1.Alterations in functional complexity of brain regions in autism spectrum disorder patients and correlations with the predicted brain age
Tianzi MENG ; Heran LI ; Shuting LIU ; Zhe LIU ; Yingnan WANG ; Rui LYU ; Haichen ZHAO ; Guangyu ZHANG ; Lemin HE ; Zhen ZHANG ; Xiaotao CAI
Chinese Journal of Medical Imaging Technology 2024;40(9):1319-1322
		                        		
		                        			
		                        			Objective To observe the alterations in functional complexity of brain regions in autism spectrum disorder(ASD)patients and correlations with the predicted brain age.Methods Open brain resting-state functional MRI(rs-MRI)data of 93 ASD patients and 96 typically developing adolescents(healthy subjects)were downloaded.The functional complexity in brain regions were extracted with self-developed virtual digital brain software,and the alterations in functional complexity of brain regions in ASD patients and correlations with their ages were analyzed.Two networks were prospectively trained with data of 65 ASD patients and 67 healthy subjects as the training set to predict brain age,and the results were evaluated,and the predicting errors were compared using test set,i.e.the other 28 ASD patients and 29 healthy subjects.Results Compared to healthy subjects,on the basis of anatomical automatic labeling(AAL)atlas,ASD patients exhibited significantly reduced functional complexity based on Shannon entropy in the left precuneus,left cuneus and right parahippocampal gyrus.Conversely,functional complexity of ASD patients based on permutation entropy significantly increased in the left cuneus and right cerebellar Crus Ⅱ region.The left hippocampus showed reduced functional complexity based on Pearson correlation coefficient,while the left middle temporal gyrus showed increased functional complexity based on Pearson correlation coefficient.The functional complexity in brain regions of ASD patients were not closely correlated with ages(all|r|<0.4).According to the trained fully connected network,the predicted brain ages of ASD patients and healthy subjects in test set were all lower than their physiological ages,but no significant difference was found between the prediction errors of ASD patients and healthy subjects(P=0.283).Conclusion Functional complexity changed in some brain region functions in ASD patients.The predicted brain ages of ASD patients based on the obtained fully connected network were on the low side,but not obviously affected by the alterations of functional complexity in brain regions.
		                        		
		                        		
		                        		
		                        	
2.Progress on study of factors influencing the prognosis and complications of surgery for discoid meniscus injury in children
Hai-Rui ZHANG ; Zhi-Yao ZHAO ; Bing-Zhe HUANG ; Xiao-Ning LIU
China Journal of Orthopaedics and Traumatology 2024;37(1):98-102
		                        		
		                        			
		                        			The discoid meniscus is a common congenital meniscal malformation that is prevalent mainly in Asians and of-ten occurs in the lateral discoid meniscus.Patients with asymptomatic discoid meniscus are usually treated by conservative methods such as observation and injury avoidance,while patients with symptoms and tears need to be treated surgically.Arthroscopic saucerization combined with partial meniscectomy and meniscus repair is the most common surgical approach.,and early to mid-term reports are good.The prognostic factors are the patient's age at surgery、follow-up time and type of surgery.Some patients experience complications such as prolonged postoperative knee pain,early osteoarthritis,retears and Osteochondritis dissecans.The incidence of prolonged postoperative knee pain was higher and the incidence of Osteochondritis dissecans was the lowest.Retears of the lateral meniscus is the main reason for reoperation.
		                        		
		                        		
		                        		
		                        	
3.Obesity is positively Associated with Depression in Older Adults: Role of Systemic Inflammation.
Ye Xin GUO ; An Qi WANG ; Xin GAO ; Jun NA ; Wei ZHE ; Yi ZENG ; Jing Rui ZHANG ; Yuan Jing JIANG ; Fei YAN ; Mukaram YUNUS ; Hui WANG ; Zhao Xue YIN
Biomedical and Environmental Sciences 2023;36(6):481-489
		                        		
		                        			OBJECTIVE:
		                        			We aimed to explore the association between obesity and depression and the role of systemic inflammation in older adults.
		                        		
		                        			METHODS:
		                        			Adults ≥ 65 years old ( n = 1,973) were interviewed at baseline in 2018 and 1,459 were followed up in 2021. General and abdominal obesity were assessed, and serum C-reactive protein (CRP) levels were measured at baseline. Depression status was assessed at baseline and at follow-up. Logistic regression was used to analyze the relationship between obesity and the incidence of depression and worsening of depressive symptoms, as well as the relationship between obesity and CRP levels. The associations of CRP levels with the geriatric depression scale, as well as with its three dimensions, were investigated using multiple linear regressions.
		                        		
