补阳还五汤治疗中风恢复期气虚血瘀证的中医量化疗效评价分析

目的探讨中医药治疗中风病恢复期气虚血瘀证型的量表(自拟)有效性评价。方法通过采用分析量表对该证型患者症状好转程度积分改变,与NIHSS评分量表类似的中医证候量表对照,反映其可行性。结果两组患者在治疗前各量表评分情况相比无明显差异(P>0.05)。治疗后,观察组患者NIHSS以及中风病气虚血瘀型评价量表评分显著低于对照组(P<0.05)。结论临床可用来评价中风病恢复期气虚血瘀证型疗效,值得临床推荐。

中医推拿按摩治疗小儿消化不良性腹泻的临床疗效观察

目的：研究中医推拿按摩治疗小儿消化不良性腹泻的效果.方法：前瞻性随机将120例小儿消化不良性腹泻患儿分为对照组和治疗组,对照组给予常规西药治疗,治疗组给予中医推拿按摩治疗,观察有效率及症状改善情况,并对患儿家属的满意度进行比较.结果：治疗组总有效率为93.33%,明显高于对照组的78.33%,两组比较差异有显著性意义（P 〈0.05）.并且治疗组治疗后患者满意度为95.00%,明显高于对照组的76.67%,两组数据相比差异具有统计学意义（P 〈0.05）.结论：中医推拿按摩治疗小儿消化不良性腹泻能够有效提升患儿满意度,其疗效优于常规西医治疗,因此具有很高临床推广价值.

重骨颗粒对膝骨关节炎患者免疫炎症水平的影响

目的观察重骨颗粒对膝骨关节炎(knee osteoarthritis,KOA)患者临床症状及相关实验室指标的影响。方法纳入60例KOA患者并分为治疗组和对照组,每组各30例。对照组予以口服盐酸氨基葡萄糖片,治疗组在对照组基础上口服重骨颗粒,两组均治疗12周。观察治疗前后疗效性评价量表和中医症状评分的变化,检测治疗前后C反应蛋白(CRP)、血沉(ESR)、IL-6、IFN-γ、骨代谢生化指标(尿Ca、尿P、BALP、TRACP-5b、IGF-1)、基质金属蛋白酶指标(MMP-1、MMP-13)、血清OPG、RANKL水平及OPG/RANKL比值。结果两组均无脱落病例,与治疗前比较,两组治疗后临床疗效指标较前均有所改善。治疗后观察组的疗效性评价量表、中医症状评分、CRP、ESR、IL-6、IFN-γ、尿Ca、尿P、TRACP-5b、MMP-1、MMP-13、RANKL水平均显著低于对照组(P<0.05或P<0.01),BALP、IGF-1、OPG水平显著高于对照组(P<0.05或P<0.01)。观察期间两组均未见明显不良反应。结论重骨颗粒可改善KOA患者临床症状,改善炎症因子及骨代谢水平,其机制可能与影响OPG/RANKL/RANK信号通路的表达有关。

来氟米特治疗慢性肾小球疾病40例临床研究

目的:探讨来氟米特(LEF)治疗原发性肾小球疾病的疗效及副反应。方法:对原发性肾小球疾病40例采用LEF联合小剂量强的松(30mg/日)治疗,观察疗效及对肝肾功能、白细胞及临床副反应。结果:40例各型慢性肾小球疾病总完全缓解率60%,总有效率96%。其中24例初治肾病综合征完全缓解20例,完全缓解率83.3%,11例难治性肾病完全缓解3例,完全缓解率27.3%。有病理资料的10例,LEF对系膜增殖性肾炎及微小病变疗效较好。LEF治疗后肝肾功能及白细胞无明显改变,与治疗前比较,P>0.05。7例肾功能不全患者治疗后6例恢复正常。结论:LEF配合小剂量强的松治疗慢性肾小球疾病有较好疗效,对已经多种药物治疗无效的难治性肾病仍可有一定疗效,不良反应轻微,价格相对较低,可较长期服用,从而减少复发,值得临床推广应用。

沙库巴曲缬沙坦治疗临床阶段舒张性心力衰竭的临床分析

目的分析沙库巴曲缬沙坦治疗临床阶段舒张性心力衰竭的有效性及安全性。方法选取2019年6月至2020年6月在第九二八医院及海南医学院第一附属医院心内科就诊的舒张性心力衰竭患者113例,随机分为对照组57例和试验观察组56例。对照组予常规抗心衰治疗,观察组将对照组中ARB/ACEI替换为沙库巴曲缬沙坦。随访前比较两组的临床资料,随访6个月后分析两组的血压、6 min步行试验NT⁃proBNP、AST、ALT、SCr及血钾水平;并比较了两组的心超相关指标及再住院率、MACE发生率、不良反应发生率。结果治疗6个月后,观察组的6MW、NT⁃proBNP、LVEDVI、LVESVI及E/e′结果较对照组明显改善,且对肾脏的保护作用优于对照组;观察组再住院率、不良反应发生率明显低于对照组,而两组间的血压、肝功能、血钾、EF、LAVI水平及MACE发生率差异无统计学意义。结论沙库巴曲缬沙坦治疗临床阶段舒张性心力衰竭安全、有效。

