Effect and Safety of Kangfuyan Capsules () for Relieving Chronic Pelvic Pain: A Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effect and safety of Kangfuyan Capsules () for treating pelvic inflammatory disease (PID) in patients with chronic pelvic pain (CPP) in a multicenter, randomized, controlled, double-blind, parallel-group clinical trial.@*METHODS@#Totally, 240 PID patients with CPP were randomized into 2 groups using a computer generated random number at a 1:1 ratio from 10 hospitals in China between September 2014 and November 2015. Patients received either oral Kangfuyan Capsules or Gongyanping Capsules (, control); the regimen for both groups comprised 4 capsules (3 times daily) for 12 weeks, with follow-up visit 4 weeks after treatment. The visual analogue scale (VAS) scores, clinical responses, remarkable cure rates for each symptom, and quality of life scores were assessed at baseline, and after 1, 2, and 3 months. Adverse events were also recorded.@*RESULTS@#The VAS scores were significantly lower (P<0.05), whereas the clinical responses, remarkable cure rates for lower abdominal pain, uterine tenderness, adnexal mass, and adnexal tenderness, and Health-related quality of life (EQ-5D) scores were higher in the Kangfuyan group than in the control group at 3 months (P<0.05). Common treatment-related adverse events included high hepatic enzyme levels, reduced hemoglobin levels, and elevated platelet counts, although all the adverse events were either mild or moderate in severity.@*CONCLUSION@#Compared with Gongyanping therapy, Kangfuyan therapy yielded markedly better analgesia effects for CPP caused by PID, with obvious long-term efficacy and good safety. (Registration No. ChiCTR190022732).

A multicenter, large-sample, randomized clinical trial on improving the median survival time of advanced non-small cell lung cancer by combination of Ginseng Rg3 and chemotherapy / 中华肿瘤杂志

Objective@#To observe the efficacy of the combination of chemotherapy and Ginseng Rg3 on advanced non-small cell lung cancer(NSCLC).@*Methods@#In the multi-center, large-sample, randomized, double blind trial, 414 patients with Ⅲ-Ⅳ NSCLC were enrolled.199 were in the experimental group and 215 the control group. The patients in the experimental group were treated with the standard first-line chemotherapy combined with Ginseng Rg3. The patients in the control group were treated with the same chemotherapy combined with placebo. Median overall survival (OS), Karnofsky performance scale (KPS), Traditional Chinese Medicine (TCM) symptoms score and side effects of two groups were observed as main indexes.@*Results@#The median OS were 12.03 months in the experimental group, which was significantly better than that in the control group (8.46 months, P<0.05). Hemoglobin and white blood cells were decreased after the first and second cycle of treatment in both groups. Both adverse events were significantly milder in the treatment group (P<0.05). In addition, after two courses of treatment, the KPS of patients was 78.95±9.14 in the experimental group and 76.77±9.15 in the control group, while the TCM symptoms score was 2.45±1.73 in the experimental group and 2.92±2.06 in the control group, with significant difference (P<0.05).@*Conclusions@#Combination of TCM with Western medicine such as chemotherapy could prolong the survival of patients with advanced NSCLC. The combined therapy improved patients′ symptoms and reduced chemotherapy induced myelosuppression.

Clinical Study on Treatment of Non-motor Symptoms of Parkinson Disease by Zishen Pingchan Granules / 中国中医药信息杂志

Objective To observe the clinical efficacy of Zishen Pingchan Granules in treating non-motor symptoms (NMS) of Parkinson disease (PD). Methods A randomized, double-blind, placebo-controlled trial was used. 124 patients with PD were randomly divided into the treatment group (n=62) and the control group (n=62). Patients not yet taking Western medicine were suspended the application of Western medicine, receiving direct TCM treatment. Patients who had already taken Western medicine were added TCM on the basis of original medicine dosage and method. The treatment group was given Zishen Pingchan Granules, while the control group was treated with placebo granule, once a bag, twice a day. The treatment lasted for 12 weeks. The clinical efficacy was assessed by using unified PD rating scale (UPDRSⅡ–Ⅲ), the scale for outcomes in PD for autonomic symptoms (SCOPA-AUT), Parkinson disease sleep scale (PDSS) and dosage of levodopa. Results The UPDRSⅡ and UPDRS Ⅲscores of the treatment group and the control group after 4, 8, and 12 week of treatment had no difference at each time point compared with before treatment (P>0.05). There was no statistical significance in scores of UPDRSⅡ and UPDRSⅢ after treatment (P>0.05). Efficacy of SCOPA-AUT in treatment group after treatment was significantly better than the control group; There was statistical significance in constipation, salivation, nocturia and sweating in SCOPA-AUT between the two groups after treatment (P<0.05). Compared with before treatment, PDSS scores in treatment group after 8 and 12 weeks of treatment increased significantly (P<0.05). After 4, 8, and 12 weeks of treatment, PDSS scores in treatment group were much higher than control group (P<0.01). By comparing PDSS score in the two groups before and after treatment, it showed that treatment group had better efficacy in extending the time to sleep, reducing nocturia, nightmares, and hallucinations (P<0.05). After 12 weeks of treatment, dosage of levodopa in control group increased significantly, which treatment group was much lower than the control group (P<0.05). Conclusion Zishen Pingchan Granules can improve the autonomic dysfunctionin and sleep quality of PD patients, and can significantly reduce the dosage of levodopa.

