To analyze the strengths and weaknesses of China’s R&D in obesity/overweight drug clinical trials by comparing domestic and international trial characteristics, and put forward suggestions based on national conditions.

Clinical trial data of drugs for overweight/obesity were retrieved from ClinicalTrials.gov (CT.gov) and the China Drug Clinical Trial Registration and Information Disclosure Platform (Registration Platform), and divided into a domestic trial group and an international trial group. A bibliometric method was used for comparative analysis from the dimensions of drug type, dosage form, trial design, number of trials, age, gender, and sample size.

Domestically, chemical drugs dominated (77.57%, 211 cases/271 cases), while international trail chemical drugs (51.30%, 256 cases/499 cases) and biological products (48.30%, 241 cases/499 cases) developed balancedly. Domestic trials focused on tablets (46.32%, 126 cases/271 cases) and injections (47.06%, 128 cases/271 cases), whereas international trials were dominated by injections (57.52%, 287 cases/499 cases) (P<0.001). Domestic randomization rate (92.25%, 250 cases/271 cases) was much higher than overseas (79.56%, 397 cases/499 cases), but blinding application was lower (44.65%, 121 cases/271 cases vs. 65.33%, 326 cases/499 cases). Few domestic trials included children (1.11%, 3 cases/271 cases), with only 3 female-specific studies.

Global obesity/overweight drug trials are mainly in China and the US, but China lags behind with unbalanced structure and insufficient population representativeness. China should improve R&D level through policy incentives and international cooperation based on clinical needs.

Investigator initiated trial (IIT) contracts serve as critical legal documents defining the rights and responsibilities of all parties involved in clinical research. This study systematically analyzed issues identified during the review of IIT contracts at a medical institution, explored the underlying causes, and proposed targeted risk prevention and control measures.

A retrospective analysis was conducted on IIT contracts reviewed at a medical institution from January and December 2025. Common issues identified during contract review were summarized and categorized. Distribution patterns and contributing factors were systematically examined.

A total of 96 IIT contracts were reviewed and 917 issue instances were identified. These issues were primarily categorized as follows: legal rights and responsibilities (36.86%, 338 cases/917 cases), protection of research participants’ rights and ethics (6.22%, 57 cases/917 cases), resources and funding management (17.78%, 163 cases/917 cases), data and intellectual property (20.72%, 190 cases/917 cases) and risks associated with human genetic resources (18.43%, 169 cases/917 cases). These issues posed potential risks for medical disputes, commercial bribery, and administrative penalties. Consequently, this study proposed core risk prevention strategies including defining key stakeholder responsibilities, strengthening participant protection, optimizing the management of research funding and conflicts of interest, establishing robust frameworks for intellectual property protection and data privacy, and enforcing strict oversight of human genetic resources.

IIT contracts management requires strengthened review of key elements and establishment of a comprehensive contract management system. The findings provide a practical reference for medical institutions to optimize IIT contract management, thereby supporting the high quality development of clinical research.

To evaluate the efficacy and safety of different dose combinations of levamlodipine besilate tablets and bisoprolol fumarate tablets compared with placebo and control.

A multicenter, randomized, double-blind, double-dummy, placebo-positive drug-controlled dose-finding study in which patients with grade 1-2 essential hypertension were randomly divided into 5 groups after 14 days of placebo, namely: group A (placebo group), group B (levamlodipine besilate 2.5 mg/placebo), group C (bisoprolol 5 mg/placebo), group D (levamlodipine besilate 2.5 mg/bisoprolol fumarate 2.5 mg group) and E group (levamlodipine besilate 2.5 mg/bisoprolol fumarate 5 mg group), treated for 56 days. 14 days, 28 days, and 56 days after treatment, the main indicators-diastolic blood pressure, and the secondary indicators-systolic blood pressure, were analyzed, and the efficacy and safety were analyzed.

After 56 days of treatment, the decrease in diastolic blood pressure was 3.26±8.09 mmHg in group A, 8.89±6.97 mmHg in group B, 7.89±6.48 mmHg in group C, 12.64±6.49 mmHg in group D, and 13.46±7.80 mmHg in group E. Compared with group A, groups B, C, D, and E, P<0.001; the reduction of blood pressure between groups D and E (combination treatment group) and group B and C (monotherapy group) was significantly lower than that of group A P<0.01, and P>0.05 between combination treatment groups (D and E) and monotherapy groups (B and C groups). In terms of reducing systolic blood pressure, group B (decrease of 13.39±11.48 mmHg), group D (decrease of 17.55±10.31 mmHg) and group E (decrease of 20.60±13.06 mmHg) and group A (decrease of 5.55±13.19 mmHg) were P<0.001; group E compared with group B and C, P<0.001; compared between group D and C, P<0.01; and P>0.05 between groups D and E of the two combination treatment groups.

