Objective To review the clinical trial registration characteristics of TCM prevention and treatment of stroke;To provide reference for future relevant clinical trials.Methods Clinical trials of TCM prevention and treatment of stroke registered on ChiCTR and NCT from the establishment of the databases to August 31,2023 were retrieved.Excel 2019 was used to remove duplication and extract relevant data.SPSS 27.0 was used to analyze the included data and drown corresponding charts.The characteristics of trails were summarized.Results Totally 540 registered clinical trials were included,among which,449(83.15%)were from ChiCTR and 91(16.85%)were from NCT.The number of registered was is generally increasing year by year.The included research involved 8 countries,of which 29 provinces of China were involved;213 institutions and 391 researchers were involved.The main source of funding was government finance(52.41%);a total of 216 368 participants were included in these trials,with the majority of trials having a sample size of 50-100 cases(32.22%).The main research type was intervention study(88.70%),and the study design was mostly randomized controlled trial(82.59%).Most of the trials(39.63%)did not clearly report the blind method,followed by double blind clinical trail(21.67%)and evaluator blind clinical trial(13.70%).Clinical trials focused on the full cycle of stroke management,including acute,convalescent,sequelae,and stroke prevention.Among them,the study of sequelae stage of stroke accounted for the largest proportion(62.04%),which specifically covered motor dysfunction,cognitive mental dysfunction,swallowing disorders,etc.The main intervention measures were acupuncture(42.41%),followed by Chinese patent medicine(21.12%)and tuina(10.37%).The main outcome evaluation indexes were motor function evaluation(17.10%)and nerve function evaluation(14.56%).Conclusion The clinical research on the TCM prevention and treatment of stroke is in a period of rapid growth with increasing attention and deepening of the research,which is conducive to improving the prognosis of patients.However,there are still some problems,such as studies with weak systematicness,unreasonable proportion structure of intervention measures,and strong subjectivity of outcome evaluation indicators.

Objective To review the clinical trial registration characteristics of TCM prevention and treatment of stroke;To provide reference for future relevant clinical trials.Methods Clinical trials of TCM prevention and treatment of stroke registered on ChiCTR and NCT from the establishment of the databases to August 31,2023 were retrieved.Excel 2019 was used to remove duplication and extract relevant data.SPSS 27.0 was used to analyze the included data and drown corresponding charts.The characteristics of trails were summarized.Results Totally 540 registered clinical trials were included,among which,449(83.15%)were from ChiCTR and 91(16.85%)were from NCT.The number of registered was is generally increasing year by year.The included research involved 8 countries,of which 29 provinces of China were involved;213 institutions and 391 researchers were involved.The main source of funding was government finance(52.41%);a total of 216 368 participants were included in these trials,with the majority of trials having a sample size of 50-100 cases(32.22%).The main research type was intervention study(88.70%),and the study design was mostly randomized controlled trial(82.59%).Most of the trials(39.63%)did not clearly report the blind method,followed by double blind clinical trail(21.67%)and evaluator blind clinical trial(13.70%).Clinical trials focused on the full cycle of stroke management,including acute,convalescent,sequelae,and stroke prevention.Among them,the study of sequelae stage of stroke accounted for the largest proportion(62.04%),which specifically covered motor dysfunction,cognitive mental dysfunction,swallowing disorders,etc.The main intervention measures were acupuncture(42.41%),followed by Chinese patent medicine(21.12%)and tuina(10.37%).The main outcome evaluation indexes were motor function evaluation(17.10%)and nerve function evaluation(14.56%).Conclusion The clinical research on the TCM prevention and treatment of stroke is in a period of rapid growth with increasing attention and deepening of the research,which is conducive to improving the prognosis of patients.However,there are still some problems,such as studies with weak systematicness,unreasonable proportion structure of intervention measures,and strong subjectivity of outcome evaluation indicators.