小剂量^(131)I预测个体甲状腺对^(131)I敏感度的研究

目的:探讨小剂量131I预测个体甲状腺对131I敏感性有效治疗甲亢、降低甲减发生率的可行性。方法:96例甲状腺机能亢进症患者,根据患者就诊先后顺序按随机数字表分为两组进行治疗。A组48例作为对照组,采用常规131I方法治疗;B组48例采用个体剂量治疗,治疗前均行TG测定,根据甲状腺吸碘率及SPECT显像所估算甲状腺重量,按每克甲状腺组织给予小剂量(0.37MBq)131I口服,20d后复查血清TG和甲状腺吸碘率(扣除颈部本底)。结合小剂量131I口服后TG变化调整每克甲状腺组织的131I治疗剂量,定期随访。结果:131I治疗后3、6、12个月,A、B两组患者的治愈率无明显差异(χ2=1.60,χ2=0.06,χ2=3.38,P>0.05);治疗12个月后两组甲减发生率差异显著(χ2=5.03,P<0.05);B组患者中,小剂量131I口服后20d,血清TG无变化者12例,TG升高(<50%)者28例,每克甲状腺组织131I治疗剂量下调10%;TG明显升高(>50%)者8例,每克甲状腺组织131I治疗剂量下调20%。本组总体疗效无显著差异(Z=0.45,P>0.05)。结论:小剂量131I口服后测定血清TG水平变化作为个体甲状腺治疗剂量的调整依据,可达到131I治疗个体最优化剂量目的,对预防131I治疗后甲减的发生具有重要的参考价值。

颅内支架成形术安全有效

颅内动脉硬化性狭窄，是国人发生缺血性脑卒中和短暂性脑缺血发作的重要原因。据调查，在每年新发生的2005万卒中的病人中，约有24万人是颅内动脉粥样硬化狭窄所致。目前对颅内动脉狭窄尚无令人满意的治疗方法。其中颅内支架成形术是近年来开展的新技术，对其安全性和疗效性评价缺乏大样本的研究。

Value of whole body diffusion weighted imaging in diagnostic and therapeutic evaluation of malignant lymphoma

Objective:The aim was to evaluate the role of whole body diffusion weighted imaging(WB-DWI) of magnetic resonance in the diagnosis and efficacy evaluation of malignant lymphoma.Methods:The clinical manifestation of whole body diffusion weighted imaging of 47 patients with malignant lymphoma being pathologically proved were carried on by retrospective analysis and to compare with 10 healthy volunteers.There were 8 cases of Hodgkin's lymphoma(HD) patients,of which WB-DWI examination of 5 cases were carried out before and after treatment and 3 cases were done after treatment.There were 39 cases of non-Hodgkin's lymphoma(NHL) patients,of which WB-DWI examination in 19 cases were acted before treatment,11 cases were done before and after treatment and 9 cases done after treatment.In apparent diffusion coefficient(ADC) diagram the ADC values of lymph nodes in patients with malignant lymphoma and healthy volunteers were measured respectively,among 16 patients the ADC values of parts of lymph node being consistent with the initial inspection were determined again and compared the values before and after,and compared with healthy volunteers.Results:Whole body magnetic resonance diffusion weighted imaging(MR-DWI) showed more sensitive to lymphoma,and 372 lymph nodes greater than 1 cm were detected with MR-DWI.Before treatment,mean ADC value of 35 patients with malignant lymphoma was(0.86 ± 0.21) × 10-3 mm2/s,of which an average ADC values of 28 cases after treatment was(1.22 ± 0.31) × 10-3 mm2/s,before and after treatment difference of the average ADC values of patients was statistically significant(P < 0.05);the average ADC value of cervical lymph nodes of 10 healthy volunteers(1.29 ± 0.12) × 10-3 mm2/s and of 30 patients with malignant lymphoma before treatment was statistically significant(P < 0.05),and to compare with 28 patients after treatment difference of the ADC values was not statistically significant(P > 0.05).Conclusion:WB-DWI and ADC values being measured in the clinical diagnosis of malignant lymphoma,staging and evaluation of efficacy of monitoring is a fast and effective technology,with some clinical value.

