There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.
Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

AIM:To investigate the changes of visual development produced by monocular atropinization in rats.
METHODS: Twenty normal SD rats were randomly divided into two groups: control group ( n = 10 ) and atropinization ( experimental) group ( n=10 ) . All the left eyes were selected as the experimental eyes, and the right eyes served as the normal eyes. The left eyes in atropinization group was produced by 1% atropine, 3 times a day and the right eyes in control group was treated with normal saline, 3 times a day. The flash visual evoked potentials ( F-VEP ) and retinoscopy refraction of the rats'both eyes were detected at five time points:0, 7, 14, 21, and 28d after atropinization, respectively. After 28d, six rats were randomly selected from both groups and each group had three rats. The expression of the c- fos mRNA was observed in both visual cortexes. Another six rats were chosen for the same test after 2d dark environment with 2h light later. The expression of c-fos mRNA was detected again.
RESULTS: After 14d anisometropia was observed in experimental group, the difference was 3. 9D ( P<
0.0 5 ) , F-VEP P1 wave of the rats left in experimental group was reached to 88. 9±1. 889ms at 21d, there was statistical difference compared with the right eye ( P<0.05). After 28d, c-fos mRNA expression in the left visual cortex of rats in the experimental group was higher than that of the right side, but there was no significant difference. But when underwent 2h light stimulation after in the darkroom 2d, the c-fos mRNA expression in in the left visual cortex of rats in the experimental group was 5 times higher than that of the right side, there was a statistically significant difference (P<0. 05).
CONCLUSION: In the critical period of visual development, monocular chronic atropine in rats can form anisometropia, may delay the transmission of the optic nerve, hinder the normal development of the visual cortex. Monocular atropinization in rats can be used as the model of anisometropia.

Objective To explore the value of the LigaSure vessel sealing in laparoscopic nephrectomy surgery. Methods Laparoscopic nephreetomies were performed in 41 cases from May 2004 to December 2006 by using LigaSure, including simple nephrectomies, radical nephrectomies and nephroureterectomies. The operative time, estimated blood loss, open conversion rate, duration of postoperative drainage, total amount of postoperative drainage, postoperative hospital day as well as complication rate were recorded and analyzed retrospectively. Results All procedures were finished successfully without conversion to open surgery. No severe vascular complication or other serious complications happened. The mean operative time was 146min (range, 35-240 min) ; mean blood loss was 163ml (range, 30-450 ml); mean time for postoperative drainage was 3d (range, 1-6 d) ; mean amount of postoperative drainage was 229ml (range, 45-435 ml). The postoperative hospital staying was 6-21 d, with the average of 10 days. Conclusions The LigaSure vessel sealing system produees a consistent, reliable, permanent seal of veins, arteries, and tissue bundles. It could decrease operative time and blood loss. This new energy-based vessel-ligation device appears to be effective in advanced laparoscopic procedures.

OBJECTIVE:To investigate the role of medication reconciliation in pharmaceutical care provided by clinical phar-macists. METHODS:Clinical pharmacists participated in pharmaceutical care for a elderly patient,and reconciled drugs as anti-in-fective drugs,cardiovascular drugs,electrolyte:stop taking unnecessary drugs:Xuebijing injection,Kang'erxin capsule,Shedan chuanbei soft capsule,Mosapride citrate tablet;adjust the dose of Dihydrochlorothiazide tabet and Potassium chloride tablet;stop taking Non first-line drug Reserpine tablet in order to decrease the risk of drug use;stop taking Furosemide tablet,Lactulose oral solution and using Suppositories glycerol timely according to the disease outcome. RESULTS&CONCLUSIONS:The medication reconciliation can avoid repeated drug use,optimize medication plan,reduce drug variety and cost and decrease the potential ADR risk of drug use so as to guarantee safe and effective drug use.

OBJECTIVETo study the efficacy and safety of Reinhartdt and sea cucumber capsule (RSC) combined with donepezil in treating Alzheimer's disease (AD), and its effect on thyroid function axis.

METHODSSixty-eight patients were randomly assigned to the RSC group, the Donepezil group and the combined treatment group, who were treated for 3 and 6 months with RSC, Donepezil and RSC combined with Donepezil, respectively. The curative effect was evaluated by scoring according to Mini-Mental State Examination (MMSE), ADAS-Cog and ADL chart, and the level of thyroid hormones, including TSH, FT3, FT4, TT3 and TT4, were measured with radioimmunoassay before treatment, 3 and 6 months after treatment respectively.