Objective:To summarize the clinical and genetic features of neuroinflammation, autoinflammation, splenomegaly and anemia (NASA) syndrome and investigate the pathogenic mechanism.Methods:The clinical data of 2 patients diagnosed with NASA syndrome at Department of Pediatrics, Peking Union Medical College Hospital were retrospectively analyzed. Variants were identified by gene panel sequencing and confirmed by Sanger sequencing. The function of IRAK4 gene variants was studied in vitro.Results:Among the 2 patients, case 1 was an 8-year-old girl and case 2 was a 10-year-old boy. Both patients presented in early childhood with anemia and hepatosplenomegaly. Case 1 was also experienced recurrent seizures. Laboratory examinations showed elevated inflammatory markers and neuroimaging revealed bilateral basal ganglia calcification. In case 2, anemia and inflammation markers were well controlled after treatment with tocilizumab, while case 1 succumbed to recurrent seizures. Genetic tests verified compound heterozygous variants in IRAK4 gene: case 1 carries a nonsense variant c.592G>T (p.G198X) and a missense variant c.248A>C (p.D83A), which were respectively from the parents; case 2 carries a c.831+3A>G variant and a frameshift variant c.540delT (p.F180Lfs*26), and the former was inherited from the father and the latter from the mother. The reverse transcription and Sanger sequencing results confirmed that c.831+3A>G variant led to exon 7 skipping. In vitro studies indicated that c.592G>T, c.540delT and c.831+3A>G variants resulted in truncated interleukin-1 receptor-associated kinase-4 (IRAK4) protein while c.248A>C do not cause changes in IRAK4 protein expression level and protein length.Conclusions:NASA syndrome should be considered in children with early-onset anemia, hepatosplenomegaly, recurrent seizures, elevated inflammatory markers and intracranial calcification. IRAK4 gene variants may lead to impaired anti-inflammatory function of IRAK4 protein, contributing to the autoinflammatory phenotype.

Objective:To summarize the clinical and genetic features of neuroinflammation, autoinflammation, splenomegaly and anemia (NASA) syndrome and investigate the pathogenic mechanism.Methods:The clinical data of 2 patients diagnosed with NASA syndrome at Department of Pediatrics, Peking Union Medical College Hospital were retrospectively analyzed. Variants were identified by gene panel sequencing and confirmed by Sanger sequencing. The function of IRAK4 gene variants was studied in vitro.Results:Among the 2 patients, case 1 was an 8-year-old girl and case 2 was a 10-year-old boy. Both patients presented in early childhood with anemia and hepatosplenomegaly. Case 1 was also experienced recurrent seizures. Laboratory examinations showed elevated inflammatory markers and neuroimaging revealed bilateral basal ganglia calcification. In case 2, anemia and inflammation markers were well controlled after treatment with tocilizumab, while case 1 succumbed to recurrent seizures. Genetic tests verified compound heterozygous variants in IRAK4 gene: case 1 carries a nonsense variant c.592G>T (p.G198X) and a missense variant c.248A>C (p.D83A), which were respectively from the parents; case 2 carries a c.831+3A>G variant and a frameshift variant c.540delT (p.F180Lfs*26), and the former was inherited from the father and the latter from the mother. The reverse transcription and Sanger sequencing results confirmed that c.831+3A>G variant led to exon 7 skipping. In vitro studies indicated that c.592G>T, c.540delT and c.831+3A>G variants resulted in truncated interleukin-1 receptor-associated kinase-4 (IRAK4) protein while c.248A>C do not cause changes in IRAK4 protein expression level and protein length.Conclusions:NASA syndrome should be considered in children with early-onset anemia, hepatosplenomegaly, recurrent seizures, elevated inflammatory markers and intracranial calcification. IRAK4 gene variants may lead to impaired anti-inflammatory function of IRAK4 protein, contributing to the autoinflammatory phenotype.

In August 2022, a patient diagnosed with PIK3CA-related overgrowth syndrome (PROS) was admitted to the Department of Burn and Plastic Surgery of the General Hospital of Eastern Theater Command. A 15-year-old male patient presented with overgrowth of the left lower limb since birth, which had progressive aggravation six months ago, accompanied by erythema and dilated veins (42 cm ×24 cm) on the left waist. MRI showed that the soft tissue of the left and right thighs was asymmetrical. There was soft tissue hypertrophy of the left thigh, vascular malformation on the left waist and a left renal cyst. The vascular malformations on the left waist were treated by sclerotherapy with 3% polydocaol injection, for which the injection volume of was 7.1 ml. Immunohistochemistry of the pathological tissue showed that PIK3CA, AKT and mTOR were positive in vascular endothelial cells and epidermal basal cells. The genetic testing suggested that there was a mutation at c. 3190_3191insA (p.H1065fs) in PIK3CA gene. On the first year after the interventional sclerotherapy, the area of erythema decreased and the overgrowth of the left lower limb did not progress significantly. This case was diagnosed by clinical manifestations, pathological examination and genetic testing, which expanded the clinical phenotype of PROS and PIK3CA mutation spectrum, providing relevant clinical data for the study of this diseases.