		                        			RESULTS:
		                        			General obesity was associated with worsening depression symptoms and incident depression, with an odds ratio ( OR) [95% confidence interval ( CI)] of 1.53 (1.13-2.12) and 1.80 (1.23-2.63), especially among old male subjects, with OR (95% CI) of 2.12 (1.25-3.58) and 2.24 (1.22-4.11), respectively; however, no significant relationship was observed between abdominal obesity and depression. In addition, general obesity was associated with high levels of CRP, with OR (95% CI) of 2.58 (1.75-3.81), especially in subjects free of depression at baseline, with OR (95% CI) of 3.15 (1.97-5.04), and CRP levels were positively correlated with a score of specific dimension (life satisfaction) of depression, P < 0.05.
		                        		
		                        			CONCLUSION
		                        			General obesity, rather than abdominal obesity, was associated with worsening depressive symptoms and incident depression, which can be partly explained by the systemic inflammatory response, and the impact of obesity on depression should be taken more seriously in the older male population.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Depression/etiology*
		                        			;
		                        		
		                        			C-Reactive Protein/metabolism*
		                        			;
		                        		
		                        			Obesity, Abdominal/epidemiology*
		                        			;
		                        		
		                        			Longitudinal Studies
		                        			;
		                        		
		                        			Inflammation/epidemiology*
		                        			;
		                        		
		                        			Obesity/complications*
		                        			
		                        		
		                        	
4.Effects of staged acupuncture on endometrial receptivity and anxiety in patients with recurrent implantation failure of thin endometrium based on "thoroughfare vessel is the sea of blood" theory.
Li-Wei XING ; Zhe HE ; Yu-Huan SUN ; Ming HE ; Shun YU ; Yang CHEN ; Jin-Long XU ; Rui MEI ; Rong ZHAO
Chinese Acupuncture & Moxibustion 2023;43(3):289-293
		                        		
		                        			OBJECTIVE:
		                        			To compare the clinical efficacy between staged acupuncture based on "thoroughfare vessel is the sea of blood" theory combined with routine hormone replacement cycle treatment and routine hormone replacement cycle treatment for patients with recurrent implantation failure (RIF) of thin endometrium.
		                        		
		                        			METHODS:
		                        			A total of 72 RIF patients with thin endometrium were randomly divided into an observation group and a control group, 36 cases in each group. The patients in the control group were treated with routine hormone replacement cycle treatment. Based on the treatment of the control group, the patients in the observation group were treated with staged acupuncture based on "thoroughfare vessel is the sea of blood" theory. The main acupoints were Neiguan (PC 6) and Gongsun (SP 4), and the supplementary acupoints were selected according to the menstrual cycle and syndrome differentiation; the acupuncture was given once every other day, 3 times a week, for 3 consecutive menstrual cycles. The thickness and shape of endometrium, and Hamilton anxiety scale (HAMA) score were observed at implantation window before and after treatment; the clinical pregnancy rate, live birth rate and cycle cancellation rate were compared between the two groups; the correlation between endometrial thickness and HAMA score was analyzed.
		                        		
		                        			RESULTS:
		                        			Compared before treatment, the endometrial thickness in the two groups and the proportion of type A+B endometrium in the observation group were increased (P<0.05), and the HAMA scores in the two groups were decreased (P<0.05) after treatment. The above indexes in the observation group were superior to those in the control group (P<0.05). The clinical pregnancy rate and live birth rate in the observation group were higher than those in the control group (P<0.05), and the cycle cancellation rate was lower than that in the control group (P<0.05). There was a negative correlation between endometrial thickness and HAMA score (P<0.05).
		                        		
		                        			CONCLUSION
		                        			Based on the routine hormone replacement cycle treatment, the addition use of staged acupuncture based on "thoroughfare vessel is the sea of blood" theory could improve the thickness and shape of endometrium, relieve anxiety, increase the clinical pregnancy rate and live birth rate, and reduce the cycle cancellation rate in RIF patients with thin endometrium. The curative effect is superior to the routine hormone replacement cycle treatment alone.
		                        		
