Latest Issue
2014 Year 20 Vol. 12 Issue
- Abstract：In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA’s industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.Keywords：herbal medicine;Chinese Medicine;clinical trial;Traditional Medicine;Complementary Medicine;review
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Published：2021-08-27 - Abstract：To determine the impact of adjunctive Buchang Naoxintong Capsule (步长脑心通胶囊, NXT) on dual antiplatelet therapy in patients with cytochrome P450 2C19*2 (CYP2C19*2) polymorphism undergoing percutaneous coronary intervention (PCI). Ninety patients with CYP2C19*2 polymorphism were enrolled, and their genotypes were confirmed by polymerase chain reaction (PCR). The patients were randomly assigned to receive either adjunctive NXT (triple group, 45 cases) or dual antiplatelet therapy (dual group, 45 cases) using a computer-generated randomization sequence and sealed envelopes. Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry. Subsequent major adverse cardiovascular events (MACE, including sudden cardiac arrest and acute coronary syndrome) were recorded during a 12-month follow-up. Baseline platelet function measurements were similar in both groups. After 7 days, percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group (42.3%±16.0% vs. 20.8%±15.2%, P<0.01, and 54.7%±18.3% vs. 21.5%±29.2%, P<0.01, respectively). During the 12-month follow-up, the rate of subsequent MACE (6/45) was significantly lower in the triple group compared with the dual group (14/45; P<0.05). Adjunctive NXT to maintenance dose clopidogrel (75 g) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19*2 polymorphism undergoing PCI.Keywords：Platelet;CYP2C19*2 gene mutation;Buchang Naoxintong Capsule;maintenance dose clopidogrel;clinical prognosis;Chinese Medicine;randomized controlled trial
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Published：2021-08-27 - Abstract：To determine the effect of combined treatment with Chinese medicine (CM) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) on patients with severe aplastic anemia (SAA). Eleven patients were treated with CM plus allo-HSCT. Nine patients received a conditioning regimen consisting of fludarabine (Flu), anti-thymocyte globulin (pig ALG), or anti-lymphocyte globulin (Rabbit ATG) and cyclophosphamide (CY), and two patients received pig ALG and CY. All patients were treated with Kidney (Shen)-reinforcing, blood-activating, and stasis-removing (KBS) herbal preparation beginning at 1 week before transplantation and ending at 8 weeks after transplantation. Chimerism status was assessed by analyzing short tandem repeat (STR) polymorphisms. All patients recovered hematopoietic function and none had graft failure. The median number of days required for the absolute neutrophil count (ANC) increased to >0.5×109/L was 15 days (12–22 days) and for spontaneous platelet recovery to >20×109/L without post-transplantation transfusion was 17 days (15–27 days). Nine patients were long-term survivors and achieved full donor chimerism. The overall cumulative incidence of acute graft versus host disease (GVHD) grades I–II and III–IV was 18.2% (2/11) and 9.1% (1/11), respectively. The overall accumulated incidence of chronic GVHD was 27.3% and all patients had limited chronic GVHD. At a median follow-up time of 32 months (range: 12–97 months), 9 patients were still alive. The estimated 5-year overall survival (OS) rate was 81.8%. The incidence of treatment-related mortality, 2-year post-transplantation, was 18.2%. Two patients died from GVHD after transplantation. Treatment with the KBS formulation may reduce the rate of graft failure and treatment-related mortality and improve the rate of OS in SAA patients with allo-HSCT.Keywords：severe aplastic anemia;allogeneic;Hematopoietic Stem Cell;transplantation;Chinese Medicine
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Published：2021-08-27 - Abstract：To evaluate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor (Draft, REC-TCM-ST) in application of Chinese medicine therapeutic effect in patients with advanced non-small cell lung cancer (NSCLC). A retrospective clinical research was used in 104 NSCLC patients in stages of III–IV, 53 cases were in Chinese medicine (CM) group and 51 cases were in Western medicine (WM) group. The therapeutic effect of the two groups was evaluated with both REC-TCM-ST and Response Evaluation Criteria in Solid Tumor (RECIST). Kaplan-Meier method was used to analyze the survival time. Kappa test method was used to test the consistency of the two kinds of