ObjectiveTo evaluate the clinical effectiveness and safety of Bairui Granules （百蕊颗粒） in the treatment of acute pharyngitis with wind-heat syndrome. MethodsA multicenter， double-blind， double-simulation， randomised controlled trial was conducted， in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited， and each center was divided into trial group and control group on the ratio of 2∶1. In the trial group， 108 cases were orally administered with Bairui Granules plus Reyanning Granules （热炎宁颗粒） simulant， and in the control group， 54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days， with a follow-up visit on the 6th day. Full analysis set （FAS） analysis and per protocol set （PPS） were used for analysis， respectively. The primary efficacy index was the disappearance rate of sore throat after 5-day treatment； the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment， as well as the visual analogue score （VAS） of sore throat before treatment， every day during the treatment， and follow-up on day 6， and the traditional Chinese medicine （TCM） syndrome score was performed before treatment and at the follow-up on day 6. The effectiveness on TCM syndrome was evaluated at the follow-up on day 6， and the changes of vital signs， blood routine， urine routine， liver functions， kidney function， the adverse events before and after the treatment were recorded， and safety analysis set （SS） was analysed. Results162 patients entered the FAS and SS analyses， and 158 cases （105 cases in the trial group and 53 cases in the control group） entered the PPS analysis. FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56% （87/108） in the trial group and 64.81% （35/54） in the control group， and the difference between groups was statistically significant （χ² = 5.10， P = 0.0239）. PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00% （84/105） in the trial group and 64.15% （34/53） in the control group， and the difference between groups was statistically significant （χ² =4.85， P = 0.0277）. FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant （P＞0.05）. Compared with those before treatment， the VAS scores of sore throat were lower in both groups during treatment on day 2， 3， 4， 5， and follow-up on day 6 （P＜0.01）， but the difference between groups at each time point was not statistically significant （P＞0.05）. TCM syndrome scores of both groups at the follow-up were lower than that before treatment， and those of the trial group were lower than those of the control group （P＜0.01）. The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group （P＜0.01）. There was no significant difference in blood routine， urine routine， liver function， kidney function between groups before and after treatment （P＞0.05）， and no serious adverse events occured in both groups. ConclusionBairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome， and it could significantly improve the clinical symptoms， accelerate the disappearance time of sore throat with good safety.

【Objective】 To explore the feasibility of en-bloc resection of bladder tumors by flexible cystoscope combined with laparoscopic instruments through urethra and to provide reference for the clinical application of this technique. 【Methods】 Self-designed and processed transurethral single-hole PORT and Olympus electronic cystoscope were used as observation mirror; Φ1.8 mm soft grasper, tissue scissors, electric hook, and ultrasonic scalpel were used as instruments; the porcine bladder was used as a model.The PORT was placed through the urethra, and the cystoscope was inserted to observe the inner wall of the bladder and the condition of the mucosa.After the lesion site was identified in the bladder cavity, the soft grasper was inserted to pull the mucosa to be removed, which was then fixed with tension at the target position to maintain a satisfactory feild of view.The surgeon held the cystoscope in the left hand, and operated the laparoscopic instruments into the bladder cavity through the PORT with the right hand.Observing with the cystoscope and lifting and pulling the mucosa with the grasper, the surgeon simulated the cutting and pushing actions to realize the en-bloc resection of the lesioned mucosa. 【Results】 The mucosa at 4 different locations were successfully resected on 2 in vitro porcine bladder models. 【Conclusion】 The in vitro experiments show that the combination of flexible electronic cystoscope and laparoscopic instruments achieves synergistic effects in en-bloc resection of bladder tumor by transurethral single-hole laparoscope without additional iatrogenic bladder injury caused by percutaneous bladder incision.This method is feasible in the treatment of bladder tumors, and has the potential of clinical application after further optimization.

In August 2022, a patient diagnosed with PIK3CA-related overgrowth syndrome (PROS) was admitted to the Department of Burn and Plastic Surgery of the General Hospital of Eastern Theater Command. A 15-year-old male patient presented with overgrowth of the left lower limb since birth, which had progressive aggravation six months ago, accompanied by erythema and dilated veins (42 cm ×24 cm) on the left waist. MRI showed that the soft tissue of the left and right thighs was asymmetrical. There was soft tissue hypertrophy of the left thigh, vascular malformation on the left waist and a left renal cyst. The vascular malformations on the left waist were treated by sclerotherapy with 3% polydocaol injection, for which the injection volume of was 7.1 ml. Immunohistochemistry of the pathological tissue showed that PIK3CA, AKT and mTOR were positive in vascular endothelial cells and epidermal basal cells. The genetic testing suggested that there was a mutation at c. 3190_3191insA (p.H1065fs) in PIK3CA gene. On the first year after the interventional sclerotherapy, the area of erythema decreased and the overgrowth of the left lower limb did not progress significantly. This case was diagnosed by clinical manifestations, pathological examination and genetic testing, which expanded the clinical phenotype of PROS and PIK3CA mutation spectrum, providing relevant clinical data for the study of this diseases.