		                        		
		                        		
		                        			Female
		                        			;
		                        		
		                        			Pregnancy
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Anxiety
		                        			;
		                        		
		                        			Anxiety Disorders
		                        			;
		                        		
		                        			Acupuncture Therapy
		                        			;
		                        		
		                        			Endometrium
		                        			;
		                        		
		                        			Hormones
		                        			
		                        		
		                        	
5.Analysis of the relationship between PI-RADS scores and the pathological results of targeted biopsy based on MRI.
Ya Min WANG ; Jin Wei SHANG ; Lai DONG ; Ling Hui LIANG ; Rui Zhe ZHAO ; Chao LIANG ; Shang Qian WANG ; Wei XIA ; Gong CHENG ; Li Xin HUA
Chinese Journal of Oncology 2023;45(11):942-947
		                        		
		                        			
		                        			Objective: To analyze the relationship between Prostate Imaging Reporting and Data System (PI-RADS) scores and the pathological results of transperineal magnetic resonance-ultrasound fusion guided biopsy. Methods: The clinical data, magnetic resonance imaging (MRI) results and prostate puncture biopsies of 517 patients who were assigned to PI-RADS score of 4 or 5 and underwent transperineal magnetic resonance-ultrasound fusion guided biopsy at The First Affiliated Hospital of Nanjing Medical University from June 2019 to March 2022 were retrospectively analyzed. Patients were divided into the PI-RADS 4 and PI-RADS 5 groups according to their PI-RADS scores and were stratified by their prostate specific antigen (PSA) values (PSA<10 ng/ml vs. PSA 10-20 ng/ml). The pathological negative rates from the biopsy, the distribution of the grade groups according to the grading system by World Health Organization/International Society of Urological Pathology (WHO/ISUP), the detection rates of prostate cancer (PCa) and clinically significant prostate cancer (CsPCa)between the groups were compared. Results: 369 patients with a PI-RADS score of 4 and 148 patients with a PI-RADS score of 5 were included in our research. The overall detection rates of PCa and CsPCa were 77.8% (402/517) and 66.7% (345/517), respectively. In the PI-RADS 4 group, patients with prostate negative biopsies or in WHO/ISUP 1, 2, 3, 4, or 5 grade groups accounted for 28.2%, 12.7%, 20.1%, 17.1%, 18.4% and 3.5%, respectively, whereas in the PI-RADS 5 group the rates were 7.4%, 6.8%, 22.3%, 22.3%, 26.4%, and 14.9%, respectively. The difference was statistically significant (P<0.001). The detection rates of PCa and CsPCa in the PI-RADS 4 group [71.8% (265/369) vs. 59.1% (218/369), P<0.001] were lower than those of the PI-RADS 5 group [92.6% (137/148) vs. 85.8% (127/148), P<0.001]. In the PI-RADS 4 group, the proportion of patients classified into WHO/ISUP 4-5 grade groups was lower than that of patients in the PI-RADS 5 group [22.0% (81/369) vs 41.2% (61/148) (P<0.001)]. The detection rates of PCa and CsPCa in the PSA<10 ng/ml stratification were less than that in the PSA 10-20 ng/ml stratification[74.1% (281/379) vs. 87.7% (121/138), P=0.001], and [60.9% (231/379) vs. 82.6% (114/138), P<0.001]. For patients with PSA<10 ng/ml, the detection rates of PCa and CsPCa in the PI-RADS 4 group were less than those in the PI-RADS5 group [70.9% (217/306) vs. 87.7% (64/73), P=0.003], and [56.2% (172/306) vs. 80.8% (59/73), P<0.001]. For those with a PSA value of 10-20 ng/ml, the detection rates of PCa and CsPCa in the PI-RADS 4 group were less than those in the PI-RADS 5 group [76.2% (48/63) vs. 97.3% (73/75), P<0.001], and [73.0% (46/63) vs. 90.7% (68/75), P=0.006]. There were statistically significant differences in the proportions of patients with prostate negative biopsy and those falling into WHO/ISUP grade groups 1, 2, 3, 4, or 5 (P<0.001) between the PI-RADS 4 group and the PI-RADS 5 group in both stratifications. Conclusions: In this study, the detection rates of CsPCa and PCa in the PI-RADS 4 group were less than those in the PI-RADS 5 group. With the increase of PI-RADS scores, the detection rate of high-grade PCa increased. The same results held for patients with PSA<10 ng/ml or with PSA 10-20 ng/ml.
		                        		
