Objective To explore achillis tendon-sliding procedure and subtalar joint capsula release by the same cut and individualization treatment used in the correction of congenital clubfoot.Methods Forty eight cases (76 feet) of congenital clubfoot who were first visit were treated by achillis tendon-sliding procedure and subtalar joint capsula release by the same cut,meantime,footplate fascia release and transfer of the anterior tibial tenden were made by individualization.Results All cases were followed-up,the average time follow-up was 1 year and 6 months,excellent were 71% and good were 15.7%.Five cases were recurrence and its rate was 6.94%.Conclusions Achillis tendon-sliding procedure and subtalar joint capsula release by the same cut can solve rotation of displacement between calcaneus and talus and individualization treatment can also solve high arch deformity and adduction of foot.This technique is a simple,safe and effective treatment for congenital clubfoot.

Objective To review the study of noninvasive imaging methods for evaluating liver fibrosis.Meth- ods The current literatures on the use of the ultrasonography,CT and MRI for the evaluation of liver fibrosis were reviewed.The principles,applications and advancement of each imaging methods were described and summarized re- spectively.The features of the newly developed imaging techniques were also discussed.Results In addition to the morphologic information,the imaging examinations can also provide functional information about the circulation sta- tus,diffusion and metabolism features of liver.The potential diagnostic value of MR elastography for liver fibrosis has been addressed.Conclusion The imaging examinations,especially the functional MRI techniques,are reliable noninvasive alternatives for the evaluation of hepatic fibrosis,with bright potentiality for clinical application.

Objective To investigate the clinical value of the combination of hysterescope and laparoecope in the treatment of tubal obstruction infertility.Methods Two hundred and sixty-slx infertile women managed by the combination of hysteroscope and laparoecope from August 2003 to December 2006 were enrolled.The postoperation tubal recapalization extent and pregnancy rate were analyzed.Results The recanalization rate of the umbrella and ampulla portion was higher (86.9%) than that of other sites (interstitial portion was 33.8%,isthmic portion was 35.5% ),and the pregnancy rote of patients with one tubal recavalization was signifieenfly higher than that of patients with bilateral tubal obstruction.The pregnancy rate was 48.0% in 12 months,little higher than 41.0% in 6 months after operation.Conclusion The combination of hysterecope and laparescope in treatment of tubal obstruction infertility has ideal effect and clinical application value.

This study was to investigate the role of urethral catheter balloon dilatation(F16)in the treatment of intrauterine adhesion after hysteroscopic surgery.A total of 523 patients with severe intrauterine adhesion(IUA)following hysteroscopic surgery underwent urethral catheter balloon dilatation during April 2000 and December 2005.During 3～15 months'follow-up,normal menses were seen in 340 patients (65.0％),nearly normal menses in 165 patients(31.5％),and menoschesis in 18 patients(3.4％).302 patients showed normal uterine cavity with no recurrent endometrial adhesion,203 patients(38.8％)were found slight IUA,and only 18 patients(3.4％)still presented with severe adhesion.No operative complication was reposed.and the pregnant rate was 47.6％.In summary.urethral catheter balloon dilatation.based therapeutic strategies is safe.effective and beneficial.

OBJECTIVETo explore the feasibility of preparing novel gypenosides long-circulating liposomes with PEG grafted on beta-sitosterol (PEG-Sito).

METHODSuccinicanhydride was adopted to connect beta-sitosterol and PEG 2000. Sphingomyelin and PEG-Sito was used as material to prepare gypenosides long-circulating liposomes by using ethanol injection method. Encapsulation efficiency was determined by using protamine precipitation method. H-NMR was used to verify the synthesis of PEG-Sito, the novel gypenosides long-circulating liposomes were characterized by particle size, zeta potential and atomic force microscope.

RESULTThe synthesis of PEG-Sito was verified by 1H-NMR. Encapsulation efficiency of long-circulating liposomes prepared by ethanol injection method was 74.3%, particle size was 288.1 nm, zeta potential was -20.25 mV, the morphology were round observed by AFM.

CONCLUSIONThe novel gypenosides long-circulating liposomes prepared with PEG-Sito was feasible, it had a high encapsulation efficiency and good morphology.

Drug Compounding ; methods ; Feasibility Studies ; Gynostemma ; chemistry ; Liposomes ; blood ; chemistry ; Plant Extracts ; chemistry ; Polyethylene Glycols ; chemistry ; Reproducibility of Results ; Sitosterols ; chemistry ; Sphingomyelins ; chemistry

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

The establishment of quality evaluation of traditional Chinese medicine system that not only accords with Chinese medicine function characteristics but also is recognized as international medical circles, is an arduous task in urgent need of solving the current modernization of traditional Chinese medicine in the process of internationalization. It is difficult to evaluate atraditional Chinese medicine by detection of single active components in traditional Chinesemedicinewiththe western medicine quality controlmethod due to the overall effects of traditional Chinese drugs, the components of the overall diversity, targets, and the complexity of the interaction between components of unpredictable make the Long-term since, domestic and foreign scholars continue to explore and put forward a series of quality evaluation of traditional Chinese medicine to promote the development of traditional Chinese medicine. This article summarized the related academic ideas and developments to, providea new thought and perspective for the quality control of traditional Chinese medicine.
Drug Evaluation ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; Humans ; Medicine, Chinese Traditional ; standards ; Quality Control

