1.Research progress on non-clinical safety evaluation of SARS-CoV-2 vaccine
Chinese Journal of Biologicals 2023;36(6):742-750
The Coronavirus Disease 2019(COVID-19) pandemic is having a dramatic impact on human health,lives,and the global economy. The development of a safe and efficacious vaccine is the most effective intervention to protect the population from the disease and limit the spread of the virus. Based on the current guidelines and research progress of severe acute respiratory symptom coronavirus 2(SARS-CoV-2) vaccines in various countries,this review summarized the research progress on non-clinical safety evaluation of SARS-CoV-2 vaccines by referring to the guidelines and relevant literatures over the world,in order to provide a reference for non-clinical research of SARS-CoV-2 vaccines.
2.Clinical study of the effect of actovegin in the prevention of acute irradiation oropharyngeal mucositis
Xuecheng ZHANG ; Feng XIAO ; Lichun WEI ; Yong ZHU ; Mei SHI
Journal of Practical Stomatology 1995;0(04):-
0.05). Regarding to the grade of irradiation mucositis, the majority of patients in the treatment group were at stage Ⅰ-Ⅱ,while those in the control at stage Ⅲ-Ⅳ(P0.05).No adverse drug reaction was observed in both groups during irradiation process.Conclusion:Actovegin can postpone the development of irradiation oropharyngeal mucositis and decrease the incidence of gradeⅢ and Ⅳmucositis.
3.Pathological Changes of Diffuse Pneumocystis carinii Infection in the Liver of an AIDS Patient
Xiaoqin GUAN ; Lichun ZHOU ; Xiaogang LIAO ; Xiao LIN ; Yuanyuan LI
Chinese Journal of Parasitology and Parasitic Diseases 1987;0(04):-
Objective To examine the pathological changes in the liver of an AIDS patient with complicated infection of Pneumocystis carinii(PC). \ Methods\ A liver biopsy was made. The tissue was stained with HE, PAS, Giemsa, GMS, and acid\|fast staining, and examined under light microscope and transmission electron microscope. \ Results\ Granulomas (acid\|fast negative) in the tissue and numerous pathogens (PAS positive) in hepatic sinusoids were detected. Giemsa and GMS staining and electron microscopy all confirmed that the pathogen was Pneumocystis carinii. \ Conclusion\ The pathological findings revealed a diffuse extrapulmonary infection of Pneumocystis carinii in the patient of AIDS.
4.Therapeutic efficacy of three-dimensional conformal radiotherapy combined with concurrent weekly cisplatin-based chemotherapy for locally advanced cervical cancer
Hongjun LU ; Mei SHI ; Lichun WEI ; Feng XIAO ; Junyue LIU ; Man XU ; Lina TAN
Chinese Journal of Radiation Oncology 2011;20(2):144-148
Objective To analyze the therapeutic efficacy and treatment related toxicities for patients with locally advanced cervical cancer treated with three-dimensional conformal radiotherapy (3DCRT) combined with concurrent chemotherapy. Methods From January 2007 to February 2008, 181 patients with stage ⅡA-ⅣA cervical cancer were retrospectively analyzed. All patients were treated with CT-based three-dimensional external beam and 192Ir intracavity radiotherapy combined with concurrent weekly cisplatin-based chemotherapy. The median age was 50 years (range, 32 to 82 years). The overall survival ( OS), disease-free survival (DFS) and local control (LC) rates were calcalated by Kaplan-Meier method and the difference was compared using Log-rank test. The treatment related toxicities were evaluated according to Radiotherapy Oncology Group (RTOG) criteria. Results With a median follow-up time of 34 months and following rate of 92. 2%, the 3-year OS, DFS and LC rates were 73.4%, 70. 4% and 91.3%,respectively. The 3-year OS rate was 66. 9% for patients with tumor diameter ≥4 cm and 86. 4% for those with tumor diameter <4 cm( χ2 =6. 29 ,P =0. 012). The incidences of grade 1 and grade 2 acute toxicities of the lower gastrointestinal tract and the genitourinary system were 40. 0% ,45.0% and 19. 9% ,4. 4%,retrospectively. There were no grade 3 or more acute toxicities. The incidence of grades 3 or 4 late toxicities of the lower gastrointestinal tract was 4. 9%. Conclusions CT-based three-dimensional external beam and 192Ir intracavity radiotherapy combined with concurrent chemotherapy can achieve good therapeutic effects for locally advanced cervical cancer. The acute and late toxicities are significantly reduced compared with historic controls as a result of incorporation of 3DCRT technique.