		                        		
		                        		
		                        			Male
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Prostatic Neoplasms/pathology*
		                        			;
		                        		
		                        			Prostate-Specific Antigen/analysis*
		                        			;
		                        		
		                        			Magnetic Resonance Imaging/methods*
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Image-Guided Biopsy/methods*
		                        			
		                        		
		                        	
6.Analysis of the relationship between PI-RADS scores and the pathological results of targeted biopsy based on MRI.
Ya Min WANG ; Jin Wei SHANG ; Lai DONG ; Ling Hui LIANG ; Rui Zhe ZHAO ; Chao LIANG ; Shang Qian WANG ; Wei XIA ; Gong CHENG ; Li Xin HUA
Chinese Journal of Oncology 2023;45(11):942-947
		                        		
		                        			
		                        			Objective: To analyze the relationship between Prostate Imaging Reporting and Data System (PI-RADS) scores and the pathological results of transperineal magnetic resonance-ultrasound fusion guided biopsy. Methods: The clinical data, magnetic resonance imaging (MRI) results and prostate puncture biopsies of 517 patients who were assigned to PI-RADS score of 4 or 5 and underwent transperineal magnetic resonance-ultrasound fusion guided biopsy at The First Affiliated Hospital of Nanjing Medical University from June 2019 to March 2022 were retrospectively analyzed. Patients were divided into the PI-RADS 4 and PI-RADS 5 groups according to their PI-RADS scores and were stratified by their prostate specific antigen (PSA) values (PSA<10 ng/ml vs. PSA 10-20 ng/ml). The pathological negative rates from the biopsy, the distribution of the grade groups according to the grading system by World Health Organization/International Society of Urological Pathology (WHO/ISUP), the detection rates of prostate cancer (PCa) and clinically significant prostate cancer (CsPCa)between the groups were compared. Results: 369 patients with a PI-RADS score of 4 and 148 patients with a PI-RADS score of 5 were included in our research. The overall detection rates of PCa and CsPCa were 77.8% (402/517) and 66.7% (345/517), respectively. In the PI-RADS 4 group, patients with prostate negative biopsies or in WHO/ISUP 1, 2, 3, 4, or 5 grade groups accounted for 28.2%, 12.7%, 20.1%, 17.1%, 18.4% and 3.5%, respectively, whereas in the PI-RADS 5 group the rates were 7.4%, 6.8%, 22.3%, 22.3%, 26.4%, and 14.9%, respectively. The difference was statistically significant (P<0.001). The detection rates of PCa and CsPCa in the PI-RADS 4 group [71.8% (265/369) vs. 59.1% (218/369), P<0.001] were lower than those of the PI-RADS 5 group [92.6% (137/148) vs. 85.8% (127/148), P<0.001]. In the PI-RADS 4 group, the proportion of patients classified into WHO/ISUP 4-5 grade groups was lower than that of patients in the PI-RADS 5 group [22.0% (81/369) vs 41.2% (61/148) (P<0.001)]. The detection rates of PCa and CsPCa in the PSA<10 ng/ml stratification were less than that in the PSA 10-20 ng/ml stratification[74.1% (281/379) vs. 87.7% (121/138), P=0.001], and [60.9% (231/379) vs. 82.6% (114/138), P<0.001]. For patients with PSA<10 ng/ml, the detection rates of PCa and CsPCa in the PI-RADS 4 group were less than those in the PI-RADS5 group [70.9% (217/306) vs. 87.7% (64/73), P=0.003], and [56.2% (172/306) vs. 80.8% (59/73), P<0.001]. For those with a PSA value of 10-20 ng/ml, the detection rates of PCa and CsPCa in the PI-RADS 4 group were less than those in the PI-RADS 5 group [76.2% (48/63) vs. 97.3% (73/75), P<0.001], and [73.0% (46/63) vs. 90.7% (68/75), P=0.006]. There were statistically significant differences in the proportions of patients with prostate negative biopsy and those falling into WHO/ISUP grade groups 1, 2, 3, 4, or 5 (P<0.001) between the PI-RADS 4 group and the PI-RADS 5 group in both stratifications. Conclusions: In this study, the detection rates of CsPCa and PCa in the PI-RADS 4 group were less than those in the PI-RADS 5 group. With the increase of PI-RADS scores, the detection rate of high-grade PCa increased. The same results held for patients with PSA<10 ng/ml or with PSA 10-20 ng/ml.
		                        		