evaluation results. According to REC-TCM-ST, the effective rate on relieving tumor mass in the CM group was significantly lower than that in the WM group (P<0.05), but there was no significant difference in tumor-mass stable rate (P>0.05); the symptom of weakness in the CM group was improved significantly, indicating better therapeutic effect than that in the WM group (P<0.01). Karnofsky score in the CM group was significantly better than that in the WM group (P<0.01). In terms of survival conditions, the median survival time and the survival rate of 6 months, 1 year and 2 years of the CM group were higher than the WM group. The total effective rate was 9.62%, and the total stable rate was 72.12% for 104 cases according to RECIST; while the total effective rate was 34.62%, and the total stable rate was 84.62% according to REC-TCM-ST, thus there were significant differences between the results of the two criteria (P<0.01), and there was also some consistency between them, but not satisfactory. REC-TCM-ST was used to evaluate the therapeutic effect of CM in the treatment of advanced NSCLC, which shows that its evaluation results can better reflect the advantages and disadvantages of CM, and the effectiveness of CM is more objective and comprehensive than RECIST, so REC-TCM-ST is worthy of further improvement and clinical expansion.Keywords：therapeutic effect evaluation;non-small cell lung cancer;Chinese medicine therapy;malignant tumor
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Published：2021-08-27 - Abstract：To clarify the effectiveness of Chinese herbal fomentation in treating chronic neck pain by means of changes in cervical kinematics. Seventy-six patients with chronic neck pain were included in the study and were randomized into two groups based on the random number generator of the SPSS software: fomentation combined with Chinese herbal (Group 1) and fomentation without any medicine (Group 2). In both groups, the fomentation lasted for 60 min and heated to 35 °C, once a day for 28 consecutive days. Standard lateral radiographs of the cervical spine were obtained including the neutral, full flexion, and full extension positions. Before and after intervention, the following parameters were used to evaluate the changes in kinematics: range of motion (ROM), sagittal alignment and instantaneous center of rotation (ICR). After treatment, the ROM was signifcantly higher than that of before treatment in Group 1 (51.5, 95% CI: 49.8–55.9; P<0.05). There was no significant difference between before and after treatment in Group 2 (P>0.05). Although C2-C7 cervical alignment was increased in both groups after treatment, no significant difference was detected between before and after treatment (P>0.05). For Group 1, the significant X coordinate variation was only observed at C5/C6 level (38.1; 95% CI: 34.0, 42.1; P<0.05). There was a significant upward trend in the Y coordinate of the ICR at C5/C6 (−30.5; 95% CI: −34.3, −26.8; P<0.05) and C6/C7 after treatment (−6.1; 95% CI: −6.7, −5.4; P<0.05). For Group 2, the ICR location of each level was not statistically different between the pre- and post-treatment (P>0.05). Chinese herbal fomentation could improve abnormal mobility in terms of ROM and ICR. Chinese herbal fomentation might be an effective treatment for chronic neck pain.Keywords：Chinese herbal fomentation;biomechanics;neck pain
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Published：2021-08-27 - Abstract：To explore the influence of Chinese medicine constitution type on the susceptibility of hypertensive patients to intracerebral haemorrhage. Primary hypertensive patients were studied and divided into the hypertension and the hypertensive intracerebral haemorrhage groups, depending on whether or not the patients had intracerebral haemorrhage. The demographic characteristics, physiological characteristics, living habits, biochemical tests, other chronic diseases, Chinese medicine constitution type, etc. were collected and compared between the two groups. The neurological deficit in the hypertensive intracerebral haemorrhage group was also compared among the different constitution types. A total of 304 patients participated in this investigation, including 213 cases in the hypertension group and 91 cases in the hypertensive intracerebral haemorrhage group. The percentages of dampness-heat and qi-depression types in the intracerebral haemorrhage group were greater than those with the same types in the hypertension group (20.9% vs 6.1%, 22.0% vs 8.0%; P<0.05). The percentages of each constitution type were different