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      2016 Year 22 Vol. 2 Issue

        OriginalPaper

      • Bo Li,Hong-yang Gao,Rui Gao,Ying-pan Zhao,Qing-na Li,Yang Zhao,Xu-dong Tang,Hong-cai Shang
        2016, 22(2): 83-87. DOI: 10.1007/s11655-015-2440-7
        Abstract：Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system. A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases, i.e. PubMed, Excerpt Medica Database, China Biology Medicine disc and China National Knowledge Infrastructure. However, no relevant study on the subjects of interest was identified. Therefore, drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine, we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial. Further, we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders. Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research. The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders.  
        Keywords：evidence-based medicine;narrative medicine;Integrative Medicine;therapeutic evaluation;evidencebased medical record   
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        Published：2021-08-27
      • Xiaoyang Hu,John Hughes,Peter Fisher,Ava Lorenc,Rachel Purtell,A-La Park,Nicola Robinson
        2016, 22(2): 88-95. DOI: 10.1007/s11655-013-1557-9
        Abstract：Musculoskeletal disorders (MSD) comprise a wide range of conditions, associated with an enormous pain and impaired mobility, and are affecting people’s lives and work. Management of musculoskeletal disorders typically involves a multidisciplinary team approach. Positive findings have been found in previous studies evaluating the effectiveness of complementary therapies, though little attention has been paid to evaluating of the effectiveness of integrated packages of care combining conventional and complementary approaches for musculoskeletal conditions in a National Health Service (NHS) setting. To determine the feasibility of all aspects of a pragmatic observational study designed: (1) to evaluate the effectiveness and cost effectiveness of integrated treatments for MSDs in an integrated NHS hospital in the UK; (2) to determine the acceptability of the study design and research process to patients; (3) to explore patients’ expectation and experience of receiving integrated treatments. This is an observational feasibility study, with 1-year recruitment and 1-year follow-up, conducted in Royal London Hospital for Integrated Medicine, University College London Hospital Trust, UK. All eligible patients with MSDs newly referred to the hospital were included in the study. Interventions are integrated packages of care (conventional and complementary) as currently provided in the hospital. SF-36™ Health Survey, short form Brief Pain Inventory, Visual Analogue Scale, and modified Client Service Receipt Inventory will be assessed at 4/5 time points. Semi-structured interview/focus group will be carried out before treatment, and 1 year after commence of treatment. We intend to conduct a pragmatic observational study of integrated medical treatment of MSDs at a public sector hospital. It will inform the design of a future trial including recruitment, retention, suitability of the outcome measures and patients experiences.  
        Keywords：Integrated Medicine;musculoskeletal disorders;feasibility study;mixed method   
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        Published：2021-08-27
      • Yan-jun Jia,Yan Zhang,Jun Liu,Yuan-lin Guo,Rui-xia Xu,Jian-jun Li
        2016, 22(2): 96-100. DOI: 10.1007/s11655-014-1846-y
        Abstract：To investigate the short- and long-term effects of Xuezhikang (血脂康, XZK), an extract of cholestin, on proprotein convertase subtilisin/kexin type 9 (PCSK9) level. Thirty rats were randomly divided into three groups and were given saline, XZK 1,200 mg/kg or lovastatin 10 mg/kg respectively by daily gavage for 3 days (n=10 for each). Sixteen patients without previous lipid-lowering drug treatment for dyslipidemia received XZK 1,200 mg daily for 8 weeks. Fasting blood samples and liver tissue were collected at day 3 for rats, while the blood samples were obtained at baseline and week 8 from patients. The serum PCSK9 and lipid profile were measured. The expression of hepatic low density lipoprotein (LDL) receptor and sterol regulatory element binding protein 2 (SREBP-2) were measured by real time-PCR. PCSK9 levels in rats were significantly increased in the XZK and lovastatin groups (P=0.002, P=0.003 vs. control) at day 3, while no significant differences were found in the levels of lipid parameters. PCSK9 levels in patients increased by 34% (P=0.006 vs. baseline) accompanied by total cholesterol and LDL-cholesterol decreased by 22% and 28% P=0.001, P=0.002 vs. baseline). The hepatic mRNA levels of LDL-receptor and SREBP-2 were significantly increased in the XZK and lovastatin groups. XZK has significant impact on PCSK9 in a short- and long-term manner in both rats and humans. Moreover, the data indicated that as lovastatin, XZK increased PCSK9 levels through SREBP-2 pathway.  
