1.Clinical application of three-dimensional visualization reconstruction technology in robot-assisted laparoscopic partial nephrectomy for renal hilar tumors with R.E.N.A.L. score≥10
Luyao CHEN ; Xiaoqiang LIU ; Yifan TAN ; Weipeng LIU ; Jieping HU ; Jing XIONG ; Kang WANG ; Tao LIU ; Gongxian WANG ; Bin FU
Chinese Journal of Urology 2025;46(5):363-368
Objective:To explore the application value of three-dimensional visualization reconstruction technology in robot-assisted laparoscopic partial nephrectomy(RAPN)for the treatment of highly complex(R.E.N.A.L. score≥10)renal hilar tumors.Methods:The clinical data of 87 patients with highly complex renal hilar tumors with R.E.N.A.L. scores ≥10 who were treated in First Affiliated Hospital of Nanchang University from January 2021 to December 2024 were retrospectively analyzed,of which 36 underwent 3D visualization reconstruction and 51 underwent conventional CT. The 3D visualization reconstruction method was to import the patient’s enhanced CT images in DICOM format into the 3D reconstruction image data processing software to produce a 3D visualization model. There were 22 males and 14 females in the 3D visualization group,with an average age of(54.2 ± 9.5)years,a body mass index of(24.8 ± 4.5)kg/m 2,and a tumor size of(4.3 ± 1.0)cm. Tumors were located on the left side in 16 cases and on the right side in 20 cases. Tumor stages were classified as T 1a in 11 cases,T 1b in 21 cases,and T 2a in 4 cases. The R.E.N.A.L. scores were distributed as follows:10 points in 21 cases,11 points in 12 cases,and 12 points in 3 cases. The estimated glomerular filtration rate(eGFR)before operation was(78.2±9.6)ml/(min·1.73 m 2). There were 35 males and 16 females in the conventional CT group,with an average age of(51.3±8.9)years,a body mass index of(25.4 ± 3.9)kg/m 2,and a tumor size of(4.1 ± 1.2)cm. Tumors were located on the left side in 25 cases and on the right side in 26 cases. Tumor stages were classified as T 1a in 12 cases,T 1b in 33 cases,and T 2a in 6 cases. The R.E.N.A.L. scores were distributed as follows:10 points in 31 cases,11 points in 18 cases,and 12 points in 2 cases . The preoperative eGFR was(80.6 ± 8.8)ml/(min·1.73 m 2). There was no statistical difference in general data and preoperative renal function between the two groups( P > 0.05). Both groups underwent RAPN. The two groups were analyzed and compared in terms of operation time,warm ischemia time,intraoperative blood loss,postoperative hospital stay,postoperative complications,and changes in renal function 3 months after surgery. Results:There were no cases of conversion to radical treatment or open surgery in both the 3D visualization group and the conventional CT group. The 3D visualization group had shorter operation time[(94.6 ± 18.5)min vs.(110.2 ± 17.2)min, P < 0.001],shorter renal artery occlusion time[(23.3 ± 4.0)min vs.(27.2 ± 3.3)min, P < 0.001],less intraoperative blood loss[120(100,250)ml vs. 150(120,300)ml, P = 0.018],and a lower proportion of intraoperative collecting system incision(19/36 vs. 38/51, P = 0.042)than the conventional CT group. There was no significant statistical difference in the time of postoperative drainage tube removal and postoperative hospital stay between the two groups( P > 0.05). One case in the 3D visualization group had postoperative fever,and two cases in the conventional CT group had postoperative obvious macroscopic hematuria. Postoperative pathological diagnosis of the patients was clear cell carcinoma in 78 cases,papillary cell carcinoma in 6 cases,chromophobe cell carcinoma in 2 cases,and oncocytoma in 1 case. No positive resection margin was found in both groups. Three months after surgery,there was no significant statistical difference in eGFR between the two groups[(70.6 ± 8.5)ml/(min·1.73 m 2)vs.(71.4 ± 9.2)ml/(min·1.73 m 2), P = 0.681]. During the median follow-up of 17.8 months,no tumor recurrence or metastasis was observed in either group. Conclusions:RAPN has good safety and feasibility in the treatment of highly complex(R.E.N.A.L. score ≥10)renal hilar tumors. Preoperative three-dimensional visualization reconstruction technology helps to reduce RAPN operation time,renal artery occlusion time and intraoperative blood loss,and has good clinical application value.