RESULTSAs compared with the baseline, MMSE score increased, ADAS-Cog score and ADL score decreased significantly in all the three groups after 3 months and 6 months of treatment (P < 0.05 and P < 0.01), but the improvement in the combined treatment group was more significant than that in the other two groups (P < 0.01). After 6 months of treatment, the levels of FT3 and FT4 in the combined treatment group were significantly changed (P < 0.01), but no significant change in all the thyroid hormones was found in the other two groups. No obvious adverse reaction occurred in all the three groups.

CONCLUSIONRSC combined with Donepezil in treating AD is effective and safe with no evident adverse reaction, better than single drug treatment, which may be through influencing the metabolism of thyroid hormones to improve the cognition function of AD patients.

Aged ; Aged, 80 and over ; Alzheimer Disease ; drug therapy ; Animals ; Capsules ; Drug Therapy, Combination ; Female ; Humans ; Indans ; therapeutic use ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Nootropic Agents ; therapeutic use ; Piperidines ; therapeutic use ; Radioimmunoassay ; Sea Cucumbers ; chemistry ; Thyroid Hormones ; blood

ATP Binding Cassette Transporter, Sub-Family B ; metabolism ; Apoptosis ; genetics ; Carcinoma, Non-Small-Cell Lung ; genetics ; metabolism ; pathology ; Genes, MDR ; Humans ; Lung Neoplasms ; genetics ; metabolism ; pathology ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; RNA, Messenger ; biosynthesis ; genetics ; Telomerase ; biosynthesis ; genetics ; Tumor Suppressor Protein p53 ; metabolism ; Vault Ribonucleoprotein Particles ; metabolism

OBJECTIVETo observe the effect of Chinese herbal medicine in treating vascular dementia (VD) and to explore the method for therapeutic effect evaluation.

METHODSMulti-center, double-blinded randomize-controlled method was adopted to observe the effect of treatment of 242 patients with VD of mild or middle degree, they were 89 cases in the TCM group, 106 cases in the western medicine group and 47 in the placebo group. Minimental state examination (MMSE), Blessed dementia scoring on TCM symptom classified evaluation were used to evaluate the therapeutic effect after 60 days treatment.

RESULTSThe total effective rate of Jiannao Yizhi Granule was 58.4%, showing a better effect than that of the placebo group and the western medicine group respectively. The treatment was superior in holistic regulation and systemic functional state improvement, it could not only improve the mild middle key symptoms of VD and the mental disorder induced reduction of functional activities, but also alleviate or eliminate the peripheral symptoms of VD.

CONCLUSIONThe effect of treatment of vascular dementia by Jiannao Yizhi Granule is certain and is worth spreading.

Aged ; Dementia, Vascular ; drug therapy ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Phytotherapy

Objective To evaluate the safety and efficacy of intra-arterial infusion neoadiuvant chemotherapy in local advanced bladder cancer. Methods Nineteen cases with T2-T4a bladder cancer were enrolled in this study.Intra-arterial infusion chemotherapy with Gemcitabine and Cisplatin (GC)were performed for 1 to 3 cycles before radical cystectomy.Postoperative values of hematological parameters,maximum diameter of tumors,TNM(tumor,node and metastasis)stages and pathological grades were compared with preoperative parameters of the same case. Results Compared to the values before GC chemotherapy,WBC count showed no significant change post-operative,(6.63±2.58)×109/L vs(5.12±2.91)×109/L(P=0.13);RBC(4.41+0.52)×1012/L vs(3.92±0.42)×1012/L(P=0.00)and platelet count(220.50±59.86)×109/L vs(157.05±56.72)×109/L(P=0.001)showed significant decrease;ALT did not show significant decrease(20.00±8.31 vs 26.88±17.04 U/L,P=0.08);Creatltme also showed no significant change(95.82±14.57 vs 88.04±17.76μmol/L,P=0.06);Maximum diameter of tumors decreased significantly(3.72±1.23 vs 2.80±1.29 cm,P=0.02).Compared with clinical TNM stages,pathological TNM stages demonstrated significant decrease in 9 cases;While cell differentiation did not show decrease. Conclusions Intra-arterial infusion with GC regimen can reduce tumor size,decrease TNM stages,while not causing significant adverse impact to radical cystectomy.Bladder-spare treatment is an option for chemotherapy-sensitive cases.

