Abstract:Objective: To observe the efficacy and safety of Yigu capsule (YGC), a Chinese herbal compound preparation, in treating postmenopausal osteoporosis (PMO) and to explore its possible mechanism.Methods: The clinical study was conducted in a prospective, randomized, double blinded method lasting for 6 months with placebo and positive control. Two hundred and ten PMO patients with confirmed diagnosis were assigned into the YGC group, the calciferol group and the placebo group. Besides being administered element calcium, they were treated with YGC, calciferol capsule and placebo capsule respectively. And such symptoms as newly found fracture and ostealgia, bone mineral density (BMD) of the 2nd–4th lumbar vertebrae (L2–4) and upper femur, blood and urinary indexes for bone metabolism, sex hormone level and adverse reaction that occurred in patients were observed.Results: In the YGC group, the total effective rate was 95. 50%, with no new occurrence of fractures, which was significantly better than that in the other two groups (P<0.05). Moreover, in the YGC group, the increase rate of BMD was 9.83% in L2–4, 4.09% in femoral neck, 4.60% in Wards triangle, 3.00% in greater trochanter, which was also better than that in the placebo group (P<0.05,P<0.01). As compared with the placebo group, levels in the YGC group of urinary oxyproline hydroxyproline/creatinine, urinary calcium/creatinine were significantly lower, serum and bone alkaline phosphatase, osteocalcin, estradiol and estradiol/testosterone were significantly higher, but no difference was shown in the comparison of testosterone level. In the observation period, no abnormality in blood or urine routine, liver or renal function was found. Only mild, transient gastro-intestinal response occurred in individual patients, but it did not affect the treatment.Conclusion: YGC could treat PMO effectively, as it could obviously increase the BMD of lumbar vertebrae and coxafemoral bone, elevate the alleviating rate of ostealgia and incessant motion time, yet causing no newly found compressive fracture of vertebrae, or and any related adverse reaction. YGC could not only promote the formation, but also inhibit the absorption of bone as well as increase the sex hormone level. Therefore, it is a pure Chinese herbal compound preparation worthy of further research and development.  
Lin Jian-jun,Jin Chang-nan,Zheng Min-lin,Ouyang Xue-nong,Zeng Jin-xiong,Dai Xi-hu
2005, 11(2): 104-110. DOI: 10.1007/BF02836465
Abstract:Objective: To observe the short-term efficacy and safety of Shenqi mixture (SQM) combined with microwave coagulation in treating primary hepatocellular carcinoma (HCC).Methods: Seventy-two patients with primary HCC of stage II – III, Karnofsky scoring ⩾50 scores and predicted survival period ⩾3 months were selected and randomly assigned into two groups, the treated group and the control group, 36 in each. Microwave therapy was applied to both groups by double leads, 60 W, 800 sec once a week for two weeks. To the treated group, SQM was given additionally through oral intake of 20 ml, three times a day for 1 month. The changes in tumor size, main symptoms, serum level of alpha-fetoprotein (AFP), immune function and adverse reaction were observed after treatment and the immune parameters of the patients were compared with 30 healthy persons in the normal control group.Results: (1) In the SQM treated group, after treatment 3 patients got completely remitted (CR), 24 partial remitted (PR), 4 unchanged (NC) and 5 progressively deteriorated (PD), the effective rate being 75.00%; while in the control group, 1 got CR, 19 PR, 9 NC and 7 PD, the effective rate being 55.56%. Comparison of the effective rate between the two groups showed significant difference (P<0.05). (2) AFP level decreased after treatment in both groups, but the decrement in the treated group was significantly higher than that in the control group (P<0.01). (3) After treatment, in the treated group, CD3+, CD4+, CD4+/CD8+ and NK activity were improved, Karnofsky scores increased and liver function bettered, with these improvements significantly superior to those in the control group (P<0. 01). (4) The improvement in symptoms such as hepatic region pain, fever, weakness, poor appetite and jaundice in the treated group after treatment was also superior to that in the control group (P<0.01). (5)The 12-month, 18-month and 24-month survival rates were higher and the recurrence rate was lower in the treated group than those in the control group, showing significant difference (P<0.05).Conclusion: Combined therapy with SQM and microwave coagulation could not only kill the tumor and residue tumor cells to prevent recurrence, but also enhance the cellular immunity of organism. It is one of the effective therapies for patients with middle-advanced hepatocarcinoma, who have lost the chance of surgical operation. It could improve clinical symptoms, elevate the quality of life, prolong the survival period of patients, but shows no evident adverse reaction.  
