ArchiveThere 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.
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.
Drug-induced cardiotoxicity is one of the important reasons for the failure of drug development, and it is urgent to establish methods to screen the impact of drugs on the heart in the early stage. However, the traditional drug safety evaluation models are unable to meet the requirements of drug development. Therefore, the development of efficient and inexpensive drug safety evaluation and mechanism study models are very important for the development of new drugs and rational clinical application of drugs. In recent years, in addition to traditional animal models, the zebrafish, Drosophila,and Caenorhabditis elegans have been used for drug safety research. Based on transgenic technology, humanized animal models with gene expression profiles and regulation similar to that of humans can be established, and the development and application of such models can be used to solve the problem of species differences in drug research. In addition, non-animal methods such as organ chips, organoids, and network toxicology have also been developed. The novel cardiac safety evaluation models would be helpful for drug cardiotoxicity prevention and treatment, as well as drug development.
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.
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.
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.
In order to explore the influencing factors of the willingness of part-time drug inspectors.
Based on the psychological contract theory, the questionnaire survey was conducted with samples of part-time drug inspectors from 13 cities in Jiangsu Province, and the factors influencing the willingness of part-time drug inspectors to inspect were analyzed from three dimensions of transactional, relational and developmental psychological contract.
A total of 212 questionnaires were distributed and 212 valid questionnaires were recovered, with an effective recovery rate of 100%. There was a significant and positive correlation between the three dimensions of psychological contract and the willingness to inspection（P<0.05）. Among them, the relational dimension had the greatest influence, the developmental dimension was the second, and the transaction dimension was the smallest.
It is suggested that inspection agencies should establish the development path, strengthen the incentive and affirmation, establish and improve the system guarantee of part-time drug inspectors, so as to improve the willingness of part-time drug inspectors for inspection.
To observe the safety and efficacy of patient-controlled intravenous analgesia （PCIA） with low-dose esketamine combined with sufentanil after off-pump coronary artery bypass grafting （OPCABG）.
Sixty patients undergoing OPCABG under general anesthesia were randomly divided into group S and group ES, with 30 patients in each group. The anesthesia induction and maintenance programs of the two groups were the same. Immediately after the operation, the group ES was injected with esketamine 0.05 mg·kg-1 intravenously, followed by continuous infusion of esketamine 0.5 µg·kg-1·min-1 for 72 h with equal volume sodium chloride injection in the group S. Then PCIA（ sufentanil 1.8 µg·kg-1 in the group ES, sufentanil 3 µg·kg-1 in the group S） was performed immediately for 72 h. The opioid dosage,analgesia satisfaction, effective pressing times of analgesia pump, rescue analgesia rate, pain and sedation score and vital signs in the two groups within 72 h after operation were observed. The time of awakening, extubation and exhaust after operation was recorded, the level of serum troponin was detected on the 4th day after operation, and the adverse drug reactions were observed within 72 h after operation.
Compared with the group S, the dosage of sufentanil and morphine decreased, the satisfaction of analgesia was higher, the rate of rescue analgesia was lower, and the Prince-Henry pain score at 12, 24, 48 and 72 h after operation in the group ES was significantly lower than that in the group S（ P<0.05）.There was no significant difference in awakening time and Ramsay sedation score, heart rate, mean arterial pressure and central venous pressure between the two groups at 6, 12, 24, 48 and 72 h after operation. There was no significant difference in the level of serum troponin between the two groups on the 4th day after operation（ P>0.05）. Within 72 h after operation,the incidence of nausea, vomiting and hypoxemia in the group ES was significantly lower than that in the group S（ P<0.05）,and there was no significant difference in the incidence of hypertension and skin pruritus（ P>0.05）.
Low-dose esketamine combined with sufentanil PCIA can be safely used after OPCABG, and can significantly reduce the dosage of sufentanil and improve the analgesia satisfaction of patients.
To observe the effects of propofol combined with etomidate on pulmonary complications and quality of recovery after laparoscopic abdominal surgery in elderly patients.
Eighty patients undergoing elective laparoscopic abdominal surgery, aged 60 to 85 years, ASA physical status Ⅱ~Ⅲ, were randomly allocated into two groups with 40 cases in each group. Both groups received midazolam 0.02-0.05 mg·kg-1 + sufentanil 0.5 μg·kg-1 + rocuronium 0.6 mg·kg-1 for anesthesia induction, propofol 2.5 mg·kg-1 was added to the control group and etomidate 0.2 mg·kg-1 combined with propofol 1 mg·kg-1 were added to the experimental group. The control group was given propofol 6-8 mg·kg-1·h-1 and remifentanil 4-6 μg·kg-1·h-1 intravenous pump for maintenance,while the experimental group was given propofol 4-6 mg·kg-1·h-1 combined with etomidate 0.2-0.4 mg·kg-1·h-1 and remifentanil 4-6 μg·kg-1·h-1 for maintenance. Patients’ heart rate （HR） and mean arterial pressure （MAP）were observed and recorded, serum interleukin （IL）-6 and tumor necrosis factor （TNF）-α concentrations were measured, QoR-15 scale score and the incidence of postoperative pulmonary complications （PPCs） were assessed.
MAP and HR were significantly higher in the experimental group than those in the control group at 30 minutes of anesthesia induction and at the end of surgery （P<0.05）. The serum concentrations of IL-6 and TNF-α in the experimental group were significantly lower than those in the control group at the end of surgery and 24 hours after surgery （P<0.05）. There was no significant difference in recovery time and extubation time between the two groups（P>0.05）, and there was no significant difference in QoR-15 scale score 1 day before surgery （P>0.05）. The QoR-15 scale score in the experimental group was significantly higher than that in the control group 1 day after operation. The incidence of PPCs was 12% （5/40） in the experimental group, which was significantly lower than that 38% （15/40） in the control group （P<0.05）.
