Objective To summarize the characteristics of fixed-dose combinations in the development of antitumor drugs so as to provide references for the development of related combinations. Methods By searching for relevant literature from domestic and overseas databases, the marketed fixed-dose antitumor drug combinations and combination therapies approved by the US FDA in the past three years were analyzed. Results The marketed fixed-dose antitumor drug combinations could significantly improve the therapeutic effects of drugs, improve patient compliance and reduce drug toxicity through multi-target synergistic effects or by improving drug delivery routes. Conclusion Fixed-dose antitumor drug combinations enjoy significant advantages in clinic but still face many challenges in the course of development. In the future, artificial intelligence can provide strong technical support and innovation incentives for the development of drugs.

Objective To review the principles of development of compound drugs for neurodegenerative diseases, summarize the related compound drugs developed in recent years and introduce their mechanism of action. Methods By searching relevant literature and databases at home and abroad, compound drugs and that have been developed or entered clinical trials and their mechanisms of action are summarized and analyzed. Results Significant progress has been made in the research on receptor suppressants, monoclonal antibody drugs, neuroprotective drugs and inflammatory suppressants. These drugs can improve memory and cognitive abilities through multi-target effects, significantly delay the progression of the disease, and bring new hopes for improving the quality of life of patients with neurodegenerative diseases and enhancing their motor function. Conclusion Compound drugs for treating neurodegenerative diseases have significant therapeutic advantages, but due to the complicated pathogenesis and irreversible course of disease, the development of these drugs remains challenging. The combination of emerging technologies such as bioinformatics technology, precision medicine, and nanodelivery systems can provide strong technical support and impetus of innovation for the development of compound drugs.

Objective To analyze the marketed combination antihypertensive drugs and the rationality of their components, explore their composition and assess their efficacy so as to provide references for the development and innovation of combination antihypertensive drugs. Methods The marketed compound drug combinations and approved drug combination therapy regimens were analyzed and summarized by searching domestic and foreign literature. Results With multiple mechanisms of action, compound antihypertensive drugs could improve drug compliance, reduce cardiovascular risks, and lower overall treatment cost. Conclusion Compound antihypertensive drugs have unique advantages in the treatment of hypertension. Compound drugs are also the best choice for the treatment of hypertension and concomitant diseases, which will provide a new impetus for the development of compound drugs in the future.

Objective To outline the principles and requirements of developing compound preparations against acquired immunodeficiency syndrome (AIDS), and summarize the simplified regimens of antiretroviral therapy (ART) so as to provide references for seeking the best drug therapy regimens. Methods By searching related domestic and foreign literature and databases, the compound preparations against AIDS on the market were sorted out and analyzed. Results The currently marketed compound preparations against AIDS could simplify ART regimens, enhance medication compliance, reduce drug side effects, lower the drug burden, and improve patients' quality of life. Conclusion Compound preparations against AIDS have significant advantages therapeutically, but there are still significant clinical needs for the treatment of and drug development for this disease, which requires more in-depth research.

Objective To summarize the current research and prospects of drug combinations used in the treatment of hepatic fibrosis(HF). Methods Related literature at home and abroad was reviewed, research findings in this field were summarized, and the key issues facing HF treatment were discussed, including the pathogenesis, medications currently used and the progress in drug combination therapies. Results The pathogenesis of HF involved hepatic stellate cell activation, iron death, autophagy and cell conduction pathway. Despite the benefits of monotherapy in controlling the disease, the therapeutic effect was limited and such problems as drug resistance existed. Because of the multi-target and multi-pathway mechanism of action, drug combinations became a hot spot in the treatment of HF. Studies showed that some drug combinations could significantly inhibit pathological processes, improve liver function indexes, and go a long way towards alleviating HF and improving prognosis. Conclusion Multi-drug combination therapies are one of the effective strategies for HF treatment, especially in case of complex pathological mechanism and multi-factor influence. It is recommended that future studies continue to optimize the combination treatment regimens. The development of compound drugs may become a new trend in new drug research.