Keywords:Primary Hepatocarcinoma;integrated traditional Chinese and Western medicine;Shenqi mixture;microwave coagulation
Abstract:Objective: To observe the therapeutic effect and mechanism of Naohuandan (NHD) in treating senile dementia (SD).Methods: Clinical study: Fifty-eight patients with SD, whose diagnosis conforms to the Diagnostic Standard of DSM-IV issued by American Association of Psychiatry, were enrolled and randomly assigned into two groups. The 30 patients in the treated group were treated with NHD, 4 capsules each time, 3 times daily. The 28 patients in the control group were treated with Piracetam, 1. 6 g each time, 3 times daily. The therapeutic course for both groups was 3 months. The therapeutic efficacy was estimated and compared by comprehensive scores of memory and cognition, scores of Mini-mental State Examination (MMSE) and Activities of Daily Living (ADL). Experimental study: Rats were divided into the control group, the model group and the high-dosage and low-dosage NHD treated groups. The protective effect of NHD on the per-oxidative damage of hippocampal neurons in β-amyloid protein induced SD model was observed and the related criteria were determined.Results: Clinical study showed that both NHD and Piracetam could improve the clinical symptoms of patients, the two medicines showing insignificant difference in total effective rate. But NHD was better in elevating MMSE score and lowering ADL score in patients than Piracetam (P< 0.05 andP<0.01). Experimental study showed that (1) 24 and 72 hrs after modeling, the activity of SOD and GSH were lower and the level of MDA higher in the model group than those in the control group (P<0.05 orP<0. 01). Compared with the model group at the corresponding time points, in the high-dosage NHD group, SOD and GSH were higher, MDA was lower (P<0. 05 orP<0. 01); but in the low-dosage NHD group, SOD at the 72th hr was higher (P<0.05) and MDA at 24th and 72th hrs was lower (P<0.01). And most of the criteria in the high-dosage NHD group was improved better than that in the low-dosage NHD group. (2) The survival rates of neurons in various groups were not different significantly (P>0.05) 24 hrs after modeling, but that in the high-dosage NHD group was significantly higher than that in the model group (P<0.01) and in the low-dosage NHD group 72 hrs after modeling(P<0.05).Conclusion: NHD is an effective Chinese herbal preparation for treatment of SD, and its mechanism is related with its inhibition on peroxidative injury and protection on neurons.  
Abstract:Objective: To explore the correlation of nonalcoholic fatty liver (NAFL) with insulin resistance and the intervention of it by Gankangyin(GKY).Methods: Ninety-six patients with NAFL were randomly assigned into the treated group and the control group. They were treated with GKY and Silymarin for 3 months respectively. Oral glucose tolerance test (OGTT) and insulin release test (IRT) were conducted and insulin sensitivity indexes were determined before and after treatment. And 32 healthy nonalcoholic persons were enrolled and used as the healthy control group.Results: Before treatment, the levels of blood glucose and insulin at different time points in OGTT test, and the insulin resistance index (IRI) were significantly higher (P<0.05 orP<0.01) while insulin sensitivity index (ISI) and insulin active index (IAI) were lower (P<0.05 orP<0.01) in the NAFL patients than those in the healthy persons. After treatment, the above-mentioned raised criteria were significantly lowered (P<0.05,P<0.01) and the lowered criteria were significantly increased (P<0.01) in the treated group, while in the control group all the criteria were insignificantly changed (P>0. 05).Conclusion: Evident insulin resistance exists in NAFL patients. GKY could’increase the insulin sensitivity, thus improving the state of insulin resistance in NAFL patients.  
Abstract:Objective: To study the effect of Shugan Shuru Granule (SSG) on the p53 gene expression in patients with hyperplastic disease of breast (HDB) to indirectly explore the mechanism of SSG’s effect on HDB on the molecular pathological level.Methods: Sixty-six patients with HDB were allocated in the treated group and the control group, with the former treated with SSG and the latter not. All patients underwent breast operation and their diseased mammary tissues were cut out, sectioned, and observed under microscopy with HE staining and immunohistochemical staining, with ABC method adopted to estimate the degree of hyperplasia and p53 gene expression. The severity of HDB was classified into normal, mild, moderate and severe grades (marked as 0 to III), according to the degree of hyperplasia in the mammary gland.Results: Hyperplasia in the control group mostly belonged to grade I – III before treatment, showing overgrowth of gland and proliferation of glandular epithelial cells, which were high columnar shaped, more stratified, with papillary or substantive dysplasia. While in the treated group, most belonged to grade 0 – I after SSG treatment, with proliferated gland and dysplasia recovered to normal or disappeared. The positive rate of p53 gene expression in the treated group was 9.09%, and in the control group 39. 39%, comparison between the two groups showing significant difference (P<0. 01), the intensity in the former was significantly weaker than that in the latter.Conclusion: SSG could not only inhibit the proliferation of mammary duct epithelia and lobuli, but also inhibit the over-expression of P53. Therefore, it could be regarded as an effective remedy for treatment of HDB and prevention of mammary cancer genesis.  
