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62 (); 112-121
doi:
10.1016/j.jor.2024.10.030

The efficacy of tranexamic acid in perioperative bleeding following total hip arthroplasty through different surgical approaches: Systematic review and meta-analysis

, , , , , , , ,
a Bone and Joint Diseases Research Center, Department of Orthopedic Surgery, Shiraz University of Medical Sciences, Shiraz, Iran
b Medical Research Fellow, INOV8 Research, Houston, TX, USA
c Sina Trauma and Surgery Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
d Department of Orthopedic Surgery, School of Medicine, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran
e Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
f Department of Orthopedic Surgery, Kerman University of Medical Sciences, Kerman, Iran
g Department of Epidemiology, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran
h Orthopedic Research Center, Department of Orthopedic Surgery, Mashhad University of Medical Sciences, Mashhad, Iran

⁎Corresponding author: Roham Borazjani. rborazjani@inov8hc.com

Received: , Accepted: ,
Professor P K Surendran Memorial Education Foundation
Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

Tranexamic acid (TXA) has been documented to reduce perioperative blood loss following orthopedic surgeries, such as total hip arthroplasty (THA). Previous studies focused on the best applicable dose and administration method to minimize blood loss. Although the surgical approach is another factor that may influence perioperative bleeding, no previous research has examined its concurrent impact alongside TXA. This meta-analysis investigated the effect of intravenous TXA on perioperative bleeding in primary THA, focusing on the surgical approach used.

The authors searched PubMed, Web of Science, Scopus, Embase, and the Cochrane Library through November 2022. Fourteen studies, comprising 1358 patients, were identified as suitable for inclusion in this meta-analysis. To assess perioperative bleeding, hemoglobin (Hb) decline, transfused blood products, total blood loss (TBL), and intraoperative blood loss (IOBL) were recorded.

The study showed that the lateral approach (LA) maintains the postoperative Hb level more effectively (WMD = 1.081, 95 % CI: 0.620–1.541). Significantly less IOBL was observed with the posterolateral approach (PLA; WMD = −70.578, 95 % CI: [-130.389] – [-10.766]). The posterior approach (PA) was associated with a reduction in TBL (WMD = −392, 95 % CI: [-474.439] – [-310.231], P-value <0.0001).

The surgical approach plays a significant role in blood management during surgery. Overall, the PLA resulted in the least IOBL, while the LA was associated with the least blood transfusion and a decline in Hb level. Additionally, the PA was linked to the lowest TBL.

Keywords

Tranexamic acid
Total hip arthroplasty
Surgical approach
Perioperative bleeding
1

1 Introduction

For most hip disorders, total hip arthroplasty (THA) is the preferred treatment if conservative therapies are not able to preserve the patient's range of motion and reduce their pain. Orthopedic surgeons are continuously seeking ways to minimize perioperative complications and improve overall outcomes since THA is a major orthopedic surgery that may result in significant bleeding and subsequent anemia, often necessitating blood transfusions.1,2

Several blood-sparing techniques have been developed to reduce the need for transfusions and mitigate subsequent anemia. Tranexamic acid (TXA), a lysine analog, reduces plasmin formation while preserving the fibrin matrix structure.3,4 Although TXA's ability to reduce perioperative blood loss has been well established, ongoing research continues to explore various factors that may influence its effectiveness, such as patient gender, the presence of comorbidities, the method of TXA administration, and the surgical approach used.5

The applied surgical approach, including direct anterior, lateral, and posterolateral approach, has been shown to affect patient outcomes.6–8 Zimmer et al. found that both the direct anterior approach (DAA) and the posterior approach (PA) are associated with less pain, greater walking distances, and improved Harris Hip Scores at short-term follow-ups compared to the lateral approach (LA).9 In a prospective study, Cheng et al. demonstrated that DAA was associated with more significant hemoglobin reduction than PA (35 g/L vs. 31 g/L).10 Similarly, Aggarwal et al. found that DAA led to slightly lower blood loss than other methods, although the difference was not statistically significant.11 Ponzio et al. also reported that fewer DAA patients required packed RBC transfusions (23 % vs. 9 %) compared to those undergoing PA.12 Using a randomized controlled trial (RCT), Rykov et al. examined variations in biomarkers between the posterolateral approach (PLA) and DAA. They discussed the administration of TXA 1500 mg and 1000 mg for individuals above and less than 100 kg. Moreover, the DAA resulted in an insignificant increase in blood loss compared to the PLA (325.7 ml vs. 273.7 ml, p = 0.24).13 Wang et al. suggested that DAA resulted in less blood loss compared to the lateral approach.14 However, Restrepo et al. did not observe any significant differences between the lateral approach and DAA.15

To the best of our knowledge, none of the published studies have explored the potential concurrent effects of surgical approaches on these outcomes. This systematic review study aims to analyze the combined effects of surgical technique and TXA administration on hemoglobin levels and bleeding parameters following primary THA.

