1.Clinical trial of sodium hyaluronate combined with recombinant human epidermal growth factor in the treatment of patients with dry eye after cataract operation
Jing-Sen QIU ; Xin-Hua WANG ; Wen-Chao DONG ; Wan-Li DIAO ; Xue-Jun XU
The Chinese Journal of Clinical Pharmacology 2024;40(18):2621-2625
Objective To evaluate the effect of sodium hyaluronate combined with recombinant human epidermal growth factor(rhEGF)in the treatment of dry eye after cataract surgery.Methods Patients with dry eye after cataract surgery were divided into treatment group and control group.The control group was treated with sodium hyaluronate eye drops via dropping into the conjunctival sac,a drop per dose,tid,for 4 weeks.On this basis,the treatment group was treated with rhEGF eye drops via dropping into the conjunctival sac,1-2 drops per dose,tid,for 4 weeks.The two groups were compared on overall clinical efficacy,dry eye symptoms before treatment and after 4 weeks of treatment.Tear-film breakup time(BUT),basic tear secretion test(schirmer Ⅰ test,SⅠT),corneal fluorescein staining(CFS)score,meibomian gland yield secretion score(MGYSS),and the levels of tear inflammatory factors were compared between two groups before treatment and after 4 weeks of treatment.The safety was evaluated.Results Finally,41 cases and 39 cases were included in the treatment group and the control group,respectively.After treatment,the total effective rates in the treatment group and the control group were 95.12%and 79.49%,with statistically significant difference(P<0.05).After 4 weeks of treatment,dry eye symptom scores of the treatment group and control group were 1.42±0.18 and 2.31±0.26;BUT were(11.89±1.26)and(10.46±1.27)s;SⅠT were(10.12±1.35)and(8.45±0.87)mm;CFS scores were 0.83±0.11 and 1.94±0.25;MGYSS scores were 10.85±1.17 and 12.43±1.56;interleukin-1β levels in tears were(35.26±3.53)and(74.12±7.55)ng·L-1;interleukin-6 levels were(8.35±0.86)and(12.41±12.56)pg·mL-1.Compared with the control group,the above indexes in the treatment group were statistically significant(all P<0.05).The incidence rates of adverse drug reactions in the treatment group and the control group were 12.20%and 10.26%,without statistically significant difference between the groups(P>0.05).Conclusion Sodium hyaluronate combined with rhEGF can significantly improve dry eye symptoms after cataract surgery,enhance the stability of tear film,reduce tear inflammatory factors,and protect the integrity of meibomian gland.
2.Current Status and Prospects of Radiation Therapy Guided by Optical Surface Monitoring Technology
Jing SHEN ; Wanqi CHEN ; Xiaorong HOU ; Jie QIU
Medical Journal of Peking Union Medical College Hospital 2024;15(1):135-140
Surface guided radiation therapy (SGRT) is a non-radiation, non-invasive technology that provides continuous postural monitoring of patients during radiotherapy. Using advanced 3D optical surface localization and tracking technology, SGRT quickly captures the surface contour information of patients through optical means to generate high-precision 3D surface contours, enabling real-time monitoring of patients during radiotherapy to ensure its accuracy. This image-guided technology has been widely applied in radiotherapy for tumors in different parts of the body, such as breast, intracranial, head and neck, and limbs. SGRT can reduce initial setup errors and provide real-time monitoring during treatment, or be combined with respiratory gating and deep inspiration breath-hold techniques. SGRT can also reduce radiation dose by reducing the use of CBCT, improve patient comfort with the use of immobilization devices, and enhance clinical speed, efficiency, and safety. This review aims to provide an overview of the commonly used technology and clinical applications of SGRT, and discuss its current limitations and future prospects.
3.A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer
Zhi-yao YOU ; Miao-fang WU ; Hui LI ; Yan-fang YE ; Li-juan WANG ; Zhong-qiu LIN ; Jing LI
Journal of Gynecologic Oncology 2024;35(1):e1-
Objective:
To identify the maximum tolerated dose (MTD) of docetaxel combined with a fixed dose of cisplatin (75 mg/m 2 ) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer.