The 2.5 mg levamlodipine besilatee tablets combined with 2.5 mg bisoprolol fumarate tablets and 2.5 mg levamlodipine besilate tablets combined with 5 mg bisoprolol fumarate tablets have good efficacy and are better than the single agent levamlodipine besilate or bisoprolol fumarate in reducing diastolic blood pressure, and are well tolerated.

To explore and analyze the efficacy of propranolol combined with Radiopharmaceutical iodine-131 in treating hyperthyroidism, its impact on thyroid function.

Patients with hyperthyroidism were collected and assigned into treatment group and control group. The control group was treated with iodine-131 alone; the treatment group was treated with a combination of propranolol and iodine-131. The efficacy, anxiety (self-rating anxiety scale, SAS) scores and depression (self-rating depression scale, SDS) scores, thyroid hormone levels, cardiac function indicators, and adverse reactions were compared between the two groups.

A total of 160 patients were enrolled, with 80 cases in each group. There was no significant difference in efficacy between the treatment group and the control group (P>0.05). There was no significant difference in adverse reactions between the two groups (P>0.05). After treatment, the SAS score, SDS score, free triiodothyronine (FT3) level, free thyroxine (FT4) level, left ventricular ejection fraction (LVEF) level, stroke volume (SV) level, heart rate level in both groups decreased, and the treatment group was lower than the control group (all P<0.05); the TSH level increased, and the treatment group was higher than the control group (P<0.05).

Compared with the use of iodine-131 alone, the combined treatment of propranolol and iodine-131 for hyperthyroidism can effectively improve thyroid function and cardiac function, and reduce anxiety and depression in patients.

To investigate the efficacy of tranexamic acid combined with phloroglucinol in fetal protection for threatened abortion and its impact on pregnancy outcome.

Patients with threatened abortion were divided into control group and treatment group according to the treatment methods. Both groups received routine fetal protection treatment. The control group was given intravenous infusion of tranexamic acid on the basis of routine treatment. The patients in the treatment group were additionally given intravenous infusion of phloroglucinol on the basis of the treatment of the control group. The clinical efficacy, remission time of clinical symptoms, uterine hemodynamics, sex hormone levels, pregnancy outcomes, and safety evaluation of the two groups were assessed.

A total of 82 cases were enrolled in this study, including 39 cases in the control group and 43 cases in the treatment group. The fetal protection success rates were 71.79% and 90.70% in the control and treatment groups, respectively, with statistically significant difference (P<0.05). The waist soreness relief time was (3.64±0.71) d in the control group and (3.26±0.62) d in the treatment group; the lower abdominal dragging pain relief time was (2.90±0.50) d and (2.65±0.53) d, respectively; and the vaginal bleeding relief time was (3.00±0.61) d and (2.72±0.59) d, respectively. After treatment, the resistance index (RI) was 0.83±0.16 and 0.76±0.14; the pulsatility index (PI) was 2.46±0.65 and 2.12±0.41, respectively; and the systolic/diastolic ratio (S/D) was 3.24±0.54 and 2.98±0.48 in the control and treatment groups, respectively. The progesterone (P) levels were (99.40±8.63) and (104.11±8.97) nmol·L^-1, respectively; the estradiol (E₂) levels were (982.73±82.77) and (1 027.18±79.41) pmol·L^-1, respectively; and the β-human chorionic gonadotropin (β-hCG) levels were (77 695.54±10 728.91) and (85 684.63±11 755.83) mIU·mL^-1 in the control and treatment groups, respectively. The abortion rates were 23.08% and 6.98%, and the term delivery rates were 61.54% and 88.37% in the two groups, respectively. The differences in the above indicators between the two groups were statistically significant (all P<0.05). During the treatment period, headache or diarrhea occurred in both groups, with total incidence rates of 7.69% and 4.65%, respectively, and the difference was not statistically significant (P>0.05).

The combined use of tranexamic acid and phloroglucinol in patients with threatened abortion can accelerate the relief of clinical symptoms, improve the success rate of fetal protection, and improve pregnancy outcomes, with no significant increase in adverse events observed.

To explore the clinical effect of insulin lispro combined with balanced salt solution in the treatment of adult emergency patients with diabetic ketoacidosis (DKA).

DKA patients were divided into a control group and an experimental group according to the treatment method. Both groups were given intravenous infusion of balanced salt solution for rehydration at the same time. The control group was given insulin aspart, and the experimental group was given insulin lispro. The blood glucose control efficacy, improvement of acidosis, and safety were compared between the two groups.

