This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.
Case-Control Studies ; Drug Hypersensitivity ; etiology ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing ; Prospective Studies

Objective To explore the value of color doppler ultrasonography by bed side in the early diagnosis of HIE in full term neonates.Methods The changes of cerebral parenchymal and cerebral arterial blood stream parameter on 35 cases of neonates clinically diagnosed HIE of mild and moderate degree and 40 cases of normal newborns on the 24,48 and 72 hours after birth were observed by color doppler ultrasonography by bed side.Results 1.The cerebral parenchyma was even echo in normal newborns,but it was maldistributed and reinforced in mild asphyxia neonates and it was more serious in moderate degree.The echo of cerebral parenchyma in mild degree was near normal in 48 hours after birth,while the echo of cerebral parenchyma in moderate degree was still maldistributed and reinforced in 48 and 72 hours after birth.2.There was obvious changes in the cerebral arterial blood stream parameter and hemodynamics of the asphyxia newborns compared with normals.The systolic peak velocity(Vs)and end diastolic velocity(Vd)of the cerebral arteries in mild and moderate degree were obviously lower than that of control group in 24,48 hours after birth(Pa0.05).3.Resistance index(RI)of the cerebral arteries in mild and moderate degree were higher than that of control group in 24,48 hours after birth(Pa0.05).Conclusion Color doppler ultrasonography by bed side is a convenient,noninvasive method for diagnosing HIE.

To optimize the pretreatment of Huanglian Jiedu decoction before ceramic membranes and verify the effect of different pretreatments in multiple model system existed in Chinese herb aqueous extract. The solution environment of Huanglian Jiedu decoction was adjusted by different pretreatments. The flux of microfiltration, transmittance of the ingredients and removal rate of common polymers were as indicators to study the effect of different solution environment It was found that flocculation had higher stable permeate flux, followed by vacuuming filtration and adjusting pH to 9. The removal rate of common polymers was comparatively high. The removal rate of protein was slightly lower than the simulated solution. The transmittance of index components were higher when adjust pH and flocculation. Membrane blocking resistance was the major factor in membrane fouling. Based on the above indicators, the effect of flocculation was comparatively significant, followed by adjusting pH to 9.
Ceramics ; chemistry ; Drugs, Chinese Herbal ; chemistry ; Flocculation ; Membranes, Artificial ; Polymers ; chemistry ; Solutions ; chemistry ; Ultrafiltration ; methods

OBJECTIVETo evaluate the efficacy and safety of wuling Capsule combined with Pinaverium Bromide in treatment of irritable bowel syndrome (IBS).

METHODSSixty-four IBS patients were randomized into two groups, the treatment group and the control group, 32 in each group. Patients in the treatment group took wuling Capsule (0. 33 g/capsule, 3 times per day) and Pinaverium Bromide (50 mg/tablet, one tablet each time, 3 times per day) , while those in the control group only took Pinaverium Bromide (50 mg/tablet, one tablet each time, 3 times per day). The therapeutic course for all was 6 weeks. IBS symptom score questionnaire, IBS-Quality of Life (IBS-QOL) , Self-Rating Depression Scale (SDS) , and Self-Rating Anxiety Scale (SAS) were assessed before and after treatment. Adverse reactions were also observed.

RESULTSThe improvement of abdominal pain, stool frequency, and stool properties, as well as changing rates of integrals were significantly higher in the treatment group than in the control group (P <0. 05). The improvement of dysphoria, body image, concerns for health, and dietary restriction of IBS-QOL, as well as changing rates of integrals were significantly higher in the treatment group than in the control group (P <0. 05). The improvement of SDS and SAS, as well as changing rates of integrals were significantly higher in the treatment group than in the control group (P <0. 05). No severe adverse reaction occurred in either group.

CONCLUSIONCombination therapy of wuling Capsule and Pinaverium Bromide could improve abdominal pain and defecation, attenuate depression and anxiety of IBS patients with higher safety.