Methods:
In this phase I trial, a time-to-event Bayesian optimal interval design was used.Docetaxel was given at a starting dose of 60 mg/m2 and was increased in 5 mg/m2 increments until the MTD was determined or the maximum dose level of 75 mg/m2 was reached. The doselimiting toxicity (DLT) rate was set at 25%, with a total sample size of 30 patients. HIPEC was delivered immediately following debulking surgery at a target temperature of 43°C for 90 minutes.
Results:
From August 2022 to November 2022, 30 patients were enrolled. Among the patients who received a dose of docetaxel ≤65 mg/m2 , no DLT was reported. DLTs were observed in one patient who received 70 mg/m2 docetaxel (grade 3 anaemia) and in three patients who received 75 mg/m2 docetaxel (one case of grade 3 anaemia, one case of grade 3 hepatic impairment and one case of grade 4 thrombocytopenia). Patients treated with docetaxel 75 mg/m2 in combination with cisplatin 75 mg/m2 had an estimated DLT rate of 25%, which was the closest to the target DLT rate and was therefore chosen as the MTD.
Conclusion
Docetaxel, in combination with a fixed dose of cisplatin (75 mg/m2), can be used safely at intraperitoneal doses of 75 mg/m2 in ovarian cancer patients who received HIPEC (43°C, 90 minutes) following debulking surgery.
4.A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer
Zhi-yao YOU ; Miao-fang WU ; Hui LI ; Yan-fang YE ; Li-juan WANG ; Zhong-qiu LIN ; Jing LI
Journal of Gynecologic Oncology 2024;35(1):e1-
Objective:
To identify the maximum tolerated dose (MTD) of docetaxel combined with a fixed dose of cisplatin (75 mg/m 2 ) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer.
Methods:
In this phase I trial, a time-to-event Bayesian optimal interval design was used.Docetaxel was given at a starting dose of 60 mg/m2 and was increased in 5 mg/m2 increments until the MTD was determined or the maximum dose level of 75 mg/m2 was reached. The doselimiting toxicity (DLT) rate was set at 25%, with a total sample size of 30 patients. HIPEC was delivered immediately following debulking surgery at a target temperature of 43°C for 90 minutes.
Results:
From August 2022 to November 2022, 30 patients were enrolled. Among the patients who received a dose of docetaxel ≤65 mg/m2 , no DLT was reported. DLTs were observed in one patient who received 70 mg/m2 docetaxel (grade 3 anaemia) and in three patients who received 75 mg/m2 docetaxel (one case of grade 3 anaemia, one case of grade 3 hepatic impairment and one case of grade 4 thrombocytopenia). Patients treated with docetaxel 75 mg/m2 in combination with cisplatin 75 mg/m2 had an estimated DLT rate of 25%, which was the closest to the target DLT rate and was therefore chosen as the MTD.
Conclusion
Docetaxel, in combination with a fixed dose of cisplatin (75 mg/m2), can be used safely at intraperitoneal doses of 75 mg/m2 in ovarian cancer patients who received HIPEC (43°C, 90 minutes) following debulking surgery.
5.A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer
Zhi-yao YOU ; Miao-fang WU ; Hui LI ; Yan-fang YE ; Li-juan WANG ; Zhong-qiu LIN ; Jing LI
Journal of Gynecologic Oncology 2024;35(1):e1-
Objective:
To identify the maximum tolerated dose (MTD) of docetaxel combined with a fixed dose of cisplatin (75 mg/m 2 ) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer.
Methods:
In this phase I trial, a time-to-event Bayesian optimal interval design was used.Docetaxel was given at a starting dose of 60 mg/m2 and was increased in 5 mg/m2 increments until the MTD was determined or the maximum dose level of 75 mg/m2 was reached. The doselimiting toxicity (DLT) rate was set at 25%, with a total sample size of 30 patients. HIPEC was delivered immediately following debulking surgery at a target temperature of 43°C for 90 minutes.
