To systematically analyze the longitudinal characteristics and development trends of registered clinical trials of lipid-lowering drugs in China from 2013 to 2025, and to provide evidence-based data for clinical researchers, policy-makers, and pharmaceutical companies.

Data were retrieved from the National Medical Products Administration (NMPA) Clinical Trial Registration and Information Disclosure Platform. Clinical trials related to lipid-lowering drugs with the first public disclosure date ranging from January 1, 2013 to December 31, 2025 were included. Trials with indications containing keywords such as "cholesterol" and "hyperlipidemia" etc. were screened. After excluding duplicate registrations, comparative analyses were conducted on data regarding basic trial information, drug characteristics and the design of innovative drug trials.

A total of 748 clinical trials were included, of which 68.45% (512 cases/748 cases) were bioequivalence (BE) trials, while phase Ⅰ, Ⅱ, and Ⅲ trials accounted for 125, 47, and 64 trials respectively, totaling 31.55% (236 cases/748 cases). BE trials increased significantly from 2016 to 2019, declined during 2020 to 2022 due to the COVID-19 pandemic, and surged again after 2023. The number of innovative drug trials grew steadily, peaking in 2025. Ninety-four innovative lipid-lowering drugs identified covered diverse therapeutic targets, including proprotein convertase subtilisin/kexin type 9 (PCSK9), angiopoietin-like protein 3 (ANGPTL3), lipoprotein(a) [Lp(a)] and apolipoprotein C3 (APOC3), with 71.28% (67 cases / 94 cases) developed by domestic companies and injections dosage form accounting for 52.13% (49 cases /94 cases). The primary endpoints of phase Ⅲ trials were predominantly the percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline, accounting for 65.52% (38 cases /58 cases), while hard endpoints such as major adverse cardiovascular events (MACE) accounted for only 15.52% (9 cases /58 cases). Target exploration showed a trend of diversification. Novel modalities such as small interfering RNA (siRNA) experienced explosive growth after 2023, with 24 registered trials in 2025. Only 8 innovative drug trials included subjects under 18 years old, all targeting familial hypercholesterolemia.

From 2013 to 2025, China’s lipid-lowering drug clinical trials underwent a critical transformation, shifting from generic drug expansion to active innovative drug research and development. Therapeutic targets have diversified, and novel drug modalities have developed rapidly.

To observe the clinical efficacy and safety of ezetimibe tablets or alirocumab injection in conjunction with rosuvastatin calcium tablets for the treatment of coronary heart disease (CHD).

Patients with CHD were randomly divided into two groups. Both groups took rosuvastatin calcium tablets, 10 mg once daily. The control group additionally received ezetimibe tablets,10 mg once daily, while the treatment group received alirocumab injection (subcutaneous injection, 75 mg per dose, once every two weeks). After 6 months of treatment, the two groups were compared in terms of clinical efficacy, lipid metabolism, cardiac function and myocardial injury markers. Adverse drug reactions during treatment were recorded.

This study enrolled a total of 118 patients, with 59 assigned to treatment group and 59 to the control group. During the 6-month treatment period, 4 patients in the control group dropped out due to changes in their condition. In treatment group, 6 patients dropped out, comprising 3 due to changes in the treatment plan and 3 who voluntarily withdrew from the study midway. Ultimately, 55 patients in the control group and 53 in the treatment group were included in the final analysis. After treatment, the total clinical effective rates were 90.57% (48 cases/53 cases) in treatment group and 72.73% (40 cases /55 cases) in control group, with statistically significant difference (P<0.05). After treatment, the cholesterol levels in the treatment and control groups were (2.58±0.40) and (3.60±0.52) mmol·L^-1, respectively; low-density lipoprotein cholesterol levels were (2.16±0.36) and (2.51±0.44) mmol·L^-1, respectively; N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were (301.12±20.11) and (326.54±25.84) pg·mL^-1, respectively; cardiac troponin Ⅰ (cTnⅠ) levels were (0.53±0.19) and (0.90±0.26) μg·L^-1, respectively; matrix metalloproteinase-9 (MMP-9) levels were (31.04±4.05) and (37.25±4.72) ng·mL^-1, respectively; left ventricular ejection fraction (LVEF) were (49.79±5.33)% and (45.09±5.21)%, respectively; left ventricular end-diastolic diameter (LVEDD) were (50.36±3.23) and (55.11±3.48) mm, respectively; and left ventricular end-systolic diameter (LVESD) were (35.04±3.72) and (40.64±3.97) mm, respectively. The aforementioned indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). Adverse drug reactions in control group included 2 cases of nausea and vomiting, 2 cases of diarrhea, 3 cases of fatigue and 2 cases of arthralgia. Treatment group reported 2 cases of nausea and vomiting, 3 cases of diarrhea, 2 cases of fatigue, 1 case of arthralgia and 2 cases of injection site redness and swelling. The overall incidence rates of adverse drug reactions in treatment and control groups were 18.87% (10 cases/53 cases) and 16.36% (9 cases/55 cases), respectively, with no statistically significant difference (P>0.05).

