Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection / 中国中药杂志

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.

Effect of Huanglian Jiedu Decoction on Monocyte Development in apoE Gene Knockout Mice / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe monocyte (Mo) development in wild type C57BL/6 mice and apoE gene knockout (apoE(-/-)) mice, and to evaluate the immuno-regulatory effect of Huanglian Jiedu Decoction (HJD) on peripheral Mo development in apoE(-/-) mice.</p><p><b>METHODS</b>Four, 8, 12, and 16 weeks old female C57BL/6 mice were set up as control groups of different ages, while 4, 8, 12, and 16 weeks old female apoE(-/-) mice were set up as hyperlipidemia groups of different ages. Four-week old female C57BL/6 mice were recruited as a blank group. Four-week old female apoE(-/-) mice were randomly divided into the control group, the Western medicine group, and the Chinese medicine group by paired comparison, 5 in each group. Equivalent clinical dose was administered to mice according to body weight. Mice in the Western medicine group were administered with Atrovastatin at the daily dose of 10 mg/kg by gastrogavage, while those in the Chinese medicine group were administered with HJD at the daily dose of 5 g/kg by gastrogavage. Body weight was detected each week. After 4 weeks blood lipids levels (such as TG, TC, LDL-C, and HDL-C), and the proportions of Mo and Ly6c(hi) were detected.</p><p><b>RESULTS</b>Compared with 4-week-old homogenic mice, the proportion of Mo decreased in 16-week-old C57BL/6 mice (P < 0.05). Levels of TC and TG, and the proportion of Ly6c(hi) subtype increased, but the proportion of Mo de- creased in 8-week-old apoE(-/-) mice (P <0. 05). Levels of TC, TG, and LDL-C increased in 12-week-old apoE(-/-) mice (P < 0.05). Levels of TC, TG, LDL-C, and HDL-C increased in 16-week-old apoE(-/-) mice (P < 0.05, P < 0.01). Compared with 8-week-old homogenic mice, the proportion of Mo decreased in 16-week-old C57BL/6 mice (P < 0.05); levels of TC and LDL-C increased in 12-week-old apoE(-/-) mice (P < 0.05); levels of TC and HDL-C increased in 16-week-old apoE(-/-) mice (P < 0.05, P < 0.01). Compared with C57BL/6 mice of the same age, TC and TG increased, HDL-C decreased (P < 0.01) in 4-and 8-week-old apoE(-/-) mice (P < 0.01); levels of TC, TG, LDL-C increased, and HDL-C level decreased in 12- and 16-week-old apoE(-/-) mice (P < 0.05, P < 0.01); the proportion of Mo increased in 4-week-old apoE(-/-) mice (P < 0.05); proportions of Mo and Ly6c(hi) increased in 8-week-old apoE(-/-) mice (P < 0.05). Compared with the blank control group, levels of TC, TG, and LDL-C, proportions of Mo and Ly6c(hi) increased (P < 0.01, P < 0.05), but HDL-C level decreased (P <0. 01) in the control group after intervention. Compared with the control group, body weight gained less in the Western medicine group and the Chinese medicine group (P < 0.05); the proportion of Ly6c(hi) subtype decreased in the Chinese medicine group (P < 0.05).</p><p><b>CONCLUSIONS</b>In development process blood lipids levels in apoE(-/-) mice are not only associated with age. Blood lipids levels induced growth changes in natural immune system are also correlated with age. In early stage of lipids development HJD intervention could correct this special immune disorder in apoE(-/-) mice.</p>

Treating influenza patients of wind-heat affecting Fei syndrome by jinhua qinggan granule: a double-blinded randomized control trial / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To assess the effect and safety of Jinhua Qinggan Granule (JHG) in treating influenza patients of wind-heat affecting Fei syndrome (WHAFS).</p><p><b>METHODS</b>Totally 136 influenza patients of WHAFS were randomized by stratification into 3 groups, the high dose JHG group (44 cases, 10 g each time), the low dose JHG group (45 cases, 5 g JHG + 5 g placebo each time), and the placebo control group (47 cases, 10 g placebo each time). All medication was administered three times daily for 5 days. The fever disappearance time, the fever disappearance rate, efficacy of TCM syndrome, the disappearance rate of main symptoms and physical signs of flu, the negative rate of virus nucleic acid in the pharyngeal secretion, and safety indicators were assessed.</p><p><b>RESULTS</b>The median fever disappearance time was 32.8 h (95% CI: 22.5-41.0 h) in the high dose JHG group, 26.0 h (95% CI: 14.5-36.5 h) in the low dose JHG group, 39.5 h (95% CI: 29.0-46.0 h) in the placebo control group. There was statistical difference in the median fever disappearance time between the low dose JHG group and the placebo control group (P = 0.011). Three days after treatment, the markedly effective rate of TCM symptoms in the low dose JHG group was 66.7%, higher than that of the placebo control group (38.3%), and its effective rate was superior to that of the high dose JHG group (P = 0.043). Five days after treatment, the recovery rate of the low dose JHG group (42.2%) was higher than that of the high dose JHG group (25.0%, P = 0.026) and that of the placebo control group (14.9%, P = 0.002). The markedly effective rate of the low dose JHG group (86.7%) was higher than that of the placebo control group (55.3%, P = 0.001). Similar effects were obtained in the low dose JHG group and the high dose JHG group, but slightly poor in partial indicators of the high dose JHG group. There was no statistical difference in adverse reaction among these three groups (P > 0.05).</p><p><b>CONCLUSIONS</b>JHG was effective and safe in treating influenza patients of WHAFS. Routinely low dose was the optimal dosage of JHG.</p>

