1.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
2.Analysis of the efficacy of adjusting the dose of imatinib with therapeutic drug monitoring in adjuvant treatment after complete resection of gastrointestinal stromal tumors
Zhiliang CHEN ; Hongkun TIAN ; Jianing DING ; Zhiying LI ; Gan MAO ; Yuqiang DU ; Qian SHEN ; Hong ZHOU ; Yong HAN ; Xiangyu ZENG ; Kaixiong TAO ; Peng ZHANG
Chinese Journal of Gastrointestinal Surgery 2024;27(11):1148-1154
Objective:To explore the efficacy of adjusting the dose of imatinib dose in the context of therapeutic drug monitoring (TDM) in patients with gastrointestinal stromal tumors (GISTs) who are receiving adjuvant therapy after complete resection of their tumors.Methods:This was a descriptive study. Inclusion criteria were (1) complete surgical resection with a pathological diagnosis of GIST, (2) postoperative adjuvant therapy with imatinib and dosage adjustment, (3) multiple TDM of imatinib, and (4) complete clinical, pathological, and follow-up data. The data of 70 patients with GISTs treated at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology between January 2015 and December 2023 were collected retrospectively. The study cohort comprised 15 (21.4%) men and 55 (78.6%) women of median age 60 years (range: 25–82). Of the eligible patients, 49 (70.0%) were at high-risk, 14 (20.0%) at intermediate-risk, six (8.6%) at low-risk, and one (1.4%) at very low risk. Patients were followed up by the gastrointestinal stromal tumor clinic every 2–3 months and their plasma concentrations of imatinib were checked. The dose was adjusted to 300 mg/d or 200 mg/d depending on whether they had had ≥ grade III adverse reactions, and whether the first plasma concentration of imatinib was ≥ 1,500 μg/L or between the expected range of 760 μg/L–1,100 μg/L. Studied indicators included adverse reactions, quality of life before and after dose adjustment, and overall survival and recurrence-free survival (RFS) after dose adjustment.Results:Before dose adjustment, all 70 patients received 400 mg of imatinib daily, with initial TDM values of 1,900 ± 568 μg/L, for a median duration of 8.3 months. After dose adjustment, 60 patients received 300 mg daily, with a TDM of 1,216 ± 350 μg/L, whereas 10 received 200 mg daily, with a TDM of 1,023 ± 269 μg/L. The median duration of treatment after dose adjustment was 23.4 months. Compared with those whose dosages were not adjusted, the incidence of bone marrow suppression was significantly lower (74.3% [52/70] vs. 51.4% [36/70], χ 2=9.202, P=0.010); as were the incidences of edema (95.7% [67/70] vs. 50.0% [35/70], χ 2=40.526, P<0.001); skin reactions (70.0% [49/70] vs. 32.9% [23/70), χ 2=22.495, P<0.001); and gastrointestinal reactions (38.6% [27/70] vs. 10.0% [7/70], χ 2=15.899, P<0.001) in those whose dosages were adjusted. The average total scores for physical health before and after dose adjustment were 76 ± 5 and 88 ± 4, respectively; whereas the mental health scores were 75 ± 6 and 89 ± 4, respectively. The median follow-up period was 36 months (range 6–126). During the first 3 years of follow-up, five high-risk patients with non-gastric GISTs developed recurrences. The 3-year overall survival rate was 100%, and the 3-year RFS rate was 92.8%, high-risk patients having a 3-year RFS rate of 89.8%. Conclusion:The adverse reactions and quality of life of GIST patients with severe adverse reactions to adjuvant imatinib therapy after complete resection can be mitigated by appropriately reducing the dosage of imatinib under the guidance of TDM.
3.Comparison of clinical effectiveness and safety between generic and branded dienogest tablets in the treatment of endometriosis
Qian LIU ; Jianing ZHANG ; Shuang ZHANG ; Qinglan LIU ; Baoyin ZHANG ; Nan SUN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(5):527-534
AIM:To evaluate the clinical effective-ness and safety of generic and branded dienogest in the treatment of endometriosis.so as to provide the basis for clinical use of dienogest.MEHTODS:The data of patients admitted to Third Affiliated Hospital of Zhengzhou University from August 2022 to August 2023 who received dienogest(2 mg/d,orally,for 6 months)for treatment of endometrio-sis were collected.The clinical efficacy and adverse reactions of generic drugs and original drugs in the treatment of endometriosis-related pain were com-pared through follow-up surveys of the two groups of patients at 3 months and 6 months respectively.RESULTS:There was highly significant reduction in pelvic pain in both groups with mean of similar in generic group(34.0±3.0)mm and branded group(34.5±3.9)mm.The most frequent drug-related ad-verse effects in generic dienogest was vaginal bleeding(93%)which was no statistical difference with branded dienogest(90%).CONCLUSION:The generic and branded dienogest have the same clini-cal effectiveness and similar safety.
