To explore the key elements in the evaluation and selection of sites for multicenter clinical trials, providing references for standardizing clinical trial site selection practices.

By integrating the practical experience of multiple sponsors, contract research organizations (CROs), and research sites, a standardized framework for site evaluation and selection was constructed.

A three-phase standardized process was proposed, encompassing pre-assessment preparation, formal evaluation, and outcome assessment. This study systematically categorized common and specific evaluation criteria, including 5 core dimensions and 17 key indicators covering site and personnel qualifications, hardware conditions, patient resources and quality systems, management processes, and special considerations.

This study constructed a comprehensive site evaluation system encompassing standardized procedures, structured dimensions, and core indicators. It achieves a transformation in evaluation practices from an experience-driven approach to a framework-guided methodology, providing an operable tool for the scientific selection of sites in multicenter clinical trials.

To analyze the current status and development trends of registered clinical trials of inhalation preparations in China, and to provide references for drug development and clinical evaluation.

Clinical trials of inhalation preparations registered on the NMPA Platform for Drug Clinical Trial Registration and Information Publicity from its inception to December 31, 2025 were retrieved. Descriptive statistical analysis was conducted on the basic information, design types, drug characteristics, and indications of the trials.

A total of 445 registered clinical trials of inhalation preparations were included, which had entered a rapid development phase in the past five years. The trials were predominantly domestic (94.61%) and bioequivalence (BE) studies (48.31%). The most common dosage forms were liquid inhalation formulations (44.04%) and dry powder inhalations (35.51%). Research and development were highly concentrated on asthma and chronic obstructive pulmonary disease, with inhaled corticosteroids and their combinations being the main directions. In contrast, trials involving childer and adolescents accounted for only 4.94%, and explorations in areas such as pulmonary fibrosis and pulmonary infections remained relatively limited. Sponsors and research resources were primarily concentrated in the more developed pharmaceutical regions such as Beijing, Shanghai, and Jiangsu.

The development of inhalation preparations in China has entered a phase of rapid growth, characterized by a dominance of generic drugs, a high concentration of therapeutic areas, and differentiated development of dosage forms. Future efforts should focus on unmet clinical needs and innovative research and development of high-technical-barrier dosage forms to promote high-quality development in this field.

To investigate relative factors of coagulation abnormalities induced by eravacycline injection in elderly patients.

Elderly patients (age ≥ 65 years) who received eravacycline for infection were enrolled. The patients were divided into the abnormal coagulation group and the normal coagulation group based on whether there was prolongation of prothrombin time (PT) by more than 3 seconds and/or a decrease in fibrinogen to ≤ 1.5 g·L^-1. The clinical data, medication prescribed, sequential organ failure assessment (SOFA) score, acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score, and nutrition risk screening 2002 (NRS2002) score before treatment were recorded. The incidence of coagulation abnormalities after eravacycline injection treatment was statistically analyzed. Comorbidities, baseline liver, kidney function, coagulation function, SOFA, APACHE Ⅱ and NRS2002 scores were compared between normal coagulation group and abnormal coagulation group. Logistic regression analyses were performed for further exploration.