Pros and Cons in Therapeutic Evaluation of Paraoxonase 1 in Nerve Agent Toxicity

PON 1 （Paraoxonase 1） has been proposed as an efficient catalytic bioscavenger to combat against OP （organophosphate） and CWNA （chemical warfare nerve agent） toxicity. Unlike stoichiometric bioscavengers such as butyrylcholinesterase, catalytic bioscavengers are cost effective with the advantage of eliminating all the OPs/CWNAs at low doses. Analysis of catalytic bioscavenger efficacy of PONI showed promising results by various group of researchers. Still, there are large numbers of grey areas which are not addressed so far. One of the major areas of interest is the pharmacokinetic analysis of infused PON 1 in multiple animal models. It is shown that previous studies in mice significantly increased half-life of PONI, while recent studies in guinea pigs from our group showed reduced half-life of PON1. Similar results were reported by other research groups in guinea pigs and non-human primates. The short half-life of exogenously administered PON1 in multiple animal models may be due to poor association of PON1 with its endogenous carrier, high density lipoprotein or lower doses of PON 1 or a reflection of species difference. These observations warrant the significance of thorough pharmacokinetic analysis of infused PON 1 and the development of alternative approaches for successful utility of PON 1 as an efficient medical countermeasure against OP/CWNA toxicity.

The value of radionuclide bone imaging on monitoring chemotherapeutic effects of multiple myeloma

Objective： To investigate the value of radionuclide whole-body bone imaging on monitoring chemotherapeutic ~ffects for multiple myeloma （MM）. Methods： Sixty patients were included. Twenty nine cases received CTD （thalidomide 100-200 rag/d; cyclophosphamide 200-300 mg/m2od, 1-4 days, every 4 weeks; and dexamethasone 20-40 rag/d, 1-4 days, every 4 weeks）; Thirty cases received VAD （vincristine 0.4 mg/d, 1-4 days, every 4 weeks; adriamycin 10 mg/d, 1-4 days, every 4 weeks; dexamethasone 40 rag/d, 1-4 days, every 4 weeks）. Radionuclide bone imagings were performed in all patients before chemotherapy, six months, twelve months and eighteen months after chemotherapy. The correlation of chemothera- peutic effects between CTD and VAD were analyzed. Results： One hundred and seventy nine bone lesions were visualized by bone scintigraphy before CTD treatment. Eighteen months after CTD chemotherapy, it was observed by bone scintigraphy that 39/179 （21.78%） lesions disappeared, 112/179 （62.57%） improved, and 281179 （15.64%） had no change. One hundred and ninety one bone lesions were showed by bone imaging before VAD treatment, 361191 （18.84%） lesions disappeared, eighteen months after chemotherapy, 103/191 （53.92%） improved, and 52/191 （27.22%） had no change. The significant dif- ference was observed in locations of MM induced bone lesions treated with CTD （H = 8.23, P 〈 0.05） and VAD （H = 11.18, P 〈 0.05）. A significant chemotherapeutic sensitivity in detecting MM induced lesions in ribs was found compared with other bone lesions. The chemotherapeutic effect of CTD was statistically significant than that of VAD （U = 2.17, P 〈 0.05）. Conclusion： Radionuclide whole-body bone imaging has great value in monitoring chemotherapeutic effects for MM.

The Potency of Sargassum dupficatum Bory Extract on Inflammatory Bowel Disease Therapy in Rattus norvegicus

Inflammatory Bowel Disease （IBD） was a chronic inflammatory disease of the digestive tract especially in small and large intestines that induced by indomethacin. Potency of ethanol and ethyl acetate extract from brown seaweed （Sargassum duplicatum Bory） against indomethacin induced jejunum damage was evaluated in Rattus norvegicus. Control rats induced by corn oil orally. IBD rats induced by indomethacin of 15 mg/kg body weight （bw） orally and incubated for 7 days. Therapy rats were treated orally by brown seaweed extract of 100 mg/kg bw respectively for seven days. Based on phytochemistry test, Sargassum duplicatum Bory extract contains flavonoids, phlorotanin, and alkaloid. The result of preparative Thin Layer Chromatography （TLC） and Infra Red （IR） spectrum of extract spots showed the same result （function group similarity） with gallic acid standard as polyphenol. Sargassum duplicatum Bory extract decreased Malondialdehid （MDA） level （54.20%） significantly using Thiobarbituric Acid （TBA） assay, repaired ZO-1 and occludin protein expressions by immunohistochemistry and repaired jejunum damage by histological observation.

