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 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 study the effect of a single dose of dexamethasone on reversal of rocuronium deep neuromuscular blockade （NMB） by sugammadex.

A total of 80 patients undergoing laparoscopic colon surgeries under general anesthesia were selected, with ASA Ⅰ- Ⅱ, and not taking steroid drug medication. The patients were randomly divided into 2 groups with 40 cases in each group. Before anesthesia induction, the trial group was given dexamethasone 0.15 mg·kg^-1, and the control group was given the same amount of chloride sodium injection. The induction and maintenance programs of anesthesia were the same in both groups. Rocuronium was administered intravenously for 5 - 10 µg·kg^-1·min^-1 to maintain deep muscle relaxation, and the post-tetanic count （PTC） was maintained at 0 - 2. After operation, all patients were immediately intravenously injected with sugammadex at a dose of 2 mg·kg^-1 when PTC was 1 - 2. The time for train of four-ratios （TOFR） to reach 0.9, extubation time and occurrence of adverse reactions were recorded.

The time of TOFR recovery to 0.9, extubation time and post-anesthesia care unit （PACU） residence time were （6.0±0.7）,（7.5±0.5） and （36.8±5.8） min in the control group, and （6.0±0.6）, （7.7±0.5） and （39.7±6.2） min in the trial group, respectively，with no significant differences between the two groups （P>0.05）. There were no differences in mean arterial pressure and heart rate between the two groups before surgery, at the time of sugammadex administration, and 5 and 10 min after administration （P>0.05）. No adverse reactions occurred in the both groups.

Dexamethasone 0.15 mg·kg^-1 has no significant effect on the reversal of deep NMB by sugammadex.

To study the effect of butylphthalide on oxidative stress indicators and its signaling pathway related factors in patients with acute cerebral infarction.

A total of 100 patients with acute cerebral infarction admitted to the hospital from August 2020 to April 2021 were divided into control group and study group by stratified blocked randomization method, with 50 patients in each group. The control group underwent conventional treatment, and the study group was treated with butylphthalide injection （100 mL, iv gtt, bid） for 14 d on the basis of conventional treatment. The two groups were compared in terms of neurological impairment score, oxidative stress indicators, related signaling pathway factors, nerve injury markers, C-reactive protein （CRP） and low-density lipoprotein （LDL） levels, as well as clinical efficacy and safety before and after treatment.

There were 3 cases in the control group and 2 cases in the study group dropped out during treatment. Finally, 47 cases in the control group and 48 cases in the study group were included respectively. After treatment, the level of malondialdehyde in the study group was significantly lower than that in the control group, while superoxide dismutase and glutathione peroxidase were significantly higher than those in the control group （P<0.05）; the Kelch-like ECH-associated protein 1 （Keap1） mRNA in the study group was significantly higher than that in the control group, while nuclear factor E2 related factor （Nrf2） and antioxidant response element （ARE）mRNA were significantly lower than those in the control group （P<0.05）. The levels of CRP and LDL in the study group were significantly lower than those in the control group （P<0.05）. The National Institutes of Health Stroke Scale score and the levels of myelin basic protein, neuron-specific enolase, and S100 calcium binding protein B in the study group were significantly lower than those in the control group （P<0.05）. The total effective rate of treatment in the study group was significantly higher than that in the control group （96% vs. 81%, P<0.05）, with no statistically significant difference in the total incidence of adverse reactions between the two groups （6% vs. 8%, P>0.05）.

Butylphthalide is effective in the treatment of patients with acute cerebral infarction, which may inhibit oxidative stress and relieve neurological damage through affecting the Keap1-Nrf2/ARE signaling pathway, and also has the advantage of regulating lipid metabolism abnormalities and reducing inflammation in the body.

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 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.