A total of 84 elderly patients were enrolled. At 1 week of eravacycline injection treatment, 33 patients developed coagulation abnormalities, with an incidence rate of 39.29% (33 cases/84 cases). The proportion of chronic liver disease of normal coagulation group and abnormal coagulation group were 6.00% (3 cases /51 cases) and 24.24% (8 cases /33 cases), respectively; the proportion of combined antithrombotic drugs were 68.00% (34 cases /51 cases) and 45.45% (15 cases /33 cases), respectively; baseline levels of white blood cell count were 8.30 (4.55, 12.41) and 11.40 (7.08, 13.88) ×10⁹·L^-1, respectively; total bilirubin (TBIL) levels were 14.00 (10.80, 19.83) and 23.50 (14.70, 46.90) umol·L^-1, respectively; direct bilirubin (DBIL) levels were 5.98 (3.69, 9.60) and 9.50 (6.20, 25.05) umol·L^-1, respectively; C-reactive protein (CRP) levels were 57.91 (22.43, 97.33) and 69.20 (33.87, 86.54) mg·L^-1, respectively; interleukin-6 (IL-6) levels were 43.11 (22.26, 106.98) and 91.12 (24.30, 181.60) pg·mL^-1, respectively; PT were 12.90 (11.95, 15.00) and 14.40 (12.80, 15.70) s, respectively; activated partial thromboplastin time (APTT) were 31.50 (28.35, 34.00) and 34.10 (30.70, 37.95) s, respectively; international normalized ratio (INR) were 1.13 (1.05, 1.29) and 1.27 (1.13, 1.36), respectively. The differences of above indicators between the two groups were all statistically significant (all P<0.05). Regression analysis showed that TBIL was associated with eravacycline injection-induced coagulation abnormalities in elderly patients, with an odds ratio (OR) of 1.04 (P<0.05). Among the 62 patients who received eravacycline injection for more than 1 week, 27 developed coagulation abnormalities by the end of treatment, with an incidence rate of 43.55% (27 cases/62 cases). The proportion of chronic kidney disease of normal coagulation group and abnormal coagulation group were 29.41% (10 cases/35 cases) and 59.26% (16 cases/27 cases), respectively; the proportion of combined antithrombotic drugs were 70.59% (24 cases /35 cases) and 40.74% (11 cases /27 cases), respectively; baseline APACHE Ⅱ scores were (14.82±6.62) and (19.68±6.38) point, respectively; NRS2002 scores were 4.00 (3.00, 4.00) and 5.00 (3.50,7.00) point, respectively; CRP levels were 57.62 (21.48, 83.29) and 88.11 (49.11, 149.80) mg·L^-1, respectively; IL-6 levels were 26.45 (13.58, 78.82) and 99.32 (43.79, 191.57) pg·mL^-1, respectively; APTT were 30.30 (28.10, 33.15) and 33.90 (28.90, 36.40) s, respectively; platelet levels were 176.50 (120.25, 225.50) and 132.00 (81.00, 195.00) ×10⁹·L^-1, respectively. The differences of above indicatiors between the two groups were all statistically significant (all P<0.05). Regression analysis showed that the NRS2002 score was associated with eravacycline-induced coagulation abnormalities in elderly patients, with an OR of 2.04 (P<0.05). The incidence of coagulation abnormalities increases with the prolongation of eravacycline injection treatment. The dosage of eravacycline of normal coagulation group and abnormal coagulation group were (0.78±0.14) and (0.84±0.17) mg·kg^-1, the difference between the two groups was not statistically significant (P>0.05)

Coagulation abnormalities may occur in elderly patients treated with eravacycline injection. Total bilirubin level and NRS2002 score are risk factors for coagulation abnormalities. Coagulation indicators should be closely monitored during treatment.

To evaluate the efficacy and safety of a 12-week regimen of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in patients with chronic hepatitis C (CHC).

CHC patients who visited our hospital and received a 12-week regimen of coblopasvir hydrochloride capsules combined with sofosbuvir tablets were enrolled as the study subjects. All patients received oral coblopasvir hydrochloride capsules (60 mg) and sofosbuvir tablets (400 mg) once daily for 12 weeks. Some patients with genotype 3b additionally received ribavirin tablets for 12 weeks at a dose of 1 000 mg·d^-1 for those weighing < 75 kg and 1 200 mg·d^-1 for those weighing ≥ 75 kg. Hepatitis C virus (HCV) ribonucleic acid and relevant laboratory indicators were measured before and after treatment. The sustained virological response at 12 weeks post-treatment (SVR12) rate was observed in all patients. Changes in liver and renal function before and after treatment were compared, and safety was evaluated.

