1.Decompression mechanism of symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous
Chunlin ZHANG ; Zhaohua HOU ; Xu YAN ; Yan JIANG ; Su FU ; Yongming NING ; Dongzhe LI ; Chao DONG ; Xiaokang LIU ; Yongkui WANG ; Zhengming CAO ; Tengyue YANG
Chinese Journal of Tissue Engineering Research 2025;29(9):1810-1819
BACKGROUND:Traditional surgery for lumbar disc herniation involves extensive excision of tissue surrounding the nerve for decompression and removal of protruding lumbar intervertebral discs,which poses various risks and complications such as nerve damage causing paralysis,lumbar instability,herniation recurrence,intervertebral space infection,and adjacent vertebral diseases. OBJECTIVE:To propose the symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous technique for lumbar spine symmetrically decompression,showing the induced resorption of herniated nucleus pulpous phenomenon and early clinical efficacy,and then analyze its decompression mechanism. METHODS:214 patients with lumbar disc herniation at Department of Orthopedics,First Affiliated Hospital of Zhengzhou University from March 2021 to May 2023 were enrolled in this study.Among them,81 patients received conservative treatment as the control group,and 133 patients received symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous treatment as the trial group.Before surgery,immediately after surgery(7-14 days),and early after surgery(over 1 year),MRI images were used to measure the volume changes of lumbar disc herniation.CT images were used to measure the posterior displacement distance of the lumbar spinous process ligament complex,as well as the width and height of the lateral recess.Japanese Orthopaedic Association scores were used to evaluate the patient's neurological function recovery. RESULTS AND CONCLUSION:(1)Control group:81 patients with lumbar disc herniation were treated conservatively,with a total of 171 herniated lumbar discs.The average follow-up time was(22.7±23.1)months.The first and second MRI measurements of 171 herniated lumbar discs showed herniated lumbar disc volumes of(551.6±257.9)mm3 and(792.2±330.4)mm3,respectively,with an average volume increase rate of(53.2±44.4)%,showing statistically significant differences(P<0.001).Out of 171 herniated lumbar discs,4 experienced natural shrinkage,with an absorption ratio of 2.3%(4/171)and an absorption rate of(24.5±9.9)%.(2)Trial group:133 patients with lumbar disc herniation had a total of 285 herniated lumbar discs.(1)Immediately after surgery:All patients were followed up immediately after surgery.229 out of 285 herniated lumbar discs experienced retraction,with an absorption ratio of 80.3%(229/285)and an average absorption rate of(21.5±20.9)%,with significant and complete absorption accounting for 6.5%.There were a total of 70 herniated lumbar discs in the upper lumbar spine,with an absorption ratio of 85.7%(60/70),an average absorption rate of(23.1±19.5)%,and a maximum absorption rate of 86.6%.There were 215 herniated lumbar discs in the lower lumbar spine,with an absorption ratio of 78.6%(169/215),an average absorption rate of(21.0±21.3)%,and a maximum absorption rate of 83.2%.Significant and complete absorption of the upper and lower lumbar vertebrae accounted for 5.7%and 6.5%,respectively,with no statistically significant difference(P>0.05).The average distance of posterior displacement of the spinous process ligament complex immediately after surgery was(5.2±2.8)mm.There were no significant differences in the width and height of the left and right lateral recess before and immediately after surgery(P>0.05).The Japanese Orthopaedic Association score immediately after surgery increased from(10.1±3.4)before surgery to(17.0±4.8),and the immediate effective rate after surgery reached 95.6%.(2)Early postoperative period:Among them,46 patients completed the early postoperative follow-up.There were 101 herniated lumbar discs,with an absorption ratio of 94%(95/101)and an average absorption rate of(36.9±23.7)%.Significant and complete absorption accounted for 30.6%,with a maximum absorption rate of 100%.Out of 101 herniated lumbar discs,3 remained unchanged in volume,with a volume invariance rate of 2.97%(3/101).Out of 101 herniated lumbar discs,3 had an increased volume of herniated lumbar discs,with an increase ratio of 2.97%(3/101)and an increase rate of(18.5±18.4)%.The Japanese Orthopaedic Association score increased from preoperative(9.3±5.1)to(23.5±4.0),with an excellent and good rate of 93.4%.(3)The early postoperative lumbar disc herniation absorption ratios of the control group and trial group were 2.3%and 85.9%,respectively,with statistically significant differences(P<0.001).(4)Complications:There were two cases of incision exudation and delayed healing in the trial group.After conservative treatment such as dressing change,no nerve injury or death occurred in the incision healing,and no cases underwent a second surgery.(5)It is concluded that symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous is a new method for treating lumbar disc herniation that can avoid extensive excision of the"ring"nerve and achieve satisfactory early clinical efficacy.It does not damage the lumbar facet joints or alter the basic anatomical structure of the lateral recess,fully preserves the herniated lumbar discs,and can induce significant or even complete induced resorption of herniated nucleus pulpous.Symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous provides a new basis and method for the clinical treatment of lumbar disc herniation.