4.Application of pulsed Thulium fiber laser enucleation in treatment of benign prostatic hyperplasia
Xiaoda LAN ; Xinyan CHE ; Jianing HAN ; Kunlin YANG ; Chao ZUO ; Qian ZHANG ; Kai ZHANG ; Yisen MENG
Chinese Journal of Urology 2024;45(5):372-378
Objective:To investigate the safety and efficacy of pulsed Thulium fiber laser enucleation (ThuFLEP) in the treatment of benign prostatic hyperplasia (BPH).Methods:Clinical data of 238 BPH patients who underwent ThuFLEP from November 2022 to November 2023 at Peking University First Hospital were retrospectively analyzed. Patients were divided into two groups based on different surgical techniques: 199 patients underwent traditional continuous-wave Thulium fiber laser prostatectomy (C-ThuFLEP group), and 39 patients underwent Thulium fiber laser enucleation with pulse modulation (P-ThuFLEP group). Propensity score matching was used to balance baseline characteristics between the two groups. Operative time, resected tissue weight, pre- and postoperative hemoglobin decrease, postoperative hospital stay, and postoperative catheterization time were recorded and compared between the matched groups. Intraoperative and short-term postoperative complications were also recorded and compared between the two groups. Follow-up assessments at 1 month postoperatively were conducted to compare the maximum urinary flow rate (Q max), international prostate symptom score (IPSS), international index of erectile function (IIEF-5) score, quality of life (QOL) score, and International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score between the two groups, as well as changes in Q max and IPSS, IIEF-5, and QOL before and after surgery. Results:After matching, a total of 60 patients were included, with 30 patients in each group. There were no statistically significant differences between the two groups in terms of age [(68.73±6.91) years vs. (71.07±7.34) years], American Society of Anesthesiologists (ASA) score (1-2/3-4: 23/7 vs. 23/7), comorbidity count (0-1/>1: 15/15 vs. 15/15), prostate volume [68.3 (50.0, 105.3) ml vs. 63.3 (45.7, 106.0) ml], preoperative IPSS score [24 (21, 29) vs. 23 (14, 26)], IIEF-5 score [5 (0, 15) vs. 5 (0, 13)], and QOL score [5 (4, 6) vs. 5 (5, 6)] (all P>0.05). The tissue removal rate in the P-ThuFLEP group was higher than that in the C-ThuFLEP group [0.82 (0.71, 1.18) g/min vs. 0.72 (0.46, 0.95) g/min, P=0.026], while there were no statistically significant differences between the two groups in operative time [47 (37, 79) min vs. 65 (33, 87) min], resected tissue weight [45 (31, 75) g vs. 33 (22, 65) g], postoperative hemoglobin decrease [17 (10, 23) g/L vs. 12 (7, 19) g/L], postoperative hospital stay [4 (3, 5) days vs. 4 (3, 5) days], and postoperative catheterization time [3 (3, 5) days vs. 3 (3, 6) days]. The incidence of intraoperative complications in both groups was 10% (3/30), with no statistically significant difference ( P=1.000), and no severe complications of grade Ⅲ or above occurred. There were no statistically significant differences in Q max [24 (15, 33) ml/s vs. 16 (10, 32) ml/s], IPSS score [14 (12, 15) vs. 9 (7, 12)], QOL score [2 (1, 3) vs. 2 (1, 3)], and IIEF-5 score [3 (0, 5) vs. 3 (0, 6)] between the C-ThuFLEP and P-ThuFLEP group at 1 month postoperatively (all P > 0.05), and both showed significant improvement compared to preoperative values (all P < 0.05). The ICIQ-SF score in the P-ThuFLEP group was lower than that in the C-ThuFLEP group [0 (0, 4) vs. 4 (3, 8)], with a statistically significant difference ( P=0.033). Conclusions:Compared with traditional continuous-wave Thulium fiber laser prostatectomy, pulse-modulated Thulium fiber laser enucleation demonstrates higher efficiency in tissue removal, lower early postoperative ICIQ-SF score for urinary incontinence, similar risk of intraoperative complications, and can be safely and effectively applied in the surgical treatment of BPH patients.