Anestesia local no reparo do trauma perineal no parto normal: estudo comparativo da eficácia da solução anestésica com e sem vasoconstritor / Local anesthesia in the repair of perineal trauma in vaginal delivery: comparative study of the efficacy of anesthetic solution with and without vasoconstrictor

|a No parto normal, o trauma provocado por episiotomia ou roturas, é frequente e a anestesia local é bastante utilizada no reparo das lesões da região vulvoperineal. Na literatura especializada, os estudos sobre as soluções anestésicas mais adequadas são escassos para essa anestesia. No entanto existem recomendações para a adoção de anestésicos com vasoconstritor pela permanência mais prolongada da solução anestésica no local, garantindo maior ação e redução da concentração plasmática da droga, mas na prática seu uso é restrito. O objetivo do estudo foi comparar a quantidade de anestésico necessária para inibir a dor durante a sutura do trauma perineal, em mulheres com episiotomia ou laceração espontânea de primeiro ou segundo graus, conforme o uso ou não de vasoconstritor na solução anestésica. Trata-se de uma pesquisa aleatorizada e controlada com mascaramento duplo, realizada no Centro de Parto Normal do Amparo Maternal na cidade de São Paulo. Foram incluídas 96 parturientes, alocadas em três blocos - laceração de primeiro grau, laceração de segundo grau e episiotomia. Em cada bloco, constituído por 32 mulheres, 16 receberam solução anestésica com vasoconstritor e 16 sem vasoconstritor. Os resultados mostraram que, na laceração de primeiro grau, a média de anestésico com vasoconstritor apresentou diferença estatisticamente significante (p=0,002), com 1,0 ml (I.C. -1,6; -0,4) menos que a média do anestésico sem vasoconstritor; em 95% dos casos, foram usados de 1 a 2 ml de solução com vasoconstritor, e em 87,5% dos casos para o anestésico sem vasoconstritor, o volume usado variou de 2 a 4 ml. Para a laceração de segundo grau, a média do anestésico com vasoconstritor foi 3,7 ml (I.C. -5,8; -1,6) menos que a média do anestésico sem vasoconstritor, sendo estatisticamente significante (p=0,001); em 87,5% dos casos, a quantidade máxima de anestésico com vasoconstritor administrada foi 6 ml, e 81,3% das mulheres ) que receberam anestésico sem vasoconstritor, a dose administrada foi de 7 ml ou mais. Considerando a extensão da laceração, adotou-se o tamanho da episiotomia praticada nas mulheres do estudo, como parâmetro para classificar a extensão da laceração. Foram agrupadas como pequenas as lacerações de menor extensão, como médias aquelas com tamanho semelhante à episiotomia e como grandes aquelas cuja extensão superou o tamanho da episiotomia. Para a episiotomia, a média de anestésico com vasoconstritor foi 0,3 ml (I.C. -2,1; 1,5) a menos que a média do anestésico sem vasoconstritor, considerada sem significância estatística (p=0,724). Os resultados permitiram confirmar a hipótese de que uso de anestésico com vasoconstritor na anestesia local para a sutura de lacerações perineais no parto normal aumenta a eficácia da anestesia local. Embora o volume de anestésico utilizado na sutura de laceração de primeiro e segundo graus seja significativamente reduzido pela associação com vasoconstritor, a relevância clínica