2

2 Materials and methods

2.1

2.1 Search strategy

This study was conducted in line with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.16 A comprehensive search was conducted across the following databases up to November 2022: PubMed, Scopus, Embase, Cochrane Library, and Web of Science. Additionally, a manual search of the first 64 pages of Google Scholar was performed to identify potentially relevant studies. The queries were developed by combining key terms with Medical Subject Headings (MeSH) terms (see supplemental materials). At this stage, there were no restrictions regarding the study type, publication date, or language.

2.2

2.2 Study selection

If a study fulfilled all of the subsequent criteria, it was included: 1) RCTs investigating the impact of intravenous TXA administration during the primary THA; 2) having a study group with a single intravenous dose of TXA compared to a control group receiving either placebo, no treatment, or normal saline; 3) peer-reviewed English-language studies; and 4) adult patients aged 18 years or older.

Our exclusion criteria were: 1) involved patients with bilateral THAs; 2) involved infected or revision THAs; 3) included patients with underlying conditions such as ankylosing spondylitis, rheumatoid arthritis, or cancer; 4) involved THA in trauma patients; 5) were in vitro or animal biomechanical studies; 6) were reviews or meta-analyses; or 7) were case studies, conference abstracts, or cohort studies.

2.3

2.3 Subgroups and measured outcomes

Studies and extracted data were classified based on the applied surgical approach during THA. The primary outcome was the change in hemoglobin levels. Secondary outcomes included the need for transfused blood products, surgery duration, intraoperative blood loss (IOBL), and total blood loss (TBL).

2.4

2.4 Data extraction and quality assessment

After removing duplicates, the selected articles were imported into a reference manager (EndNote X20). An independent reviewer (RB) initially screened titles and abstracts to identify relevant studies. Full-text reviews of the remaining papers were then conducted according to the inclusion criteria. After selecting appropriate studies, two researchers (RKh and AKh) independently assessed the quality using the Cochrane Collaboration Risk of Bias Tool.17 Two researchers extracted data such as author information, sample size, mean age, gender, surgical approach, pre- and postsurgical hemoglobin levels, the number of patients receiving allogenic packed red blood cells, and TBL and IOBL. Any discrepancies in the screening and data extraction process were resolved by consensus or arbitration by the senior author (RB).

2.5

2.5 Data analysis

All analyses were conducted using CAM Version 2. Mantel–Haenszel odds ratios (ORs) or mean differences (MDs) were calculated to summarize the results, with 95 % confidence intervals (95 % CI) used for each outcome. If continuous data were reported as medians, ranges, or interquartile ranges, means, and standard deviations were computed using the formula provided by Hozo et al.18 The I2 statistic was used to measure the heterogeneity, with thresholds of low (25 %), moderate (50 %), and high (75 %) heterogeneity. Forest plots were utilized to illustrate overall summary effects, pooled estimates, and study results. A P-value of less than 0.05 was considered statistically significant. In a sensitivity analysis, studies were removed one by one to assess the robustness and consistency of the combined results. All data were combined using a random-effects model to avoid overestimating the effects. Publication bias was evaluated using a funnel plot and Egger's test.

3

3 Results

3.1

3.1 Study identification

As shown in Fig. 1, the initial search yielded 3103 results using the predefined strategy. Of these, we excluded 1704 duplications and another 1364 studies based on the exclusion criteria. After reviewing the full-text articles, six studies were classified as conference abstracts,1,3,4,6–8 and five articles were disqualified for failing to focus on surgical approaches.19–23 Eleven additional studies were excluded for various reasons, including lack of a placebo group,24 inclusion of patients with femur fractures,4,25 combined hip and knee arthroplasty,26 two combined approaches,27,28 one in Chinese,29 patients with RA,30,31 IV single dose was not included32 and being a non-randomized study.33 Analyzing the listed studies' references led to the discovery and addition of one study.34 Ultimately, a total of 1358 patients from 14 randomized controlled trials were included in this meta-analysis.34–47 Attempts to contact the authors for specific data were unsuccessful, as they either did not respond or no longer had access to the raw data.