5.Randomized study of kezhi Capsules in Treating Nonalconolic Fatty Liver
Yuewu YANG ; Gemin XIAO ; Baiming ZHAO ; Hongzhi YANG ; Min DAI ; Lichun TENG
The Journal of Practical Medicine 2014;(4):638-640
Objective To evaluate the effect and side effects of Kezhi capsule in short-term treatment of nonalcoholic fatty liver disease (NAFLD). Methods 60 NAFLD cases of outpatients according to the inclusion criteria of were randomly assigned to two groups: the treated group-30cases with the prescription of Kezhi capsule , and the control group-30cases with the prescription of Xuezhikang. The treatment Course of taking Kezhi capusule (1.25 g, tid, po) and Xuezhikang(0.6 g, bid, po)was 24 weeks. Results After treatment in both groups we saw the significant decrease of the levels of ALT, AST, TC, TG, LDL-C, CREAT, BUN, BMI and TCM Syndromes scores, and the improvement of the ultrasonographic findings of liver steatosis. In the Xuezhikang group we saw higher decrease of TC and TG than the Kezhi capsule group with statistic difference (P < 0.05), while in Kezhi capsule group we saw higher decrease of BMI , TCM Syndromes scores and the improvement of the ultrasonographic findings of liver steatosis than the xuezhikang group with statistic difference (P < 0.05). Conclusions The results show that kezhi capsule is effective for the treatment of NAFLD without obvious side effects.
6.The correlation between DVH at CT-image based 192Ir intracavitary brachytherapy and effects or complications for patients with locally advanced cervical cancer
Mei SHI ; Lichun WEI ; Junyue LIU ; Feng XIAO ; Ying XUE ; Yong ZHU ; Jianping LI ; Xiaoli YOU
Chinese Journal of Radiation Oncology 2011;20(1):49-53
Objective To investigate the correlation between dose volume histogram(DVH)of tumor targets and organs at risk(OAR)at CT-image based 192Ir brachytherapy and effects and complications for patients with locally advanced cervical cancer. Methods Ten patients with FIGO stage ⅢB cervical cancer received CT image-based 192Ir intracavitary brachytherapy after 54 Gy of three-dimentional four-field pelvic external beam radiotherapy and concurrent weekly cisplatin chemotherapy. Before each brachytherapy,CT images were acquired with applicators in place. Gross tumor volume(GTV), clinical target volume (CTV)and OAR were contoured and inverse treatment planning was designed and optimized by using PLATO treatment planning system. Conventional two-dimensional plans were also designed for comparison.The total intracavitary brachytherapy dose was 30 -42 Gy in 5 -7 fractions. The patients were followed, and the local control and complications were analyzed. The biologically equivalent dose(BED)and biologically equivalent dose in 2 Gy fractions(BED2)for GTV, CTV and OAR were calculated. The minimum dose in the most irradiated tissue volume 2 cm3(D2 cm3)adjacent to the applicator of the sigmoid colon, rectum,bladder and small bowel was determined from the DVH. Results The 1-year local pelvic control rate was 90% and grade 1-2 late complication of sigmoid colon and rectum was 50%. No grade 3 or more complications developed. On CT-image based planning, the BED and BED2 to 90% of the CTV(D90)were 95.50 Gy ± 7. 81 Gy and 79. 73 Gy ± 6. 57 Gy. The BED and BED2 to 90% of the GTV(D90)were 101.86 Gy ± 7.27 Gy and 84. 95 Gy ± 6. 1 Gy. The volume enclosed by 90% of prescribed dose(V90)for GTV and CTV were 92% ±4% and 87% ±7% respectively. The D2cm3 for rectum and sigmoid colon were 74. 97 Gy ±1.64 Gy and 67. 93 Gy ± 4. 30 Gy(EQD2, α/β = 3). Comparing with 2D brachytherapy plans , CT - image based planning has improved D90 and V90 for GTV and CTV with similar dose at point A and rectum reference point. Conclusions Computer tomography-image based 192Ir brachytherapy has resulted in the better dose distribution to the tumor targets with excellent tumor control and acceptable toxicity.