		                        		
		                        		
		                        			Male
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Prostatic Neoplasms/pathology*
		                        			;
		                        		
		                        			Prostate-Specific Antigen/analysis*
		                        			;
		                        		
		                        			Magnetic Resonance Imaging/methods*
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Image-Guided Biopsy/methods*
		                        			
		                        		
		                        	
7.Effect of Suanzaoren Decoction on molecular levels of bile acids in serum, liver, and ileum of insomnia mice.
Zhe ZHANG ; Yun-Fang HUANG ; Wen-Wen ZHAO ; Xiu-Rui SUN ; Hong-Cui HAN ; Xue WANG ; Zi-Qi JING ; Peng-Kai MA ; Yu-Jie ZHANG
China Journal of Chinese Materia Medica 2022;47(1):159-166
		                        		
		                        			
		                        			To explore the mechanism of Suanzaoren Decoction in the treatment of insomnia from endogenous bile acid regulation, the present study investigated the hepatoprotective effect of Suanzaoren Decoction and the molecular changes of bile acids in the serum, liver, and ileum of insomnia model mice and Suanzaoren Decoction treated mice. The insomnia model in mice was established by the sleep deprivation method. After Suanzaoren Decoction(48.96 mg·kg~(-1)·d~(-1)) intervention by gavage for 7 days, the related indicators, such as water consumption, food intake, body weight, aspartate aminotransferase(AST), alanine transaminase(ALT), and total bile acid(TBA) were detected, and the pathological changes of the liver and ileum were observed. The molecular levels and distribution of 23 bile acids in the serum, liver, and ileum were analyzed by UPLC-MS/MS combined with principal component analysis(PCA) and partial least squares discriminant analysis(PLS-DA). The results showed that Suanzaoren Decoction could improve the decreased water consumption and food intake, weight loss, and increased AST and ALT in the model group, and effectively reverse the injury and inflammation in the liver and ileum. The bile acids in the liver of the insomnia model mice were in the stage of decompensation, and the bile acids in the serum, liver, and ileum of the mice decreased or increased. Suanzaoren Decoction could regulate the anomaly of some bile acids back to normal. Seven bile acids including glycoursodeoxycholic acid(GUDCA), glycodesoxycholic acid(GDCA), tauro-α-MCA(T-α-MCA), α-MCA, taurodeoxycholate(TDCA), T-β-MCA, and LCA were screened out as the main discriminant components by PLS-DA. It is concluded that Suanzaoren Decoction possesses the hepatoprotective effect and bile acids could serve as the biochemical indicators to evaluate the drug efficacy in the treatment of abnormal liver functions caused by insomnia. The mechanism of Suanzao-ren Decoction in soothing the liver, resolving depression, tranquilizing the mind, and improving sleep may be related to the molecular regulation of bile acid signals.
		                        		
		                        		
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Bile Acids and Salts
		                        			;
		                        		
		                        			Chromatography, Liquid
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			Ileum
		                        			;
		                        		
		                        			Liver
		                        			;
		                        		
		                        			Mice
		                        			;
		                        		
		                        			Sleep Initiation and Maintenance Disorders/drug therapy*
		                        			;
		                        		
		                        			Tandem Mass Spectrometry
		                        			
		                        		
		                        	
8.Evaluation of Astragali Radix quality grade based on appearance characteristics and internal ingredients.
Xiu-Rui SUN ; Gui-Jie WEI ; Hong-Ya WANG ; Wen-Wen ZHAO ; Zhe ZHANG ; Ting ZHANG ; Feng WEI ; Yu-Jie ZHANG
China Journal of Chinese Materia Medica 2021;46(4):966-971
		                        		
		                        			
		                        			This study is to provide the basis of establishing a quality evaluation system, based on the differences in appearance and internal components of Astragali Radix from different sources. The diameter of 18 batches of Astragali Radix, the content of alcohol(water) extract and 7 kinds of flavonoids were determined. The peak area ratio of flavonoid aglycon to aglycone was calculated. PCA and CA were carried out by synthesizing various indexes. The results of PCA and CA showed that Astragali Radix was obviously clustered into three types. Alcohol extract, formononetin/formosan glycosides,(pilose isoflavones+astragalus flavonoid A)/pilose isoflavone glucoside are the most significant differences in the variable importance projection index(VIP) of Astragali Radix. Combining the diameter, alcohol(water) extract, flavonoid aglycon to aglycone peak area ratio can provide an analysis method for the establishment of the grade evaluation system of Astragali Radix.
		                        		