between genders in both groups. In addition, there were more male cases (14/20) with qi-depression type and more female cases (7/8) with phlegm-dampness type in the hypertensive intracerebral haemorrhage group than those with the same types (3/17 and 9/34, respectively) in the hypertension group (P<0.05). The cases with phlegm-dampness and qi-depression types had greater levels of blood lipids in the intracerebral haemorrhage group than those with the same types in the hypertension group (P<0.05). Furthermore, the cases with the qi-deficiency type presented with a more severe neurological deficit than those with the other types (P<0.05). Chinese medicine constitution type might have an impact on the susceptibility of hypertensive patients to have an intracerebral haemorrhage. The heat-dampness and qi-depression types might lead to greater susceptibility than the other types. In addition, the patient’s gender and blood lipids might also influence the susceptibility along with the constitution type.Keywords：Chinese Medicine;constitution type;susceptibility;hypertensive intracerebral haemorrhage
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Published：2021-08-27 - Abstract：To investigate the correlations among persistent viral infection, heart function and Chinese medicine (CM) difined-syndromes in patients with dilated cardiomyopathy (DCM). Fifty patients with DCM in the First Affiliated Hospital of Zhejiang Chinese Medical University from October 2009 to December 2011 were selected as the research subjects, and 30 healthy people were simultaneously selected as the normal control group to detect persistent viral infections after admission. The CM syndrome type and grade of heart function were then evaluated. The expression level of Coxsackie adenovirus receptor (CAR) was detected using the flow cytometry (FCM) technique, coxsackie virus RNA (CVB-RNA) using reverse transcription polymerase chain reaction (RTPCR), and the plasma brain natriuretic peptide (BNP) level with a Triage meter plus diagnosis instrument. Finally, the parameters such as left ventricular end diastolic diameter (LVEDd) and left ventricular ejection fraction (LVEF) were measured by ultrasonic cardiogram. Person correlation analysis was used for measured data, Spearman correlation analysis for rating data, and the Chi-square test for numerical data. CVB-RNA was positive in 22 patients (44%) with DCM, while only 6 cases (20%) were CVB-RNA-positive in the normal control group, with a significant difference between the two groups (P<0.01). The expression level of CAR was significantly elevated in the DCM group compared with the normal control group (P<0.01). In CVB-RNA-positive patients (22 cases), the expression level of CAR was significantly higher than in CVB-RNA-negative patients (28 cases; P<0.01). In the DCM patients, there was a positive correlation between the CAR expression and the BNP level (r=0.34, P<0.05), while no significant difference was found between the CAR expression and the LVEF and LVEDd (r=−0.32, 0.30, P>0.05). There was no clear correlation between virus infection and the CM syndrome types in DCM patients (r=−0.22, P>0.05). According to the sequence of syndrome types: phlegm → qi deficiency → blood stasis → hydroretention with asthenic yang (from low to high), a positive correlation was existed between the BNP levels and CM syndrome types (r=0.139, P<0.05). The expression of CAR on the surface of white cells could be used to detect persistent viral infection. The expression level of CAR and heart function in DCM patients were highly correlated. The expression level of BNP may serve as an objective index for differentiating CM syndromes for patients with DCM.Keywords：dilated cardiomyopathy;persistent viral infection;coxsackie adenovirus receptor;heart function;Chinese medicine syndrome type;brain natriuretic peptide
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Published：2021-08-27 - Abstract：To explore the pharmacological anti-inflammatory mechanism of Chinese formula Qingwen Baidu Decoction (清瘟败毒饮, QBD) from the view of holistic biology. The rats were randomly divided into a normal conrol group, a lipopolysaccharide (LPS) group, the low- and high-dose QBD groups, and a dexamethasone (DXM) group. NR8383 cells were treated with culture fluid containing 6% serum from rats of each group respectively. Inflammatory mediators were detected by reverse transcription polymerase chain reaction (RT-PCR), Western blotting hybridization, enzyme linked immunosorbent assay (ELISA), polymerase chain reaction (PCR) gene array and