A total of 110 CHC patients were enrolled. After treatment, 97.27% (107 cases/110 cases) of patients achieved SVR12. Specifically, the SVR12 rate was 93.33% (14 cases/15 cases) in patients with decompensated cirrhosis, 92.86% (13 cases/14 cases) in patients with genotype 3b CHC, 87.50% (7 cases/8 cases) in patients with moderate-to-severe renal impairment, and 83.33% (5 cases/6 cases) in genotype 3b patients receiving ribavirin combination therapy. The alanine aminotransferase levels before and after treatment were 58.70 (31.85, 100.45) and 20.60 (13.30, 31.33) U·L^-1, respectively; the aspartate aminotransferase levels were 52.75 (28.68, 82.13) and 23.30 (17.78, 33.73) U·L^-1, respectively; the total bilirubin levels were 13.90 (9.60, 20.25) and 11.70 (8.78, 18.85) μmol·L^-1, respectively; the albumin levels were 42.80 (38.10, 45.30) and 45.10 (42.13, 46.73) g·L^-1, respectively. After treatment, the aforementioned indicators showed statistically significant differences compared to before treatment (P<0.05, P<0.001). The estimated glomerular filtration rates before and after treatment were 102.09 (87.66, 108.68) and 99.23 (84.00, 104.28) mL·min^-1, respectively, with no statistically significant difference (P>0.05). The main adverse drug reactions were fatigue (6.36%), decreased appetite (4.55%), abdominal distension (1.82%) and abdominal pain (1.82%). The overall incidence of adverse drug reactions was 10.91% (12 cases/110 cases), and the incidence in patients with decompensated cirrhosis was 13.33% (2 cases/15 cases). No serious adverse drug reaction occurred.

The 12-week regimen of coblopasvir hydrochloride capsules combined with sofosbuvir tablets demonstrated favorable efficacy and high safety in real-world CHC patients, including those with genotype 3b, decompensated cirrhosis, or moderate-to-severe renal impairment.

To investigate the influencing factors of the steady-state concentration/dose ratio (C/D) for milnacipran tablets based on therapeutic drug monitoring (TDM), with the goal of promoting individualized use of this medication.

Inpatients who underwent milnacipran TDM were included in this study. General information, including gender, age, body mass index (BMI) and serum creatinine levels were collected through the medical record system. Additionally, dosage and comedication data were recorded. The analysis of these data was conducted using SPSS 23.0.

A total of 156 patients with steady-state concentrations determined by milnacipran TDM were included in the analysis. The steady-state concentration of milnacipran was found to be 95.52 (67.34, 126.97) ng·mL^-1, C/D was 0.95 (0.71, 1.24) ng·mL^-1·mg^-1·d. Multiple linear regression analysis indicated that renal function statistically significantly influenced C/D (P<0.05). C/D ratio in patients with renal insufficiency and patients with normal insufficiency were 1.16 (0.79,1.50) and 0.92 (0.64,1.08) ng·mL^-1·mg^-1·d, with statisticaly significant difference (P<0.05).

The factors influencing milnacipran’s C/D are complex; therefore, for patients with renal insufficiency, regular monitoring of serum drug concentrations is recommended to ensure both safety and efficacy in its use.

To observe the clinical efficacy and safety of fumarate furosemide tablets combined with mosapride tablets in the treatment of refractory non erosive gastroesophageal reflux disease (rNERD).

The rNERD patients admitted to our hospital were divided into control group (oral administration of 20 mg fumarate fumarate tablets, qd) and treatment group (addition of mosapride citrate tablets, taken before meals, 5 mg each time, tid) according to the treatment method, with a treatment course of 8 weeks. Compared the clinical symptoms, esophageal motility indicators, gastrointestinal hormone indicators, quality of life and clinical efficacy of two groups, and conducted safety evaluation.