2.Comprehensive Clinical Evaluation of Different Preparations of Amphotericin B Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition)
Chaoli CHEN ; Ran FU ; Donghan WANG ; Luyao CHANG ; Yang SONG ; Jing YU ; Chunhua ZHOU
Herald of Medicine 2025;44(11):1835-1842
Objective To conduct a comprehensive evaluation of Amphotericin B Deoxycholate(AmB-D)for injection,Liposomal Amphotericin B(L-AmB)for injection,and Amphotericin B Colloidal Dispersion(ABCD)for injection,and to provide a reference for the selection and rational use of drugs in medical institutions.Methods Based on the quantitative evaluation and selection record form in the A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),evidence was collected to conduct a comprehensive assessment of the included drugs.Results Comprehensively considering the pharmacological properties,efficacy,safety,economy,and other attributes of different preparations of amphotericin B,the quantitative scoring results were ranked from high to low,with ABCD(CSPC Ouyi Pharmaceutical Co.,Ltd.)scoring 79.10 points,L-AmB(Gilead Sciences)scoring 78.30 points,and L-AmB(Shanghai Shangyao Xinya Pharmaceutical Co.,Ltd.)scoring 72.01 points.AmB-D(Shanghai Shanghai Pharmaceutical Xinya Pharmaceutical Co.,Ltd)scored 63.20 points,and AmB-D(North China Pharmaceutical Co.,Ltd.)scored 59.78 points.Conclusion Both L-AmB and ABCD have better clinical efficacy and higher safety in the treatment of invasive fungal infections,and ABCD has a better price advantage than L-AmB.Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),the evaluation results of different preparations of amphotericin B can provide a reference for the selection and rational use of amphotericin B in medical institutions.
3.Comprehensive Clinical Evaluation of Different Preparations of Amphotericin B Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition)
Chaoli CHEN ; Ran FU ; Donghan WANG ; Luyao CHANG ; Yang SONG ; Jing YU ; Chunhua ZHOU
Herald of Medicine 2025;44(11):1835-1842
Objective To conduct a comprehensive evaluation of Amphotericin B Deoxycholate(AmB-D)for injection,Liposomal Amphotericin B(L-AmB)for injection,and Amphotericin B Colloidal Dispersion(ABCD)for injection,and to provide a reference for the selection and rational use of drugs in medical institutions.Methods Based on the quantitative evaluation and selection record form in the A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),evidence was collected to conduct a comprehensive assessment of the included drugs.Results Comprehensively considering the pharmacological properties,efficacy,safety,economy,and other attributes of different preparations of amphotericin B,the quantitative scoring results were ranked from high to low,with ABCD(CSPC Ouyi Pharmaceutical Co.,Ltd.)scoring 79.10 points,L-AmB(Gilead Sciences)scoring 78.30 points,and L-AmB(Shanghai Shangyao Xinya Pharmaceutical Co.,Ltd.)scoring 72.01 points.AmB-D(Shanghai Shanghai Pharmaceutical Xinya Pharmaceutical Co.,Ltd)scored 63.20 points,and AmB-D(North China Pharmaceutical Co.,Ltd.)scored 59.78 points.Conclusion Both L-AmB and ABCD have better clinical efficacy and higher safety in the treatment of invasive fungal infections,and ABCD has a better price advantage than L-AmB.Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),the evaluation results of different preparations of amphotericin B can provide a reference for the selection and rational use of amphotericin B in medical institutions.