        Keywords：proprotein convertase subtilisin/kexin type 9;Xuezhikang;Statin;lipid profile;Chinese Medicine   
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        Published：2021-08-27
      • Qian Zhang,Chun-sheng Li,Shuo Wang,Wei Gu
        2016, 22(2): 101-109. DOI: 10.1007/s11655-014-1857-8
        Abstract：To investigate the action of Shen-Fu Injection (参附注射液, SFI) in regulating the expression of the serum complements and inflammatory cytokines synthesized and released in response to the stress of global ischemia accompanying cardiac arrest (CA) and resuscitation. Thirty pigs were randomly divided into the sham (n=6) and 3 returns of spontaneous circulation (ROSC) groups (n=24). After 8-min untreated ventricular fibrillation and 2-min basic life support, 24 pigs of the ROSC groups were randomized into three groups (n=8 per group), which received central venous injection of SFI (SFI group), epinephrine (EP group), or saline (SA group). Hemodynamic status and blood samples were obtained at 0, 0.5, 1, 2, 4, 6, 12, and 24 h after ROSC. Serum concentrations of specific activation markers of the complement system C3, C4 and C5b-9 were increased during cardiopulmonary resuscitation throught 24 h after ROSC. There were intense changes of various pro-inflammatory cytokines and anti-inflammatory cytokines as early as 0.5 h after CA. Compared with the EP and SA groups, SFI treatment reduced the proinflammatory cytokines levels of interleukin (IL)-6, IL-8 and tumor necrosis factor α (TNF-α, P<0.05), and increased the anti-inflammatory cytokine levels of IL-4 and IL-10 (P<0.05). Further, SFI treatment decreased the values of C3, C4 and C5b-9 compared with the EP and SA groups. SFI, derived from the ancient Chinese medicine, has significant effects in attenuating post-resuscitation immune dysfunction by modulating the expression of complements and cytokines levels. The current study provided an experimental basis for the clinical application of a potential pharmacologic target for post resuscitation immune dysfunction.  
        Keywords：cardiac arrest;complement activation;cytokines;immune dysfunction   
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        Published：2021-08-27
      • Lin Yang,Ming-wei Yu,Xiao-min Wang,Yi Zhang,Guo-wang Yang,Xiao-qin Luo,Rui-yun Peng,Ya-bing Gao,Li Zhao,Li-feng Wang
        2016, 22(2): 110-115. DOI: 10.1007/s11655-015-2152-z
        Abstract：To investigate the effects of Heijiangdan Ointment (黑绛丹膏, HJD) on oxidative stress in 60Co γ-ray radiation-induced dermatitis in mice. Female Wistar mice with grade 4 radiation dermatitis induced by 60Co γ-rays were randomly divided into four groups (n=12 per group); the HJD-treated, recombinant human epidermal growth factor (rhEGF)-treated, Trolox-treated, and untreated groups, along with a negative control group. On the 11th and 21st days after treatment, 6 mice in each group were chosen for evaluation. The levels of superoxide dismutase (SOD), malondialdehyde (MDA), and lactate dehydrogenase (LDH) were detected using spectrophotometric methods. The fibroblast mitochondria were observed by transmission electron microscopy (TEM). The expressions of fibroblast growth factor 2 (FGF-2) and transforming growth factor β1 (TGF-β1) were analyzed by western blot. Compared with the untreated group, the levels of SOD, MDA and LDH, on the 11th and 21st days after treatment showed significant difference (P<0.05). TEM analysis indicated that fibroblast mitochondria in the untreated group exhibited swelling and the cristae appeared fractured, while in the HJD group, the swelling of mitochondria was limited and the rough endoplasmic reticulum appeared more relaxed. The expressions of FGF-2 and TGF-β1 increased in the untreated group compared with the negative control group (P<0.05). After treatment, the expression of FGF-2, rhEGF and Trolox in the HJD group were significantly increased compared with the untreated group (P<0.05), or compared with the negative control group (P<0.05). The expression of TGF-β1 showed significant difference between untreated and negative control groups (P<0.05). HJD and Trolox increased the level of TGF-β1 and the difference was marked as compared with the untreated and negative control groups (P<0.05). HJD relieves oxidative stress-induced injury, increases the antioxidant activity, mitigates the fibroblast mitochondrial damage, up-regulates the expression of growth factor, and promotes mitochondrial repair in mice.  