Objective To establish an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the determination of trazodone concentrations in serum of patients that can be used for clinical individualized medications with trazodone. Methods The chromatographic column was MSCB-2A (2.1 mm × 50 mm, 2.5μm). The mobile phase consisted of methanol (B) -water (A, containing 0.01 % ammonia) under gradient elution (the gradient set at 0~0.2 min, 55 % B; 0.2~2.0 min, 55 %~95 % B; 2.0~-2.5 min, 95 %~95 % B; 2.5~2.6 min, 95 %~55 % B; 2. 6~3. 0 min, 55 %~55 % B). The flow rate was 0.5 mL·min^{- 1}, the column temperature 40℃, and the injection volume 0.1 μL in a positive ion mode. The serum was precipitated by acetonitrile, and diazepam was used as the internal standard. The specificity, standard curve and lower limit of quantification, precision and recovery, matrix effect, and stability of the method were investigated. Meanwhile, this method was applied to the determination of blood concentrations of 16 patients using trazodone, and the test results were analyzed before intervention opinions were given. Results The linear range of trazodone in serum was 10.0 to 1 500.0 ng·mL^-1 (R² = 0.9994). The relative standard deviation (RSD) of intra-day and inter-day precision of low, medium, and high quality control concentration samples (50.0, 400.0, 1 000.0 ng·mL^-1) was less than 7%, and the accuracy ranged from 91.90% to 98.67%. The serum with low, medium, and high concentrations of trazodone remained stable at room temperature for 4 h, for 24 h in a 2 to 8℃ refrigerator, after long-term freezing of 3 months or repeated freeze-thaw cycles. The accuracy ranged from 95.04% to 105.78% under varied conditions. The method was also applied to the therapeutic drug monitoring of clinical samples of trazodone. Conclusion This UPLC-MS/MS method is rapid, simple, stable, accurate, highly sensitive, and almost pollution-free in the detection of plasma concentrations of trazodone This method has been successfully applied to the clinical individualized medication of trazodone.

Objective To investigate the effect of Erzhu Tianma granules (EZTM) on model rats with prehypertension (PHT) phlegm-dampness syndrome. Methods WKY rats were randomly divided into the control group, model group and EZTM high (1 944 mg·kg^-1·d^-1), medium (972 mg·kg^-1·d^-1) and low (486 mg·kg^-1·d^-1) dose groups. A high-salt and high-fat diet was used to induce PHT phlegm-dampness syndrome in the model and EZTM rats. Different doses of EZTM were used as a six-week intervention. The activity, mental state, fecal character and other syndrome indexes were observed, and the general condition score was recorded. The body weight, Lee's index and blood pressure (SBP, DBP, MAP) were measured. Blood was collected from the abdominal aorta, and blood lipid (TC, TG, HDL-C, LDL-C), inflammatory factors (CRP, TNF-α, IL-1β, IL-6), oxidative stress index (SOD, MDA), vasorelaxation factor (NO), TMAO levels, safety indexes (GLU, ALT, AST, Cr, BUN) were detected. The thoracic aorta was extracted and observed via HE and Masson staining. Results Compared with the control group, the model group showed symptoms of phlegm-dampness syndrome, such as lethargy, laziness, lack of energy and loose stool. The scores of general conditions, body weight, Lee's index and blood pressure were increased (P<0.01), BP was maintained at 130-140/75-80 mmHg, TC, TG and LDL-C were increased (P<0.01), HDL-C was decreased (P<0.01), CRP, TNF-α and IL-1β were increased (P<0.01), SOD activity was decreased (P<0.01), MDA was increased (P<0.01), NO was decreased (P<0.01), and TMAO was increased (P<0.01). The intima of the thoracic aorta was irregular, a small number of inflammatory cells were infiltrated, the thickness of the media thickened, the arrangement of smooth muscle cells was disorderly, and the collagen fibers increased significantly. Compared with the model group, the phlegm-dampness syndrome of rats in EZTM high and medium dose groups was improved. The score of general conditions, body weight, Lee's index and blood pressure decreased (P<0.01), TC, TG, LDL-C decreased (P<0.01), HDL-C increased (P<0.01), CRP, TNF-α, IL-1β decreased (P<0.01), SOD activity increased (P<0.01), MDA decreased (P<0.01), NO increased (P<0.01), and TMAO decreased (P<0.01). The intima of the thoracic aorta was smooth, no obvious inflammatory infiltration was observed, the thickness of the media was moderate, smooth muscle cells were arranged neatly, and the collagen fibers were reduced. The effect of high-dose EZTM was more pronounced. There were no significant differences in safety indexes between these groups (P>0.05). Conclusion Erzhu Tianma granules can effectively reduce blood pressure, body weight, Lee's index and general condition scores, and improve the manifestations of phlegm-dampness syndrome, especially at a high dose. The mechanism may be related to correcting dyslipidemia, anti-inflammation, antioxidant stress, increasing NO contents, reducing TMAO production, and improving the pathological structural changes of the aorta.

