Differential Prognostic Implications of Pre- and Post-Stent Fractional Flow Reserve in Patients Undergoing Percutaneous Coronary Intervention

Background and Objectives@#The influence of pre-intervention coronary physiologic status on outcomes post percutaneous coronary intervention (PCI) is not well known. We sought to investigate the prognostic implications of pre-PCI fractional flow reserve (FFR) combined with post-PCI FFR. @*Methods@#A total of 1,479 PCI patients with pre-and post-PCI FFR data were analyzed. The patients were classified according to the median values of pre-PCI FFR (0.71) and post-PCI FFR (0.88). The primary outcome was target vessel failure (TVF) at 2 years. @*Results@#The risk of TVF was higher in the low pre-PCI FFR group than in the high pre-PCI FFR group (hazard ratio, 1.82; 95% confidence interval, 1.15–2.87; p=0.011). In 4 group comparisons, the cumulative incidences of TVF at 2 years were 3.8%, 4.1%, 4.8%, and 10.2% in the high pre-/high post-, low pre-/high post-, high pre-/low post-, and low pre-/low post-PCI FFR groups, respectively. The risk of TVF was the highest in the low pre-/low post-PCI FFR group among the groups (p values for comparisons 0.05). When the prognostic value of the post-PCI FFR was evaluated according to the pre-PCI FFR, the risk of TVF significantly decreased with an increase in postPCI FFR in the low pre-PCI FFR group, but not in the high pre-PCI FFR group. @*Conclusions@#Pre-PCI FFR was associated with clinical outcomes after PCI, and the prognostic value of post-PCI FFR differed according to the pre-PCI FFR.

Long-term outcomes of intravascular ultrasound-guided drug-eluting stent implantation in patients with chronic kidney disease: ULTIMATE CKD subgroup analysis / 中华心血管病杂志

Objective: To explore the long-term effect of intravascular ultrasound (IVUS) guidance on patients with chronic kidney disease (CKD) undergoing drug-eluting stent (DES) implantation. Methods: Data used in this study derived from ULTIMATE trial, which was a prospective, multicenter, randomized study. From August 2014 to May 2017, 1 448 patients with coronary heart disease undergoing DES implantation were selected from 8 domestic centers and randomly divided into two groups in the ratio of 1∶1 (IVUS or coronary angiography guided stent implantation). A total of 1 443 patients with the baseline serum creatine available were enrolled. The patients were divided into CKD group and non CKD group. CKD was defined as the estimated glomerular filtration rate (eGFR) derived from Cockcroft Gault (CG) formula< 60 ml·min-1·1.73 m-2 for at least 3 months. Primary endpoint of this study was target vessel failure (TVF) at 3 years, including cardiac death, target vessel myocardial infarction, and clinically-driven target vessel revascularization. Kaplan Meier method was used for survival analysis, and log rank test was used to compare the occurrence of end-point events in each group. Cox proportional hazards model was used to calculate HR and 95%CI, and interaction was tested. Multivariate Cox regression was used to analyze the independent influencing factors of TVF. Results: A total of 1 443 patients with coronary heart disease were enrolled in this study, including 349 (24.2%) patients in CKD group and 1 094 patients in non CKD group. In CKD group, IVUS was used to guide stent implantation in 180 cases and angiography was used in 169 cases; in non CKD group, IVUS was used to guide stent implantation in 543 cases and angiography was used in 551 cases. Three-year clinical follow-up was available in 1 418 patients (98.3%). The incidence of TVF in CKD group was 12.0% (42/349), which was higher than that in non CKD group (7.4% (81/1 094) (P = 0.01). The difference was mainly due to the higher cardiac mortality in CKD group (4.6% (16/349) vs. 1.5% (16/1094), P<0.001). In CKD group, the incidence of TVF in patients who underwent IVUS guided stent implantation was lower than that in angiography guided stent implantation (8.3% (15/180) vs. 16.0% (27/169), P = 0.03). There was no significant difference in the incidence of TVF between IVUS guided stent implantation and angiography guided stent implantation in non CKD group (5.9% (32/543) vs. 8.9% (49/551), P = 0.06), and there was no interaction (P = 0.47). Multivariate Cox regression analysis showed that IVUS guidance (HR = 0.56, 95%CI 0.39-0.81, P = 0.002), CKD (HR = 1.83, 95%CI 1.17-2.87, P = 0.010) and stent length (every 10 mm increase) (HR = 1.11, 95%CI 1.04-1.19, P = 0.002) were independent risk factors for TVF within 3 years after DES implantation. Conclusions: CKD patients undergoing DES implantation are associated with a higher risk of 3-year TVF. More importantly, the risk of TVF could be significantly decreased through IVUS guidance in comparison with angiography guidance in patients with CKD.

