The paper summarizes the authorized invention patents, device registration and the relevant published articles of acupuncture medical devices of TCM in recent 5 years, and analyzes the current status and challenges in this field. It is discovered that the optimization and substitution in diagnosis and treatment of acupuncture are involved in the development of acupuncture medical devices. The technology application of these devices are composed of traditional and emerging engineering technologies; and the theoretical guidance for their development requires the integration of traditional acupuncture principles with modern medical theories. The development of acupuncture medical devices highlights the characteristics of multidimensional integration, treatment for specific ailments, portability and wearability, painlessness and non-invasion, precision and personalization, as well as intelligent automation. Upon analysis, it is shown that in the development and product transformation of acupuncture medical devices in recent years, the theoretical principles of acupuncture of TCM have not been fully utilized yet, the transformation of patented product is low, the clinical evidence of product is insufficient, and the market competitiveness needs improvement. In the future, The theoretic guidance of acupuncture of TCM should be enhanced in the development of acupuncture medical devices, a production-education- research model with the combination of medicine and engineering be constructed, clinical verification of product be emphasized, and product development paradigms be advanced, so as to meet the demands of the medical market.
Acupuncture Therapy/trends* ; Humans ; Medicine, Chinese Traditional/instrumentation* ; Equipment and Supplies

Background: Endoscopy plays an important role in the early detection of gastric neoplastic lesions, but different techniques lead to different diagnostic accuracy. Aims: To explore and compare the diagnostic value of conventional endoscopy with white light imaging (WLI) and magnifying endoscopy with narrow-band imaging (ME-NBI) for early gastric neoplastic lesions. Methods: Patients suspected of having early gastric neoplastic lesions by WLI were collected consecutively from Jan. 2016 to Jun. 2018 at Shanghai Renji Hospital, and received ME-NBI within 2 weeks. The diagnosis based on WLI and ME-NBI was recorded, respectively. Targeted biopsy was re-performed in patients with suspected neoplastic lesion yet having no abnormalities in first biopsy. Patients with neoplastic lesions proved by pathology were treated with endoscopic resection or surgical operation and enrolled in the analysis. Using pathological diagnosis as gold standard, the diagnostic performance of WLI and ME-NBI for distinguishing intestinal-type gastric adenoma and early gastric cancer (EGC) was evaluated. Results: A total of 301 patients (301 lesions) were included, including 171 adenoma and 130 EGC. The interobserver agreement between two endoscopists was optimal for both WLI and ME-NBI observation (WLI: κ=0.70; ME-NBI: κ=0.81). The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of ME-NBI for distinguishing intestinal-type gastric adenoma from EGC were higher than those of WLI (89.2% vs. 76.9%, 90.6% vs. 71.9%, 87.9% vs. 67.6%, 91.7% vs. 80.4%, and 90.0% vs. 74.1%, respectively, all P<0.05). Conclusions: ME-NBI is superior to WLI in distinguishing intestinal-type gastric adenoma from EGC.

Objective To study the diagnostic value of Japan narrow band imaging expert team ( JNET) classification for differentiating pathological type of colorectal lesions. Methods A total of 418 colorectal lesions were retrospectively diagnosed by magnifying endoscopy with narrow band imaging ( ME-NBI) using JNET classification by two inexperienced doctors after a short time of training in JNET classification. Then lesions were diagnosed with Sano classification by the two doctors. Diagnostic results were compared with histologic findings as a golden standard. Results The sensitivity, specificity, and accuracy of JNET classification and Sano classification for neoplastic lesion differentiation were 98. 2％ VS 98. 5％, 77. 8％ VS 66. 7％, and 96. 9％ VS 96. 4％, respectively ( all P>0. 05 ) . These indicators for diagnosing cancerous lesions, including high grade intraepithelial neoplasia, intramucosal carcinoma and submucosal carcinoma, were 66. 7％ VS 80. 2％ ( P=0. 023) , 87. 6％ VS 79. 5％ ( P=0. 006) , and 82. 1％ VS 79. 7％( P=0. 379 ) , respectively, and those for predicting submucosal deep invasive cancers were 34. 8％ VS 39. 1％, 100. 0％ VS 99. 0％, and 96. 4％ VS 96. 3％, respectively ( all P>0. 05) . The diagnostic accuracy of JNET classification for differentiating neoplastic lesions were 95. 2％ in those with diameter <10 mm, 97. 0％ in 10～<20 mm, and 97. 8％ in ≥20 mm (P=0. 483), this finding were 95. 2％, 85. 1％ and 72. 1％ for cancer, respectively ( P<0. 0001 ) , and 100％, 96. 3％, and 94. 4％ for submucosal deep invasive cancer, respectively (P=0. 026). Shape and location of colorectal lesions showed no significant effect on the diagnostic efficacy of JNET classification. Conclusion JNET classification is valuable for doctors without experience of ME-NBI in diagnosing colorectal lesions and the efficiency is slightly superior to Sano classification. However, the accuracy of diagnosis for cancer with diameter ≥20 mm need to be improved.