4.Clinical application of three-dimensional visualization reconstruction technology in robot-assisted laparoscopic partial nephrectomy for renal hilar tumors with R.E.N.A.L. score≥10
Luyao CHEN ; Xiaoqiang LIU ; Yifan TAN ; Weipeng LIU ; Jieping HU ; Jing XIONG ; Kang WANG ; Tao LIU ; Gongxian WANG ; Bin FU
Chinese Journal of Urology 2025;46(5):363-368
Objective:To explore the application value of three-dimensional visualization reconstruction technology in robot-assisted laparoscopic partial nephrectomy(RAPN)for the treatment of highly complex(R.E.N.A.L. score≥10)renal hilar tumors.Methods:The clinical data of 87 patients with highly complex renal hilar tumors with R.E.N.A.L. scores ≥10 who were treated in First Affiliated Hospital of Nanchang University from January 2021 to December 2024 were retrospectively analyzed,of which 36 underwent 3D visualization reconstruction and 51 underwent conventional CT. The 3D visualization reconstruction method was to import the patient’s enhanced CT images in DICOM format into the 3D reconstruction image data processing software to produce a 3D visualization model. There were 22 males and 14 females in the 3D visualization group,with an average age of(54.2 ± 9.5)years,a body mass index of(24.8 ± 4.5)kg/m 2,and a tumor size of(4.3 ± 1.0)cm. Tumors were located on the left side in 16 cases and on the right side in 20 cases. Tumor stages were classified as T 1a in 11 cases,T 1b in 21 cases,and T 2a in 4 cases. The R.E.N.A.L. scores were distributed as follows:10 points in 21 cases,11 points in 12 cases,and 12 points in 3 cases. The estimated glomerular filtration rate(eGFR)before operation was(78.2±9.6)ml/(min·1.73 m 2). There were 35 males and 16 females in the conventional CT group,with an average age of(51.3±8.9)years,a body mass index of(25.4 ± 3.9)kg/m 2,and a tumor size of(4.1 ± 1.2)cm. Tumors were located on the left side in 25 cases and on the right side in 26 cases. Tumor stages were classified as T 1a in 12 cases,T 1b in 33 cases,and T 2a in 6 cases. The R.E.N.A.L. scores were distributed as follows:10 points in 31 cases,11 points in 18 cases,and 12 points in 2 cases . The preoperative eGFR was(80.6 ± 8.8)ml/(min·1.73 m 2). There was no statistical difference in general data and preoperative renal function between the two groups( P > 0.05). Both groups underwent RAPN. The two groups were analyzed and compared in terms of operation time,warm ischemia time,intraoperative blood loss,postoperative hospital stay,postoperative complications,and changes in renal function 3 months after surgery. Results:There were no cases of conversion to radical treatment or open surgery in both the 3D visualization group and the conventional CT group. The 3D visualization group had shorter operation time[(94.6 ± 18.5)min vs.(110.2 ± 17.2)min, P < 0.001],shorter renal artery occlusion time[(23.3 ± 4.0)min vs.(27.2 ± 3.3)min, P < 0.001],less intraoperative blood loss[120(100,250)ml vs. 150(120,300)ml, P = 0.018],and a lower proportion of intraoperative collecting system incision(19/36 vs. 38/51, P = 0.042)than the conventional CT group. There was no significant statistical difference in the time of postoperative drainage tube removal and postoperative hospital stay between the two groups( P > 0.05). One case in the 3D visualization group had postoperative fever,and two cases in the conventional CT group had postoperative obvious macroscopic hematuria. Postoperative pathological diagnosis of the patients was clear cell carcinoma in 78 cases,papillary cell carcinoma in 6 cases,chromophobe cell carcinoma in 2 cases,and oncocytoma in 1 case. No positive resection margin was found in both groups. Three months after surgery,there was no significant statistical difference in eGFR between the two groups[(70.6 ± 8.5)ml/(min·1.73 m 2)vs.(71.4 ± 9.2)ml/(min·1.73 m 2), P = 0.681]. During the median follow-up of 17.8 months,no tumor recurrence or metastasis was observed in either group. Conclusions:RAPN has good safety and feasibility in the treatment of highly complex(R.E.N.A.L. score ≥10)renal hilar tumors. Preoperative three-dimensional visualization reconstruction technology helps to reduce RAPN operation time,renal artery occlusion time and intraoperative blood loss,and has good clinical application value.