Results:
From August 2022 to November 2022, 30 patients were enrolled. Among the patients who received a dose of docetaxel ≤65 mg/m2 , no DLT was reported. DLTs were observed in one patient who received 70 mg/m2 docetaxel (grade 3 anaemia) and in three patients who received 75 mg/m2 docetaxel (one case of grade 3 anaemia, one case of grade 3 hepatic impairment and one case of grade 4 thrombocytopenia). Patients treated with docetaxel 75 mg/m2 in combination with cisplatin 75 mg/m2 had an estimated DLT rate of 25%, which was the closest to the target DLT rate and was therefore chosen as the MTD.
Conclusion
Docetaxel, in combination with a fixed dose of cisplatin (75 mg/m2), can be used safely at intraperitoneal doses of 75 mg/m2 in ovarian cancer patients who received HIPEC (43°C, 90 minutes) following debulking surgery.
6.Efficacy and mechanism of Xuefu Zhuyu Decoction on model rats of coronary heart disease with heart blood stasis syndrome based on metabolomics.
Jing LI ; Zhi-Hua GUO ; Jian-He LIU ; Sen-Jie ZHONG ; Hui-Fang KUANG ; Yang YANG ; Yi LIU ; Qiu-Yan ZHANG
China Journal of Chinese Materia Medica 2023;48(20):5623-5631
This study investigated the effects of Xuefu Zhuyu Decoction on myocardial metabolites in a rat model of coronary heart disease with heart blood stasis syndrome and explored the therapeutic mechanism of blood circulation-promoting and blood stasis-removing therapy. SD rats were randomly divided into a sham operation group, a model group, a Xuefu Zhuyu Decoction group(14.04 g·kg~(-1)), and a trimetazidine group(5.4 mg·kg~(-1)). The sham operation group underwent thread insertion without ligation, while the other groups underwent coronary artery left anterior descending branch ligation to induce a model of coronary heart disease with heart blood stasis syndrome. Three days after modeling, drug intervention was performed, and samples were taken after 14 days of intervention. General conditions were observed, and electrocardiogram and cardiac ultrasound indices were measured. Hematoxylin-eosin(HE) staining and Masson staining were used to observe tissue pathological morphology. The enzyme linked immunosorbent assay(ELISA) was used to measure the levels of triglyceride(TG) and total cholesterol(TC) in the serum. Ultra high performance liquid chromatography-quantitative exactive-mass spectrometry(UHPLC-QE-MS) technology was used to screen differential metabolites in myocardial tissue and conduct metabolic pathway enrichment analysis. The results showed that Xuefu Zhuyu Decoction significantly improved the general condition of the model rats, reduced heart rate and ST segment elevation in the electrocardiogram, increased left ventricular ejection fraction(LVEF) and left ventricular fractional shortening(LVFS), and decreased left ventricular internal diameter in diastole(LVIDd) and left ventricular internal diameter in systole(LVIDs). HE staining and Masson staining showed that Xuefu Zhuyu Decoction effectively alleviated myocardial tissue structural disorders, inflammatory cell infiltration, and collagen fiber deposition in the model rats. ELISA results showed that Xuefu Zhuyu Decoction effectively regulated serum TG and TC levels in the model rats. There were significant differences in the metabolic phenotypes of myocardial samples in each group. Fourteen differential metabolites were identified in the Xuefu Zhuyu Decoction group, involving five metabolic pathways, including arginine and proline metabolism, glycerophospholipid metabolism, aminoacyl-tRNA biosynthesis, ether lipid metabolism, and alanine, aspartate, and glutamate metabolism. Xuefu Zhuyu Decoction improved cardiac function and myocardial structural damage in the rat model of coronary heart disease with heart blood stasis syndrome, and its biological mechanism involved the regulation of lipid metabolism, choline metabolism, amino acid metabolism, energy metabolism, and protein synthesis pathways.
