Investigation and suggestions on the smoothness of reporting channels for adverse drug reaction of pharmaceutical manufacturers in China based on the public perspective / 中国药房

OBJECTIVE To provide the suggestions for improving t he enthusiasm of the public to report adverse drug reactions （ADRs），promoting pharmaceutical manufacturers to improve the smoothness of ADR reporting channels by the public and the enthusiasm of assuming the main responsibility for drug safety ，and to provide reference for the performance of drug safety supervision by regulatory departments in China. METHODS Taking 180 pharmaceutical manufacturers that had entered the top 1 000 in the world as the objects ，the questionnaire was prepared to investigate the smoothness of ADR reporting channels through 4 channels：contact number ，e-mail，official website and new media （including Wechat and microblog ） of enterprise . The questionnaire involved the establishment of public reporting channels ，the records and the feedback of enterprises. The existing problems were analyzed and suggestions were put forward. RESULTS & CONCLUSIONS More than 70％ of pharmaceutical manufacturers in China had established the channels for reporting ADR by the public ，which were mainly regular channels such as contact numbers and e-mail ，and each channel had the phenomenon that ADR information couldn ’t be reported. More than 60％ of the public channels established by manufactures lacked inquiry and supplement for the miss ing part of th e reported information ； only 24 pharmaceutical manufacturers provided feedback on ADR information ，and the feedback contents were monotonous. gywf2021-11It is suggested that pharmaceutical manufacturers should pay more attention to ADR monitoring among the public ，consider increasing multiple reporting channels while ensuring the smoothness of channels ，strengthen the training of employee ’s information collection ability to improve the quality of information ，timely feed back the ADR information reported by the public ， and increase the feedback content concerned by the public.

Efecto de Diferentes Técnicas de Acabado y Pulido Sobre la Rugosidad de un Composite de Nanoparticulas / Effect of Different Finishing and Polishing Techniques on the Roughness of a Nanoparticle Composite

El objetivo fue comparar la rugosidad de un composite nanoparticulado con diferentes técnicas de acabado y pulido. Se obtuvieron 20 discos en conformadores ad-hoc en los que se insertó un composite nanoparticulado en capas de 2mm. Se activó cada incremento durante 30s con una intensidad de 1450 mw/cm2. Todas las probetas se pulieron con la secuencia completa de discos Sof-lex a velocidad media y luego se asignaron a uno de 4 grupos (n=5) tratados de la siguiente manera: G1: sin tratamiento extra; G2: con cepillos Astrobrush y JC-SICRA-G; G3: con pasta de diamantes Diamond Gloss aplicada con fieltro; y pasta de óxido de aluminio Poligloss y fieltro; G4: igual que G3 + cepillos (igual que G2). Las superficies se evaluaron con un perfilómetro óptico tridimensional. Se registró la rugosidad promedio (Ra) en tres puntos de cada espécimen, se consideró la Ra a la media de los tres registros obtenidos. Los datos se analizaron mediante ANOVA de una vía y prueba de Tukey para comparaciones múltiples. Los resultados obtenidos fueron: G1: 132,20nm (26,16); G2: 77,20 nm (20,64); G3: 78,74 nm (10,04); G4: 66,47nm (31,08). Se encontró diferencia estadísticamente significativa entre los grupos (P=0.0017); de las comparaciones múltiples surge que G1 presentó una rugosidad media significativamente mayor que los restantes. G1>G2 (P<0.01), G1>G3 (P<0,05), G1>G4 (P<0,01). En conclusión, el uso de sistemas anexos de pulido permite lograr mayor lisura superficial. El uso de más de un sistema complementario no mejora el resultado (AU)

Segmental resection combined with anoplasty for the treatment of circumferential mixed hemorrhoids

Circumferential mixed hemorrhoids are very difficult to treat non-surgically. Therefore, it is important to explore the surgical methods for its complete resolution as well as maintenance of normal anal anatomy and function. The present study was designed to evaluate the effect of segmented and plastic hemorrhoidectomy (SPH) on patients with circumferential mixed hemorrhoids. A total of 300 patients with circumferential mixed hemorrhoids were divided into experimental group (n=150) undergoing SPH and control group (n=150) undergoing Milligan-Morgan hemorrhoidectomy. There were no differences in cure and effectiveness rates between two groups. Compared with the control group, patients in the experimental group had shorter healing time (15.7±1.3 vs 12.5±0.7 days) and recovery to normal activity (18.5±2.7 vs 14.7±1.2 days). In addition, anal function of all patients in the experimental group was normal during short- and long-term follow-up. However, more cases in the control group showed anal dampness and itching, and poor control of intestinal liquid. Compared with the control group, patients in the experimental group had better outcomes in overall anal function and smoothness at 6, 12, and 18 months after operation as well as patient satisfaction. Furthermore, the rating in the visual analogue scale for defecation pain and edema in the experimental group was less than that in the control group. SPH was more effective, had fewer complications, better protection of anal function, and a better cosmetic result.

