To investigate the efficacy and safety of amisulpride combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and concomitant hyperprolactinemia in acute phase.

A total of 72 patients who had poor efficacy and increased prolactin levels after a 8-week treatment of amisulpride were randomly divided into control group and study group, with 36 patients in each group. The patients in the control group continued to be treated with amisulpride （400 - 1 200 mg·d^-1）, while the patients in the study group received aripiprazole （the initial dose was 5 mg·d^-1, which could be increased to 10-30 mg·d^-1） on the basis of amsulpride, for an additional 8 weeks of treatment. The scores of Positive and Negative Syndrome Scale （PANSS） and Treatment Emergent Symptom Scale （TESS） and the levels of serum prolactin were compared between the two groups at the time of enrollment and different time points of treatment.

Two cases were dropped out in each group and 34 cases were completed in each group. The effective rate of the study group was significantly higher than that of the control group at the 2nd, 4th, and 8th weekend of treatment （P<0.05）. At the end of 4 and 8 weeks, the total PANSS score in the study group was significantly lower than that in the control group （P<0.01）, and significantly decreased compared with that at the time of enrollment （P<0.01）. At the end of treatment, the reduction of PANSS total score, positive score, and psychopathology score of the study group were significantly higher than those of the control group （P<0.01）. The prolactin levels in the study group was significantly lower than that in the control group at the 4th and 8th weekend of treatment （P<0.01）, and was also significantly lower than that at the time of enrollment （P<0.01）. The increase of serum prolactin in female patients in the study group was more significant than that in male patients （P<0.01） after 8 weeks of treatment with amisulpride, and the decrease of serum prolactin in female patients was also more significant than that in male patients （P<0.01） after treatment combined with aripiprazole. There were no significant difference in TESS score and incidence rate of adverse reactions between the two groups （P>0.05）.

After combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and elevated serum prolactin, the therapeutic effect can be increased, the serum prolactin level can be reduced, and the benefits are more obvious in female patients, with no significant increase in adverse reactions.

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 know the current status of clinical trial institutions on psychiatric specialty in China since the drug clinical trial institution registration came into force.

By searching for the psychiatric professional institutions and investigators registrated in the drug clinical trial institution filing management information platform and clinical trial data of psychiatric drugs published on the official website of the National Medical Products Administration, the regional distribution of psychiatric drug clinical trial institutions, principal investigators, and the number and types of clinical trials were statistically analyzed.

After the implementation of the filing system, as of March 10, 2023, there were a total of 104 psychiatric professional filing institutions in China, distributed in 26 provincial-level administrative regions across the country, with a total of 927 registered researchers. Except for one psychiatric hospital, which was a second level hospital, all other hospitals were third level hospitals. A total of 91 institutions had undertaken 122 clinical trials, and among the top ten institutions in terms of project quantity, there were 9 psychiatric hospitals.

The psychiatric departments of the tertiary comprehensive hospitals are the main force for clinical trial institutions registration, but in terms of undertaking clinical trials, specialized psychiatric hospitals have the main advantage, and there are problems such as uneven distribution of registered institutions regions, registered investigators, and the number of clinical trials undertaken.

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 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 analyze the approval for marketing, drug characteristics, and differences of novel hematological antineoplastic drugs between China and the United States, and provide reference for pharmaceutical management, drug research and development, drug review and approval in China.

The websites of the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration of China and package insert of drug were searched, and the novel hematological antineoplastic drugs approved for marketing in the United States from 1997 to 2021 and China from 1999 to 2021 were collected. The drug names, approval types, approval dates, accelerated drug marketing registration procedures, drug action mechanism and indications were extracted, and the approval status and timeliness of new drugs, as well as the number of approvals for different types of drugs were analyzed.

From 1997 to 2021, a total of 69 novel hematological antineoplastic drugs approved in the United States, which included 42 new molecular entities and 27 new therapeutic biologics. Sixty-five drugs were approved through expedited development and review pathways. From 1999 to 2021, China approved a total of 36 novel hematological antineoplastic drugs, including 24, 11, and 1 for chemical drugs, biologics products, and traditional Chinese medicine, respectively. Twenty-five drugs were approved to use accelerated drug marketing registration procedures. The number of approved drugs in both countries has significantly increased from 2017 to 2021, with 26 (87%) out of 30 novel hematological antineoplastic drugs in the United States being the first global approval drugs, and 8 (32%) out of 25 novel hematological antineoplastic drugs in China being the first global approval drugs, and the average approval time for the other 17 drugs was 6 years later than that of the United States. The novel hematological antineoplastic drugs approved in China covered multiple drug targets, which were closer to the targets of new molecular entities approved in the United States and could be used to treat multiple types of hematology neoplasms. However, the biological targets were still limited compared with the United States, which mainly used for lymphoid tissue tumors. There were no drugs used for myeloid tumors, and the types were relatively single. From 2017 to 2021, among the 17 novel hematological antineoplastic drugs approved for marketing in China had been approved in the United States, only 6 drugs had the same indications as the United States, and one drug had more indications than the United States.

In recent years, the number of novel hematological antineoplastic drugs approved for marketing in China has significantly increased. Diverse accelerated drug marketing registration procedures has been used for the review and approval of novel hematological antineoplastic drugs. The target types of approved novel hematological antineoplastic drugs have increased, but the timeliness of new drug review and approval and the international influence of domestic drugs still need to be enhanced. The research and development of domestic novel hematological antineoplastic drugs should avoid single target aggregation, and pay attention to the exploration of new indications of drugs and new combined treatment schemes.