Objective To establish a method for determination of 28 elements in Coicis Semen by stir-frying with bran, and evaluate the risks of these toxic elements in order to facilitate quality control of Coicis Semen. Methods After microwave digestion, the samples were analyzed by inductively coupled plasma mass spectrometry (ICP-MS) and the risk of Pb, Cd, As, Hg and Cu was assessed. Results The linearity of each element was good. The precision was less than 3.0% and the recovery ranged from 81.2% to 112.0%. The contents of K, Mg, Ca, Fe, Zn, Mn, Al and Na in Coicis Semen by stir-frying with bran were higher (>50 mg·kg^-1), while those of Cu, B, Li, Ni, Ba, Sr, Mo, Cr and Ti were lower (1~5 mg·kg^-1). V, Se, Co, As, Pb, Be, Cd, Ag, Tl, Au, Hg, Sb were trace elements (<1 mg·kg^-1). According to the limits of heavy metals and harmful elements in botanical medicines stipulated in the current 2020 edition of Chinese Pharmacopoeia (hereinafter referred to as the Chinese Pharmacopoeia) (Part I), the same amounts of lead, cadmium and cadmium were found in the 15 batches of Coicis Semen by stir-frying with bran. The pass rate of lead, cadmium, arsenic, mercury and copper in the 15 batches of Coicis Semen by stir-frying with bran was 100%. Risk assessment showed that the hazard indices (HI) of Pb, Cd, As, Hg and Cu in the 15 batches of Coicis Semen by stir-frying with bran were less than 1, indicating that the risk was acceptable. Conclusion The multi-element analytical method developed in this study has a high sensitivity and good specificity, which, combined with risk assessment techniques, can provide a reference for quality control of Coicis Semen by stir-frying with bran.

Objective Ames test, Chromosome aberration test and mouse bone marrow micronucleus test were used to evaluate the genotoxicity risk of xueshuantong injection. Methods Ames test, Five strains of bacteria including TA97, TA98, TA100, TA102 and TA1535 were exposed to xueshuantong injection at concentrations of 128.0, 320.0, 800.0, 2 000.0 and 5 000.0 μg/plate by plate incorporation ,with and without S9 respectively. Chromosome aberration test, CHL cells were exposed to xueshuantong injection for 4 h (with and without S9) or 24 h (without S9) at concentrations of 125, 250 and 500 μg·mL^-1. The number of cells with structural and numerical aberrations in 300 metaphase cells in each group was counted under oil lens. Mouse bone marrow micronucleus test, KM mice were dosed with 104.3 , 208.6 and 417.2 mg·kg^-1 by intravenous injection of xueshuantong injection for two days, and the bone marrow samples were collected at 24 h after the last treatment.The number of immature erythrocytes per animal were scored , and the proportion of immature among total erythrocytes was determined for each animal by counting erythrocytes for bone marrow. Results Compared with the concurrent solvent control, the mean number of revertant colonies in each group increased less than once. Compared with the concurrent solvent control, there was no significant difference in the rate of structural aberration and numerical aberration caused by xueshuantong injection (P>0.05). At 24 h post-administration of xueshuantong injection, there was no significant difference in the average micronucleated polychromatic erythrocyte rate in each group compared with the solvent control (P>0.05). Conclusion The genotoxicity evaluation result of xueshuantong injection is negative under the test conditions.

Objective To give tips about how to improve the regulation of cellular and gene therapies in China and promote high-quality development of the industry. Methods The ways in which cellular and gene therapy products were regulated in the US, Japan and Europe were compared by reviewing regulations and literature. The implications for China were analyzed in the light of actual regulation in China and the needs of industrial development. Results and Conclusion Based on the current practices related to the review and approval of cellular and gene therapies in China and by learning from the regulatory models and review process designs of the United States, Japan and Europe, China's regulatory system can be upgraded by means of innovative regulatory concepts, integration of review resources, more international exchanges and cooperation as well as intensified efforts.