Segmentación automática del movimiento en la valoración funcional del miembro superior en niños con parálisis cerebral / Automatic movement segmentation in the upper limb functional assessment of children with cerebral palsy

Resumen: La Parálisis Cerebral (PC) es un grupo de trastornos pre, post y perinatales permanentes del desarrollo, movimiento y postura debidos a alteraciones no progresivas ocurridas durante el desarrollo cerebral, producto de lesiones del Sistema Nervioso Central. Debido a la importancia del uso del miembro superior en las actividades de la vida diaria, es importante considerar formas eficientes de medir el desempeño motor de este miembro en los pacientes con PC. Una forma de obtener la evaluación del miembro torácico es grabando movimientos definidos y calculando la suavidad de los mismos, utilizando un tablero seleccionador de figuras instrumentado. Nuestro objetivo es desarrollar un protocolo de valoración para el miembro superior, que a su vez sea objetivo, eficiente y que otorgue una medición cuantitativa del grado de afectación motora de los niños con PC en un entorno clínico.

Abstract: Cerebral Palsy (CP) is a group of permanent pre, post and perinatal disorders of the motor and posture development due to non-progressive alterations in brain's natural development caused by injuries in the Central Nervous System. Due to the importance of the daily use of the upper limb members, it's important to consider more efficient ways to evaluate the performance in patients diagnosed with CP. One way to obtain an evaluation of the performance of the thoracic member is recording defined movements and calculating the smoothness, using an instrumented sorting block box. Our objective is to create a protocol of valuation for the upper member that is objective, efficient and that gives a quantitative feedback of the grade of the motor affectation of child with PC in a clinical environment.

The efficacy of Nebivolol on patient with mild or moderate mssential hypertension by different smbulatory blood pressure monitoring methods / 中国综合临床

Objective To evaluate the efficacy of Nebivolol on patients with mild or moderate essential hypertension(EH) using different methods of ambulatory blood pressure monitoring.Methods Forty-seven patients with mild or moderate EH were enrolled as our subjects after a 2-week administration of placebo.They were administrated Nebivolol (5 mg) once daily for 12 weeks.All the patients completed ambulatory blood pressure monitoring before and after taking Nebivolol for 12 weeks.The overall and individual methods were used to calculate the trough-to-peak ratio (T/P ratio) and smooth index (SI).Results (1) For all of 42 patients treated with Nebivolol (5 mg) for 12 weeks,the systolic blood pressure(SBP),diastolic blood pressure(DBP) of the whole-day,daytime and nighttime after treatment were decreased compared to before treatment (the whole day:(144.1 ± 9.8),(124.4 ± 10.4) mmHg vs.(93.2 ± 6.3),(79.2 ± 7.2) mmHg;daytime:(148.9 ± 9.7),(128.3 ± 10.5) mmHg vs.(96.8 ±6.1),(82.2 ±7.5) mmHg;nighttime:(133.9 ± 11.9),(115.9 ± 12.0) mmHg vs.(85.7 ± 8.0),(72.5 ± 7.5) mmHg),and there was significant difference (t =8.06,8.74,8.00,8.82,5.75,and 6.57 respectively; P ＜ 0.01).T/P ratios of SBP/DBP calculated by overall method were 78.4％ (17.4/22.2) and 61.2％ (9.0/14.7),but it were (79.3 ±0.4) ％ and (58.5 ±0.5) ％ by individual calculation method.(2) Among 30 patients with better effect,the SBP,DBP of the whole-day,daytime and nighttime after treatment were decreased compared to before treatment (the whole day:(143.4 ± 9.1),(127.5 ±10.7) mmHgvs.(92.6 ±6.2),(81.6±7.6) mmHg;daytime:(147.8 ±9.1),(131.0 ±10.5)mmHg vs.(95.8 ± 6.4),(84.1 ± 7.5) mmHg; nighttime:(134.7 ± 11.6),(119.6 ± 13.2) mmHg vs.(86.2 ± 7.4),(75.2 ± 8.5) mmHg),and there was significant difference(t =11.18,12.77,11.14,12.85,7.37,and 8.74 respectively,P ＜0.01).T/P ratios of SBP/DBP were 78.9％ (18.3/23.2),75.3％ (11.6/15.4) and SIof SBP/DBP were 7.4(19.5/2.6),7.1 (14.2/2.0) calculated by overall method,but T/P ratios of SBP/DBPwere (78.4 ± 0.4) ％,(74.6 ± 0.4) ％ and SI were (1.35 ± 0.73),(1.34 ± 0.54) calculated by individualmethod.Conclusion Nebivolol (5 mg once daily) can significantly reduce ambulatory blood pressure.Overall calculation method is better than individual method in terms of assessing the time of durative action and smooth effect by trough peak ratio and smooth index.