        Keywords：Chinese Medicine;Heijiangdan Ointment;radiation dermatitis;oxidative stress;antioxidant;fibroblast mitochondria;transmission electron microscope;growth factor   
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        Published：2021-08-27
      • Li-hong Wang,Xu Wang,Xi-zhong Yu,Wen-ting Xu
        2016, 22(2): 116-123. DOI: 10.1007/s11655-015-2147-9
        Abstract：To investigate the effect of Shouwu Jiangqi Decoction (首乌僵芪汤, SJD) on polycystic ovary syndrome (PCOS) with insulin resistance (IR) in rats and to explore the underlining molecular mechanisms. A total of 51 female Sprague-Dawley rats were randomly divided into 6 groups: control group (n=7), model group (n=8), SJD high-dose group (n=9), SJD medium-dose group (n=9), SJD low-dose group (n=9) and DMBG group (n=9). Radioimmunoassay was used to measure serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and testosterone concentrations and qRT-PCR and western blot were used to examine the expression levels of mRNA and protein respectively of insulin receptor substrate 1 (IRS-1) and phosphatidylinositide 3-kinases (PI3K) p85α in different groups. FSH level signififi cantly decreased in the model group compared with the normal control (P<0.01), and high-dose SJD and DMBG can signififi cantly increase FSH level (P<0.01). LH level showed a mild increase without statistic signififi cance in the model group compared with the control and different dosages of SJD had no signififi cance effect on LH level, while DMBG can signififi cantly decrease LH level (P<0.01). Testosterone level signififi cantly increased in the model group compared with the control group (P<0.01), and high-dose SJD and DMBG can signififi cantly decrease testosterone level (P<0.01). The expression of IRS-1 as well as PI3Kp85α were significantly decreased in the model group compared with the normal control group at both mRNA (P<0.001) and protein (P<0.01) level, and both high-dose SJD and DMBG can enhance IRS-1 and PI3K expression (P<0.05). SJD has potent therapeutic effects on PCOS with IR in rats. The therapeutic effects of SJD on IR and ovulatory dysfunction are probably achieved through correcting the defective insulin signaling transduction.  
        Keywords：polycystic ovary syndrome;insulin resistance;insulin signaling pathway;Chinese Medicine   
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        Published：2021-08-27
      • Yue-min Kuang,Yan Zhu,Rui-lan Gao,Jing Hu,Zhi-yong Jiang,Li Huang,Ya-jun Tong,Xin-guo Luo,Xin-fang Gao,Zhi-yin Zheng
        2016, 22(2): 124-129. DOI: 10.1007/s11655-015-2158-6
        Abstract：To evaluate the effificacy and safety of Pai-Neng-Da Capsule (派能达胶囊, panaxadiol saponins component, PND), a new Chinese patent medicine, on patients with chronic aplastic anemia (CAA) and to explore the optimal therapeutic regimen for CAA. A total of 36 patients with CAA were enrolled and divided into three groups: the AP group (20 cases, andriol 120 mg/day + PND 240 mg/day), the ACP group (13 cases, andriol 120 mg/day + cyclosporine 3–6 mg kd-1 day-1 + PND 240 mg/day), and the PND group (3 cases, PND 240 mg/day). All patients were treated and followed up for 6 months. Peripheral blood counts, renal and hepatic function and Chinese medical (CM) symptoms of patients were assessed and all indices were gathered at the beginning and end of the study. In the AP group, no signifificant hematologic difference was observed at the end of 6-month treatment comparing with the beginning. In the ACP group, the blood counts were maintained at the same level after the 6-month treatment. In the PND group, trilineage hematologic improvement was displayed at the end of 6-month treatment comparing with the beginning. No significant difference was showed in renal and hepatic function in all patients. All patients’ clinical symptom improved according to CM symptom score. The effective rates were 95%, 73% and 100%, respectively. PND improved the effificacy and decreased side effects by cutting down the dosage of andriol, and it could also improve patients’ clinical symptom and quality of life. PND were effective and safe in the treatment of CAA, it could be used alone or in combination with pharmacological agents such as andriol and cyclosporine.  
        Keywords：chronic aplastic anemia;new Chinese Patent medicine;panaxadiol saponins component   
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        Published：2021-08-27
      • Da-ke Zhong,Dan Tang,Li Xue,Jin Wen,You-ping Li
        2016, 22(2): 130-140. DOI: 10.1007/s11655-014-1849-8
        Abstract：To review and assess the effect of single moxibustion for exercise-induced fatigue: (EIF). Computer-search for 8 medical databases and 5 clinical trail registries were conducted for: randomized controlled trials (RCTs), added with hand-search for 10 Chinese acupuncture-moxibustion journals and additional references. Data from included RCTs were pooled by RevMan5.1. Methodology quality of RCTs was judged by Cochrane Collaboration assessment tool while quality of primary outcomes was evaluated by GRADE3.2. Five RCTs were finally included, all reported in small sample size with high risk of: bias. Comparisons on single moxibustion and rest relief (without treatment) were studied. Six outcomes were reported, all favored moxibustion to rest relief for EIF. Primary outcomes showed as rating of perceived exertion (RPE) with mean difference (MD)=−0.49, 95% confidence interval (CI) [−0.80, −0.19], 800-m race performance with MD=−2.21, 95% CI [−3.57, −0.85], and Harvard Step Index (HSI) with MD=14.75, 95% CI [8.35, 21.15]. Moreover, all primary outcomes as RPE, 800-m race performance and HSI were rated low quality. Single moxibustion might be considered effective for EIF. However, due to small samples of included RCTs, high risk of bias among studies and poor quality of primary outcomes and subjects restricted to Chinese athletes only, these results present limitation, and should be taken with caution for practice. More large-size studies with rigorous design are warranted to further test effectiveness of moxibustion for EIF.  
