OBJECTIVES: To evaluate the one-year outcomes of valve-in-valve transcatheter mitral valve replacement (ViV-TMVR) using SAPIEN 3 valve for treating mitral bioprosthetic valve failure. METHODS: A retrospective analysis was conducted on 26 patients with mitral bioprosthetic valve failure who underwent ViV-TMVR at West China Hospital, Sichuan University, between November 2022 and July 2024. The age of patients was 71.5 (64.5, 74.5) years, and 69.2% were female. Bioprosthetic valve failure occurred at (9.7±3.7) years after initial surgical implantation, with the most common failure mode being mixed stenosis and regurgitation (53.8%). The SAPIEN 3 valve was implanted via either a transseptal or transapical approach. Echocardiography was performed preoperatively, immediately post-procedure, and at 1 month, 6 months, and 1 year post-procedure. Outcomes included all-cause mortality, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 score, and postoperative complications. RESULTS: The procedure was performed via the transseptal approach in 21 patients (80.8%) and the transapical approach in 5 patients (19.2%). All procedures were technically successful. No paravalvular leakage was observed immediately post-procedure, and mitral valve hemodynamics improved significantly. At the 1-year follow-up, 2 patients had died. Two patients (8.3% of survivors) were of NYHA functional class Ⅲ, and KCCQ-12 score improved to (88.4±14.6) points (both P<0.01). Echocardio-graphy at 1 year postoperatively showed significant reductions in peak mitral valve velocity [to (2.29±0.32) m/s] and mean transvalvular pressure gradient [to (9.5±3.5) mmHg, 1 mmHg=0.133 kPa] compared to baseline (both P<0.05). No moderate or severe mitral regurgitation or paravalvular leakage was observed. The proportion of patients with moderate-to-severe pulmonary hypertension decreased from 65.4% preoperatively to 13.0% at 1 year (P<0.05). CONCLUSIONS ViV-TMVR with the SAPIEN 3 valve for mitral biopro-sthetic valve failure is associated with high procedural success, significantly improved valve hemodynamics of the mitral value, alleviation of pulmonary hypertension, enhanced quality of life, and a low rate of complications at 1 year after the operation.
Humans ; Female ; Male ; Retrospective Studies ; Aged ; Bioprosthesis ; Heart Valve Prosthesis ; Mitral Valve/surgery* ; Heart Valve Prosthesis Implantation/methods* ; Middle Aged ; Prosthesis Failure ; Treatment Outcome ; Mitral Valve Insufficiency/surgery*

OBJECTIVE: To evaluate the efficacy and safety of Mahuang Zhisou Capsule (MHZSC), a compound traditional Chinese herbal medicine, in treatment of acute upper respiratory tract infection of wind-cold syndrome. METHODS: A multi-center, double-blind, double dummy, randomized controlled trial was conducted. A total of 240 patients were randomized into treatment group (120 cases, treated with MHZSC) and control group (120 cases, treated with Mahuang Zhisou Pill). The therapeutic course was 3 days. RESULTS: Seven cases were excluded and three cases lost to follow-up. Two hundred and thirty-three cases entered intention-to-treat (ITT) analysis and 230 cases fitted in per-protocol population set (PPS) analysis. After treatment, the therapeutic effect of upper respiratory tract infection was calculated by ITT and PPS analysis respectively. The significant response rate and total response rate in the treatment group were 78.07% and 98.25% (ITT and PPS), while the significant response rates in the control group were 70.59% (ITT) and 70.69%(PPS), and the total response rates were 95.80% (ITT) and 95.69% (PPS) respectively. There were no significant differences in clinical efficacy between the two groups (P>0.05). CONCLUSION: MHZSC is effective and safe in treatment of acute upper respiratory tract infection of external wind-cold syndrome.

Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

OBJECTIVE: To evaluate the efficacy and safety of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with wind-warm syndrome. METHODS: The multiple center, double-blinded, double-dummy and randomized controlled method was conducted. Three hundred and sixty patients were randomly divided into the treatment group A (n=120, treated with Yiqing Shuangjie Capsule and Chaihuang analogues), treatment group B (n=120, treated with Yiqing Shuangjie Tablet and Chaihuang analogues) and the control group (n=120, treated with Chaihuang Tablet and Yiqing Shuangjie Capsule analogues). Every drug was administered 3 pills each time. Patients in the three groups were all treated for 5 days and three times daily. The accumulated scores of syndrome, clinical symptoms, adverse effect and body temperature were recorded before and after the treatment. The safety indexes, such as routine tests of blood, urine and stool, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment. RESULTS: Three cases were excluded and eighteen cases lost to follow-up. There were 343 patients who entered to the intention-to-treat (ITT) analysis and 339 patients fitted in the per-protocol population set (PPS) analysis. After treatment, the therapeutic effects of respiratory tract infection were calculated by ITT and PPS analysis respectively. The rates of total obvious effect were 84.96% and 87.27% respectively in the treatment group A, and the total response rates were 96.46% and 97.27% respectively. The rates of total obvious effect were 85.47% and 86.20% respectively in the treatment group B, and the total response rates were 97.45% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and the total response rates both were 99.12%. There was significant difference among the three groups (P<0.05). The effects of traditional Chinese medicine syndrome were also detected by ITT and PPS analysis respectively. In the treatment group A, the total obvious effect rates were 84.07% and 85.46% respectively, and the total response rates were 96.46% and 97.27% respectively. In the treatment group B, the rates of total obvious effect were 88.89% and 89.65% respectively, and the total response rates were 97.44% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and total response rates both were 99.12%. There was also statistical significant difference among the three groups (P<0.05). ITT and PPS analysis had the same results. No adverse effect was found in the trial. CONCLUSION: Yiqing Shuangjie Capsule and Tablet are effective and safe in treating acute upper respiratory tract infection of wind heat syndrome without obvious adverse effect.