AIM To observe the endometrium receptivity of polycystic ovary syndrome patients and research advance of expression of HOXA10 in endometrium.METHODS Eighty PCOS patients were divided into treatment group and control group,40 persons in each group randomly.The control group was treated with clomiphene (CC) + human menopausal gonadotropin (HMG) + human chorionic gonadotropin (HCG),and the treatment group was treated with CC + HMG + HCG + Yin-Nourishing Yang-Supplementing.After 3 periods,take a record for below:endometrial thickness (Em) in the middle,advanced stage and mid-secretory phase of hyperplasia endometrii,the levels of spiral artery PI/RI in midluteum endometrium,the levels in serum of E2 and P in midluteum endometrium,the expression of HOXA10 mRNA from both groups,clinical pregnancy rate and abortion rate for each group.RESULTS Compared with the control group,endometrial thickness in the treatment group was increased and there is statistical difference in the middle and late follicle phases (P ＜ 0.05),but there was no statistical difference in midluteum endometrium (P ＞ 0.05);the level of E2 and P in the treatment group were raised (P ＜0.05) with statistical significance;PI and RI were obviously contracted (P ＜ 0.01).Expression of HOXA10 mRNA was increased (P ＜ 0.01).Compared with the control group,the treatment group had a significant difference in pregnancy rate (P ＜ 0.05).The abortion rate was lower,but there was no statistical significance (P ＞ 0.05).CONCLUSION Yin-Nourishing Yang-Supplementing Treatment can obtain higher pregnancy rate and lower abortion rate of PCOS patients and the mechanism might be associated with raising the expression of HOXA10 mRNA and reducing spiral artery PI/RI,also improving the function of corpus luteum treatment,then to improve the receptivity of endometrium.Yin-Nourishing Yang-Supplementing Treatment is well worth popularizing in further clinical application.

Objective To observe the activation of anti-viral innate immune response of type Ⅰinterferon and inhibition of hepatitis B virus (HBV)genome replication in mice by HBV-3p-siRNA. Methods HBV-3p-siRNA was designed by targeting specific sequence of HBV S/P mRNA and was generated by in vitro transcription.Negative control siRNA (NC-siRNA)and non-modified HBV-siRNA were used as control groups.Blood samples were collected from tail vein of mice and the model of HBV-infected mice were established by hydrodynamic injection.Forty mice were divided into 4 groups with 10 in each group.The model group was only injected with pGL3.0-HBV1 .2 copy plasmid.The negative control group received peritoneal injection of NC-siRNA.HBV-siRNA group received peritoneal injection of HBV-siRNA and HBV-3p-siRNA group received peritoneal injection of HBV-3p-siRNA.The interferon-β(IFN-β)and hepatitis B surface antigen (HBsAg)in serum were detected by enzyme linked immunosorbent assay (ELISA).The copies of HBV DNA were assessed by fluore scence quantitative polymerase chain reaction (PCR ).The statistical difference between groups was determined using One way-ANOVA analysis by LSD or Dunnett T3.Results Serum level of IFN-β was (12.37±5 .32)pg/mL in model group,(22.61 ±6.29 )pg/mL in negative control group,(26.40±5 .39)pg/mL in HBV-siRNA group and (68.37± 21 .00 ) pg/mL in HBV-3p-siRNA group.The secretions of IFN-β into serum were significantly enhanced by HBV-siRNA and HBV-3p-siRNA compared with model group (F =23.988 and 46.523,respectively,both P <0.01).Serum level of HBsAg was (2 864.86±907.11 )ng/mL in model group,(2 198.86±456.89 )ng/mL in negative control group,(1 049.71 ± 396.28 )ng/mL in HBV-siRNA group and (640.86±383.08)ng/mL in HBV-3p-siRNA group.The expressions of HBsAg were inhibited by HBV-3p-siRNA and HBV-siRNA compared with model group (F = 23.537 and 39.144, respectively;P =0.025 and 0.010,respectively).Serum level of HBV DNA was (2.54 ×104 ±1 .46 × 104 )copy/mL in model group,(2.22×104 ±2.62×103 )copy/mL in negative control group,(3.59×103 ±2.88×103 )copy/mL in HBV-siRNA group and (2.65 ×103 ±1 .46×103 )copy/mL in HBV-3p-siRNA group.Serum level of HBV DNA were inhibited by HBV-3p-siRNA and HBV-siRNA compared with model group (F =15 .013 and 16.741 ,respectively,both P <0.05 ).All of the indicated siRNA used in the experiments showed no apparent effects on the body mass index of the mice models.Conclusion HBV-3p-siRNA,which induces the production of IFN-β and inhibits HBV replication through gene silencing in vivo ,may be a powerful bifunctional antiviral molecule.