Evaluation of the effects of nifedipine GITS on the blood pressure parameters in subacute cerebral infarction with essential hypertension by ambulatory blood pressure monitoring / 中国综合临床

Objective To study the antihypertensive efficacy and influence on the blood pressure parameters of nifedipine GITS therapy in patients with subacute cerebral infarction with essential hypertension by ambulatory blood pressure monitoring (ABPM).Methods Fifty-one cases of subacute cerebral infarction with essential hypertension were treated with nifedipine GITS for 14 days.ABPM were performed in all cases before and after treatment.The blood pressure parameters of blood pressure variability (BPV),morning blood pressure surge(MBPS),Trough/Peak(T/P),and smoothness index(SI) were analyzed.Results (1) After treatment with nifedipine GITS 30 mg/d for two weeks,the average 24-hour systolic blood pressure (SBP),day-time systolic blood pressure (dSBP),night-time systolic blood pressure (nSBP),24-hour diastolic blood pressure (DBP),day-time diastolic blood pressure (dDBP),night-time diastolic blood pressure (nDBP) significantly decreased((144.70 ± 14.89) mm Hg vs (163.10 ± 16.48) mm Hg,(145.67 ± 15.20) mm Hg vs (164.55 ±16.81) mm Hg,(140.85 ± 19.46) mm Hg vs (156.73 ±20.55) mm Hg,(81.24 ±8.88) mm Hg vs(89.49 ± 10.06) mm Hg,(81.25 ±9.40) mm Hg vs (90.18 ± 10.64) mm Hg,(81.34 ± 12.10) mm Hg vs (86.28 ±12.11) mmHg;t=11.01,11.53,5.29,8.71,7.53,2.31;P＜0.05)).(2) Defining the standard deviation(SD) of average blood pressure as the indexes of BPV,the blood pressure variability of systolic blood pressure(SBPV),day-time systolic blood pressure variability (dSBPV),night-time systolic blood pressure (nSBPV) decreased significantly ((16.52 ± 4.38) mm Hg vs (19.78 ± 6.72) mm Hg,(15.45 ± 4.71)mm Hg vs (17.88 ± 7.25)mm Hg,(14.94 ± 5.89) mm Hg vs (19.17 ± 8.27) mm Hg; t =3.38,2.19,2.99 ;P ＜0.05)) and the diastolic blood pressure didn't change.(3) There was negative correlation between smoothness index (SI) and BPV (r =-0.28 ; P ＜ 0.05).(4) The decreases of morning blood pressure surge (MBPS) of SBP was more significant after treatment ((22.65 ± 12.77) mm Hg) than that before treatment ((31.94 ±16.36) mm Hg).(5) The median of T/P ratio calculated by group methods was 0.721 for SBP and 0.676 for DBP,and it was 0.588 ± 0.360 for SBP and 0.628 ± 0.433 for DBP calculated by individual method.The medians of T/P ratio were above 0.5 by both methods.Conclusion It is of great significance to effectively control blood pressure and BPV in patients with stroke.Nifedipine GITS can constantly release medicine;it can lower the blood pressure,and significantly reduce BPV and MBPS.

