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Objective: Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings. Methods: Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results: A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics. Conclusions: Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.

Objective: Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect. Methods: Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results: Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap. Conclusion: Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.

Occurrence and methods for the removal of nonylphenolic compounds in drinking water have been gaining increased attention due to their widespread presence in natural water and the potential health risks from the consumptions of drinking water. The purpose of this study was to assess the occurrence of nonylphenol (NP), octylphenol (OP), and bisphenol-A (BPA) in water sources and treated water in Taiwan, to evaluate the treatment efficiencies of these compounds in both the conventional (coagulation, sedimentation, filtration and chlorination) and advanced treatment processes. The treatment efficiencies of these chemicals were assessed based on their concentrations in water sources, and the results were verified with laboratory simulated treatment processes. A survey of NP, OP, and BPA in 11 Taiwanese water sources showed that all of them could be identified in most of the sampled sources, and that higher concentrations of NP were found when the raw water was contaminated by domestic wastewater. However, higher treatment efficiency could be observed when the NP concentration in water source is high. Laboratory simulation studies of conventional treatment processes showed that chlorination played an important role in the degradation of NP in raw water. Treatment efficiencies of 60%-90% were achieved for NP removal when sufficient chlorine dosages were applied to satisfy chlorine demands. However, results also showed that conventional coagulation and rapid filtration processes were less effective in the reduction of phenolic compounds in water., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Objective: To investigate the function of the auditory efferent system in patients with chronic idiopathic tinnitus, but normal pure-tone audiograms., Methods: We studied 15 subjects with normal hearing that had experienced either unilateral or bilateral persistent tinnitus for at least 3 months. The ears of the 15 subjects were classified into tinnitus-positive-ear (TPE) and tinnitus-negative-ear (TNE) groups. The control-ear group (CE) comprised the ears of 15 subjects with normal hearing and no tinnitus. We measured different types of otoacoustic emissions (OAEs), including spontaneous (SOAEs), transient evoked (TEOAEs), and distortion product (DPOAEs). We also analyzed contralateral suppression of OAEs and auditory brainstem responses (ABRs). Data were compared among TPE, TNE, and CE groups., Results: The data associated with cochlear mechanics, including the prevalence of SOAEs, the number of SOAE peaks, and the overall TEOAE responses in the absence of a contralateral stimulus, were not significantly different among the TPE, TNE, and CE groups. In the TPE group, contralateral stimuli failed to significantly suppress overall TEOAEs, and contralateral suppression of DPOAEs was significantly reduced over a limited frequency range. Furthermore, the TPE group showed prolonged latencies in waves III and V of ABRs., Conclusion: This study demonstrated that abnormal contralateral suppression of OAEs and ABRs indicated a dysfunction in the ipsilateral efferent medial olivocochlear system; this might play a role in normal-hearing tinnitus.

Background: Perioperative use of dexmedetomidine is associated with reduction in postoperative analgesic requirements. This study examined whether dexmedetomidine added to i.v. patient-controlled analgesia (PCA) morphine could improve analgesia while reducing opioid-related side-effects., Methods: In this double-blinded, randomized, controlled study, 100 women undergoing abdominal total hysterectomy were allocated to receive either morphine 1 mg ml(-1) alone (Group M) or morphine 1 mg ml(-1) plus dexmedetomidine 5 microg ml(-1) (Group D) for postoperative i.v. PCA, which was programmed to deliver 1 ml per demand with a 5 min lockout interval and no background infusion. Cumulative PCA requirements, pain intensities, cardiovascular and respiratory variables, and PCA-related adverse events were recorded for 24 h after operation., Results: Compared with Group M, patients in Group D required 29% less morphine during the 0-24 h postoperative period and reported significantly lower pain levels from the second postoperative hour onwards and throughout the study. Whereas levels of sedation were similar between the groups at each observational time point, decreases in heart rate and mean blood pressure from presurgery baseline at 1, 2, and 4 h after operation were significantly greater in Group D (by a range of 5-7 beats min(-1) and 10-13%, respectively). The 4-24 h incidence of nausea was significantly lower in Group D (34% vs 56.3%, P<0.05). There was no bradycardia, hypotension, oversedation, or respiratory depression., Conclusions: The addition of dexmedetomidine to i.v. PCA morphine resulted in superior analgesia, significant morphine sparing, less morphine-induced nausea, and was devoid of additional sedation and untoward haemodynamic changes.

