Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male ; Female ; Humans ; Aged ; Natriuretic Peptide, Brain ; Simendan/therapeutic use* ; Non-ST Elevated Myocardial Infarction ; Heart Failure/drug therapy* ; Peptide Fragments ; Arrhythmias, Cardiac ; Biomarkers ; Prognosis

Objective: To explore the diagnosis, surgical management and outcome of jugular foramen chondrosarcoma (CSA). Methods: Fifteen patients with jugular foramen CSA hospitalized in the Department of Otorhinolaryngology Head and Neck Surgery of Chinese PLA General Hospital from December 2002 to February 2020 were retrospectively collected,of whom 2 were male and 13 were female, aging from 22 to 61 years old. The clinical symptoms and signs, imaging features, differential diagnosis, surgical approaches, function of facial nerve and cranial nerves IX to XII, and surgical outcomes were analyzed. Results: Patients with jugular foramen CSA mainly presented with facial paralysis, hearing loss, hoarseness, cough, tinnitus and local mass. Computed tomography (CT) and magnetic resonance (MR) could provide important information for diagnosis. CT showed irregular destruction on bone margin of the jugular foramen. MR demonstrated iso or hypointense on T1WI, hyperintense on T2WI and heterogeneous contrast-enhancement. Surgical approaches were chosen upon the sizes and scopes of the tumors. Inferior temporal fossa A approach was adopted in 12 cases, inferior temporal fossa B approach in 2 cases and mastoid combined parotid approach in 1 case. Five patients with facial nerve involved received great auricular nerve graft. The House Brackmann (H-B) grading scale was used to evaluate the facial nerve function. Preoperative facial nerve function ranked grade Ⅴ in 4 cases and grade Ⅵ in 1 case. Postoperative facial nerve function improved to grade Ⅲ in 2 cases and grade Ⅵ in 3 cases. Five patients presented with cranial nerves Ⅸ and Ⅹ palsies. Hoarseness and cough of 2 cases improved after operation, while the other 3 cases did not. All the patients were diagnosed CSA by histopathology and immunohistochemistry, with immunohistochemical staining showing vimentin and S-100 positive, but cytokeratin negative in tumor cells. All patients survived during 28 to 234 months' follow-up. Two patients suffered from tumor recurrence 7 years after surgery and received revision surgery. No complications such as cerebrospinal fluid leakage and intracranial infection occurred after operation. Conclusions: Jugular foramen CSA lacks characteristic symptoms or signs. Imaging is helpful to differential diagnosis. Surgery is the primary treatment of jugular foramen CSA. Patients with facial paralysis should receive surgery in time as to restore the facial nerve. Long-term follow-up is necessary after surgery in case of recurrence.
Humans ; Male ; Female ; Young Adult ; Adult ; Middle Aged ; Facial Paralysis/etiology* ; Diagnosis, Differential ; Jugular Foramina ; Retrospective Studies ; Cough ; Hoarseness ; Neoplasm Recurrence, Local ; Chondrosarcoma/surgery*