5.Hemophagocytic syndrome secondary to invasive NK cell leukemia and T-cell lymphoma treated with the modified MINE protocol: report of three cases and literature review
Di WU ; Miaojing LI ; Yao LI ; Tongxia LU ; Luyao FU ; Pengcheng HE
Chinese Journal of Hematology 2024;45(6):599-601
Lymphoma-associated hemophagocytic syndrome is aggressive with rapid progression, particularly in NK/T cell lymphoma. The MINE regimen is a salvage treatment for aggressive non-Hodgkin lymphoma. In our center, the modified MINE regimen was applied to treat three patients with hemophagocytic syndrome secondary to aggressive NK cell leukemia and T-cell lymphoma. The modified MINE regimen showed good efficacy against NK/T cell lymphoma, control of the inflammatory state of secondary hemophagocytic syndrome, and good tolerability.
6.Optogenetics in oral and craniofacial research
ZHANG QINMENG ; SONG LUYAO ; FU MENGDIE ; HE JIN ; YANG GUOLI ; JIANG ZHIWEI
Journal of Zhejiang University. Science. B 2024;25(8):656-671
Optogenetics combines optics and genetic engineering to control specific gene expression and biological functions and has the advantages of precise spatiotemporal control,noninvasiveness,and high efficiency.Genetically modified photosensory sensors are engineered into proteins to modulate conformational changes with light stimulation.Therefore,optogenetic techniques can provide new insights into oral biological processes at different levels,ranging from the subcellular and cellular levels to neural circuits and behavioral models.Here,we introduce the origins of optogenetics and highlight the recent progress of optogenetic approaches in oral and craniofacial research,focusing on the ability to apply optogenetics to the study of basic scientific neural mechanisms and to establish different oral behavioral test models in vivo(orofacial movement,licking,eating,and drinking),such as channelrhodopsin(ChR),archaerhodopsin(Arch),and halorhodopsin from Natronomonas pharaonis(NpHR).We also review the synergic and antagonistic effects of optogenetics in preclinical studies of trigeminal neuralgia and maxillofacial cellulitis.In addition,optogenetic tools have been used to control the neurogenic differentiation of dental pulp stem cells in translational studies.Although the scope of optogenetic tools is increasing,there are limited large animal experiments and clinical studies in dental research.Potential future directions include exploring therapeutic strategies for addressing loss of taste in patients with coronavirus disease 2019(COVID-19),studying oral bacterial biofilms,enhancing craniomaxillofacial and periodontal tissue regeneration,and elucidating the possible pathogenesis of dry sockets,xerostomia,and burning mouth syndrome.
7.Exploration of the Theory of the Treatment of Insomnia by Hewei-Acupuncture
Tianqi HUANG ; Luyao FU ; Kelin HE
Journal of Zhejiang Chinese Medical University 2024;48(7):781-786
[Objective]To summarize the clinical experience of Professor MA Ruijie in the treatment of insomnia by using Hewei-acupuncture,with a view to illustrating the theoretical basis and clinical application of Hewei-acupuncture in the treatment of insomnia.[Methods]Through the clinical study with the teacher,combined with the review of Chinese medical textbooks and modern medical clinical research literature on insomnia.Professor MA's understanding of the etiology and pathogenesis of insomnia,the composition and basis of the acupuncture points of Hewei-acupuncture,and the theoretical and mechanistic study of Hewei-acupuncture for the treatment of insomnia were elaborated,and Professor MA's ideas of identification and treatment of this disease were analyzed.[Results]Professor MA believes that the sleep and wakefulness of human beings are controlled by the heart and spirit,and regulated by the Yin and Yang of Ying and Wei,which are related to the functions of internal organs,among which the malfunctioning of the spleen and stomach is closely related to the occurrence of insomnia.Professor MA's treatment of this disease is characterized by the importance of the theory of meridian and collateral disease and the Qi of the spleen and stomach in the middle-Jiao,and she believes that the foot Yangming stomach meridian Qi reversal,Ying and Wei are out of harmony;the spleen and stomach deficiency,the heart and spirit of the loss of nourishment;and elevation disorders,misdirection of the good offices are important reasons for the occurrence of insomnia.Hewei-acupuncture is a summary of Professor MA's clinical experience in treating insomnia and other neurological disorders by taking"Tianshu"(ST25),"Zusanli"(ST36),"Neiguan"(PC6)and"Gongsun"(SP4)as the main acupoints.This method relieves insomnia by regulating Qi of the spleen and stomach,strengthening the function of the spleen and stomach,and balancing Yin and Yang of the organism.[Conclusion]Hewei-acupuncture in the clinical treatment of insomnia is characterized by streamlining of acupoints,light pain,and good long-term efficacy,which is of practical significance in guiding the clinical treatment of insomnia.