Combination of propofol and etomidate for anesthesia can alleviate the perioperative inflammatory response, reduce the incidence of PPCs and improve the quality of postoperative recovery in elderly patients undergoing laparoscopic abdominal surgery.
To evaluate the effects of butorphanol combined with quadratus lumborum block （QLB） on postoperative analgesia and early rehabilitation quality in patients with colorectal cancer.
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.
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）.
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.
To quantitative evaluate of selective Janus kinase inhibitors in treatment of atopic dermatitis, and provide scientific basis for drug selection and clinical rational drug use.
According to the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions （the Second Edition）, a comprehensive evaluation of upadacitinib and abrocitinib was conducted from five aspects of pharmaceutical characteristics, efficacy, safety, economy,and other attributes, and scores were assigned.
The total scores of upadacitinib and abrocitinib were 80.5 and 80.2 respectively. Upadacitinib and abrocitinib had definite therapeutic effects in terms of itching relief, and skin lesion clearance. But when combined with topical corticosteroids and other drugs, the improvement in efficacy of abrocitinib was better than that of upadacitinib. Upadacitinib had a wider range of applicability compared to abrocitinib, but the incidence of adverse reactions in the blood system of abrocitinib was lower than that of upadacitinib. Upadacitinib and abrocitinib were recommended for admission.
Abrocitinib is suitable for patients who seek quick results and build confidence, as well as those who need to flexibly adjust treatment plans based on their condition. Upadacitinib is preferred for adolescents over 12 years old, patients with severe renal insufficiency, or concomitant diseases such as rheumatoid arthritis and ulcerative colitis.
To provide reference for selection and clinical rational use of third-generation anti-seizure medications in medical institutions through a comprehensive evaluation of perampanel and lacosamide.
A percentage based evaluation system was developed based on the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions （the Second Edition）. Referring to drug instructions, clinical treatment guidelines, and relevant literature, perampanel and lacosamide were quantitatively scored from five dimensions of pharmaceutical characteristics,effectiveness, safety, economy, and other attributes.
The final evaluation score was 77.41 for perampanel and 69.06 for lacosamide. The score of perampanel was higher than 70, so the recommendation for entering the drug use catalog of medical institutions was “strong recommendation”. There was a significant difference in effectiveness and economy between the two drugs. Perampanel had more evidence-based proofs and indications for the treatment of drug-resistant epilepsy and lower average daily treatment cost, so the effectiveness and economy of perampanel was slightly better than that of lacosamide. However, in terms of safety, perampanel had a Boxed Warning from the U. S. Food and Drug Administration about severe psychiatric and behavioral reactions, and it was not as recommended as lacosamide in patients with pregnancy or liver dysfunction.
Perampanel and lacosamide each have advantages in different attributes, and medical institutions can decide whether to introduce them based on the characteristics of patient population and the availability of alternative drugs.
To synthesize the available clinical evidence to evaluate the efficacy and safety of lanadelumab,avoralstat, berotralstat, garadacimab, donidalorsen and plasma-derived C1-esterase inhibitor for preventing the acute attack of hereditary angioedema （HAE） using network meta-analysis.
PubMed, Cochrane Library, Embase, Web of Science, CNKI, Wanfang, and VIP databases were searched for randomized controlled trials that evaluated the efficacy and safety of these six drugs in the prevention of the acute attack of HAE from the establishment of the library to January 2024. A network meta-analysis （NMA） was performed by Stata 17.0 and R 4.3.2.
A total of 10 randomized controlled trials fulfilling the inclusion criteria were retrieved, including 619 patients. NMA showed that five kinds of drugs were superior to placebo in reducing the number of acute HAE attacks every 4 weeks （P<0.05）. The surface under the cumulative ranking sorting results showed that garadacimab was the most efficacious （MD=2.59, 95%CI: 1.38 to 3.79）. For the comparison between placebo and these drugs, there were no significant differences in the incidence of adverse events and serious adverse events. The SUCRA indicated that lanadelumab had the lowest incidence of adverse events and donidalorsen had the lowest incidence of serious adverse events.
Garadacimab is the most effective drug of all these first-line agents used to prevent acute attacks of HAE, while lanadelumab has better safety.
To mine the adverse drug event （ADE） signals of ramucirumab based on the database of FDA Adverse Event Reporting System （FAERS）, so as to provide evidence for safe clinical medication.
The ADE reports related to ramucirumab from the second quarter of 2014 to the fourth quarter of 2023 in the FAERS database were extracted, and the reporting odds ratio method of disproportional method and comprehensive standard method of British Medicines and Healthcare Products Regulatory Agency were used for data mining and analysis.
A total of 4 704 ADE reports of ramucirumab were collected. Most reporting objects were male （58.38%）, with the age of 65-85 （40.45%）. The main sources of reported events was Japan （46.64%）. A total of 140 ADE signals were detected,involving 18 system organ class （SOC）. Among them, a large number of reports were general disorders and administration site conditions （18.04%）, neoplasms benign, malignant and unspecified （15.82%）, respiratory, thoracic and mediastinal disorders （13.32%） and gastrointestinal disorders （12.83%）. ADE signals with high frequency were basically consistent with the drug instructions. The ADE signals that need to be focused on clinically were mainly hemorrhagic ADE such as gastrointestinal bleeding, tumor bleeding, colorectal bleeding, and brainstem bleeding, as well as ADE of organ perforation.
The medication evaluation of patients should be done before using ramucirumab. During treatment, close attention should be paid to the occurrence of ADE such as bleeding and perforation, and timely intervention should be taken in case of abnormality.
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