There were 44 patients enrolled in the control group and 48 patients in the experimental group. After treatment, the fasting blood glucose (FBG) of the control group was (5.77±1.08) mmol·L^-1, the 2-hour postprandial glucose (2 h PG) was (12.11±4.27) mmol·L^-1, the mean amplitude of glycemic excursions (MAGE) was (3.48±1.04) mmol·L^-1, the 24-hour mean blood glucose (24 h MBG) was (7.84±1.57) mmol·L^-1, the beta-hydroxybutyrate (β-HB) was (0.35±0.11) mmol·L^-1, the carbon dioxide combining power (CO₂CP) was (20.06±6.43) mmol·L^-1, and the potential of hydrogen (pH) value was 7.58±1.13. For the experimental group, the FBG was (5.36±1.26) mmol·L^-1, the 2 h PG was (10.22±2.52) mmol·L^-1, the MAGE was (3.32±0.92) mmol·L^-1, the 24 h MBG was (7.60±1.44) mmol·L^-1, the β-HB was (0.30±0.14) mmol·L^-1, the CO₂CP was (21.34±6.54) mmol·L^-1, and the pH was 7.55±1.07. The experimental group had significantly lower levels of FBG, 2 h PG, MAGE, and 24 h MBG compared to the control group(all P<0.05). There was no significant difference in β-HB, CO₂CP, and pH value between the two groups (all P>0.05). There was 1 case of hypoglycemia in the control group and 3 cases of hypoglycemia in the experimental group. There were no gastrointestinal adverse reactions such as abdominal distension in both groups, and there was no significant difference in the total incidence of adverse reactions between the two groups (P>0.05).

Insulin lispro combined with balanced salt solution can effectively control blood glucose, improve acidosis and electrolyte levels, exert no significant adverse effects on renal function, and has good safety in the treatment of adult emergency DKA patients.

To observe the clinical efficacy and safety of tenecteplase bridging endovascular thrombectomy versus direct thrombectomy in the treatment of acute basilar artery occlusion stroke.

Patients with acute basilar artery occlusion stroke were collected and divided into a control group and an experimental group based on different treatment methods. Compared the differences in clinical efficacy, vascular recanalization rate, thrombectomy-related indicators, infarct-related parameters, cerebral hemodynamic indicators, serum biomarkers, neurological function, 90-day prognosis, and adverse reactions between the two groups.

A total of 112 patients with acute basilar artery occlusion stroke were enrolled, including 57 cases in the control group and 55 cases in the experimental group. After treatment, the overall effective rate of the experimental group was 52.73% (29 cases/55 cases), which was higher than that of the control group 33.33%,(19 cases/57 cases) (P<0.05). At the time of treatment, the effective recanalization rates in the experimental group and the control group were 85.45% (47 cases/55 cases) and 80.70% (46 cases/57 cases), respectively, while the complete recanalization rates were 56.36% (31 cases/55 cases) and 49.12% (28 cases/57 cases), respectively. There was no statistically significant difference in the above indicators between the two groups (P>0.05). The first-pass effect (FPE) rates in the experimental group and the control group were 72.73% (40 cases/55 cases) and 52.63% (30 cases/57 cases), respectively, and the number of thrombectomy procedures was 1.91±0.48 and 2.11±0.52, respectively, with statistically significant differences (P<0.05). The thrombectomy time in the experimental group and the control group was (64.29±10.29) and (66.37±12.32) min, respectively, and the residual stenosis rates were 10.91% (6 cases/55 cases) and 21.05% (12 cases/57 cases), respectively, with no statistically significant differences (P>0.05). At 24 hours after the operation, the ischemic area volume of the experimental group and the control group was (82.66±15.21) and (93.61±18.65) mL. respectively, the ischemic core volume was (60.19±8.52) and (65.15±9.10) mL, respectively, the ischemic penumbra volume was (22.47±5.18) mL and (28.46±7.22) mL, respectively, the final infarct growth volume was (30.47±8.16) and (35.04±9.04) mL, respectively, the salvage rates of the ischemic penumbra were (69.93±8.11)% and (64.71±7.52)%, respectively, and the peak systolic velocity was (119.86±28.79) and (105.24±24.35) cm·s^-1, respectively, the end-diastolic velocity was (44.44±7.16) and (34.89±8.05) cm·s^-1, respectively; the resistance index (RI) was 0.63±0.04 and 0.67±0.05, respectively; the pulsatility index (PI) was 0.70±0.07 and 0.74±0.06, respectively; The serum neurofilament light chain (NfL) levels were (345.26±30.15) and (372.34±54.19) pg·mL^-1, respectively, and the glial fibrillary acidic protein (GFAP) levels were (526.37±74.91) and (566.42±82.21) pg·mL^-1, respectively. There were statistically significant differences in the above indicators between the two groups (P<0.05). At 7 days, 30 days postoperatively, the NIHSS scores of the experimental group were (10.42±2.13), (7.47±1.92) points, respectively, all of which were lower than those of the control group [(11.56±2.29), (8.37±2.04) points]. During the follow-up period, 11 bleeding events occurred in the experimental group, including 4 cases of symptomatic intracerebral hemorrhage (sICH), 6 cases of asymptomatic intracerebral hemorrhage (aICH), and 1 case of upper gastrointestinal bleeding; 9 bleeding events occurred in the control group, including 4 cases of sICH and 5 cases of aICH. The difference was not statistically significant (P>0.05). The rate of favorable prognosis at 90 days was 54.55% (30 cases/55 cases) in the experimental group, which was higher than the 33.33% (19 cases/57 cases) in the control group (P<0.05). There were no significant differences between the two groups in all-cause mortality or re-infarction rate (P>0.05). The overall incidence of adverse reactions was 9.09% (5 cases/55 cases) in the experimental group and 10.53% (6 cases/57 cases) in the control group, with no statistically significant difference between the groups (P>0.05).