2.Clinical observation of lamellar keratectomy and corneal collagen crosslinking in the treatment of superficial fungal keratitis
Limei LIU ; Xinhong HAN ; Chunxiu MING ; Pengfei ZHANG ; Chao WANG
International Eye Science 2025;25(5):802-807
AIM:To evaluate the clinical efficacy of lamellar keratectomy and corneal collagen crosslinking(LKCCC)in treating superficial fungal keratitis.METHODS: Retrospective analysis. Totally 79 patients(79 eyes)with superficial fungal keratitis who underwent LKCCC in our hospital from January 2014 to October 2023 were included. After admission, routine antifungal drug treatment for 7 d showed no obvious improvement or progressive aggravation. The maximum diameter of corneal lesions in all patients was ≤7 mm, the maximum depth was no more than 50% of the corneal thickness at the location, and the remaining healthy corneal thickness was ≥300 μm. The follow-up time was 90 to 112 d.RESULTS:Among the included 79 eyes, the lesions were located in the central region of the cornea in 6 eyes, in the paracentral region in 61 eyes, and in the peripheral region in 12 eyes. Hypopyon was observed in 5 cases. LKCCC was successfully administered in 79 eyes, cured in 76 eyes(96%), and failed in 3 eyes(4%). The healing time of corneal epithelium in 76 cured eyes was 3-15 d, of which 51 eyes(67%)healed within 7 d and 24 eyes(32%)healed within 3 d. The uncorrected visual acuity(UCVA)and best corrected visual acuity(BCVA)of 76 eyes of cured patients were statistically significant compared with those preoperatively(P<0.0167). Two of the 3 failed eyes were located at the edge of the lesion and recovered after re-keratectomy. One eye was located in the center of the lesion and recovered after being covered by bulbar conjunctival flap. At the last follow-up, no other complications were observed in all patients except superficial cloud and thinning of cornea.CONCLUSION:LKCCC is a rapid and effective treatment for superficial fungal keratitis and can be considered a new treatment option.