OBJECTIVE Topreparealipidderivativeofgemcitabine(Gem)anditspolymericmi-celles to overcome the disadvantages of Gem.METHODS N-benzyl-3′-acetyl-gemcitabine(BAG)was synthesized.A BAG-loaded poloxamer polymeric micelle (BAG∶poloxamer 188 =10∶1 ,mol/mol)was prepared using an injection method.The micelles were characterized with a laser particle size and elec-tric charge instru ment and negatively-stained trans mission electron microscopy.Hu man breast cancer cells MCF-7 were cultured with Gem or BAG polymeric micelles of 5,10,20,30,50,70,90 μmol·L-1 for 24,48 and 72 h,respectively.The inhibitory rate of cells was measured with an MTT method.The MCF-7 cytotoxicity of BAG polymeric micelles was investigated.A pharmacodynamic study was per-formed on the mice bearing mouse hepatocellular cancer cells H22.Intravenous (iv)and oral (ig)ad-ministration was used at the dose of Ge m 40 mg·kg -1 or BAG polymeric micelles 62 mg·kg -1 .The mice were administered on the 1 st,4th and 7th day and sacrificed on the 8th day.Tumor inhibitory rates were measured.RESULTS TheBAGstructurewasidentifiedbythinlayerchromatograph,1Hand13C NMR,infrared ray chromatograph and mass spectrum.The appearance of BAG micelles was a slightly blue suspension.The micelles were spheres according to the electron microscopic observation.Their size was 62.82 nm and the zeta potential was -18.8 mV.The half inhibition concentration (IC50)of Gem and BAG polymeric micelles was 40.6 and 90.0 μmol·L-1 ,5.0 and 14.9 μmol·L-1 ,5.0 and 1 3.6 μmol·L-1 at 24,48 and 72 h,respectively according to the MTT results.According to the in vivo results,compared with the tumor model group,Gem (ig),Gem (iv)and BAG polymeric micelles (iv and ig)had significant effect on the tumor weight of H22 cell xenograft mice (P<0.01 ).As for anti-tumor efficiency,BAG polymeric micelles (ig)were better than Gem (ig)(P<0.05);BAG polymeric micelles (iv)were better than BAG polymeric micelles (ig)(P<0.05),and BAG polymeric micelles (iv)were almostequaltoGem(iv).CONCLUSION ThelipidderivativeofGemcanbeloadedinthepoloxamer 1 88 polymeric micelles.BAG polymeric micelles show in vitro MCF-7 cell inhibition and in vivo inhibition of mouse H22 xerografts;iv or ig.BAG polymeric micelles (ig)show better anti-tumor effect than Gem (ig),indicating that BAG polymeric micelles are a promising novel anti-tumor oral preparation.

Objective To investigate the correlation between iodine intake,BRAF mutation in thyroid gland and clinical biologic characteristics in papillary thyroid carcinoma(PTC) cases.Methods A total of 159 PTC patients and 200 healthy controls were enrolled in this study.Urine iodine was tested,BRAFV600E mutation was detected by PCR.The correlation was analyzed between BRAF mutation and iodine intake,BRAF mutation and clinical biologic characteristics of PTC respectively.Results The median urinary iodine (MUI) of the patients and healthy controls was 336 μg/L and 196 μg/L respectively (P =0.004).The overall prevalence of the BRAFV600E mutation in this series of PTC was 63.5％,showing a clear correlation of BRAFV~E mutation with iodine intake (P =0.006).There was no correlation of BRAFV600E mutation with age,gender,tumor size,extrathyroid extension or nodulor goiter in PTC (P ＞ 0.05).But there was a significant association of BRAFV~E mutation with lymph node metastasis (P =0.008) and Hashimoto's thyroiditis (P =0.037).Conclusions High iodine intake may be a risk factor for PTC occurrence.In PTC cases,high iodine intake may be a risk factor of BRAFV600E mutation.BRAFV600E mutations increase both in PTC with cervical lymph node metastases and uncoexisting Hashimoto' s thyroiditis.

Objective To evaluate the effect of neoadjuvant chemotherapy by different arteriovenous ways on ovarian function of patients with locally advanced cervical cancer after surgery. Methods We retrospectively studied 38 cases of young women (surgical age <45 years) who were diagnosed with locally advanced squamous cell carcinoma of the cervix and undergone radical hysterectomy with ovaries. According to the way of adjuvant chemotherapy, these cases were divided into 20 cases of group A (arterial embolization chemotherapy), 18 cases of group B (intravenous chemotherapy). Each patient underwent a course of chemotherapy. Then we retrospectively analyzed and compared serum estradiol (E2 ), follicle stimulating hormone (FSH), lute-inizing hormone (LH) in two groups before and after surgery to assess ovarian function. We compared E2 ,FSH and LH levels 2-3 weeks after chemotherapy (before surgery) and 1 month after surgery,and 6 months after surgery in two groups. Results The E2 levels in group A 1 month before and after surgery significantly decreased, while FSH increased compared with those be-fore chemotherapy(P<0. 05). LH levels in two groups at different time points and 6 months after surgery showed no significant difference (P>0. 05) compared with those before chemotherapy. the E2 , FSH and LH levels in group B at different time points presented no significant difference (P>0. 05). Only E2 level in group A was significantly lower than that in group B before surger-y. Conclusion For patients with locally advanced cervical cancer, the effect of arterial embolization chemotherapy before sur-gical intervention on ovarian function is transient and reversible, while intravenous chemotherapy before surgery exerts few effects on ovarian function. Retaining ovaries in radical hysterectomy is a safe and effective method to protect the endocrine function for young patients with locally advanced cervical cancer.