Is There An Advantage of Using Dingkun Pill (定坤丹) alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial

Objective: To evaluate the effects of Chinese medicine Dingkun Pill (定坤丹) alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS). Methods: This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment. Results: Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01). After treatment, TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P<0.05 or P<0.01); TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P<0.01), and no differences were observed between Diane-35 group and combined group (P>0.05). Conclusions: Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638)     

Penetrating Facial Injury with an “Airsoft” Pellet: A Case Report

Airsoft is a recreational combat sport that originated in Japan in the 1970s and is currently increasing in popularity in the UK. Participants use air or electrically powered weapons to fire small plastic pellets at a controlled pressure. UK law strictly regulates the maximum muzzle velocity and the type of ammunition used in these weapons. A search of published papers found several reports of penetrating ocular injuries caused by Airsoft pellets, but no reports of penetrating injuries to other areas of the body. We report the case of a 25-year-old man who sustained a penetrating injury to the cheek after being shot with an Airsoft weapon.     

大力救心丹治疗冠状动脉粥样硬化性心脏病心绞痛疗效观察

目的：探讨大力救心丹治疗冠状动脉粥样硬化性心脏病（冠心病）心绞痛的临床疗效及其安全性。方法：将１２２例冠心病心绞痛患者随机分为治疗组８２例和对照组４０例，治疗组口服大力救心丹，每次６ｇ，每日３次；对照组口服麝香保心丸，每次２丸，每日３次。结果：经治疗６周后，治疗组显效２８例，有效５０例，无效３例，加重１例，总有效率９５．１％；对照组显效１１例，有效１８例，无效７例，加重４例，总有效率７２．５％，２组总有效率比较有非常显著性差异（χ２＝９．０２，Ｐ＜０．０１）。心电图疗效比较，治疗组显效２４例，有效３７例，无效２１例，总有效率７４．４％；对照组显效７例，有效１３例，无效１６例，恶化４例，总有效率５０．０％，２组总有效率比较有非常显著性差异（χ２＝９．３５，Ｐ＜０．０１）。２组药物均可显著降低心绞痛发作频率和硝酸甘油日耗量。同时，治疗组各型患者治疗后舌脉、证候均有明显改善。结论：用大力救心丹辨证治疗冠心病心绞痛疗效好而且安全     

定坤丹治疗子宫内膜薄型不孕的临床效果

目的 观察定坤丹治疗子宫内膜薄型不孕的临床效果,为优化子宫内膜薄型不孕的治疗方案提供参考。方法 选取187例子宫内膜薄型不孕患者,在保证组间基本特征匹配原则上,利用计算机软件产生的随机数,按照1∶1的比例分为对照组(93例)和观察组(94例)。对照组给予雌二醇+地屈孕酮干预,观察组在对照组的基础上加用定坤丹。比较治疗3个周期后两组患者的子宫内膜厚度、孕激素浓度及临床妊娠率。结果 观察组患者排卵期平均子宫内膜厚度显著高于对照组(P<0.01),黄体期孕激素浓度显著高于对照组(P<0.01),累计临床妊娠率显著高于对照组(P<0.05)。结论 定坤丹可以明显改善子宫内膜薄型不孕患者排卵期子宫内膜厚度,提高黄体功能,改善妊娠结局。     

Utilizing mixer torque rheometer in the prediction of optimal wet massing parameters for pellet formulation by extrusion/spheronization

In this study, we aimed to optimize theophylline pellet formulations using a two-factor three-level full-factorial design (3²) by monitoring the concentration of two pellet excipients, polyvinyl pyrrolidone K30 (PVP) binder solution (X1) and the hydrophilic excipient mannitol (X2). Their impact on pellet characteristics (responses) were evaluated. Increasing PVP concentration in the binder solution resulted in an increase in the wet mass torque value. The effect of mannitol, however, was antagonistic. Moreover, the pellet particle size was significantly influenced by the level of mannitol, PVP solution, and quadratic effect of mannitol. Mannitol significantly antagonized the pellet particle size. Furthermore, increased mannitol concentrations significantly enhanced drug dissolution rate from the pellets, whereas PVP concentration in the binder solution significantly reduced the drug dissolution rate. In conclusion, wet granulations can be controlled by monitoring the composition of the binder solution and pellet composition.     