PRISMA flow diagram.
Fig. 1 PRISMA flow diagram.
3.2

3.2 Study characteristics

Table 1 presents the characteristics of the included studies. All included RCTs enrolled patients undergoing unilateral THA who received a single dose of TXA. Among the 1358 patients, 699 (51.5 %) received TXA. Most cases received 15 mg/kg of TXA (413 patients, 59.1 %), while 123 patients (17.6 %) received 10 mg/kg, 101 patients (14.4 %) received 3000 mg, and 121 patients (8.9 %) received 1000 mg.

Table 1 Detailed characteristics of included studies.
Authors [year] Country Sample Size Surgical Approach Cemented vs. Uncemented Sample size (intervention/control) Male/Female TXA dose Transfusion Transfusion indication Drain Thromboembolism prophylaxis Anesthesia
Benoni et al.2001,35 Sweden 38 LA Cemented 18/20 19/19 10 mg/kg Allogeneic Case-by-casea One drain for 24–33h LMWH General + Spinal
Yamasaki et al.2004,45 Japan 40 PLA Uncemented 20/20 37/3 1000 mg Autologous Autologous Two drains were removed on 2nd day after the operation Nothing Spinal
Claeys et al. 2007,37 Belgium 40 LA uncemented acetabular cup & cemented femoral stem 20/20 12/28 15 mg/kg Allogeneic Hb < 8.5 g/dl or Hct <27 % of normal range Three (intra-articular, subfascial, and subcutaneous) low-vacuum drains LMWH Spinal
Malhotra et al. 201141 India 50 PA Uncemented 25/25 28/22 15 mg/kg Allogeneic Hb reduction >25 % of baseline + clinical symptoms One drain under the gluteal muscle LMWH Spinal
Na et al. 201642 Korea 55 PLA Uncemented 29/26 36/29 10 mg/kg Allogeneic Hb ≤ 8 g/dl One drain Intermittent pneumatic compression Spinal
Pachore et al. 201943 India 74 PA Uncemented 37/37 47/27 10 mg/kg N/M Hct <27 % of the normal range One drain was removed at 48 h. Anti- thromboembolic stockings Spinal
Wang et al. 201644 China 77 PLA Uncemented 39/38 32/45 10 mg/kg N/M Hb < 7 g/dL or clinical symptoms One drain without a clamp was removed the next morning. LMWH + Leg pump General + Spinal
Wang et al. 201644 China 80 PLA Uncemented 42/38 29/51 15 mg/kg N/M Same as above One drain without a clamp was removed the next morning. LMWH + Leg pump General + Spinal
Zhao et al. 201847 China 80 DAA N/M 40/40 48/32 15 mg/kg N/M Hb < 7 g/dL or clinical symptoms No drain LMWH General
Chin et al. 202036 New Zealand 81 PA N/M 42/39 N/M 1000 mg N/M Hb < 8 g/dl or clinical symptoms One drain in the fascia Lata removed after 24 h N/M Spinal with or without general
Johansson et al. 200539 Sweden 100 PLA Cemented 47/53 53/57 15 mg/kg Allogeneic Hb < 9 g/dL, with consideration of clinical well-being One drain for 24h Deltaparin Spinal
Yi et al. 201646 China 100 PLA N/M 50/50 53/47 15 mg/kg Allogeneic Hb < 7 g/dL or anemia-related organ dysfunction. One drain was clamped for 2 h. LMWH N/M
Jaszczyk et al. 201538 Poland 124 LA Uncemented 61/63 62/62 15 mg/kg Allogeneic N/M A Redon drainage was removed on 2nd day postoperation. Enoxaparin Spinal
Wei et al. 201434 China 201 PA Uncemented 101/100 123/78 3000 mg N/M Intraoperative: MAP <70 mmHg. Postoperative: Hb < 9 g/dl One drain was clamped for 30 min and removed the next morning after the surgery. LMWH N/M
Kimura et al. 2021 $40 Brazil 116 PLA cementless 57/59 36/80 15 mg/kg Allogeneic Intraoperative: blood loss> 500 mL or hemodynamic instability. Postoperative: Hb < 7 g/dL or clinical symptoms.b No drain LMWH Spinal
Kimura et al. 2021 &40 Brazil 140 PLA cementless 71/69 99/41 15 mg/kg Allogeneic Same as above No drain LMWH Spinal
a With regard to age, cardiovascular status, hemoglobin concentration, and blood loss.
b Chronic obstructive pulmonary disease or symptomatic cardiac disease: Hb < 10 g/dL.