To evaluate the safety and efficacy of andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome.

OBJECTIVE: To evaluate the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (IBS) with stagnation of qi and cold. METHODS: A prospective, randomized, placebo-controlled, double-blind clinical study was undertaken. One hundred and ninety-eight patients with IBS and syndrome of stagnation of qi and cold were randomly divided into high-dose Dinggui Oil group (DGO-H, 1.2 g, 3 times daily; n=66), low-dose Dinggui Oil group (DGO-L, 0.8 g, 3 times daily, n=66), and placebo group (placebo, 5.0 g, 3 times daily, n=66). Patients in the three groups were all treated for 2 weeks. RESULTS: The total significant effective rates for IBS were 54.1%, 28.8% and 21.9% in the DGO-H, DGO-L, and placebo groups, and the total effective rates for the syndrome of stagnation of qi and cold were 54.1%, 25.8% and 23.4% in the three groups, respectively. Dinggui Oil Capsule showed a higher efficacy than the placebo in relieving the abdominal pain (P<0.01). No adverse effects were found in this trial. CONCLUSION: Dinggui Oil Capsule is effective and safe in relieving abdominal pain due to IBS with stagnation of qi and cold.

OBJECTIVE: To evaluate the safety and efficacy of Yiqi Pingchuan Granule in treating acute attack of asthma due to qi deficiency and cold syndrome. METHODS: A randomized controlled trial was conducted. A total of 80 patients with an acute attack of asthma were included. They were allocated into two groups randomly in a ratio of three to one. Sixty patients in the treatment group received Yiqi Pingchuan Granule and 20 patients in the control group received Ruyi Dingchuan Pill. Patients in both groups were treated for 7 days. RESULTS: There were no significant differences in traditional Chinese medicine syndrome, clinical symptoms and lung function between the two groups (P>0.05). After treatment, the forced expiratory volume in 1 second was increased in the treatment group (P<0.05), and the peak expiratory flow was accelerated in the control group (P<0.05). No significant side effects were noted in both groups. CONCLUSION: Yiqi Pingchuan Granule is safe and effective in treating acute attack of asthma due to qi deficiency and cold syndrome.

OBJECTIVE: To evaluate the safety and efficacy of Chaige Qingre Granule, a traditional Chinese compound herbal medicine, in treating acute upper respiratory tract infection of wind heat syndrome. METHODS: A multi-center, double-blinded, randomized controlled trial was conducted. In the phase II, 60 patients with acute upper respiratory tract infection were randomly divided into the trial group (n=30) and the control group (n=30). In the phase III, 112 patients were randomly divided into the trial group (n=84) and the control group (n=28). The trial group received 6 g Chaige Qingre Granule, and the control group received 6 g Fufang Shuanghua Granule (another traditional Chinese compound herbal medicine). The two groups were all treated for 3 days and four times daily. Clinical symptoms, syndromes, adverse effect, blood, urine and stool test, hepatorenal function and electrocardiogram were examined before and after the treatment. RESULTS: After treatment, the overall obvious response rates of the trial group and the control group were 78.57%, 82.14% (by per-protocol analysis) and 75.86%, 79.31% (by intention-to-treat analysis) respectively, and the overall response rates of the two groups were 96.43%, 100% (by per-protocol analysis) and 93.10%, 96.55% (by intention-to-treat analysis) respectively in phase II. There were no significant differences between the two groups (P>0.05). In the phase III, the overall obvious response rates of the trial group and the control group were 90.54%, 73.08% (by per-protocol analysis) and 88.16%, 70.37% (by intention-to-treat analysis) respectively, and the overall response rates of the two groups were 94.59%, 96.15% (by per-protocol analysis) and 92.11%, 92.59% (by intention-to-treat analysis) respectively. There were no statistical differences between the two groups (P>0.05) too. No adverse effects were found in the trial. CONCLUSION: Chaige Qingre Granule is effective and safe in treating acute upper respiratory tract infection of wind heat syndrome.