3.Accuracy of multivariate discriminant analysis versus fibrosis-4 in evaluating the liver fibrosis degree in patients with chronic HBV infection
Hongyu LIU ; Xiaoting LI ; Jianning JIANG ; Chao JIN ; Cailian CAI ; Keshan WANG ; Fangpeng LING ; Bingling FAN ; Minghua SU
Journal of Clinical Hepatology 2025;41(4):677-683
ObjectiveTo investigate the accuracy of multiple discriminant analysis (MDA) versus fibrosis-4 (FIB-4) in assessing liver fibrosis degree in patients with HBV infection, as well as the possibility of MDA as an indicator for disease progression. MethodsA total of 263 patients with HBV infection who underwent liver biopsy in The First Affiliated Hospital of Guangxi Medical University from April 2010 to April 2024 were included, and their clinical data were collected. According to the results of pathological examination, they were divided into non-significant fibrosis group (F<2) with 126 patients and significant fibrosis group (F≥2) with 137 patients. The correlation of MDA and FIB-4 with liver fibrosis degree was analyzed, and MDA and FIB-4 were compared in terms of their accuracy in assessing significant liver fibrosis. A total of 62 patients completed follow-up, and according to the presence or absence of progression to liver cirrhosis at the last follow-up visit, they were divided into progressive group with 21 patients and non-progressive group with 41 patients; the efficacy of MDA and FIB-4 in diagnosing disease progression was analyzed and compared. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the Kruskal-Wallis H test was used for comparison between multiple groups, and the Bonferroni method was used for further comparison between two groups. The chi-square test was used for comparison of categorical data. The Spearman’s correlation coefficient was used for correlation analysis. The Wilcoxon signed rank sum test was used for the analysis of baseline data and data at the end of follow-up, and the binary Logistic regression analysis was used to investigate the influencing factors for progression to liver cirrhosis. The receiver operating characteristic (ROC) curve was used to investigate the diagnostic efficacy of indicators, the Z-test was used for comparison of the area under the ROC curve (AUC), and the paired chi-square test was used for comparison of the sensitivity, specificity, and accuracy of the two indicators. ResultsThe correlation coefficient between FIB-4 and liver fibrosis degree was 0.378, while the correlation coefficient between MDA and liver fibrosis degree was -0.325 (both P<0.001). FIB-4 had an AUC of 0.688, a sensitivity of 64.96%, a specificity of 68.87%, a positive predictive value of 67.42%, a negative predictive value of 63.36%, an accuracy of 65.40%, and a cut-off value of 1.01, while MDA had an AUC of 0.653, a sensitivity of 52.55%, a specificity of 78.57%, a positive predictive value of 72.73%, a negative predictive value of 60.37%, an accuracy of 65.02%, and a cut-off value of 0.29, suggesting that compared with FIB-4, MDA had a lower sensitivity (P=0.004) and a higher specificity (P=0.001). The progressive group had a significantly higher age than the non-progressive group at baseline (t=2.611, P=0.011). For the progressive group, there was an increase in FIB-4 and a reduction in MDA from baseline to the end of follow-up (both P<0.001), while the non-progressive group showed no significant changes (both P>0.05). The multivariate Logistic regression analysis showed that aspartate aminotransferase (odds ratio [OR]=0.940, 95% confidence interval [CI]: 0.885 — 0.998, P<0.05) and MDA (OR=0.445, 95%CI: 0.279 — 0.710, P<0.001) were independent influencing factors for disease progression. MDA had an AUC of 0.893 and an optimal cut-off value of -0.01 in diagnosing the disease progression of liver cirrhosis. ConclusionMDA has a comparable accuracy to FIB-4 in the diagnosis of significant liver fibrosis, and MDA<-0.01 has a high accuracy in diagnosing the progression of liver fibrosis to liver cirrhosis, which can help to reduce the need for liver biopsy in clinical practice.
4.Effect of optimized intense pulsed light on meibomian gland morphology and function in patients with meibomian gland dysfunction
Yifan ZHOU ; Pengfei ZHANG ; Lifeng LIU ; Xinhong HAN ; Chao WANG ; Limei LIU
International Eye Science 2025;25(6):968-974
AIM: To assess the impact of optimized pulsed technology(OPT)on the morphological and functional changes of meibomian glands in patients with meibomian gland dysfunction(MGD).METHODS: This prospective case-control study enrolled 60 MGD patients(60 right eyes)treated at Weifang Eye Hospital from September 2023 to February 2024. Patients were categorized into mild, moderate, and severe groups based on the extent of meibomian gland loss, with 20 cases(20 eyes)per group. Treatments consisted of bilateral OPT combined with meibomian gland massages, administered biweekly over four sessions. Ocular surface function indicators including the ocular surface disease index(OSDI), corneal fluorescein staining(CFS), non-invasive average tear break-up time(NIBUTav), and non-invasive tear meniscus height(NITMH), as well as meibomian gland function