Zee Kwan-Yat, Chan Pui Sze, Ho Johnson Chun Sing, Lai Stanley Man Lung, Corbet Esmonde Francis, Leung Wai Keung
Faculty of Dentistry, The University of Hong Kong, Hong Kong, SAR China.
Chin Med. 2016 Sep 20;11:40. doi: 10.1186/s13020-016-0111-z. eCollection 2016.
Yunu-Jian (YJ) is a Chinese medicine (CM) heat purging formula, which is used to reduce wei huo (stomach-heat, SH) and enrich shen yin (kidney-yin, KY). This formula is also commonly used to manage diabetes mellitus and gum/oral inflammation. The activity of YJ can be modified or refined by the addition of other CM herbs and/or minor changes to one of its five key ingredients. The aim of this study was to evaluate the adjunctive use of modified YJ (mYJ) or YJ containing additional osteoblast-stimulating and inflammation-modulating CM herbs in the non-surgical periodontal treatment of smokers with chronic periodontitis in a randomized, double-blind, prospective, placebo-controlled study.
Healthy adult male smokers with untreated chronic periodontitis who showed CM syndrome of SH and KY deficiency (KYD) whilst attending a dental teaching hospital from October to December, 2005, were invited to participate in a randomized double-blind, placebo-controlled clinical trial. The trial itself involved the once-daily oral administration of a placebo or mYJ for 3 months as an adjunct to non-surgical periodontal therapy. Several periodontal parameters, including radiographic alveolar bone density, were measured by computer-assisted densitometric image analysis (CADIA) on selected sites, and CM signs of SH and KYD were followed from their baseline values to various time points up to 12 months or the end of study.
Twenty-five smokers (consumed 25.0 ± 15.3 smoking-pack years, ranged 7.5-80; aged 46.3 ± 6.8 years) with periodontitis and SH and KYD were recruited (Placebo, n = 14; mYJ, n = 11). All of the participants showed good tolerance towards the CM recipe. All of the periodontal parameters had improved after 12-month follow-up, and no statistically significant differences were detected between the control group and test group, except for the higher CADIA values observed compared with the baseline at 12 months for test sites (P = 0.025). 4/3/3 test vs 14/13/13 control participants had persisting SH and KYD at 6, 9 and 12 months (P < 0.001), respectively.
The adjunctive use of mYJ preserved the post-treatment increases in the radiographic alveolar bone density at the study sites and led to an overall improvement in SH and KYD compared with the controls. Trial registration HKU Clinical Trial Register, HKCTR-1848 (www.hkuctr.com/Study/Show/3acbf983831244d29d50b543540bf6e9).
玉女煎（YJ）是一种中医清热方剂，用于清胃火（SH）和滋肾阴（KY）。该方剂也常用于治疗糖尿病和牙龈/口腔炎症。通过添加其他中药或对其五种关键成分之一进行微小改变，可以调整或优化YJ的活性。本研究的目的是在一项随机、双盲、前瞻性、安慰剂对照研究中，评估改良玉女煎（mYJ）或含有额外成骨细胞刺激和炎症调节中药的YJ在慢性牙周炎吸烟者非手术牙周治疗中的辅助应用。
2005年10月至12月期间，在一家牙科教学医院就诊的患有未经治疗的慢性牙周炎且表现出胃火和肾阴亏虚（KYD）中医证候的健康成年男性吸烟者被邀请参加一项随机双盲、安慰剂对照临床试验。该试验包括每天口服一次安慰剂或mYJ，持续3个月，作为非手术牙周治疗的辅助治疗。通过计算机辅助密度测量图像分析（CADIA）在选定部位测量包括放射学牙槽骨密度在内的几个牙周参数，并跟踪胃火和肾阴亏虚的中医症状从基线值到长达12个月或研究结束的各个时间点的变化。
招募了25名患有牙周炎以及胃火和肾阴亏虚的吸烟者（吸烟量为25.0±15.3包年，范围为7.5 - 80；年龄为46.3±6.8岁）（安慰剂组，n = 14；mYJ组，n = 11）。所有参与者对中药配方耐受性良好。12个月随访后所有牙周参数均有所改善，除了试验部位在12个月时观察到的CADIA值高于基线（P = 0.025）外，对照组和试验组之间未检测到统计学上的显著差异。试验组/对照组分别有4/14、3/13、3/13名参与者在6、9和12个月时仍存在胃火和肾阴亏虚（P < 0.001）。
与对照组相比，mYJ的辅助使用在研究部位维持了治疗后放射学牙槽骨密度的增加，并导致胃火和肾阴亏虚总体改善。试验注册香港大学临床试验注册中心，HKCTR - 1848（www.hkuctr.com/Study/Show/3acbf983831244d29d50b543540bf6e9）。