Clinical observation of acupuncture and traction plus Ba Duan Jin (Eight-brocade Exercise) for improving discogenic low back pain / 针灸推拿医学（英文版）

Objective: To observe the short-term and long-term efficacy of acupuncture and traction plus Ba Duan Jin (Eight-brocade Exercise) in treating discogenic low back pain (DLBP). Methods: Sixty patients were divided into an observation group and a control group using the random number table method, with 30 cases in each group. The control group was intervened by acupuncture and traction, while the observation group was given additional Ba Duan Jin (Eight-brocade Exercise) practice. The intervention lasted for a total of 1 month, with a follow-up study conducted 6 months later. The visual analog scale (VAS) and Oswestry disability index (ODI) scores in the two groups were compared before and after treatment, and the efficacy was compared at the end of the treatment between the two groups; the relapse rate was compared at the 6-month follow-up between the two groups. Results: The pain VAS and ODI scores decreased after treatment in both groups, and the intra-group differences were statistically significant (all P<0.05); the pain VAS and ODI scores in the observation group were lower than those in the control group after treatment with statistical significance (both P<0.05). At the 6-month follow-up, the relapse rate was 10.3％ in the observation group versus 48.0％ in the control group, and the between-group difference was statistically significant (P<0.05). Conclusion: The combination of acupuncture, traction and Ba Duan Jin (Eight-brocade Exercise) is an effective method for DLBP and patients who received this method are less likely to relapse.

Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial / 世界急诊医学杂志（英文）

BACKGROUND@# Stent failure is more likely in the lipid rich and thrombus laden culprit lesions underlying ST-segment elevation myocardial infarction (STEMI). This study assessed the effectiveness of post-dilatation in primary percutaneous coronary intervention (pPCI) for acute STEMI.@*METHODS@# The multi-center POST-STEMI trial enrolled 41 consecutive STEMI patients with symptom onset <12 hours undergoing manual thrombus aspiration and Promus Element stent implantation. Patients were randomly assigned to control group (n=20) or post-dilatation group (n=21) in which a non-compliant balloon was inflated to >16 atm pressure. Strut apposition and coverage were evaluated by optical coherence tomography (OCT) after intracoronary verapamil administration via thrombus aspiration catheter, post pPCI and at 7-month follow-up. The primary endpoint was rate of incomplete strut apposition (ISA) at 7 months after pPCI.@*RESULTS@# There were similar baseline characteristics except for stent length (21.9 [SD 6.5] mm vs. 26.0 [SD 5.8] mm, respectively, P=0.03). In post-dilatation vs. control group, ISA rate was lower (2.5% vs. 4.5%, P=0.04) immediately after pPCI without affecting final TIMI flow 3 rate (95.2% vs. 95.0%, P>0.05) or corrected TIMI frame counts (22.6±9.4 vs. 22.0±9.7, P>0.05); and at 7-month follow-up (0.7% vs. 1.8%, P<0.0001), the primary study endpoint, with similar strut coverage (98.5% vs. 98.4%, P=0.63) and 1-year rate of major adverse cardiovascular events (MACE).@*CONCLUSION@# In STEMI patients, post-dilatation after stent implantation and thrombus aspiration improved strut apposition up to 7 months without affecting coronary blood flow or 1-year MACE rate. Larger and longer term studies are warranted to further assess safety (ClinicalTrials.gov identifi er: NCT02121223).