7.The Possibility Study of Bio-verification of Radiation Location and Dose Distribution for High Energy X-ray in Radiation Therapy
Quanshi ZHANG ; Kai LI ; Xiwen WANG ; Baowei HUA ; Lichun CHUI ; Qi WANG ; Xiao WANG ; Lei HUANG
Chinese Journal of Medical Physics 2010;27(1):1573-1577
Purpose:The image information and technique of positron emitter nuclei generated by high energy X-ray photonuclear reactions with body tissues from MM50 is studied.It is explored to verify for dose delivery and location monitoring in tumor target after high energy photon radiation therapy with the image information.Materials and Methods:The technique is based on the photonuclear reactio-as in body tissues elemental composition ~(12)C,~(16)O and ~(14)N with high energy X-Ray,energies well above 20 MeV,resulting primarily in ~(11)C and ~(15)O but also ~(13)N.The induced positron activity distributions were scanned off-line in a PET/CT after irradiation.The activity distributions and position may be used to verify for dose delivery and location in tumor target.These radiations are similar to RT in three fields with some different dose delivery from TPS.The phantom began to be scanned off-line in a PET/CT a couple of minutes after irradiation.The scanning time is respectively 20 minutes and(2~5)mniutes for ~(12)C and ~(16)O.The levels of the beam energy are 10MV,25MV,50 MV.The extent of dose is 1.0 Gy~10.0 Gy.Since measured PET images change with time post irradiation,as a result of the different decay tim-es of the radionuclides,the signals from activated ~(12)C,~(16)O within the irradiated volume could be separated from each other.Most informationis obrained from the carbon and oxygen radionuclide's which the most abundant elements are in soft tissue.A brain phantom Rlade oneself was irradiated with high energy X-ray beams from IBA MM50.The 3D radiation treatment planning system,Nucletron-TPP 3.2,was used to calculate the delivered dose distributions.The phantom was directly simulated in the Nucletron-TPP after CT scan.PET/CT is fro-m GE Discovery LS Ⅱ.Resuits:It was confirmed that no activity was detected at 10 Mv X-ray energy,which was far below the energy threshold for photonuclear reactions.Totally 25 MV X-ray beams can produce photonuclear reactions and get to activity distributions images in PET/CT.It need to greater dose in order to good images information.For 50 MV X-ray beams,2 Gy-3 Gy dose,a normal RT dose,can get to activity distributions images.Conclusions:It was concluded that the PET-CT image acquired from the activity of the ~(15)O and ~(11)C positron emitter nuclei might provide the area and dose distribution information of 50 MV X-ray irradiation in a phantom.It can verify the in vivo dose delivery and location in tumor target after high energy X-ray RT.