5.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
6.Analysis of the efficacy of adjusting the dose of imatinib with therapeutic drug monitoring in adjuvant treatment after complete resection of gastrointestinal stromal tumors
Zhiliang CHEN ; Hongkun TIAN ; Jianing DING ; Zhiying LI ; Gan MAO ; Yuqiang DU ; Qian SHEN ; Hong ZHOU ; Yong HAN ; Xiangyu ZENG ; Kaixiong TAO ; Peng ZHANG
Chinese Journal of Gastrointestinal Surgery 2024;27(11):1148-1154
Objective:To explore the efficacy of adjusting the dose of imatinib dose in the context of therapeutic drug monitoring (TDM) in patients with gastrointestinal stromal tumors (GISTs) who are receiving adjuvant therapy after complete resection of their tumors.Methods:This was a descriptive study. Inclusion criteria were (1) complete surgical resection with a pathological diagnosis of GIST, (2) postoperative adjuvant therapy with imatinib and dosage adjustment, (3) multiple TDM of imatinib, and (4) complete clinical, pathological, and follow-up data. The data of 70 patients with GISTs treated at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology between January 2015 and December 2023 were collected retrospectively. The study cohort comprised 15 (21.4%) men and 55 (78.6%) women of median age 60 years (range: 25–82). Of the eligible patients, 49 (70.0%) were at high-risk, 14 (20.0%) at intermediate-risk, six (8.6%) at low-risk, and one (1.4%) at very low risk. Patients were followed up by the gastrointestinal stromal tumor clinic every 2–3 months and their plasma concentrations of imatinib were checked. The dose was adjusted to 300 mg/d or 200 mg/d depending on whether they had had ≥ grade III adverse reactions, and whether the first plasma concentration of imatinib was ≥ 1,500 μg/L or between the expected range of 760 μg/L–1,100 μg/L. Studied indicators included adverse reactions, quality of life before and after dose adjustment, and overall survival and recurrence-free survival (RFS) after dose adjustment.Results:Before dose adjustment, all 70 patients received 400 mg of imatinib daily, with initial TDM values of 1,900 ± 568 μg/L, for a median duration of 8.3 months. After dose adjustment, 60 patients received 300 mg daily, with a TDM of 1,216 ± 350 μg/L, whereas 10 received 200 mg daily, with a TDM of 1,023 ± 269 μg/L. The median duration of treatment after dose adjustment was 23.4 months. Compared with those whose dosages were not adjusted, the incidence of bone marrow suppression was significantly lower (74.3% [52/70] vs. 51.4% [36/70], χ 2=9.202, P=0.010); as were the incidences of edema (95.7% [67/70] vs. 50.0% [35/70], χ 2=40.526, P<0.001); skin reactions (70.0% [49/70] vs. 32.9% [23/70), χ 2=22.495, P<0.001); and gastrointestinal reactions (38.6% [27/70] vs. 10.0% [7/70], χ 2=15.899, P<0.001) in those whose dosages were adjusted. The average total scores for physical health before and after dose adjustment were 76 ± 5 and 88 ± 4, respectively; whereas the mental health scores were 75 ± 6 and 89 ± 4, respectively. The median follow-up period was 36 months (range 6–126). During the first 3 years of follow-up, five high-risk patients with non-gastric GISTs developed recurrences. The 3-year overall survival rate was 100%, and the 3-year RFS rate was 92.8%, high-risk patients having a 3-year RFS rate of 89.8%. Conclusion:The adverse reactions and quality of life of GIST patients with severe adverse reactions to adjuvant imatinib therapy after complete resection can be mitigated by appropriately reducing the dosage of imatinib under the guidance of TDM.
7.Expert consensus on the management of auditory hallucinations in inpatients with mental illness
Yanhua QU ; Dongmei XU ; Jing SHAO ; Shan ZHANG ; Mengqian ZHANG ; Jianing GU ; Xiaolu YE ; Feifei LI ; Wei LUO ; Wanting LI ; Li WANG ; Fangzhu SHI ; Xiaoyu FENG ; Qian ZHOU ; Juan ZHAO
Chinese Journal of Practical Nursing 2024;40(14):1080-1090
Objective:To standardize the management of auditory hallucination symptoms in inpatients with mental illness and develop an expert consensus on the management of auditory hallucinations in hospitalized psychiatric patients.Methods:From March 2023 to July 2023, the Mental Health Committee of the Chinese Nursing Association focused on the key issues in the management of auditory hallucinations symptoms in inpatients with mental illness, based on clinical practice, using literature analysis combined with the work experience of mental health experts, and formed the first draft of the expert consensus on the management of auditory hallucinations in inpatients with mental illness (hereinafter referred to as the consensus). Through 3 rounds of expert consultation and 3 rounds of expert demonstration meeting, the draft was adjusted, revised, and improved.Results:37 experts were included in the Delphi expert consultation, 1 male and 36 females with 39-67(51.48 ± 6.61) years old. The positive coefficients of experts in 3 rounds of Delphi expert consultations were all 100%, and the degrees of expert authority were 0.924, 0.938 and 0.949, respectively. The average importance value of each item was higher than 4.00, the variation coefficient of each item was less than 0.25. The Kendall harmony coefficient of the experts were 0.179, 0.195 and 0.198, respectively (all P<0.05). There were 15, 12, 12 experts in the first, seeond, third rounds of expert demonstration meeting. Finally, a consensus was reached on the recommendation of 4 parts, included auditory hallucination assessment, management format, symptom management implementation, and precautions. Conclusions:The consensus covers all parts of the management of auditory hallucination symptoms in hospitalized patients with mental disorders, which is practical and scientific. It is helpful to guide mental health professionals to standardize the management of auditory hallucination symptoms, improve the quality of nursing and ensure the safety of patients.