Objective To analyze the problems with the quality of Glycyrrhiza inflata Bat. and Glycyrrhiza glabra L., identify obstacles to development and offer solutions. Methods Through talks with enterprises, field investigation, literature research and studies on the quality standard for Glycyrrhiza inflata Bat. and Glycyrrhiza glabra L., the status quo of the Glycyrrhiza inflata Bat. and Glycyrrhiza glabra L. industry in Xinjiang, the problems with pharmaceutical standards and opportunities of development were analyzed. Results The rate of defective Glycyrrhiza inflata Bat. and Glycyrrhiza glabra L. in the medicinal field was high by the content determination standard specified in the Pharmacopoeia of the People's Republic of China (2020 edition). However, the licorice of three sources contained flavonoids with pharmacological action, so liquiritin alone could not be used as an indicator of quality control. Conclusion It is recommended that the quality standard for Glycyrrhiza inflata Bat. and Glycyrrhiza glabra L. be revised to adopt various flavonoid components as the quality evaluation indexes of licorice so as to promote its cultivation in China.

Objective To guide the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications” (referred to as the “Guidelines”), providing a reference for standardizing pharmacovigilance activities and clinical practices related to topical traditional Chinese medicines (TCMs) in China. Methods Summarize the traditional formulations of topical TCMs mentioned in the “Guidelines”, and provide a detailed interpretation of the potential risks and control measures in the clinical application of topical TCMs. Results The Guidelines highlight the safety of medications containing mineral Chinese medicinal materials, toxic Chinese medicinal materials, and the use of TCMs in special populations such as pediatric, elderly, and pregnant patients. Comprehensive risk assessment and control measures are provided. Conclusion The irrational clinical application of topical TCMs increases the risk of medication-related adverse events. The guidelines offers valuable reference and guidance for better standardizing pharmacovigilance activities in the clinical application of topical TCMs.

Objective To analyze the risks to safety posed by Ondansetron in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions retrieved from China adverse drug reaction database (from January 1, 2004 to September 30, 2022) and WHO Vigilyze (from inception to October 31, 2022) and other databases (from inception to December 31, 2023) were analyzed. Results In the serious adverse reaction report of ondansetron, adverse reactions such as anaphylactic shock, dyspnea, and liver dysfunction are prominent. ondansetron in pregnancy is associated with a risk of cleft lip and palate. If pregnant women use ondansetron before and after delivery, breastfeeding should be suspended. Conclusion Medical institutions should pay attention to the teratogenic risk of Ondansetron and weigh the risk and benifit before using it in pregnant women. The drug marketing authorization holder should update the drug labeling in time, strengthen the risk communication with medical institutions, and promote the rational use of medicines.

Objective To establish electronic triggers for active monitoring of digoxin adverse drug event (ADE) based on the China Hospital Pharmacovigilance System (CHPS). Methods The initial electronic triggers of digoxin ADEs were prepared by referring to literature, drug instructions and ADR databases. Using Delphi method, the trigger items are revised; the medical records of hospitalized patients treated with digoxin in a Grade-III hospital were retrospectively reviewed, and the positive predictive value (PPV) of the trigger was calculated and compared with the spontaneous reporting of adverse events in the hospital. Results There were 18 electronic triggers for digoxin ADE initially proposed. After investigation and discussion by Delphi method, 16 triggers were set into active monitoring schemes using CHPS integrated modeling tool, including 4 laboratory indicators, 2 antidotes, 7 clinical symptoms and 3 intervention measures. The overall PPV of triggers was 29.37% (79/269). There were 41 true positive ADE cases detected by electronic triggers and confirmed by manual audit, the detection rate was 13.67% (41/300), however, the spontaneous reporting rate of adverse reaction monitoring system was 0. Conclusion The electronic triggers based on CHPS can be effectively used to monitor ADEs actively in medical institutions, enhance the monitoring sensitivity and improve the reporting rate of adverse reactions.

