There are two modes of Institutional Re- view Board(IRB)review:"expedited"and"full board"or"full committee"review.The preliminary requirement of expedited review is minimal risk.Taking some interna- tional guidelines as reference,and considering the scope of review of IRB which review biomedical research involv- ing human subjects in China as well,this paper put for- ward the categories of research subject to expedited review and the operating procedure of expedited review,point out several items which should be paid attention to when con- ducting expedited review in the meantime.

This paper reported the acute toxicity test and the long-term toxicity test of Tongbi Tablets in rats and dogs. The LD_(50) of mice was 5.29g/kg. For dogs following oral administration (0.513g/kg/day, which was a tenth part of mice'LD_(50)) for 6 months running, the toxic symptom of strychnine-like and an increase in BUN could be-observed after 4-month administration. Both recoveried after breaking off the administration. For 0.051g/kg/day dosage group of dogs(administered for 6 months running)and all dosage groups of rats, no toxic symptom was observed, suggesting that the clinical dosage of this medicine was safe.

Objective To study the changes of 5-hydroxytryptamine(5-HT),its receptor,IL-2 and IL-6 in rats' ileum with spleen deficiency combined with gastric ulcer.To explore the pathogenesis of this disease and the therapic mechanism of sijunzi decoction. Methods Immunohistochemical technique,image analysis,radioimmunoassay and Western blotting were used. Results The 5-HT-positive cells of rat ileum were detected in mucosal and glandular cells.The 5-HTR-positive cells of rat ileum were found in the connective tissues between the intestinal villus and intestinal glands,and in neuroplex and smooth muscle tissues.The expression of 5HT and 5-HTR in ileum increased during the experimental spleen deficiency combined with gastric ulcer in rats.The 5-HTR level of rat ileum was higher.After treatment with Sijunzi decoction,all the changes have been reversed.The level of IL-2 and IL-6 increased during the early period of this disease.When the disease doveloped,the synthesis or secretion of IL-2 and IL-6 decreased. Conclusion The increased contents of 5-HT and its receptor in ileum tissues might be one of the causes of spleen-deficiency combined with gastric ulcer in rats.The mechanism of Sijunzi decoction is to reverse the changes.And the changed activity of IL-2 and IL-6 may be related with the degree of the disease.

Objective To analyze the expression of programmed death ligand 1 (PD-L1),p16 proteins and DNA topoisomerase Ⅱ α (TOPO Ⅱ α) in cervical cancer and their clinical significances.Methods A total of 181 paraffin-embedded operating specimens and the biopsy including 106 cervical squamous cell carcinoma,30 high grade cervical intraepithelial neoplasia (CIN),30 low grade CIN and 33 normal cervical were selected from January 2014 to December 2015.An immunohistochemical EnVision method was used to detect the expression of PD-L1,p16 and TOPO Ⅱ α.Results The positive rate of PD-L1 expression in cervical squamous cell carcinoma was 66.0 ％ (70/106),but it was not expressed in high grade CIN,low grade CIN and normal cervical tissues,the differences were statistically significant (all P =0.000).Whereas,in squamous cell carcinoma,the positive rate of PD-L1 in poor differentiation group [77.3 ％ (51/66)] was higher than that in middle or high differentiation group [56.5 ％ (21/40)],and the difference was statistically significant (x2 =7.02,P =0.01).According to the FIGO stage,the positive rate in stage Ⅰ-Ⅱ group [54.9 ％ (28/51)] was lower than that in stage Ⅲ-Ⅳ group [76.4 ％ (42/55)],and the difference was statistically significant (x2 =5.47,P =0.02).But there was no statistical significance in lesion size or lymph node metastasis (both P ＞ 0.05).The positive rate of p16 in cervical squamous cell carcinoma was 99.1％ (105/ 106),in high grade CIN was 86.7 ％ (26/30),in low grade CIN was 26.7 ％ (8/30),and no expression in normal cervical tissues,the differences were statistically significant (all P ＜ 0.001).The expression of p16 had no relationship with histological differentiation,FIGO stage,lesion size,and lymph node metastasis (all P ＞ 0.05).The positive expression rate of TOPO Ⅱ α in cervical squamous cell carcinoma was 97.2 ％ (103/106),compared with that in high grade CIN [73.3 ％ (22/30)],low grade CIN [66.7 ％ (20/30)],and normal cervical tissues (no expression),the differences were statistically significant (all P =0.000).But there was nosignificant difference in the positive expression rate of TOPOⅡ α between high grade and low grade CIN (x2 =0.32,P =0.570).The expression of TOPO 1Ⅱ α had no relationship with histological differentiation,FIGO stage,lesion size and lymph node metastasis (all P ＞ 0.05).Conclusion The expression of PD-L1,p16 and TOPO Ⅱ α is associated with the invasion of cervical cancer.PD-L1 may be an immune checkpoint for the treatment of patients with invasive cervical cancer.