parameters such as meibomian gland expressibility score(MGES)and meibomian gland secretion score(MGYSS)were observed and recorded before treatment and at 3 mo after final treatment. Cellular-level assessments using in vivo confocal microscopy(IVCM)examined meibomian gland acinar unit density(MGAUD), inflammatory cell density(ICD), meibomian gland acinar longest diameter(MGALD)and meibomian gland acinar shortest diameter(MGASD).RESULTS: At baseline, no significant differences were found in NITMH across groups(P>0.05). Statistical significance were observed in NIBUTav, MGES, MGYSS, MGAUD, MGALD, and MGASD(all P<0.05). Compared to the mild group, the moderate and severe groups showed significant differences in OSDI, CFS, and ICD(all P<0.05), though no significant differences existed between moderate and severe groups(all P>0.05). At 3 mo after treatment, all groups showed no significant differences in NITMH(all P>0.05). All parameters improved significantly in the mild group(all P<0.05); all indicators improved in the moderate group(P>0.05), except for MGASD before and after treatment(all P<0.05); significant improvements were noted in OSDI, CFS, and NIBUTav in the severe group(all P<0.05), while MGES and MGYSS did not differ significantly(all P>0.05). IVCM parameters(MGAUD, ICD, MGALD, and MGASD)showed no significant change in the severe group(all P>0.05).CONCLUSION:OPT effectively enhances various ocular surface functions and improves gland expressibility and secretion quality in mild to moderate MGD cases, while also positively impacting certain cellular parameters. In severe cases, where most acinar functions are lost and structural reversibility is limited, OPT can still mitigate MGD symptoms and decelerate disease progression.
5.Pharmacokinetic Differences of Seven Components in Different Phases of Banxia Xiexintang in Rats
Chao HE ; Siyi LIU ; Mingyun WANG ; Qi WANG ; Jingwen ZHOU ; Tong ZHANG ; Yiqiong PU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):215-222
ObjectiveTo evaluate the effects of phases on the pharmacokinetic behavior of seven components from Banxia Xiexintang(BXT) in normal rats by investigating and comparing their pharmacokinetic profiles in different phase samples. MethodsThe phase separation of BXT was carried out by centrifugation-dialysis method, and three phase samples were obtained, including the precipitated phase(PP), colloidal phase(CP) and true solution phase(TP). A total of 24 male SD rats were randomly divided into BXT, PP, CP and TP groups(n=6). The BXT group was gavaged at a dose of 24.1 g·kg-1(calculated by the dosage of raw materials). After proper treatments, PP, CP and TP groups were administrated at the same dose as that of BXT group, respectively. Blood was collected from each group at set time points after gavage of BXT and the phase samples. The contents of 7 components(baicalin, wogonoside, wogonin, berberine, palmatine, ammonium glycyrrhizinate and isoliquiritin) in rat plasma were determined by ultra-high performance liquid chromatography-triple quadrupole tandem mass spectrometry(UPLC-QqQ-MS/MS), and the pharmacokinetic parameters of each component were analyzed by DAS 2.0. ResultsThe peak concentration of baicalin was the highest among the blood-entered components in each group, followed by wogonoside. The results of the concentration-time curves and pharmacokinetic parameters of the 7 components showed that the area under the concentration-time curve(AUC) of isoliquiritin in the BXT group was the highest, followed by that in the CP group. AUC values of baicalin, wogonoside, wogonin and ammonium glycyrrhizinate in the BXT group were similar to those of the CP group, and AUC of palmatine in the BXT group was similar to that of the PP group. The elimination half-life(t1/2) values of baicalin and wogonoside in the BXT group was the longest, the t1/2 values of ammonium glycyrrhizinate and berberine were similar to those of the CP group, and the t1/2 of palmatine was similar to that of the PP group. The t1/2 of wogonin was the longest in the PP group, and the t1/2 of isoliquiritin was the longest in the TP group was the longest, which was similar to that in the PP group. Except for isoliquiritin, the other 6 components showed double peaks in the concentration-time curve of the PP group, indicating that the above components might be reabsorbed through the enterohepatic circulation in vivo, which resulted in the maintenance of high plasma concentrations for a long time, and consequently exhibited sustained-release properties. ConclusionThe pharmacokinetic characteristics of the components in different phases were different, and the CP phase may be the effective phase from the perspective of the pharmacological action of BXT. Compared with the BXT group, the in vivo action times of some components in the CP and PP groups were prolonged. The study explores the phase differences of traditional Chinese medicine(TCM) compound decoction in the aspect of pharmacokinetics, and verifies that the phase states from TCM compound decoction will affect the pharmacokinetic behaviors of the active components, which may consequently lead to the difference in in vivo effects.