Rats
;
Animals
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Stroke Volume
;
Rats, Sprague-Dawley
;
Ventricular Function, Left
;
Coronary Disease/drug therapy*
;
Metabolomics
7.Baimai Ointment relieves chronic pain induced by chronic compression of dorsal root ganglion in rats by regulating neuroactive ligand-receptor interaction and HIF-1 signaling pathway.
Fang-Ting ZHOU ; Ying ZONG ; Wu-Qiong HOU ; Sen-Sen LI ; Fei YANG ; Li-Ting XU ; Xia MAO ; Yu-Dong LIU ; Xiao-Hui SU ; Hong-Ye WAN ; Jing-Feng OUYANG ; Qiu-Yan GUO ; Wei-Jie LI ; Zhen WANG ; Chao WANG ; Na LIN
China Journal of Chinese Materia Medica 2023;48(23):6457-6474
The Baimai Ointment with the effect of relaxing sinew and activating collaterals demonstrates a definite effect on Baimai disease with pain, spasm, stiffness and other symptoms, while the pharmacodynamic characteristics and mechanism of this agent remain unclear. In this study, a rat model of chronic compression of L4 dorsal root ganglion(CCD) was established by lumbar disc herniation, and the efficacy and mechanism of Baimai Ointment in the treatment of CCD were preliminarily explored by behavioral tests, side effect evaluation, network analysis, antagonist and molecular biology verification. The pharmacodynamic experiment indicated that Baimai Ointment significantly improved the pain thresholds(mechanical pain, thermal pain, and cold pain) and gait behavior of CCD model rats without causing tolerance or obvious toxic and side effects. Baimai Ointment inhibited the second-phase nociceptive response of mice in the formalin test, increased the hot plate threshold of normal mice, and down-regulated the expression of inflammatory cytokines in the spinal cord. Network analysis showed that Baimai Ointment had synergistic effect in the treatment of CCD and was related to descending inhibition/facilitation system and neuroinflammation. Furthermore, behavioral tests, Western blot, and immunofluorescence assay revealed that the pain-relieving effect of Baimai Ointment on CCD may be related to the regulation of the interaction between neuroactive ligand and receptors(neuroligands) such as CHRNA7, ADRA2A, and ADRB2, and the down-regulation of the expression of NOS2/pERK/PI3K, the core regulatory element of HIF-1 signaling pathway in spinal microglia. The findings preliminarily reveal the mechanism of relaxing sinew and activating collaterals of Baimai Ointment in the treatment of Baimai disease, providing a reference for the rational drug use and further research of this agent.
Rats
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Mice
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Animals
;
Chronic Pain/metabolism*
;
Rats, Sprague-Dawley
;
Ganglia, Spinal/metabolism*
;
Ligands
;
Signal Transduction
;
Hyperalgesia/metabolism*
;
Drugs, Chinese Herbal
8.Diagnostic Value of Structural MRI in Spinocerebellar Ataxia Type 3
Wen-ting ZENG ; Jing ZHAO ; Man-shi HU ; Hai-shan QIU ; Chao WU ; Jian-ping CHU
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(1):106-114
ObjectiveTo explore the role of structural MRI in the diagnosis of spinocerebellar ataxia type 3 (SCA3) and further evaluate its correlation with disease severity and disease duration. MethodsWe prospectively enrolled 81 genetically diagnosed SCA3 patients [59 symptomatic (sym-SCA3) and 22 pre-symptomatic (pre-SCA3)] and 35 age- and sex-matched healthy controls (HCs). MRI structural images (3D T1 MPRAGE) and clinical data of all subjects were collected. Three observers with different radiological experience measured the width of the superior, middle and inferior cerebellar peduncle (SCP, MCP and ICP), the anterior-posterior diameters of the pons and spinal cord at the levels of the foramen magnum and upper edge of the 3rd-5th cervical vertebra. One observer performed the measurements again 2 months later to assess for the intra- and