Both ezetimibe tablets and alirocumab injection demonstrate good therapeutic efficacy in the treatment of coronary heart disease. However, the combination of alirocumab injection with rosuvastatin calcium tablets can further improve lipid metabolism and cardiac function.

To observe the clinical efficacy and safety of cinacalcet tablets combined with calcitriol pills in diabetic nephropathy (DN) patients undergoing hemodialysis.

DN patients receiving hemodialysis in our hospital were divided into treatment group and control group based on different medication regimens. The control group was treated with calcitriol pills, administered orally twice a week. The dosage was 0.25-1.5 μg for patients with intact parathyroid hormone (iPTH) 300-600 ng·L^-1, 0.5-2.0 μg for those with (iPTH) 600-1 000 ng·L^-1, and 2.0-4.0 μg for those with iPTH > 1 000 ng·L^-1. The treatment group received cinacalcet tablets in addition to the control group’s treatment. The initial dose of cinacalcet tablet was 25 mg per day, adjusted every 2-4 weeks, the dose remained unchanged for patients with serum calcium < 2.1 mmol·L^-1; increased to 50 mg per day for those with serum calcium>2.0 mmol·L^-1; and decreased to 75 mg per day for those with serum calcium<1.8 mmol·L^-1. Both groups were treated for 6 months. Clinical efficacy, calcium-phosphorus metabolism, renal function, bone metabolism, iPTH levels and parathyroid gland volume were compared between the two groups, and safety was evaluated.

A total of 94 patients were included in this study, with 47 cases in each of treatment and control groups. After treatment, the total effective rates were 95.74% (45 cases/47 cases) in treatment group and 80.85% (38 cases /47 cases) in control group, showing statistically significant difference (P<0.05). After treatment, the blood calcium levels in treatment and control groups were (2.78±0.21) and (2.49±0.23) mmol·L^-1, respectively; blood phosphorus levels were (1.11±0.13) and (1.39±0.17) mmol·L^-1, respectively; calcium-phosphorus product levels were 3.09±0.24 and 3.46±0.29, respectively; fibroblast growth factor 23 (FGF23) levels were (60.55±7.21) and (71.62±7.84) ng·L^-1, respectively; alkaline phosphatase levels were (91.06±28.43) and (110.35±32.19) U·L^-1, respectively; osteoprotegerin levels were (6 892.43±395.46) and (7 142.58±411.27) ng·L^-1, respectively; iPTH levels were (623.08±57.19) and (721.57±61.46) ng·L^-1, respectively; and parathyroid gland volumes were (0.81±0.19) and (1.11±0.18) cm³, respectively. All of these indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). The main adverse drug reactions in treatment group included pruritus (2 cases), myalgia (3 cases), nausea and vomiting (1 case) and diarrhea (1 case). In the control group, adverse drug reactions were pruritus (1 case), myalgia (2 cases), nausea and vomiting (2 cases) and diarrhea (1 case). The total incidence of adverse drug reactions were 12.77% (6 cases/47 cases) in treatment group and 14.89% (7 cases/47 cases) in control group, with no statistically significant difference (P>0.05).

The combination of cinacalcet tablets and calcitriol pills effectively corrects disorders of calcium-phosphorus and bone metabolism, reduces iPTH levels, and decreases parathyroid gland volume in DN patients on hemodialysis, with a favorable safety profile.