Objective To compare transurethral resection of bladder tumor (TURBT) with submucosal low-dose gemcitabine injection (SIOG) combined with TURBT in the treatment of medium-high risk non-muscle invasive bladder cancer (NMIBC), and to evaluate their clinical efficacy and pharmacoeconomics. Methods The clinical data of 270 patients with medium-high risk NMIBC (TURBT 213 cases, SIOG + TURBT 57 cases) in our hospital from January 1, 2015 to August 31, 2020 were collected, and matched on a 1 to 1 scale using propensity score matching and were divided into two groups. Each group had 52 patients. After the clinical efficacy of two groups was analyzed, the cost was calculated, a Markov model with 1 year as a cycle and 10 years for 1000 persons was constructed to evaluate the pharmacoeconomics of the two treatment regimens. Results The rates of non-recurrence at 3, 6 and 12 months in the TURBT group and the rates of non-recurrence at 3, 6 and 12 months in the SIOG + TURBT group were 90.38% vs 100.00 %, 84.62% vs 98.08% and 78.85% vs 92.31%, respectively. There was a significant difference in the non-recurrence rate of tumor 6 months after surgery (P < 0.05), According to a log-rank test, there was a significant difference in tumor recurrence rate between the two groups at 1 year (P < 0.05). The cumulative average costs per person for the treatment protocols of TURBT and SIOG + TURBT were ¥217,117.20 and ¥190,701.12, with health effects of 5.56 QALYs and 5.77 QALYs respectively. Patients treated with treatment protocols of SIOG + TURBT increased 0.21 QALYs and saved lifetime cost of ¥26,416.08. The treatment protocols of SIOG + TURBT had a cost-effectiveness advantage over the treatment protocols of TURBT. Conclusion Compared with the treatment protocols of TURBT, the treatment protocols of SIOG + TURBT had a better clinical effect and cost-effectiveness in the treatment of medium-high-risk NMIBC. This technique is worth promoting in clinical practice.

Objective Analysis of nonclinical immunotoxicity of CAT-T cell products, in order to provide a reference for safe clinical use. Methods The current research on CAR-T was outlined. The principles, characteristics, priorities of research, and immune-related toxicity of CAR-T products were analyzed based on related guidelines and immunotoxicity tests. Results The guidelines for evaluating the immunotoxicity of different types of CAR-T were inadequate. Currently, immunotoxicity tests were usually integrated into standard toxicity tests for initial screening before corresponding immune functional tests were selected as additional tests based on the results. TDAR was a preferable method for the overall evaluation of CAR-T immune toxicity. Conclusion There is a lack of appropriate evaluation strategies for the immunotoxicity evaluation of CAR-T cell products.

Objective Analysis of the occurrence characteristics of adverse events of macitentan, ambrisentan and bosentan, in order to provide a reference for the clinical selection of endothelin receptor antagonists. Methods Based on all adverse event reports in the FDA Adverse Event Reporting System(FAERS) and Japanese Adverse Drug Event Report(JADER) database from October 1, 2013 through December 31, 2023. We used the reporting odds ratio (ROR) method and the information component (IC) method to calculate the signals of endothelin receptor antagonist-associated adverse events. The positive signals were analyzed and compared. Log-rank test and nonparametric test were used to compare the differences in the time to induce ADE of endothelin receptor antagonists. Results Based on two database, total of 35 150 adverse event reports were obtained for macitentan, 75 177 for ambrisentan, and 22 707 for bosentan. Macitentan and ambrisentan-induced anaemia was reported in highest numbers in JADER, and macitentan, ambrisentan and bosentan-induced fluid retention was reported in highest numbers in FAERS. Bosentan hepatic impairment PT signal intensity was significantly higher than that of macitentan and irisentan. Anemia signal ranked highest in JADER and fluid retention signal ranked highest in FAERS. Bosentan hepatic impairment PT signal strength was significantly higher than that of macitentan and irisentan. Macitentan anemia PT signal strength was significantly higher than that of anrisentan and bosentan. Anlisentan fluid retention PT signal strength was significantly higher than that of macitentan and bosentan. Adverse event signalling in minor patients revealed that bosentan was more likely to induce liver function test abnormalities in minor patients than other endothelin receptor antagonists. Ambrisentan was more likely to induce nasopharyngeal discomfort in minor patients. The use of macitentan in underage patients should focus on anaemia, thrombocytopenia, abnormal liver function tests, epistaxis, decreased blood pressure, and hypokalaemia. Macitentan combined with nitric oxide synthase inhibitor [173 (IQR 40~544)] is the fastest combination regimen to induce adverse events, and bosentan combined with prostacyclin receptor antagonistsa [632.5 (IQR 222.75~1 225.5)] had the longest time for the induction of adverse events. Conclusion There are differences in the signal intensity of risk of adverse events and the time of adverse event induction for different endothelin receptor antagonists. Individualized dosing and monitoring of patients should be carried out to reduce possible adverse events and ensure patient safety.

