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  • Xu ZHANG, Jia-hui ZHOU, Bei ZHANG, Hai-cheng SONG, Yue-yi REN
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(6): 422-425.
    AIM

    To explore the median effective dose (ED50) of ciprofol combined with remifentanil for sedation in painless gastroscopy of school-aged children.

    METHODS

    School-aged children scheduled for painless gastroscopy were selected, regardless of gender, aged 6-12 years old. Following the intravenous injection of remifentanil 0.5 μg·kg-1, the pediatric patient was administered with ciprofol (starting with an initial dose of 0.5 mg·kg-1, the dose for the next child was determined using the Dixon sequential method, based on the sedation situation. A decrease of 0.05 mg·kg-1 was applied for successful sedation, while an increase of 0.05 mg·kg-1 was applied for failed sedation). The ED50, 95% effective dose (ED95) and corresponding 95% confidence interval (CI) of ciprofol were calculated by Probit method. The mean arterial pressure (MAP), heart rate (HR), and respiratory rate (RR) of the pediatric patients before sedation (T0), after remifentanil administration (T1), and after ciprofol administration (T2), as well as the occurrence of adverse reactions were recorded.

    RESULTS

    The ED50 of ciprofol when combined with 0.5 μg·kg-1 remifentanil in anesthesia induction for school-aged children in painless gastroscopy was 0.302 mg·kg-1 (95% CI: 0.184 to 0.356 mg·kg-1),and the ED95 was 0.461 mg·kg-1 (95% CI: 0.390 to 1.004 mg·kg-1). Compared with those at T0, the MAP, HR, and RR of the children decreased significantly at T1 and T2 (P<0.05). Compared with those at T1, only MAP decreased significantly at T2 (P<0.05).During the examination, there were 6 cases of hypotension, 5 cases of bradycardia, and 5 cases of respiratory depression (including 3 cases of transient apnea), with no injection pain or chest wall rigidity.

    CONCLUSION

    The ED50 of ciprofol combined with 0.5 μg·kg-1 remifentanil for sedation in painless gastroscopy of school-aged children was 0.302 mg·kg-1 (95% CI: 0.184 to 0.356 mg·kg-1),and the ED95 was 0.461 mg·kg-1 (95% CI: 0.390 to 1.004 mg·kg-1).

  • Chen-liang FAN, Xiao-yan WU, Xiao-si LI, Jun-jie YU
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(6): 476-480.
    AIM

    To assess the in vitro antibacterial activity of polymyxin B in combination with meropenem, amikacin, and fosfomycin against carbapenem-resistant Enterobacteriaceae (CRE) strains carrying various resistance genes.

    METHODS

    A total of 76 CRE strains isolated from the clinical laboratory of our hospital between 2019 and 2021 were collected for identification and confirmation of carbapenemase genotype. The minimum inhibitory concentrations (MIC) of polymyxin B, meropenem, amikacin, and fosfomycin against CRE were determined using the broth microdilution method.The in vitro combined sensitivity tests of polymyxin B with meropenem, amikacin, and fosfomycin were performed using the microdilution checkerboard method to calculate the fractional inhibitory concentration index (FICI) for determining their interactions.

    RESULTS

    Among the 76 strains of CRE, 24 strains were identified to carry the blaKPC, while 28 strains carried the blaNDM and another 24 strains carried the blaOXA-48-like. The drug-resistance rates of CRE strains to polymyxin B, meropenem, amikacin, and fosfomycin were determined as 3%, 92%, 39%, and 45%, respectively. The highest synergistic + partial synergistic rate was observed in combination of polymyxin B with meropenem (54%), followed by fosfomycin (43%) and amikacin (18%). For CRE carrying blaKPC, blaOXA-48-like, or blaNDM, the synergistic + partial synergistic rates of polymyxin B combined with fosfomycin were 37%, 42%, and 50%, respectively, while combined with meropenem were 75%, 21%, and 64%, respectively, and combined with amikacin were 8%, 25%, and 21%, respectively. No antagonistic effect was observed between polymyxin B and these three antibiotics.