To investigate the effects of roxadustat capsules combined with multi-dimensional exercise rehabilitation training on microinflammation and vascular endothelial function in elderly hemodialysis patients.

Elderly patients who underwent regular dialysis and took roxadustat capsules were randomly divided into the treatment group and the control group according to the random number table. Patients in the control group took roxadustat capsules. Patients in the treatment group were given roxadustat capsules combined with multi-dimensional exercise rehabilitation training. For those weighing less than 60 kg, treated with roxadustat capsules 100 mg per time; for those weighing more than 60 kg, took roxadustat capsules 120 mg each time; three times a week. The multidimensional exercise included resistance exercise, aerobic exercise, and mindfulness meditation during dialysis, 3 times per week, 70 minutes each session, lasting 6 months. Clinical efficacy, microinflammatory factor indicators, endothelial function indicators, biochemical indicators, and adverse drug reactions were collected before and after the study.

A total of 235 cases were enrolled in this study. The treatment group included 115 cases. The control group included 120 cases. After the treatment, the total effective rates of the treatment group and the control group were 90.43% (104 cases /115 cases) and 79.17% (95 cases /120 cases), respectively, and the difference was statistically significant (P<0.05). The total effective rate in the non-diabetic patients of the treatment group was 94.38% (84 cases /89 cases), significantly higher than the 80.65% (75 cases / 93 cases) in the diabetic patients of the treatment group (P<0.05). After treatment, the levels of serum nuclear transcription factor (NF-κB) in the treatment and the control groups were (24.78±4.67) and (36.09±4.25) ng·L^-1, respectively; interleukin-6 (IL-6) levels were (25.38±4.24) and (28.47±4.62) ng·L^-1; interferon-γ (IFN-γ) levels were (40.66±4.89) and (50.01±5.95) ng·L^-1; serum endothelin-1 (ET-1) levels were (87.41±26.59) and (120.70±28.52) ng·L^-1; soluble vascular cell adhesion molecule-1 (sVCAM-1) levels were (2 848.50±84.75) and (5 639.82±125.63) μg·L^-1; and plasma endothelial microparticles (EMP) counts were (95.43±20.19) and (110.55±26.78) per μL, respectively. The above indicators in the treatment group were statistically significantly different from those in the control group (all P<0.05). The main adverse drug reactions in the treatment group and the control group were nausea, vomiting, indigestion and fatigue. The total incidence of adverse drug reaction rates in the treatment group and the control group were 11.30% (13 cases /115 cases) and 11.67% (14 cases /120 cases), respectively. There was no statistically significant difference (P>0.05).

Roxadustat capsules combined with multidimensional exercise rehabilitation training has shown significant efficacy in microinflammation and vascular endothelial dysfunction in elderly hemodialysis patients, which can reduce microinflammatory responses and improve vascular endothelial function, outperforming the effects of roxadustat capsules alone, with good safety.

To explore the efficacy and safty of different administration routes of dexmedetomidine injection in elderly patients undergoing total hip arthroplasty (THA).

The elderly THA patients were randomly divided into the intravenous group (ID group, ropivacaine injection nerve block, 0.5 μg·kg^-1 dexmedetomidine injection administered by intravenous pump) and the perineural group (PD group, 0.5 μg·kg^-1 dexmedetomidine injection combined with ropivacaine injection nerve block). Compare the postoperative visual analog scale (VAS) scores, inflammatory factors, hemodynamic parameters, awakening time, incidence and duration of emergence agitation (EA), mini-mental state examination (MMSE) scores, riker sedation-agitation scale (RSAS), oxidative stress and immune function between the two groups and safty evaluation was conduated.