8.Research on the influence of light with different wavelength on the motion behavior of carp robots.
Yong PENG ; Yang ZHAO ; Qian ZHANG ; Zhiyong BAO ; Xiaoyue LIU ; Hui ZHANG ; Jianing LIU ; Yudong WEN
Journal of Biomedical Engineering 2021;38(4):647-654
In order to study the effect of light with different wavelengths on the motion behavior of carp robots, phototaxis experiment, anatomical experiment, light control experiment and speed measurement experiment were carried out in this study. Blue, green, yellow and red light with different wavelength were used to conduct phototaxis experiments on carp to observe their movement behavior. By dissecting the skull bones of the carp to determine the appropriate location to carry the light control device, we independently developed a light control carrying device which was suitable for any illumination intensity environment. The experiment of the light-controlled carp robots was carried out. The motion behavior of the carp robot was checked by using computer binocular stereo vision technology. The motion trajectory of the carp robot was tracked and obtained by applying kernel correlation filter (KCF) algorithm. The motion velocity of the carp robot at different wavelengths was calculated according to their motion trajectory. The results showed that carps' sensitivity to different light changed from strong to weak in the order of blue, red, yellow and green, so that using light with different wavelengths to control the speed of the carp robot has certain laws to follow. A new method to avoid brain damage in carp robots control can be provided in this study.
Algorithms
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Animals
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Carps
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Motion
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Phototaxis
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Robotics
9.Partial research progress on precision hyperthermia for malignant tumors
Chinese Journal of Radiation Oncology 2020;29(3):233-236
Since the 21st century,with the changes of people's living habits and the aggravation ofenvironmental pollution,the incidence of tumors has been increasing day by day,which has become the main deathcauseof human diseases.Atpresent,in addition to the three major conventional treatments of tumors,the emergence of hyperthermia provides a safer and more effective solution for the prevention and treatment of tumors.Attributed to the rapid development of mechanical manufacturing,computertechnology,molecularbiology,materials science and other disciplines,precision hyperthermia presented by radiofrequency and ultrasonic focusing hyperthermia guided by magnetic resonance imaging (MRI) non-invasive temperature measure technology,as well as molecular level targeted hyperthermia have provided a broader perspective for the treatment of tumors.This article reviews the partial research progress on precision hyperthermia to understand the current general situation of precision hyperthermia for tumors.
10.Construction and immunogenicity of a genetic engineered strain expressing nontoxic ST1-LT(B)-alpha-beta fusion protein against diarrhea of piglet.
Jie SONG ; Mingming QIAN ; Jianing BAI ; Baohua ZHAO
Chinese Journal of Biotechnology 2008;24(8):1340-1347
We constructed a recombinant strain BL21 (DE3) (pETST3LTBalphabeta) including ST1-LT(B)-alpha-beta fusion gene via molecular technology. The SDS-PAGE and Western blotting indicated that the ST1-LT(B)-alpha-beta fusion protein was highly expressed in Escherichia coli and the molecular weight of the fusion protein was about 110 kD. The recombinant strain was induced in different concentrations of lactose and different aeration rate. The optimal culture conditions in 20 L fermentor were 1% inoculation (V/V), initial aeration 5 L/min, 0.03 mol/L lactose addition 3 hours after inoculation, and increased the aeration to 12.5 L/min for the following 6 hours. The fusion protein was about 38.53% of total cellular protein. It was nontoxic, immunogenic and protective against enterotoxigenic E. coli and Clostridium perfringens infection. The constructed recombinant strain BL21 (DE3) (pETST3LTBalphabeta) could serve as a candidate vaccine strain against diarrhea of piglet.
Animals
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Bacterial Toxins
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biosynthesis
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genetics
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Calcium-Binding Proteins
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biosynthesis
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genetics
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Clostridium perfringens
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genetics
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Dysentery
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prevention & control
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veterinary
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Enterotoxins
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biosynthesis
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genetics
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Escherichia coli
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genetics
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immunology
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Escherichia coli Proteins
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biosynthesis
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genetics
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Recombinant Fusion Proteins
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biosynthesis
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genetics
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immunology
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Swine
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Transformation, Bacterial
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genetics
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Type C Phospholipases
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biosynthesis
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genetics
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Vaccines, Synthetic
;
immunology

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