Objective:To compare the effect of temporal external fixator and digital guide plate in the immediate reconstruction of mandibular defect after segmental mandibulectomy.Methods:The clinical data of all patients who received segmental mandibulectomy and immediate mandibular reconstruction with free vascularized bone graft by a single surgical team in the Department of Oral & Maxillofacial-Head & Neck Oncology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine from August 2016 to December 2017 were retrospectively analyzed. According to different auxiliary methods, the patients were divided into temporal external fixator (TEF) group and computer aided design-manufacture (CAD-CAM) group. The width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were measured by CT before and one month after surgery, and the difference before and after surgery was calculated to evaluate the surgical effect. SPSS 19.0 was used for statistical analysis, and the data were expressed as Mean ± SD. Independent sample t-test was used for comparison of indexes of surgical time and surgical effect evaluation between the two groups, and P<0.05 indicated statistically significant differences. Results:A total of 29 patients were enrolled, including 13 patients in TEF group, 4 males and 9 females, aged (47.7±14.5) years, including 7 ameloblastomas, 2 squamous cell carcinomas, 2 abnormal proliferation of bone fibers, 1 rhabdomyosarcoma and 1 osteosarcoma. In the CAD-CAM group, there were 16 cases, including 11 males and 5 females, aged (42.4±19.7) years, including 10 ameloblastomas, 3 squamous cell carcinomas, 1 osteoblastoma, 1 otogenic fibromyxoma and 1 osteosarcoma. The bone grafts in 29 patients were all alive, the wounds healed primarily, and the occlusal relationship and facial contour of the patients were fine. After 3 years follow-up, there were no postoperative complications and tumor recurrence. The function of the supply area was not affected. The operative time was (7.12±1.40) h in the TEF group and (4.72±1.10) h in the CAD-CAM group, and the difference between the two groups was statistically significant ( P<0.01). In the TEF group, the difference of the width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were (1.08±1.12) mm, (2.08±1.61) mm, (1.77±3.15) mm, respectively; CAD-CAM group were (0.88±1.15) mm, (0.94±1.34) mm, (0.87±1.47) mm, respectively, and there was no statistical significance between the two groups ( P>0.05). Conclusions:It took significantly longer to perform immediate mandibular reconstruction assisted by TEF than that assisted by CAD-CAM in surgery, but both groups achieved better surgical results. It is simpler and more effective to use TEF when time is urgent or technology is too limited to carry out preoperative digital design.

Objective:To compare the effect of temporal external fixator and digital guide plate in the immediate reconstruction of mandibular defect after segmental mandibulectomy.Methods:The clinical data of all patients who received segmental mandibulectomy and immediate mandibular reconstruction with free vascularized bone graft by a single surgical team in the Department of Oral & Maxillofacial-Head & Neck Oncology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine from August 2016 to December 2017 were retrospectively analyzed. According to different auxiliary methods, the patients were divided into temporal external fixator (TEF) group and computer aided design-manufacture (CAD-CAM) group. The width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were measured by CT before and one month after surgery, and the difference before and after surgery was calculated to evaluate the surgical effect. SPSS 19.0 was used for statistical analysis, and the data were expressed as Mean ± SD. Independent sample t-test was used for comparison of indexes of surgical time and surgical effect evaluation between the two groups, and P<0.05 indicated statistically significant differences. Results:A total of 29 patients were enrolled, including 13 patients in TEF group, 4 males and 9 females, aged (47.7±14.5) years, including 7 ameloblastomas, 2 squamous cell carcinomas, 2 abnormal proliferation of bone fibers, 1 rhabdomyosarcoma and 1 osteosarcoma. In the CAD-CAM group, there were 16 cases, including 11 males and 5 females, aged (42.4±19.7) years, including 10 ameloblastomas, 3 squamous cell carcinomas, 1 osteoblastoma, 1 otogenic fibromyxoma and 1 osteosarcoma. The bone grafts in 29 patients were all alive, the wounds healed primarily, and the occlusal relationship and facial contour of the patients were fine. After 3 years follow-up, there were no postoperative complications and tumor recurrence. The function of the supply area was not affected. The operative time was (7.12±1.40) h in the TEF group and (4.72±1.10) h in the CAD-CAM group, and the difference between the two groups was statistically significant ( P<0.01). In the TEF group, the difference of the width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were (1.08±1.12) mm, (2.08±1.61) mm, (1.77±3.15) mm, respectively; CAD-CAM group were (0.88±1.15) mm, (0.94±1.34) mm, (0.87±1.47) mm, respectively, and there was no statistical significance between the two groups ( P>0.05). Conclusions:It took significantly longer to perform immediate mandibular reconstruction assisted by TEF than that assisted by CAD-CAM in surgery, but both groups achieved better surgical results. It is simpler and more effective to use TEF when time is urgent or technology is too limited to carry out preoperative digital design.