8.Tougu Xiaotong Granule containing serum induces cartilage differentiation of bone marrow stromal stem cells
Boling LIU ; Xihai LI ; Lichun XIAO ; Guiqing LIANG ; Guangwen WU ; Zhaohui LI ; Qiyong CHEN
Chinese Journal of Tissue Engineering Research 2013;(32):5863-5870
BACKGROUND:Bone marrow stromal stem cel s have multilineage differentiation capacity and can differentiate into transparent chondrocytes under certain conditions, which can provide new thoughts for treatment of osteoarthritis. OBJECTIVE:To investigate the effects of Tougu Xiaotong Granule containing serum on the cartilage differentiation of bone marrow stromal stem cel s. METHODS:Bone marrow stromal stem cel s from Sprague-Dawley rat limbs were cultured in vitro, and those cel s at passage 3 were used in the study. Cel s were divided into six groups:saline serum group, Tougu Xiaotong Granule water extract group, Tougu Xiaotong Granule alcohol extract group, chondroinductive group, Tougu Xiaotong Granule water extract and chondroinductive group, Tougu Xiaotong Granule alcohol extract and chondroinductive group. The Sox9, col agen Ⅱ, and col agen X mRNA and protein expression levels were tested by real-time polymerase chain reaction and western blot analysis. RESULTS AND CONCLUSION:After cel s were intervened with drug-containing serum for 14 days, the Sox9, col agen Ⅱ, and col agen X mRNA and protein expression in Tougu Xiaotong Granule water extract group, Tougu Xiaotong Granule alcohol extract group, chondroinductive group, Tougu Xiaotong Granule water extract and chondroinductive group, Tougu Xiaotong Granule alcohol extract and chondroinductive group were significantly higher than that in saline serum group (P<0.05, P<0.01). In addition, the chondroinductive group, Tougu Xiaotong Granule water extract serum and chondroinductive group, Tougu Xiaotong Granule alcohol extract and chondroinductive group showed significantly higher expression levels than Tougu Xiaotong Granule water extract serum group, Tougu Xiaotong Granule alcohol extract group (P<0.01). Sox9 expression in Tougu Xiaotong Granule water extract serum and chondroinductive group were significantly higher than that in the chondroinductive group. Experimental findings indicate that, Tougu Xiaotong Granule containing serum can accelerate bone marrow stromal stem cel s differentiate into cartilage cel s by up-regulation of Sox9 expression.
9.The role of digital subtraction angiography in the diagnosis and treatment of small intestinal tumor with massive lower gastrointestinal hemorrhage
Haiyi LIU ; Lichun WANG ; Yujian ZENG ; Bing XU ; Junmin SONG ; Yongyang YU ; Xiao LI ; Cun WANG ; Lie YANG ; Zongguang ZHOU
Cancer Research and Clinic 2008;20(9):610-611
Objective To discuss the diagnostic value of DSA for massive hemorrhage in lower gastrointestinal tract resulting from tumour. Methods 24 patients with massive lower gastrointestinal hemorrhage were performed DSA and then operated as tumour. Results Among 24 patients, 17 cases demonstrated direct signs of hemorrhage, 9 cases visible turnout vessels; 24 patients all showed clumping tumour-specifie dyeing. Conclusion DSA is of great value to determining the location and qualitation of the massive lower gastrointestinal hemorrhage resuhing from tumours.
10.Effect of Parasep? feces centrifuge tube method on detecting schistosome eggs
Nian MA ; Huaming ZHANG ; Xiong LIU ; Chuanyun XIAO ; Xiaohong WEN ; Xia LI ; Lichun DONG ; Caixia CUI ; Zuwu TU
Chinese Journal of Schistosomiasis Control 2014;(4):431-433
Objective To evaluate the effect of the Parasep? feces centrifuge tube method on detecting schistosome eggs. Methods A total of 803 residents aged from 6-65 years were selected in 2 schistosomiasis endemic villages Jiangling Coun-ty Hubei Province and their stool samples were collected and detected parallelly by the Kato-Katz technique nylon silk egg hatching method and Parasep? feces centrifuge tube method at the same time. Results Among the 803 people 15 cases were found of schistosome egg positive and the positive rate was 1.87%. The positive rates of the Kato-Katz technique nylon silk egg hatching method and Parasep? feces centrifuge tube method were 0.75% 1.49% and 1.12% respectively. The schistosome eggs got with the Parasep? feces centrifuge tube method were clear and easy to identify. Conclusion In low endemic areas of schistosomiasis the Parasep? feces centrifuge tube method can be used as schistosomiasis japonica etiology diagnosis method.