Analysis of Pulse Signals Based on Array Pulse Volume / 中国结合医学杂志

OBJECTIVE@#To collect and analyze multi-dimensional pulse diagram features with the array sensor of a pressure profile system (PPS) and study the characteristic parameters of the new multi-dimensional pulse diagram by pulse diagram analysis technology.@*METHODS@#The pulse signals at the Guan position of left wrist were acquired from 105 volunteers at the Shanghai University of Traditional Chinese Medicine. We obtained the pulse data using an array sensor with 3×4 channels. Three dimensional pulse diagrams were constructed for the validated pulse data, and the array pulse volume (APV) parameter was computed by a linear interpolation algorithm. The APV differences among normal pulse (NP), wiry pulse (WP) and slippery pulse (SP) were analyzed using one-way analysis of variance. The coefficients of variation (CV) were calculated for WP, SP and NP.@*RESULTS@#The APV difference between WP and NP in the 105 volunteers was statistically significant (6.26±0.28 vs. 6.04±0.36, P=0.048), as well as the difference between WP and SP (6.26±0.28 vs. 6.07±0.46, P=0.049). However, no statistically significant difference was found between NP and SP (P=0.75). WP showed a similar CV (4.47%) to those of NP (5.96%) and SP (7.58%).@*CONCLUSION@#The new parameter APV could differentiate between NP or SP and WP. Accordingly, APV could be considered an useful parameter for the analysis of array pulse diagrams in Chinese medicine.

Anterior Subcutaneous Transposition of the Ulnar Nerve Affects Elbow Range of Motion: A Mean 13.5 Years of Follow-up / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Surgical decompression of the ulnar nerve is effective for cubital tunnel syndrome. However, deep approaches may result in iatrogenic elbow stiffness. This long-term study was to evaluate the range of motion (ROM) of the elbow and functional outcomes after anterior subcutaneous transposition.</p><p><b>METHODS</b>A total of 115 patients (78 male and 37 female; mean age: 46.6 years) who underwent anterior subcutaneous transposition of the ulnar nerve between 2001 and 2005 were evaluated retrospectively; mean follow-up was 13.5 years. Elbow ROM was measured as flexion arc, flexion, and extension preoperatively and at the final follow-up, and compared via a mixed analysis of variance adjusting for age. Neuropathy was assessed preoperatively using a modified McGowan neuropathy grade and postoperatively using modified Wilson-Krout criteria. An ordinal logistic regression analysis used postoperative modified Wilson-Krout criteria as the outcome and preoperative factors as predictors.</p><p><b>RESULTS</b>Preoperative McGowan grades were Grade 1 in 14 patients (12.2%), Grade 2A in 28 (24.3%), Grade 2B in 53 (46.1%), and Grade 3 in 20 (17.4%) patients. Postoperatively, 66 patients (57.4%) had excellent results, 26 (22.6%) had good results, 16 (13.9%) had fair results, and 7 (6.1%) had poor results at the final follow-up, as per the Wilson-Krout criteria. There were no complications. Pre- and postoperative elbow ROM was significantly decreased in patients with previous trauma or surgery of the elbow compared with those without (P < 0.05). Anterior subcutaneous transposition of the ulnar nerve did not significantly affect elbow ROM regardless of previous trauma or surgical history nor preoperative ROM (P > 0.05), after adjusting for age. Patients with prolonged symptoms prior to surgery and worse neuropathy tended to have less satisfactory functional outcomes (P < 0.05), after adjusting for covariates.</p><p><b>CONCLUSIONS</b>Anterior subcutaneous transposition of the ulnar nerve is an effective and reliable treatment of cubital tunnel syndrome with satisfactory outcomes and minimal effect on elbow ROM.</p>

One-year Outcomes in Patients with ST-segment Elevation Myocardial Infarction Caused by Unprotected Left Main Coronary Artery Occlusion Treated by Primary Percutaneous Coronary Intervention / 中华医学杂志(英文版)

