Unveiling quality of clinical trial in China:from concern to confirmation

The cornerstone of scientifically valid and ethically sound clinical trials is in compliance with established global quality requirements.Although China has made significant progress over the past 20 years in terms of the clinical trial quantity[1],quality and participation in multiregional trials[2],there still remain concerns regarding the trial quality,which could be associated with the self-inspection initiative in 2015[3].

Therapeutic potential and pharmacological activities of Atractylodes lancea (Thunb.) DC.

The rhizome of Atractylodes Iancen(A.lancea)(Thunb.) DC.(AL)is extensively used in Chinese,Thai,and Japanese traditional medicines as crude extracts/decoctions or a component in various herbal formulations.Various pharmacological activities of Al.and its major constituents have been demonstrated in ritro.ex ciro.and in animal models.Results from the toxicity studies in animal models suggest safety profile of AL,and its active constituents.Despite extensive use with positive impression in many diseases,there has not been a clinical study that can conclusively support its efficacy and safely profile in human.This review comprehensively summarizes current information on the pharmacological activities of AL and their active constituents including anticancer,anti-inflammatory,antimicrobial and antipyretic activities,as well as activities on central nervous,cardiovascular,and gastrointestinal systems.

Adjuvant tamoxifen switched to exemestane treatment in postmenopausal women with estrogen receptor-positive early breast cancer:A pragmatic,multicenter,and prospective clinical trial in China

Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in China.Methods:Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy.The primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer,appearance of a second primary or contralateral breast cancer,or death due to any cause.Other endpoints included the proportion of patients experiencing each event,incidence rate per annum,relationships between human epidermal growth factor receptor 2 status and time to event,and relationship between disease history variables and time to event.Results:Overall,558 patients were included in the full analysis set:397(71.1%)completed the study,20experienced an event,and 141 discontinued[47 owing to an adverse event(AE);37 no longer willing to participate].Median duration of treatment was 29.5(range,0.1-57.7)months.Median time to event was not reached.Eventfree survival probability at 36 months was 91.4%(95%CI,87.7%-95.1%).The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years(20/565).Multivariate analysis showed an association between tumor,lymph node,and metastasis stage at initial diagnosis and time to event[hazard ratio:1.532(95%CI,1.129-2.080);P=0.006].Most AEs were grade 1 or 2 in severity,with arthralgia(7.7%)being the most common treatment-related AE.Conclusions:This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+breast cancer previously treated with adjuvant tamoxifen for 2-3 years.No new safety signals were identified in the Chinese population.

Change of Subcutaneous Tissue Mass at the Deltoid and Thigh Areas in Japanese Infants Followed from 2 to 15 Months

We previously investigated the thickness of the epidermis and lengths from the skin surface to the muscle fascia and bone based on measurements taken from the ultrasonic echograms of Japanese infants aged 2, 3, 4, 5, 6, and 12 - 15 months. The appropriate needle length for intramuscular injection was 16 mm (5/8 inch) in Japanese infants at any age and site. In the present study, we examined these lengths in 21 infants with physical growth from 2 to 15 months. Average height increased from 58.5 to 73.6 cm and average body weight from 5835 to 9226 g until 15 months. The circumference of the thigh increased from 22.3 cm at 2 months to a maximum of 25.9 cm at 6 months, while that of the deltoid area was 15.2 cm at 2 months and 15.9 cm at 6 months. Subcutaneous mass (length from the skin surface to the muscle fascia) at the thigh increased between 3 and 4 months and decreased at 12 - 15 months and showed good relationship to the circumference of the thigh. Subcutaneous mass at the center of the deltoid area showed the same size until 6 months. Muscle mass (lengths from the muscle fascia to the bone) at thigh and deltoid areas remained the same until 6 months. Ultrasonic echogram is an effective tool for evaluating subcutaneous and muscle mass in young infants.

Effects of Excision of a Mass Lesion of the Precentral Region of the Left Hemisphere on Disturbances of Graphomotor Output

In the present study, the effect of neurosurgery on graphomotor output of a right-handed female patient with a mass lesion of the precentral region of the left frontal lobe was reported. For examination of handwriting movements a digitizing tablet was used. Preoperatively, the patient showed longer movement times than healthy subjects and patients with lesions of the left frontal lobe without involvement of the precentral region. Furthermore, the analysis of kinematic data revealed a severe dysfluency of her handwriting. Postoperatively, a significant improvement of writing time and fluency of handwriting was observed. Since the integrity of handwriting plays an important role in everyday functioning, disturbances of handwriting movements should be objectified and reassessed in follow-up assessment using new techniques such as digitizing tablets.

