To scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine (TCM) and provide reference for the formation of "triple combination" registration review evidence system.

Based on the Delphi method, after literature research and expert investigation, two rounds of expert consultation were carried out, and the expert consultation results were evaluated by the mean, variation index, coordination coefficient, etc., and the core indicators for human use experience evaluation of TCM were further screened and optimized.

22 experts in various fields were selected to conduct a questionnaire survey. The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%, and the authority indicators of involved experts were 0.852 and 0.865. According to the mean value and coefficient of variation of the indicators, combined with the revision suggestions of experts, the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.

The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data, promote the formation of high-quality and evaluable human use experience evidence, and support the research and development of new TCM products.

To analyse and predict the potential quality markers of Aurantii fructus immaturus which based on HPLC fingerprint, chemical pattern recognition, the "Five Principles" of quality markers and network pharmacology.

The fingerprint of Aurantii fructus immaturus was established by HPLC; OPLS-DA was used to screen the main difference components among the common peak groups; the "active ingredient-target-pathway" network of differential components was constructed by network pharmacology method to further support its rationality as potential quality makers (Q-Marker) of Aurantii fructus immaturus.

The fingerprints of 22 batches of Aurantii fructus immaturus were established, and 36 common peaks were identified. Two different components of naringin and neohesperidin were screened by OPLS-DA analysis. Network pharmacology confirmed that naringin and neohesperidin can be used as potential Q-Markers of Aurantii fructus immaturus.

The established HPLC fingerprint method is stable and feasible, and the two differential components of naringin and neohesperidin screened can be used as potential Q-Markers of Aurantii fructus immaturus, which provided reference for the quality control and pharmacological mechanism research of Aurantii fructus immaturus.

To evaluate the anesthetic effects of remimazolam in total intravenous anesthesia (TIVA) patients undergoing radical thyroidectomy.

Patients aged 18~65 with ASA physical status Ⅰ~Ⅱ were scheduled for radical thyroidectomy under TIVA. The current study consisted of two parts. Part Ⅰ: The anesthetic induction dose of remimazolam was determined using modified Dixon's up-and-down method. Part Ⅱ: The effect of remimazolam in anesthetic maintenance of TIVA was evaluated. The patients were randomly divided into two groups, propofol as control P group and remimazolam as experimental R group. After endotracheal intubation, propofol or remimazolam was continuously infused under TIVA to complete surgery. The onset time, intubation time, drug consumption and hemodynamics at certain time points were analyzed. In addition, the awakening time and adverse effects were also compared. The cognitive functions were evaluated by scale of MMSE and MoCA.

The anesthetic induction doses of propofol and remimazolam were 1.76 mg·kg^-1 and 0.43 mg·kg^-1 respectively. The onset time of the two groups had no significant difference (P>0.05). However, the intubation time of remimazolam group (103.23±9.14) s was significantly increased than that of the control group (86.58±8.32) s (P<0.05). The mean pump speed of remimazolam was 1.12 mg·kg^-1·h^-1 in TIVA. The hemodynamics of remimazolam group [MAP: (88.2±8.4) mmHg; HR: (74.2±7.1) per minute] was more stable than that of the control group [MAP: (77.9±7.4) mmHg; HR: (68.8±6.5) per minute] (P<0.05). The awakening time of remimazolam group (19.31±4.26) min was enhanced compared with the control group (13.86±3.65) min (P<0.05). The adverse effects and cognitive functions of the two groups had no statistical differences (P>0.05).

Remimazolam is safe for clinical anesthetic induction and intraoperative maintenance undergoing radical thyroidectomy, and the hemodynamics is more stable in TIVA.

To analyze the absolute lag and relative lag time of new drug approvals in China from 2011 to 2021 and reasons causing the lag, and to preliminarily explore the potential factors that affect the new drug launch lag.

The information on new drugs approved for marketing in China, the United States, the European Union and Japan was collected from 2011 to 2021. The durations between the time when the new drugs approved for marketing in China were first approved for marketing in the world were calculated to analyze absolute lag and relative lag in China. Multiple regression analysis was used to determine the factors related to drug lag.

