Exploration and reflection on evaluation methodology of human use experience for new Chinese drug development / 中国中药杂志

The "triple combination" review system provides an opportunity for the transformation of human use experience into new Chinese drugs. However, there are some methodological and technical limitations in the assessment of human experience. Hence, the efficacy and safety evaluation methods should be established in accordance with the characteristics of Chinese herbs. This study summarized some evidence-based methodology to promote the transformation of human use experience to new Chinese drugs, mainly including the individualized pragmatic randomized controlled trial(RCT), cluster RCT, single-case RCT, single arm RCT with objective performance criteria, and partially nested RCT. As the real world data can be used to support the transformation of human experience, attention should be paid to convenient and efficient collection of data, prudent selection of design types, and adoption of appropriate ana-lysis methods to deal with confounding bias, including multi-factor regression model and propensity score. The newly proposed mixed research method can also be utilized to assess the human use experience, which is suitable for mining the theory of traditional Chinese medicine(TCM) and expert experience from different aspects. Meanwhile, considering the study design requirements and TCM cha-racteristics, this study put forward the common problems and solutions in the development of new Chinese drugs based on human use experience, including how to select the feasible outcome indicators, how to collect prescription data in the case of herb and dosage adjustment, and how to evaluate the comprehensive effectiveness of TCM from the perspective of "combination of disease and syndrome".

Angiogenesis and Hepatic Fibrosis: Western and Chinese Medicine Therapies on the Road / 中国结合医学杂志

Hepatic fibrosis is a common feature of almost all chronic liver diseases. Formation of new vessels (angiogenesis) is a process strictly related to the progressive fibrogenesis which leads to cirrhosis and liver cancer. This review mainly concerns the relationship between angiogenesis and hepatic fibrosis, by considering the mechanism of angiogenesis, cells in angiogenesis, anti-angiogenic and Chinese medicine therapies.

Summarization of professor He Pu-ren's channel syndrome differentiation for treatment of complicated and difficult diseases / 中国针灸

Channel syndrome differentiation is a more commonly-used syndrome differentiation method of Professor HE Pu-ren clinically, which includes the 3 aspects: differentiation of diseases and syndromes on the channel parts along the body surface; differentiation of diseases and syndromes of the internal organs connected with the channels; differentiation of qi and blood of the channels. According to results of the channel syndrome differentiation, with flexible application of the HE's Santong methods and selection of corresponding treatment program, many complicated and difficult diseases are cured.

Effects of "three ways" method of acupuncture on serum levels of tumor necrosis factor-alpha and interleukin-1beta patients with acute ischemic cerebrovascular diseases / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the effect of "Three ways" method of acupuncture on serum levels of tumor necrosis factor-alpha (TNF-alpha) and interleukin-1beta (IL-1beta) in patients with acute ischemic cerebrovascular diseases (ICVD).</p><p><b>METHODS</b>Sixty patients with acute cerebral infarction were randomly divided into the treated group treated by "Three ways" method of acupuncture and the control group by hand and foot acupuncture on acupoints of the hands and feet. Serum levels of TNF-alpha and IL-1beta were detected with radioimmunoassay before treatment and at the 6th, 12th and 28th days of treatment. Neurological deficit score (NDS) and Barthel Index (BI) were also observed in the same time.</p><p><b>RESULTS</b>After treatment, serum levels of TNF-alpha and IL-1beta in both groups decreased significantly (P < 0.05), approaching the normal range at the 28th day of treatment, which were even lower in the treated group than those in the control group, and the decreasing trend were significantly different (P < 0.05). Compared with the control group, the effect in decreasing NDS and increasing BI in the treated group was better than that in the control group (P < 0.05).</p><p><b>CONCLUSION</b>"Three ways" method of acupuncture could reduce serum levels of TNF-alpha and IL-1beta, alleviate injury of nervous function so as to improve the daily life ability, superior to hand and foot acupuncture.</p>

Influence of mimic cardiac rate on hydrodynamics of different mechanical prosthetic cardiac valves in vitro / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To assess the influence of mimic cardiac rate on hydrodynamics of different mechanical prosthetic cardiac valves.</p><p><b>METHODS</b>US-made CarboMedics bileaflet valve, China-made Jiuling bileaflet valve and C-L tilting disc valve were tested via a pulsatile flow simulator in the aortic position. Testing conditions were set at mimic cardiac rates of 55 bpm, 75 bpm, 100 bpm with a constant mimic cardiac output of 4 L/min. The mean pressure differences (deltaP), leakage volumes (L(E)V) and closing volumes (C(L)V) across each valve, and effective orifice areas (EOA) were analyzed.</p><p><b>RESULTS</b>Within physiological range, deltaP, L(E)V, and C(L)V decreased as mimic cardiac rate increased, with a large extent of variance. EOA increased along with an increase in mimic cardiac rate. It was a different response in terms of cardiac rate alteration for different types of mechanical prosthetic cardiac valves.</p><p><b>CONCLUSION</b>Mimic cardiac rate change affects hydrodynamics of mechanical prosthetic cardiac valves. Within physiological range, the hydrodynamic of prosthetic bileaflet valve is better than that of tilting disc valve.</p>