Drug clinical trials constitute a critical link in new drug development and an essential means to verify the safety and efficacy of pharmaceuticals. The protection of participants’ rights and interests and the prevention of risks directly affect the scientific ethics and social credibility of the trials. Vulnerable groups， due to restricted autonomous decision-making capacities or special social status， are more susceptible to safety risks. Children are a typical representative of vulnerable groups. Their physiological particularities， cognitive limitations， and dependence collectively epitomize the universal protection demands of vulnerable research participants. Taking children as an instance， this paper analyzes the current weak links in the protection of pediatric research participants. Integrating advanced international experience with domestic practical demands， it comprehensively identified protection risk points at every stage and constructed a multi-stakeholder collaborative mechanism for the full-process protection of pediatric research participants. This mechanism incorporated seven main entities， including drug regulatory authorities， sponsors， researchers， and ethics committees， covering the pre-trial， intra-trial， and post-trial phases to meet the requirements of full-chain and multi-dimensional protection. It provided references for the subsequent establishment of a systematic protection mechanism for vulnerable populations.

Objective To investigate the clinicopathological features and correlation between synchronous multiple early gastric cancer (SMEGC)and single early gastric cancer (EGC).Methods From January 2008 to December 2016,the clinical data of 994 patients with EGC who underwent open or laparoscopic gastrectomy surgery were collected from the electronic medical data base of the First Affiliated Hospital of Nanjing Medical University and Xuzhou No.1 People's Hospital.The data of patients including gender,age,tumor morphologys,tumor location,tumor size,histological type,depth of invasion,lymph nodes metastasis,lymphovascular metastasis,peripheral nerve invasion,and blood types were analyzed.T test and Chi square test were used for statistical analysis.Results Among 994 EGC patients,27 cases (2.7％) were SMEGC,and 967 cases (97.3％) were single EGC.The percentage of male and female of single EGC were 71.4％ (690/967) and 28.6％ (277/967),respectively;the percentage of male and female of SMEGC were 88.9％ (24/27) and 11.1％ (3/27),respectively,and there was statistically significant difference in the gender composition ratio between single EGC and SMEGC (x2 =3.975,P=0.046).The incidence of ulcer in single EGC and SMEGC were 50.6％ (489/ 967) and 29.6 ％ (8/27),respectively,and the difference in the incidence of ulcers between single EGC and SMEGC was statistically significant (x2 =4.653,P=0.031).There were no statistically significant differences between single EGC and SMEGC in gross morphology,depth of invasion,lymph nodes metastasis,lymphovascular metastasis,peripheral nerve invasion,tumor location,pathological type and blood types (all P＞0.05).In the SMEGC patients,the incidence of main lesions invading the mucosa was 48.1％ (13/27) and submucosa invasion was 51.9％ (14/27);and for minor lesions,the corresponding incidences were 77.8％ (21/27) and 22.2％ (6/27),respectively,and the difference was statistically significant (x2 =5.063,P＜0.05).There were no statistically significant differences between the main lesions and minor lesions in tumor size,pathological type,with or without ulcers,gross morphology and tumor location (all P＞0.05).Conclusions The main risk factors of SMEGC are male and no ulcerative lesions.The clinicopathological features are similar between main lesions and minor lesions in SMEGC.

Objective To compare the cumulative analgesic effects of electroacupuncture at Sanyinjiao (SP6), Xuanzhong (GB39) and non-acupoint in treating primary dysmenorrhea. Method By adopting a multi-centered randomized controlled study method, 501 patients recruited from Dongzhimen Hospital of Beijing University of Chinese Medicine, China-Japan Friendship Hospital, Beijing Hospital of Traditional Chinese Medicine of Capital Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Huguosi Hospital of Chinese Medicine of Beijing University of Chinese Medicine and the Outpatient of Shandong University of Traditional Chinese Medicine were randomized into a Sanyinjiao group, a Xuanzhong group, and a non-acupoint group, 167 subjects in each group. The electroacupuncture intervention was applied when dysmenorrhea flared up and the Visual Analogue Scale (VAS) ≥40 mm, with frequency at 2/100 Hz and intensity during patient’s endurance, 30 min each time, once a day, and for successive 3 d. Before the first treatment, 30 min after the first treatment, and respectively prior to the second and third treatment, VAS was used to measure the pain intensity. Meanwhile, the Retrospective Symptom Scale (RSS-COX 2) was investigated before the first treatment, right after the removal of needles for the first treatment, before the second and third treatment. Result The decrease of VAS in Sanyinjiao group was more significant than that in Xuanzhong group and non-acupoint group (MD=﹣2.92 mm, P=0.028; MD=﹣3.47 mm, P=0.009), while there was no significant difference between Xuanzhong group and non-acupoint group (MD=﹣0.56 mm, P=0.674); there were no significant differences in comparing the RSS-COX2 total score among the three groups (P=0.086). Conclusion Sanyinjiao (SP6) can produce a more significant cumulative analgesic effect for primary dysmenorrhea patient than Xuanzhong and non-acupoint, and the effects of Xuanzhong and non-acupoit are equivalent.

Objective To investigate the effect of comprehensive nursing intervention on postoperative pain of patients undergoing general surgery.Methods 100 patients undergoing general surgery with postoperative pain were divided into the observation group and the control group with 50 patients in each group.The control group received routine nursing,and the observation group received comprehensive nursing intervention.The nursing effect was compared between two groups.Results The number of cases using the PCA and analgesics in the observation group was fewer than those in the control group,and there were significant difference between them.The cases of pain level Ⅰ in the observation group were more than those in the control group,and the cases of pain level Ⅲ in the observation group were fewer than those in the control group,and there were significant difference between them.The satisfaction degree of the observation group were more than those in the control group,and there were significant differences between them.Conclusions The effect of comprehensive nursing intervention in cases with postoperative pain undergoing general surgery is obvious,so it is worth being used.