For patients with acute basilar artery occlusion stroke with onset <6 hours, ASA grade ≤Ⅲ, and baseline mRS 0-2, tenecteplase bridging endovascular thrombectomy and direct thrombectomy achieve similar recanalization outcomes in the treatment of acute basilar artery occlusion stroke. The bridging approach reduces the number of thrombectomy attempts required, further improves cerebral blood flow perfusion, promotes neurological function and prognosis, while maintaining a safety profile comparable to that of direct thrombectomy.

To evaluate the clinical efficacy and safety of β-lactam antibiotics (BLAs) combined with tigecycline (TGC) in the treatment of complicated urinary tract infections (cUTIs) in perimenopausal women, and to provide evidence-based data for optimizing clinical treatment regimens in this population.

A retrospective study was conducted on the clinical data of 102 perimenopausal women with cUTI admitted to our hospital from March 2023 to March 2025. The patients were divided into a experimental group (52 cases) and a control group (50 cases) based on treatment regimens. The control group received BLAs (cefoperazone-sulbactam) monotherapy, while the treatment group received BLAs combined with TGC therapy. Both groups underwent continuous treatment for 14 days. Changes in various indicators before and after treatment were recorded.

After treatment, the white blood cell (WBC) counts in the control group and the experimental group were (8.21±1.19)×10 and (7.55±1.22)×10/L, respectively; serum amyloid A (SAA) levels were (25.31±4.65) and (22.91±4.12) mg·L^-1, respectively; soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) levels were (22.52±4.18) and (20.85±3.55) pg·mL^-1, respectively; urinary heparin-binding protein (U-HBP) levels were (77.60±8.54) and (74.06±7.43) ng·mL^-1, respectively. The CD4⁺/CD8⁺ ratios were 1.62±0.20 and 1.74±0.25, immunoglobulin M (IgM) levels were (1.57±0.20) and (1.72±0.28) g·L^-1, and immunoglobulin G (IgG) levels were (11.33±1.71) and (12.06±1.46) g·L^-1 in the two groups, respectively. In the visual analogue scale (VAS) assessment, the urgency VAS scores were 1.66±0.48 and 1.44±0.50, dysuria VAS scores were 1.90±0.36 and 1.71±0.50, and frequency VAS scores were 1.76±0.48 and 1.54±0.54 in the control group and the experimental group, respectively. The scores of physiological function, mental health, role-emotional, social functioning, vitality, general health, bodily pain, and role-physical were (82.26±8.29) vs. (86.88±9.10), (77.22±7.12) vs. (80.56±8.60), (79.82±8.49) vs. (83.92±9.83), (79.28±8.12) vs. (82.79±8.70), (81.54±9.50) vs. (85.44±8.63), (79.30±7.97) vs. (83.67±8.94), (79.52±8.10) vs. (84.96±9.15), and (82.96±9.17) vs. (87.04±8.71) in the control and experimental groups, respectively. All the above differences were statistically significant (all P<0.05). The total incidence rates of adverse reactions were 8.00% (4 cases/50 cases) in the control group and 5.77% (3 cases/52 cases) in the experimental group, with no statistically significant difference (P>0.05).

Compared with monotherapy with β-lactam antibiotics, combination therapy with tigecycline further improves urinary bacterial clearance rate and cure rate, as well as enhance inflammatory markers, immune function, clinical symptoms, and quality of life. However, there is no statistically significant difference in overall response rates between the two groups. The combination therapy dose not increase adverse drug reactions.