Analysis on acupoint prescription for acupoint sticking therapy of treating winter diseases in summer for preventing and curing chronic cough and asthma / 中国针灸

Based on ZhangShi YiTong written by ZHANG Lu of Qing dynasty, and the record that external application of Baijiezi (seeds of Brassica Alba) for treating asthma of cold syndrome, retrospective study is conducted to modern literature of treating winter diseases in summer with acupoint sticking therapy for preventing and treating chronic cough and asthma. Learning from thoughts and methods of evidence-based medicine, and according to subject characteristics of TCM and acupuncture, acupoints and point-selecting discipline of prescription for preventing and treating chronic cough and asthma in summer with acupoint sticking are analyzed. The results show that the top ten common acupoints used for acupoint sticking therapy of treating winter diseases in summer are Feishu (BL 13), Dingchuan (EX-B 1), Xinshu (BL 15), Geshu (BL 17), Danzhong (CV 17), Shenshu (BL 23), Gaohuang (BL 43), Dazhui (GV 14), Pishu (BL 20), Tiantu (CV 22), most of which belong to the Bladder Meridian of Foot-Taiyang, Conception Vessel and Governor Vessel or extra-meridian points. It refers that the core acupoints of acupoint sticking therapy are Feishu (BL 13), Dingchuan (EX-B 1), Xinshu (BL 15), Geshu (BL 17), Danzhong (CV 17), and adjunct points can be selected by syndrome, disease different stage, disease or symptoms.

Comment of the criteria for assessment of therapeutic effects of acupuncture and moxibustion on spastic paralysis of apoplexy / 中国针灸

Acupuncture and moxibustion have obvious therapeutic effect on spastic paralysis of apoplexy, but there is no common standard for evaluation of therapeutic effects. Available standards for assessment of therapeutic effect of acupuncture and moxibustion on spastic paralysis of apoplexy are not complete. Acupuncture and moxibustion improve clinical symptoms of the patient of spastic paralysis of apoplexy to a considerable degree, a evaluation system for results of clinical symptoms of the patient can be set up, so as to perfect the criteria for evaluation of therapeutic effects of acupuncture and moxibustion on this disease.

Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS) / 中国中药杂志

<p><b>OBJECTIVE</b>To evaluate the effects of traditional Chinese medicine in 461 cases of severe acute respiratory syndrome(SARS) on glucocorticoid's dosage.</p><p><b>METHOD</b>By using the polycentric nonrandomized concurrent controled trial and under the condition of glucocorticoid use, the patierts were divided into two groups: the integrated traditional Chinese and western mendicine(ITCWM) and simplicity western mendicine alone(WM). The observation indexes were time in hospital, pneumonia duration, mortality, glucocorticoid's gross dosage, glucocorticoid's average dosage of days and glucocorticoid use time.</p><p><b>RESULT</b>In the ITCWM group, average time in hospital was shortened (P = 0.058), pneumonia duration was shortened (P = 0.057), mortality fell (P = -0.001). The median of glucocorticoid' s gross dosage was 1,277.0 mg x d(-1) in the ITCWM group, and that was 1,680.0 mg x d(-1) in the WM group (P = 0.083). The median of glucocorticoid's average dosage of days was 84.40 mg x d(-1) in the ITCWM group, and that was 115.33 mg x d(-1) in the WM group (P = 0.025). According to the analysis of 461 cases divided by stages and different ponderance, within 7 days after illness, in the ITCWM group, the glucocorticoid' s average dosage decreased. In the common type, the dosage in the ITCWM and in the WM was 146.43 mg x d(-1), and 183.64 mg x d(-1), respectively (P = 0.057), in the severe type, that was 137.71 and 177.86 mg x d(-1), respectively (P = 0.001).</p><p><b>CONCLUSION</b>Compared with the group of simplicity western mendicine, in the group of integratived Chinese and western mendicine, time in hospital shorten, pneumonia duration shorten, mortality fall, simultaneity, glucocorticoid's average dosage is decreased. The use of TCM in the forepart of treatment can be capable of decreasing glucocorticoid's dosage.</p>

Effects of D-galactose combined with lesions of nucleus basalis of Meynert on hippocampal long-term potentiation and synaptic morphology / 中国应用生理学杂志

<p><b>AIM</b>To study the changes of synaptic plasticity in rat model with Alzheimer disease (AD).</p><p><b>METHODS</b>AD rat model was conducted by D-galactose intraperitoneal injection combined with lesions of nucleus basalis of Meynert (nbM). Behavioral performance, LTP in dentate gyrus and synaptic morphology in hippocampal CA1 were observed.</p><p><b>RESULTS</b>(1) Escape latencies in place test in model rats were longer than that in control rats, and swimming time and distance between the two groups in platform quadrant were significant differently (P < 0.01). (2) The numerical density (Nu) and surface density (Su) of synaptic contact zones markedly decreased (P < 0.01) in model rats. (3) Augment of population spike (PS) in perforant path-dentate gyrus of model rats after high frequency stimulation was smaller than that of the control (P < 0.05).</p><p><b>CONCLUSION</b>The results suggest that the decreased synaptic plasticity in hippocampus could responsible for the impairment of spatial learning of model rats.</p>