Keywords:Shugan Shuru Granule;hyperplastic disease of breast;p53 gene
Abstract:Objective: To observe the therapeutic effect of Xuesaitong soft capsule (XST and its effect on platelet counts, coagulation factor 1 (CF1) as well as hemorrheologic indexes in treating patients with acute cerebral infarction (ACI).Methods: Two hundred and four patients with ACI were assigned into two groups, the control group (n = 96) and the treated group (n = 108). They were all treated with conventional Western medicines, including mannitol, troxerutin, citicoline, piracetam and aspirin, while to the treated group, XST was given additionally through oral intake, twice a day, 2 capsules each time for 8 successive weeks. The clinical efficacy was evaluated according to the nerve function deficits scoring and the changes of platelet count. CF1 and hemorrheological indexes were measured before and after treatment.Results: The total effective rate was 87.0% in the treated group, and 87. 5% in the control group, respectively, showing insignificant difference between them. But the markedly effective rate in the treated group (66.7%) was significantly higher than that in the control group (27.1%,P<0. 01). The count of platelet was not changed significantly in both groups after treatment, while CF1 in them evidently lowered at the end of the 4th and 8th weeks of treatment, but showed insignificant difference between the two groups. The hematocrit, whole blood viscosity and plasma viscosity in both groups were all improved significantly after treatment, but also showed insignificant difference in comparison of the two groups.Conclusion: XST has good efficacy in auxiliary treatment of patients with ACI, though its mechanism remains to be further explored.  
Keywords:Xuesaitong soft capsule;nerve function deficits scoring;hemorrheologic indexes;acute cerebral infarction
Shi Hong-zhi,Gao Nan-nan,Li Yong-zhi,Yu Jing-guang,Fan Quan-chun,Bai Gui-e,Xin Bing-mu
2005, 11(2): 132-135. DOI: 10.1007/BF02836470
Abstract:Objective: To study the effects of L. F04, the active fraction ofLycopus lucidus, on erythrocytes rheological property so as to investigate its mechanism in promoting blood circulation and removing blood stasis.Method: The effects of L. F04 (used for treatment for 10 days in different dosages) on deformability, aggregation and membrane liquidity of erythrocytes (MLE) as well as whole blood apparent viscosity (ηb) were examined on the basis of rat model of blood-stasis syndrome induced by venous injection of high molecular weight dextran.Result: As compared with the normal control group, the model group’s RBC deformability and MLE were lower, and the aggregation of erythrocytes and ηb were higher. Compared with the model group, both L. F04 0. 612g/kg and 0.306g/kg showed significant effect in improving deformability and inhibiting aggregation of red blood cells (RBC) and reducing blood viscosity. The trend of improving MLE was also shown.Conclusion: L. F04 could significantly improve the abnormal rheological property of erythrocytes.  