A total of 102 cases were included, 51 in the ID group and 51 in the PD group. At 48 hours after surgery, the resting VAS scores of ID group and PD group were (1.85±0.73) and (1.52±0.61) points, and the movement VAS scores were (3.61±0.64) and (3.27±0.42) points, respectively. The rest/movement VAS scores of PD group were significantly lower than those of ID group (all P<0.05). Immediately after surgery, C-reactive protein (CRP) in ID group and PD group were (6.80±1.03) and (6.13±0.75) mg·L^-1, interleukin-1β (IL-1β) were (8.06±0.87) and (6.07±0.63) pg·mL^-1, tumor necrosis factor-α (TNF-α) were (99.24±12.03) and (81.10±9.25) ng·mL^-1, interleukin-8 (IL-8) were (8.03±0.73) and (6.19±0.68) pg·mL^-1, interleukin-6 (IL-6) were (39.68±7.25) and (32.35±6.86) pg·mL^-1; 1 day after surgery, CRP in ID group and PD group were (6.07±1.07) and (5.37±0.81) mg·L^-1, IL-1β were (6.71±0.66) and (5.24±0.65) pg·mL^-1, TNF-α were (98.21±11.00) and (77.48±10.78) ng·mL^-1, IL-8 were (6.76±0.57) and (5.29±0.60) pg·mL^-1, IL-6 were (37.93±8.65) and (30.34±7.20) pg·mL^-1; 3 day after surgery, CRP in ID group and PD group were (5.53±1.04) and (5.06±0.64) mg·L^-1, IL-1β were (6.11±0.73) and (4.30±0.68) pg·mL^-1, TNF-α were (83.97±13.78) and (51.32±9.69) ng·mL^-1, IL-8 were (6.26±0.67) and (4.33±0.52) pg·mL^-1, IL-6 were (31.35±7.06) and (28.24±5.23) pg·mL^-1. The levels of CRP, IL-1β, TNF-α, IL-8 and IL-6 in PD group were statistically significantly lower than those in ID group immediately after operation, 1 day and 3 days after operation (all P<0.05). The recovery time of ID group and PD group was (28.93±3.00) and (25.93±2.91) min, respectively; the incidence of EA was 23.53% and 7.84%, respectively; the duration of EA was (2.32±0.38) and (1.82±0.36) days, respectively. Immediately after surgery, superoxide dismu-tase (SOD) in ID group and PD group were (136.47±16.96) and (154.81±15.38) U·mL^-1, malondialdehyde (MDA) were (8.89±1.24) and (6.54±1.13) nmol·mL ^-1, CD4⁺ were (29.28±2.94)% and (32.62±2.57)%, CD4⁺/CD8⁺ were (1.34±0.39)% and (1.55±0.37)%; 1 day after surgery, SOD in ID group and PD group were (149.82±17.54) and (157.73±16.52) U·mL^-1, MDA were (6.04±1.10) and (4.37±1.02) nmol·mL ^-1, CD4⁺ were (24.75±1.71)% and (28.36±2.31)%, CD4⁺/CD8⁺ were (1.24±0.31)% and (1.37±0.33)%; 3 day after surgery, SOD in ID group and PD group were (156.44±19.73) and (164.39±19.15) U·mL^-1, MDA were (5.27±0.95) and (4.05±0.68) nmol·mL ^-1, CD4⁺ were (27.35±1.78)% and (31.16±2.33)%, CD4⁺/CD8⁺ were (1.22±0.35)% and (1.43±0.40)%. SOD、CD4⁺、CD4⁺/CD8⁺ in PD group were statistically significantly higher than those in ID group (all P<0.05), MDA was statistically significantly lower than that in ID group (P<0.05). Among the routes of administration, ID was a risk factor for EA during general anesthesia in THA in elderly patients (P<0.05). Among the administration doses, different administration doses did not increase the risk of EA during general anesthesia in elderly patients with THA (P>0.05).

Compared with intravenous administration, peripheral dexmedetomidine injection can effectively reduce the incidence of EA, reduce inflammation and oxidative stress, improve analgesia and immune function in elderly patients with THA, and the effect can be achieved at a lower dose, which is recommended as the preferred anesthesia auxiliary scheme.

To investigate the efficacy and safety of programmed death-1 (PD-1) inhibitor targeted therapy combined with the oxaliplatin+5-fluorouracil+calcium leucovorin (mFOLFOX6) chemotherapy regimen in the preoperative neoadjuvant treatment of locally advanced middle-low rectal cancer.