6.Pharmacokinetic Differences of Seven Components in Different Phases of Banxia Xiexintang in Rats
Chao HE ; Siyi LIU ; Mingyun WANG ; Qi WANG ; Jingwen ZHOU ; Tong ZHANG ; Yiqiong PU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):215-222
ObjectiveTo evaluate the effects of phases on the pharmacokinetic behavior of seven components from Banxia Xiexintang(BXT) in normal rats by investigating and comparing their pharmacokinetic profiles in different phase samples. MethodsThe phase separation of BXT was carried out by centrifugation-dialysis method, and three phase samples were obtained, including the precipitated phase(PP), colloidal phase(CP) and true solution phase(TP). A total of 24 male SD rats were randomly divided into BXT, PP, CP and TP groups(n=6). The BXT group was gavaged at a dose of 24.1 g·kg-1(calculated by the dosage of raw materials). After proper treatments, PP, CP and TP groups were administrated at the same dose as that of BXT group, respectively. Blood was collected from each group at set time points after gavage of BXT and the phase samples. The contents of 7 components(baicalin, wogonoside, wogonin, berberine, palmatine, ammonium glycyrrhizinate and isoliquiritin) in rat plasma were determined by ultra-high performance liquid chromatography-triple quadrupole tandem mass spectrometry(UPLC-QqQ-MS/MS), and the pharmacokinetic parameters of each component were analyzed by DAS 2.0. ResultsThe peak concentration of baicalin was the highest among the blood-entered components in each group, followed by wogonoside. The results of the concentration-time curves and pharmacokinetic parameters of the 7 components showed that the area under the concentration-time curve(AUC) of isoliquiritin in the BXT group was the highest, followed by that in the CP group. AUC values of baicalin, wogonoside, wogonin and ammonium glycyrrhizinate in the BXT group were similar to those of the CP group, and AUC of palmatine in the BXT group was similar to that of the PP group. The elimination half-life(t1/2) values of baicalin and wogonoside in the BXT group was the longest, the t1/2 values of ammonium glycyrrhizinate and berberine were similar to those of the CP group, and the t1/2 of palmatine was similar to that of the PP group. The t1/2 of wogonin was the longest in the PP group, and the t1/2 of isoliquiritin was the longest in the TP group was the longest, which was similar to that in the PP group. Except for isoliquiritin, the other 6 components showed double peaks in the concentration-time curve of the PP group, indicating that the above components might be reabsorbed through the enterohepatic circulation in vivo, which resulted in the maintenance of high plasma concentrations for a long time, and consequently exhibited sustained-release properties. ConclusionThe pharmacokinetic characteristics of the components in different phases were different, and the CP phase may be the effective phase from the perspective of the pharmacological action of BXT. Compared with the BXT group, the in vivo action times of some components in the CP and PP groups were prolonged. The study explores the phase differences of traditional Chinese medicine(TCM) compound decoction in the aspect of pharmacokinetics, and verifies that the phase states from TCM compound decoction will affect the pharmacokinetic behaviors of the active components, which may consequently lead to the difference in in vivo effects.
7.Development of Electrospinning Setup for Vascular Tissue-Engineering Application with Thick-Hierarchical Fiber Alignment
Shen CHEN ; Chao XIE ; Xiaoxi LONG ; Xianwei WANG ; Xudong LI ; Peng LIU ; Jiabin LIU ; Zuyong WANG
Tissue Engineering and Regenerative Medicine 2025;22(2):195-210
BACKGROUND:
Tissue engineering holds promise for vascular repair and regeneration by mimicking the extracellular matrix of blood vessels. However, achieving a functional and thick vascular wall with aligned fiber architecture by electrospinning remains a significant challenge.