Keywords:Lycopus lucidus;blood-stasis;deformability of erythrocytes;aggregation of erythrocytes;membrane liquidity of erythrocytes;whole blood apparent viscosity;L. F04
Abstract:Objective: To evaluate the dynamic change of Thl/Th2 cytokines in serum, peritoneal lavage fluid (PLF) and splenic macrophages (SM) in rats with severe peritonitis, and to observe the therapeutic effects of recombinant interleukin-12 (rlL-2) and Shenmai injection (SMI), a Chinese medicinal preparation.Methods: Severe peritonitis (SP) model was induced by intraperitoneal injection of E. coli and B. frag, and mild peritonitis (MP) model was induced by cecal ligation and punching. Then the following experiments were done: (1) Survival rates of animals after every 6 hrs in the 72 hrs after modeling were recorded, serum and PLF levels of cytokines, including tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), and interleukin-10 (IL-10), 6 hrs, 12 hrs, 24 hrs and 48 hrs after modeling were measured. (2) Model rats were treated with rIL-12 or SMI, the survival rate was recorded and serum levels of TNF-α, INF-γ, and IL-10 before and after treatment were measured, and (3) amount of these cytokines produced by SM were determined 6 hrs, 12 hrs and 24 hrs after treatment. The survival rates and levels of cytokines were then compared between the groups (model group treated with rIL-12 or SMI, untreated model group, and blank group).Results: Serum and PLF levels of IFN-γ, TNF-α at all the time points in SP rats were significantly lower than those in MP rats while those of IL-10 6 hrs and 12 hrs after modeling were significantly higher in the former than that in the latter (P<0.05). IFN-γ secretion of SM in SP rats was significantly higher than that in MP rats 6 hrs after modeling (P<0. 05). Administration of rlL-12 or SMI given before modeling could improve the survival rate of the model rats (P<0.05) and cause significant increase of the serum level and SM secretion of IFN-γ.Conclusion: Imbalance in promoting/antagonizing inflammatory cytokines and Th2 response dominance appear in SP rats early at the initiating stage, and SM secretion of inflammation promoting factor also reduces. Administration in time of rIL-12 and SMI, may increase the survival rate, and its mechanism may be related with their immuno-stimulating action.  
Abstract:Objective: To observe the effect of Tribuli saponins (TS) on left ventricular remodeling after acute myocardial infarction (AMI) in rats with hyperlipemia.Methods: A composite model of myocardial infarction and hyperlipemia was established and treated with TS to observe its effect on cardiac structure and function by echocardiography.Results: (1) Cardiac function: As compared with the model group, the fractional shortening (FS) and ejection fraction (EF) got increased, and the left ventricular end diastolic volume (LVEDV) and systolic volume (LVESV) got lower in the groups treated with high dose TS and simvastatin (P<0.05 orP<0.01), but difference between the two treated groups was insignificant. (2) Cardiac structure: As compared with the model group, the left ventricular dimension end diastole (LVDd) and systole (LVDs) in the groups treated with high dose TS and simvastatin got lower (P<0.05 orP<0.01). No treatment showed any effect on the thickness of ventricular wall. (3)Ventricular weight index: Both high dose TS and simvastatin could decrease the left ventricular weight index (LVWI) (P<0.05).Conclusion: TS could attenuate the left ventricular remodeling after acute myocardial infarction to certain extent, and improve cardiac function in the early phase after AMI, thus playing an important role in controlling morbidity and mortality of cardiac events and long-term prognosis.  
Abstract:Objective: To investigate the effects of triptolide tablet in the treatment of patients with psoriasis vulgaris.Methods: By an open clinical study of 103 patients with psoriasis vulgaris. Psoriasis area severity index (PASI) was measured and recorded before and after treatment for efficacy evaluation.Results: Of the 103 patients, markedly effective was got in 41 (39.7%), improved in 37 (35.8%) and ineffective in 25 (24.5%), the total effective rate being 75.7%, and the adverse reaction was shown only in few patients with decreased WBC during the treatment period.Conclusion: Triptolide tablet is effective for the treatment of psoriasis vulgaris during the one-year follow-up.  
Abstract:Objective: To compare the therapeutic effects of Radix Tripterygium hypoglaucum tablet (THT) and Tripterygium glycosides tablet (TGT) in treating erosive oral lichen planus(EOLP).Methods: The patients were randomized into two groups, and they were treated with THT (n = 47) or TGT (n = 47), respectively. The therapeutic effects were evaluated after 3 months treatment.Results: For the patients of grade 1, the total efficacy in TGT group was 85. 71%, compared with 52. 38% in THT group, the efficacy was statistically greater in the group receiving TGT (P = 0.043). However, for the patients of grade 2, the difference was not statistically significant (P = 0.173).Conclusion: TGT is more effective in treating EOLP than THT for grade 1 patients. However, TGT is not suitable for patients of child bearing age.  
Abstract:Oxidation and free radicals participate in the pathological process of multiple diseases in organisms, and acupuncture shows good effect in antagonizing oxygen stress (OS). This article reviews the effect of acupuncture in antagonizing oxygen stress and the mechanism of its anti-free radical effect in various diseases. The authors hold that acupuncture not only has a chain-blocking effect, but also has preventive and repairing effects of anti-oxidation. And anti-OS action is one of the important mechanisms of acupuncture.