Elderly patients with locally advanced middle-low rectal cancer were divided into control group and treatment group according to the treatment method. Patients in the control group received the conventional mFOLFOX6 chemotherapy regimen, with one cycle every 2 weeks for a total of 4 cycles. Patients in the treatment group received the conventional neoadjuvant chemotherapy with the mFOLFOX6 regimen combined with the PD-1 inhibitor camrelizumab injection (200 mg intravenously infused on day 1 of each cycle), with one cycle every 2 weeks for a total of 4 cycles. The surgical intervention was undertaken 4-6 weeks following completion of the chemotherapy regimen. The short-term efficacy evaluation of solid tumors, malignant tumor markers, anorectal dynamics and surgical efficiency were compared between the two groups and the safety was evaluction.

A total of 97 patients were recruited, with 54 assigned to the control group and 43 in the treatment group. After treatment, the objective response rates (ORR) were 25.93% (14 cases/54 cases) in the control group and 48.84% (21 cases/43 cases) in the treatment group; the disease control rates (DCR) were 57.41% (31 cases/54 cases) in the control group and 76.74% (33 cases/43 cases) in the treatment group, with statistically significant differences (P<0.05). After treatment, the carcinoembryonic antigen (CEA) levels in the control group and treatment group were (3.27±0.48) and (2.75±0.43) μg·L^-1, respectively; the carbohydrate antigen 199 (CA199) levels were (22.19±3.17) and (19.80±2.94) KU·L^-1, respectively. The above indicators demonstrated statistically significant differences between the treatment and control groups (all P<0.001). After treatment, the rectal resting pressure (RRP) levels in the control group and treatment group were (11.36±1.75) and (13.95±2.03) mmHg, respectively; the maximal tolerable rectalvolume (MTV) levels were (142.97±18.39) and (135.43±15.96) mL, respectively; the rectal compliance (RC) levels were (3.13±0.58) and (2.75±0.39) mL·mmHg^-1, respectively. The above indicators demonstrated statistically significant differences between the treatment and control groups (all P<0.05). The incidence of postoperative complications was 20.37% (11 cases/54 cases) in the control group and 18.60% (8 cases/43 cases) in the treatment group, with no statistically significant difference (P>0.05).

Preoperative targeted therapy with a PD-1 inhibitor combined with the mFOLFOX6 chemotherapy regimen can significantly improve the short-term efficacy of solid tumors, reduce tumor marker levels, optimize anorectal dynamics and quality of life in patients with locally advanced middle-low rectal cancer, with mild immunosuppression and good safety.

To analyze the occurrence and risk factors of acute kidney injury (AKI) in patients with hematologic malignancies who experienced severe delayed excretion after high-dose methotrexate (HD-MTX) chemotherapy, and to explore dose adjustment strategies for reusing HD-MTX in these patients.

A retrospective analysis was conducted on clinical data of hematologic malignancy patients treated with HD-MTX in the hematology and oncology departments. Patients with severe delayed MTX excretion (defined as serum MTX >30 μmol·L^-1 at 24 h, >3 μmol·L^-1 at 48 h, >0.3 μmol·L^-1 at 72 h, or prolonged low-level MTX >0.3 μmol·L^-1 for >6 days) were included. Patients were divided into three groups based on AKI severity, group A was mild AKI, group B was moderate AKT, group C was severe AKI. Statistical methods were used to analyze risk factors for severe excretion delay and AKI.

Among 26 patients (28 HD-MTX cycles) with severe delayed excretion, AKI occurred in all cycles (100.00%). Group A accounted for 21.43% (6 cases/28 cases), Group B accounted for 46.43% (13 cases/28 cases), accounted for 32.14% (9 cases/28 cases). Pre-treatment albumin levels in group A, group B and group C were (42.22±4.63), (39.08±4.3) and (35.25±4.19) g·L^-1. Among patients with moderate/severe AKI, 11 received 19 subsequent HD-MTX cycles at reduced doses (1/3-1× original), with no recurrence of excretion delay or AKI.

Low pre-treatment albumin levels, particularly <35 g·L^-1 are strongly associated with severe MTX-related AKI. Patients with a history of MTX-induced AKI can safely reuse HD-MTX at adjusted doses (based on renal recovery and clinical indicators) without AKI recurrence.

To observe the efficacy and safety of mycophenolate mofetil capsules combined with belimumab injection in the treatment of systemic lupus erythematosus (SLE) with acute kidney injury (AKI).