    CONCLUSION

    The combination of polymyxin B and meropenem exhibits the best synergistic antibacterial effect against CRE, and the combined effect is related to the drug-resistance genotype of bacteria, so active detection of drug-resistance genes can help to promote the rational use of antibiotics in clinical practice.

  • Ya-shi LIU, Hong-chao LI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(6): 406-410.

    Compared to adult economic evaluation, pediatric pharmacoeconomics evaluation has the characteristics, such as the limited disease types, difficult to accurately measure health utility, easily ignored family spillover effects, unmet medical needs, and higher appropriateness requirements. There are specialized tools and resources in the field of pediatric pharmacoeconomics evaluation including the pediatric quality appraisal questionnaire, pediatric economic database evaluation database, and pediatric economic evaluation textbook. The characteristics of pediatric pharmacoeconomics evaluation is necessary to be pay attention, and specialized tools and resources should be actively used to improve the practicality and standardization of future pediatric pharmacoeconomics.

  • Kun-peng SUI, Wei ZHANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(6): 401-405.

    Latent tuberculosis infection (LTBI) is a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens without evidence of clinically manifested active tuberculosis. Although LTBI is not contagious, about 5%-15% patients will develop active tuberculosis. Young age and immunosuppression are risk factors for the progression of LTBI to active tuberculosis. Due to the immature immune system, rheumatic disease and anti-rheumatic drugs, children with rheumatic disease are more susceptible to Mycobacterium tuberculosis, and LTBI is also prone to develop into active tuberculosis. China is still a country with a high burden of tuberculosis, more attentions should be paid to LTBI in rheumatic children. Screening for LTBI and preventive anti-tuberculosis treatment can reduce the occurrence of active tuberculosis and ensure the health of rheumatic children.

  • Yan LIU, Ying-bin WANG, Li ZHANG, Lu CAO, Wei ZHANG, Xin-fang LI, Jia GUO, Jing-yu ZHANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 321-326.

    There are many factors affecting the prognosis of tumor patients, and the related mechanisms are still unclear, among which anesthetics also have certain influence on the prognosis of tumor patients. Benzodiazepines are widely used in surgical anesthesia for tumor patients due to their sedative properties. Previous studies have found that diazepam and midazolam can inhibit the proliferation of tumor cells and induce apoptosis or necrosis. In addition, midazolam can also stabilize the perioperative state of patients, improve the efficacy of chemotherapy drugs, and thus improve the prognosis of patients. Remimazolam can improve the prognosis of tumor patients by alleviating intraoperative stress and immunosuppression. The direct effect of remimazolam on the prognosis of these tumor patients and the related mechanisms need to be further explored.

  • Yong-zheng FAN, Li-jun HAN, Liang ZHAO
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 327-333.

    Opioid drugs activate G protein and (or) β-arrestin protein signaling pathways by acting on opioid receptors, which can generate analgesia and anesthesia effects, but the accompanying respiratory depression is a serious and common clinical problem. Until now, one of the goals of the basic research and therapeutic application of opioid drugs is to separate the analgesic effect from the respiratory depression side effect, so as to develop new opioid drugs with strong analgesic activity and reduced respiratory depression side effect. At present, peripheral selective opioid agonists, biased opioid agonists, mixed opioid agonists, endogenous opioid peptides and opioid splicing variant agonists have been developed successively, of which the biased opioid agonist oliceridine (TRV130) has been marketed. As the research progresses, more new opioid drugs will be used in clinical treatment to improve drug safety.

  • Xin LIU, Jin-guo ZHAI
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 339-343.

    In recent years, many new drug treatment targets have been found, which provided the basis for the precise treatment of antipsychotic drugs and promoted the research and development of new antipsychotic drugs. The development of trace amine-associated receptor 1 agonist, glycine transporter-1 inhibitor, peripherally restricted muscarinic receptor antagonist, 5-hydroxytryptamine 2A/2C receptor inverse agonist and other new drugs have provided new possibilities for the treatment of psychotic symptoms and attracted much attention due to their significant efficacy and mild adverse reactions.