<p><b>Background</b>Very few data have been reported for ST-segment elevation myocardial infarction (STEMI) caused by unprotected left main coronary artery (ULMCA) occlusion, and very little is known about the results of this subgroup of patients who underwent primary percutaneous coronary intervention (PCI). The aim of this study was to determine the clinical features and outcomes of patients with STEMI who underwent primary PCI for acute ULMCA occlusion.</p><p><b>Methods</b>From January 2000 to February 2014, 372 patients with STEMI caused by ULMCA acute occlusion (ULMCA-STEMI) who underwent primary PCI at one of two centers were enrolled. The 230 patients with non-ST-segment elevation MI (NSTEMI) caused by ULMCA lesion (ULMCA-NSTEMI) who underwent emergency PCI were designated the control group. The main indexes were the major adverse cardiac events (MACEs) in-hospital, at 1 month, and at 1 year.</p><p><b>Results</b>Compared to the NSTEMI patients, the patients with STEMI had significantly higher rates of Killip class≥III (21.2% vs. 3.5%, χ = 36.253, P < 0.001) and cardiac arrest (8.3% vs. 3.5%, χ = 5.529, P = 0.019). For both groups, the proportions of one-year cardiac death in the patients with a post-procedure thrombolysis in myocardial infarction (TIMI) flow grade<3 were significantly higher than those in the patients with a TIMI flow grade of 3 (STEMI group: 51.7% [15/29] vs. 4.1% [14/343], P < 0.001; NSTEMI group: 33.3% [3/9] vs. 13.6% [3/221], P = 0.001; respectively]. Landmark analysis showed that the patients in STEMI group were associated with higher risks of MACE (16.7% vs. 9.1%, P = 0.009) and cardiac death (5.4% vs. 1.3%, P = 0.011) compared with NSTEMI patients at 1 month. Meanwhile, in patients with ULMCA, the landmark analysis for incidences of MACE and cardiac death was similar between the STEMI and NSTEMI (all P = 0.72) in the intervals of 1-12 months. However, patients who were diagnosed with STEMI or NSTEMI had no significant difference in reinfarction (all P > 0.05) and TVR (all P > 0.05) in the intervals of 0-1 month as well as 1 month to 1 year. The results of Cox regression analysis showed that the differences in the independent predictors for MACE included the variables of Killip class ≥ III and intra-aortic balloon pump support for the STEMI patients and the variables of previous MI, ULMCA distal bifurcation, and 2-stent for distal ULMCA lesions for the NSTEMI patients.</p><p><b>Conclusions</b>Compared to the NSTEMI patients, the patients with STEMI and ULMCA lesions still remain at a much higher risk for adverse events at 1 year, especially on 1 month. If a successful PCI procedure is performed, the 1-year outcomes in those patients might improve.</p>

Whole Exome Sequencing Reveals A Novel Frameshift Mutation in the BMPR2 Gene in A Chinese Family With Pulmonary Arterial Hypertension / 中国循环杂志

Objectives: To investigate the genetic mutation in a Chinese family with Pulmonary Arterial Hypertension (PAH). Methods: Whole exome sequencing was performed in two patients and two healthy family members in the PAH pedigree. Patient-specific variations were screened by bioinformatics methods and compared between groups. To further identify the association between these variations and PAH, Sanger sequencing was used to analyze the genotype of PAH patients and 100 healthy controls. Results: Two affected persons were found among the eight family members. The patients was presented as dyspnea after exercise, and right-heart catheterization was performed to measure the mean pulmonary arterial pressure (mPAP, 77 mmHg), cardiac output (CO, 4.92 L/min), and pulmonary vascular resistance (PVR, 13.4 Wood units). The hereditary characteristic in this family presented in mother and child, suggesting an autosomal dominant patter. Exome sequencing, mutation detection and sanger variants validation revealed a novel heterozygous frameshift mutation (c.747_748 insCCTTTGATGGAACATGA:p.V250fs) in the BMPR2 gene. Meanwhile, this heterozygous insertion mutation was absent in 100 ethnically matched control samples screened by direct sanger sequencing. Conclusions: Our study revealed a novel heterozygous frameshift mutation in the BMPR2 gene, expanding the BMPR2 mutation spectrums.