Objective To compare the diagnostic accuracy of white light endoscopy ( WLE ) and magnifying endoscopy combined with narrow-band imaging ( ME-NBI) for intestinal-type gastric adenoma in benign lesions. Methods Data of patients with suspected early gastric neoplastic lesions diagnosed with WLE were collected from Shanghai Renji Hospital from January 2016 to December 2017. Patients with suspected early gastric neoplastic lesions by WLE were examined with WLE, ME-NBI and targeted biopsy again within 2 weeks. The results of WLE, ME-NBI and biopsy were recorded. Using pathological diagnosis as the golden standard, diagnostic efficacy of WLE and ME-NBI for intestinal-type gastric adenoma and other non-adenoma lesions was evaluated. Results A total of 232 patients ( 232 lesions) were included, i. e. , 124 intestinal-type gastric adenoma and 108 other non-adenoma lesions such as atrophy, ulcers, hyperplasia, low-grade intraepithelial neoplasia, etc. . The sensitivity, negative predictive value and accuracy of ME-NBI in intestinal-type gastric adenoma were higher than those of WLE ( 92. 7％ VS 71. 8％, 91. 6％ VS 73. 7％, 91. 8％ VS 80. 6％, all P <0. 01 ) . The specificity was consistent ( both 90. 7％) . There was no significant difference in the positive predictive value between WLE and ME-NBI ( 92. 0％ VS 89. 9％, P>0. 05 ) . Conclusion Diagnostic efficacy of ME-NBI in intestinal-type gastric adenoma from other non-adenoma lesions is significantly higher than that of WLE.

Objective To assess the potential risk factors of canceration for intestinal?type gastric adenoma. Methods A retrospective study were performed on the data of 142 intestinal?type gastric adenoma patients who underwent endoscopic resection and was confirmed by postoperative histopathology at Digestive Endoscopy Centre, Shanghai Renji Hospital from May 2012 to December 2016. Potential risk factors for canceration of intestinal?type gastric adenoma were analyzed using univariate and multivariate Logistic analysis. Results A total of 142 intestinal?type gastric adenomas from 142 patients were collected in the study,comprised of 124 noncancerous lesions(low grade intraepithelial neoplasia)and 18 cancerous lesions (high grade intraepithelial neoplasia or carcinoma). Age 65 and older(P=0.03, OR=3.37, 95%CI:1.10?10.29),size equal or greater than 2 cm(P= 0.04, OR= 3.93, 95%CI: 1.07?14.49), and Helicobacter Pylori infection(P=0.04,OR=3.60,95%CI:1.07?12.14)were significantly associated with canceration in the univariate Logistic regression analysis. In the multivariate regression analysis,age 65 and older(P=0.03,OR=4.36,95%CI:1.17?16.24),size equal or greater than 2 cm(P=0.02,OR=5.79, 95%CI:1.28?26.12),and Helicobacter Pylori infection(P=0.03,OR=3.89,95%CI:1.15?13.59)were independent risk factors of canceration. Conclusion Intestinal?type gastric adenoma has varying degrees of intraepithelial neoplasia. Patient who is 65 years or older, or with Helicobacter Pylori infection, and lesion diameter of more than 2 cm are the potential risk factors of carceration.