Objective:To explore the clinical symptoms, imaging and histopathological features of fibroadipose vascular anomaly (FAVA), and to propose the differential diagnostic criteria for FAVA and intramuscular venous malformation (IMVM).Methods:Clinical data of FAVA and IMVM patients admitted to the Department of Burn and Plastic Surgery, Jinling Hospital of Nanjing Medical University, General Hospital of Eastern Theater Command from January 2016 to December 2020 were retrospectively analyzed. The patients were divided into FAVA group and IMVM group, and the clinical symptoms, coagulation function and imaging results of the two groups were analyzed. The pathological characteristics of the surgically resected specimens were observed by HE staining, and the similarities and differences between FAVA and IMVM were summarized. Pearson chi-square test was used to investigate the occurrence of local intravascular coagulation (LIC) between the two groups, and P<0.05 was considered statistically significant. Results:Fourteen patients were included in FAVA group, including 4 males and 10 females. The age of treatment was (28.2 ± 13.2) years old and the age of onset was (20.5 ± 10.1) years old. A total of 39 patients were included in the IMVM group, including 16 males and 23 females. The age of treatment was (28.5 ± 14.1) years old and the age of onset was (18.8 ± 9.5) years old. The clinical symptoms of FAVA and IMVM patients were pain, swelling and paresthesia. MRI images of the FAVA group showed fat signal in muscle and varicose vascular shadow. The IMVM group showed large irregular vascular shadows in muscle without fat signal. Histopathological observation revealed fibroadipose hyperplasia accompanied by varicose veins in FAVA group. However, in IMVM group, the lesions showed a large number of malformed veins mixed with muscle, without fibroadipose hyperplasia. There were 2 cases of LIC in FAVA group and 21 cases of LIC in IMVM group, the difference was statistically significant ( χ2 =4.39, P=0.036). Conclusion:The clinical symptoms of FAVA and IMVM are similar. The differential diagnosis of FAVA and IMVM requires MRI and pathological examination. The main difference is that there is fibroadipose hyperplasia in FAVA lesion, while there is no fibroadipose hyperplasia in IMVM lesion.

Objective:To explore the clinical symptoms, imaging and histopathological features of fibroadipose vascular anomaly (FAVA), and to propose the differential diagnostic criteria for FAVA and intramuscular venous malformation (IMVM).Methods:Clinical data of FAVA and IMVM patients admitted to the Department of Burn and Plastic Surgery, Jinling Hospital of Nanjing Medical University, General Hospital of Eastern Theater Command from January 2016 to December 2020 were retrospectively analyzed. The patients were divided into FAVA group and IMVM group, and the clinical symptoms, coagulation function and imaging results of the two groups were analyzed. The pathological characteristics of the surgically resected specimens were observed by HE staining, and the similarities and differences between FAVA and IMVM were summarized. Pearson chi-square test was used to investigate the occurrence of local intravascular coagulation (LIC) between the two groups, and P<0.05 was considered statistically significant. Results:Fourteen patients were included in FAVA group, including 4 males and 10 females. The age of treatment was (28.2 ± 13.2) years old and the age of onset was (20.5 ± 10.1) years old. A total of 39 patients were included in the IMVM group, including 16 males and 23 females. The age of treatment was (28.5 ± 14.1) years old and the age of onset was (18.8 ± 9.5) years old. The clinical symptoms of FAVA and IMVM patients were pain, swelling and paresthesia. MRI images of the FAVA group showed fat signal in muscle and varicose vascular shadow. The IMVM group showed large irregular vascular shadows in muscle without fat signal. Histopathological observation revealed fibroadipose hyperplasia accompanied by varicose veins in FAVA group. However, in IMVM group, the lesions showed a large number of malformed veins mixed with muscle, without fibroadipose hyperplasia. There were 2 cases of LIC in FAVA group and 21 cases of LIC in IMVM group, the difference was statistically significant ( χ2 =4.39, P=0.036). Conclusion:The clinical symptoms of FAVA and IMVM are similar. The differential diagnosis of FAVA and IMVM requires MRI and pathological examination. The main difference is that there is fibroadipose hyperplasia in FAVA lesion, while there is no fibroadipose hyperplasia in IMVM lesion.