Kidney-replenishing herb modulates phenotype of NK cells at fetal-maternal interface by up-regulating IDO expression of trophoblasts / 中国免疫学杂志

Objective:To study the mechanism of kidney-replenishing herb in regulating the tolerance of fetal-maternal interface and the effect of IDO on modulating the phenotype of decidual NK cells. Methods: Indoleamine-2,3-dioxygenase ( IDO) expression in villus tissues from normal pregnancies and recurrent spontaneous abortion (RSA) patients was monitored by immunohisto-chemistry (IHC). IDO expression in HTR-8/Svneo cells treated with control or herb serum medium was detected by flow cytometry (FCM). The influence of kidney-replenishing herb on modulating the phenotype of NK cells,CD16 and CD56 expression in peripheral NK cells co-cultured with control or herb serum medium in the presence or absence of 1-methyltryptophan (1-MT) treated HTR-8/Svneo cells were measured by FCM. Results: IDO expression was decreased in villus tissue of RSA patients compared to normal preg-nancies. Herb medium could increase the IDO expression of HTR-8/Svneo. Kidney-replenishing herb could enhance the regulatory function of trophoblasts on NK cells and further induce the immune tolerance at fetal-maternal interface in IDO dependent and independent manners. Conclusion: Kidney-replenishing herb can modulate the phenotype of peripheral NK cell by up-regulating IDO expression in trophoblasts and play a role in the treatment of RSA patients.

Simultaneous determination of eight constituents in Tiantai No.1 Tablets by HPLC-ELSD / 中成药

AIM To establish an HPLC-ELSD method for the simultaneous content determination of gastrodin,parishin A,parishin B,ginsenosides Rg1,Re,Rf,Rb1 and Rd in Tiantai No.1 Tablets (Ginseng Radix et Rhizoma,Gastrodiae Rhizoma,Cistanches Herba,etc.).METHODS The analysis of methanol extract of this drug was performed on a 45 ℃C thermostatic Alltima C1scolumn (4.6 mm × 250 mm,5 μm),with the mobile phase comprising of acetonitrie-0.1％ phosphoric acid flowing at 1.0 mL/min in a gradient elution manner.RESULTS Eight constituents showed good linear relationships within their own ranges (r ＞ 0.999 0),whose average recoveries were 96.94％-97.93％ with the RSDs of 1.06％-2.48％.CONCLUSION This simple,accurate and reliable method can be used for the quality control of Tiantai No.1 Tablets.

Research on early-warning and evaluation of traditional Chinese medicine industry security based on BP neural network / 中草药

Through literature research, the safety evaluation index of traditional Chinese medicine (TCM) industry is identified, missing index value is calculated using the grey system theory, and the index weight is determined by the entropy weight method. The TCM industry safety from 2002 to 2014 was evaluated by grey relational analysis, and the TCM industry security evaluation index data from 2015 to 2020 are predicted using grey prediction and linear regression model method, combining the predicted value with historical data, TCM industry security BP neural network prediction model is established, and TCM industry security from 2015 to 2020 will be early warning. The results show that the next six years, TCM industry in China is safe, only mild prevention.

Simultaneous determination of eight constituents in Tiantai No.1 Tablets by HPLC-ELSD / 中成药

AIM To establish an HPLC-ELSD method for the simultaneous content determination of gastrodin,parishin A,parishin B,ginsenosides Rg1,Re,Rf,Rb1 and Rd in Tiantai No.1 Tablets (Ginseng Radix et Rhizoma,Gastrodiae Rhizoma,Cistanches Herba,etc.).METHODS The analysis of methanol extract of this drug was performed on a 45 ℃C thermostatic Alltima C1scolumn (4.6 mm × 250 mm,5 μm),with the mobile phase comprising of acetonitrie-0.1％ phosphoric acid flowing at 1.0 mL/min in a gradient elution manner.RESULTS Eight constituents showed good linear relationships within their own ranges (r ＞ 0.999 0),whose average recoveries were 96.94％-97.93％ with the RSDs of 1.06％-2.48％.CONCLUSION This simple,accurate and reliable method can be used for the quality control of Tiantai No.1 Tablets.