  • Jin-zhong WANG, Shuo HAN, She-liang SHEN, Jia XU, Xu-lu WANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 369-373.
    AIM

    To evaluate the effects of butorphanol combined with quadratus lumborum block (QLB) on postoperative analgesia and early rehabilitation quality in patients with colorectal cancer.

    METHODS

    Sixty patients undergoing elective laparoscopic radical resection of colorectal cancer under general anesthesia were randomly divided into two groups, with 30 cases in each group. The induction and maintenance of anesthesia were the same in the two groups.Patients in group B received patient-controlled intravenous analgesia (PCIA) with butorphanol 0.2 mg·kg-1 diluted to 200 mL with sodium chloride injection. Patients in group BQ received ultrasound-guided bilateral anterior QLB and 0.25% ropivacaine 20 mL was injected bilaterally on the basis of that in the group B. Visual analogue scale (VAS) and Bruggrmann comfort scale (BCS) were used to evaluate the analgesic effect of the two groups after operation. The serum levels of interleukin (IL)-6, C-reactive protein (CRP) and tumor necrosis factor (TNF) -α were detected before operation and 24 h after operation. The postoperative recovery and hospitalization satisfaction score of the patients were evaluated,the consumption of butorphanol and the requirement for rescue analgesia within 48 h after operation were recorded, and the occurrence of postoperative nausea and vomiting was observed.

    RESULTS

    The VAS scores of the group BQ were lower than those of the group B at 2, 6, 12 and 24 h after operation (P<0.05), and the BCS scores of the group BQ were higher than those of the group B (P<0.05). The levels of IL-6, TNF-α and CRP at 24 h after operation in both groups were higher than those before operation (P<0.05), but those in the group BQ were lower than those in the group B (P<0.05). The postoperative anal exhaust time, liquid food intake time, ambulation time and hospitalization time in the group BQ were shorter than those in the group B (P<0.05), and the hospitalization satisfaction in the group BQ was higher than that in the group B (P<0.05). The consumption of butorphanol within 48 h after operation in the group BQ was less than that in the group B (P<0.05), and the requirement for rescue analgesia in the group BQ was lower than that in the group B (P<0.05).No serious adverse reactions occurred in the two groups, but the incidence of nausea and vomiting in the group BQ was significantly lower than that in the group B (P<0.05).

    CONCLUSION

    Butorphanol combined with QLB for postoperative analgesia in patients undergoing laparoscopic radical resection of colorectal cancer can effectively enhance the postoperative analgesic effect, reduce the inflammatory response of the body, and promote the early recovery of patients.

  • Lin ZHOU, Lei WANG, Man XING, Tao YANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 344-348.

    Recurrent vulvovaginal candidiasis (RVVC) is one of the common recurrent and refractory diseases that troubles women. Oteseconazole, the first drug for the treatment of RVVC, is an oral azole metallic enzyme inhibitor targeting fungal sterol 14α-demethylase (CYP51) developed by Mycovia Pharmaceuticals, Inc., and was approved for sale in the United States on April 26, 2022. Clinical trials have shown that oteseconazole has a significant therapeutic effect on RVVC with minimal adverse reactions.

  • Teng ZHANG, Tie-wei ZHANG
    Chinese Journal of New Drugs and Clinical Remedies. 2024, 43(5): 349-354.

    The difficulties in diagnosing rare diseases, seeking medical treatment, and low drug accessibility have become a public health governance challenge in China and even globally. The fragmentation of China’s rare disease prevention and protection system is evident, and relevant policies urgently require legal authorization and solidification.Research and development of rare disease drugs lack effective legal and policy incentives. Special legislation is an effective way to solve the dilemma of rare disease prevention and protection. Promoting special legislation for rare diseases in China at present is an inherent requirement for achieving social justice and protecting the right to health of patients. There is a broad social consensus and mature experience outside the region for reference. The functional positioning of special legislation for the prevention and protection of rare diseases should be clarified, a reasonable value orientation for differential treatment should be established, and the construction of special legislation for rare diseases should be promoted through adhering to the idea of central coordination and local pilot parallel promotion.