Six studies utilized the PLA for THA,39,40,42,44–46 four used PA,34,36,41,43 three employed Lateral,35,37,38 and one used DAA.47 Drains were used in almost all studies except for those by Zhao et al. and Kimura et al.40,47 Two out of three studies using the lateral approach (81 out of 99 patients) administered 15 mg/kg of IV TXA.37,38 Among the studies using PLA, three administered a single dose of IV TXA at 15 mg/kg (149 patients),39,44,46 two studies used 10 mg/kg (68 patients),42,44 and one study used 1000 mg (20 patients).45 Eight studies used allogenic packed cells for transfusion.35,37–42,46 Preoperatively collected autologous units were transfused in the study by Yamasaki et al.45 The remaining five studies implied the use of allogenic transfusion, though they did not explicitly mention it.34,36,43,44,47

3.3

3.3 Risk of bias assessment

Thirteen studies were rated as having "some concerns" based on methodological evaluation, primarily due to potential bias in the third (missing outcome data) and fourth (measurement of the result) domains. One study was categorized as "high risk" (Supplementary Figs. 1 and 2).

3.4

3.4 Meta-analysis for hemoglobin change

Thirteen studies, encompassing 19 reports, provided data on preoperative and postoperative hemoglobin levels or hemoglobin changes.34,36–47 We excluded the study by Benoni et al. as it did not report hemoglobin data.35 A subgroup analysis was conducted based on the surgical approaches used (DAA, PLA, PA, and lateral approach). Due to significant heterogeneity across the studies (p = 0.001, I2 = 58.28 %), a random-effects model was applied. TXA significantly preserves the Hb levels compared to the placebo group (all P-values <0.001). As shown in Fig. 2, the lateral approach combined with a single IV dose of TXA was the most effective in preserving hemoglobin levels (WMD = 1.081, 95 % CI: 0.620–1.541), followed by the PLA (WMD = 1.001, 95 % CI: 0.744–1.257), PA (WMD = 0.900, 95 % CI: 0.509–1.291), and DAA (WMD = 0.830, 95 % CI: 0.414–1.246). A sensitivity analysis using a random-effects model confirmed the robustness of these results, showing no individual study had a substantial impact on the overall weighted mean difference (WMD) (Fig. 3).

Hemoglobin changes.
Fig. 2 Hemoglobin changes.
Sensitivity Analysis regarding hemoglobin changes as the primary outcome.
Fig. 3 Sensitivity Analysis regarding hemoglobin changes as the primary outcome.
3.5

3.5 Meta-analysis for intraoperative blood loss

Eleven studies reported the IOBL and involved 782 patients, with 389 (49.7 %) in the TXA group and 393 (50.3 %) in the placebo group.35–39,41–43,45–47 Of the TXA patients, 84 (21.6 %) received 10 mg/kg,35,42,43 243 (62.5 %) received 15 mg/kg,37–39,41,46,47 and 62 (15.9 %) received 1000 mg of TXA.36,45 The meta-analysis (Fig. 4) revealed a statistically significant less IOBL in the TXA group compared to the placebo group (WMD = −30.082, 95 % CI: [−41.400 to −18.765], P-value <0.001). When analyzed by surgical approach, the PLA was associated with the most significant reduction in IOBL (WMD = −70.578, 95 % CI: [−130.389 to −10.766], P-value = 0.001), followed by the LA (WMD = −55.157, 95 % CI: [−87.659 to −22.656], P-value = 0.001).