Clinical Relevance of Coronary Fractional Flow Reserve: Art-of-state / 中华医学杂志(英文版)

<p><b>OBJECTIVE</b>The objective was to delineate the current knowledge of fractional flow reserve (FFR) in terms of definition, features, clinical applications, and pitfalls of measurement of FFR.</p><p><b>DATA SOURCES</b>We searched database for primary studies published in English. The database of National Library of Medicine (NLM), MEDLINE, and PubMed up to July 2014 was used to conduct a search using the keyword term "FFR".</p><p><b>STUDY SELECTION</b>The articles about the definition, features, clinical application, and pitfalls of measurement of FFR were identified, retrieved, and reviewed.</p><p><b>RESULTS</b>Coronary pressure-derived FFR rapidly assesses the hemodynamic significance of individual coronary artery lesions and can readily be performed in the catheterization laboratory. The use of FFR has been shown to effectively guide coronary revascularization procedures leading to improved patient outcomes.</p><p><b>CONCLUSIONS</b>FFR is a valuable tool to determine the functional significance of coronary stenosis. It combines physiological and anatomical information, and can be followed immediately by percutaneous coronary intervention (PCI) if necessary. The technique of FFR measurement can be performed easily, rapidly, and safely in the catheterization laboratory. By systematic use of FFR in dubious stenosis and multi-vessel disease, PCI can be made an even more effective and better treatment than it is currently. The current clinical evidence for FFR should encourage cardiologists to use this tool in the catheterization laboratory.</p>

Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Recent studies reported that percutaneous coronary intervention with stent implantation was safe and feasible for the treatment of left main coronary artery (LMCA) disease in select patients. However, it is unclear whether drug-eluting stents (DESs) have better outcomes in patients with LMCA disease compared with bare-metal stent (BMS) during long-term follow-up in Chinese populations.</p><p><b>METHODS</b>From a perspective multicenter registry, 1136 consecutive patients, who underwent BMS or DES implantation for unprotected LMCA stenosis, were divided into two groups: 1007 underwent DES implantation, and 129 underwent BMS implantation. The primary outcome was the rate of major adverse cardiac events (MACEs), including cardiovascular (CV) death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years postimplantation.</p><p><b>RESULTS</b>Patients in the DES group were older and more likely to have hyperlipidemia and bifurcation lesions. They had smaller vessels and longer lesions than patients in the BMS group. In the adjusted cohort of patients, the DES group had significantly lower 5 years rates of MACE (19.4% vs. 31.8%, P = 0.022), CV death (7.0% vs. 14.7%, P = 0.045), and MI (5.4% vs. 12.4%, P = 0.049) than the BMS group. There were no significant differences in the rate of TLR (10.9% vs. 17.8%, P = 0.110) and stent thrombosis (4.7% vs. 3.9%, P = 0.758). The rates of MACE (80.6% vs. 68.2%, P = 0.023), CV death (93.0% vs. 85.3%, P = 0.045), TLR (84.5% vs. 72.1%, P = 0.014), and MI (89.9% vs. 80.6%, P = 0.029) free survival were significantly higher in the DES group than in the BMS group. When the propensity score was included as a covariate in the Cox model, the adjusted hazard ratios for the risk of CV death and MI were 0.41 (95% confidence interval [CI]: 0.21-0.63, P = 0.029) and 0.29 (95% CI: 0.08-0.92, P = 0.037), respectively.</p><p><b>CONCLUSIONS</b>DES implantation was associated with more favorable clinical outcomes than BMS implantation for the treatment of LMCA disease even though there was no significant difference in the rate of TLR between the two groups.</p>