8.The application and efficacy of modified early unclamping technique in robot-assisted laparoscopic partial nephrectomy for patients with renal tumors
Luyao CHEN ; Weipeng LIU ; Yu LI ; Jin ZENG ; Xiaoqiang LIU ; Xiangpeng ZHAN ; Gongxian WANG ; Bin FU
Chinese Journal of Urology 2022;43(2):81-85
Objective:To investigate the efficacy and safety of modified early unclamping technique in robot-assisted laparoscopic partial nephrectomy (RAPN) for patients with renal tumors.Methods:A total of 32 renal tumor patients undergoing RAPN with modified early unclamping technique between January 2019 and August 2020 were retrospectively collected, including 18 males and 14 females. The average age was (48.5±11.2) years old, average BMI was (23.8±3.7) kg/m 2, average tumor size was (4.2±1.4)cm with 18 left tumors and 14 right tumors, average R. E.N.A.L. score was 7.6±0.4, and average preoperative eGFR was (84.0±18.6)ml/(min·1.73 m 2). The control group included 66 renal tumor patients undergoing RAPN with standard unclamping technique during the same period by the same surgeon, including 42 males and 24 females. The average age was (50.2±13.8) years old, average BMI was (24.0±4.5)kg/m 2, average tumor size was (4.1±1.6)cm with 35 left tumors and 31 right tumors, average R. E.N.A.L. score was 7.5±0.5, and average preoperative eGFR was (82.8±20.2) ml/(min·1.73 m 2). There was no significant difference in above variables between two groups. Modified early unclamping technique used barbed wire to continually suture 2-3 needles in a short time to close the large space at the outer after the inner suture, and then loosen the blocking clip to restore renal blood supply. The operative time, warm ischemia time, blood loss, postoperative tube removal time, postoperative hospital stay and 3 months postoperative renal function of two groups were compared. Results:All of the 98 RAPN were performed successfully and no patient was converted to radical nephrectomy or open surgery. There was no significant difference in operation time [(120.9±22.8)vs.(111.6±25.0)min, P=0.079], postoperative tube removal time [(4.0±0.6)day vs.(3.8±0.8) day, P=0.214] and postoperative hospital stay [(5.1±0.7)day vs.(5.2±0.5) day, P=0.419] between the two groups. Compared with the standard unclamping group, the modified early unclamping group had obvious less warm ischemia time [(13.5±3.6)min vs.(21.2±4.4) min, P<0.001]. There was no difference in intraoperative estimated blood loss between two groups (110 ml vs. 100 ml, P=0.480). No blood transfusion, urine leakage, postoperative hemorrhage occurred in either group. The 3 months postoperative renal function decline of modified early unclamping group was slightly less than standard unclamping group [(10.5±7.6)ml/(min·1.73m 2)vs.(13.2±6.4) ml/(min·1.73m 2)], but did not reach statistical significance ( P=0.069). The median follow-up period was 12.4 months(4-24 months) without any recurrence or metastasis. Conclusions:The modified early unclamping technique in RAPN for patients with renal tumors is safe and feasible. Compared with the standard unclamping technique, the modified early unclamping technique could shorten the warm ischemia time without increasing blood loss and complications, and might protect the postoperative renal function, which has high value in clinical practice.