Objective To explore the role of clinical pharmacists in the course of anti-infection treatment, and exchange experience related to individualized treatment of patients with pulmonary aspergillus infection secondary to sepsis so as to promote clinical rational drug use. Methods Clinical pharmacists participated in the whole process of anti-infection treatment of a patient with pulmonary aspergillus infection secondary to sepsis by assisting clinicians in formulating and adjusting treatment plans, monitoring voriconazole concentrations in blood, and providing individualized medications and pharmaceutical care. Results The condition of the patient was improved eventually, which offered experience for providing better pharmaceutical care in the future. Conclusion Clinical pharmacists' participation in medications against pulmonary aspergillus infection secondary to sepsis can help ensure the effectiveness and safety of drug treatment for patients so that the worth of clinical pharmacists can be proved.

Objective To explore the correlation between fulminate type 1 diabetes mellitus and allopurinol-induced drug hypersensitivity syndrome, and to provide reference for clinical practice. Methods A patient with HLA-B*5801 allele who developed secondary fulminant type 1 diabetes mellitus after allopurinol-induced hypersensitivity syndrome and was reported. The characteristics of the case and the related mechanism of drug-induced adverse reactions were analyzed according to the relevant literature, and the treatment measures for such patients were sorted out. Results The patient lost islet function completely and needed long-term multiple daily insulin injection to control blood glucose in the future. Previous studies and case reports suggest that this adverse event may be related to the use of allopurinol. Conclusion This case suggests that HLA-B*5801 gene testing should be performed before allopurinol treatment. Clinicians should be aware of the risk of secondary autoimmune diseases associated with drug-induced hypersensitivity syndrome.

Objective To remind health care professionals to be more alert to the risk of severe constipation associated with dapagliflozin and to provide reference for safe use of this drug. Methods The clinical process of treating a patient who developed severe constipation after taking dapagliflozin tablets was analyzed. Based on related literature, the possible mechanisms and treatment regimens of severe constipation caused by sodium-glucose cotransporter 2 inhibitors (SGLT-2i) were studied. Results One patient developed severe constipation after taking dapagliflozin. After discontinuation of the drug, the patient's constipation improved. However, upon re-administration of dapagliflozin, the patient relapsed into constipation. Immediately after drug withdrawal and treatment with laxatives to moisten the intestines, the patient's conditions improved. The causal relationship of adverse reactions was defined as “definite”, so the severe constipation of this patient was considered to have been caused by dapagliflozin. Conclusion Constipation poses a significant threat to patients' quality of life and may potentially precipitate cardiovascular events. Therefore, it is imperative to enhance clinicians' awareness and pharmacological surveillance regarding the adverse effects of constipation associated with dapagliflozin and SGLT-2i.

Objective To explore the clinical characteristics and potential risk factors of severe acute pancreatitis caused by pegaspargase and caution clinicians against the adverse effect of this drug. Methods The clinical data of one child with T lymphoblastic lymphoma who developed acute severe pancreatitis after medication with pegaspargase was studied. After withdrawal of pegaspargase, fasting, and supplemental treatment, the patient's symptoms were significantly relieved. After evaluation and repeated use of pegaspargase, acute pancreatitis reoccurred but improved as result of symptomatic treatment. The risk factors for pancreatitis were analyzed based on the Naranjo score and literature review. Results Based on the manifestations of acute pancreatitis, the relationship with the timing of medication, and a Naranjo score of 9, pegaspargase was confirmed as the cause of acute pancreatitis, and a high-fat diet might be a risk factor. Conclusion Clinicians should advance their understanding of and be alert to acute pancreatitis associated with pegaspargase. Low-fat diet should be recommended during treatment.

Small cell lung cancer (SCLC) is a highly invasive neuroendocrine carcinoma that is prone to metastasis and progression, with high rates of drug resistance and recurrence. The current treatment options have limited benefits for patient survival. On May 16, 2024, the FDA approved the marketing of tarlatamab, providing a new treatment plan for SCLC patients who have previously received first-line or second-line treatment. Clinical studies have shown that this drug is effctive and safe. This article reviews the pharmacological effects，clinical studies，safety，usage and dosage of tarlatamab.