Analysis of porphyrin photosensitizers using HPLC method / 药学学报

Photodynamic therapy (PDT), because of its good targeting, minimal invasion, and safety, is becoming a very active area in cancer prevention and treatment, in which the photosensitizers have proved to be the core element for PDT. We developed a new HPLC method for analyzing porphyrin photosensitizers using Shiseido Capcell PAK C18 (150 mm x 4.6 mm, 5 µm) as the column at 30 °C, methanol-1% aqueous solution of acetic acid as the mobile phase in a flow rate of 1.0 mL · min(-1) in a gradient elution mode, and the detection wavelength at 380 nm. This method, showing good specificity, precision, accuracy and robusty via methodology validations, can be applied to the purity test and assay of porphyrin photosensitizers, and has played a key guide role in the R&D of the new porphyrin photosensitizer--sinoporphyrin sodium.

"Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations / 中国中药杂志

We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in that it enhances the pharmaceutical manufactures the ability to control enterprise risk and eliminate the negative impact on traditional Chinese medicine. With the widely used and ADR report concentrated Radix Bupleuri injection as an example, the author provide a new approach to post-marketing clinical research.

Comparison of short- and long-term outcome after percutaneous transluminal interventional therapy in octogenarians with coronary artery disease from radial or femoral approach / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the short-term and long-term outcome after percutaneous coronary intervention (PCI) between transradial intervention (TRI) and transfemoral intervention (TFI) in elderly patients.</p><p><b>METHODS</b>From January 2005 to December 2010, 488 consecutive elderly patients ( ≥ 80 years old) were enrolled in this retrospective study. Patients were divided into TRI group (n = 235, PCIs were performed trans-radial approach) and TFI group (n = 253, PCIs were performed trans-femoral approach). Efficacy and safety data were compared between the two groups.</p><p><b>RESULTS</b>There were no differences in success rate of stenting, procedure time, contrast amount, rates of contrast-induced nephropathy, major adverse cardiovascular events during hospitalization, at one year follow up and at two years follow up. Lower vascular complications were associated with TRI approach[ 17.9% (42/253) vs. 26.9% (68/253) , P < 0.05], especially in TIMI major bleeding ratio [1.3% (3/235) vs. 4.7% (12/253) , P < 0.05], TIMI minor bleeding [5.1% (12/235) vs. 15.8% (40/253) , P < 0.01], and time lying in bed [3.6 (2.8-4.2)h vs. 24.4 (24.0-25.1)h, P < 0.01] and hospitalization [3.0 (3.0-4.0)d vs. 5.0 (5.0-6.0)d, P < 0.01], and higher rates of crossover approach were associated with TRI [11.5% (27/235) vs. 2.0(5/253) , P < 0.01].</p><p><b>CONCLUSION</b>TRI is as feasible, safe and effective as TFI in elderly patients during short-term and long-term follow up, and TRI is associated with higher rates of crossover approach.</p>

Analysis of one case of adolescent blastic plasmacytoid dendritic cell neoplasm / 中国实验血液学杂志

This study was purposed to summarize the clinical characteristics and laboratorial data of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in pediatric patients in order to enhance understanding this disease in diagnosis and therapy. A rare case of BPDCN in children was enrolled in this study. The blood routine test, examination of bone marrow cell morphology, histopathology and immunophenotype of the skin lesions were performed and analysed, the single cell suspensions of the biopsied skin mass were detected by flow cytometry. The results showed that tumor cells expressed CD4, CD56, CD43 and CD123, while not expressed CD19, CD20, CD3, CD8, CD13, CD11b and myeloperoxidase (MPO). According to the clinical and laboratorial features and the results from histopathological and immunophenotype examinations, BPDCN was confirmed. It is concluded that BPDCN in children is an extremely rare hematopoietic malignancy with presenting a rapidly and fatally aggressive clinical course. The diagnosis of this disease is mainly based on the clinical presentations, pathologic and immunohistochemical features. BPDCN is a highly aggressive disease, its prognosis is very poor, its pathogenesis remans still unclear. A standard treatment protocol for BPDCN has not yet been established.