During the period from 2011 to 2021, a total of 280 new drugs were approved in China, among which 180, 82 and 154 drugs exist absolute lags with the United States, the European Union and Japan, respectively. The median duration of the overall relative lag was 1 359 days. The median length of the lag gradually increased from 2011 to 2014, and reached a peak (3 438 days) in 2014; the median length dropped significantly from 2015 to 2018; the median length in 2019 to 2021 decreased year by year. The overall lag in 2020 and 2021 were below the overall median lag, 1 134 days and 500 days respectively (B=-1 153.840, P<0.05). New drugs in theraprutic area of sensory organs were related to a shorter median approval lag, and new drugs of orphan drug designation (B=441.147, P<0.01) and classified as biological products (B=502.205, P<0.01) were related to a longer median approval lag.

In the past years of 2011—2021, the drug lag issue in China has been significantly improved, but the lag phenomenon still exists in new drugs in various therapeutic fields. Under the background of the new policy implement, key factors to reduce the delay in the launch of new drugs include further improving the quality and efficiency of new drug review and approval, strengthening the communication between government approval agencies and applying companies, connecting with international common rules, and encouraging companies to conduct international multi-center clinical trials.

To systematically explore the correlation between serum tacrolimus trough concentration (C₀) and the efficacy in patients with systemic lupus erythematosus (SLE), and to obtain the effective concentration threshold of tacrolimus in such patients, so as to provide reference for the safety and efficacy of clinical medication.

The clinical and laboratory data of SLE patients treated with tacrolimus in our hospital from January 2016 to December 2021 were collected retrospectively, including demographic information (sex, age, height, and weight), course of disease, results of laboratory test, medication, monitoring data on blood concentration and clinical response, and efficacy and safety were evaluated. The correlation between C₀ and efficacy was analyzed, and the threshold of effective concentration of tacrolimus was determined by receiver operating characteristic curve (ROC).

A total of 72 patients who met the criteria were included in this study, and 176 monitoring data of C₀ (0.1~10.3 ng·mL^-1) were collected. There was a weak correlation between daily dose of tacrolimus and C₀ (r=0.326). With the prolonging of time of tacrolimus treatment, there was no significant change in C₀, and there was significant difference in complement C3 among different blood concentration groups (P<0.05). There was no significant difference in other biochemical indexes. In the effective concentration study, 124 monitoring results of blood concentration in 59 patients with long-term of tacrolimus treatment (tacrolimus >3 months) were analyzed. They were divided into effective group (76 cases) and ineffective group (48 cases) according to clinical manifestations and biochemical indexes. Binary logistics regression analysis showed that C₀ had a significant effect on the curative effect of the patients (P<0.001). The area under ROC curve (AUC) is 0.763 (P<0.001, 95%CI: 0.674~0.851).

This study showed that the drug dose affected the blood concentration of tacrolimus in patients with SLE, and there was a correlation between the plasma concentration of tacrolimus and the curative effect. The threshold of its effective concentration was determined by ROC curve analysis, which is 1.55 ng·mL^-1.

To investigate the status and tendency of utilization of drugs to prevent chemotherapy-induced nausea and vomiting in Nanjing so as to provide a reference for the management of rational clinical use of these drugs.

The drugs to prevent chemotherapy-induced nausea and vomiting used in 46 hospitals of Nanjing during 2018-2021 were analyzed statistically regarding their types, consumption sum, defined daily doses (DDDs) and defined daily cost (DDC).

The consumption sum of 5-hydroxytryptamine 3 (5-HT₃) receptor antagonist in 46 hospitals of Nanjing increased at an average annual rate of 17.78% and 12.39%, respectively, between 2018 and 2020. In 2021, the consumption sum decreased by 46.21%, showing negative growth. The DDDs of 5-HT₃ receptor antagonist increased slightly in 2019 and continued to decrease thereafter, with decreasing rates of 2.47% and 1.36%, respectively. The consumption sum and DDDs of the first generation 5-HT₃ receptor antagonist decreased, while palonosetron, the second generation 5-HT₃ receptor antagonist, increased steadily year by year. The consumption sum and DDDs of neurokinin-1 (NK-1) receptor antagonists increased significantly year by year. Fosaprepitant rapidly occupied the market of NK-1 receptor antagonist, which is about 20% market share in the first year and nearly 90% market share in the second year. In 2021, its DDDs increased by 923.44%. However, the consumption sum and DDDs of Aprepitant decreased significantly year by year.

The drug regimen for preventing chemotherapy-induced nausea and vomiting and the unreasonable application of fosaprepitant in Nanjing should be further paid attention to.