Polishing of The Composite Resin restorations-Literature Review

The widespread use of aesthetic fillings has highlighted their advantages and disadvantages. One of the most troublesome features of earlier aesthetic materials was the difficulty of finishing the restoration surface to decrease adherence of food debris. The rougher the finished surface, the greater the possibility of bacterial accumulation and discolouration of restoration along the restoration margin with secondary caries formation. Aside from these clinical implications, patients are highly discerning and could detect roughness of 0.30 μm with their tongue. The aesthetic restoration should mimic the appearance of natural dentition and should have an enamel-like appearance. An increased demand for superior aesthetics from composite resin has increased the demand for more eff icient and simple polishing techniques. The development of nanocomposites has given a new perspective to the polishing of composite resins. Nanocomposites claim the advantage of improved gloss, optical characteristics and reduced wear. To date, results of in vitro studies have been equivocal regarding the most efficient and effective polishing system. There is variation in the effects of different finishing and polishing instruments on the surface roughness due to great diversity in size, shape, composition and distribution of the filler particles of composite resins, type of resin and a wide variety of finishing and polishing instruments. This paper will review the different factors that affect polishing techniques used in achieving the desired polish on composite resin restorations.

Study of T/P rate and smoothness index of candesartan cliexetil on essential hypertension / 中国基层医药

Objective To study the T/P rate and smoothness index of Candesartan Cliexetil on slight and middle essential hypertension. Methods 50 patients with slight and middle essential hypertension were treated by Candesartan Cliexetil 8mg taken orally everyday,the course of treatment was 4 weeks. 24h ambulatory blood pressure monitoring(ABPM) was given before and after treatment, the T/P rate and smoothness index were calculated. Results Four weeks after treatment, 24h SBP(148.2±10.7) mm Hg and 24 h D BP (97.6±6.5) mm Hg, dSBP(152.5±9.8) mm Hg and dDBP(96.0±5.3) mm Hg, nSBP(138.3±7.6) mm Hg and nDBP(89.2±8.3) mm Hg, SBP load (87.5±12.2) % and DBP load (36.48±26.4) % with pre-treatment (130.2±7.2) mm Hg, (79.5±7.8) mm Hg, (133.4±7.2)mm Hg, (81.8±6.6)mm Hg,(121.9±7.3) mm Hg, (72.1±7.4) mm Hg, (84.7±9.9)%,(26.7 ±8.3) % have significant difference(P < 0.01). T/P rates were SBP 70% and DBP 63%. Smoothness indexes were SBP(1.21±0.82) and DBP(1.13±0.51). Conclusion Candesartan cilexetil in the treatment of essential hyper-tension is safe and effective,can get a good T/P ratio and smoothness index.

Clinical study on antihypertensive effect trough to peak ratio of nifedipine GITS / 中国临床药理学与治疗学

Aim To explore the best way of calculating antihypertensive effect of nifedipine GITS on trough to peak ratio (T/PR), and smoothness index (SI) of the drug from ambulatory blood pressure monitoring (ABPM). Methods 32 cases of mild to moderate essential hypertension patients were enrolled and each was given 30 mg of nifedipine GITS once daily. ABPM was repeated for four weeks. ABPM data were analyzed statistically and T/PR calculated by both individual and whole group way. Results The casual blood pressure(CBP) and ABP were lowered by (24?12)/(12?8) mmHg and ( 14.5 ? 3.9 )/( 11.2 ? 3.0) mmHg .The T/PR by individual way was 0.65 ? 0.23 for SBP and 0.66 ? 0.25 for DBP, while by whole group way 0.62 for SBP and 0.68 for DBP. The smoothness index (SI), a new method for assessing the homogeneity of 24 hour blood pressure reduction by antihypertensive therapy, was 3.74 for SBP and 3.77 for DBP after treatment. Conclusion Nifedipine GITS lowers blood pressure effectively and smoothly for 24 hours long. Antihypertensive effects can be reflected by T/PR and SI.

THE AMOUT OF LOSS AND THE DEGREE OF SURFACE SMOOTHNESS OF GOLD ALLOY BY GOLD ALLOY POLISHING RUBBER POINT MATERIALS / 대한치과보철학회지