Therapeutic efficacy evaluation of rabbit anti-thymocyte globulin combined with cyclosporine A in children with aplastic anemia / 中国实验血液学杂志

This study was aimed to investigate the therapeutic efficacy of rabbit anti-thymocyte globulin (r-ATG) combined with cyclosporine A (CsA) and to analyse the efficacy-related factors in children with aplastic anemia (AA). Twenty five AA children treated with r-ATG [3.5 mg/(kg·d)×5 days] combined with CsA were analyzed retrospectively. The lymphocyte subgroups, CD4(+)/CD8 ratio and expression of CD55, CD59 on surface of neutrophils and erythrocytes in peripheral blood were detected by direct immunofluorescence method and flow cytometry; the responsive time, effective rate, adverse effects and infections after immunosuppressive therapy (IST) were analyzed; the distribution of T-lymphocyte subgroups in IST-effective and IST-uneffective groups was compared, and therapeutic efficacy-related factors were evaluated. The results showed that the response to treatments was found in 21 out of 25 cases, the total responsive rate was 84.0%; the response time was 3 - 6 months, average of 4 months; the effective rates in month 3, 6, 9, 12 after treatment were 56.0%, 72.0%, 80.0% and 84.0% respectively. The AA children with age ≥ 5 years old, course of disease < 6 months and absolute neutrophil value ≥ 1.5 ×10(9)/L on 30 days after IST had good curative effect; the effective rate in AA children with age ≥ 5 years old, course of disease < 6 months, high or reverse ratio of CD4(+)/CD8(+) and absolute neutrophil value ≥ 1.5×10(9)/L after IST was higher than that in AA children with age < 5 years old, course of disease ≥ 6 months, normal ratio of CD4(+)/CD8(+) and absolute neutrophil value after IST < 1.5×10(9)/L (94.4% vs 57.1%, 90.4% vs 50.0%, 94.1% vs 62.5%, 94.1% vs 62.5%) (P < 0.05). The high effective rate was observed in AA children with decrease of CD55 and CD59 expression, but there was no significant difference (P > 0.05) as compared with normal expression of CD55, CD59. It is concluded that the treatment using r-ATG (3.5 mg/kg·d × 5 d) combined with CsA is a safe and effective for children with AA. Age, course of disease and absolute neutrophil value on 30 days after IST are the main factors affecting curative affect.

Risk factors and clinical outcome of coronary artery aneurysms developed after drug-eluting stent implantation / 中华心血管病杂志

<p><b>OBJECTIVE</b>To evaluate risk factors and clinical outcome of coronary artery aneurysms (CAA) developed after drug-eluting stent implantation evidenced by coronary angiographic follow-up.</p><p><b>METHODS</b>This study analyzed 4500 consecutive patient with de novo coronary artery stenosis receiving drug-eluting stent (DES) implantation from January 2004 to May 2009. Seven hundred and sixty patients with angiographic follow-ups at 6 - 8 months and 28 - 48 months after the index procedure were enrolled. CAA was defined as a localized dilatation exceeding 1.5 times the diameter of the adjacent artery. The independent risk factors and major adverse cardiac events (MACE) including cardiac death, myocardial infarction, target-vessel revascularization (TVR) and in-stent thrombosis were analyzed.</p><p><b>RESULTS</b>CAA was detected in 70 patients with 70 lesions (9.2%, 70/760). Logistic analysis showed that lesion in an infarct-related artery (OR: 5.9, P < 0.01), lesion in the left anterior descending artery (OR: 4.5, P < 0.01), lesion with chronic total occlusion (OR: 3.4, P < 0.05), and lesion length > 33 mm (OR: 2.9, P < 0.05) were independent risk factors for CAA. Follow-up duration was (1131 ± 478) days. MACE was found in 19 patients and all received TVR. There were 11 patients with myocardial infarction and 8 patients with evidence of in-stent thrombosis. Mortality was zero during follow-up.</p><p><b>CONCLUSIONS</b>The risk factors for the development of CAA after DES are lesions in an infarct-related artery, in the left anterior descending artery, with chronic total occlusion, and with lesion length > 33 mm. MACE is not uncommon in patients with CAA and long-ferm clinical follow-up is warranted for patients with CAA.</p>