Patients were divided into control group and treatment group according to random number table method. The control group was treated with mycophenolate mofetil capsules, mycophenolate orally, 0.5 g per time, twice a day. The treatment group was treated with belimumab injection on the basis of control group. Take 10 mg·kg^-1 belimumab injection, dissolve in 250 mL normal saline, intravenous infusion, once every 2 weeks for the first 3 times, and once every 4 weeks thereafter. Both groups were treated for 6 months. Symptom score, inflammatory injury index, renal function index, immune function and clinical efficacy were compared between the two groups, and safety evaluations conducted.

A total of 197 cases were screened, with 127 cases enrolled. The treatment group consisted of 63 cases and the control group consisted of 64 cases. In control group, 4 cases dropped out due to mid course transfer, and 60 cases were included. In treatemnt group, 4 cases dropped out due to giving up treatment, and 59 cases were included. After treatment, the British isles lupus assessment group (BILAG) scores in treatment group and control group were (12.05±2.14) and (17.24±3.27) points, respectively; the systemic lupus erythematosus disease activity index (SLEDAI) scores were (6.41±1.33) and (9.25±1.98) points, respectively; the levels of mannose-binding lectin (MBL) were (62.09±6.10) and (78.34±8.51) ng·L^-1, respectively; the levels of serum creatinine (Scr) were (172.20±21.08) and (228.36±25.42) μmol·L^-1, respectively; the levels of blood urea nitrogen (BUN) were (10.07±1.96) and (15.24±3.17) mmol·L^-1, respectively; the levels of immunoglobulin M (IgM) were (1.17±0.21) and (2.19±0.30) g·L^-1, respectively; the levels of IgG were (5.93±0.89) and (4.87±0.65) g·L^-1, respectively. The above indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). The total clinical effective rates of treatment group and control group were 88.14% (52 cases/59 cases) and 71.67% (43 cases/60 cases), respectively, with treatment group significantly higher than control group (P<0.05). The main adverse drug reactions of control group were elevated transaminase levels, nausea, vomiting and diarrhea; treatment group mainly had elevated transaminase levels, nausea and vomiting, vascular edema and diarrhea. The total incidence of adverse drug reactions in control group and treatment group were 10.00% (6 cases/60 cases) and 13.56% (8 cases/59 cases), respectively, with no statistically significant difference (P>0.05).

Mortimycophanate capsules combined with belimumab injection in the treatment of SLE patients with AKI is effective, can improve clinical symptoms and renal function, reduce inflammation, improve immune function, and has good safety.

To analyze the steady state plasma concentrations and dose-corrected concentration(C/D) influencing factors of vortioxetine tablets in patients with depression, and to provide guidance in the practice of rational clinical use of vortioxetine tablets in patients with depression.

Patients with depression who took vortioxetine and underwent therapeutic drug monitoring of blood concentrations in our hospital from March 2022 to November 2024 were selected as the study subjects, and their blood concentrations were monitored. Laboratory indicators, demographic information and the effect of coadministration on dose-corrected concentrations of vortioxetine tablets were statistically analyzed by SPSS 26.0.

A total of 90 patients were enrolled, and 107 sessions of blood concentration monitoring were performed. In depressed patients, the steady state plasma concentration was (28.05±20.28) ng·mL^-1, the administered daily dose was (14.86 ± 5.21) mg·d^-1, and the dose-corrected concentration was (1.96±1.24) ng·mL^-1·mg^-1·d. 69.16% (74 cases/107 cases) of C/D exceeded the upper limit of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie(AGNP) guideline reference range. The body weight, alanine aminotransferase(ALT), and urea, as well as the combination of paliperidone, aripiprazole, or clozapine all had a significant effect on the dose-corrected concentration of vortioxetine (all P<0.05). Multiple linear regression analysis revealed that body weight and the combination of aripiprazole had a significant effect on vortioxetine C/D (F=8.517, R²=0.148, P<0.001).

When vortioxetine is used clinically, the dosage should be adjusted according to the patient’s body weight. When it is used in conjunction with aripiprazole, regular monitoring of the plasma concentration should be carried out.