After clinical adjustment of dental casting restoration, re-polishing procedure is recommanded because the smooth gold sureface is lost. But there is the possibility to get more loose contact than that intended by loss of gold alloy according to the kinds of polishing materials and polishing time. Therefore in this study I polished type II gold alloy with 390gm force, 20,000rpm speed, and 8 kinds of gold alloy polishing materials, fabricated by 4 companies and then measured the amount of loss of gold alloy with Surfcorder SEF30D and observed alloy surfaces polished by 3 brown rubber points with SEM. The amount of loss of gold alloys polished with 8 kinds of polishing materials and the degree of smoothness of gold alloys according to polishing time and polishing materials were compared. The following results were obtained : 1. When the amount of loss of gold alloys polished with 3 kinds of brown rubber point was compared, Alphalex brown point had the most amount of alloy loss, followed in decreasing order by Shofu brown point and Eveflex brown point. There was statistically significant difference in the amount of alloy loss according to polishing materials. 2. When the amount of loss of gold alloys polished with 5 kinds of green rubber point was compared, Shofu green point had the most amount of alloy loss, followed in decreasing order by Alphaflex green point, Dedeco green clasp polisher, and Eveflex green point. There was statistically significant difference in the amount of alloy loss according to polishing materials except Alphaflex green point and Dedeco green clasp polisher. 3. When the amount of loss of gold alloys polished with all kinds of rubber point was compared, there was no significant difference in Eveflex brown point, Alphaflex green point, and Dedeco green claps polisher. 4. When average amount of alloy loss per 1 revolution by polishing materials was compared, Alphalex brown point had the greatest value as 0.329micrometer and Shofu supergreen point had the lowest value as 0.022micrometer. 5. When the degree of sureface smoothness of gold alloy polished with 3 kinds of brown rubber point was compared, in Alphalex brown point surface roughness was completely lost after 20 seconds polishing time, in Shofu brown point 30 seconds, in Eveflex brown point 40 seconds. But in every gold alloys fine scratch formed by rubber points was observed. Based on the results of this study, as rubber polishing materials used in polishing of dental casting restoration after clinical adjustment influenced on the tightness of occlusal or proximal contact, we should make dental casting restoration with minimum error through careful laboratory procedure and form very smooth surface of restoration with tripoli and rouge after use of silicone polishing materials.

THE AMOUT OF LOSS AND THE DEGREE OF SURFACE SMOOTHNESS OF GOLD ALLOY BY GOLD ALLOY POLISHING RUBBER POINT MATERIALS / 대한치과보철학회지

After clinical adjustment of dental casting restoration, re-polishing procedure is recommanded because the smooth gold sureface is lost. But there is the possibility to get more loose contact than that intended by loss of gold alloy according to the kinds of polishing materials and polishing time. Therefore in this study I polished type II gold alloy with 390gm force, 20,000rpm speed, and 8 kinds of gold alloy polishing materials, fabricated by 4 companies and then measured the amount of loss of gold alloy with Surfcorder SEF30D and observed alloy surfaces polished by 3 brown rubber points with SEM. The amount of loss of gold alloys polished with 8 kinds of polishing materials and the degree of smoothness of gold alloys according to polishing time and polishing materials were compared. The following results were obtained : 1. When the amount of loss of gold alloys polished with 3 kinds of brown rubber point was compared, Alphalex brown point had the most amount of alloy loss, followed in decreasing order by Shofu brown point and Eveflex brown point. There was statistically significant difference in the amount of alloy loss according to polishing materials. 2. When the amount of loss of gold alloys polished with 5 kinds of green rubber point was compared, Shofu green point had the most amount of alloy loss, followed in decreasing order by Alphaflex green point, Dedeco green clasp polisher, and Eveflex green point. There was statistically significant difference in the amount of alloy loss according to polishing materials except Alphaflex green point and Dedeco green clasp polisher. 3. When the amount of loss of gold alloys polished with all kinds of rubber point was compared, there was no significant difference in Eveflex brown point, Alphaflex green point, and Dedeco green claps polisher. 4. When average amount of alloy loss per 1 revolution by polishing materials was compared, Alphalex brown point had the greatest value as 0.329micrometer and Shofu supergreen point had the lowest value as 0.022micrometer. 5. When the degree of sureface smoothness of gold alloy polished with 3 kinds of brown rubber point was compared, in Alphalex brown point surface roughness was completely lost after 20 seconds polishing time, in Shofu brown point 30 seconds, in Eveflex brown point 40 seconds. But in every gold alloys fine scratch formed by rubber points was observed. Based on the results of this study, as rubber polishing materials used in polishing of dental casting restoration after clinical adjustment influenced on the tightness of occlusal or proximal contact, we should make dental casting restoration with minimum error through careful laboratory procedure and form very smooth surface of restoration with tripoli and rouge after use of silicone polishing materials.