Background: Nalbuphine, a mixed agonist-antagonist opioid, has a potential to attenuate the mu-opioid effects and to enhance the kappa-opioid effects. However, when morphine and nalbuphine are mixed together, the clinical interactions in different combining ratios on analgesic effect and adverse events are unknown., Methods: This randomized, double-blind controlled study investigated five different combining ratios of morphine and nalbuphine in 311 patients undergoing gynaecologic operations. The concentrations [morphine (mg ml(-1))]/[nalbuphine (mg ml(-1))] were 1/0 in Group 1, 0.75/0.25 (ratio 1:3) in Group 2, 0.5/0.5 (ratio 1:1) in Group 3, 0.25/0.75 (ratio 3:1) in Group 4, and 0/1 in Group 5. Patient-controlled analgesia (PCA) requirement, postoperative pain, and adverse events were evaluated throughout the postoperative 24 h period., Results: Twenty-four hour PCA requirements were similar among the five groups. Verbal rating scores for pain were statistically higher in Groups 2 and 4 than in Group 3. The incidences of pruritus were higher in Group 1 (15.6%) than in Group 2 (6.2%), Group 3 (3.4%), Group 4 (1.6%), and Group 5 (0%). The incidences and severity of dizziness, nausea, and vomiting were not significantly different., Conclusions: The interaction between morphine and nalbuphine in PCA admixture on analgesia is additive. Combinations of morphine and nalbuphine in PCA can decrease the incidence of pruritus, and the antipruritus effect is ratio-dependent. This may provide a novel combination strategy of opioid agonist and agonist-antagonist for postoperative pain management after gynaecologic surgery.

Background: This study was designed to examine the analgesic and dose-related antiemetic efficacy of diphenhydramine-morphine mixture for intravenous patient-controlled analgesia (PCA)., Methods: Healthy women, undergoing abdominal total hysterectomy were recruited to this double-blinded randomized placebo-controlled study. Patients were randomly allocated to one of three groups (n=40 each). In group 1, patients received saline at induction and morphine 1 mg ml(-1) alone for postoperative PCA. Patients in groups 2 and 3 received diphenhydramine 30 mg i.v. at induction and were given a 1.2:1 or a 4.8:1 ratio, respectively, of diphenhydramine-morphine mixture for postoperative PCA., Results: A total of 112 patients completed the study. The incidence of postoperative nausea (31.6% vs 67.6%, P<0.01) and vomiting (15.8% vs 40.5%, <0.05) was significantly lower in group 3 than in group 1. Furthermore, the incidence of severe nausea was significantly lower in group 3 than in group 1 (2.6% vs 24.3%, P<0.05). The rescue antiemetic requirements were also significantly less in group 3 than in group 1 (5.3% vs 24.3%, P<0.05). However, there was no significant difference between group 2 and group 1 in any of the comparisons. Pain intensity, 24-h morphine consumption and diphenhydramine-related side-effects, such as sedation or dry mouth, did not differ among the three groups., Conclusion: An initial bolus of diphenhydramine 30 mg at anaesthetic induction followed by postoperative PCA with a 4.8:1, but not 1.2:1, diphenhydramine-morphine mixture provides an effective antiemetic efficacy without morphine-sparing effects.

Equilibrium and kinetic adsorption of tri-valent (arsenite) and penta-valent (arsenate) arsenic to activated alumina is elucidated. The properties of activated alumina, including porosity, specific surface area, and skeleton density were first measured. A batch reactor with temperature control was employed to determine both adsorption capacity and adsorption kinetics for arsenite and arsenate to activated-alumina grains. The Freundlich and Langmuir isotherm equations were then used to describe the partitioning behavior for the system at different pH. A pore diffusion model, coupled with the observed Freundlich or Langmuir isotherm equations, was used to interpret an observed experimental adsorption kinetic curve for arsenite at one specific condition. The model was found to fit with the experimental data fairly well, and pore diffusion coefficients can be extracted. The model, incorporated with the interpreted pore diffusion coefficient, was then employed to predict the experimental data for arsenite and arsenate at various conditions, including different initial arsenic concentrations, grain sizes of activated alumina, and system pHs. The model predictions were found to describe the experimental data fairly well, even though the tested conditions substantially differed from one another. The agreement among the models and experimental data indicated that the adsorption and diffusion of arsenate and arsenite can be simulated by the proposed model.