The perineal trauma, caused by episiotomy or ruptures, is quite frequent during the spontaneous delivery, being the local anesthesia widely utilized when repairing lesions in the vulvo-perineal region. Throughout the specialized literature, scarce are the studies on the most suitable anesthetic solutions for this kind of anesthesia. Even though there are recommendations for the adoption of the anesthetic with vasoconstrictor, because of the prolonged permanence of the anesthetic solution in the region, thus ensuring a bigger time of action, and because of the reduction in the plasmatic concentration of the drug, its utilization in practice is restricted. The goal of the study was to compare the necessary quantity of anesthetic to inhibit pain during the suture of the perineal trauma in women with an episiotomy or with first or second degree spontaneous lacerations, according to the use or not of vasoconstrictor in the anesthetic solution. This is a randomized and controlled research, with double blind trial, performed in the Birth Centre at Amparo Maternal, in the city of Sao Paulo. There were 96 parturients included in the study and then divided into three blocks: first degree laceration, second degree laceration and episiotomy. In each block, constituted of 32 women, 16 women were administered the anesthetic solution with vasoconstrictor and 16 with no vasoconstrictor. Results show that in the first degree laceration block the average of anesthetic with vasoconstrictor presented a statistically significant difference (p=0,002), with 1,0 ml (C.I. -1,6; -0,4) less than the average of the anesthetic without vasoconstrictor; in 95% of the cases, 1 to 2 ml of the solution with vasoconstrictor was utilized, while in 87,5% of the cases, the anesthetic without vasoconstrictor varied from 2 to 4 ml. In the second degree laceration block, the average of anesthetic solution with vasoconstrictor was 3,7 ml (C.I. -5,8; -1,6) less than the average of the anesthetic without vasoconstrictor, being statistically significant (p=0,001); in 87,5% of the cases, the maximum quantity of anesthetic with vasoconstrictor administered was 6 ml, while in 81,3% of the cases, women who were given the anesthetic without vasoconstrictor, received 7 ml or more. Considering the extent of the laceration, the size of the episiotomy practiced on the women of the study was adopted as a parameter to classify the extent of the laceration. The lacerations of a smaller extent were grouped as small-sized, the ones in which the size was similar to the size of the episiotomy were grouped as medium-sized, and as large-sized the ones that oversized the episiotomy. For the episiotomy, the average of anesthetic with vasoconstrictor was 0,3 ml (C.I. -2,1; 1,5) less than the average of the anesthetic without vasoconstrictor, with no statistic significance (p=0,724). Results allow us to confirm the hypothesis that the utilization of the anesthetic

Acute subcutaneous toxicity study of Hirudinaria manillensis (Lesson) LEECH homogenate in mice

Background: The vosoactive effects of proteins isolated from leech saliva and leech homogenate have been the focus of many recent studies because of its therapeutic potential. Possible nonlethal and lethal toxic effects have to be determined before any therapeutic effects could be tested. The general objective is to take the first step in drug design by performing an acute toxicity studyMethods: In this randomized, double-blind trial, Swiss mice were administered subcutaneously with varying doses of leech Hirudinaria manillensis (Lesson) homogenate and observed for possible acute toxicity. Toxidromes appearing within the two-week period after the administration of the substance were noted. Necropsy was performed on all the mice subjects. The LD(50) was computed using the log dose-response probit analysis. The doses (in g/kg body weight) were 3.54, 5.0 and 7.06Results: The LD(50) at Day 2 of Hirudinaria manillensis extract was 4.6124 g/kg body weight. The LD(50) at Day 14 was not obtained, because the test animals incurred mortalities beyond Day 2, which could be explained by a delayed toxicity of the test substance. Mice injected with 7.06 g/kg showed the most number of observable toxidromes, involving several organ systems, which generally had an early onset and persisted until the time of death of the mice. Mice treated with 3.54 g/kg showed toxidromes with early onset time, but they were not as consistent as the highest dose and the effects were generally not long-lasting. Motor activity was the most affected among the toxidromes. Gross pathologic findings revealed that the intestine, liver, heart, stomach, lungs and kidney are the commonly affected organs, which had marked changes in all dose groupsConclusions: The crude H. manillensis leech extract caused toxicity in mice, with toxidromes involving mainly the nervous system, specifically the somatosensory and neuromuscular systems. The LD(50) could not be determined in this study. However, using the data at Day 2, LD(50) was 4.6124 g/kg body weight. The LOAEL could be less than or equal to 3.54 g/kg body weight. No observable adverse effect level could not be determined. (Author)

Treatment of recurrent aphthous ulcer with amlexanox paste / 实用口腔医学杂志

0.05), on the 4th day 7.56?6.87 and 10.00?7.07 (P0.05). After therapy all the data of electrocardiogram, blood routine examination and blood biochemical test of the cases were without clinical significance. Conclusion:50 g/L amlexanox is effective and safe in the treatment of RAU.

Clinical Study on Amlexanox Oral Coating for Treatment of Minor Recurrent Aphthous Ulcer / 中国药房

OBJECTIVE:To study the effects and security of amlexanox oral coating for treatment of minor recurrent aphthous ulcer(MIAU). METHODS:A randomized double-blind experiment was carried on 42 patients with MIAU were randomly divided into experimental group(20 patients),and control group(22 patients),each group respectively administered with amlexanox coating and placebo,at the lesion site 4 times a day for 5 days.RESULTS:At 3 days,the effective rates of healing in the experimental and control group were 85.0% and 36.4%,respectively(P