protein expression levels of c-JNK among groups (P>0.05).

    Conclusion:

    Duzhong Yaotong Pill can inhibit spinal dorsal horn inflammation in LDH rats, and its mechanism may be related to the inhibition of the c-JNK/CXCL1 signaling pathway.

  • Yang JI, Ming-xia LIU, Yu-ning WANG, Guang-chao WEI, Hao PAN
    Chinese Journal of New Drugs. 2026, 35(13): 1426-1431.
    Objective:

    To design a coaxial drug-loaded composite fiber membrane with a core-shell structure. The coaxial drug-loaded fiber membrane was fabricated using electrospinning and electrospraying techniques, achieving satisfactory quality with demonstrated efficacy in promoting wound healing and antibacterial activity.

    Methods:

    Physicochemical characterization, quality control, and in vitro and in vivo efficacy evaluation were conducted on the fabricated composite fiber membrane.

    Results:

    The coaxial nanofibers exhibited a distinct core-shell structure and excellent antibacterial efficacy. H&E staining and VEGF immunohistochemistry confirmed that the coaxial drug-loaded composite fiber membrane promoted collagen synthesis, accelerated neovascularization, and facilitated wound healing.

    Conclusion:

    The prepared coaxial drug-loaded composite fiber membrane meets all the testing requirements and can effectively promote wound healing and inhibit bacteria, providing a new approach for the development of novel wound dressings.

  • Yi-xin CUI, Xiao-xia YE, Jian LE
    Chinese Journal of New Drugs. 2026, 35(13): 1432-1439.
    Objective:

    To investigate the in vitro release behavior of benzoyl peroxide gel using a diffusion cell method, and to obtain release profiles with subsequent kinetic model fitting.

    Methods:

    The method was established with Franz diffusion cell. The PEG400-ethanol-water (25∶25∶50) is selected as receiving medium. The nylon membrane with 0.45 μm is used as the artificial membrane. The release amount was determined by high performance liquid chromatography (HPLC). The release data were fitted to zero-order, first-order, Korsmeyer-Peppas, and Higuchi models to identify the optimal release model.

    Results:

    An in vitro release testing method for benzoyl peroxide gel was successfully established. The release data of benzoyl peroxide were best fitted by the zero-order kinetic model, whereas the release data of benzoic acid were best described by the Higuchi model.

    Conclusion:

    The established in vitro release method is suitable for evaluating the release characteristics of benzoyl peroxide gel and provides a useful reference for the quality assessment of topical formulations containing poorly soluble drugs.

  • Ya-lan LÜ, Xin-hong LI
    Chinese Journal of New Drugs. 2026, 35(13): 1440-1446.
    Objective:

    To detect adverse drug reaction (ADR) signals of selective serotonin reuptake inhibitors (SSRIs) based on the FDA Adverse Event Reporting System (FAERS) database, and to provide a reference for the safety evaluation of these drugs.

    Methods:

    The proportional reporting ratio (PRR), reporting odds ratio (ROR), and Bayesian confidence propagation neural network (BCPNN) methods were used to detect ADR signals.

    Results:

    The adverse reaction reports of SSRIs mainly involved the following system organ classes: psychiatric disorders, nervous system disorders, general disorders and administration siteconditions, injury, poisoning and procedural complications, and gastrointestinal disorders. A total of 70 positive signals were detected. Fluvoxamine showed potential ADR signals for galactorrhea (IC 95%CI lower limit 0.79, PRR 95%CI lower limit 3.88, ROR 95%CI lower limit 3.88) and hyperprolactinemia (IC 95%CI lower limit 0.78, PRR 95%CI lower limit 3.57, ROR 95%CI lower limit 3.57). The other four SSRIs all showed potential ADR signals of fetal exposure during pregnancy. Citalopram showed a potential ADR signal for small for gestational age (IC 95%CI lower limit 3.38, PRR 95%CI lower limit 2.47, ROR 95%CI lower limit 2.48).

    Conclusion:

    This study identified potential ADR signals of SSRIs, suggesting that caution should be exercised when using SSRIs during pregnancy and that patients receiving fluvoxamine should be monitored for galactorrhea or hyperprolactinemia, so as to provide a reference for clinical safe medication.

  • Hong-ye GENG, Li-xuan LI, Cheng-yuan LU, Shu-ling WANG
    Chinese Journal of New Drugs. 2026, 35(13): 1447-1456.
    Objective:

    To evaluate the efficacy, safety, and economics of tirzepatide in the treatment of overweight/obesity.

    Methods:

    A comprehensive comparison of the efficacy of tirzepatide and semaglutide in the treatment of overweight/obesity was performed using reticulated Meta-analysis (NMA), and cost-effectiveness analysis was used for pharmacoeconomic evaluation.

    Results:

    A total of 14 randomized controlled trials were searched. The NMA showed that for efficacy, the tirzepatide group was significantly better than the simelglutide group in terms of weight loss (MD=-6.50%, 95%CI: -8.13% to -4.87%), waist circumference reduction (MD=-5.40%), and the attainment rate of >15% weight loss (RR=1.28) (P<0.001), but the glycemic control was not statistically different. For safety, the overall incidence of gastrointestinal adverse events was similar in both groups, with a lower risk of vomiting with telbivudine (RR=0.70, 95%CI: 0.55~0.89). For the pharmacoeconomics, the ICER value of 87 714.55 yuan was well below the willingness-to-pay threshold, suggesting that tirzepatide was more cost-effective compared with semaglutide.

    Conclusion:

    The weight loss efficacy and economy of tirzepatide are significantly better than those of semaglutide, and its long-term safety needs to be further verified in the future.

  • Yan-mei RAO, Li DONG, Zhe HUANG
    Chinese Journal of New Drugs. 2026, 35(12): 1233-1242.
    Objective:

    To explore the characteristics and policy tools of cell and gene therapy industry policies in China's three major urban agglomerations and to comprehensively improve the development of China's cell and gene therapy industry policies.

    Methods:

    Based on the content analysis method, a quantitative text analysis of 88 cell and gene therapy industry-related policies issued by the relevant departments of the three major urban agglomerations was conducted from the dimensions of policy tools and policy themes by constructing a policy tool framework.

    Results:

    In terms of the use of policy tools, supply-type>environment-type>demand-type. In terms of policy themes, "industry" and "development" appear most frequently in the word clouds of the policy texts of the three major city clusters, indicating that the three major urban agglomerations have clear objectives and plans to promote the development of the cell and gene therapy industry.

    Conclusion:

    It is recommended that China balance the use of cell and gene therpy industrial policy tools, increase the proportion of demand-type and environment-type policy tools, emphasize the concept of risk supervision, accelerate the application transformation and industrialization of cell and gene therapy, improve the construction and top-level design of cell and gene therapy industry policies, and promote multi-faceted coordinated development.