Meta-analysis of the intraoperative blood loss.
Fig. 4 Meta-analysis of the intraoperative blood loss.
3.6

3.6 Meta-analysis for operation duration

Nine of the 14 studies reported the duration of THA operations.34,37–39,41–43,45,47 The operation duration was comparable between the TXA and placebo groups (WMD = −1.652, 95 % CI: 3.765 to 0.461, P-value = 0.125). In five studies, the TXA group's operation lasted longer, but none of these findings were statistically significant (P-values >0.05). Two studies used the PA,34,41 one used the PLA,42 and two used the lateral approach.37,38 Four studies, which employed PA,43 PLA,39,45 and the DDA,47 showed contrary findings, with only Zhao et al.47 reported a statistically significant shorter operation time for the TXA group than the control group in a DAA approach (WMD = −4.200, 95 % CI: 7.612 to −0.788, P-value = 0.016) (see Fig. 5).

Meta-analysis of the Operation duration.
Fig. 5 Meta-analysis of the Operation duration.
3.7

3.7 Meta-analysis for total

The pooled analysis of total blood loss (TBL) revealed that the blood loss in the TXA group was significantly lower than that of the control group (WMD = −306.666, 95 % CI: [−350.381 to −262.951], P-value <0.0001). As shown in Fig. 6, the posterior approach resulted in the least amount of TBL (WMD = −392, 95 % CI: [−474.439 to −310.231], P-value <0.0001), followed by the posterolateral approach (WMD = −280, 95 % CI: [−355.573 to −205.806], P-value <0.0001), and the lateral approach (WMD = −303, 95 % CI: [−458.634 to −149.141], P-value <0.0001).

Meta-analysis of the total blood loss.
Fig. 6 Meta-analysis of the total blood loss.
3.8

3.8 Meta-analysis for transfused blood products

Fig. 7 presents a meta-analysis of allogeneic blood transfusions. TXA significantly reduced the incidence of allogenic blood transfusions compared to a placebo (OR = 0.295, 95 % CI: 0.203–0.428, P-value <0.001). Regarding the surgical approach, the posterolateral approach (OR = 0.342, 95 % CI: 0.216–0.541, P-value <0.001) and posterior approach (OR = 0.244, 95 % CI: 0.090–0.665, P-value = 0.006) exhibited higher odds ratios compared to the lateral approach (OR = 0.210, 95 % CI: 0.082–0.539, P-value = 0.001).

Patients receiving allogenic blood transfusion.
Fig. 7 Patients receiving allogenic blood transfusion.
4

4 Discussion

Our findings revealed that patients who underwent the PLA experienced the least IOBL. At the same time, those with the LA exhibited the smallest Hb drop and the lowest need for blood transfusions. Additionally, the PA resulted in the lowest TBL. Moreover, our results corroborate previous studies demonstrating the beneficial impact of TXA in reducing blood loss in patients undergoing THA.

The effectiveness of TXA in THA has been well studied in the past, emphasizing the drug's optimal dosage, mode of administration, etc.48 Melo et al.21 conducted a prospective trial to examine if intravenous tranexamic acid could lower blood hemoglobin levels and postoperative bleeding rates following THA. A total of 42 patients were divided into three groups: Group 1 received 15 mg/kg of TXA intravenously before the incision; Group 2 received the same initial dose as Group 1, plus an additional 10 mg/kg intravenously via an infusion pump during surgery; Group 3 served as the control group. Various factors, such as pre- and postoperative hemoglobin levels and the volume of blood drained through the Portovac drain on the first postoperative day, were monitored to measure blood loss.49 The results demonstrated a marked decrease in the drainage amount and the postoperative Hb drop without increasing thromboembolic events.21 In another study by Nikose et al., adult patients were randomly divided into three experimental groups, each receiving one, two, or three doses of TXA at different intervals alongside a control group. Blood transfusion rates and hematocrit levels were used to estimate total blood loss. The results demonstrated that the experimental groups had significantly lower perioperative blood loss than the control group, with TXA administration leading to a more significant reduction in serum hemoglobin levels.23

Numerous studies have explored the advantages and disadvantages of different surgical approaches, particularly comparing anterior approaches, such as the direct anterior approach (DAA) and anterolateral approach (ALA), with posterior approaches. However, we excluded several DAA studies based on the inclusion/exclusion criteria. Wang et al., in a meta-analysis, compared DAA and PA, finding that the DAA group experienced less blood loss.50 Similarly, Aggarwal et al. found that patients undergoing ALA had the lowest estimated blood loss.11 Petis et al. reported that patients undergoing THA with the direct lateral approach (DLA), compared to DAA, had higher perioperative blood loss and a greater need for blood transfusions.51