A total of 120 patients were included, with 59 in control group and 61 in treatment group. After treatment, the gastroesophageal reflux disease scale (Gerd Q) scores of treatment group and control group were (6.89±1.29) and (7.56±1.64) points, respectively; the gastroesophageal reflux disease symptom frequency scale (FSSG) scores were (7.95±1.71) and (9.00±2.24) points, respectively; the lower esophageal sphincter pressure (LESP) were (22.19±4.33) and (19.67±4.38) mmHg, respectively; the pepsinogen Ⅰ (PG Ⅰ) levels were (121.21±26.75) and (111.57±20.28) pg·mL^-1, respectively; the pepsinogen Ⅱ (PG Ⅱ) levels were (13.58±3.17) and (15.12±3.57) pg·mL^-1, respectively; the gastrin (GAS) levels were (72.16±11.23) and (67.97±10.94) pg·mL^-1, respectively; the scores of the gastroesophageal reflux disease quality of life scale (GERD-QOL) were (32.82±7.24) and (29.75±5.37) points, respectively. The differences in the above indicators were all statistically significant between the two groups (P<0.05, P<0.01). The total clinical effective rate of treatment group was 90.16% (55 cases/61 cases), which was significantly higher than 76.27% (45 cases/59 cases) in control group (P<0.05). The adverse drug reactions in control group mainly included diarrhea, constipation and nausea; treatment group included diarrhea, constipation and dry mouth. The total incidence of adverse drug reactions in treatment group and control group were 8.20% (5 cases/61 cases) and 6.78% (4 cases/59 cases), respectively, with no statistically significant difference (P>0.05).

The combination of vonoprazan fumarate tablets and mosapride citrate tablets has a synergistic effect in the treatment of rNERD, which can effectively improve the clinical symptoms and quality of life of rNERD. Its mechanism of action may be related to multiple effects such as synergistic improvement of esophageal motility and regulation of gastrointestinal hormone levels, and the combination regimen has good safety.

To evaluate the application effect of roxadustat capsules combined with recombinant human erythropoietin (rHuEPO) for injection in hemodialysis patients with renal anemia.

Patients with renal anemia undergoing hemodialysis were randomly divided into control group and treatment group using a random number table method. The control group received treatment with rHuEPO injection, intravenous injection of 120-150 IU·kg^-1, 2-3 times a week; the treatment group was administered roxadustat capsules orally after meals (100 mg for patients weighing <60 kg, 120 mg for patients weighing ≥60 kg) on the basis of the control group, 3 times per week. Both groups were treated continuously for 3 months. Iron metabolism indicators, anemia indicators and inflammatory factors were compared between the two groups. Clinical efficacy and adverse drug reactions were also assessed.

A total of 148 patients were enrolled in this study, including 70 cases in treatment group and 68 cases in control group. After treatment, the overall clinical effective rates of treatment group and control group were 95.71% (67 cases/70 cases) and 83.82% (57 cases/68 cases), respectively, with a statistically significant difference (P<0.05). After treatment, the serum iron (SI) levels of treatment group and control group were (15.98±4.04) and (13.41±3.72) μmol·L^-1, respectively; the transferrin saturation (TSAT) levels were (35.23±5.03)% and (29.38±4.94)%, respectively; the serum ferritin (SF) levels were (284.69±31.41) and (219.57±28.47) μg·L^-1, respectively; the hemoglobin (Hb) levels were (97.57±11.16) and (91.09±9.84) g·L^-1, respectively; the hematocrit (Hct) levels were (34.62±4.09)% and (28.34±3.47)%, respectively; the red blood cell (RBC) counts were (3.41±0.74) and (2.77±0.61)×10¹²·L^-1, respectively; the interleukin-6 (IL-6) levels were (58.02±6.19) and (64.23±7.63) ng·L^-1, respectively; and the tumor necrosis factor-α (TNF-α) levels were (111.02±12.54) and (120.63±15.29) ng·L^-1, respectively. There were statistically significant differences in all the above indicators between treatment group and control group (all P<0.05). Adverse drug reactions in treatment group included dizziness, fever, elevated blood pressure, nausea and vomiting, diarrhea and abnormal liver function, while those in control group included dizziness, fever, elevated blood pressure, nausea and vomiting, diarrhea and abnormal liver function. The total incidence of adverse drug reactions in treatment and control groups were 17.14% (12 cases/70 cases) and 19.12% (13 cases/68 cases), respectively, with no statistically significant difference (P>0.05).

Roxadustat capsules combined with rHuEPO solution for injection can improve iron metabolism and anemia status, reduce inflammatory factor levels, and do not increase the risk of adverse drug reactions in hemodialysis patients with renal anemia.