Trihalomethanes (THMs) are important disinfection byproducts (DBPs) in drinking water. To understand the magnitude of exposure to THMs for the people in southern Taiwan, models are used to estimate the inhalation exposure associated with drinking water based on raw water quality. Two parts of models are used in this study, one for estimating THM concentration from raw water quality, and one for estimating inhalation exposure to people. Important raw water quality and operational parameters, including TOC, UV254, pH, temperature, chlorine dosage, and water residence time of a major water treatment plant in south Taiwan were collected. An empirical THM formation model was then employed to predict the THM concentration at consumers' dwellings based on the parameters collected. Differences between the predicted results and experimental data were found to be small, indicating that the model is appropriate. The predicted THM concentration distribution was served as input parameters for the exposure models. Three major scenarios associated with probable inhalation exposure of THMs, including shower, pre- and post-cooking activities, and cooking processes, were considered in the exposure models. The model results show that the mean inhalation exposure of THMs for shower, pre- and post-cooking activities, and cooking processes are 26.4, 1.56, 3.29 micrograms/day, respectively. The total inhalation exposure (summation of the three scenarios) was found to be comparable with that for direct ingestion, indicating that inhalation is an important pathway for THM exposure from drinking water.

The objective of this research was to develop a rationale for selecting representative water quality parameters for organic contaminants and microorganisms and determining their respective contaminant level (or regulated value) for the source water quality standards in Taiwan. It was observed that chemical oxygen demand (COD) and total organic carbon (TOC) have strong correlation with UV254 in spite of the raw water which suggests, TOC and COD should be regarded as the surrogate parameters for water quality concerns. It was also proposed to implement 4.0 mg/L of TOC as a source water criteria at the present time and to adopt a more stringent value (2.0 mg/L of TOC) in the next phase (at 2002). The total coliform regulated from 10,000 to 20,000 most probable number (MPN)/100 ml level appears to be the most economic and logical way to control trihalomethanes (THM) formation and disinfection efficiency at the water treatment plant in Taiwan.

Construction well divers in Taiwan reportedly suffer a high prevalence of dysbaric osteonecrosis. We studied five divers working at the same construction site. We recorded their diving methods, diving depths, bottom times, work patterns, water temperatures, and heart rates. We also monitored gas bubbles in the subclavian vein in selected dives. A crude but effective hot-water system protected divers against hypothermia and allowed them to work in 24 degrees-27 degrees C water. Divers worked approximately 6.6 h a day and progressed approximately 3.0 m a day while excavating an average of 148 buckets of sand and rock each weighing 49.5 kg. The divers sustained a heart rate increase of 49%. Sixty percent of their equivalent single dive bottom times exceeded the U.S. Navy's no-decompression limits. Two cases of venous bubbles were detected, and one of these divers showed symptoms of decompression sickness. The prolonged bottom time and lack of a decompression schedule probably contributed to a risk of decompression sickness and dysbaric osteonecrosis.

It has been hypothesized that enhanced oxidant sensitivity of glucose-6-phosphate dehydrogenase (G6PD) deficient red cells(RBCs) is the underlying mechanism for drug- or chemical-induced hemolytic crises in G6PD-deficiency. To further test this hypothesis, we used an alloxan-glutathione system to mimic oxidative stress and see how oxidative damage might affect RBC deformability. RBC deformability, a major determinant of RBC survival in vivo, was monitored by a laser viscodiffractometer. Under our experimental conditions, GSH alone had very little effect on the deformability of either normal or G6PD-deficient RBCs. In contrast, alloxan alone induced a small but significant decrease in the deformability of either normal or G6PD-deficient RBCs. Interestingly, alloxan and GSH together induced a further decrease in the deformability of either normal or G6PD-deficient RBCs. The decrease in deformability in G6PD-deficient RBCs was much more profound than in normal RBCs. In addition, an alloxan-vitamin C system produced a similar deleterious effect on RBC deformability as that produced by the alloxan-GSH system. Appreciable amount of hydroxyl radicals was generated by both alloxan-GSH and alloxan-vitamin C systems as evidenced by the production of hydroxylated products of salicylate which was used as a radical trap. Moreover, salicylate could ameliorate the deleterious effect of the alloxan system on the deformability of RBCs. Taken together, our results demonstrated that G6PD-deficient RBCs were particularly susceptible to oxidant-induced damage leading to a dramatic decrease in their deformability and thus provided strong support for the hypothesis that enhanced oxidant sensitivity of G6PD-deficient RBCs is the underlying mechanism for accelerated destruction of these RBCs in vivo.