Objective To write the school-based teaching material of pathology,and apply it to the students in higher vocational colleges to evaluate the application effect.Methods Two classes of clinical medical students of Grade 201 1were divided into two groups:the experimental group(Class1,58 students) and the control group(Class2,60 students).Both of the two groups take the integration of theory and practice teaching method.The traditional teaching material was applied in the control group while the school-based teaching materials were adopted in the experimental group.Statistical analysis software SPSS 13.0 and two samples t test were used to compare the preparing effect before the class,case study effect and the final examination of the two groups.After the end of the course,students' teaching satisfaction questionnaire was conducted,and the results of the survey for the rank sum test were analyzed.Results The scores of preparing effect before class were higher in experimental group(84.4 ±6.2) than those in the control group(78.2 ±5.8),t=5.61,P=0.001; the case study effect in experimental group(78.6 ± 6.6) was higher than that of the control group(72.8 ± 5.3),t=5.27,P=0.002; there was no significant differences in the final examination between the two class [experimental group (83.5 ± 6.8),control group (81.6 ± 6.9)],t=1.51,P=0.183.The questionnaire shows,in the aspect of the difficulty of teaching material,the degree of satisfaction in the experimental group(satisfied:28,general:30,unsatisfied:0) was higher than the control group(satisfied:18,general:37,unsatisfied:5),Z=-2.43,P=0.015; in the aspect of reading interest,the degree of satisfaction in the experimental group(satisfied:32,general:25,unsatisfied:1) was higher than the control group(satisfied:22,general:35,unsatisfied:3),Z=-2.09,P=0.036; in the aspect of emphasizing on the key point,the degree of satisfaction in the experimental group(satisfied:20,general:38,unsatisfied:0) was higher than the control group(satisfied:12,general:39,unsatisfied:9),Z=-2.72,P=0.007; in the aspect of self-study effect,the degree of satisfaction in the experimental group(satisfied:20,general:38,unsatisfied:0) was higher than the control group(satisfied:16,general:39,unsatisfied:5),Z=-3.13,P=0.002; but there was no significant differences in classroomlearning effect(experimental group:satisfied,38,general,20,unsatisfied,0; control group:satisfied,36,general,23,unsatisfied,1),Z=-0.68,P=0.497.Conclusions The school-based teaching material can contribute to the students' self-learning,enhancing the students' interest of learning and knowledge-application ability.

Objective To evaluate the mid-long term effects of hysteroscopic treatment of abnormal uterine bleeding(AUB).Methods A total of 432 patients admitted from January 2002 to November 2005 with AUB were treated with hysteroscopy.All the patients were followed for at least 12 months.Among the 432 patients,391 were diagnosed as having benign lesions,including endometrial polyp in 96 patients(22.2%),submucous myoma in 38 patients(8.8%),and endometrial hyperplasia in 257 patients(59.5%),receiving transcervical myoma resection or transcervical endometrium resection.The other 41 patients were diagnosed as having stage Ⅰ endometrial carcinoma,and a total hysterectomy and bilateral adnexectomy with selective pelvic lymphadenectomy was performed.Results All the operations were successfully completed,without uterine perforation or other complications.During a follow-up of 12～57 months(mean,39 months) in the 391 patients with benign lesions,amenorrhea was found in 63 patients(16.1%,63/391),hypomenorrhea( 1.5 cm in 8 patients,and a second hysteroscopic endometrial resection was given at 5～19 months after first operation.All the 8 patients were further followed for 18～36 months,with findings of amenorrhea in 5 of them and hypomenorrhea in 3.All the 41 patients with stage Ⅰ endometrial carcinoma survived without recurrence during a follow-up period for 26～41 months(mean,38 months).Conclusions Hysteroscopic treatment can be the first choice for treating non-malignant AUB.Pre-operational pathological examination and ultrasonography can enhance the safety and efficacy of the operation.