Anti-Tumor Efficacy of Gene Vaccine Expressing PSMA

OBJECTIVE To observe anti-tumor effects of PVAX-PSMA gene vaccine. METHODS The PSMA gene was inserted into a mammalian expression vector, PVAX-1, to construct the DNA vaccine candidate, and was then used to vaccinate C57BL/6 mice. Animals vaccinated with PVAX-1 and NaC1 were used as controls. Anti-PSMA antibody was detected in sera of the animals. The proliferation and cytotoxicity of the spleen cells were observed. The immunized mice were inoculated with RM-1 cells. The mice were inoculated with RM-1 cells, and then the mice were immunized. The anti-tumor efficacy of the gene vaccine was evaluated by the ratio of tumor formation, tumor volume, tumor mass before and after gene vaccination and evaluated by survival rate of the immunized mice. RESULTS High level of anti-PSMA antibody was induced in the PVAX-PSMA group. The splenocytes from PVAX-PSMA group were stimulated to produce strong proliferation responses and significant cytotoxic T-cells （CTL） activity. After the mice were immunized with PVAX-PSMA gene, tumor occurrence was decreased, and the growth velocity of tumor was markedly reduced, resulting in prolonged tumor-free time （P 〈 0.05）. CONCLUSION PVAX-PSMA gene vaccine has significant anti- tumor effects and provides an experimental basis for primary prevention and immunotherapy of prostate cancer.

The clinical effect and safety evaluation of Shugan Quzhi capsule in the treatment of adult simple obesity

Shugan Quzhi capsule is a hospital preparation of Xinhua Hospital affiliated to School of Medicine, Shanghai Jiaotong University. It has been used to treat adult patients with fatty liver caused by obesity, high cholesterol and other factors. In the present study, we investigated the clinical efficacy and safety of Shugan Quzhi capsule in adult simple obesity. The patients were randomly divided into the treatment group and control group. The whole treatment lasted 2 months under the same nutritional condition and diet intervention. Body weight, body mass index, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatinine, urine and blood routine examination were recorded before and after treatment. Our data showed that the total effective rate of treatment group was 66.67%, and body weight and body mass index after treatment the body were significantly decreased （P〈0.01）. The levels of total cholesterol, triglyceride, high-density lipoprotein and low-density lipoprotein after treatment were lower than before treatment, but there was no statistical difference （P〉0.05）. The total effective rate of control group was 39.13%, and the body weight and body mass index atter treatment were also significantly lower than before （P〈0.01）. There was no significant difference between the treatment group and control group （P〉0.05）. There were no significant changes in liver function, renal function, urine routine and blood routine examination data after treatment. The results suggested that Shugan Quzhi capsule had certain therapeutic efficacy and safety in adult simple obesity.

Therapeutic evaluation of lumbar tender point deep massage for chronic non-specific low back pain

OBJECTIVE:To observe the therapeutic effect of lumbar tender point deep tissue massage plus lumbar traction on chronic non-specific low back pain using change in pressure pain threshold,muscle hardness and pain intensity as indices.METHODS:We randomly divided 64 patients into a treatment group(32 cases) and a control group(32 cases).Two drop-outs occurred in each group.Patients in the treatment group received tender point deep tissue massage plus lumbar traction and patients in the control group received lumbar traction,alone.We used a tissue hardness meter/algometer and visual analog scale(VAS) to assess the pressure pain threshold,muscle hardness and pain intensity.RESULTS:Following treatment,we obtained the following results in the treatment and control groups,respectively:the pressure pain threshold difference was 1.5±0.8 and 1.1±0.7;the muscle hardness difference was 4.2±1.6 and 3.5±1.3;and the VAS score difference was 1.9±0.9 and 1.4±0.8.Compared to the control group,the treatment group had higher pressure pain threshold(t=2.09,P<0.05),and lower muscle hardness(t=2.05,P<0.05) and pain intensity(t=2.46,P<0.05).CONCLUSION:Lumbar tender point deep tissue massage combined with lumbar traction produced better improvement in pressure pain threshold,muscle hardness and pain intensity in patients with chronic non-specific low back pain than with lumbar traction alone.

Brief introduction for application of the USA national drug code

The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.

Clinical Research Progress of Acupuncture-moxibustion for Chronic Urticaria

To learn the current research status of acupuncture-moxibustion in treating chronic urticaria, the relevant clinical reports indexed by CNKI and VlP databases during 2000 and 2012 were retrieved, and then summarized and analyzed from the aspects of treatment method, acupoint selection, medicine, treatment frequency, and criteria of therapeutic efficacy, for guiding the treatment of chronic urticaria with acupuncture-moxibustion. The results show that acupuncture-moxibustion therapy has stable therapeutic efficacy in treating chronic urticaria with low adverse reaction rate, but the current evaluation criteria are too subiective to cluantifv.

Brief introduction for application of USA authorized generic drugs

The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.