Bayesian bent‐cable growth mixture tobit models for longitudinal data with skewness and detection limit: application to AIDS studies

This paper presents a new Bayesian methodology for identifying a transition period for the development of drug resistance to antiretroviral drug or therapy in HIV/AIDS studies or other related fields. Estimation of such a transition period requires an availability of longitudinal data where growth trajectories of a response variable tend to exhibit a gradual change from a declining trend to an increasing trend rather than an abrupt change. We assess this clinically important feature of the longitudinal HIV/AIDS data using the bent‐cable framework within a growth mixture Tobit model. To account for heterogeneity of drug resistance among subjects, the parameters of the bent‐cable growth mixture Tobit model are also allowed to differ by subgroups (subpopulations) of patients classified into latent classes on the basis of trajectories of observed viral load data with skewness and left‐censoring. The proposed methods are illustrated using real data from an AIDS clinical study. Copyright © 2016 John Wiley & Sons, Ltd.     

中医药核心指标集研究利益相关群体选择实施要点＊

核心指标集是通过一系列规范的研制过程，形成某种疾病所有相关临床研究必须报告的、统一的、标准化的最小指标集合。确定哪些指标为核心结局指标，需要经过不同利益相关群体层层筛选并最终达成共识决定。相关利益群体的代表性，决定了核心指标集的系统性和合理性。因此，在核心指标集研制过程中利益相关群体的选择至关重要。本文对中医药核心指标集研制中利益相关群体的种类选择、样本量、参与环节、权重分配以及患者代表群的特殊性等相关要点进行归纳总结，以期为中医药核心指标集研究的开展提供方法学借鉴。     

“龙虎交战”针法针刺八脉交会穴对偏头痛患者头痛天数及血清CGRP表达的影响＊

目的 观察“龙虎交战”针法针刺八脉交会穴对无先兆偏头痛（Migraine without aura，MO）患者头痛天数及外周血降钙素基因相关肽（Calcitonin gene related peptide，CGRP）表达水平的影响。方法 按照头痛程度将90例MO受试者区层随机分为治疗Ⅰ组、治疗Ⅱ组和对照组各30例。治疗Ⅰ组施以“龙虎交战”针法针刺八脉交会穴（外关和足临泣），治疗Ⅱ组施以平补平泻针法针刺八脉交会穴（外关和足临泣），对照组施以平补平泻针法针刺非经非穴点，每次留针30分钟，5次/周，共治疗20次。于治疗前、治疗结束4周后的随访分别记录三组患者头痛天数的变化情况以判定疗效，并采集患者治疗前、治疗结束4周后随访的肘部静脉血用ELISA法检测血清中的CGRP含量的变化。结果 ①各组治疗前患者的头痛天数无显著差异（Ｐ > 0.05），治疗Ⅰ组、治疗Ⅱ组和对照组治疗结束4周后随访的头痛天数较治疗前均显著降低（Ｐ < 0.05）；治疗Ⅰ组头痛天数的降低显著优于治疗Ⅱ组和对照组（Ｐ < 0.001），治疗Ⅱ组头痛天数的降低显著优于对照组（Ｐ < 0.05）；②3组治疗前CGRP的表达无显著差异，治疗Ⅰ组、治疗Ⅱ组治疗结束4周后随访CGRP的表达较治疗前均显著下降（Ｐ < 0.001），对照组治疗结束4周后随访CGRP的表达较治疗前差异无显著性（Ｐ > 0.05）；治疗Ⅰ组CGRP治疗结束4周随访的表达较治疗Ⅱ组和对照组均显著下降（Ｐ < 0.01），治疗Ⅱ组CGRP的表达较对照组显著下降（P < 0.01）。结论 ①八脉交会穴施以“龙虎交战”针法针刺能明显改善MO患者的头痛天数，同时降低MO患者血清CGRP的表达水平，这可能是针刺八脉交会穴治疗MO的机制之一；②非经非穴点的针刺效应无持续性，而八脉交会穴的针刺效应具有持续性；③八脉交会穴可以充分发挥复式针刺手法的治疗效应，提示我们在临床上治疗疾病时不仅要注意腧穴配伍，恰当的针刺手法更是提高临床疗效、事半功倍的关键。     

“耳脑脏腑相关”理论构建＊

通过系统整理中医传统理论中耳与脑、脏腑与脑、耳与脏腑之间的联系，结合体表刺激耳迷走神经-孤束核-默认网络脑效应机制研究，将传统针灸与现代医学相融合，提出“耳脑脏腑”相关理论。刺激耳甲的耳穴心不仅可以直接调节心神，通过耳脑相关机制调理脑与脑神，还可以配合或间接刺激耳甲区的五脏，调理五脏之神（心神、肝魂、肺魄、脾意和肾志），从而实现神脑并调和体用兼治之功，对于脑失常、神失常、五脏神失常类的疾病，理论上来说，具有较好的临床疗效。“耳脑脏腑相关”理论的提出，对于揭示采用耳穴心治疗脑系疾病和相关脏腑病提供了理论支持，对于加强中医原创理论创新提供典型范例，实现了继承与创新的结合，对于现代拓展脑病、脑科学和相关脏腑病研究提供了新方向和新思路。     