OBJECTIVE: To investigate the complications of tourniquet in the clinical application of lower tibiofibular fracture. METHODS: From June 2018 to September 2019, 33 cases of closed lower tibiofibular fractures (AO type 43A) were treated with plates and screws and were divided into two groups according to whether pueumatic tourniquet was used:16 cases in the observation group, 13 males and 3 females, aged 18 to 69 (38.8±17.0) years, the operation time after injury was (6.9±1.7) days, and tourniquet was not used during operation. There were 17 cases in the control group, 13 males and 4 females, aged from 21 to 71 (43.8±12.4) years, the operation time after injury was (6.5±1.0) days, automatic pneumatic tourniquetwas routinely used in the operation. The operation time, blood loss, postoperative swelling, pain and other complications were compared between two groups. RESULTS: Total of 33 patients were followed up for an average of 15 months. There was no significant difference in operation time and blood loss between two groups ( CONCLUSION The fracture of lower tibiofibular segment is superficial and easy to be exposed and fixed during operation. In order to avoid tourniquet complications, it is not recommended to use air bag tourniquet routinely or minimize the application time of tourniquet.
Adolescent ; Adult ; Aged ; Female ; Fracture Fixation, Internal ; Fractures, Bone/surgery* ; Humans ; Male ; Middle Aged ; Operative Time ; Retrospective Studies ; Tourniquets ; Treatment Outcome ; Young Adult

Pulmonary hypertension (PH) is a severe pathophysiological condition characterized by pulmonary artery remodeling and continuous increases in pulmonary artery pressure, which may eventually develop to right heart failure and death. Although newly discovered and incredible treatment strategies in recent years have improved the prognosis of PH, limited types of effective and economical drugs for PH still makes it as a life-threatening disease. Some drugs from Chinese materia medica (CMM) have been traditionally applied in the treatment of lung diseases. Accumulating evidence suggests active pharmaceutical ingredients (APIs) derived from those medicines brings promising future for the prevention and treatment of PH. In this review, we summarized the pharmacological effects of APIs derived from CMM which are potent in treating PH, so as to provide new thoughts for initial drug discovery and identification of potential therapeutic strategies in alternative medicine for PH.
China ; Drugs, Chinese Herbal ; Humans ; Hypertension, Pulmonary/drug therapy* ; Materia Medica ; Medicine, Chinese Traditional

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
Biomedical Research ; Clinical Trials as Topic ; Consensus ; Drugs, Chinese Herbal ; Ethical Review ; Humans ; Medicine, Chinese Traditional ; Multicenter Studies as Topic ; Pharmaceutical Preparations

This Paper aimed to analyze and identify the chemical constituents from the seeds of Celosia argentea by UPLC-ESI-Q-TOF-MS. The analysis was performed on an ACQUITY HSS T3 reverse phase column(2.1 mm ×100 mm, 1.8 μm). The mobile phase consisting of 0.1% formic acid acetonitrile and 0.1% aqueous formic acid was used for gradient elution, and the flow rate was 0.4 mL·min~(-1). Mass spectrometry was applied for the qualitative analysis under positive and negative ionization modes and ESI ion source. Data was analyzed by Masslynx 4.1 software, literatures in SciFinder database, and standards. A total of 49 compounds, including 14 triterpenoids, 17 flavonoids, 11 cyclic peptides, 2 phenols, 2 organic acids, and 3 steroids were putatively identified. Among them, 19 compounds were firstly reported from this species. In-depth chemical constituent analysis for the seeds of C. argentea were accomplished here, and the findings could lay a good foundation for its quality control and clarifying the material basis of its efficacy.
Celosia ; chemistry ; Chromatography, High Pressure Liquid ; Phytochemicals ; analysis ; Seeds ; chemistry ; Spectrometry, Mass, Electrospray Ionization