This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
Equipment and Supplies ; standards ; Risk Assessment ; United States ; United States Food and Drug Administration

We investigated the molecular characteristics of the full-length genome of 14 dengue serotype 1 virus (DENV-1)strains isolated in Sino-Myanmar border region in Yunnan Province,China during 2013-2015.Isolation of dengue virus was using C6/36 cell culture method.Viral RNA was extracted from virus isolates,and then the full-length genome was amplified by RT-PCR.The homology and phylogenetic analysis was made on the nucleotide and deduced amino acid sequences by bioinformatics software including ClastalX1.83 and MEGA6 etc.Results showed that fourteen strains of DENV-1 isolated from dengue fever cases,of these,9 strains from Ruili City of Dehong Prefecture,3 from Lincang Prefecture,2 from Kunming City.RT-PCR and sequencing indicated that the full-length genes (10 735 nt) of 14 DENV-1 strains were obtained,and their open reading frame (95-10 271) were coded 3 392 amino acid residues.The genotypes of DENV-1 were revealed by homology and phylogenetic analysis based on structural and non-structural proteins.Thirteen were genotype Ⅰ (G-Ⅰ) (7 from indigenous cases in Ruili and Lincang and 6 from imported case from Myanmar to Ruili,Lincang and Kunming),and 1 G-Ⅲ from imported case from India to Kunming.The phylogenic analysis indicated that the 13 isolates from Yunnan divided into 2 phylogenic subgroups,and they had a closer genetic relationship with the strains isolated from Southeast Asia.The gene sequences of the 13 G-Ⅰ strains have been acquired,the rate of their nucleotide homology and amino acid homology were 97.02 ％-100 ％ and 98.78 ％100 ％ respectively.Compared with 6 strains from Southeast Asia,nucleotide homology and amino acid homology were 96.53％-99.53％ and 97.33％-100％ respectively.Compared with prototype strain (US_Hawaii) of DENV-1,nucleotide homology and amino acid homology were 93.76％-94.45 ％ and 95.86 ％-96.91％ respectively.Compared with US_Hawaii strain,there were 44 and 150 different sites in amino acid of structural and non-structural proteins,respectively.The G-1 of DENV-1 have been popular in Sino-Myanmar border region in Yunnan,2013-2015.They have genetic diversity but multiple transmission sources were from Myanmar,and should strengthen control cross-border spread of dengue fever in this region.It is necessary to further study that change of the amino acid sites of Yunnan strains of DENV-1 is related to its antigenicity and pathogenicity.

Objective To assess the therapeutic efficacy of a recombined adenovirus expressing p53 (rAd-p53) via intrapleural injec-tion in the treatment of lung cancer with malignant pleural effusion. Methods Thirty-six cases with lung cancer and malignant pleural effu-sion were randomly divided into two groups,which were given intravenous injection of Nedaplatin with (observation group,n=20) or without (control group,n=16) intrapleural injection of rAd-p53,respectively. Between the two groups,the efficacy in treatment of pleural effusion, the amelioration of maximal ventilatory volume ( MVV) ,Kamofsky scoring ( KPS) and quality of life were compared. Results The efficacy in treatment of pleural effusion in observation group are significantly higher than that in control group(17/20 vs. 50%,P<0. 05). The cases with KPS≥80 in observation group were significantly increased following treatment (5/20 vs. 11/20,P <0. 05). However,there was no difference with the cases in control group. Conclusion Intrapleural injection of recombinant adenovirus expressing p53 (rAd-p53) is effec-tive to reduce the occurrence of malignant pleural effusion and increase the quality of life remarkably.

This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.

Objective To observe the efficacy,safety and defecation function of laparoscopic modified Soave short muscle sheath in the treatment of children with Hirschcolon(HD).Methods A total of 91 children with HD admitted to our hospital from January 2018 to May 2023 were selected for the study,and were divided into observation group(modified laparoscopic Soave short muscle sheath operation,41 cases)and control group(traditional laparoscopic Soave Hirschacolon radical resection,50 cases)according to random number table method.Operation time,postoperative blood loss,postoperative defecation time,postoperative hospital stay,length of resection intestine and preoperative enema time were compared between the two groups.White blood cell count(WBC)and C-reactive protein(CRP)levels before and after operation were compared between the two groups,and pain scores were compared between the two groups 12 h,24 h,36 h and 48 h after operation.Postoperative defecation function and postoperative complications were compared between the two groups.Results The operation time[(134.07±22.08)min],postoperative blood loss[(5.17±0.87)ml],postoperative defecation time[(2.10±0.32)d],postoperative hospital stay[(7.59±1.25)d],length of intestinal tube resection[(15.24±2.25)cm]and preoperative enema time[(13.61±2.14)min]in observation group were all lower than those in control group[(159.78±25.44)min,(7.61±1.41)ml,(2.46±0.53)d,(10.59±1.84)d,(16.67±2.54)cm and(16.44±2.57)min](P＜0.05).After operation,the serum WBC and CRP levels of the two groups were significantly increased,but the serum WBC and CRP levels of the observation group were lower than those of the control group(P＜0.05).The pain scores of the observation group(3.42±0.69,3.17±0.64,2.52±0.58,2.06±0.53)at 12 h,24 h,36 h and 48 h were lower than those of the control group(4.47±0.76,3.78±0.72,3.31±0.66,2.83±0.64)(P＜0.05).There was no significant difference in defecation function between the two groups(P＞0.05).The total incidence of postoperative complications was 17.07％in the observation group,which was lower than 34.00％in the control group(P＜0.05).Conclusion The effect of laparoscopic modified Soave short muscle sheath in HD children is better,which can effectively improve various clinical indicators and defecation function,relieve postoperative pain,reduce the degree of infection,reduce postoperative complications,and have higher safety.