Anxiety ; Anxiety Disorders ; Biomedical Research ; Capsules ; Defecation ; Depression ; Depressive Disorder ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Irritable Bowel Syndrome ; drug therapy ; Morpholines ; therapeutic use ; Quality of Life ; Surveys and Questionnaires

OBJECTIVESynthetical evaluation of promoting effect of some kinds of transdermal enhancers was carried through.

METHODDiclofenac sodium was used as model, and azone and l-menthol and synthetic borneol and olieic acid and essential oil from Cnidium monnieri were used as transdermal enhancers. Transdermal absorption experimentation of diclofenac sodium on the device of penetrating skins in vitro was done. Cumulation of permeation amount and penetrating rates and steady fluxes and lag times were observed, and grey relational cluster method was used to evaluate the promoting effect of some kinds of transdermal enhancers.

RESULTAs for promoting effect on diclofenac sodium, azone and l-menthol were the best, and synthetic borneol and olieic acid ranked behind.

CONCLUSIONGrey relational cluster method can evaluate promoting effect objectively and fairly.

Administration, Cutaneous ; Animals ; Azepines ; pharmacology ; Bornanes ; pharmacology ; Cluster Analysis ; Cnidium ; chemistry ; Diclofenac ; administration & dosage ; pharmacokinetics ; Male ; Menthol ; pharmacology ; Oils, Volatile ; isolation & purification ; pharmacology ; Rabbits ; Skin Absorption ; drug effects

Objective To evaluate the hematological adverse events of sunitinib in treatment of advanced renal cell carcinoma.Methods Forty-four male patients and 18 female patients were included in this study.They were all with metastatic renal cell carcinoma and received sunitinib treatment at the dose of 50 mg daily in repeated 6 weeks cycle (4 weeks on and 2 weeks off).Toxicity was assessed every cycle with tumor assessments every 2 cycles via CT or PET-CT.Results Fifty patients (80.6％) had experienced treatment-related hematotoxicity,including leucocytopenia,anemia and thrombocytopenia.Severe hematological adverse events ( grade 3 -4 ) occured in 18 patients ( 29.0％ ) and slight events ( grade 1 - 2 ) in others (51.6％).Most of the hematological adverse events were manageable and reversible and treatment-changes (dose reduction,interruption) were necessary in severe cases.Almost half of the dose reduction (9/21,42.9％ ) were owing to hematotoxicity.Conclusions Sunitinib of 50 mg dose on schedule 4/2 is effective and well-tolerated in advanced renal carcinoma patients.Hematological adverse events are frequent in Chinese patients and can be controlled well.

Objective The aim of this study is to investigate the role of angiotensin-converting enzyme (ACE)gene susceptibility to systemic lupus erythematosus(SLE)by familial studies.Methods PCR-based re- striction fragment length polymorphism(RFLP)was applied to genotype single nucleotide polymorphism(SNP) G261T of the ACE gene.A total of 119 patients with SLE from 119 families were recruited.In addition,316 family members of these patients were also genotyped.A family-based association study was carried out to ex- plore the association between gene polymorphism and SLE.We studied the SNP encoding non-synonymous substitution in the ACE gene with respect to genetic susceptibility to SLE.Results Among 119 SLE patients. the frequency of ACEG261TG,T alleles was 44.8%.55.2% respectively,the frequency of ACEG261T GG,GT and TT genotypes was 13.9%,62.0%,24.1% respectively,Univariate(single-marker)family-based association test(FBAT)demonstrated that variant alleles at the SNP,rs4303,exon 5 of ACE gene were significantly asso- ciated with genetic susceptibility to SLE in Additive Model(Z=2.877,P=0.004),Dominant Model(Z=2.557, P=0.011).Recessive Model(Z=2.202,P=0.028).Transmission-disequilibrium test(TDT)and sib transmission -disequilibrium test(STDT)showed an excess of the allele of T from heterozygous parents to affected offspring or higher frequency of the allele of T in the patients than their normal siblings(X~2=11.66,P=0.001).Conclu- sion Our findings suggest that the ACE gene may he the susceptible gene to SLE in Chinese population,and the individuals carrying ACE-261T allele is significantly associated with susceptibility to SLE.