inter-observer reliability, respectively. One-way ANOVA, rank-sum test, ROC curve and Random Forest were used to evaluate the diagnostic value of the above metrics for SCA3, and the correlation between the metrics and clinical variables was analyzed. ResultsNot depending on the radiological experience, the metrics based on morphological MRI showed high intra- and inter-observer reliability, among which bilateral superior and middle cerebellar peduncles performed best. The diameters of bilateral SCP, MCP, ICP, pons and spinal cord (except spinal cord at the level of the upper edge of the 5th cervical vertebra) decreased successively in HCs, pre-SCA3 and sym-SCA3 with a statistical difference (P<0.017). ROC analysis revealed that the left MCP had the highest diagnostic value for pre-SCA3 (AUC=0.911), with sensitivity, specificity and a cut-off value of 85.7%, 95.5% and 10.15 mm, respectively. In contrast, the right SCP had the highest diagnostic value for sym-SCA3 (AUC=0.999), with sensitivity, specificity and a cut-off value of 100%, 98.3% and 2.62 mm, respectively. The Random Forest model based on the above metrics also had high diagnostic efficiency (AUC= 0.970, specificity=93.1%), and the left MCP contributed the most. Correlation analysis showed that the above metrics had a significantly or moderately negative correlation with the Scale for the Assessment and Rating of Ataxia (SARA) and disease duration (P<0.05). ConclusionNot depending on radiological experience, measurements of brain structure based on morphological MRI are reliable, which can help diagnose SCA3 and predict disease severity and duration. The left MCP and the right SCP perform best for predicting pre-SCA3 and sym-SCA3, respectively. Therefore, the structural MRI is recommended for assisting the clinical diagnosis of SCA3.
9.Expert consensus on the prevention and treatment of adverse reactions in subcutaneous immunotherapy(2023, Chongqing).
Yu Cheng YANG ; Yang SHEN ; Xiang Dong WANG ; Yan JIANG ; Qian Hui QIU ; Jian LI ; Shao Qing YU ; Xia KE ; Feng LIU ; Yuan Teng XU ; Hong Fei LOU ; Hong Tian WANG ; Guo Dong YU ; Rui XU ; Juan MENG ; Cui Da MENG ; Na SUN ; Jian Jun CHEN ; Ming ZENG ; Zhi Hai XIE ; Yue Qi SUN ; Jun TANG ; Ke Qing ZHAO ; Wei Tian ZHANG ; Zhao Hui SHI ; Cheng Li XU ; Yan Li YANG ; Mei Ping LU ; Hui Ping YE ; Xin WEI ; Bin SUN ; Yun Fang AN ; Ya Nan SUN ; Yu Rong GU ; Tian Hong ZHANG ; Luo BA ; Qin Tai YANG ; Jing YE ; Yu XU ; Hua Bin LI
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(7):643-656
10.Application of Optical Genome Mapping Technology in Detecting Complex Chromosomal Rearrangement
Shu-jing HE ; Zhi-qiang ZHANG ; Yi-juan HUANG ; Li-nan XU ; Yuan-qiu CHEN ; Cong FANG ; Zi REN
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(6):943-948
ObjectiveTo investigate the application of optical genome mapping (OGM) technology in detecting complex chromosomal rearrangement. MethodsWe recruited five patients who were diagnosed as complex chromosomal rearrangement at the Reproductive Medicine Center of the Sixth Affiliated Hospital of Sun Yat-sen University from January 2022 to June 2023. They underwent OGM, nanopore sequencing and pre-implantation genetic testing (PGT). The results were compared with the results of karyotype and chromosomal microarray analysis (CMA)/ copy number variation sequencing (CNV-Seq). ResultsOGM could detect translocation, invert inversion, and triplet translocation, which were consistent with the results of OGM and CMA/ CNV-Seq. But OGM could not detect Robertsonian translocation. ConclusionBecause of its ultra-long reads, OGM realizes the detection across repetitive regions, and it has great advantages when applied in patients with complex chromosome rearrangement or uncertain karyotype analysis. It can accurately locate breakpoints.

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