9.Analysis of robot-assisted laparoscopic versus laparoscopic partial nephrectomy for the treatment of completely endophytic renal tumors
Luyao CHEN ; Situ XIONG ; Wen DENG ; Yunqiang XIONG ; Tao CHEN ; Xiangpeng ZHAN ; Weipeng LIU ; Jin ZENG ; Jing XIONG ; Gongxian WANG ; Bin FU
Chinese Journal of Urology 2022;43(5):335-338
Objective:To compare the efficacy and safety of robot-assisted laparoscopic and laparoscopic partial nephrectomy (RAPN and LPN) for patients with completely endophytic renal tumor.Methods:A total of 73 patients with completely endophytic renal tumor receiving RAPN (n=29) or LPN (n=44) in our center between January 2015 and June 2021 were retrospectively collected. There were 21 males and 8 females in RAPN group. The average age was 48.6±13.7 years old, average tumor size was 2.9±0.9 cm with 13 left tumors and 16 right tumors, average R. E.N.A.L. score was 9.2±1.0, and average preoperative eGFR was 82.6±10.7 ml/(min·1.73 m 2). There were 27 males and 17 females in LPN group. The average age was 50.1±12.3 years old, average tumor size was 2.9±0.9 cm with 24 left tumors and 20 right tumors, average R. E.N.A.L. score was 9.1±1.3, and average preoperative eGFR was 81.7±9.6 ml/(min·1.73 m 2). There was no significant difference in above variables between two groups. The operative time, warm ischemia time, blood loss, postoperative complication, postoperative hospital stay and postoperative 3 months renal function of two groups were compared. Results:All 73 patients successfully underwent RAPN or LPN and no patient converted to radical nephrectomy or open surgery. There was no significant difference in operation time [140(80, 160) min vs. 150 (90, 180) min, P=0.264], intraoperative estimated blood loss[150 (100, 200)vs. 180 (120, 200) ml, P=0.576]and postoperative hospital stay (7.0±2.7 vs. 7.4±2.1 days, P=0.480) between two groups. Compared with LPN group, RAPN group had obvious less warm ischemia time (23.1±3.3 vs. 27.6±4.7 min, P<0.001). No obvious complication occurred in RAPN group and one case with postoperative hemorrhage occurred in LPN group. No positive margin occurred in either group. There was no difference in renal function 3 months after operation between the two groups [73.2±6.3 vs.70.5±7.6ml/(min·1.73 m 2), P=0.117]. The median follow-up period was 22.6 months with no tumor recurrence or metastasis. Conclusions:For experienced surgeons, both RAPN and LPN are safe and feasible for patients with completely endophytic renal tumor. Compared with LPN, RAPN has advantages of perioperative curative effect, which could reduce the operating difficulty and shorten the warm ischemia time.
10.Analysis of influential factors for dose-corrected trough concentration of amisulpride based on therapeutic drug monitoring
Yiqi WANG ; Luyao CHANG ; Ran FU ; Lingjiao WANG ; Jing YU ; Chunhua ZHOU
China Pharmacy 2022;33(24):3020-3024
OBJECTIVE To analyze the influential factors for dose-corrected trough concentration (C/D) of amisulpride, and to provide reference for rational use of it in clinic. METHODS The results of the last serum concentration monitoring and relevant medical data of schizophrenic inpatients who were monitored for the treatment of amisulpride in the Mental Health Center of the First Hospital of Hebei Medical University from March to November 2021 were collected retrospectively and analyzed the effects of age, sex, body mass index (BMI), serum creatinine level, and combined medication on the C/D value of amisulpride. RESULTS A total of 133 schizophrenic inpatients were included, and median dose of amisulpride was 600.00 mg/d, median serum concentration was 332.57 ng/mL, and median value of C/D was 0.61 ng·d/(mL·mg). The serum concentration of 49 patients was within the recommended range of relevant guideline (100-320 ng/mL), and 27 patients exceeded the laboratory warning concentration (640 ng/mL). There was no statistical significance in drug dose, serum concentration or C/D value among the patients of different genders (P>0.05). The serum concentration of minor patients was significantly lower than that of adult patients (P<0.05), but there was no statistical significance in drug dose or C/D value between minor patients and adult patients (P>0.05). The C/D value of amisulpride in obese patients (BMI>28 kg/m2) was significantly lower than that in normal patients (BMI 18.5- 23.9 kg/m2); the combination of olanzapine, sodium valproate and benzodiazepines did not affect the C/D value of amisulpride (P>0.05); the level of serum creatinine in patients was not related to the dose of amisulpride (r=0.081, P>0.05), but was positively related to the C/D value of the drug (r=0.285, P<0.05). CONCLUSIONS The age, BMI and serum creatinine level of patients are closely related to the C/D value of amisulpride. In the clinical treatment of schizophrenia with amisulpride, we should fully consider the patient’s age, body mass, serum creatinine and other factors, and develop a personalized drug regimen for patients to ensure the safety and effectiveness of treatment.

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