Latest ArticlesTo explore the efficacy and safety of sintilimab combined with anlotinib in treatment of advanced non-small cell lung cancer (NSCLC).
The clinical data of 60 patients with advanced NSCLC treated with sintilimab (200 mg ivgtt qd, on day 1, 21 days per cycle) combined with anlotinib (10 mg po qd, taken for 14 d and stopped for 7 d,21 days per cycle) in our hospital from May 2019 to August 2021 were retrospectively analyzed. The patient’s clinical characteristics, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and the occurrence of adverse reactions were recorded. The relationship between different clinical characteristics and short-term efficacy was analyzed, and the multivariate regression analysis was conducted to identify prognostic risk factors.
The ORR for all patients was 33% and the DCR was 72%. Among them, The ORR of 29 first-line treatment patients was 52% and DCR was 83%. The ORR of 31 second or above-line treatment patients was 16% and the DCR was 61%. The response rate of stage Ⅲ patients was higher than that in stage Ⅳ patients (80% vs. 24%, P < 0.05), and squamous cell carcinoma type had a higher response rate than adenocarcinoma and other pathological types (56% vs. 13% vs. 50%, P < 0.05). The patients with first-line treatment had higher response rate than second-line treatment or above (52% vs. 16%, P < 0.05). The median PFS for all patients was 5.1 months. The median PFS in first-line treatment was significantly longer than that in second-line or above (23.3 months vs. 3.0 months, P < 0.05). The patients aged ≥ 65 years had an increased risk of disease progression compared with aged < 65 years (HR = 2.215, 95%CI:1.043 to 4.705, P < 0.05). The patients with ECOG scored 2 had an increased risk of disease progression compared with ECOG scored 1 (HR = 8.905, 95%CI:3.671 to 21.603, P < 0.05). First-line treatment patients had a lower risk of disease progression compared with second-line or above treatment (HR = 0.233, 95%CI:0.107 to 0.506, P < 0.05). The overall incidence of adverse reactions was 60%,and the adverse reactions ≥ 3 grade accounted for 8%, which were fatigue, liver damage and diabetes. All of them were improved after symptomatic treatment.
Sintilimab combined with anlotinib in treatment of advanced NSCLC has a certain efficacy, and are well tolerated by patients. Age, ECOG score, and treatment lines are independent risk factors for prognosis.
To observe the effect of vonoprazan quadruple 14-day therapy on Helicobacter pylori (Hp) infection.
A total of 120 Hp positive patients were included and divided into treatment group and control group, 60 cases in each group. The treatment group was given vonoprazan 20 mg + bismuth potassium citrate 220 mg + amoxicillin 1 000 mg+ furazoldone 100 mg, and the control group was given omeprazole 20 mg+ amoxicillin 1 000 mg+ bismuth potassium citrate 220 mg+ furazoldone 100 mg, twice a day for 14 days. The 14C-urea breath test was performed in all patients 4 to 6 weeks after the course of treatment, and the eradication rate of Hp and the occurrence of adverse reactions in the two groups were observed respectively.
Among the 120 patients included, there were 57 males and 63 females, aged from 20 to 69 years old, with an average age of (37.9±5.4) years. The Hp eradication rate in the treatment group was higher than that in the control group (97% vs. 80%, P < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P > 0.05).
Quadruple 14-day therapy with vonoprazan is a safe and highly effective treatment for Hp eradication and can be used as a first- and second-line treatment.
To evaluate the influences of vitamin D2 injection on serum 25-hydroxyvitmin D (25(OH)D) and immune function in men with vitamin D deficiency aged 80 and over.
A total of 48 men with vitamin D deficiency aged 80 and over were given intramuscular vitamin D2 600 000 IU every month until the serum 25(OH)D reached and over 30 µg·L-1. The levels of serum 25(OH)D2, 25(OH)D3, T lymphocyte cells (including CD3+, CD4+, CD8+), B lymphocyte cells (CD19+), and blood calcium and phosphorus were detected before and after treatment. And adverse reactions were observed.
A total of 40 patients completed the study. It took (6.2±1.4) months for 25(OH)D to reach targeted serum concentration. Compared with those before treatment, the serum levels of 25(OH)D2 after the treatment increased by (27.42±5.47) µg·L-1, 25(OH)D3 decreased by (5.25±3.38) µg·L-1, and the total 25(OH)D increased by (22.45±6.15) µg·L-1 (all P<0.01). And the serum levels of CD4+ T cells increased by (3.71±6.26)%, CD4+/CD8+ increased 0.31±0.93, and CD19+ B cell increased by (1.50±3.31)% (all P<0.05). There were no significant differences in serum CD3+ T cells, alanine aminotransferase, blood glucose, creatinine, calcium, and phosphorus before and after the treatment (P>0.05). No severe adverse drug reactions occurred during the treatment.
Vitamin D2 injection is helpful for increasing serum 25(OH)D2 levels and regulating immune function in men with vitamin D deficiency aged 80 and over.
To evaluate the relative risk of respiratory tract disease in rheumatoid arthritis (RA) patients treated with tofacitinib.
From PubMed, Embase, Web of Science, and Cochrane Library databases, the double-blind randomized controlled trials (RCTs) of RA patients who treated with tofacitinib were searched, and the search time limit was from the establishment of the databases to September 2022. The Cochrane risk of bias tool was used to evaluate the quality of the included trials, the RevMan 5.3 software was used for statistical analysis, and the Mantel-Haenszel fixed-effects method was used for relative risk (RR) comparison to evaluate the results.