While some studies reported no differences in hemoglobin decline, blood loss, or transfusion rates, Yang et al. found no significant differences in intraoperative blood loss between PLA and DAA in their systematic review and meta-analysis.52 Restrepo et al. compared the amount of transfusion and blood loss in patients undergoing THA using DAA and LA and found similar results.15 Additionally, Rykov et al. found only a minor, statistically insignificant difference in blood loss between DAA and PLA.53

4.1

4.1 Clinical application

Blood transfusions have long been a cornerstone in managing surgical blood loss and perioperative anemia. However, patients with acute or chronic anemia are at an increased risk of morbidity and mortality, and conventional treatments have not significantly improved outcomes.54,55 Blood transfusion-related complications contribute to extended hospital stays and higher healthcare costs.56–59 To address these challenges, multimodal perioperative patient blood management strategies have been developed. These strategies effectively manage anemia and blood transfusion, which are critical predictors of poor outcomes.60 Consequently, it is imperative to implement measures to prevent excessive perioperative blood loss. The surgical approach is another factor affecting perioperative blood management, which interacts with other contributing elements such as preoperative evaluation, hemoglobin optimization, management of bleeding risk factors, and blood conservation techniques.48

4.2

4.2 Limitations

The study's limitations include insufficient studies and significant heterogeneity in variables, making it challenging to compare surgical approaches and identify the most effective plane for reducing bleeding. However, the findings can aid surgeons' decision-making when choosing between PLA, PA, or LA for a THA surgical approach. Researchers should consider factors like anesthesia type, surgeon assistants, procedure length, surgical approach, body temperature, positioning, and ventilation to ensure accurate future meta-analyses.55

5

5 Conclusion

In conclusion, this study demonstrates the efficacy of TXA in maintaining hemostasis following THA, with the surgical approach playing a pivotal role in patient outcomes. The PLA was associated with the least intraoperative blood loss, while the LA showed the greatest preservation of hemoglobin levels and the lowest blood transfusions. The PA resulted in the least total blood loss. Our results emphasize the significance of tailoring the surgical approach and TXA administration to optimize blood management strategies during THA. Despite the promising results, heterogeneity among the included studies and the limited number of trials warrants further investigation to refine recommendations for clinical practice. Future high-quality trials should focus on standardized protocols for TXA administration and surgical techniques to enhance the comparability of outcomes and provide clearer guidance for perioperative blood management in THA.

CRediT authorship contribution statement

Roya Khorram: Conceptualization, Resources, Writing – review & editing, Supervision, and. Roham Borazjani: All authors had full access to the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis. Armin Khavandegar: Methodology, Writing – original draft. Morteza Behjat: Methodology, Formal analysis. Elham Rahmanipour: Investigation, Writing – review & editing, Supervision. Reza Vafadar: Formal analysis, Writing – original draft. Mohebat Vali: Conceptualization, Writing – review & editing, Visualization. Ali Parsa: Investigation, Writing – original draft. Mohammad Ghorbani: Methodology, Writing – original draft, Formal analysis.

Conflict of interest

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethical approval

The present study is a systematic review and did not involve any direct interaction with human subjects or animal experimentation. Therefore, ethical approval was not required.

Data Availability

All data analyzed and synthesized in this study are sourced from previously published original studies. The references for these studies are provided in the reference section of the article, and readers can access the original publications for detailed data.

Compliance with ethical standards author-disclosure

This article complies with all relevant ethical standards and guidelines for scientific research. The study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and followed transparent and rigorous methods in data extraction, analysis, and reporting.

Informed consent informed-consent

Informed consent was not applicable for this study as it did not involve direct interaction with human subjects.

Authorship declaration author-disclosure

All authors listed meet the authorship criteria according to the latest guidelines of the International Committee of Medical Journal Editors.

Guardian/patient's consent informed-consent

Not applicable.

Ethical approval author-disclosure

The present study is a systematic review and did not involve any direct interaction with human subjects or animal experimentation. Therefore, ethical approval was not required.

Funding

No funding was received for this research.

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