Objective     To compare the perioperative outcomes of atypical segmentectomy between robotic-assisted thoracoscopic surgery (RATS) and conventional video-assisted thoracoscopic surgery (VATS) in early-stage non-small cell lung cancer (NSCLC). Methods    The data of patients who underwent minimally invasive anatomic atypical segmentectomy in our hospital from October 2016 to December 2021 were collected. These patients were divided into a RATS group and a VATS group according to the operation method. Propensity score (PS) matching was used to select patients with close clinical baseline characteristics, and the perioperative results of the two groups were compared. Results    A total of 1 048 patients were enrolled, including 320 males and 728 females, with a mean age of 53.51±11.13 years. There were 277 patients in the RATS group and 771 patients in the VATS group. After 1∶1 PS matching, 277 pairs were selected. Both groups were well balanced for age, sex, smoking history, body mass index, Charlson comorbidity index, pulmonary function, tumor size, tumor location, and histological type. All patients were R0 resection, and there were no deaths within 30 days after surgery. The RATS group had shorter operative time [85 (75, 105) min vs. 115 (95, 140) min, P<0.001] and less blood loss [50 (30, 100) mL vs. 60 (50, 100) mL, P=0.001]. There were no statistical differences between the two groups in lymph node resection, conversion to thoracotomy, thoracic drainage time, total amount of thoracic drainage or postoperative complications (P>0.05). Conclusion    Both RATS and VATS atypical segment-ectomies are safe and feasible for early-stage NSCLC. RATS can effectively shorten the operative time, and reduce blood loss.

Objective    To summarize the experience of robot-assisted lung basal segmentectomy, and analyze the clinical application value of intersegmental tunneling and pulmonary ligament approach for S9 and/or S10 segmentectomy. Methods    The clinical data of 78 patients who underwent robotic lung basal segmentectomy in our hospital between January 2020 to May 2022 were retrospectively reviewed. There were 32 males and 46 females with a median age of 50 (33-72) years. The patients who underwent S9 and/or S10 segmentectomy were divided into a single-direction group (pulmonary ligament approach, n=19) and a bi-direction group (intersegmental tunneling, n=19) according to different approaches, and the perioperative outcomes between the two groups were compared. Results    All patients successfully completed the operation, without conversion to thoracotomy and lobectomy, serious complications, or perioperative death. The median operation time was 100 (40-185) min, the blood loss was 50 (10-210) mL, and the median number of dissected lymph nodes was 3 (1-14). There were 4 (5.1%) patients with postoperative air leakage, and 4 (5.1%) patients with hydropneumothorax. No patient showed localized atelectasis or lung congestion at 6 months after the operation. Further analysis showed that there was no significant difference in the operation time, blood loss, thoracic drainage time, complications or postoperative hospital stay between the single-direction and bi-direction groups (P>0.05). However, the number of dissected lymph nodes of the bi-direction group was more than that of the single-direction group [6 (1-13) vs. 5 (1-9), P=0.040]. Conclusion    The robotic lung basal segmentectomy for pulmonary nodules is safe and effective. The  perioperative results of robotic S9 and/or S10 complex segmentectomy using intersegmental tunneling and pulmonary ligament approach are similar.

Myoclonus dystonia syndrome (MDS) is an inherited movement disorder, and most MDS-related mutations have so far been found in the ε-sarcoglycan (SGCE) coding gene. By generating SGCE-knockout (KO) and human 237 C > T mutation knock-in (KI) mice, we showed here that both KO and KI mice exerted typical movement defects similar to those of MDS patients. SGCE promoted filopodia development in vitro and inhibited excitatory synapse formation both in vivo and in vitro. Loss of function of SGCE leading to excessive excitatory synapses that may ultimately contribute to MDS pathology. Indeed, using a zebrafish MDS model, we found that among 1700 screened chemical compounds, Vigabatrin was the most potent in readily reversing MDS symptoms of mouse disease models. Our study strengthens the notion that mutations of SGCE lead to MDS and most likely, SGCE functions to brake synaptogenesis in the CNS.