Objective To evaluate the application significance of Bosniak renal cyst classification. Methods The operations of 497 cases of cystic renal masses were performed from 2002 to 2007 in our hospital.The average age of these cases was 42-years old,the average diameter of renal cysts was 5.4 cm. There were 212 left lesions,265 right and 20 bilateral.According to Bosniak classification,there were 339 cases of category I,49 cases of category Ⅱ(including 23 cases of category ⅡF),44 cases of category Ⅲ and 65 cases of category Ⅳ.Renal cystectomy was performed in 372 cases when nephron sparing surgery performed in 51 eases and radical nephrectomy performed in 74 cases.Results Malignant tumors were found in 89 cases and benign lesions were found in 408 cases.The malignant rate was 0.9% in category I,10.2% in category Ⅱ(13.O%in category ⅡF),52.3% in category Ⅲ,89.2% in category Ⅳ.There was significant difference among the 4 groups,but there was no significant difference between category ⅡF and non-Ⅱ F of category Ⅱ.403 cases were followed up for 1-5 years with 75 cases of malignancy and 328 cases of benign lesions.Recurrence or metastasis was found in 9 malignant cases.Conclusions Careful follow-up should be performed in category I and Ⅱ,especially in the cases of Ⅱ F category and the eases with changes of diameter or morphology.It is definite that surgery should be performed in the cases of renal cyst with category Ⅲ or Ⅳ for their high malignant rate.

Objective To discuss the treatment of synchronous bilateral renal cell carcinoma.Methods Fourteen cases of synchronous bilateral renal cell carcinoma with 12 males and 2 females were treated from 1994 to 2005.Lumbago occurred in 4 cases and hematuria in 2 cases.All the cases were diagnosed with the CT scan,IVU,US and/or MR.Six cases received bilateral operation simultaneously,8 cases received sequential operations.Radical nephrectomy on one side and partial nephrectomy on the opposite side was conducted in 8 patients.Partial nephrectomy on both sides was performed for 6 patients. Results Twenty-two operations were performed in 14 cases.The average operative time was(263±52)min in simultaneous operation and(155±46)min in others.The length of hospital stay was(11.5±2.1)d in simultaneous operation and(7.4±1.2)d in staging operatiom Ten cases were followed up for 6-41 months.The renal function remained good in 7 patients.The SCr increased in 3 cases with no need for dialysis.One case died 25 months later with metastasis of lung.One case with local recurrence died 38 months later.One case died of cerebral hemorrhage.Conclusions The renal function and treating tumor must be considered in managing synchronous bilateral renal cell carcinoma.The geheral condition of patient and the position of tumor should be evaluated in order to make a treatment plan.

Objective To discuss the etiology and management of hemorrhage after partial nephrectomy because of renal cancer. Methods Of the 382 cases performed partial nephrectomy during a 10-year period, 5 patients(1.3%) had postoperative hemorrhage because of a renal artery pseudoaneurysm. The ages of these patients were from 42 to 63 years. All the tumors were malignant with an average diameter of 2. 8 cm. The renal pedicle was blocked in 2 cases with tumor size larger than 3 cm. The kidney was reconstructed with interrupted 0 chromic sutures in "8"or "U" style. Delayed postoperative hemorrhage occurred from 6 days to 3 months. The blood loss was from 1000 to 4500mi. Shock or lower blood pressure occurred in 3 patients. Nephrectomy was performed in 1 patient and selective angiographic embolization was performed in other 4 cases. Results Angiography revealed renal artery pseudoaneurysm in all 5 cases at the third (4 cases) or fourth branch(1 patient).Percutaneous embolization was successful in 4 patients. Four cases were followed up for 2 to 9 years without complication. Conclusions Delayed postoperative hemorrhage following partial nephrectomy is an uncommon but potentially life-threatening complication. Super-selective angiographic embolization could be the first choice of treatment.