Development of oral pharmaceutical formulation of standardized crude ethanolic extract of Atractylodes lancea(Thunb) DC.

Cholangiocarcinoma(CCA), the adenocarcinoma of the biliary duct, is commonly reported in Asia with the highest incidence in northeastern Thailand. Chemotherapy of this type of cancer is limited due to the lack of effective chemotherapeutic drugs. A series of previous studies support further research and development of Atractylodes lancea(Thunb) DC.(AL) as a potential candidate for the treatment of CCA as a crude ethanolic extract. In the present study, we aimed to develop an oral pharmaceutical formulation(capsule) of the standardized AL crude ethanolic extract for further clinical development in patients with CCA. Major steps included macroscopic and microscopic authentication of the AL rhizomes, preparation of standardized AL extract, preparation of oral pharmaceutical formulation(capsule) of the standardized AL extract, quantitative and qualitative analysis of the marker compound(atractylodin) in the formulated AL extract, evaluation of contaminations of heavy metals, pesticides residues, and microorganisms in the ground AL rhizomes and the formulated(capsule) powder of AL, physicochemical and pharmaceutical properties of the formulated AL extract/capsule, and cytotoxicity evaluation of the formulated AL extract. Results of all evaluations confirmed satisfactory pharmaceutical properties of oral(capsule) formulation of the standardized AL extract.

Appropriate Needle Lengths Determined Using Ultrasonic Echograms for Intramuscular Injections in Japanese Infants

Adjuvanted vaccines are recommended for administration through an intramuscular route. The Centers for Disease Control and Prevention (CDC) has recommended the anterolateral thigh using a 22 - 25-G 25-mm (1 inch) needle for infants, injected at a 90° into the skin surface, and using a 16 mm (5/8 inch) for newborns. Appropriate needle lengths may differ depending on racial backgrounds. In the present study, the thickness of the epidermis and lengths from the skin surface to the muscle fascia and bone were measured using ultrasonic echograms in order to determine suitable needle lengths for Japanese infants aged 2, 3, 4, 5, 6, and 12 - 15 months old. The thickness of the epidermis was 1.44 - 1.54 mm (95% CI), and the lengths from the skin surface to the muscle fascia and bone were 11.52 - 12.28 mm (95% CI), and 25.66 - 26.93 mm (95% CI), respectively, at the anterolateral thigh. At the center of the deltoid muscle, skin thickness was similar to that at the thigh, furthermore the lengths from the skin surface to the muscle fascia and bone were 8.49 - 9.10 mm (95% CI), and 17.38 - 18.31 mm (95% CI), respectively. The lengths from the skin surface to the muscle fascia and bone were 1 - 2 mm shorter in 2-month-old infants than those in older generations. Therefore, the appropriate needle length for intramuscular injections in Japanese infants was 16 mm (5/8 inch) at any age and sites, and with 25 mm (1 inch) needles at a 90° angle being associated with the risk of over-penetration.

Gum Chewing and Cognition: An Overview

In recent years, there was a debate about the effects of gum chewing on various aspects of cognitive functioning. In this review, the results of previous studies are presented and summarized. There is a clear indication that gum chewing can improve various aspects of cognitive functioning including memory, attention and both executive and intellectual functioning. However, there is also clear evidence that chewing gum during cognitive tasks can adversely affect task performance. Therefore, it can be concluded that the replication of (beneficial or detrimental) effects of gum chewing on cognition has been proven to be very difficult. Consequently, the robustness of reported effects of gum chewing on cognition has to be questioned. Suggestions for future research are given.

单肺通气期间肺动静脉分流及缺氧性肺血管收缩对动脉血七氟烷浓度的影响

七氟烷因其血气分配系数低、起效及消除迅速而被广泛应用于临床麻醉。尽管单肺通气（one—lungventilation，OLV）期间连续吸入恒定浓度的七氟烷，但临床上仍有一些患者会出现不自主体动、心动过速和高血压，提示可能存在麻醉深度不足。我们观察到1例患者在OLV期间出现动脉血七氟烷浓度及脉搏血氧饱和度同时一过性显著下降。尽管吸入和呼出的七氟烷浓度保持稳定，但由于动脉血的七氟烷浓度低于预期值可能会导致单肺通气期间麻醉深度不足。