antibody array. It is showed that the levels of interleukin (IL)-1α, IL-4 and IL-12 were enhanced in the low-dose QBD group; levels of IL-1α, IL-12 and IL-18 were augmented in the high-dose QBD group, compared with the LPS group after ELISA detection. Western blot showed that IL-1β and tumor necrosis factor (TNF)-α expression of the control group were lower than other groups. IL-1β level of the low-dose and high-dose QBD groups detected by RT-PCR was higher in early stage but lower after 24 h than that of the control group (P<0.01). Expression of 84 main inflammatory cytokines and receptors was detected by rat inflammatory cytokines and receptors PCR array. Up-regulation genes were 22 in both the LPS group and the low-dose QBD group, among which 16 up-regulating genes were the same. In these 16 genes, the up-regulating amplitude of 9 genes in the low-dose QBD group was less than that in the LPS group, 4 were similar to and 3 were more. Twenty-nine main cytokines were inspected by rat cytokine antibody array. Intergroup gray value differences were found in 7 expressed cytokines. The levels of these 7 cytokines in the lowdose QBD group were all lower than those in the the LPS group. QBD has anti-inflammatory effect on sepsis by changing the level of inflammatory mediators.Keywords：sepsis;summer heat syndrome;Qingwen Baidu Decoction;cytokine;mediator network;Chinese Medicine
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Published：2021-08-27 - Abstract：To observe the clinical curative effect of Chinese medicine Bushen Huoxue Granule(补肾活血颗粒, BHG) on Parkinson’s disease (PD) patients with depressive state. Sixty-two PD patients with depressive state were randomly assigned to two groups by using a random number table, 31 in each group. Madopar was given to all as the conventional treatment. The fluoxetine hydrochloride dispersible tablet was given to the patients in the control group and BHG was given to those in the treatment group. The therapeutic course for all was 12 weeks. Before and after treatment, Hamilton depression rating scale (HAMD) was applied to judge the curative effect, and the changes of cerebral neurotransmitters levels in the brain of patients were detected by encephalofluctuograph technique. The scores of HAMD in the two groups were decreased markedly after 12-week treatment. It was lower in the treatment group than that in the control group with significant difference (P<0.01). The contents of norepinephrine (NE) and 5-serotonin (5-HT) in the PD patients were obviously lower than normal value. There was no significant difference between the two groups before treatment (P>0.05). The contents of NE and 5-HT were all increased in the two groups after treatment (P<0.05), with significant differences between the two groups (P<0.01). BHG could increase the contents of NE and 5-HT in PD patients’ brain to improve the depressive state of PD patients.Keywords：Parkinson’s disease;Bushen Huoxue Granule;depressive state;cerebral neurotransmitters;Chinese Medicine
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Published：2021-08-27 - Abstract：To observe the effectiveness and safety of Kangquan Recipe (康泉方, KQR) for benign prostatic hyperplasia (BPH) patients. One hundred and six BPH patients were randomly assigned to the treatment group (53 cases) and the control group (53 cases) according to a random number table. The treatment group was given KQR orally; the control group was given cernilton orally. After 24-week treatment, the clinical effect and safety were evaluated using the International Prostatic Symptom Score (I-PSS), quality of life (QOL), maximum flow rate (Qmax), average flow rate (Qave), residual urine volume (RUV), total prostatic volume (TPV), etc. After treatment, the score of I-PSS was decreased from 16.9±5.6 to 12.5±4.6 in the treatment group, significantly lower compared with the control group; the levels of Qmax and Qave were from 10.9±3.5 to 15.6±4.5 and 5.4±2.1 to 7.3±2.5 (mL/s) in the treatment group, significantly higher compared with the control group; the levels of RUV and TPV were from 70.8±28.2 to 35.2±21.8 and 37.2±16.9 to 30.1±10.8 (mL) in the treatment group, significantly lower compared with the control group (all P<0.05). The incidence rate of adverse reaction was similar between the two groups (P>0.05). KQR is effective and safe for the treatment of BPH.Keywords：benign prostatic hyperplasia;Kangquan Recipe;Chinese Medicine;urodynamics
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Published：2021-08-27
OriginalPaper
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