METHODS:
A novel electrospinning setup was developed that utilizes an auxiliary electrode and a spring. The impact of process parameters on fiber size and morphology was investigated. The structure and functions of the scaffolds were evaluated through material characterization and assessments of cellular biocompatibility.
RESULTS:
The new setup enabled controlled deposition of fibers in different designed orientations. The fabricated small-diameter vascular scaffolds consisted of an inner layer of longitudinally oriented fibers and an outer layer of circumferentially oriented fibers (L + C vascular scaffold). Key parameters, including rotational speed, the utilization of the auxiliary electrode, and top-to-collector distance (TCD) significantly influenced fiber orientation. Additionally, voltage, TCD, feed rate, needle size, auxiliary electrode and collector-auxiliary electrode distance affected fiber diameter and distribution. Mechanical advantages and improved surface wettability of L + C vascular scaffold were confirmed through tensile testing and water contact angle. Cellular experiments indicated that L + C vascular scaffold facilitated cell adhesion and proliferation, with human umbilical vein endothelial cells and smooth muscle cells attaching and elongating along the fiber direction of the inner and outer layer, respectively.
CONCLUSION
This study demonstrated the feasibility of fabricating fiber-aligned, thick-walled vascular scaffolds using a modified electrospinning setup. The findings provided insights into how the auxiliary electrode, specific collector influenced fiber deposition, potentially advancing biomimetic vascular scaffold engineering.
8.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
Background:
and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking.
Methods:
This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance.
Results:
Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal.
Conclusions
The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy.
9.Impact of Onset-to-Door Time on Endovascular Therapy for Basilar Artery Occlusion
Tianlong LIU ; Chunrong TAO ; Zhongjun CHEN ; Lihua XU ; Yuyou ZHU ; Rui LI ; Jun SUN ; Li WANG ; Chao ZHANG ; Jianlong SONG ; Xiaozhong JING ; Adnan I. QURESHI ; Mohamad ABDALKADER ; Thanh N. NGUYEN ; Raul G. NOGUEIRA ; Jeffrey L. SAVER ; Wei HU
Journal of Stroke 2025;27(1):140-143
10.Efficacy and Safety of Automated Insulin Delivery Systems in Patients with Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis
Wenqi FAN ; Chao DENG ; Ruoyao XU ; Zhenqi LIU ; Richard David LESLIE ; Zhiguang ZHOU ; Xia LI
Diabetes & Metabolism Journal 2025;49(2):235-251
Background:
Automated insulin delivery (AID) systems studies are upsurging, half of which were published in the last 5 years. We aimed to evaluate the efficacy and safety of AID systems in patients with type 1 diabetes mellitus (T1DM).
Methods:
We searched PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov until August 31, 2023. Randomized clinical trials that compared AID systems with other insulin-based treatments in patients with T1DM were considered eligible. Studies characteristics and glycemic metrics was extracted by three researchers independently.
Results:
Sixty-five trials (3,623 patients) were included. The percentage of time in range (TIR) was 11.74% (95% confidence interval [CI], 9.37 to 14.12; P<0.001) higher with AID systems compared with control treatments. Patients on AID systems had more pronounced improvement of time below range when diabetes duration was more than 20 years (–1.80% vs. –0.86%, P=0.031) and baseline glycosylated hemoglobin lower than 7.5% (–1.93% vs. –0.87%, P=0.033). Dual-hormone full closed-loop systems revealed a greater improvement in TIR compared with hybrid closed-loop systems (–19.64% vs. –10.87%). Notably, glycemia risk index (GRI) (–3.74; 95% CI, –6.34 to –1.14; P<0.01) was also improved with AID therapy.
Conclusion
AID systems showed significant advantages compared to other insulin-based treatments in improving glucose control represented by TIR and GRI in patients with T1DM, with more favorable effect in euglycemia by dual-hormone full closedloop systems as well as less hypoglycemia for patients who are within target for glycemic control and have longer diabetes duration.

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