Objective To evaluate the mid-long term effects of laparoscopic treatment of ovarian endometriosis cysts.Methods Clinical data of 209 cases of ovarian endometriosis cysts treated by laparoscopic operation from January 2002 to December 2005 were retrospectively analyzed.All the patients were followed for at least 12 months(12-54 months).There were 115 cases of unilateral ovarian cyst enucleation,62 cases of bilateral enucleation,11 cases of unilateral adnexectomy,and 21 cases of unilateral adnexectomy combined with contralateral cyst enucleation.Oral gestrinone was administrated in patients without childbearing intentions,while in patients demanding a child,no drug was given and an early pregnancy was encouraged.Results Conversions to open surgery were required in 7 cases.No complications occurred.Ovarian endometriosis cysts recurred in 17 cases(8.1%),including 7 cases of stage Ⅲendometriosis and 10 cases of stage Ⅳ endometriosis.Of the 35 cases of infertility,intrauterine pregnancy was obtained in 16 cases,with a pregnancy rate of 45.7%.The pregnancy occurred at 4-29 months after operation(within 2 years in 10 cases).Of the 157 cases of dysmenorrhea,a complete relief was achieved in 95 cases(60.5%)and an improvement was obtained in 62 cases(39.5%).Conclusions Laparoscopic treatment is suitable for all stages of ovarian endometriosis cysts.Postoperative drug administration and long-term follow-up are necessary to lower the recurrence rate.

Objective To explore the relationship between the change of serum β-HCG and the effect of　conservative treatment in tubal ectopic pregnancy.Methods 95 patients with tubal ectopic pregnancy were treated with single dose methotrexate injection.Among them,87 patients were successfully cured,16 patients were treated with the 2nd dose and Chinese herbal medicine orally:8 patients failed.The change of serum β-HCG levels after the first and 2nd course of treatment were measured.Results It showed that after the first or 2nd course of treatment,the cases which serum β-HCG level reducing less than 15%in patients who had successful treatment were signiflcantly lower than that in patients who failed(P＜0.05).Conclusion Detecting the change of serum β-HCG concentration can evaluate the therapeutic effect in tubal ectopic pregnancy with conservative treatment,and according that surgical operation should be chosen if serum β-HCG reduce less than 15%after two courses of treatment.

Objective To discuss the relationship between leptin level and polycystic ovary syndrome (PCOS) in adolescent patients with polycystic ovary syndrome, and to explore the classification diagnosis method of adolescent PCOS and indicator for clinical monitoring of obese patients. Methods All enrolled adolescent individuals were assigned into four groups: 30 normal adolescent individuals in the control group, 30 simple adolescent obese individuals in the simple obesity group,27 obese adolescent PCOS patients in the obese PCOS group and 14 nonobese adolescent PCOS patients in the nonobese PCOS group. The fasting serum samples were prepared for leptin level measurement and analysis, Results The serum leptin level of in the control group, the simple obesity group, the obese PCOS group and the nonobese PCOS group were ( 19.44 ± 6. 63 ) μg/L vs.(23.09 ±7. 39) μg/L, (42. 99 ±9. 83) μg/L and (31, 92 ±7, 02) μg/L,respectively. Leptin in the obese PCOS group was significantly higher than that in the control group and the simple obese group (t = 2. 903 and 2. 714 respectively,Ps ＜ 0. 05 ). Conclusion Monitoring the serum level of leptin can not only aid the classification of adolescent PCOS patients and guide the treatment, but also can serve as a indicator for therapeutic monitoring of obese adolescent PCOS.

During 2004 to 2009, 701 patients with diabetes were under community-hospital-based integrated management at Zhonghua and Xiagang community health-care service centers, Xiamen, Fujian.Changes of clinical indicators, life-style and frequency of checks for its complications in them were compared before and after the management. All clinical indicators decreased with length of management, with fasting blood glucose from ( 7. 6 ± 2. 3 ) mmol/L before management to ( 7. 3 ± 2. 0) mmol/L half a year after management, (7. 2 ± 2. 1 ) mmol/L one year after management, (6. 9 ± 1.7 ) mmol/L two years after management. Their life-style also improved significantly and frequency of checks for complications increased with: 54. 4% for retinopathy, 52. 5% for diabetic foot, and 51.8% for neuropathy after management (P ＜0. 05).