Fourteen double-blind RCTs were included, with a total of 6 372 RA patients. The results of meta-analysis showed that compared with the control group, the risk of lower respiratory tract infection was significantly increased in the tofacitinib group (RR= 2.32, 95% CI:1.27 to 4.24,P=0.006), while the risk of pulmonary embolism was significantly reduced (RR=0.16, 95% CI:0.03 to 0.94, P=0.04). There was no significant difference in the risk of upper respiratory tract infection, influenza, pneumonia, opportunistic respiratory tract infection, and other non-infectious respiratory adverse events between the tofacitinib group and the control group (P>0.05).
Tofacitinib used for the treatment of RA will increase the risk of lower respiratory tract infection, but has no correlation with the risk of other respiratory tract diseases.
To evaluate the economics of pembrolizumab in the first-line treatment of patients with unresectable or metastatic microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer.
Based on the Chinese healthcare system, a partitioned survival model was constructed to compare the cost and utility between pembrolizumab and standard of care using KEYNOTE-177 clinical trial data. The cycle length and time horizon of the model was set as 21 days and 10 years, respectively. The incremental cost-effectiveness ratio (ICER) was used as the evaluation indicator. Scenario analysis and sensitivity analysis were also performed.
Compared with standard of care, the ICER of pembrolizumab was 221 546.85 yuan·QALY-1, which was lower than 3 times China’s per capita gross domestic product (GDP) in 2021. The pembrolizumab was dominant when patient assistance program was considered. The results of one-way sensitivity analysis showed that the proportion of pembrolizumab on subsequent treatment in the standard of care, pembrolizumab price and discounting exhibited the significant impact on the ICER. The results of probability sensitivity analysis showed that under the 3 times China’s per capita GDP in 2021, the probability of pembrolizumab being cost-effectiveness was 63.36%.
Pembrolizumab has a cost-effective advantage over standard of care as first-line treatment for unresectable or metastatic MSI-H/dMMR colorectal cancer in China.
To mining the signals of adverse drug event (ADE) related to cardiac disorders (CRADE) in cinacalcet and etelcalcetide, and provide reference for clinical medicine safety.
ADE reports of cinacalcet and etelcalcetide from the first quarter of 2013 to the first quarter of 2023 in the FDA adverse event reporting system were collected. CRADE signals of cinacalcet and etelcalcetide were detected by frequency method. The frequency and signal intensity of CRADE, and the relationship to course of treatment and therapeutic dose were analyzed.
A total of 13 136 477 ADE reports were included, and the CRADE reports of cinacalcet and etelcalcetide were 631 and 327, respectively. Two new signals of cardiac arrest and angina pectoris were found in the signal mining of CRADE of the two drugs. Aortic stenosis and coronary stenosis were two additional new signals for etelcalcetide. The signal intensity of each CRADE of cinacalcet was generally lower than that of etelcalcetide. Among etelcalcetide CRADE, aortic stenosis and unstable angina showed stronger signals, with reported odds ratio of 259.307 and 179.621, respectively, which were much higher than that of other CRADE. When the dose of cinacalcet was 30 mg·d-1, the frequency of CRADE was higher. CRADE was reported more frequently when the course of medication was longer than 8 weeks.
New CRADE signals of cinacalcet and etelcalcetide have been found. It is necessary to pay attention to the safety of therapeutic drugs when using cinacalcet for a long course of treatment, or when using etecalcetide in patients with cardiovascular disease.
To comprehend the current status of new drug development in China, this article examines the new drug applications (NDAs) approved by the National Medical Products Administration (NMPA) in 2023. The analysis is conducted based on drug category, therapeutic area, target, and priority review and approval, providing a valuable reference for researchers in fields related to pharmaceutical innovation. As of December 31, 2023, the NMPA had approved a total of 190 NDAs, comprising 117 chemical drugs, 64 biological products, and 9 traditional Chinese medicines. Among these,37 were categorized as new drugs in Class 1, and 117 were improved new drugs. Notably, anti-tumor drugs maintained a dominant position, accounting for 34.2% of the total approvals. Furthermore, there was a significant increase in approvals for pediatric drugs and drugs targeting rare diseases.
Esketamine is a powerful narcotic analgesic, which has been used in clinical anesthesia and postoperative analgesia. Esketamine can be administered through a variety of ways, with strong analgesic effect, rapid onset, rapid elimination, and no inhibition of spontaneous respiration. It has certain advantages in pediatric anesthesia, obstetric anesthesia, and anesthesia in patients with low blood volume or burn, and is suitable for elderly patients. So esketamine is widely used in clinic. However, the dosage, application method and the choice of combination drugs of esketamine remain to be further discussed.
miR-132 is a widely expressed regulatory RNA in the cardiovascular system. When miR-132 is highly expressed in cardiac tissues, it will affect the signaling pathways related to cardiomyocyte growth, autophagy, calcium processing and contraction, and cause progressive adverse cardiac remodeling, thus leading to heart failure events. Studies had found that targeted inhibition of miR-132 could reduce cardiac hypertrophy and improve cardiac function, bringing certain clinical benefits to patients with heart failure. CDR132L is a synthetic lead-optimized oligonucleotide inhibitor of miR-132.The efficacy and safety of CDR132L had been demonstrated for the first time in clinical trials. Antisense oligonucleotides targeting miR-132 are potential future therapies for ischemic or non-ischemic heart failure.