Cervical Trigger Point Acupuncture for Treatment of Somatic Tinnitus

Cervicogenic somatic tinnitus is a subtype of subjective tinnitus and is defined as tinnitus in which forceful contractions of jaw and neck muscles modulate its psychoacoustic attributes. Various physical therapies have been proposed for the treatment of somatosensory tinnitus although there is no definitive cure for it. This report describes the use of acupuncture in the treatment of a 71-year-old woman with chronic neck pain who suffered from a left-sided tinnitus for 2 years as well. The tinnitus and neck pain severity was rated as 7 and 6, respectively, on a numeric rating scale of 10. On examination, she had restricted cervical range of motion and several myofascial trigger points in cervical muscles. Audiometric tests of the patient were normal. She received trigger point acupuncture of cervical muscles twice per week for 10 sessions. Her tinnitus completely disappeared after the third session and did not return during the 5-year follow-up. Her neck pain intensity also decreased to 1 on the numeric rating scale after 10 sessions. Based on the results of this study, direct trigger point acupuncture of cervical muscles may be beneficial in the treatment of somatic tinnitus with a long-duration effect.     

Efficacy of Topical Vibratory Stimulation for Reducing Pain During Trigger Point Injection to the Gastrocnemius: A Randomized Controlled Trial

ObjectiveTo evaluate the efficacy of topical vibratory stimulation for reducing pain during trigger point injection (TPI).DesignDouble-blind randomized placebo-controlled clinical trial.SettingTertiary care university hospital.ParticipantsA total of 136 participants were randomly recruited from among patients with myofascial pain syndrome who were scheduled for TPI. Of these, 65 were excluded because they met the exclusion criteria, and 11 because they refused to participate. Finally, 60 participants were enrolled. No participants dropped out of the study.InterventionParticipants were randomly assigned to the vibration group or control group. TPI was performed with 0.5% lidocaine using a 25-gauge needle. A vibrator was applied to the popliteal fossa for 3 to 5 seconds prior to and during TPI to the gastrocnemius; 100-Hz vibration was turned on for the vibration group and turned off for the control group.Main Outcome MeasuresPain intensity during TPI was assessed using a 100-mm visual analog scale (VAS) as a primary outcome, and participant satisfaction and preference for repeated use were measured using 5-point Likert scales as a secondary outcome. These parameters were evaluated immediately after TPI. The primary outcome was evaluated using analysis of covariance and secondary outcome using the Mann-Whitney U test.ResultsVAS scores for pain during TPI were significantly lower in the vibration group (30.30; 95% confidence interval [CI], 22.65-39.26) compared with the control group (47.58; 95% CI, 38.80-56.52; F=7.74; P< .01). The mean difference in VAS scores between the 2 groups was 17.27 (95% CI, 5.24-29.30). Participant satisfaction and preference for repeated use were significantly higher in the vibration group than in the control group (P<.05). No participant showed any side effects.ConclusionTopical vibratory stimulation significantly decreased pain during TPI of the gastrocnemius.     

附着龈重建应用于口腔种植修复中的临床效果观察

目的探讨附着龈重建应用于口腔种植修复中的临床效果。方法将本院于2016年10月-2018年10月期间收治的行口腔种植修复治疗的附着龈缺失患者82例作为研究资料,依据治疗方案分组,对照组为传统修复治疗方案,观察组采用附着龈重建治疗修复方案,各41例,评价两组术后不同阶段附着龈宽度、龈缘外形及附着点重建改善效果,并评价患者评价治疗满意度。结果术后3个月观察组患者附着龈宽度改善Ⅲ级率56.10%明显高于对照组0.00%,龈缘外形与附着点重建Ⅲ级率60.98%明显高于对照组0.00%(P <0.05);术后6个月观察组患者附着龈宽度改善Ⅲ级率75.61%明显高于对照组0.00%,龈缘外形与附着点重建Ⅲ级率73.17%明显高于对照组0.00%(P <0.05);观察组治疗满意度97.56%与对照组70.73%比较明显更高(P <0.05)。结论针对行口腔种植修复治疗的附着龈缺失患者采用附着龈重建治疗修复方案利于快速恢复附着龈增加宽度,改善龈缘外形及附着点重建效果,获得患者的高度满意度,治疗价值较高。     

Ovarian hyperstimulation syndrome following GnRH agonist trigger for final follicular maturation in a patient undergoing random start ovarian stimulation for egg-donation cycle with an inadvertent concomitant early pregnancy

Abstract

We report the first case of OHSS following GnRH agonist trigger for final follicular maturation in random start ovarian stimulation for egg-donation cycles during inadvertent concomitant early pregnancy. As an additional note, the sustained activity exerted by the increasing endogenous hCG production seemed to be responsible for the suboptimal performance in terms of oocyte yield in the current case. OHSS can occur in random-start stimulations protocols even after the use of a GnRH agonist for triggering in case of concomitant unnoticed early pregnancy especially if stimulation is commenced in the periovulatory/luteal phase. The present case report introduces a note of extreme caution when proceeding with this protocol in an otherwise fertile population (egg-donors, elective or oncologic oocyte cryopreservation).