		                        		
		                        		
		                        			Astragalus Plant
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			Glucosides
		                        			;
		                        		
		                        			Glycosides
		                        			;
		                        		
		                        			Plant Roots
		                        			
		                        		
		                        	
9.Study on liver diseases with zebrafish as an important tool.
Zhi-Qi LI ; Yue XU ; Xia ZHAO ; Zhe JIA ; Zhao-Yi WANG ; Dan FENG ; Cui-Bai LI ; Zhi-Qiang MA ; Chong-Jun ZHAO ; Rui-Chao LIN
China Journal of Chinese Materia Medica 2021;46(2):320-332
		                        		
		                        			
		                        			With the increasing incidence of hepatobiliary diseases, it is particularly important to understand the role of molecular, cellular and physiological factors in the clinical diagnosis and treatment with traditional Chinese medicine(TCM) in the development of liver disease. Appropriate animal models can help us identify the possible mechanisms of relevant diseases. Danio rerio(zebrafish) model was traditionally used to study embryonic development, and has been gradually used in screening and evaluation of liver diseases and relevant drug in recent years. Zebrafish embryos develop rapidly and the digestive organs of 5-day-old juvenile fish are all mature. At this stage, they may develop hepatobiliary diseases induced by developmental defects or compounds. Zebrafish liver is similar to human liver in cell composition, function, signal transduction, response to injury and cell process mediating liver disease. Furthermore, due to the high conservation of genes and proteins between humans and zebrafish, zebrafish becomes an alternative system for studying basic mechanisms of liver disease. Therefore, genetic screening could be performed to identify new genes involving specific disease processes, and chemical screening could be made for drugs in specific processes. This paper briefly introduced the experimental properties of zebrafish as model system, emphasized the study progress of zebrafish models for pathological mechanism of liver diseases, especially fatty liver, and drug screening and evaluation, so as to provide ideas and techniques for the future liver toxicity assessment of TCM.
		                        		
		                        		
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Drug Evaluation, Preclinical
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Liver
		                        			;
		                        		
		                        			Liver Diseases/genetics*
		                        			;
		                        		
		                        			Medicine, Chinese Traditional
		                        			;
		                        		
		                        			Zebrafish/genetics*
		                        			
		                        		
		                        	
10.Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.
Jia-Bo WANG ; Zhong-Xia WANG ; Jing JING ; Peng ZHAO ; Jing-Hui DONG ; Yong-Feng ZHOU ; Guang YANG ; Ming NIU ; Xu ZHAO ; Tian-Jun JIANG ; Jing-Feng BI ; Zhe XU ; Ping ZHANG ; Dan WU ; Zhao-Fang BAI ; Yu-Ming GUO ; Si-Miao YU ; Yong-Qiang SUN ; Zi-Teng ZHANG ; Xiao-Yan ZHAN ; Peng-Yan LI ; Jin-Biao DING ; Peng-Fei ZHAO ; Xue-Ai SONG ; Jian-Yuan TANG ; Dong-Chu HE ; Zhu CHEN ; En-Qiang QIN ; Rui-Lin WANG ; Xiao-He XIAO
Chinese journal of integrative medicine 2020;26(9):648-655
		                        		
		                        			OBJECTIVES:
		                        			To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
		                        		
		                        			METHODS:
		                        			A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
		                        		
		                        			RESULTS:
		                        			An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
		                        		
		                        			CONCLUSIONS
		                        			Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
		                        		
		                        		
		                        		
		                        			Administration, Inhalation
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			China
		                        			;
		                        		
		                        			Coronavirus Infections
		                        			;
		                        		
		                        			diagnosis
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			mortality
		                        			;
		                        		
		                        			Dose-Response Relationship, Drug
		                        			;
		                        		
		                        			Drug Administration Schedule
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Follow-Up Studies
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Integrative Medicine
		                        			;
		                        		
		                        			Interferon-alpha
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Lopinavir
		                        			;
		                        		
		                        			administration & dosage
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Pandemics
		                        			;
		                        		
		                        			Pneumonia, Viral
		                        			;
		                        		
		                        			diagnosis
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			mortality
		                        			;
		                        		
		                        			Risk Assessment
		                        			;
		                        		
		                        			Severe Acute Respiratory Syndrome
		                        			;
		                        		
		                        			diagnosis
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			mortality
		                        			;
		                        		
		                        			Severity of Illness Index
		                        			;
		                        		
		                        			Survival Rate
		                        			
		                        		
		                        	
            
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