        Keywords：moxibustion;exercise-induced fatigue;randomized controlled trial;systematic review   
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        Published：2021-08-27
      • Wei-jiang Song,Jing Luo,Tong Wu,Shu-kun Yao
        2016, 22(2): 141-149. DOI: 10.1007/s11655-015-2143-0
        Abstract：To evaluate the efficacy and safety of oral oxymatrine preparation for the treatment of chronic hepatitis B (CHB). Randomized controlled trials (RCTs) on oral oxymatrine preparation in treating patients with CHB were retrieved until October 2013 by searching PubMed, the Cochrane Library, Embase and four Chinese databases, irrespective of language and publication status. Data extraction and data analyses were conducted according to the Cochrane standards. The risk of bias for each included trials and the quality of evidence on pre-specified outcomes were assessed. The RevMan software was used for statistical analyses. Totally 52 RCTs enrolling 5,227 participants were included, of which 51 RCTs were included in meta-analyses. Oral oxymatrine preparation including oxymatrine capsule and oxymatrine tablet were associated with statistically significant effect on the clearance of hepatitis B virus (HBV) DNA, HBV surface antigen and HBV e antigen, and were beneficial to the normalization of serum alanine aminotransferase and aspartate aminotransferase. Nevertheless, the overall methodological quality and the quality of evidence in the included trials were poor. In addition, safety of oral oxymatrine preparation was not confirmed. Oral oxymatrine preparation showed some potential benefits for patients with CHB. However, the overall quality of evidence was limited and the safety of oral oxymatrine preparation for CHB patients was still unproven. More high quality evidence from rigorously designed RCTs is warranted to support the clinical use of oral oxymatrine preparation for patients with CHB.  
        Keywords：Oxymatrine;alkaloid;Chinese Herb;hepatitis B;chronic;systematic review   
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        Published：2021-08-27
      • Wei-heng Chen,Xian-xiang Liu,Pei-jian Tong,Hong-sheng Zhan
        2016, 22(2): 150-153. DOI: 10.1007/s11655-015-2432-7
        Abstract：Literature review shows that Chinese medicine and other related treatment are still the main stream treatment of knee osteoarthritis. Currently, there is short of handbook guiding Chinese medicine from evidence-based medical evidence, so it is a top priority to develop a clinical guideline from the expert consensus. After several rounds of discussion during the conference and examination by letter, which has collected opinions from nearly one hundred experts, consensus was reached. Nonpharmacologic interventions include health education, medical exercise, acupuncture, massage, acupotomology, and physiotherapy. Pharmacological interventions are as follows. Topical application includes fumigation, application, hot compressed, ironing and iontophoresis with Chinese herbs, etc. Chinese patent medicine for external use includes plaster, ointment, etc. Western medicine for external use mainly includes emulsion, ointment, plaster and embrocation containing nonsteroidal anti-inflammatory drugs (NSAIDs). Intraarticular injection mainly includes sodium hyaluronic acid, chitosan (for injection) with prudent use of glucocorticoid. Chinese herbal medicine and Chinese patent medicine can be taken referring to syndrome differentiation which mainly includes syndromes of qi stagnation and blood stasis, cold dampness, deficiency of Gan (Liver) and Shen (Kidney), deficiency of qi and blood. Western medicine mainly includes analgesic, NSAIDs, diseases modifying drugs. Surgery procedures mainly include joint irrigation, arthroscopic surgery, osteotomy, arthroplasty, etc.  
        Keywords：knee osteoarthritis;Chinese Medicine;Integrative Medicine;expert opinion   
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        Published：2021-08-27
      • Jun-jie Jiang,Wen Zhang,Yan-ming Xie,Jian-nong Wang,Fu-yuan He,Xin Xiong
        2016, 22(2): 154-160. DOI: 10.1007/s11655-014-1995-z
        Abstract：Although many population pharmacokinetics (PPK) researches have been conducted on chemical drugs, few have been in the field of Chinese medicine (CM). Each ingredient in CMs possesses different pharmacokinetic characteristics, therefore, it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations. To develop an expert consensus on study design and implementation for PPK of CM, in August 2013, 6 experts in the field of PPK, CMs pharmacology, and statistics discussed problems on the PPK research protocol of CMs, and a consensus was reached. The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with definite therapeutic effects were selected as indices, and specific time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifies the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment of dosages of CMs.  
        Keywords：population pharmacokinetics;expert consensus;research protocol;Chinese Medicine   
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        Published：2021-08-27
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