Construction of a Tissue‐Engineered Annulus Fibrosus

The intervertebral disc is composed of load‐bearing fibrocartilage that may be subjected to compressive forces up to 10 times the body weight. The multilaminated outer layer, the annulus fibrosus (AF), is vulnerable to damage and its regenerative potential is limited, sometimes leading to nuclear herniation. Scaffold‐based tissue engineering of AF using stem cell technology has enabled the development of bi‐laminate constructs after 10 weeks of culture. It is difficult to know if these constructs are limited by the differentiation state of the stem cells or the culture system. In this study, we have characterized an expandable scaffold‐free neoconstruct using autologous AF cells. The construct was prepared from pellet cultures derived from monolayer cultures of AF cells from mature pigs that became embedded in their own extracellular matrix. The pellet cultures were incubated for 24 h in a standardized conical tube and then carefully transferred intact to a culture flask and incubated for 21 days to allow continued matrix synthesis. Cell viability was maintained above 90% throughout the culture period. The engineered scaffold‐free construct was compared with the native AF tissue by characterization of gene expression of representative markers, histological architecture, and biochemical composition. The morphological and biochemical characteristics of the cultured disc construct are very similar to that of native AF. The cell number per gram of construct was equal to that of native AF. Expression of aggrecan was elevated in the engineered construct compared with RNA extracted from the AF. The glycosaminoglycan content in the engineered construct showed no significant difference to that from native construct. These data indicate that scaffold‐free tissue constructs prepared from AF cells using a pellet‐culture format may be useful for in vitro expansion for transplantation into damaged discs.     

Influence of MCC II fraction and storage conditions on pellet properties

Microcrystalline cellulose II (MCC II) – a polymorph of commonly used MCC I – was introduced as new pelletization aid in wet-extrusion/spheronization leading to fast disintegrating pellets. Previous investigations suggested that pellet properties were influenced by the fraction of MCC II. Furthermore, it is unknown whether the storage conditions can affect the disintegration behavior. Therefore, the effects of MCC II fraction and the storage conditions on several pellet properties were investigated.MCC II-based pellets were prepared of pure MCC II or binary mixtures containing 10–50% (steps of 10%) MCC II as pelletization aid and theophylline, chloramphenicol or lactose. The pellets were characterized by their aspect ratio, equivalent diameter, water content, tensile strength, porosity as well as shrinking, and disintegration behavior and drug release according to their MCC II fraction. Furthermore, the pellets were stored at different relative humidities (0–97%rh), and the influence on their disintegration and drug release was investigated.With increasing MCC II fraction, the pellets became lager in size, decreased their porosity, and required higher water contents for spheronization. Moreover, the disintegration time increased and the disintegration itself was incomplete. Furthermore, the storage conditions had an impact on the disintegration properties of MCC II-based pellets. The disintegrating was affected irreversibly after storage at high humidity (80–97%rh) resulting in a slow drug release. Therefore, MCC II-based pellets need to be stored below 80%rh to secure a fast disintegration.A better knowledge of the properties of MCC II-based pellets was obtained providing a basis for a successful manufacturing and adequate storage of MCC II-based pellets prepared by extrusion/spheronization.     

心复宁丸治疗急性病毒性心肌炎42例

目的观察心复宁丸治疗急性病毒性心肌炎(VMC)的疗效。方法将82例急性VMC患者随机分为治疗组42例与对照组40例,均予西医常规治疗,治疗组加心复宁丸口服;15天1个疗程,治疗2个疗程对比疗效。结果治疗组总有效率95.24%,对照组75.00%,两组比较有显著性差异(χ2=6.72,P0.01)。结论心复宁丸治疗急性VMC有较好的疗效。     

步长稳心颗粒对慢性心力衰竭患者室性早搏及心功能的影响

目的:评价步长稳心颗粒对慢性心力衰竭患者室性早搏、心功能及血浆脑钠肽(BNP)的影响。方法:将60例慢性心力衰竭并室性早搏患者随机分为对照组30例和治疗组30例,对照组给予地高辛、利尿剂、血管紧张素转换酶抑制剂或血管紧张素Ⅱ受体拮抗剂及β受体阻滞剂治疗,治疗组在此基础上加用步长稳心颗粒。观察治疗前及治疗结束后患者室性早搏发作次数、心功能及BNP变化。结果:与治疗前相比,治疗组的左心室短轴缩短率(LVFS)、心搏量(SV)、左心室射血分数(LVEF)、BNP值明显改善,室性早搏次数减少;与对照组比较,治疗组的临床疗效显效率和总有效率均高于对照组,室性早搏次数、SV、LVFS、LVEF、BNP值差异显著。结论:稳心颗粒有效控制心力衰竭患者室性早搏次数,能改善慢性心力衰竭患者的心功能,可以作为心力衰竭的辅助治疗。     

盐酸莫西沙星微丸胶囊的制备和溶出度研究

目的制备盐酸莫西沙星微丸胶囊研究其溶出行为。方法采用挤出滚圆法制备载药丸心,溶剂法制备盐酸莫西沙星固体分散体,离心造粒法制备成品微丸。考察微丸的粉体学性质及微丸胶囊的溶出行为。结果本方法制备的盐酸莫西沙星微丸胶囊质量好,溶出迅速。结论该方法制备盐酸莫西沙星微丸胶囊可行。